Introducer sheath cylinder with peel-off perfusion orifice

Abstract

A perfusion sheath having a covered perfusion orifice. The covers each have a pulling member attached thereto. The pull member is used to remove the perfusion orifice cover from the perfusion orifice when the perfusion sheath barrel is deployed in the patient. The perfusion sheath is deployed in the patient through the arterial incision. When deployed, the one or more tractors extend out of the arterial incision. Application of tension to the pull member causes the pull member to tear the perfusion orifice cover away from the perfusion orifice. The perfusion sheath has a plurality of perfusion apertures each positioned to provide limb perfusion when the cover is removed for arterial incisions of different depths. Upon deployment of the perfusion sheath, the pull member is tensioned to remove the cover from a selected perfusion orifice, which will provide limb perfusion for the depth of the arterial incision.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

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

[0002] Intravascular medical devices such as percutaneous pumps (e.g., Impella 2.5 from Abiomed, Inc., Danvers, Massachusetts) TM Systems), catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems are commonly used in minimally invasive procedures in cardiovascular, cerebrovascular, and peripheral vascular systems. Such medical devices can be introduced into patients in various ways. The blood pump assembly is surgically or percutaneously introduced through the vascular system during a cardiac procedure. Such intravascular procedures are minimally invasive. In a common approach, the pump assembly is inserted through the femoral artery through a catheterization procedure using a sheath such as a stripping introducer sheath. The femoral artery is commonly used for such procedures, mainly due to easy access. The sheath is inserted into the femoral artery through an arteriotomy (an access site in the artery) to establish an insertion path for the pump assembly. A portion of the pump assembly is then pushed through the lumen of the introducer sheath and into the artery. After the pump assembly has been inserted, the introducer sheath is removed, for example by stripping. A repositioning sheath can then be pushed on the pump assembly and pushed into the arteriotomy.

[0003] The introducer sheath must be large enough in diameter to accommodate an intravascular device (e.g., a blood pump). To date, the smallest heart pump available is the Impella 2.5 percutaneous heart pump, which has a motor diameter of approximately 12 Fr. Therefore, the introducer sheath must be at least 13 Fr to introduce an Impella 2.5 pump. Other pumps and devices are larger than the Impella 2.5, for example, the Impella CP pump, which has a motor diameter of approximately 14 Fr, and the Impella 5.0 pump, which has a motor diameter of approximately 21 Fr or greater, depending on the type of device. Such devices will have even larger introducer sheaths. Unless the context indicates otherwise or is otherwise understood by one skilled in the art, terms such as "about" mean within ±20%. Summary of the invention

[0004] The present invention describes a perfusion sheath for providing continuous distal limb perfusion. The perfusion sheath includes: a sheath body including an outer surface and a cavity therethrough; at least one perfusion orifice positioned in the sheath body between the proximal end of the sheath body to the distal end of the sheath body; a removable perfusion orifice cover positioned on the at least one orifice in the sheath body; and a puller attached to the removable perfusion orifice cover. The cavity extends from the distal end of the sheath body to the proximal end of the sheath body. The perfusion orifice enables fluid communication through the outer surface of the sheath body.

[0005] The present invention also describes a method for providing continuous distal limb perfusion using the perfusion sheath described above. The method includes: providing the perfusion sheath described above, establishing a puncture through the patient's skin; inserting the perfusion sheath through the puncture and into the patient's artery through the arteriotomy; positioning the perfusion sheath in the artery for continuous distal limb perfusion; determining a perfusion orifice to be opened among the plurality of perfusion orifices; and tensioning a puller corresponding to the determined perfusion orifice to peel off a perfusion orifice cover associated with the puller and open the determined perfusion orifice to provide continuous distal limb perfusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The foregoing and other objects and advantages will become apparent upon consideration of the following detailed description taken in conjunction with the accompanying drawings, wherein like reference characters refer to like parts throughout, and wherein:

[0007] Figure 1 showing an isometric view of an exemplary sheath according to an embodiment of the present invention;

[0008] Figure 2 show Figure 1 Side cross-sectional view of the sheath positioned in the shallow femoral artery;

[0009] Figure 3 show Figure 1 A lateral cross-sectional view of the sheath positioned in the medium femoral artery;

[0010] Figure 4 show Figure 1 A side cross-sectional view of the sheath positioned in the deep femoral artery;

[0011] Figure 5 A side cross-sectional view showing the sheath positioned in the femoral artery;

