Device for blood distribution

Abstract

An apparatus includes a hub including a front port, a side port, and a rear port, the rear port including a hemostasis valve. The device also includes a sheath extending from the hemostasis valve through the front port and shaped to define one or more lateral openings within the hub. The sheath is configured for insertion into the blood vessel such that after insertion, a flow rate of blood between the side port and the blood vessel via the transverse opening can be controlled using an instrument through the hemostasis valve and into the sheath such that the instrument closes at least a portion of the transverse opening. Other embodiments are also described.

Description

Field of the Invention

[0001] The present invention relates to the field of medical devices, and in particular to devices for shunting blood from an artery to a vein. background

[0002] U.S. Patent 8,545,432 describes a retrograde flow system for treating an artery. The system includes an arterial access device adapted to be introduced into the artery and receive blood flow from the artery. A shunt is fluidly connected to the arterial access device, wherein the shunt provides 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 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 blocks fluid flow through the shunt in response to fluid being injected into the arterial access device.

[0003] US Patent 7,063,685 describes a hemostatic valve that is closed when not in use, but provides an unobstructed fluid path when access is through a Luer / connector. An automatic closing valve within the hemostatic valve housing is flush with its top surface. When access is made using a connector or Luer, the valve fully opens, allowing an unobstructed high-flow rate fluid path. SUMMARY OF THE INVENTION

[0004] According to some embodiments of the present invention, there is provided a device comprising a hub, the hub comprising a front port, a side port and a rear port, the rear port comprising a hemostatic valve. The device also comprises a sheath extending from the hemostatic valve through the front port and shaped to define one or more transverse openings in the hub. The sheath is configured to be inserted into a blood vessel so that after insertion, a flow rate of blood between the side port and the blood vessel via the transverse opening can be controlled using an instrument passing through the hemostatic valve and entering the sheath so that the instrument closes at least a portion of the transverse opening.

[0005] In some embodiments, the cross-sectional area of ​​the lumen of the side port is at least 3.8 mm 2 .

[0006] In some embodiments, the total area of ​​the lateral openings is at least as large as the area of ​​the side ports.

[0007] In some embodiments, the sheath comprises: a rear sheath disposed within the hub and shaped to define a transverse opening; and A front sheath is connected to the rear sheath and is configured for insertion into a blood vessel.

[0008] In some embodiments, the sheath is connected to the rear port.

[0009] In some embodiments, the device further comprises a tube configured to connect to the side port.

[0010] In some embodiments, the apparatus further comprises said device.

[0011] In some embodiments, the device includes a dilator configured to facilitate insertion by dilating the vessel.

[0012] In some embodiments, the instrument includes one or more markings configured to indicate the size of the portion of the transverse opening closed by the instrument by progressively entering the markings of the hub as the instrument is advanced through the hemostatic valve.

[0013] In some embodiments, the openings are arranged in one or more rows.

[0014] In some embodiments, the opening comprises one or more slots.

[0015] In some embodiments, the device further comprises a blood filter disposed between the lateral opening and the side port such that blood flows through the blood filter.

[0016] According to some embodiments of the present invention, a method is also provided, comprising: inserting a sheath into a blood vessel, the sheath extending from a hemostatic valve at a rear port of a hub through a front port of the hub and into the blood vessel, the sheath being shaped to define one or more transverse openings in the hub. The method further comprises: after inserting the sheath, controlling the flow rate of blood between the side port of the hub and the blood vessel through the transverse opening by passing an instrument through the hemostatic valve and into the sheath so that the instrument closes at least a portion of the transverse opening.

[0017] According to some embodiments of the present invention, there is also provided a kit for use with a hub, the hub comprising a front port connected to a sheath and a rear port comprising a hemostatic valve. The kit comprises a tube and an adapter configured to be connected to the tube and configured to be inserted through the hemostatic valve so that after the sheath is inserted into a blood vessel, blood flows between the blood vessel and the tube via the adapter.

[0018] In some embodiments, the adapter includes one or more barbs configured to inhibit the adapter from leaving the hub after insertion of the adapter.

[0019] In some embodiments, the adapter comprises: A straight connector, the straight connector comprising: a leading end configured for insertion through the hemostatic valve; and Backend; and A tube connector includes a front port connected to a rear end of the straight connector and configured to be connected to a tube.

