Three-tube repositioning sheath tube

Abstract

A repositioning sheath for percutaneous delivery of a medical device into a blood vessel includes an outer body having an outer wall surface and an inner wall surface defining a lumen. The repositioning sheath also includes a first tube defining a first lumen and a second tube defining a second lumen. The first tube is disposed within the lumen of the outer body, and the second tube is disposed within the lumen of the outer body.

Description

Cross - reference to related patent applications

[0001] This application claims the priority of U.S. Provisional Application No. 63 / 430,488, filed on December 6, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to a repositioning sheath for delivering medical devices. More particularly, the present disclosure relates to a repositioning sheath having at least two tubes disposed therein for accommodating at least two medical devices. Background Art

[0003] In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a patient's blood vessel (e.g., the femoral artery), and then the medical device is inserted into the introducer sheath for introduction into the patient's vasculature. In many cases, the medical device includes a catheter or other device, such as a blood pump. After delivering the medical device, it may be necessary to replace the introducer sheath with a repositioning sheath that allows repositioning of the delivered medical device and is smaller in size than the introducer sheath. Replacing the introducer sheath with a repositioning sheath can increase blood flow, thereby reducing the likelihood of intravascular ischemia. In these cases, it may be desirable for the repositioning sheath to be able to accommodate at least two medical devices simultaneously. There is a need for an improved repositioning sheath that can accommodate two medical devices simultaneously. Summary of the Invention

[0004] In Example 1, a repositioning sheath for percutaneous delivery of a medical device to a blood vessel includes: an outer body having an outer wall surface and an inner wall surface, the inner wall surface defining a lumen; a first tube defining a first lumen, the first tube being disposed within the lumen of the outer body; and a second tube defining a second lumen, the second tube being disposed within the lumen of the outer body.

[0005] In Example 2, the repositioning sheath of Example 1 further includes the first tube being radially spaced apart from the inner wall surface of the outer body.

[0006] In Example 3, the repositioning sheath of Example 1 or Example 2 further includes the second tube being radially spaced apart from the inner wall surface of the outer body.

[0007] In Example 4, the repositioning sheath of any one of Examples 1-3, wherein the second tube and the first tube are arranged such that the first tube and the second tube are in contact with each other.

[0008] In Example 5, the repositioning sheath of any one of Examples 1-4 further includes the first tube having an inner diameter of about 0.094 inches and an outer diameter of about 0.110 inches, and the second tube having an inner diameter of about 0.039 inches and an outer diameter of about 0.043 inches.

[0009] In Example 6, the repositioning sheath of Example 5 further includes that the sheath has a distal end opposite to the proximal end, and the distal end of the sheath includes a tapered distal tip having a length of about 3 centimeters.

[0010] In Example 7, the repositioning sheath of any one of Examples 1-6, wherein the tapered distal tip is made of polyether block amide with a hardness of 40.

[0011] In Example 8, a delivery system for positioning at least one medical device into a blood vessel includes: a repositioning sheath having an outer body extending between a proximal end and a distal end, the outer body defining a lumen, the repositioning sheath configured to be inserted into a blood vessel, and the repositioning sheath further includes: a first tube defining a first lumen, the first tube disposed within the lumen of the outer body; a second tube defining a second lumen, the second tube disposed within the lumen of the outer body; and a hub engaged with the proximal end of the repositioning sheath.

[0012] In Example 9, the delivery system of Example 8 further includes: the first tube is radially spaced apart from the inner wall surface of the outer body, and optionally, the second tube is radially spaced apart from the inner wall surface of the outer body.

[0013] In Example 10, the delivery system of Example 8 or Example 9 further includes: the hub is thermoformed with the proximal end of the repositioning sheath such that the axial and radial positions of the first tube and the second tube at the proximal end of the repositioning sheath are fixed.