[0012] Figure 6 show Figure 5 A side cross-sectional view of a sheath positioned in a femoral artery with a perfusion port cover peeled away from the sheath body;

[0013] Figure 7 show Figure 1 A partial cross-sectional view of a sheath of FIG. 1 , wherein a portion of the puller is attached to the perfusion port cover;

[0014] Figure 8 show Figure 1 A partial side cross-sectional view of the sheath of FIG. 1 , wherein the puller is separating the perfusion orifice cover;

[0015] Fig. 9 show Figure 1 A partial side cross-sectional view of a sheath of FIG. 1 , wherein the perfusion port cover is peeled away from the sheath body by a puller; and

[0016] Fig.10 is to use Figure 1 Flowchart of a method for providing continuous distal limb perfusion using a sheath. DETAILED DESCRIPTION

[0017] Embodiments of the present disclosure are described in detail with reference to the accompanying drawings, wherein the same reference symbols identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be implemented in various forms. Well-known functions or configurations are not described in detail to avoid unnecessary details obscuring the present disclosure. Therefore, the specific structures and functional details disclosed herein should not be interpreted as limitations, but only as the basis for the claims and as a representative basis for teaching those skilled in the art to apply the present disclosure to various applications in practice to any appropriately detailed structure.

[0018] In order to provide an overall understanding of the systems, methods, and devices described herein, certain exemplary embodiments will be described. Although the embodiments and features described herein are specifically described for use in conjunction with a percutaneous heart pump system, it should be understood that the components and other features outlined below may be combined with each other 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 therapy and heart assist devices, including balloon pumps, heart assist devices implanted using surgical incisions, and other vascular devices.

[0019] Although existing introducer sheaths are generally useful for device insertion, they have disadvantages. For example, due to their size, the introducer sheath can block the cross-sectional area of ​​the artery and thus occlude the artery, which can greatly restrict downstream blood flow. Restricted blood flow can be problematic for a variety of reasons, including causing intermittent claudication, leg numbness / weakness, and limb ischemia, which can even lead to limb loss. Blood flow blockage can also increase the risk of bleeding at the access site because the restricted blood flow through the introducer sheath causes pressure to build up in the arteriotomy.

[0020] Conventionally, limb ischemia is referred to as a "distal perfusion" problem in the sense that it typically occurs downstream of the access site of the device. In the present disclosure, a "distal" component is the portion of the component that is located farthest from the clinician, and a "proximal" component is the portion of the component that is closest to the clinician. In the case where the sheath is deployed in the patient's body, the end of the sheath that is deployed in the patient's body is the "distal" end, and the handle or end that is located outside the patient's body and held by the clinician is the "proximal" end.

[0021] For relatively large medical devices (e.g., having a maximum outer diameter equal to or greater than 12Fr), the outer diameter size of the introducer sheath (or repositioning sheath) used in combination with the medical device is substantially similar to the inner diameter of the artery or blood vessel where the sheath is positioned. This matching between the outer diameter of the sheath and the inner diameter of the artery or blood vessel prevents blood from flowing through the position where the sheath is inserted. That is, blood flow can be blocked at the upstream position of the sheath provided in the arteriotomy, and is prevented from flowing to the downstream position of the arteriotomy where the sheath is provided. In addition, for these relatively large medical devices, the introducer 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 inserted / withdrawn from the arteriotomy in the arteriotomy. Whether a relatively large or relatively small medical device is deployed, and whether the introducer sheath or repositioning sheath is considered to be relatively large accordingly, can depend on the specific patient's anatomical structure.

[0022] In general, the challenges mentioned above are more obvious for long vascular procedures. Some procedures in the catheterization laboratory are short-term and therefore present less risk of limb ischemia. For example, the risk caused by a procedure that generally only requires up to 4 to 5 hours (wherein the physician regularly checks the distal (limb) perfusion) is less than that of a longer procedure. However, even for a short procedure, the technician may not monitor the patient enough to confirm that the patient's limbs have enough perfusion, or miss warning signs of insufficient limb perfusion. In addition, some patients may be transferred to the ICU, where the introducer sheath or repositioning sheath remains in the patient's body for a long time of 1-14 days. In this case, the problem of vascular occlusion and related limb ischemia and access site bleeding may be aggravated.