[0020] In some embodiments, the tube connector further includes a rear port configured to connect to the tube.

[0021] In some embodiments, the tube connector further comprises: a rear port including another hemostasis valve; and One or more side ports, at least one of the one or more side ports being configured to connect to a tube.

[0022] In some embodiments, the tube connector comprises a T-connector.

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

[0024] 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.

[0025] In some embodiments, the kit further comprises: another hub, the other hub comprising another front port, side ports, and another rear port, the other rear port comprising another hemostasis valve; and another sheath extending from the other hemostasis valve through the other front port and shaped to define one or more lateral openings in the other hub, The other sheath is configured to be inserted into another blood vessel, so that after the insertion, an instrument is used that passes through another hemostatic valve and enters the other sheath so that the instrument closes at least a portion of the lateral opening, thereby controlling the flow rate of blood between the side port and the other blood vessel through the lateral opening.

[0026] According to some embodiments of the present invention, there is also provided a device including a sheath. The device also includes a hub including a front port connected to the sheath and a rear port including a hemostatic valve. The device also includes an adapter passing through the hemostatic valve and a tube connected to the adapter, so that after the sheath is inserted into the blood vessel, blood flows between the blood vessel and the tube via the adapter.

[0027] According to some embodiments of the present invention, there is also provided a method, the method comprising inserting an adapter connected to a tube through a hemostatic valve at a rear port of a hub. The method further comprises inserting a sheath connected to a front port of the hub into a blood vessel, so that blood flows between the blood vessel and the tube via the adapter.

[0028] In some embodiments, The adapter is a first adapter, the hub is a first hub, the hemostasis valve is a first hemostasis valve, the sheath is a first sheath, and the blood vessel is a first blood vessel, and The method further includes: inserting a second adapter through a second hemostatic valve at a rear port of a second hub; inserting a second sheath connected to the front port of the second hub into a second blood vessel; and The tube is connected to the second hub such that blood flows between the first blood vessel and the second blood vessel via the tube.

[0029] In some embodiments, connecting the tube to the second hub includes connecting the tube to the second hub via a device configured to perform a function selected from the group consisting of: filtering blood, indicating a flow rate of blood, and facilitating control of the flow rate.

[0030] In some embodiments, The hub is a first hub, the hemostasis valve is a first hemostasis valve, the sheath is a first sheath, and the blood vessel is a first blood vessel, and The method further includes: 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 into the second blood vessel, the sheath being shaped to define one or more lateral openings in the second hub; and The tube is connected to the second hub such that blood flows between the first blood vessel and the second blood vessel via the tube and the lateral opening.

[0031] The present invention will be more fully understood from the following detailed description of embodiments of the present invention taken in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS Figure 1A is a schematic diagram of an introducer device according to some embodiments of the present invention; Figure 1B According to some embodiments of the present invention, Figure 1A A schematic diagram of a cross-section of an introducer device; Figure 2A-2B is a schematic diagram of a sheath according to some embodiments of the present invention; Figure 3 is a schematic diagram of a technique for controlling the flow rate of blood through a hub according to some embodiments of the present invention; Figure 4 is a schematic diagram of an introducer device according to some embodiments of the present invention; Figure 5A-Figure 5B is a schematic diagram of an adapter connected to a tube according to some embodiments of the present invention; Figure 6A-6C is a schematic diagram of a technique for diverting blood according to some embodiments of the present invention; and Figure 7 is a schematic diagram of a kit for use with a conventional introducer hub according to some embodiments of the present invention. DETAILED DESCRIPTION

[0032] 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 the sheath is percutaneously inserted into the blood vessel, other tools and devices can be passed through the sheath and into the blood vessel via the hub.

[0033] In the process of clearing an occlusive lesion from an artery (e.g., the carotid artery), blood flow toward the lesion can be stopped to prevent any emboli from being carried downstream. When downstream flow through the artery is stopped, blood reaching the lesion area via other arteries can be diverted through the sheath and introducer hub so that any debris generated by the process can be safely removed from the subject's body. To prevent excessive blood loss, blood can be shunted to the subject's vein through a filter. For example, blood can be shunted to the femoral vein, radial artery, or jugular vein.

[0034] 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 a tube 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 usually includes a hemostatic valve.