[0014] In Example 11, the delivery system of any one of Examples 8 to 10 further includes: the distal end of the repositioning sheath includes a tapered distal tip formed of a molded polymeric material such that the axial and radial positions of the first tube and the second tube are fixed at the distal end.

[0015] In Example 12, the delivery system of any one of Examples 8 to 11 further includes: the inner diameter of the first tube is about 0.094 inches and the outer diameter is about 0.110 inches.

[0016] In Example 13, the delivery system of any one of Examples 8 to 12 further includes: the inner diameter of the second tube is about 0.039 inches and the outer diameter is about 0.043 inches.

[0017] In Example 14, the delivery system of any one of Examples 8 to 13 further includes: the tapered distal tip is composed of polyether block amide with a hardness of 50.

[0018] In Example 15, the delivery system of any one of Examples 8 to 14 further includes: the outer body of the repositioning sheath is composed of polyether block amide with a hardness of 55.

[0019] In Example 16, a repositioning sheath for use with a percutaneous intravascular blood pump includes: an outer body having a proximal end and a distal end opposite the proximal end, and a lumen extending between the proximal and distal ends, the outer body having an outer wall surface and an inner wall surface; a first tube defining a first lumen, the first tube disposed within the lumen of the outer body; a second tube defining a second lumen, the second tube disposed within the lumen of the outer body; and wherein the first tube is radially spaced from the inner wall surface of the outer body, and the second tube is radially spaced from the inner wall surface of the outer body.

[0020] In Example 17, the repositioning sheath of Example 16 further includes: the first tube and the second tube are arranged in contact with each other.

[0021] In Example 18, the repositioning sheath of Example 16 further includes: the inner diameter of the outer body of the repositioning sheath is approximately 0.166 inches, and the outer diameter is approximately 0.206 inches.

[0022] In Example 19, the repositioning sheath of Example 16 further includes: the inner diameter of the first tube is approximately 0.094 inches, the outer diameter is approximately 0.110 inches, and the inner diameter of the second tube is approximately 0.039 inches, and the outer diameter is approximately 0.043 inches.

[0023] In Example 20, the repositioning sheath of Example 16 further includes: the distal end of the repositioning sheath includes a tapered distal tip having a length of approximately 3 cm.

[0024] In Example 21, the repositioning sheath of Example 20 further includes: the tapered distal tip is composed of polyether block amide with a hardness of 40.

[0025] In Example 22, the repositioning sheath of Example 16 further includes: the outer body of the repositioning sheath is composed of polyether block amide with a hardness of 55.

[0026] In Example 23, a delivery system for positioning at least one medical device into a blood vessel includes: a repositioning sheath having an outer body extending between a proximal end and a distal end, the outer body defining a lumen, and the repositioning sheath being configured for insertion into a blood vessel, the repositioning sheath further includes: a first tube defining a first lumen, the first tube disposed within the lumen of the outer body; a second tube defining a second lumen, the second tube disposed within the lumen of the outer body; and wherein the first tube is radially spaced from the inner wall surface of the outer body, and the second tube is radially spaced from the inner wall surface of the outer body. The delivery system further includes a hemostatic valve hub engaged with the proximal end of the repositioning sheath.

[0027] In Example 24, the delivery system of Example 23 further includes: the hub is thermally molded to the proximal end of the repositioning sheath such that the axial and radial positions of the first tube and the second tube at the proximal end of the repositioning sheath are fixed.

[0028] In Example 25, the delivery system of Example 24 further includes: the distal end of the repositioning sheath includes a tapered distal tip formed of a molded polymeric material such that the axial and radial positions of the first tube and the second tube at the distal end are fixed.

[0029] In Example 26, the delivery system of Example 24 further includes: the length of the tapered distal tip is approximately 3 cm.

[0030] In Example 27, the delivery system of Example 23 further includes: the inner diameter of the outer body of the repositioning sheath is approximately 0.166 inches and the outer diameter is approximately 0.206 inches.

