Triple tube type reconfiguration seal

Abstract

A repositioning sheath for use in percutaneously delivering 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 further 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

[Technical Field]

[0001] The present disclosure relates to a repositioning sheath for use in delivering medical devices. More particularly, the present disclosure relates to a repositioning sheath having at least two tubes disposed therein for receiving at least two medical devices. [Background technology]

[0002] In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a patient's blood vessel, such as the femoral artery, and a medical device is inserted into the introducer sheath for introduction into the patient's vascular system. In various instances, the medical device includes a catheter or other device, such as a blood pump. After delivery of the medical device, it may be desirable to exchange the introducer sheath for a repositioning sheath that allows for repositioning of the delivered medical device but is smaller in size than the introducer sheath. Replacing the introducer sheath with a repositioning sheath may increase blood flow, thereby reducing the likelihood of ischemia within the vessel. In these instances, it may be desirable for the repositioning sheath to simultaneously accommodate at least two medical devices. There is a need for an improved repositioning sheath that can simultaneously accommodate two medical devices. Summary of the Invention

[0003] In Example 1, a repositioning sheath for use in percutaneously delivering a medical device into a blood vessel includes an outer body having an outer wall surface and an 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.

[0004] In Example 2, the repositioning sheath of Example 1 further includes the first tube being radially spaced from the inner wall surface of the outer body. In Example 3, the repositioning sheath of Example 1 or Example 2 further includes the second tube being radially spaced from the inner wall surface of the outer body.

[0005] In Example 4, in the repositioning sheath of any one of Examples 1 to 3, the second tube and the first tube are positioned such that the first tube and the second tube contact each other.

[0006] In Example 5, the repositioning sheath of any one of Examples 1-4 further includes: the first tube has an inner diameter of about 0.094 inches (about 2.4 mm) and an outer body of about 0.110 inches (about 2.8 mm); and the second tube has an inner diameter of about 0.039 inches (about 0.991 mm) and an outer diameter of about 0.043 inches (about 1.092 mm).

[0007] In Example 6, the repositioning sheath of Example 5 further includes the sheath having a distal end opposite the proximal end, the distal end of the sheath comprising a tapered distal tip having a length of about 3 cm.

[0008] In Example 7, the repositioning sheath of any one of Examples 1-6, wherein the tapered distal tip is made of polyether block amide having a durometer of 40. In Example 8, a delivery system for positioning at least one medical device within 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 for insertion into the blood vessel, the repositioning sheath further including a first tube defining a first lumen, the first tube disposed within the lumen of the outer body, and a second tube defining a second lumen, the second tube disposed within the lumen of the outer body. The delivery system further includes a hub engaged with the proximal end of the sheath.

[0009] In Example 9, the delivery system of Example 8 further includes: a first tube radially spaced from an inner wall surface of the outer body; and optionally, a second tube radially spaced from an inner wall surface of the outer body.

[0010] In Example 10, the delivery system of Example 8 or Example 9 further includes the hub being thermoformed with the proximal end of the repositioning sheath such that the axial and radial alignment of the first tube and the second tube is fixed at the proximal end of the repositioning sheath.

[0011] In Example 11, the delivery system of any one of Examples 8-10 further includes: a distal end of the repositioning sheath comprising a tapered distal tip formed from a molded polymeric material such that the axial and radial alignment of the first tube and the second tube is fixed at the distal end.

[0012] In Example 12, the delivery system of any one of Examples 8-11 further includes: the first tube having an inner diameter of about 0.094 inches (about 2.4 mm) and an outer diameter of about 0.110 inches (about 2.8 mm).

[0013] In Example 13, the delivery system of any one of Examples 8-12 further includes the second tube having an inner diameter of about 0.039 inches (about 0.991 mm) and an outer diameter of about 0.043 inches (about 1.092 mm).