[0035] One challenge with conventional introducers is the inability to control the flow rate of blood through the hub.

[0036] 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 shunt. In the introducer, the sheath does not terminate at the front port of the hub, but instead extends through the hub to the rear port of the hub. The portion of the sheath within the hub is formed to define one or more lateral openings through which blood can flow. By passing an instrument such as a dilator or occluder through the rear port of the hub and inserting it into the sheath, the opening can be selectively blocked, thereby reducing the flow rate of the blood. Advantageously, the instrument can include markings to indicate to the physician the extent to which the opening is blocked.

[0037] Another challenge with conventional introducers is that the rate of blood flow may be limited by the relatively small lumen of the side port.

[0038] The improved introducer described above may address this challenge by providing a side port with a widened lumen.

[0039] In addition, an embodiment of the present invention provides an adapter configured to increase the flow rate through a conventional hub. The adapter is inserted through a hemostatic valve of a rear port of the hub, and a tube for blood flow is connected to the adapter. Thus, the adapter facilitates use of the wider rear port of the hub rather than the side port for blood flow.

[0040] The adapter can be used on the arterial side or the venous side of the shunt. On the arterial side, the adapter usually includes one or more side ports, one of which is connected to the tube, and the back port of the adapter is used for the passage of tools and devices. On the venous side, the tube can be connected to the back port of the adapter, and the adapter does not have to include any side ports.

[0041] Introducer with flow control Reference first Figure 1A , Figure 1A is a schematic diagram of an apparatus 20 according to some embodiments of the present invention. Figure 1B , Figure 1B is a schematic diagram of a cross section AA through device 20 according to some embodiments of the present invention.

[0042] The device 20 includes a hub 22 including a front port 24, a side port 26, and a rear port 28, the rear port 28 including a hemostatic valve 30. Each of the ports may include a Figure 1A The side port 26 in the case of a protrusion from the hub body, as in Figure 1A a cavity recessed within the hub body as in the case of the rear port 28, or as in Figure 1A Simple opening of the case in the front port 24.

[0043] The device 20 also includes a sheath 32 extending from the hemostatic valve through the front port and shaped to define one or more transverse openings 34 in the hub 22. For example, for each of the openings 34, the 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 6Fr-18Fr. Typically, the rear end of the sheath 32 is coupled to the rear port 28.

[0044] The sheath 32 is configured to be inserted into a blood vessel. Figure 3 As further described, after the sheath is inserted into the blood vessel, the flow rate of blood between the side port 26 and the blood vessel through the opening 34 can be controlled by using an instrument that passes through the hemostatic valve 30 and enters the sheath so that the instrument closes at least a portion of the opening.

[0045] Typically, the cross-sectional area of ​​the lumen of the side port 26 is larger than the cross-sectional area in 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 .

[0046] 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 the blood flow rate is not limited by the openings. For example, the total area of ​​the openings can be 20%-100% larger than the area of ​​the side port lumen. As a specific example, the area of ​​the side port lumen can be 4 mm 2 , and the total area of ​​the opening can be 5mm 2 -8mm 2 .

[0047] Typically, during surgery on an artery, a sheath is inserted into a vein to facilitate blood shunting from the artery to the vein. As a specific example, during surgery on the carotid artery, a sheath may be inserted into a femoral vein, a radial artery, or a jugular vein to facilitate blood shunting from the carotid artery to the vein.

[0048] In other embodiments, the sheath is inserted into the artery. In such embodiments, a separate conventional introducer can be used to introduce the tool into the artery, so that the rear port 28 of the device 20 can be reserved for controlling the flow rate of the blood.

[0049] Typically, the device 20 also includes a tube 36 configured to be connected to the side port 26. For example, the tube 36 can be permanently connected to the side port, such as by being bonded to the inner or outer wall of the side port. Alternatively, the tube can be configured to be reversibly connected to the side port, such as via a Luer lock connection.

[0050] Tube 36 is configured to transport blood to or from hub 22 .

[0051] For example, for embodiments in which sheath 32 is inserted into a vein, tube 36 may be connected to another introducer device that includes another sheath inserted into an artery so that the tube delivers blood from the artery to hub 22. (See below for Figure 6C An example of such an embodiment is described) Alternatively, for an embodiment in which sheath 32 is inserted into an artery, tube 36 can be connected to another introducer device that includes another sheath inserted into a vein so that the tube delivers blood from the hub to the vein. In each of the above examples, the tube can be connected to another introducer directly or via another tube, and the connection can be permanent or reversible.

