Sheath including built-in male lure connector

Abstract

A sheath for receiving a medical device, comprising a hub and a body. The body is configured to be positioned inside a patient. An access channel is coupled to the hub, and a stopcock is coupled to the access channel on the opposite side of the hub. The stopcock includes a first leg coupled to the access channel, a second leg having a male Luer connector, and a third leg having a female Luer connector.

Description

Technical Field

[0001] The present disclosure relates to a sheath for delivering an intravascular medical device. More specifically, the present disclosure relates to a sheath for constructing a bypass blood flow circuit.

Background Art

[0002] In a procedure for delivering an intravascular medical device, an introduction sheath is inserted into a patient's blood vessel such as the femoral artery, and one or more medical devices are inserted into the introduction sheath and advanced within the blood vessel. In some situations, a relatively large medical device such as a blood pump is delivered through the introduction sheath. Such a device is typically delivered by a large-diameter introduction sheath. However, such a sheath can inhibit blood flow within the blood vessel and thereby cause ischemia.

Summary of the Invention

[0003] In Example 1, a sheath for receiving a medical device includes a hub configured to receive the medical device. A body portion is coupled to the hub and configured to be disposed within the patient. The body portion is configured to receive the medical device from the hub. An access flow path is coupled to the hub. A stopcock is coupled to the access flow path on a side opposite the hub. The stopcock includes a first leg coupled to the access flow path, a second leg having a male Luer connector, and a third leg having a female Luer connector.

[0004] In Example 2, the sheath of Example 1, wherein the hub includes a port configured to receive the medical device. In Example 3, the sheath of Example 2, wherein the port is a first port and the hub further includes a second port.

[0005] In Example 4, the sheath is one of Examples 1 to 3, and the stopcock further comprises a first leg, a second leg, and a stopcock lumen defined within the third leg, and the stopcock further comprises a lever, the lever pivotable to selectively isolate one of the first leg, the second leg, and the third leg from the other legs.

[0006] In Example 5, the sheath is one of those from Examples 1 to 4, and the body portion has a size of 16 French. In Example 6, the sheath is one of those from Examples 1 to 4, and the body portion has a size of 6 French.

[0007] In Example 7, the sheath is one of Examples 1 to 6, and the hub includes a hub lumen configured to receive a medical device. In Example 8, the sheath is one of the examples from Examples 1 to 7, and the body portion includes a body portion lumen configured to receive a medical device.

[0008] In Example 9, the sheath is one of those from Examples 1 to 8, and the access channel includes an access lumen. In Example 10, the medical device assembly includes a first sheath having a first hub and a first body portion coupled to the first hub. The first body portion is configured to be positioned within the patient. A first access channel is coupled to the first hub. A first three-way stopcock is coupled to the first access channel. The first three-way stopcock includes a male Luer connector. The medical device assembly further includes a second sheath having a second hub and a second body portion coupled to the second hub. The second body portion is configured to be positioned within the patient. A second access channel is coupled to the second hub. A second three-way stopcock is coupled to the second access channel. The second three-way stopcock includes a female Luer connector configured to be coupled to the male Luer connector of the first sheath.

[0009] In Example 11, the medical device assembly of Example 10 is used, wherein the first body portion has a first size, and the second body portion has a second size, the second size being smaller than the first size.

[0010] In Example 12, the medical device assembly is the same as in Example 11, with a first size of 16 French and a second size of 6 French. Example 13 further includes a medical device assembly of any of Examples 10 to 12, the medical device configured to advance through a first body portion.

[0011] In Example 14, the medical device assembly is the same as in Example 13, and the medical device is a blood pump. In Example 15, the medical device assembly is one of Examples 10 to 13, wherein the female Luer connector is a first female Luer connector, and the second three-way stopcock further includes a second female Luer connector.

[0012] In Example 16, a sheath for receiving a medical device includes a hub having a hub lumen and a port coupled to the hub lumen. The port and hub lumen are configured to receive the medical device. A body portion is coupled to the hub and configured to be placed inside a patient. The body portion includes a body lumen coupled to the hub lumen, and the body lumen is configured to receive the medical device. An access channel is coupled to the hub and includes an access lumen coupled to the hub lumen. A stopcock is coupled to the access channel on the side opposite the hub. The stopcock includes a stopcock lumen coupled to the access lumen, a first leg coupled to the access channel, a second leg including a male Luer connector, and a third leg including a female Luer connector.