[0014] In Example 14, the delivery system of any one of Examples 8-13 further includes the tapered distal tip being comprised of a polyether block amide having a durometer of 50. In Example 15, the delivery system of any one of Examples 8-14 further includes: the outer body of the repositioning sheath is comprised of a polyether block amide having a durometer of 55.

[0015] In Example 16, a repositioning sheath for use with a percutaneous intravascular blood pump includes an outer body having a proximal end, a distal end opposite the proximal end, and a lumen extending between the proximal end and the distal end, the outer body having an outer wall surface and an inner wall surface, 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, the first tube being radially spaced from the inner wall surface of the outer body, and the second tube being radially spaced from the inner wall surface of the outer body.

[0016] In Example 17, the repositioning sheath of Example 16 further includes the first tube and the second tube being positioned such that the first tube and the second tube contact each other.

[0017] In Example 18, the repositioning sheath of Example 16 further includes the outer body of the repositioning sheath having an inner diameter of about 0.166 inches (about 4.2 mm) and an outer diameter of about 0.206 inches (about 5.2 mm).

[0018] In Example 19, the repositioning sheath of Example 16 further includes: the first tube having an inner diameter of about 0.094 inches (about 2.4 mm) and an outer diameter of about 0.110 inches (about 2.8 mm); and the second tube having an inner diameter of about 0.039 inches (about 0.991 mm) and an outer diameter of about 0.043 inches (about 1.092 mm).

[0019] In Example 20, the repositioning sheath of Example 16 further includes: a distal end of the repositioning sheath comprising a tapered distal tip having a length of about 3 cm. In Example 21, the repositioning sheath of Example 20 further includes the tapered distal tip being made of a 40 durometer polyether block amide.

[0020] In Example 22, the repositioning sheath of Example 16 further includes the outer body of the repositioning sheath being comprised of a polyether block amide having a durometer of 55. In Example 23, a delivery system for positioning at least one medical device within 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 for insertion into a blood vessel, the repositioning sheath further including a first tube defining a first lumen, the first tube disposed within the lumen of the outer body, and a second tube defining a second lumen, the second tube disposed within the lumen of the outer body, the first tube being radially spaced from an inner wall surface of the outer body, and the second tube being radially spaced from the inner wall surface of the outer body. The delivery system further includes a hemostasis valve hub engaged with the proximal end of the repositioning sheath.

[0021] In Example 24, the delivery system of Example 23 further includes a hub formed by thermoforming with the proximal end of the repositioning sheath such that the axial and radial alignment of the first tube and the second tube is fixed at the proximal end of the repositioning sheath.

[0022] In Example 25, the delivery system of Example 24 further includes a distal end of the repositioning sheath having a tapered distal tip formed from a molded polymeric material such that the axial and radial alignment of the first tube and the second tube is fixed at the distal end.

[0023] In Example 26, the delivery system of Example 24 further includes the tapered distal tip having a length of about 3 cm. In Example 27, the delivery system of Example 23 further includes the outer body of the repositioning sheath having an inner diameter of about 0.166 inches (about 4.2 mm) and an outer diameter of about 0.206 inches (about 5.2 mm).

[0024] In Example 28, the delivery system of Example 23 further includes, wherein the first tube has an inner diameter of about 0.094 inches (about 2.4 mm) and an outer diameter of about 0.110 inches (about 2.8 mm).

[0025] In Example 29, the delivery system of Example 23 further includes the second tube having an inner diameter of about 0.039 inches (about 0.991 mm) and an outer diameter of about 0.043 inches (about 1.092 mm).

[0026] In Example 30, the delivery system of Example 23 further includes the tapered distal tip being made of a polyether block amide having a durometer of 40. In Example 31, the delivery system of Example 23 further includes the outer body of the repositioning sheath being comprised of a polyether block amide having a durometer of 55.