[0023] A known intervention to the blocked femoral artery is bypass (i.e., femoral artery-femoral artery (i.e., femoral-femoral) bypass for arterial vascular reconstruction). The technology includes obtaining access to the opposite leg of the main access site-usually using a small sheath (e.g., using a 4Fr catheter). Using a similar sheath to obtain access to a portion of the same branch distal to the main access site, two sheaths are connected together to achieve perfusion of the femoral artery of the patient's main access branch using blood flow from the relative branch of the patient. However, this invasive procedure is accompanied by other risks, including difficulty in obtaining access to the femoral artery portion distal to the access site in the blocked branch (due to lack of flow, pressure, pulsatility, or a combination of these), other resources (time, material and use of additional components) allocation, increased infection risk and other risks associated with multiple access sites. Another possible intervention is to use extracorporeal membrane oxygenation (ECMO) to perfuse blood to the access site distal. However, ECMO intervention may present the same challenges as femoral-to-femoral bypass.

[0024] Another possible intervention to address access sites with undesirable heavy bleeding is to close the access site with collagen, or metal clips or sutures. However, such interventions are often unplanned and hasty, and proper placement may be difficult to visualize due to continued bleeding at the access site.

[0025] Therefore, there is a need for improved sheaths for delivering intravascular devices and for providing continuous blood perfusion distal to the device within a patient's body.

[0026] The system, method and device of the present disclosure provide for inserting the introducer sheath in the patient's blood vessel (e.g., artery, such as femoral artery). The sheath comprises a cavity configured for the medical device to pass through. The sheath is also configured to allow fluid to flow in the artery without being significantly blocked and unable to reach the patient's area downstream of the sheath, which will be described in more detail below.

[0027] Figure 1 An isometric view of an exemplary sheath 10 according to one aspect of the present technology is shown, the sheath 10 including one or more peel-away perfusion ports. The sheath 10 (which may be an introducer sheath, a peel-away sheath, etc.) is adapted to be inserted into an arteriotomy of a patient (which may be formed in a femoral artery of the patient). The sheath 10 includes an introducer 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. Figure 1In the example, the sheath body 12 is tubular with a substantially circular cross section. As used herein, "substantially circular" is a shape that appears to the viewer to be more circular than some other shapes. It should be understood that other designs and configurations can be used for the sheath body 12 when they are considered suitable for their application.

[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 to allow passage of a medical device such as a percutaneous blood pump (not shown). An example of such a percutaneous pump is the Impella System (Abiomed, Inc., Danvers, Massachusetts). Such a pump may generally have a catheter body 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 appreciated that other percutaneous or intravascular medical devices may be used in conjunction with the present disclosure to deliver the device through the sheath 10.

[0029] The chamber 22 of sheath body 12 has a cross section of approximately circular shape, and it has a certain diameter. Chamber 22 is designed and dimensioned so that sheath 10 can be inserted in an artery (e.g., femoral artery) and pass in an artery (e.g., femoral artery), that is, the diameter of chamber 22 is suitably less than the diameter of an artery. In addition, chamber 22 is dimensioned so that a medical device can pass through the internal length of chamber 22, that is, the diameter of chamber 22 is suitably greater than the maximum diameter of the medical device that will pass through. Therefore, the diameter of chamber 22 only needs to be slightly greater than the maximum cross section of a medical device and slightly less than the diameter of an artery.

[0030] Reference again Figure 1 , the sheath 10 further includes at least one perfusion port 24 formed along the length of the sheath body 12. Although sheaths having only one peel-away perfusion port are contemplated, the sheaths described herein have multiple peel-away perfusion ports, which may provide other advantages described below. Figure 1 A plurality of stripping perfusion orifices 24 are exemplified. A plurality of perfusion orifice covers 26 for covering the plurality of perfusion orifices 24 are also exemplified, each cover having a puller attached thereto. The puller is biocompatible and extends outside the arteriotomy. Biocompatible materials are well known to those skilled in the art and are not described in detail herein. A puller 28 is provided to strip the cover 26 from the selected perfusion orifice. The puller 28 may be a rope, a wire, a filament, a braid, a lace, and a ribbon, or may be any suitable connector that can be attached or attached to the corresponding perfusion orifice cover 26. The attached plurality of pullers 28 may extend along the interior of the sheath body 12 or the outer surface 16 of the sheath body 12. As described above, the puller 28 may extend outside the patient's body when the sheath 10 is deployed in the patient.