[0013] In Example 17, the sheath is the same as in Example 16, where the port is a first port and the hub further includes a second port. In Example 18, the sheath of Example 16 is provided, wherein the stopcock lumen is defined within a first leg, a second leg, and a third leg, and the stopcock further includes a lever, the lever being pivotable to selectively isolate one of the first leg, the second leg, and the third leg from the other legs.

[0014] In Example 19, the sheath is the same as in Example 16, but the body portion has a size of 16 French. In Example 20, the sheath is the same as in Example 16, but the body portion has a size of 6 French.

[0015] In Example 21, the medical device assembly includes a first sheath having a first hub and a first body portion coupled to the first hub. The first body portion is configured to be positioned within the patient. A first access channel is coupled to the first hub. A first three-way stopcock is coupled to the first access channel. The first three-way stopcock includes a male Luer connector. The medical device assembly further includes a second sheath having a second hub and a second body portion coupled to the second hub. The second body portion is configured to be positioned within the patient. A second access channel is coupled to the second hub. A second three-way stopcock is coupled to the second access channel. The second three-way stopcock includes a female Luer connector configured to be coupled to the male Luer connector of the first sheath.

[0016] In Example 22, the medical device assembly of Example 21 is used, wherein the first body portion has a first size, and the second body portion has a second size, the second size being smaller than the first size.

[0017] In Example 23, the medical device assembly of Example 22 is used, with the first size being 16 French and the second size being 6 French. Example 24 further includes the medical device assembly of Example 21, which is configured to advance through the first body portion.

[0018] In Example 25, the medical device assembly of Example 21 is further comprising a first female Luer connector and a second three-way stopcock which further includes a second female Luer connector.

[0019] In Example 26, the sheath assembly includes a first sheath and a second sheath, the first sheath having a first body and a first stopcock, the first stopcock including a male lure connector, and the second sheath having a second body and a second stopcock, the second stopcock including a female lure connector. The method of using the sheath assembly is as follows: To position the first body portion of the first sheath inside the patient's blood vessel, To position the second body portion of the second sheath within the patient's blood vessel, The first sheath and the second sheath are joined via the male lure connector of the first sheath and the female lure connector of the second sheath. To receive blood from the blood vessel into the first body of the first sheath, To supply blood from the first sheath to the second sheath through the first stopcock and the second stopcock, and Supplying blood to the blood vessels from the second body of the second sheath. Includes.

[0020] Example 27 is the method of Example 26, further comprising the step of advancing the medical device through the first body portion of the first sheath. Example 28 is the method of Example 27, further comprising the step of advancing the medical device to the target cardiac location.

[0021] In Example 29, the method of Example 28 is used, but the target cardiac position is the left ventricle. In Example 30, the method of Example 27 is used, but the medical device is a blood pump. In Example 31, in the method of Example 26, the step of disposing the first body portion of the first sheath within the blood vessel of the patient includes disposing the first body portion in the retrograde direction.

[0022] In Example 32, in the method of Example 26, the step of disposing the second body portion of the second sheath within the blood vessel of the patient includes disposing the second body portion in the anterograde direction. In Example 33, in the method of Example 26, the first body portion has a first size, the second body portion has a second size, and the second size is smaller than the first size.

[0023] In Example 34, in the method of Example 33, the first size is 16 French, and the second size is 6 French. In Example 35, in the method of Example 26, the blood vessel is the femoral artery.

[0024] Although multiple embodiments of the present invention are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description. In the detailed description, exemplary embodiments of the present invention are shown and described. Therefore, the drawings and the detailed description are to be regarded as illustrative and not to be construed as restrictive.

Brief Description of the Drawings

[0025] [Figure 1] Cross-sectional view of an introducer sheath inserted into a blood vessel according to an embodiment of the present disclosure. [Figure 2] Cross-sectional view of the introducer sheath of FIG. 1 inserted into a blood vessel and a medical device inserted into the introducer sheath according to a specific embodiment of the present disclosure. [Figure 3] Perspective view of the introducer sheath of FIG. 1 according to an embodiment of the present disclosure. [Figure 4] Side view of the introducer sheath of FIG. 1 according to an embodiment of the present disclosure. [Figure 5]A side view of the stopcock of the introducer sheath of Figure 1, according to an embodiment of the present disclosure. [Figure 6] A side view of a medical device assembly including the introducer sheath and forward access sheath shown in Figure 1, according to a particular embodiment of the present disclosure. [Figure 7] A schematic diagram of a method for delivering a medical device to a target location within a patient using a sheath assembly, according to a specific embodiment disclosed herein. [Modes for carrying out the invention]

[0026] While the present invention may be applied to various modifications and alternative forms, specific embodiments are illustrated in the drawings and described herein in detail. However, the present invention is not intended to be limited to the specific embodiments described. Rather, the present invention is intended to encompass all modifications, equivalents, and alternative forms that fall within the scope of the invention as defined by the appended claims.