[0027] In Example 32, a delivery system for positioning at least one medical device within 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 for insertion into the 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, and a second tube defining a second lumen, the second tube being disposed within the lumen of the outer body, the repositioning sheath having an inner diameter of approximately 0.166 inches (approximately 4.2 mm), the first tube having an outer diameter of approximately 0.110 inches (approximately 2.8 mm), and the second tube having an outer diameter of approximately 0.39 inches, the first tube being radially spaced from an inner wall surface of the outer body, and the second tube being radially spaced from the inner wall surface of the outer body. The delivery system further includes a hemostasis valve hub engaged with the proximal end of the repositioning sheath.

[0028] In Example 33, the delivery system of Example 32 further includes the hub being thermoformed with the proximal end of the repositioning sheath such that the axial and radial alignment of the first tube and the second tube is fixed at the proximal end of the repositioning sheath.

[0029] In Example 34, the delivery system of Example 33 further includes a distal end of the repositioning sheath having a tapered distal tip formed from a molded polymeric material such that the axial and radial alignment of the first tube and the second tube is fixed at the distal end.

[0030] In Example 35, the delivery system of Example 34 further includes the tapered distal tip having a length of about 3 cm. [Brief explanation of the drawings]

[0031] [Figure 1] FIG. 1 is a side view of an introducer sheath extending into a blood vessel, in accordance with components of the present disclosure; [Figure 2] 1 is a cross-sectional view of a medical device positioned within a blood vessel according to an embodiment of the present disclosure. [Figure 3] FIG. 10 is a side perspective view of a repositioning sheath attached to a hub in accordance with an embodiment of the present disclosure. [Figure 4] FIG. 4 is a cross-sectional view of the repositioning sheath of FIG. 3. DETAILED DESCRIPTION OF THE INVENTION

[0032] FIG. 1 shows a side cross-sectional view of a blood vessel V with an introducer sheath 100 at least partially inserted therein. In some embodiments, the introducer sheath 100 is used to facilitate the entry of various relatively large medical devices, such as a blood pump, through the introducer sheath 100 and into the blood vessel V, as described further herein. For this reason, 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 forms a lumen 112 of the introducer sheath 100. The introducer sheath 100 may be formed from a variety of polymeric or metallic materials. In further embodiments, the introducer sheath 100 may include an additional surface coating. The surface coating may include, but is not limited to, silicone, PET, or any other applicable polymer.

[0033] A hub 120 is generally included at the proximal end 106 of the introducer sheath 100 and on the proximal opening 107. The hub 120, also referred to herein as a hemostatic valve hub, is configured for hemostasis, i.e., to prevent blood from leaking out of the introducer sheath 100 during use. More specifically, a medical device, e.g., a catheter 168, may be inserted through the hub 120 and the introducer sheath 100 into the blood vessel V, and the hub 120 may maintain hemostasis between the catheter 168, the introducer sheath 100, and the surrounding environment. In some embodiments, the catheter 168 may be coupled to a medical device, such as the blood pump 150 shown in FIG. 2. After insertion of the catheter 168, it may be desirable to secure the axial and radial position of the catheter 168 to ensure that the catheter 168 (and any coupled medical device) is properly positioned during use. Additionally, in some instances, it may be desirable for the operator to reposition catheter 168 (and any connected medical devices) after insertion. Accordingly, in some embodiments, hub 120 may include a clamping port 130, consisting of several components within hub 120, for securing catheter 168 relative to hub 120 and vessel V. However, in other embodiments, clamping port 130 may not be incorporated.

