Device for shunting blood

Abstract

The device includes a hub including a front port, a side port, and a rear port including a hemostatic valve. The device further includes a sheath shaped to extend from the hemostatic valve through the front port and define one or more side openings in the hub. The sheath is configured to be inserted into a blood vessel such that, after insertion, the flow of blood between the side port and the blood vessel through the side openings can be controlled using an instrument passing through the hemostatic valve and into the sheath to close at least a portion of the side openings. Other embodiments are also described.

Description

[Technical Field]

[0001] The present invention relates to the field of medical devices, and in particular to devices for shunting blood from arteries to veins. [Background technology]

[0002] U.S. Patent No. 8,545,432 describes a retrograde flow system for treating an artery. The system includes an arterial access device introduced into an artery to receive blood flow from the artery. A shunt is fluidly connected to the arterial access device, providing a path for blood to flow from the arterial access device to a return site. A flow control assembly is coupled to the shunt and is adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. A shut-off valve assembly automatically shuts off fluid flow through the shunt in response to injection of fluid into the arterial access device.

[0003] U.S. Patent No. 7,063,685 describes a hemostatic valve that is closed when not accessed, but provides an unobstructed flow path when accessed by a luer fitting / connector. A self-closing valve within the hemostatic valve housing is flush with its top surface. When accessed by a connector or luer fitting, the valve opens fully, allowing an unobstructed high flow path. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 8,545,432 [Patent Document 2] U.S. Patent No. 7,063,685 Summary of the Invention [Means for solving the problem]

[0005] Some embodiments of the present invention provide a device including a hub including a front port, a side port, and a rear port including a hemostasis valve. The device further includes a sheath shaped to extend from the hemostasis valve through the front port and define one or more side openings in the hub. The sheath is configured to be inserted into a blood vessel such that, after insertion, the flow of blood between the side port and the blood vessel through the side openings can be controlled using an instrument passing through the hemostasis valve and into the sheath to close at least a portion of the side openings.

[0006] In some embodiments, the cross-sectional area of the lumen of the side port is at least 3.8 mm 2 is.

[0007] In some embodiments, the total area of the lateral openings is at least as large as the area of the side ports.

[0008] In some embodiments, the sheath comprises: a rear sheath disposed within the hub and shaped to define a lateral opening; a front sheath connected to the rear sheath and configured to be inserted into a blood vessel; Includes:

[0009] In some embodiments, the sheath is connected to a rear port.

[0010] In some embodiments, the device further comprises a tube configured to connect to the side port.

[0011] In some embodiments, the apparatus further comprises an appliance.

[0012] In some embodiments, the device includes a dilator configured to dilate the blood vessel, thereby facilitating insertion.

[0013] In some embodiments, the device includes one or more markings configured to indicate the size of the portion of the lateral opening closed by the device by gradually penetrating the hub as the device is pushed through the hemostatic valve.

[0014] In some embodiments, the openings are arranged in one or more rows.

[0015] In some embodiments, the opening comprises one or more slots.

[0016] In some embodiments, the device further includes a blood filter disposed between the lateral opening and the side port such that blood flows through the blood filter.

[0017] Some embodiments of the present invention further provide a method including inserting a sheath into a blood vessel, the sheath extending from a hemostasis valve at a rear port of the hub through a front port of the hub, the sheath being shaped to define one or more side openings in the hub. After the sheath inserting step, the method further includes controlling the flow of blood between the side port of the hub and the blood vessel through the side openings by passing an instrument through the sheath and through the hemostasis valve such that the instrument closes at least a portion of the side openings.

[0018] According to some embodiments of the present invention, there is further provided a kit for use with the hub including a front port connected to a sheath and a rear port including a hemostasis valve, the kit including a tube and an adapter configured to connect to the tube, the adapter configured to be inserted through the hemostasis valve such that, following insertion of the sheath into the blood vessel, blood flows between the blood vessel and the tube through the adapter.

[0019] In some embodiments, the adapter includes one or more barbs configured to prevent the adapter from exiting the hub after insertion of the adapter.