[0027] Large-bore introducer sheaths can obstruct blood flow within blood vessels, potentially causing ischemia. Therefore, physicians typically construct a bypass circuit using a second sheath with antegrade access. This circuit allows blood to flow through the sheath and return to the blood vessel downstream of the large-bore introducer sheath. However, such bypass circuits are cumbersome to construct and usually require the use of separate connectors, such as male-to-male Luer connectors, to connect the female Luer connectors of the sheaths. Therefore, specific embodiments of this disclosure relate to sheaths, sheath assemblies, and methods for facilitating the construction of bypass blood flow circuits using both male and female Luer connectors.

[0028] Figure 1 shows a cross-sectional view of a blood vessel V with a sheath 100 (e.g., an introducer sheath 100) partially inserted into the blood vessel V. In some embodiments, the introducer sheath 100 facilitates the passage of various relatively large medical devices, such as blood pumps, into the blood vessel V through the introducer sheath 100, as will be described later. Therefore, the introducer sheath 100 is sometimes referred to as a large-diameter introducer sheath. The introducer sheath 100 includes a proximal end 106 and a distal end 108 opposite the proximal end 106. The introducer sheath 100 includes a proximal opening (not shown) located adjacent to the proximal end 106 and a distal opening 109 located adjacent to the distal end 108. The body portion 110 of the introducer sheath 100 extends between the proximal end 106 and the distal end 108, and the body portion 110 defines the body lumen 112. The introducer sheath 100 also includes a hub 120 at the proximal end 106. When in use, the hub 120 is located outside the patient's body and facilitates the reception of one or more medical devices and the advancement of these medical devices through the body lumen 112 and the blood vessel V. As described later, the hub 120 includes one or more openings or ports for receiving medical devices. The hub 120 also promotes hemostasis; that is, the hub 120 reduces the loss of blood from the patient's body.

[0029] In some embodiments, the sheath 100 may be a repositioning sheath rather than an introducer sheath. Figure 2 shows a cross-sectional view of the body portion 110 of the introducer sheath 100 when a medical device (exemplary, a blood pump 150) is inserted into the introducer sheath 100. The blood pump 150 is advanced through the introducer sheath 100 into a blood vessel V and may be positioned at a target location, more specifically, a target cardiac location such as the left ventricle. The blood pump 150 generally includes an impeller assembly housing 140 and a motor housing 142. In some embodiments, the impeller assembly housing 140 and the motor housing 142 may be constructed as a single unit or integrally. The impeller assembly housing 140 holds an impeller assembly 144 inside. The impeller assembly 144 includes an impeller shaft 146 and an impeller 148, the impeller 148 which rotates relative to the impeller assembly housing 140 to drive blood through the blood pump 150. More specifically, the impeller 148 directs blood into the blood inlet 151 of the impeller assembly housing 140, through the impeller assembly housing 140, and out through the blood outlet 152 of the impeller assembly housing 140. In some embodiments, the impeller shaft 146 and the impeller 148 may be integrated, while in other embodiments, the impeller shaft 146 and the impeller 148 may be separate components. As shown in Figure 2, the inlet 151 may be formed at the end of the impeller assembly housing 140, and the outlet 152 may be formed on the side of the impeller assembly housing 140. In other embodiments, the inlet 151 and / or outlet 152 may be formed on other parts of the impeller assembly housing 140. In some embodiments, the impeller assembly housing 140 may be coupled to a distally extending cannula (not shown) that receives and supplies blood to the inlet 151.