[0031] The introducer sheath 10 is deployed with a perfusion orifice cover 26 disposed on each perfusion orifice 24. As described in more detail herein, after the introducer sheath 10 is positioned in the patient's vasculature, a puller 28 attached to one of the perfusion orifice covers 26 of a selected perfusion orifice 24 is pulled, thereby removing the perfusion orifice cover 26 to which the puller 28 is attached from the selected perfusion orifice, thereby opening the perfusion orifice 24 in the sidewall of the introducer sheath body 12. The plurality of perfusion orifices 24 are positioned laterally on the sidewall of the introducer sheath body 12 and are intentionally spaced (e.g., evenly spaced) along the length of the sheath body 12. Although the distance between the perfusion orifices 24 can be any distance suitable for the application of the sheath 10, the distance of about 2.5 cm between each perfusion orifice 24 is an example of a distance that allows the user to position the introducer sheath so that one of the perfusion orifices will be positioned in the blood flow path to support the desired perfusion. Each of the plurality of perfusion orifices 24 can be formed in any shape (such as circular, oval, or square) and is sized to allow blood to flow therethrough at an acceptable rate when the perfusion orifice cover is removed from the perfusion orifice. Each of the plurality of perfusion orifice covers 26 is configured to be stripped (or removed) from the sheath body 12 to allow blood to flow therethrough, as described in more detail below.

[0032] Figure 2-4 The sheath 10 is illustrated as being inserted into an arteriotomy 40 of a patient, wherein a sheath hub 30 is located at the surface of a skin 32. When the sheath 10 is inserted in the proper position, the distal end 18 of the sheath 10 is axially aligned with a femoral artery 34. The figures show the patient's body tissue 32 and the femoral artery 34, as well as a skin insertion site 38 and an arteriotomy 40, into which the sheath 10 is inserted. The sheath body 12 bends as it enters the arteriotomy 40. When the sheath 10 is inserted into the artery 34, one or more perfusion orifices 24 may be aligned with a blood flow path in the lumen of the artery 34, while the remaining perfusion orifices 24 are not aligned with a blood flow path in the lumen of the artery 34, but are disposed on the surface of the arterial lumen or outside the arterial lumen, such as Figure 2-4 as shown in .

[0033] After inserting the sheath 10 into the artery 34, the clinician or other caregiver can peel off or remove the perfusion orifice cover 26 that is aligned with the blood flow path in the lumen of the artery 34 to open the perfusion orifice, thereby providing continuous distal limb perfusion - by allowing blood to flow out of the more proximal portion of the sheath. When the perfusion orifice is opened, blood flows from the upstream position of the sheath 10, through the distal end of the sheath, through the open perfusion orifice, and into the portion of the artery on the other side of the arteriotomy.

[0034] The plurality of perfusion orifices 24 are formed along the length of the sheath body 12 to meet the anatomical requirements of the patient (i.e., different placements take into account the different anatomical structures of the patient with respect to the depth of the femoral artery relative to the skin surface). Specifically, the covered perfusion orifices are arranged so that the first perfusion orifice will align with the lumen of the superficial femoral artery, the second perfusion orifice will align with the lumen of the middle femoral artery, and the third perfusion orifice will align with the deep femoral artery. The depth is the length from the surface of the skin 32 to the internal lumen of the femoral artery 34. For example, if Figure 2-4 As shown in FIG. 1 , depending on the depth of the femoral artery 34, the position of one of the plurality of perfusion orifices 24 is substantially along the bend 42 of the sheath 10 when it transitions from the insertion angle at the arteriotomy 40 to the position where the sheath 10 is coaxially positioned with the lumen of the artery 34. Thereafter, by withdrawing the puller 28 / perfusion orifice cover 26 corresponding to the perfusion orifice 24 at the bend 42, the perfusion orifice positioned at (or near) the bend 42 in the sheath body 12 (i.e., the perfusion orifice positioned in the arterial lumen to allow blood to flow therethrough) can be opened (or uncovered) to allow blood to flow from the sheath lumen 22 through the perfusion orifice, out of the sheath body 12, and back into the artery 34, as indicated by Figure 5 and Figure 6 As shown by arrows A and B in the figure, the fluid flow in the artery 34 is maintained. Specifically, the opened perfusion orifice 24 allows blood to flow from the distal end 18 of the sheath 10 (the distal end of the sheath located in the distal part of the artery) through the opened perfusion orifice in the lumen 22 to the opposite side of the arteriotomy to provide continuous distal limb perfusion and prevent distal limb claudication.