[0031] In Example 28, the delivery system of Example 23 further includes: the inner diameter of the first tube is approximately 0.094 inches and the outer diameter is approximately 0.110 inches.

[0032] In Example 29, the delivery system of Example 23 further includes: the inner diameter of the second tube is approximately 0.039 inches and the outer diameter is approximately 0.043 inches.

[0033] In Example 30, the delivery system of Example 23 further includes: the tapered distal tip is composed of polyether block amide with a hardness of 40.

[0034] In Example 31, the delivery system of Example 23 further includes: the outer body of the repositioning sheath is composed of polyether block amide with a hardness of 55.

[0035] In Example 32, a delivery system for positioning at least one medical device into a blood vessel includes: a repositioning sheath having an outer body extending between a proximal end and a distal end, the outer body defining a lumen, and the repositioning sheath being configured for insertion into a blood vessel, the repositioning sheath including: a first tube defining a first lumen, the first tube being disposed within the lumen of the outer body; a second tube defining a second lumen, the second tube being disposed within the lumen of the outer body; and wherein, the inner diameter of the repositioning sheath is approximately 0.166 inches, the outer diameter of the first tube is approximately 0.110 inches, and the outer diameter of the second tube is approximately 0.39 inches such that the first tube is radially spaced from the inner wall surface of the outer body and the second tube is radially spaced from the inner wall surface of the outer body. The delivery system further includes a hemostatic valve hub engaged with the proximal end of the repositioning sheath.

[0036] In Example 33, the delivery system of Example 32 further comprises: the hub is thermally molded to the proximal end of the repositioning sheath such that the axial and radial positions of the first tube and the second tube are fixed at the proximal end of the repositioning sheath.

[0037] In Example 34, the delivery system of Example 33 further comprises: the distal end of the repositioning sheath includes a tapered distal tip formed of a molded polymeric material such that the axial and radial positions of the first tube and the second tube are fixed at the distal end.

[0038] In Example 35, the delivery system of Example 34 further comprises: the length of the tapered distal tip is about 3 cm. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 A side view of an introducer sheath extending into a blood vessel, showing elements in accordance with the present disclosure.

[0040] Figure 2 A cross-sectional view of a medical device positioned within a blood vessel, showing an embodiment in accordance with the present disclosure.

[0041] Figure 3 A side perspective view of a repositioning sheath attached to a hub, showing an embodiment in accordance with the present disclosure.

[0042] Figure 4 Shows Figure 3 A cross-sectional view of the repositioning sheath in DETAILED DESCRIPTION

[0043] Figure 1 A side cross-sectional view of a blood vessel V is shown, with an introducer sheath 100 at least partially inserted into the blood vessel V. In some embodiments, the introducer sheath 100 is used to facilitate the passage of various relatively large medical devices (such as a blood pump as will be further described herein) through the introducer sheath 100 into the blood vessel V. Thus, the introducer sheath 100 may be referred to as a large-bore 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 adjacent the proximal end 106 and a distal opening 109 adjacent the distal end 108. A 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 a lumen 112 of the introducer sheath 100. The introducer sheath 100 may be formed of various polymeric materials or metallic materials. In further embodiments, the introducer sheath 100 may include additional surface coatings. The surface coating may include, but is not limited to, silicone, PET, or any other suitable polymer.

[0044] The hub 120 is typically disposed at the proximal end 106 of the introducer sheath 100 and covers its proximal opening 107. The hub 120, also referred to herein as a hemostatic valve hub, is used for hemostasis, that is, to prevent blood from leaking out of the introducer sheath 100 during use. More specifically, a medical device (such as a catheter 168) can be inserted through the hub 120 and the introducer sheath 100 into the blood vessel V, and the hub 120 can maintain a hemostatic state between the catheter 168, the introducer sheath 100, and the external environment. In some embodiments, the catheter 168 can be connected to a medical device such as a blood pump 150 (as Figure 2 shown). After inserting the catheter 168, it may be necessary to fix the axial and radial positions of the catheter 168 to ensure that the catheter 168 (and any connected medical device) is in the correct position during use. Additionally, in certain cases, an operator may also wish to reposition the catheter 168 (and any connected medical device) after insertion. Thus, in some embodiments, the hub 120 can include a fastening port 130 composed of multiple components within the hub 120 for fixing the catheter 168 relative to the hub 120 and the blood vessel V. However, in other embodiments, the fastening port 130 may not be included.