[0020] In some embodiments, the adapter comprises: a front end configured to be inserted through a hemostatic valve; and rear end, a straight connector including: a tubing connector including a front port connected to a rear end of the straight connector and configured to connect to a tube; Includes:

[0021] In some embodiments, the tube connector further comprises a rear port configured to connect to a tube.

[0022] In some embodiments, the tube connector comprises: a rear port including another hemostatic valve; one or more side ports, at least one of which is configured to connect to a tube; Further includes:

[0023] In some embodiments, the tube connector comprises a T-connector.

[0024] In some embodiments, the tube connector comprises a Y-connector.

[0025] In some embodiments, the kit further includes another adapter configured to be inserted into another hub connected to another sheath configured to be inserted into another blood vessel.

[0026] In some embodiments, the kit comprises: another hub including another front port, a side port, and another rear port including another hemostasis valve; a separate sheath extending from the separate hemostasis valve through the separate front port and shaped to define one or more side openings in the separate hub; Further comprising: Another sheath is configured to be inserted into another blood vessel, so that after insertion, the flow of blood between the side port and the another blood vessel through the lateral opening can be controlled using an instrument passing through another hemostatic valve and into the another sheath to close at least a portion of the lateral opening.

[0027] According to some embodiments of the present invention, there is further provided a device including a sheath, the device further including a hub including a front port connected to the sheath and a rear port including a hemostasis valve, the device further including an adapter passing through the hemostasis valve, and tubing connected to the adapter such that after insertion of the sheath into the blood vessel, blood flows between the blood vessel and the tubing through the adapter.

[0028] Some embodiments of the present invention further provide a method including inserting an adapter connected to a tube through a hemostasis valve at a rear port of the hub, the method further including inserting a sheath connected to a front port of the hub into the blood vessel such that blood flows between the blood vessel and the tube through the adapter.

[0029] In some embodiments, the adapter is a first adapter, the hub is a first hub, the hemostatic valve is a first hemostatic valve, the sheath is a first sheath, and the blood vessel is a first blood vessel; The method comprises: inserting a second adapter through a second hemostatic valve at a rear port of the second hub; inserting a second sheath connected to the front port of the second hub into the second blood vessel; connecting the tubing to the second hub so that blood flows through the tubing between the first blood vessel and the second blood vessel; Further includes:

[0030] In some embodiments, connecting the tubing to the second hub includes connecting the tubing to the second hub through a device configured to perform a function selected from the group of functions consisting of filtering the blood, indicating a flow rate of the blood, and facilitating control of the flow rate.

[0031] In some embodiments, the hub is a first hub, the hemostatic valve is a first hemostatic valve, the sheath is a first sheath, and the blood vessel is a first blood vessel; The method comprises: inserting a second sheath into the second blood vessel, the second sheath extending from a second hemostatic valve at the rear port of the second hub through the front port of the second hub and shaped to define one or more side openings in the second hub; connecting the tubing to the second hub so that blood flows between the first blood vessel and the second blood vessel through the tubing and the side opening; Further includes:

[0032] The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken in conjunction with the drawings. [Brief explanation of the drawings]

[0033] [Figure 1A] 1 is a schematic illustration of an introducer device according to some embodiments of the present invention. [Figure 1B] 1B is a schematic diagram of a cross section through the introducer device of FIG. 1A according to some embodiments of the present invention. [Figure 2A] 1 is a schematic illustration of a sheath according to some embodiments of the present invention. [Figure 2B] 1 is a schematic illustration of a sheath according to some embodiments of the present invention. [Figure 3] 1 is a schematic illustration of a technique for controlling the rate of blood flow through a hub according to some embodiments of the present invention. [Figure 4] 1 is a schematic illustration of an introducer device according to some embodiments of the present invention. [Figure 5A] 1 is a schematic illustration of an adapter connected to a tube according to some embodiments of the present invention. [Figure 5B] 1 is a schematic illustration of an adapter connected to a tube according to some embodiments of the present invention. [Figure 6A] 1 is a schematic illustration of a technique for shunting blood according to some embodiments of the present invention. [Figure 6B] 1 is a schematic illustration of a technique for shunting blood according to some embodiments of the present invention. [Figure 6C] 1 is a schematic illustration of a technique for shunting blood according to some embodiments of the present invention. [Figure 7] 1 is a schematic illustration of a kit for use with a conventional introducer hub, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0034] overview In some procedures, an introducer device, also referred to herein simply as an "introducer," provides access to a subject's blood vessel. The introducer includes a sheath connected to an introducer hub. Optionally, after percutaneous insertion of the sheath into the blood vessel, other tools and devices may pass through the sheath and through the hub into the blood vessel.