[0052] Alternatively, tube 36 may carry blood from the hub to a collection bag.

[0053] In some embodiments, the device 20 further includes a blood filter 54 disposed between the lateral opening and the side port such that blood flows through the blood filter 54. For example, the hub 22 may include a cylindrical blood filter 54 surrounding the sheath 32.

[0054] Alternatively or additionally, side port 26 may contain a blood filter.

[0055] 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 the movable objects can be viewed through the transparent portion of the hub. The movable objects are configured to move in response to blood flow through the hub, thereby indicating the flow to a physician. The movable objects can have any of the features described in U.S. Patent Application 17 / 576,953, the disclosure of which is incorporated herein by reference.

[0056] Now refer to Figure 2A-2B , which is a schematic diagram of the sheath 32 according to some embodiments of the present invention.

[0057] In some embodiments, the openings 34 are arranged in one or more rows 38, such as a plurality of rows 38 distributed around the circumference of the sheath 32. For example, Figure 1A and Figure 2A As shown, 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.

[0058] In such an embodiment, opening 34 may be circular or may have any other suitable shape.

[0059] Alternatively or additionally, such as Figure 2B As shown, the opening may include one or more slots 40, such as a plurality (eg, 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.

[0060] In some embodiments, Figure 2A-2B As shown, the sheath 32 includes a rear sheath 32b and a front sheath 32f, the rear sheath 32b being disposed within the hub 22 and being shaped to define an opening 34. The front sheath 32f is connected (e.g., coupled) to the rear sheath 32b; in particular, the rear end of the front sheath is connected to the front end of the rear sheath so that blood can flow between the front sheath and the rear sheath. The front sheath, which is generally more flexible than the rear sheath, is configured for insertion into a blood vessel.

[0061] 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 the rear sheath is integral with the hub. Alternatively, regardless of the material the hub is made of and regardless of the technique used to manufacture the hub, for embodiments in which the sheath does not include connected front and rear segments, the rear sheath 32b or the entire sheath 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 extrudate.

[0062] Reference now Figure 3 , which is a schematic diagram of techniques for controlling the flow rate of blood through hub 22 according to some embodiments of the present invention.

[0063] In order to control the flow rate between the side port 26 and the blood vessel into which the sheath 32 is inserted, the device 42 passes through the hemostatic valve 30. As the device 42 is further advanced into the sheath, the device blocks more of the opening 34, thereby limiting the blow flow between the side port and the sheath. Conversely, as the device is withdrawn, more openings are opened, so that the flow rate through the openings increases. In some embodiments, the device 42 is provided in a kit together with the other components of the device 20.

[0064] Typically, the outer diameter of the device is approximately the same as the inner diameter of the sheath 32 to facilitate controlling the flow rate of blood between the side port and the sheath as described above.

[0065] In some embodiments, the device 42 includes a dilator 44 configured to facilitate insertion of the sheath into the blood vessel by dilating 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 via the rear port 28 and the hemostatic valve 30 until the dilator pierces the blood vessel. Subsequently, the dilator can be withdrawn until at least a portion of the opening 34 is unobstructed. Subsequently, the dilator can be further withdrawn or advanced to control the flow rate through the opening 34.

[0066] In other embodiments, a separate instrument 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.

[0067] Typically, the instrument 42 includes one or more markings 46 configured to indicate the size of the portion of the lateral opening closed by the instrument by the markings 46 gradually entering the hub as the instrument is pushed through the hemostatic valve. In other words, the markings are placed so that when the opening is completely unobstructed, all of the markings are outside the hub, but as obstruction increases, more of the markings enter the hub. Thus, the physician can easily determine the degree of obstruction based on the degree to which the markings are visible.

[0068] For example, the markings 46 may include a series of arcs 48 placed at different corresponding positions along the longitudinal axis of the instrument, such that the number of visible arcs 48 indicates the degree to which the opening is blocked. (Each arc 48 may be closed, thereby defining a circle.) For embodiments in which the openings 34 are arranged in rows, the arcs may be placed so that the number of visible arcs equals the number of openings in each row that are not blocked by the instrument.