[0030] Continuing to refer to Figure 2, the motor housing 142 supports a motor 154, which is configured to rotationally drive an impeller 148 relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates a drive shaft 156 coupled to a drive magnet 158. The rotation of the drive magnet 158 ​​causes a driven magnet 160, which is connected to the impeller assembly housing 140. More specifically, in embodiments comprising an impeller shaft 146, the impeller shaft 146 and the impeller 148 are configured to rotate together with the driven magnet 160. In other embodiments, the motor 154 may be coupled to the impeller assembly housing 140 via other components. Furthermore, as shown in Figure 2, a catheter 162 extends from the proximal end of the blood pump 150. In some embodiments, the catheter 162 may be coupled to the motor housing 142 via tapered connectors and / or various other connecting means. The catheter 162 may have a flexible structure to facilitate delivery of the blood pump 150. Although the introducer sheath 100 is shown herein together with the blood pump 150, various other medical devices may also be used in combination with the introducer sheath 100.

[0031] Figures 3 and 4 show the introducer sheath 100 in more detail. As shown, the hub 120 includes a first arm 164 having a first port 166 and a second arm 168 having a second port 170. Both the first port 166 and the second port 170 are coupled to a medical device and configured to allow the medical device to extend into the hub lumen 172 (Figure 4). The hub lumen 172 is coupled to the body lumen 112 (Figure 4), and as a result, the medical device is advanced through the body lumen 112 to a target position in the patient. The first port 166 and the second port 170 may also include internal seals to facilitate hemostasis.

[0032] Continuing to refer to Figures 3 and 4, the hub 120 further includes a third port 174, which may also be referred to as an access port or side arm. The third port 174 is coupled to an access channel 176, which may also be referred to as a flush channel or flush line. The access channel 176 includes an access lumen 178 (Figure 4) coupled to the hub lumen 172. On the opposite side of the third port 174, the access channel 176 is coupled to a three-way stopcock 180. The stopcock 180 includes a first leg 182, a second leg 184, and a third leg 186, which are coupled to the access channel 176. The first leg 182, the second leg 184, and the third leg 186 together define a stopcock lumen 188 (Figure 4) coupled to the access lumen 178. The stopcock 180 also includes a pivotable lever 190 for selectively isolating one of the first leg 182, the second leg 184, and the third leg 186 from the other legs. These features of the stopcock 180 are described in further detail herein.

[0033] Figure 5 shows the stopcock 180 in more detail. As shown, the second leg 184 of the stopcock 180 includes a male Luer connector 192 (also called a male Luer lock connector, and generally includes an outer collar 193 with an internal thread 194 and a spigot 195). The third leg 186 of the stopcock 180 includes a female Luer connector 196 (also called a female Luer lock connector, and generally includes a spigot 197 with an external thread 198).

[0034] Figure 6 shows a medical device assembly 200 that forms a bypass circuit for a patient's blood vessel V (e.g., the femoral artery). The medical device assembly 200 includes a first introducer sheath, more specifically the introducer sheath 100 described herein. The introducer sheath 100 includes the components and features described herein, namely a first hub 120, a first body portion 110 coupled to the first hub 120, a first access channel 176 coupled to the first hub 120, and a first three-way stopcock 180 (including a male Luer connector 192) coupled to the first access channel 176. The first body portion 110 of the sheath 100 is positioned retrogradely within the blood vessel V (i.e., the first body portion 110 is positioned opposite to the direction of blood flow within the blood vessel V). The medical device assembly 200 further includes a second introducer sheath 300, which may have the same or similar features as the first introducer sheath 100. Generally, the second introducer sheath 300 includes a second hub 320, a second body portion 310 coupled to the second hub 320, a second access channel 376 coupled to the second hub 320, and a second three-way stopcock 380 (including a female Luer connector 396) coupled to the second access channel 376. The female Luer connector 396 is coupled to a male Luer connector 192. The second body portion 310 of the sheath 300 is positioned anterogradely within the blood vessel V (i.e., the second body portion 310 is positioned to face the same direction as the blood flow within the blood vessel V). As a result, blood in blood vessel V flows into the first body section 110, passes through the first hub 120, the first access channel 176, the first stopcock 180, the second stopcock 380, the second access channel 376, the second hub 320, and the second body section 310, and then flows back into blood vessel V.