[0035] During a procedure to clear an occlusive lesion from an artery, such as the carotid artery, blood flow toward the lesion can be stopped to prevent any emboli from being carried downstream. While downstream flow through the artery is stopped, blood reaching the area of the lesion through other arteries can be diverted through a sheath and introducer hub so that any debris generated by the procedure can be safely removed from the subject's body. To prevent excessive blood loss, the blood can be shunted through a filter into the subject's veins. For example, the blood may be shunted into the femoral, radial, or jugular veins.

[0036] In a conventional introducer, the front port of the hub is connected to the rear end of the sheath, and the side port of the hub is connected to tubing through which blood can be shunted. While blood flows through the side port, a guidewire, stent, and / or any other tool or device can pass through the rear port of the hub, which typically includes a hemostatic valve.

[0037] One problem with conventional introducers is the inability to control the rate of blood flow through the hub.

[0038] To address this challenge, embodiments of the present invention provide an improved introducer that can be used on either the arterial or venous side of a short tract. In this introducer, the sheath does not terminate at the front port of the hub, but rather extends through the hub to the rear port of the hub. The portion of the sheath inside the hub is shaped to define one or more side openings through which blood can flow. By inserting an instrument, such as a dilator or occluder, into the sheath through the rear port of the hub, the openings can be selectively blocked, thereby reducing blood flow. Advantageously, the instrument can include markings that indicate to the physician the extent to which the openings are blocked.

[0039] Another problem with conventional introducers is that blood flow rate can be limited by the relatively small lumen of the side port.

[0040] The improved introducer described above can address this problem by providing a side port with a wide lumen.

[0041] Additionally, embodiments of the present invention provide an adapter configured to increase the flow rate through a conventional hub. The adapter is inserted through a hemostasis valve in the rear port of the hub, and tubing for blood flow is connected to the adapter. The adapter, in other words, facilitates using the wider rear port of the hub for blood flow rather than the side port.

[0042] The adapter can be used on either the arterial or venous side of the short circuit. On the arterial side, the adapter typically includes one or more side ports, one of which is connected to tubing, and a rear port on the adapter is used for the passage of tools and devices. On the venous side, tubing can be connected to the rear port on the adapter; the adapter does not necessarily include any side ports.

[0043] Introducer with flow control Please refer first to Figure 1A, which is a schematic illustration of an introducer device 20, according to some embodiments of the present invention, and further to Figure 1B, which is a schematic illustration of cross section AA through device 20, according to some embodiments of the present invention.

[0044] Device 20 includes a hub 22 that includes a front port 24, a side port 26, and a rear port 28 that includes a hemostatic valve 30. Each of these ports may include a protrusion from the body of the hub, as in the case of side port 26 in FIG. 1A, a recessed chamber within the body of the hub, as in the case of rear port 28 in FIG. 1A, or a simple opening, as in the case of front port 24 in FIG. 1A.

[0045] The device 20 further includes a sheath 32 shaped to extend from the hemostatic valve through the front port and define one or more side openings 34 within the hub 22. For example, for each opening 34, a vector normal to the opening can be perpendicular to the longitudinal axis of the sheath 32 at the opening. The sheath 32 can have any suitable diameter, such as 6 to 18 Fr. Typically, the rear end of the sheath 32 is coupled to the rear port 28.

[0046] Sheath 32 is configured to be inserted into a blood vessel. As described in more detail below with reference to Figure 3, after insertion of the sheath into the blood vessel, the flow of blood through opening 34 between side port 26 and the blood vessel can be controlled using an instrument that passes into the sheath through hemostatic valve 30 to close at least a portion of the opening.