[0069] As an alternative or in addition to arc 48, indicia 46 may include alphanumeric indicia, such as number 50, so that the forward visible indicia indicates the amount of obstruction. For embodiments where openings 34 are arranged in rows, the forward visible indicia may indicate the number of openings in each row that are not obstructed by an instrument.

[0070] In some embodiments, the instrument is also marked with a scale 52 that facilitates interpretation of the markings. For example, for embodiments in which the markings include the number 50, the scale 52 may include a minimum number and a maximum number separated from each other by a hyphen.

[0071] Adapter for increased flow rates Reference now Figure 4 , which is a schematic diagram of a conventional introducer device 21 with an adapter 56 according to some embodiments of the present invention. Figure 5A-Figure 5B , which is a schematic diagram of an adapter 56 connected to a tube 36 according to some embodiments of the present invention.

[0072] The device 21 includes a hub 23 and a sheath 33 having conventional features and connected to each other in a conventional manner. In particular, the sheath 33 is not shaped to define any lateral openings and does not pass through the hub 23; instead, the sheath 33 is connected to the front port 25 of the hub.

[0073] The adapter 56 is configured to facilitate blood flow between the hub 23 and the tube 36 via the rear port 28 of the hub. In particular, the adapter is configured to be permanently or reversibly connected to the tube, and is configured for insertion through the hemostatic valve 30 so that after the sheath 33 is inserted into the blood vessel, blood flows between the blood vessel and the tube 36 via the adapter. Typically, to facilitate such flow, the diameter of the lumen of the adapter 56 at the narrowest portion of the lumen is at least 2 mm.

[0074] Typically, the adapter 56 includes a straight connector 58 and a tube connector 60, which is configured to connect to the tube 36. The straight connector 58 includes a front end 59 and a rear end 64, and the front end 59 is configured for insertion of a hemostatic valve through the hub 23. The tube connector 60 includes a front port 66 connected to the rear end 64. Typically, the tube connector 60 also includes a rear port 68.

[0075] Typically, the front port 66 is connected to the rear end 64 via a Luer lock connection. For example, the front port 66 may include a male Luer lock, and the rear end 64 may include a female Luer lock connected to the male Luer lock. Alternatively, the front port 66 may be coupled to the rear end 64.

[0076] In other embodiments, adapter 56 is manufactured as a single integrated connector that may include features of straight connector 58 and tube connector 60 .

[0077] In some embodiments, Figure 5B As shown, rear port 68 is configured to connect to tube 36, such as by bonding or luer locking to the tube. Typically, in such embodiments, the tube connector does not include any side ports, and sheath 33 is inserted into a vein.

[0078] In other embodiments, Figure 4 and Figure 5A As shown, the tube connector 60 includes one or more side ports 72, at least one of which is configured to be connected to the tube 36, such as by bonding or Luer lock to the tube. (Alternatively, the side port can be connected to the tube via the 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. A guidewire, catheter, stent and / or any other tool or device can be passed through the rear port 68.

[0079] For example, Figure 4 As shown, the tube connector may include a T-shaped connector including a single-sided port 72 that is perpendicular to an axis passing between the front port 66 and the rear port 68 .

[0080] Alternatively, if Figure 5A As shown, the tube connector can include a Y-shaped connector including one or more side ports 72 that are angled relative to an axis passing between the front port 66 and the rear port 68. For example, the Y-shaped connector can include two side ports. One side port can be connected to the tube 36, while the other side port can be connected to another tube 76. Saline, contrast media, and / or any other fluid can be inserted into the blood vessel via the tube 76.

[0081] As yet another alternative, the tube connector can include a series of two T-connectors or two Y-connectors, or a Y-connector connected to a T-connector. Typically, in such an embodiment, the rear port of the front member of the series includes a Luer lock for locking to the rear member of the series, and the rear port of the rear member of the series includes a hemostatic valve 70.

[0082] In some embodiments, the adapter 56 includes one or more barbs 74 that are configured to inhibit the adapter from leaving the hub 23 after the adapter is inserted into the hub. Figure 4 As shown, for embodiments in which the adapter includes a straight connector 58, the straight connector can include a barb 74. Each barb 74 is shaped so that the barb creates relatively little resistance when passed forward through the hemostatic valve 30, but creates significant resistance when pulled rearward. For example, each barb can include a triangular protrusion that is wider at the rear than at the front, so that the valve resists sliding of the protrusion backward through the valve.