[0034] FIG. 2 shows a cross-sectional view of the introducer sheath 100 of FIG. 1 after a medical device, illustratively a blood pump 150, has been inserted into the introducer sheath 100. As described above, a catheter, such as catheter 168, may be coupled to the proximal end of the blood pump 150 and extend outside of 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 may be fabricated integrally or monolithically. The impeller assembly housing 140 mounts 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 pump blood through the blood pump 150. More specifically, impeller 148 directs blood from a blood inlet 151 formed on impeller assembly housing 140, through impeller assembly housing 140, and out a blood outlet 152 formed on impeller assembly housing 140. In some embodiments, impeller shaft 146 and impeller 148 may be integrally formed, while in other embodiments, impeller shaft 146 and impeller 148 may be separate components. As shown in FIG. 2 , inlet 151 may be formed at an end of impeller assembly housing 140, and outlet 152 may be formed in a side of impeller assembly housing 140. In other embodiments, inlet 151 and / or outlet 152 may be formed in other portions of impeller assembly housing 140. In some embodiments, impeller assembly housing 140 may be coupled with a distally extending cannula, which may receive and deliver blood to inlet 151.

[0035] 2 , the motor housing 142 carries a motor 154 configured to rotatably drive the 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. Rotation of the drive magnet 158 ​​causes rotation of a driven magnet 160 connected to the impeller assembly housing 140. More specifically, in embodiments incorporating the impeller shaft 146, the impeller shaft 146 and impeller 148 are configured to rotate with the driven magnet 160. In other embodiments, the motor 154 may be coupled to the impeller assembly housing 140 via other components. While the introducer sheath 100 is illustrated above in conjunction with use with the blood pump 150, various other medical devices may be used with the introducer sheath 100 and hemostasis valve hub 120.

[0036] Although the introducer sheath 100 may be used for the initial delivery of medical devices into the blood vessel V, after delivery of the device, it may be desirable to exchange the introducer sheath 100 for a smaller sheath to increase blood flow and thereby reduce the chance of ischemia or hemostasis within the blood vessel V. In these instances, the introducer sheath 100 may be removed and replaced with a replacement sheath having a smaller size, or more specifically, a smaller diameter, than the introducer sheath 100. As described further herein, the replacement sheath may have a hub 120 coupled thereto. The delivered medical device, or a portion thereof, fits within the replacement sheath, which allows for the placement or replacement of one or more of the delivered medical devices within the patient's body.

[0037] For example, FIG. 3 shows a side view of a repositioning sheath 170 with a proximal end 171 coupled to a hub 120. The hub 120 may have a first arm 122 and a second arm 124 that allow at least two medical devices to extend through the hub 120 simultaneously. In these cases, the devices may be received through the repositioning sheath 170 and within the hub 120. As shown in FIG. 3, the repositioning sheath 170 has a proximal end 171 coupled 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 extending between the proximal end 171 and the distal end 172. The outer body 178 is defined by an outer surface 173 and an inner surface 175, as shown in the cross-sectional view of FIG. 4. The outer body 178 may be constructed from a polymeric material, including, but not limited to, silicone, polyether block amide (PEBAX®), polyurethane, Hytrel®, or various other thermoformable or thermosetting polymers. The material of the outer body 178 may also have various levels of stiffness. For example, in some instances, the outer body 178 may be constructed from PEBAX® with a durometer hardness of 55. However, various other durometer hardness values ​​may characterize the material comprising the outer body 178, and the foregoing examples are not intended to be limiting.

[0038] As shown by the dashed lines in FIG. 3 , a first tube 180 and a 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 may be fluidly connected to the first and second tubes 180, 190, respectively. Such an arrangement allows medical devices extending through the first and second tubes 180, 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 may be inserted into the first tube 180, and a medical device extending through the second arm 124 may be inserted into the second tube 190. Furthermore, the first tube 180 and the second tube 190 extend 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 can receive devices therethrough without the devices contacting each other. A medical device, such as a catheter, extending into the first tube 180 can extend into the first arm 122, and 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, the devices received therein (e.g., the catheter and stylet) do not contact each other during operation of the repositioning sheath 170. As shown in FIG. 3 , the hub 120 and the repositioning sheath 170 can be configured to receive a plug 188 or a stylet that can be received in the second arm 124 and the second tube 190 when no medical device is received therein. This reduces the likelihood of blood leaking out of hub 120 through second arm 124 while hub 120 and repositioning sheath 170 are in use.