[0047] Typically, the cross-sectional area of the lumen of the side port 26 is larger than that of conventional introducers. For example, the inner diameter D0 of the side port may be at least 2 mm and / or the cross-sectional area of the lumen may be at least 3.1 mm. 2 It can be said that:

[0048] Typically, the total area of the openings 34 is at least as large as the cross-sectional area of the side port lumen so that blood flow is not restricted by the openings. For example, the total area of the openings is 20-100% larger than the area of the side port lumen. As a specific example, the area of the side port lumen is 4 mm 2 The total area of the opening can be 5 to 8 mm 2 It can be said that:

[0049] Typically, during arterial procedures, a sheath is inserted into a vein to facilitate short-circuiting of blood from the artery to the vein. As a specific example, during carotid procedures, a sheath may be inserted into the femoral, radial, or jugular vein to facilitate short-circuiting of blood from the carotid to the vein.

[0050] In other embodiments, the sheath is inserted into the artery, and in such embodiments, a separate conventional introducer can be used to introduce the tool into the artery, such that the rear port 28 of the device 20 can be reserved for controlling the blood flow rate.

[0051] Typically, the device 20 further includes tubing 36 configured to connect to the side port 26. For example, the tubing 36 can be permanently connected to the side port, such as by being bonded to an inner or outer wall of the side port. Alternatively, the tubing can be configured to reversibly connect to the side port, such as by a luer lock connection.

[0052] Tubing 36 is configured to carry blood to and from hub 22 .

[0053] For example, in embodiments in which sheath 32 is inserted into a vein, tubing 36 can be connected to another introducer device that includes another sheath inserted into the artery, such that the tubing carries blood from the artery to hub 22 (an example of such an embodiment is described below with reference to FIG. 6C). Alternatively, in embodiments in which sheath 32 is inserted into an artery, tubing 36 can be connected to another introducer device that includes another sheath inserted into the vein, such that the tubing carries blood from the hub to the vein. In each of the above examples, the tubing can be connected to another introducer directly or through another tube, and the connection can be permanent or reversible.

[0054] Alternatively, tubing 36 can carry blood from the hub to a collection bag.

[0055] In some embodiments, the device 20 further includes a hemofilter 54 disposed between the lateral opening and the side port such that blood flows through the hemofilter 54. For example, the hub 22 can enclose a cylindrical hemofilter 54 that surrounds the sheath 32.

[0056] Alternatively or additionally, the side port 26 can contain a blood filter.

[0057] In some embodiments, at least a portion of the hub 22 is transparent. One or more movable objects, such as beads, are disposed within the hub so that they can be observed through the transparent portion of the hub. The movable objects are configured to move in response to blood flow through the hub, thereby indicating this flow to a physician. The movable objects can have any of the features described in U.S. Patent Application No. 17 / 576,953, the disclosure of which is incorporated herein by reference.

[0058] Reference is now made additionally to Figures 2A-2B, which are schematic illustrations of sheath 32 according to some embodiments of the present invention.

[0059] In some embodiments, the openings 34 are arranged in one or more rows 38, for example, multiple rows 38 distributed around the circumference of the sheath 32. For example, as shown in Figures 1A and 2A, the openings 34 can be arranged in four rows distributed around the circumference of the sheath. Each row can include any number of openings, such as between two and ten openings.

[0060] In such an embodiment, the opening 34 may be circular or have any other suitable shape.

[0061] 2B, the opening may include one or more slots 40, such as a plurality (e.g., four) of slots 40 distributed around the circumference of the sheath 32. Typically, in such embodiments, the longitudinal axis of each slot is parallel to the longitudinal axis of the sheath at the slot.

[0062] 2A-2B, sheath 32 includes a rear sheath 32b that is positioned within hub 22 and shaped to define opening 34, and a front sheath 32f. Front sheath 32f is connected (e.g., joined) to rear sheath 32b, specifically, the rear end of the front sheath is connected to the front end of the rear sheath, to allow blood flow between the front and rear sheaths. The front sheath, which is typically more flexible than the rear sheath, is configured to be inserted into a blood vessel.