[0035] Each perfusion port 24 is initially covered with a peel-away perfusion port cover 26, wherein a portion of a corresponding puller 28 is attached to the perfusion port cover 26, such as Figure 7 In order to open a selected perfusion orifice 24 (i.e., a perfusion orifice located at a depth such that the opening of the orifice is aligned with the direction of blood flow, which may be a perfusion orifice located closest to the bend in the sheath body 12), the puller 28 attached to the perfusion orifice cover 26 corresponding to the selected perfusion orifice 24 is pulled so that it rises at the first end of the perfusion orifice cover 26 in the vertical direction indicated by arrow C. The portion of the puller 28 at the first (proximal) end of the perfusion orifice cover is separated therefrom, as shown in FIG. Figure 8 As shown. Then, the retractor 28 is pulled by the clinician to peel off and uncover the perfusion orifice 24. Specifically, when the retractor 28 is pulled, the perfusion orifice cover 26 is first separated from the second (distal) end 44 of the perfusion orifice cover 26. Then, as the retractor 28 is further pulled (i.e., tension), the perfusion orifice cover 26 is peeled off from the distal side of the perfusion orifice 24 to the proximal side of the perfusion orifice 24, as shown. Fig. 9 As shown by arrow D in FIG.

[0036] Reference again Figure 2-4 , which illustrates the positioning of the sheath 10 in the superficial femoral artery, the middle femoral artery, and the deep femoral artery. In the superficial femoral artery (less than 2 cm deep from the surface of the skin 32) Figure 2 ), the plurality of perfusion orifices 24 are arranged so that the perfusion orifice proximal to the sheath seat 30 is positioned along the bend 42 of the sheath 10 (as it transitions from the insertion angle at the arteriotomy 40 to a position where the sheath 10 is aligned with the luminal axis of the artery 34). In the mid-femoral artery ( Figure 3 ), the plurality of perfusion orifices 24 are arranged so that the intermediate perfusion orifice 24 is positioned along the bend 42 of the sheath 10 (when it transitions from the insertion angle at the arteriotomy 40 to a position where the sheath 10 is aligned with the luminal axis of the artery 34). Finally, in the deep femoral artery ( Figure 4 ), the plurality of perfusion orifices 24 are arranged so that the perfusion orifice 24 farthest from the sheath seat 30 is positioned along the bend 42 of the sheath 10 (when it transitions from the insertion angle at the arteriotomy 40 to the position where the sheath 10 is aligned with the luminal axis of the artery 34). In some cases, ultrasound imaging can be used to determine the depth of the femoral artery of a specific patient. Alternatively or additionally, ultrasound imaging can facilitate the arrangement of one of the plurality of perfusion orifices 24 so that when opened, the perfusion orifice 24 will support continuous distal limb perfusion. For example, in some embodiments, the perfusion orifice and / or the covering can be visible during ultrasound imaging, and the user can be able to confirm that the specific perfusion orifice is properly positioned within the artery to support distal limb perfusion when the perfusion orifice is exposed by removing the covering.

[0037] Although the present disclosure shows the sheath 10 as having one perfusion port 24 ( Figure 5 and Figure 6 ) and the sheath 10 has three perfusion ports 24 ( Figure 1-4 as well as Figure 7-9 ), but any number of perfusion orifices may be formed along the length of the sheath body 12 of the sheath 10 .

[0038] To assist the clinician in opening the appropriate perfusion port on the sheath body, each of the plurality of perfusion port covers 26 may be differently colored, and each of the plurality of pullers 28 may have the same color as its corresponding perfusion port cover 26. Figure 2-4, the perfusion port cover and its corresponding puller positioned closest to the sheath cartridge seat 30 may be blue, while the perfusion port cover and its corresponding puller positioned farthest from the sheath cartridge seat 30 may be yellow.

[0039] The multiple perfusion orifice covers 26 can be attached to the sheath barrel 10 using various bonding techniques to cover the multiple perfusion orifices 24. These techniques prevent leakage through the perfusion orifice covers 26, and allow the perfusion orifice covers 26 to be peeled off (or removed) from the sheath barrel body 12. As shown, the multiple perfusion orifice covers 26 can be attached to the sheath barrel body 12 with adhesives, which are designed to withstand high compression forces but inferior shear loads so that the perfusion orifice covers 26 can be peeled off from the sheath barrel body 12. In other aspects, the multiple perfusion orifice covers can be thermally bonded (heat sealed) and perforated so that the perfusion orifice covers can be torn off under high loads. Perforations can be applied by hot stamping or laser etching operations.