[0045] Figure 2 A cross-sectional view of the introducer sheath 100 is shown after inserting a medical device (such as a blood pump 150) into Figure 1 it. As described above, a catheter such as the catheter 168 can be connected to the proximal end of the blood pump 150 and extend outside the blood vessel V and the introducer sheath 100. 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 can be integrally or monolithically constructed. The impeller assembly housing 140 houses an impeller assembly 144 therein. The impeller assembly 144 includes an impeller shaft 146 and an impeller 148 that rotates relative to the impeller assembly housing 140 to drive blood through the blood pump 150. More specifically, the impeller 148 causes blood to flow into the impeller assembly housing 140 from a blood inlet 151 formed on the impeller assembly housing 140, pass through the impeller assembly housing 140, and flow out from a blood outlet 152 formed on the impeller assembly housing 140. In some embodiments, the impeller shaft 146 and the impeller 148 can be integrally formed, and in other embodiments, the impeller shaft 146 and the impeller 148 can be separate components. As Figure 2 shown, the inlet 151 can be formed at the end of the impeller assembly housing 140, and the outlet 152 can be formed on the side of the impeller assembly housing 140. In other embodiments, the inlet 151 and / or the outlet 152 can be formed on other parts of the impeller assembly housing 140. In some embodiments, the impeller assembly housing 140 can be connected to a cannula extending distally, and the cannula can receive blood and deliver the blood to the inlet 151.

[0046] Continuing to refer toFigure 2 , the motor housing 142 houses the motor 154, and the motor 154 is configured to rotatably drive the impeller 148 relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates the drive shaft 156, and the drive shaft 156 is connected to the drive magnet 158. The rotation of the drive magnet 158 causes the driven magnet 160 to rotate, and the driven magnet 160 is connected to the impeller assembly housing 140. More specifically, in embodiments that include the impeller shaft 146, the impeller shaft 146 and the impeller 148 are configured to rotate with the driven magnet 160. In other embodiments, the motor 154 may be connected to the impeller assembly housing 140 through other components. Although the use of the introducer sheath 100 has been described above in connection with the blood pump 150, various other medical devices may also be used in combination with the introducer sheath 100 and the hemostatic valve hub 120.

[0047] Although the introducer sheath 100 can be used for the initial delivery of a medical device into the blood vessel V, after the device is delivered, it may be desirable to replace the introducer sheath 100 with a smaller sheath to increase blood flow, thereby reducing the likelihood of ischemia or blood flow obstruction within the blood vessel V. In these cases, the introducer sheath 100 can be removed and replaced with a repositioning sheath that is smaller in size (more specifically, diameter) than the introducer sheath 100. As will be further described herein, the repositioning sheath can be connected to the hub 120. The delivered medical device or a portion thereof can be adapted to fit within the repositioning sheath, and the repositioning sheath allows for the positioning or repositioning of one or more delivered medical devices within the patient.