[0063] In some embodiments, the hub 22 is manufactured by molding a polymer such as acrylonitrile butadiene styrene (ABS) or polycarbonate. In such embodiments, the rear sheath 32b can be molded with the hub so that it is integral with the hub. Alternatively, regardless of the raw material from which the hub is manufactured and regardless of the technique used to manufacture the hub, the rear sheath 32b, or the entire sheath for embodiments in which the sheath does not include connected front and rear sections, can be manufactured separately from the hub and then connected (e.g., bonded) to the rear port 28. For example, the rear sheath 32b can be manufactured by extruding a polymer such as polyethylene or polyether block amide (PEBA) and then forming the opening 34 in the extrusion.

[0064] Please refer now to FIG. 3, which is a schematic illustration of a technique for controlling the rate of blood flow through hub 22, according to some embodiments of the present invention.

[0065] To control the flow of blood between the side port 26 and the blood vessel into which the sheath 32 is inserted, the instrument 42 passes through the hemostatic valve 30. As the instrument 42 is threaded deeper into the sheath, the instrument blocks more of the openings 34, thereby restricting blood flow between the side port and the sheath. Conversely, as the instrument is withdrawn, more openings are opened, increasing the flow rate through those openings. In some embodiments, the instrument 42 is provided in a kit with other components of the device 20.

[0066] Typically, the outer diameter of the device is approximately the same as the inner diameter of the sheath 32 to facilitate controlling the rate of blood flow between the side port and the sheath as described above.

[0067] In some embodiments, the instrument 42 includes a dilator 44 configured to dilate the blood vessel, thereby facilitating insertion of the sheath into the blood vessel. In other words, after dilating the blood vessel, the dilator 44 can be used to control the flow rate. For example, the dilator can be passed through the sheath through the rear port 28 and the hemostatic valve 30 until it perforates the blood vessel. The dilator can then be withdrawn until at least a portion of the opening 34 is unobstructed. The dilator can then be further withdrawn or advanced to control the flow rate through the opening 34.

[0068] In other embodiments, a separate device 42 is used. For example, after the dilator is fully withdrawn from the hub, an occluder, which is shorter than the dilator and therefore easier to use, can be inserted into the hub and used for flow control.

[0069] Typically, the device 42 includes one or more markings 46 configured to indicate the size of the portion of the transverse opening that will be closed by the device, with the markings 46 gradually penetrating the hub as the device is pushed through the hemostatic valve. In other words, the markings are positioned so that when the opening is completely unobstructed, all of the markings are outside the hub, but as the obstruction increases, more of the markings penetrate into the hub. Thus, a physician can immediately determine the degree of obstruction based on the visibility of the markings.

[0070] For example, the markings 46 may include a series of arcs 48 positioned at different respective locations along the longitudinal axis of the instrument, whereby the number of arcs 48 visible indicates the extent to which the openings are blocked (each arc 48 may close, i.e., define a circle). For embodiments in which the openings 34 are arranged in rows, the arcs may be positioned such that the number of visible arcs equals the number of openings in each row that are not blocked by the instrument.

[0071] Instead of or in addition to the arcs 48, the markings 46 may include alphanumeric markings, such as the number 50, such that the front-most visible marking indicates the amount of blockage. For embodiments in which the openings 34 are arranged in rows, the front-most visible marking may indicate the number of openings in each row that are not blocked by the device.

[0072] In some embodiments, graduations 52 are also marked on the device to facilitate interpreting the markings. For example, for embodiments in which the markings include the number 50, the graduations 52 may include a minimum and a maximum number separated from each other by a hyphen.

[0073] Adapter for increased flow rate Please refer now to Figure 4, which is a schematic illustration of a conventional introducer device 21 having an adapter 56, in accordance with some embodiments of the present invention. Also, please refer to Figures 5A-5B, which are schematic illustrations of an adapter 56 connected to a tube 36, in accordance with some embodiments of the present invention.