[0039] In some instances, hub 120 is thermomolded onto proximal end 171. In a further example, hub 120 is glued onto proximal end 171. In this manner, proximal end 171 is shaped such that first tube 180 and second tube 190 disposed within repositioning sheath 170 are secured to one another at proximal end 171 and held in place axially and radially, as described further herein. In other embodiments, first tube 180 and second tube 190 may be molded into repositioning sheath 170 prior to coupling with hub 120. Thus, first tube 180 and second tube 190 may be secured axially and radially at proximal end 171 of repositioning sheath 170 without hub 120 attached. Furthermore, in some embodiments, distal tip 174 is formed from a melted or thermoformed polyamide such that distal tip 174 is molded and solidified. In this manner, first tube 180 and second tube 190 may be molded into repositioning sheath 170 at distal end 172 as well. Thus, the axial and radial orientation of first tube 180 and second tube 190 may be fixed at distal end 172 of repositioning sheath 170 as well.

[0040] Additionally, the distal tip 174 may be formed of a radiopaque material so that an operator can monitor the placement of the distal tip 174 using various imaging processes when the repositioning sheath 170 is inserted into a patient. Continuing to refer to FIG. 3 , the distal tip 174 is defined by a length L1. In some embodiments, the length L1 may range from about 1 cm to about 6 cm. For example, in some instances, the length L1 has a value of about 3 cm. A longer length L1 may be desirable because the tapered design of the distal tip 174 may facilitate transition of the repositioning sheath 170 into the blood vessel V due to its tapered diameter. In other words, the tapered design of the distal tip 174 allows more blood to flow around the repositioning sheath 170 at the distal end 172 of the repositioning sheath 170, increasing the ease with which blood can flow around the repositioning sheath 170.

[0041] The characteristics and arrangement of first tube 180, second tube 190, and repositioning sheath 170 are further described with reference to the cross-sectional view of FIG. 4. As shown, repositioning sheath outer body 178 defines a lumen 176 extending between a proximal end 171 and a distal end 172. Outer body 178 includes an outer surface 173 defined by an outer diameter D1. Outer diameter D1 can range from about 3 mm to about 7 mm. For example, in some instances, diameter D1 is about 5.2 mm. Further, outer body 178 can include an inner surface 175 defined by an inner diameter D2. Inner diameter D2 can range from about 2 mm to about 6 mm. For example, in some instances, inner diameter D2 can be 4.2 mm.

[0042] First tube 180 and second tube 190 are disposed within lumen 176 of outer body 178. First tube 180 is formed by outer body 182, which further defines lumen 184. First tube 180 is further defined by an outer diameter D3 and an inner diameter D4. In some embodiments, outer diameter D3 has a value between about 0.082 inches (about 2 mm) and about 0.230 inches (about 5.8 mm). For example, in some instances, outer diameter D3 has a value between about 0.110 inches (about 2.8 mm). In further embodiments, inner diameter D4 has a value between about 0.066 inches (about 1.7 mm) and about 0.214 inches (about 5.4 mm). For example, in some instances, inner diameter D4 has a value between about 0.094 inches (about 2.4 mm). Furthermore, in some cases, as shown in the cross-sectional view of FIG. 4 , first tube 180 can be maintained radially spaced apart from inner surface 175 of outer body 178 of repositioning sheath 170. This is due, at least in part, to outer diameter D3 being smaller than inner diameter D2. However, in other embodiments, first tube 180 and second tube 190 can be configured such that first tube 180 and second tube 190 contact inner surface 175 of outer body 178. In further embodiments, only one of first tube 180 and second tube 190 can contact inner surface 175 of outer body 178. For example, in some cases, first tube 180 can be radially spaced apart from inner surface 175 of outer body 178, while second tube 190 contacts inner surface 175. In other cases, the first tube 180 may contact the inner surface 175 of the outer body 178, and the second tube 190 is maintained radially spaced apart from the inner surface 175 of the outer body 178. Additionally, the first tube 180 and the second tube 190 may be positioned such that the tubes 180, 190 contact each other. In other embodiments, the first tube 180 is spaced apart from the second tube 190. However, various other arrangements of the first tube 180 and the second tube 190 may be used.