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

[0041] Fig.10Shown is a method 100 for providing continuous distal limb perfusion using sheath 10 according to the present technology. In the initial procedure, in step 102, a clinician or other caregiver sets up the puncture through the patient's skin, and the sheath 10 is percutaneously inserted through the puncture site, and is inserted into the patient's artery through the arteriotomy. The clinician or caregiver can carry out other steps between the puncture (place) and the arteriotomy with one hand, and the other hand inserts the sheath through the puncture (place) and the arteriotomy. For example, the clinician or other caregivers can utilize guide wire and continuous dilator to gradually expand the puncture (place) and the arteriotomy to be enough to accommodate the sheath 10, which can be an introducer sheath or repositioning sheath. In step 104, the sheath 10 is advanced until its distal end 18 is located in the artery and the proximal end 20 of the sheath 10 is located outside the patient. After positioning the sheath 10, in step 106, the clinician determines which perfusion orifice 24 will be opened for continuous limb perfusion. Thereafter, at step 108, the clinician pulls the puller 28 corresponding to the selected perfusion orifice 24 to peel (or remove) the cover 26 to which the puller 28 is attached from the sheath body 12 of the sheath 10. The perfusion orifice 24 (now open) allows blood to flow from a location upstream of the patient's arteriotomy through the sheath body 12 of the sheath 10 to the patient's downstream vasculature (downstream of the arteriotomy), thereby achieving continuous limb perfusion.

[0042] Based on the foregoing and with reference to the various drawings, it will be understood by those skilled in the art that certain modifications may be made to the present disclosure without departing from the scope of the present disclosure. Although several aspects of the present disclosure have been shown in the drawings, it is not intended that the present disclosure be limited thereto, but rather that the scope of the present disclosure be as wide as the technical field allows, and the specification is interpreted similarly. Therefore, the above description should not be interpreted as being restrictive, but merely an example of specific aspects of the present technology. Exemplary Embodiments

[0043] As mentioned, the perfusion sheath described herein can be implemented in various ways. In this regard, the foregoing disclosure is intended to include, but is not limited to, the systems, methods, and combinations and sub-combinations thereof set forth in the following exemplary embodiment items.

[0044] In a first aspect, a perfusion sheath is described, and it has a sheath body, and this sheath body has an outer surface and a cavity through which this cavity extends from the distal end of the sheath body to the proximal end of the sheath body. At least one perfusion orifice is arranged in the sheath body, and it is positioned between the proximal end of the sheath body and the distal end of the sheath body, and this perfusion orifice is realized by the fluid communication of the sheath body outer surface. Also there is a removable perfusion orifice covering and a traction member, and this removable perfusion orifice covering is positioned above the described at least one orifice in the sheath body, and this traction member is attached to the removable perfusion orifice covering.

[0045] In one aspect, when the sheath body is inserted into the arteriotomy, the pull has a certain length so that the pull will extend outside the arteriotomy. In a further aspect, the pull is selected from: ropes, wires, filaments, braids, laces and strips. In a further aspect, the pull is a biocompatible material. According to any of the above aspects, the sheath body may have a plurality of perfusion orifices, each of which is provided with a removable cover attached thereto and a pull attached to each removable cover. According to any of the above aspects, the cover is attached to the perfusion orifice using an adhesive or by heat sealing.

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

[0047] In any of the above aspects, the puller can be attached to the perfusion orifice cover from a proximal side of the perfusion orifice cover to a distal side of the perfusion orifice cover, the proximal side being positioned closer to the arteriotomy than the distal side when the perfusion sheath is deployed in the patient. In a further aspect, the puller can be lightly attached to the perfusion orifice cover at the proximal side and more firmly attached to the perfusion orifice cover at the distal side of the perfusion orifice cover, such that when tensioned, the puller is separated from the cover at the proximal side and then pulled away from the perfusion orifice at the distal side.

[0048] In a further aspect, the sheath may have three perfusion orifices, wherein each perfusion orifice is positioned at a selected distance from the proximal end of the perfusion sheath. In a still further aspect, the perfusion orifices are positioned so that when the perfusion sheath is inserted into the patient, one of the perfusion orifices will be positioned along the bend of the perfusion sheath (as the sheath transitions from the insertion angle at the arteriotomy to a position aligned with the luminal axis of the vasculature into which the perfusion sheath is inserted).

[0049] In further aspects, the perfusion sheath may have a first perfusion orifice having a selected position such that when the perfusion sheath is inserted into the arteriotomy, the perfusion orifice is positioned about 2 cm or less below the surface of the arteriotomy. In still further aspects where there is a second perfusion orifice, the second perfusion orifice may have a selected position such that when the perfusion sheath is inserted into the arteriotomy, the perfusion orifice is positioned greater than about 2 cm to about 4.5 cm below the surface of the arteriotomy. In those aspects where the perfusion sheath has a third perfusion orifice, the third perfusion orifice has a selected position such that when the perfusion sheath is inserted into the arteriotomy, the perfusion orifice is positioned greater than about 4.5 cm below the surface of the arteriotomy.