[0083] In some embodiments, another tube 62 is connected to the side port 27 of the hub. Saline, contrast media, and / or any other fluid may be inserted into the blood vessel via the tube 62.

[0084] Reference now Figure 6A-6C , which is a schematic diagram of a technique for diverting blood according to some embodiments of the present invention.

[0085] As mentioned above Figure 1A As mentioned, tube 36 may help to shunt blood between the two vessels.

[0086] For example, one adapter 56 can be inserted into a first introducer that is inserted into a first blood vessel, and another adapter can be inserted into a second introducer that is inserted into a second blood vessel. Blood can then flow between the two blood vessels via tube 36.

[0087] As a specific example, Fig. 6A As shown, the tube 36 can be connected at one end to an arterial side adapter 56a (which includes, for example, Figure 4 or Figure 5A adapter), and at the other end is connected to a venous side adapter 56v (which includes, for example Figure 5B adapter). Alternatively, Figure 6BAs shown, the two adapters can be connected to each other via a device 78 for filtering blood, indicating the flow rate of blood, and / or controlling the flow rate of blood. In particular, the arterial side adapter 56a can be directly connected to the inlet port of the device 78 or connected to the inlet port of the device 78 via the arterial side tube 36a, and the venous side adapter 56v can be directly connected to the outlet port of the device 78 or connected to the outlet port of the device 78 via the venous side tube 36v. (Each connection can be permanent, such as via a bond, or reversible, such as via a Luer lock.) For example, exemplary embodiments of the device 78 are described in International Application PCT / IB2022 / 052688 and U.S. Patent Application 17 / 576,953, the disclosures of each of which are incorporated herein by reference.

[0088] Alternatively, if Figure 6C As shown, the adapter 56 and the introducer device 20 can be connected to each other via the tube 36. The advantage of this embodiment is that the widened side port of the adapter 56 and the device 20 helps to increase the flow rate, but if necessary, the flow rate can be reduced using the instrument 42. Generally, in this embodiment, the adapter 56 is inserted into the arterial side introducer, and the sheath 32 of the device 20 is inserted into the vein.

[0089] Alternatively, to facilitate diversion of blood, tube 36 may convey blood from the arterial side adapter to a collecting bag.

[0090] Reference now Figure 7 , which is a schematic diagram of a kit for use with a conventional introducer hub according to some embodiments of the present invention.

[0091] Typically, the arterial side adapter and / or the venous side adapter are provided in a kit 80 together with the tube 36. (The tube may be pre-connected to at least one of the adapters.) The kit 80 may further include additional components, such as the device 20, the instrument 42, the apparatus 78 ( Figure 6B ) and / or conventional introducers. Thus, advantageously, kit 80 can facilitate implementation of any suitable diversion technique, such as Figure 6A-6C Any of the techniques shown in .

[0092] Those skilled in the art will recognize that the present invention is not limited to what is specifically shown and described above. On the contrary, the scope of embodiments of the present invention includes combinations and sub-combinations of the various features described above and variations and modifications thereof that are not in the prior art that will occur to those skilled in the art after reading the above description. The documents incorporated by reference into this patent application are considered to be an integral part of the present application, except to the extent that any term is defined in these incorporated documents in a manner that conflicts with the definition explicitly or implicitly made in this specification, only the definition in this specification should be considered.

Claims

1. A device comprising: a hub, the hub comprising a front port, a side port, and a rear port, the rear port comprising a hemostatic valve; and a sheath extending from the hemostatic valve through the front port and shaped to define one or more transverse openings within the hub, The sheath is configured to be inserted into a blood vessel so that, after insertion, an instrument is used that passes through the hemostatic valve and enters the sheath so that the instrument closes at least a portion of the lateral opening, thereby being able to control the flow rate of blood between the side port and the blood vessel via the lateral opening.

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

3. The device according to claim 1, wherein: The total area of ​​the lateral openings is at least as large as the area of ​​the side ports.

4. The device according to any one of claims 1 to 3, wherein: The sheath tube comprises: a rear sheath disposed within the hub and shaped to define the transverse opening; and A front sheath is connected to the rear sheath and is configured to be inserted into the blood vessel.