[0048] For example, Figure 3 a side view of the repositioning sheath 170 is shown, with its proximal end 171 connected to the hub 120. The hub 120 can have a first arm 122 and a second arm 124 such that at least two medical devices can extend through the hub 120 simultaneously. In these cases, the devices can pass through the repositioning sheath 170 and into the hub 120. As Figure 3 shown, the repositioning sheath 170 has a proximal end 171 connected to the hub 120 and a distal end 172 defined by a tapered distal tip 174. The repositioning sheath 170 has an outer body 178 that extends between the proximal end 171 and the distal end 172. As Figure 4 shown in the cross-sectional view, the outer body 178 is defined by an outer surface 173 and an inner surface 175. The outer body 178 can be made of a polymeric material, including but not limited to silicone, polyether block amide polyurethane, or various other thermoformed or thermoset polymers. The material of the outer body 178 can also have different degrees of hardness. For example, in some cases, the outer body 178 can be made of a material with a hardness of 55. However, the material of the outer body 178 can be characterized by various other hardness values, and the above example is not intended to be limiting.

[0049] As Figure 3 shown by the dashed lines therein, the first tube 180 and the second tube 190 extend through the repositioning sheath 170. The lumens defined by the first arm 122 and the second arm 124 of the hub 120 can be in fluid connection with the first tube 180 and the second tube 190, respectively. Such an arrangement allows medical devices extending through the first tube 180 and the second tube 190 to extend through the first arm 122 and the second arm 124 of the hub 120, respectively. For example, a medical device extending through the first arm 122 can be inserted into the first tube 180, and a medical device extending through the second arm 124 can be inserted into the second tube 190. Further, the first tube 180 and the second tube 190 pass through the first arm 122 and the second arm 124 independently of each other. In other words, the first tube 180 and the second tube 190 are capable of receiving the devices passing through them without the devices contacting each other. For example, a medical device (such as a catheter) extending within the first tube 180 can extend into the first arm 122, while another medical device (such as a stylet) inserted into the second arm 124 can extend through the second tube 190. Due to the arrangement of the first tube 180 and the second tube 190, during the operation of the repositioning sheath 170, the devices (such as a catheter and a stylet) accommodated therein do not contact each other. As Figure 3 shown, the hub 120 and the repositioning sheath 170 can be configured to accommodate a plug 188 or a stylet, which can be accommodated within the second arm 124 and the second tube 190 when no medical device is accommodated within the second arm 124 and the second tube 190. This reduces the likelihood of blood leaking from the hub 120 through the second arm 124 when using the hub 120 and the repositioning sheath 170.

[0050] In some cases, the hub 120 is thermoformed onto the proximal end 171. In a further example, the hub 120 is glued to the proximal end 171. In this way, the proximal end 171 is molded such that the first tube 180 and the second tube 190 disposed within the repositioning sheath 170 are fixed to each other at the proximal end 171 and remain in place axially and radially, as will be further described below. In other embodiments, the first tube 180 and the second tube 190 can be molded within the repositioning sheath 170 before being connected to the hub 120. Thus, even without being combined with the hub 120, the first tube 180 and the second tube 190 can be axially and radially fixed at the proximal end 171 of the repositioning sheath 170. Additionally, in some embodiments, the distal tip 174 is formed of melted or thermoformed polyamide such that the distal tip 174 is molded and cured. In this way, the first tube 180 and the second tube 190 can also be molded therein at the distal end 172 of the repositioning sheath 170. Thus, the axial and radial positioning of the first tube 180 and the second tube 190 can be fixed at the distal end 172 of the repositioning sheath 170.

[0051] In addition, the distal tip 174 may be formed of a radiopaque material such that when the repositioning sheath 170 is inserted into the patient, the operator can monitor the positioning of the distal tip 174 using various imaging procedures. Continuing to refer to Figure 3 , the distal tip 174 is defined by a length L1. In some embodiments, the value of the length L1 may be between about 1 centimeter and about 6 centimeters. For example, in certain cases, the value of the length L1 is about 3 centimeters. A longer length L1 may be desirable because the tapered design of the distal tip 174 may make it easier for the repositioning sheath 170 to enter the blood vessel V due to the tapering diameter. In other words, the tapered design of the distal tip 174 allows for more blood flow around the distal end 172 of the repositioning sheath 170, thereby making it easier for blood to flow around the repositioning sheath 170.