[0074] The device 21 includes a hub 23 and a sheath 33 having conventional features and connected to one another in a conventional manner. In particular, the sheath 33 is not shaped to define any side openings and does not pass through the hub 23; rather, the sheath 33 is connected to the front port 25 of the hub.

[0075] The adapter 56 is configured to facilitate blood flow between the hub 23 and the tubing 36 through the rear port 28 of the hub. In particular, the adapter is configured to permanently or reversibly connect to the tubing and, following insertion of the sheath 33 into the blood vessel, to be inserted through the hemostatic valve 30 such that blood flows through the adapter between the blood vessel and the tubing 36. Typically, to facilitate this flow, the lumen diameter of the adapter 56 at its narrowest portion is at least 2 mm.

[0076] Typically, adapter 56 includes a straight connector 58 and a tubing connector 60 configured to connect to tubing 36. Straight connector 58 includes a front end 59 configured to be inserted through the hemostasis valve of hub 23, and a rear end 64. Tube connector 60 includes a front port 66 connected to rear end 64. Typically, tubing connector 60 also includes a rear port 68.

[0077] Typically, the front port 66 is connected to the rear end 64 by a luer lock connection. For example, the front port 66 can include a male luer lock and the rear end 64 can include a female luer lock connected to the male luer lock. Alternatively, the front port 66 can be bonded to the rear end 64.

[0078] In other embodiments, the adapter 56 is manufactured as a single, integral connector that may include the features of the straight connector 58 and the tubing connector 60 .

[0079] 5B, rear port 68 is configured to connect to tubing 36, for example, by being bonded or luer locked to the tubing. Typically, in such embodiments, the tubing connector does not include any side ports, and sheath 33 is inserted into a vein.

[0080] 4 and 5A, the tubing connector 60 includes one or more side ports 72, at least one of which is configured to connect to the tubing 36, e.g., by being bonded or luer-locked to the tubing (optionally, the side port can be connected to the tubing through a suction port). Typically, in such an embodiment, the rear port 68 includes another hemostatic valve 70, and the sheath 33 is inserted into the artery. The rear port 68 can accommodate the passage of a guidewire, catheter, stent, and / or any other tool or device.

[0081] For example, as shown in FIG. 4, the tube connector may include a T-connector that includes a single side port 72 perpendicular to an axis passing between the front port 66 and the rear port 68 .

[0082] 5A, the tubing connector may include a Y-connector that includes one or more side ports 72 at an oblique angle to an axis passing between the front port 66 and the rear port 68. For example, the Y-connector may include two side ports. One of the side ports may be connected to the tubing 36, and the other side port may be connected to another tubing 76. Saline, contrast, and / or any other fluid may be inserted into the blood vessel through the tubing 76.

[0083] As yet another alternative, the tubing connectors may include a series of two T-connectors, or two Y-connectors, or a T-connector connected to a Y-connector. Typically, in such embodiments, the rear port of the front member of the series includes a luer lock for locking to the rear member of the series, while the rear port of the rear member of the series includes a hemostatic valve 70.

[0084] In some embodiments, the adapter 56 includes one or more barbs 74 configured to prevent the adapter from exiting the hub 23 after insertion of the adapter into the hub. For example, as shown in FIG. 4 , for embodiments in which the adapter includes a straight connector 58, the straight connector can include barbs 74. Each barb 74 is shaped to provide relatively little resistance when threaded forward through the hemostatic valve 30, but significant resistance when pulled rearward. For example, each barb can include a triangular protrusion that is wider at the rear than at the front, such that the valve resists rearward sliding of the protrusion through it.

[0085] In some embodiments, another tube 62 is connected to the side port 27 of the hub. Saline, contrast, and / or any other fluid can be inserted through the tube 62 into the blood vessel.

[0086] Reference is now made to Figures 6A-6C, which are schematic illustrations of techniques for shunting blood according to some embodiments of the present invention.

[0087] As discussed above with reference to FIG. 1A, the tube 36 can facilitate shunting of blood between two blood vessels.