[0035] By connecting sheaths 100 and 300 via male and female lure connectors, the use of separate connectors such as male-to-male lure connectors becomes unnecessary. Figure 7 shows a schematic diagram of an exemplary method 400 for delivering a medical device to a target location in a patient using a sheath assembly, according to an embodiment of the subject matter disclosed herein. In the following description of method 400, the first sheath 100 and the second sheath 300 shown in Figure 6 and their features will be referenced, but it will be understood that any sheath envisioned herein can be used in a similar manner. In block 402, the method is initiated by forming an access site in the patient's blood vessel, which may be, for example, the femoral artery. In block 404, the first body portion 110 of the first sheath 100 is positioned retrogradely in the patient's blood vessel. In block 406, a medical device, such as a blood pump 150, is advanced through the first body portion 110 of the first sheath 100 to a target location, more specifically a target cardiac location, such as the left ventricle. The medical device is then activated, and more specifically the blood pump 150 is activated to provide cardiac support to the patient. In block 408, the second body portion 310 of the second sheath 300 is positioned anterogradely within the patient's blood vessel. In block 410, the first sheath 100 and the second sheath 300 are connected via the first internal male Luer connector 192 of the first sheath 100 and the female Luer connector 396 of the second sheath 300. In block 412, blood flows through the bypass circuit formed by the first sheath 100 and the second sheath 300. More specifically, blood in the blood vessel flows into the first body portion 110, passes through the first hub 120, the first access channel 176, the first stopcock 180, the second stopcock 380, the second access channel 376, the second hub 320, and the second body portion 310, and flows back into the blood vessel, supplying sufficient blood perfusion to the patient's lower limbs.

[0036] In some embodiments, the first sheath 100 and the second sheath 300 may have different sizes, such that the first sheath 100 accepts a medical device while the second sheath 300 does not. That is, the first body portion 110 of the first sheath 100 has a first size, and the second body portion 310 of the second sheath 300 has a second size, the second size being smaller than the first size. For example, the first size may be 16 French and the second size may be 6 French. In other embodiments, the first sheath 100 and / or the second sheath 300 may have other sizes.

[0037] The exemplary embodiments described herein can be modified and added in various ways, but these will not depart from the scope of the invention. For example, even if the embodiments described herein refer to certain features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described herein.

Claims

1. A sheath for receiving medical devices, This sheath features a hub configured to accept medical devices, The sheath comprises a body portion, which is configured to be coupled to the hub and positioned within the patient, and the body portion is configured to receive the medical device from the hub. This sheath is equipped with an access channel that is connected to the hub, The sheath comprises a stopcock coupled to the access channel on the opposite side of the hub, the stopcock comprising a first leg coupled to the access channel, a second leg including a male luer connector, and a third leg including a female luer connector.

2. The sheath according to claim 1, wherein the hub comprises a port configured to receive the medical device.

3. The sheath according to claim 2, wherein the port is a first port, and the hub further comprises a second port.

4. The sheath according to any one of claims 1 to 3, wherein the stopcock further comprises a first leg, a second leg, and a stopcock lumen defined inside the third leg, and the stopcock further comprises a lever, the lever pivotable to selectively isolate one of the first leg, the second leg, and the third leg from the other legs.

5. The body portion is a sheath according to any one of claims 1 to 4, having a size of 16 French.

6. The body portion is a sheath according to any one of claims 1 to 4, having a size of 6 French.

7. The sheath according to any one of claims 1 to 6, wherein the hub comprises a hub lumen configured to receive a medical device.

8. The sheath according to any one of claims 1 to 7, wherein the body portion comprises a body portion lumen configured to receive a medical device.

9. The sheath according to any one of claims 1 to 8, wherein the access channel comprises an access lumen.

10. A medical device assembly, This medical device assembly comprises a first sheath, the first sheath being, The first hub, A first body portion is connected to the first hub and configured to be positioned inside the patient, A first access channel connected to the first hub, A first three-way stopcock, which includes a male lure connector, is coupled to the first access channel. Equipped with, This medical device assembly comprises a second sheath, the second sheath being, The second hub, A second body portion is connected to the second hub and configured to be positioned within the patient, A second access channel connected to the second hub, A second three-way stopcock, including a female lure connector configured to be coupled to the second access channel and to the male lure connector of the first sheath, and A medical device assembly comprising the above features.

11. The medical device assembly according to claim 10, wherein the first body portion has a first size, and the second body portion has a second size, and the second size is smaller than the first size.

12. The medical device assembly according to claim 11, wherein the first size is 16 French and the second size is 6 French.

13. The medical device assembly according to any one of claims 10 to 12, further comprising a medical device configured to advance through a first body portion.

14. The medical device assembly according to claim 13, wherein the medical device is a blood pump.

15. The medical device assembly according to any one of claims 10 to 13, wherein the female Luer connector is a first female Luer connector, and the second three-way stopcock further comprises a second female Luer connector.

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