[0052] Reference will be made to Figure 4 a cross-sectional view of

[0053] to further describe the characteristics and arrangement of the first tube 180, the second tube 190, and the repositioning sheath 170. As shown, the outer body 178 of the repositioning sheath defines a lumen 176 that extends between a proximal end 171 and a distal end 172. The outer body 178 includes an outer surface 173 defined by an outer diameter D1. The value of the outer diameter D1 may be between about 3 millimeters and about 7 millimeters. For example, in certain cases, the value of the diameter D1 is about 5.2 millimeters. In addition, the outer body 178 may include an inner surface 175 defined by an inner diameter D2. The value of the inner diameter D2 may be between about 2 millimeters and about 6 millimeters. For example, in certain cases, the value of the inner diameter D2 may be 4.2 millimeters. Figure 4As shown in the cross-sectional view, the first tube 180 can be radially spaced from the inner surface 175 of the outer body 178 of the repositioning sheath 170. This is at least partly due to the outer diameter D3 being smaller than the inner diameter D2. However, in other embodiments, the first tube 180 and the second tube 190 can be configured such that the first tube 180 and the second tube 190 contact the inner surface 175 of the outer body 178. In a further embodiment, only one of the first tube 180 and the second tube 190 can contact the inner surface 175 of the outer body 178. For example, in some cases, the first tube 180 can be radially spaced from the inner surface 175 of the outer body 178, while the second tube 190 contacts the inner surface 175. In other cases, the first tube 180 can contact the inner surface 175 of the outer body 178, while the second tube 190 is radially spaced from the inner surface 175 of the outer body 178. Additionally, the first tube 180 and the second tube 190 can be arranged such that these tubes 180, 190 contact each other. In other embodiments, the first tube 180 is spaced from the second tube 190. However, various other arrangements of the first tube 180 and the second tube 190 can be used.

[0054] Continuing to refer to Figure 4 , the second tube 190 is also shown as being disposed within the lumen 176 of the repositioning sheath 170. The second tube 190 includes an outer body 192 that defines a lumen 194 extending therethrough. Additionally, the second tube 190 includes an inner diameter D5 and an outer diameter D6. The value of the inner diameter D5 can be between approximately 0.018 inches (about 0.5 mm) and approximately 0.1 inches (about 2.5 mm). For example, in some cases, the value of the inner diameter D5 is about 0.039 inches (about 1 mm). The value of the outer diameter D6 can be between approximately 0.021 inches (about 0.5 mm) and approximately 0.11 inches (about 2.8 mm). For example, in some cases, the value of the outer diameter D6 is about 0.043 inches (about 1 mm).

[0055] Similar to that described for the reference first tube 180, the second tube 190 is arranged such that it can be radially spaced from the inner surface 175 of the outer body 178 of the repositioning sheath 170. Further, the second tube 190 is shown to be radially spaced from the first tube 180. In this way, the outer body 182 of the first tube 180 and the outer body 192 of the second tube 190 can be in contact with neither each other nor the inner surface 175 of the outer body 178 of the repositioning sheath 170. Thus, although the repositioning sheath 170, the first tube 180, and the second tube 190 are molded together with each other and are radially and axially fixed at the distal end 172 and the proximal end 171 of the repositioning sheath 170, the first tube 180 and the second tube 190 can remain spaced apart from each other and from the inner surface 175 of the outer body 178 when extending between the proximal end 171 and the distal end 172. Due to the fixed positioning of the first tube 180 and the second tube 190 at the distal end 172 and the proximal end 171, the movement or sliding of the first tube 180 and the second tube 190 within the outer body 178 is reduced. In other embodiments, the first tube 180 and the second tube 190 can be in contact with each other. In other embodiments, the first tube 180 and / or the second tube 190 can be in contact with the inner surface 175 of the outer body 178 of the repositioning sheath 170.