5. The device according to any one of claims 1 to 3, wherein: The sheath is connected to the rear port.

6. The apparatus of any one of claims 1-3, further comprising a tube configured to connect to the side port.

7. The apparatus according to any one of claims 1-3, further comprising the instrument.

8. The device according to claim 7, wherein: The device includes a dilator configured to facilitate the insertion by dilating the blood vessel.

9. The device according to claim 7, wherein: The instrument includes one or more markings configured to indicate a size of a portion of the transverse opening closed by the instrument by the marking progressively entering the hub as the instrument is pushed through the hemostatic valve.

10. The device according to any one of claims 1 to 3, wherein: The openings are arranged in one or more rows.

11. The device according to any one of claims 1 to 3, wherein: The opening includes one or more slots.

12. The apparatus of any one of claims 1-3, further comprising a blood filter disposed between the lateral opening and the side port such that the blood flows through the blood filter.

13. A method comprising: inserting a sheath into a blood vessel, the sheath extending from a hemostatic valve at a rear port of the hub through a front port of the hub, the sheath being shaped to define one or more transverse openings within the hub; and After the sheath is inserted, the flow rate of blood between the side port of the hub and the blood vessel through the lateral opening is controlled by passing an instrument through the hemostatic valve and into the sheath such that the instrument closes at least a portion of the lateral opening.

14. A kit for use with a hub comprising a front port connected to a sheath and a rear port comprising a hemostatic valve, the kit comprising: Tube; and An adapter is configured to be connected to the tube and is configured to be inserted through the hemostatic valve so that after the sheath is inserted into a blood vessel, blood flows between the blood vessel and the tube via the adapter.

15. The kit of claim 14, wherein: The adapter includes one or more barbs configured to inhibit the adapter from being removed from the hub after insertion of the adapter.

16. The kit of claim 14, wherein the adapter comprises: A straight connector, the straight connector comprising: a leading end configured for insertion through the hemostatic valve; and Backend; and A tube connector includes a front port connected to a rear end of the straight connector and is configured to be connected to the tube.

17. The kit of claim 16, wherein: The tube connector also includes a rear port configured to connect to the tube.

18. The kit of claim 16, wherein: The pipe connector further comprises: a rear port comprising another hemostatic valve; and One or more side ports, at least one of the one or more side ports being configured to be connected to the tube.

19. The kit of claim 16, wherein: The pipe connector comprises a T-shaped connector.

20. The kit of claim 16, wherein: The tube connector comprises a Y-shaped connector.

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

22. The kit according to any one of claims 14-20, further comprising: another hub, the other hub comprising another front port, a side port, and another rear port, the other rear port comprising another hemostatic valve; and another sheath extending from the other hemostatic valve through the other front port and shaped to define one or more lateral openings in the other hub, The other sheath is configured to be inserted into another blood vessel, so that after the insertion, an instrument is used that passes through the other hemostatic valve and enters the other sheath, so that the instrument closes at least a portion of the lateral opening, thereby being able to control the flow rate of blood between the side port and the other blood vessel via the lateral opening.

23. A device comprising: Sheath; a hub including a front port connected to the sheath and a rear port including a hemostatic valve; an adapter, the adapter passing through the hemostatic valve; and A tube is connected to the adapter so that after the sheath tube is inserted into a blood vessel, blood flows between the blood vessel and the tube via the adapter.

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

25. The method according to claim 24, wherein 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, and in, The method further comprises: inserting a second adapter through a second hemostasis valve at a rear port of a second hub; inserting a second sheath connected to the front port of the second hub into a second blood vessel; and The tube is connected to the second hub such that the blood flows between the first blood vessel and the second blood vessel via the tube.

26. The method according to claim 25, wherein: Connecting the tube to the second hub includes connecting the tube to the second hub via a device configured to perform a function selected from the group consisting of: filtering the blood, indicating a flow rate of the blood, and facilitating control of the flow rate.

27. The method according to any one of claims 24 to 26, wherein 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, and in, The method further comprises: inserting a second sheath into a second blood vessel, the second sheath extending from a second hemostasis valve at a rear port of the second hub through a front port of the second hub, the sheath being shaped to define one or more transverse openings in the second hub; and The tube is connected to the second hub such that the blood flows between the first blood vessel and the second blood vessel via the tube and the lateral opening.

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