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

[0051] In another aspect, this paper describes the method for providing continuous distal limb perfusion. According to the method of the present invention, a perfusion sheath is provided, and the perfusion sheath has a sheath body, and the sheath body has an external surface and a cavity therethrough, and the cavity extends from the distal end of the sheath body to the proximal end of the sheath body. The sheath body has a plurality of perfusion orifices in the sheath body, and it is positioned between the proximal end of the sheath body to the distal end of the sheath body, and wherein each perfusion orifice realizes the fluid communication by the external surface of the sheath body. The orifice has a removable perfusion orifice covering, and it is positioned on each of the plurality of perfusion orifices in the sheath body, and wherein the puller is attached to one or more removable perfusion orifice coverings. According to the method, prepare the insertion site by the patient's skin. The perfusion sheath is inserted by puncture (place) and inserted in the artery of the patient by the arteriotomy. A perfusion sheath is positioned within the artery for continuous distal limb perfusion, and thereafter a determination is made whether a perfusion orifice is to be opened, and in those aspects where there are multiple perfusion orifices, whether one of the multiple perfusion orifices is selected. A corresponding retractor of the determined perfusion orifice is tensioned to peel off the perfusion orifice cover associated with the retractor and to open the determined perfusion orifice to provide continuous distal limb perfusion.

[0052] In a further aspect, the opened perfusion orifice allows blood to flow from an upstream location of the arteriotomy through the sheath body of the sheath to the downstream vasculature of the patient. According to the method, the perfusion sheath can be positioned within the artery for continuous distal limb perfusion, with the proximal end of the sheath body disposed outside the patient.

[0053] According to the above aspects of the method, the puller can be attached to the perfusion orifice cover from a proximal side of the perfusion orifice cover to a distal side of the perfusion orifice cover, the proximal side of the perfusion orifice cover being positioned closer to the arteriotomy than the distal side of the perfusion orifice cover when the perfusion sheath is positioned in the patient. In a further aspect, the puller can be lightly attached to the perfusion orifice cover at the proximal side of the perfusion orifice cover and more firmly attached to the perfusion orifice cover at the distal side of the perfusion orifice cover so that when tensioned, the puller is separated from the perfusion orifice cover at the proximal side of the perfusion orifice cover and then pulled away from the perfusion orifice at the distal side of the perfusion orifice cover. In any of the above aspects, the puller can be a colored puller. In a further aspect, each puller has a different color.

[0054] Based on the foregoing and with reference to the various accompanying drawings, those skilled in the art will appreciate that certain modifications may be made to the present disclosure without departing from the scope of the present disclosure. Although several aspects of the present disclosure have been shown in the drawings, it is not intended that the present disclosure be limited thereto, but that the scope of the present disclosure is as wide as the technical field allows, and the specification is interpreted in the same manner. Therefore, the above description should not be interpreted as being restrictive, but only as an example of a specific embodiment. Those skilled in the art will foresee other modifications within the scope and spirit of the appended claims.

[0055] While specific benefits are listed above, various embodiments may include some, none, or all of the listed benefits.

[0056] Other technical benefits may be apparent to those skilled in the art after reading the drawings and description.

[0057] First, it should be understood that although exemplary embodiments are illustrated in the drawings and described below, the principles of the present disclosure can be implemented using any number of technologies, whether currently known or not. The present disclosure should not be limited in any way to the exemplary embodiments and technologies illustrated in the drawings and described below.

[0058] Unless specifically noted otherwise, the articles depicted in the figures are not necessarily drawn to scale.

[0059] Without departing from the scope of the present disclosure, the systems, devices, and methods described herein may be modified, added, or omitted. For example, the components of the systems and devices may be integrated or separated. In addition, the operation of the systems and devices disclosed herein may be performed by more, less, or other components, and the methods described may include more, less, or other steps. In addition, the steps may be performed in any suitable order. As used in this document, "each / each" refers to each member in a set or each member in a subset of a set.

Claims

1. A perfusion sheath, comprising: a sheath body including an exterior 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 orifice in the sheath body, the at least one perfusion orifice positioned between the proximal end of the sheath body to the distal end of the sheath body, the perfusion orifice enabling fluid communication through the exterior surface of the sheath body; a removable perfusion port cover positioned over the at least one port in the sheath body; and A puller is attached to the removable perfusion port cover.