[0088] For example, one adapter 56 can be inserted into a first introducer inserted into a first blood vessel, and another adapter can be inserted into a second introducer inserted into a second blood vessel. Blood can then flow through tubing 36 between the two blood vessels.

[0089] As a specific example, as shown in Figure 6A, tubing 36 can be connected at one end to an arterial adapter 56a, such as the adapter of Figure 4 or Figure 5A, and at the other end to a venous adapter 56v, such as the adapter of Figure 5B. Alternatively, as shown in Figure 6B, the two adapters can be connected to each other through a device 78 for filtering blood, indicating blood flow rate, and / or controlling blood flow rate. In particular, arterial adapter 56a can be connected to an inlet port of device 78 directly or through arterial tubing 36a, and venous adapter 56v can be connected to an outlet port of device 78 directly or through venous tubing 36v. (Each connection may be permanent, e.g., via a bond, or reversible, e.g., via a Luer lock.) Exemplary embodiments of device 78 are described, for example, in International Patent Application No. PCT / IB2022 / 052688 and U.S. Patent Application No. 17 / 576,953, the disclosures of each of which are incorporated herein by reference.

[0090] Alternatively, as shown in Figure 6C, the adapter 56 and introducer device 20 can be connected to one another through tubing 36. An advantage of such an embodiment is that the adapter 56 and widened side port of device 20 facilitate increased flow rate, but the flow rate can be reduced as needed using tool 42. Typically, in such an embodiment, the adapter 56 is inserted into the arterial introducer and the sheath 32 of device 20 is inserted into the vein.

[0091] Instead of facilitating a short circuit of the blood, the tubing 36 can carry the blood from the arterial adapter to a collection bag.

[0092] Reference is now made to Figure 7, which is a schematic illustration of a kit for use with a conventional introducer hub, according to some embodiments of the present invention.

[0093] Typically, the arterial and / or venous adapters are provided in kit 80 along with tubing 36. (The tubing may be pre-connected to at least one of the adapters.) Kit 80 may further include additional components, such as apparatus 20, instrument 42, device 78 (FIG. 6B), and / or a conventional introducer. That is, kit 80 may advantageously facilitate performing any suitable short-path technique, such as any of the techniques shown in FIGS. 6A-6C.

[0094] It will be recognized by those skilled in the art that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of embodiments of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not present in the prior art and would occur to those skilled in the art upon reading and understanding the foregoing description. Documents incorporated by reference into this patent application are to be considered an integral part of this application, but to the extent that any term defined in such incorporated document is contrary to a definition expressly or impliedly made herein, only the definition in this specification shall be considered.

Claims

1. 1. An apparatus comprising: a hub including a front port, a side port, and a rear port including a hemostasis valve; a sheath extending from the hemostasis valve through the front port and shaped to define one or more side openings in the hub; Including, the sheath is configured to be inserted into a blood vessel such that, after insertion, the flow of blood between the side port and the blood vessel through the lateral opening can be controlled using an instrument passing through the hemostatic valve and into the sheath to close at least a portion of the lateral opening. Device.

2. The cross-sectional area of the lumen of the side port is at least 3.8 mm 2 2. The device of claim 1, wherein:

3. 2. The device of claim 1, wherein the total area of said transverse openings is at least as large as the area of said side ports.

4. The sheath a rear sheath disposed within the hub and shaped to define the lateral opening; a front sheath connected to the rear sheath and configured to be inserted into the blood vessel; Including, 4. An apparatus according to any one of claims 1 to 3.

5. 4. The device of claim 1, wherein the sheath is connected to the rear port.

6. The device of claim 1 , further comprising a tube configured to connect to the side port.

7. 4. The apparatus of claim 1, further comprising the appliance.

8. The device of claim 7 , wherein the tool comprises a dilator configured to dilate the blood vessel and thereby facilitate the insertion.

9. The device of claim 7, wherein the instrument includes one or more markings configured to indicate the size of the portion of the lateral opening that is closed by the instrument by gradually penetrating the hub as the instrument is pushed through the hemostasis valve.

10. 4. The device of claim 1, wherein the openings are arranged in one or more rows.