[0056] As described herein, the first tube 180 and the second tube 190 are configured to receive medical devices extending therethrough. For example, the first tube 180 can be configured to receive a catheter, a blood pump, a guide wire, a guiding catheter, or a small sheath. Additionally, the second tube 190 can be configured to receive a guide wire, a stylet, a plug, a contrast agent injection, a drug injection, or other devices flushed with heparin or saline. However, the medical devices and substances listed above are provided only as examples, and more medical devices or substances can be used with the first tube 180 and / or the second tube 190.

[0057] The above-described first tube 180 and second tube 190 are disposed within the repositioning sheath 170, and the configuration in which the repositioning sheath 170 is connected to the hub 120 allows two separate medical devices to extend into or through the hub 120 and into or through the repositioning sheath 170 while remaining separated from each other. This can reduce the likelihood of the medical devices being damaged or interfering with each other during insertion, repositioning, and / or removal.

[0058] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, although the above embodiments relate to specific features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the above features.

Claims

1. A repositioning sheath for percutaneous delivery of a medical device into a blood vessel, the repositioning sheath comprising: An outer body having an outer wall surface and an inner wall surface, the inner wall surface defining a lumen; A first tube defining a first lumen, the first tube being disposed within the lumen of the outer body; And A second tube defining a second lumen, the second tube being disposed within the lumen of the outer body.

2. The repositioning sheath according to claim 1, wherein the first tube is radially spaced apart from the inner wall surface of the outer body.

3. The repositioning sheath according to claim 1 or 2, wherein the second tube is radially spaced apart from the inner wall surface of the outer body.

4. The repositioning sheath according to any one of claims 1-3, wherein the second tube and the first tube are arranged such that the first tube and the second tube are in contact with each other.

5. The repositioning sheath according to any one of claims 1-4, wherein the first tube has a first inner diameter and the second tube has a second inner diameter, the first inner diameter being greater than the second inner diameter.

6. The repositioning sheath according to any one of claims 1-5, wherein the sheath has a distal end opposite the proximal end, and the distal end of the sheath includes a tapered distal tip.

7. The repositioning sheath according to claim 6, wherein the tapered distal tip is made of polyether block amide having a hardness of 40.

8. A delivery system for positioning at least one medical device into a blood vessel, the delivery system comprising: A repositioning sheath having an outer body extending between a proximal end and a distal end, the outer body defining a lumen, the repositioning sheath configured to be inserted into a blood vessel, the repositioning sheath further comprising: A first tube defining a first lumen, the first tube being disposed within the lumen of the outer body; and A second tube defining a second lumen, the second tube being disposed within the lumen of the outer body; and A hub engaged with the proximal end of the repositioning sheath.

9. The delivery system according to claim 8, wherein the first tube is radially spaced apart from the inner wall surface of the outer body, and optionally, wherein the second tube is radially spaced apart from the inner wall surface of the outer body.

10. The delivery system according to claim 8 or 9, wherein the hub is thermoformed with the proximal end of the repositioning sheath such that the axial and radial positions of the first tube and the second tube at the proximal end of the repositioning sheath are fixed.

11. The delivery system according to any one of claims 8-10, wherein the distal end of the repositioning sheath includes a tapered distal tip formed of a molded polymeric material such that the axial and radial positions of the first tube and the second tube at the distal end are fixed.

12. The delivery system according to any one of claims 8-11, wherein the first tube has a first inner diameter and the second tube has a second inner diameter, the first inner diameter being greater than the second inner diameter.

13. The delivery system according to claim 12, wherein the first inner diameter is about 2.4 millimeters and the second inner diameter is about 1 millimeter.

14. The delivery system according to any one of claims 11 - 13, wherein the tapered distal tip is made of polyether block amide having a hardness of 50.

15. The delivery system according to any one of claims 8 - 14, wherein the outer body of the repositioning sheath is made of polyether block amide having a hardness of 55.

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