2. The perfusion sheath according to claim 1, wherein: The length of the retractor is such that the retractor will extend outside the arteriotomy when the sheath body is inserted into the arteriotomy.

3. The perfusion sheath according to claim 1 or claim 2, wherein the puller is selected from the group consisting of: a rope, a wire, a filament, a braid, a lace, and a ribbon. The perfusion sheath according to any one of claims 1 to 3, wherein the puller is made of a biocompatible material.

5. The perfusion sheath according to any one of claims 1 to 4, wherein the sheath body comprises a plurality of perfusion ports, each perfusion port being provided with a removable cover attached thereto and a puller attached to each removable cover.

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

7. The perfusion sheath according to any one of claims 1 to 6, wherein the sheath is made of 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 blends thereof.

10. The perfusion sheath according to any one of claims 1-9, wherein the puller is attached to the perfusion orifice cover from a proximal side of the perfusion orifice cover to a distal side of the perfusion orifice cover, the proximal side being positioned closer to the arteriotomy than the distal side when the perfusion sheath is deployed in a patient.

11. The perfusion sheath of claim 10, wherein the puller is lightly attached to the perfusion orifice cover at the proximal side and more firmly attached to the perfusion cover at the distal side of the perfusion orifice cover, such that when tensioned, the puller is separated from the cover at the proximal side and then pulled away from the perfusion orifice at the distal side.

12. The perfusion sheath of any one of claims 5-10, wherein the sheath comprises three perfusion orifices, wherein each perfusion orifice is positioned at a selected distance from the proximal end of the perfusion sheath.

13. The perfusion sheath of claim 12, wherein the perfusion orifices are positioned such that when the perfusion sheath is inserted into a patient, one of the perfusion orifices will be positioned along the bend of the perfusion sheath as the sheath transitions from an insertion angle at the arteriotomy to a position aligned with the lumen of the vascular system into which the perfusion sheath is inserted.

14. The perfusion sheath of claim 13, wherein the perfusion sheath comprises a first perfusion orifice having a selected position such that when the perfusion sheath is inserted into the arteriotomy, the perfusion orifice is positioned approximately 2 cm or less below the surface of the arteriotomy.

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

16. The perfusion sheath of any one of claims 13-15, wherein the perfusion sheath comprises a third perfusion orifice having a selected position such that when the perfusion sheath is inserted into the arteriotomy, the perfusion orifice is positioned greater than about 4.5 cm below the surface of the arteriotomy.

17. The perfusion sheath according to any one of claims 2-16, wherein the puller is a colored puller.

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

19. A method for providing continuous distal limb perfusion, the method comprising: A perfusion sheath is provided, the perfusion sheath comprising: a sheath body including an exterior 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 orifices in the sheath body, the plurality of perfusion orifices being positioned between the proximal end of the sheath body to the distal end of the sheath body, each perfusion orifice enabling fluid communication through the exterior surface of the sheath body; a removable perfusion port cover positioned over each of the plurality of perfusion ports in the sheath body; and a puller attached to the removable perfusion port cover; establishing a puncture through the patient's skin; inserting the perfusion sheath through the puncture site and into the artery of the patient through the arteriotomy; Positioning the perfusion sheath in the artery for continuous distal limb perfusion; determining a perfusion orifice of the plurality of perfusion orifices to be opened; and The retractor corresponding to the identified perfusion orifice is tensioned to peel off the perfusion orifice cover associated with the retractor and open the identified perfusion orifice to provide the continuous distal limb perfusion.

20. The method of claim 19, wherein the opened perfusion orifice allows blood to flow from a location upstream of the arteriotomy through a sheath body of the sheath to downstream vasculature of the patient.

21. 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 disposed outside of the patient.

22. The method of any one of claims 19-21, wherein the puller is attached to the perfusion orifice cover from a proximal side of the perfusion orifice cover to a distal side of the perfusion orifice cover, the proximal side of the perfusion orifice cover being closer to the arteriotomy than the distal side of the perfusion orifice cover when the perfusion sheath is positioned in the patient.

23. The method of claim 22, wherein the puller is lightly attached to the perfusion orifice cover at the proximal side of the perfusion orifice cover and more firmly attached to the perfusion orifice cover at the distal side of the perfusion orifice cover, such that when tensioned, the puller is separated from the perfusion orifice cover at the proximal side of the perfusion orifice cover and then pulled away from the perfusion orifice at the distal side of the perfusion orifice cover.

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

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

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