11. 4. The device of claim 1, wherein the opening comprises one or more slots.

12. 4. The device of claim 1, further comprising a blood filter disposed between the transverse opening and the side port so that the blood flows through the blood filter.

13. inserting a sheath into the blood vessel, the sheath extending from a hemostasis valve at a rear port of the hub through a front port of the hub and shaped to define one or more side openings in the hub; After the sheath insertion step, controlling the flow of blood between the hub side port and the blood vessel through the side opening by passing the instrument through the hemostatic valve and into the sheath such that the instrument closes at least a portion of the side opening; A method comprising:

14. 1. A kit for use with a hub including a front port connected to a sheath and a rear port including a hemostasis valve, Tube and an adapter configured to connect to the tubing, the adapter configured to be inserted through the hemostasis valve such that, following insertion of the sheath into a blood vessel, blood flows between the blood vessel and the tubing through the adapter; Kit including:

15. 15. The kit of claim 14, wherein the adapter includes one or more barbs configured to prevent the adapter from exiting the hub after the insertion of the adapter.

16. The adapter is a front end configured to be inserted through the hemostasis valve; and rear end, a straight connector including: a tube connector including a front port connected to the rear end of the straight connector and configured to connect to the tube; Including, The kit of claim 14.

17. 17. The kit of claim 16, wherein the tube connector further comprises a rear port configured to connect to the tube.

18. The tube connector includes: a rear port including another hemostatic valve; one or more side ports, at least one of which is configured to connect to the tube; Further comprising:

17. The kit of claim 16.

19. 17. The kit of claim 16, wherein the tube connector comprises a T-connector.

20. 17. The kit of claim 16, wherein the tube connector comprises a Y-connector.

21. 21. The kit of any one of claims 14 to 20, further comprising another adapter configured to be inserted into another hub connected to another sheath configured to be inserted into another blood vessel.

22. another hub including another front port, a side port, and another rear port including another hemostasis valve; a further sheath extending from the further hemostatic valve through the further front port and shaped to define one or more side openings in the further hub; Further comprising: the other sheath is configured to be inserted into another blood vessel such that after the insertion, the flow of blood between the side port and the other blood vessel through the lateral opening can be controlled using an instrument passing through the other hemostatic valve and into the other sheath to close at least a portion of the lateral opening.

21. The kit of any one of claims 14 to 20.

23. Sheath and a hub including a front port connected to the sheath and a rear port including a hemostasis valve; an adapter that passes through the hemostasis valve; a tube connected to the adapter, such that after insertion of the sheath into a blood vessel, blood flows between the blood vessel and the tube through the adapter; An apparatus comprising:

24. inserting an adapter connected to tubing through a hemostasis valve at the rear port of the hub; inserting a sheath connected to the front port of the hub into a blood vessel so that blood flows between the blood vessel and the tube through the adapter; A method comprising:

25. the adapter is a first adapter, the hub is a first hub, the hemostatic valve is a first hemostatic valve, the sheath is a first sheath, and the blood vessel is a first blood vessel; The method is inserting a second adapter through a second hemostasis valve at a rear port of the second hub; inserting a second sheath connected to a front port of the second hub into a second blood vessel; connecting the tube to the second hub so that the blood flows through the tube between the first blood vessel and the second blood vessel; Further comprising:

25. The method of claim 24.

26. 26. The method of claim 25, wherein connecting the tubing to the second hub comprises connecting the tubing to the second hub through a device configured to perform a function selected from the group of functions consisting of filtering the blood, indicating a flow rate of the blood, and facilitating control of the flow rate.

27. the hub is a first hub, the hemostatic valve is a first hemostatic valve, the sheath is a first sheath, and the blood vessel is a first blood vessel; The method is inserting a second sheath into a second blood vessel, the second sheath extending from a second hemostatic valve at a rear port of the second hub through a front port of the second hub and shaped to define one or more side openings in the second hub; connecting the tube to the second hub so that the blood flows between the first blood vessel and the second blood vessel through the tube and the side opening; Further comprising:

27. The method of any one of claims 24 to 26.

Images