[0043] With continued reference to FIG. 4 , second tube 190 is also shown disposed within lumen 176 of repositioning sheath 170. Second tube 190 includes an outer body 192 defining a lumen 194 extending therethrough. Second tube 190 further includes an inner diameter D5 and an outer diameter D6. The inner diameter D5 may range from about 0.018 inches (about 0.5 mm) to about 0.1 inches (about 2.5 mm). For example, in some instances, the inner diameter D5 may be about 0.039 inches (about 0.991 mm). The outer diameter D6 may range from about 0.021 inches (about 0.5 mm) to about 0.11 inches (about 2.8 mm). For example, in some instances, the outer diameter D6 may be about 0.043 inches (about 1.092 mm).

[0044] Similar to that described with reference to first tube 180, second tube 190 is positioned such that it may be radially spaced apart from inner surface 175 of outer body 178 of repositioning sheath 170. Additionally, second tube 190 is shown radially spaced apart from first tube 180. In this manner, outer body 182 of first tube 180 and outer body 192 of second tube 190 may not contact each other or inner surface 175 of outer body 178 of repositioning sheath 170. Thus, repositioning sheath 170, first tube 180, and second tube 190 are molded together and radially and axially fixed at distal end 172 and proximal end 171 of repositioning sheath 170. First tube 180 and second tube 190 can be maintained spaced apart from each other and from inner surface 175 of outer body 178 as they extend between proximal end 171 and distal end 172. Due to the fixed arrangement of first tube 180 and second tube 190 at distal end 172 and proximal end 171, movement or sliding of first and second tubes 180, 190 within outer body 178 is reduced. In other embodiments, first tube 180 and second tube 190 can contact each other. In other embodiments, first tube 180 and / or second tube 190 can contact inner surface 175 of outer body 178 of repositioning sheath 170.

[0045] As described herein, first tube 180 and second tube 190 are configured to receive a medical device extending therethrough. For example, first tube 180 may be configured to receive a catheter, a blood pump, a guidewire, a guide catheter, or a small sheath. Additionally, second tube 190 may be configured to receive a guidewire, a stylet, a plug, a contrast injection, a drug injection, or other mechanism for flushing with heparin or saline. However, the medical devices and substances listed above are provided merely as examples, and additional medical devices or substances may be used with first tube 180 and / or second tube 190.

[0046] The above-described configuration in which first tube 180 and second tube 190 are disposed within repositioning sheath 170 and repositioning sheath 170 is coupled to hub 120 allows two separate medical devices to extend into or through hub 120 and into or through repositioning sheath 170 while remaining separated from one another. This may reduce the likelihood of the medical devices damaging or interfering with one another during insertion, repositioning, and / or removal of the medical devices.

[0047] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the features described above.

Claims

1. 1. A repositioning sheath for use in percutaneously delivering a medical device into a blood vessel, comprising: an outer body having an outer wall surface and an 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; a second tube defining a second lumen, the second tube being disposed within the lumen of the outer body.

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

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

4. The repositioning sheath of claim 1 , wherein the second tube and the first tube are positioned such that the first tube and the second tube contact each other.

5. 5. The repositioning sheath of claim 1, wherein the first tube has a first inner diameter and the second tube has a second inner diameter, the first inner diameter being larger than the second inner diameter.

6. 6. The repositioning sheath of claim 1, wherein the repositioning sheath has a distal end opposite a proximal end, the distal end of the repositioning sheath comprising a tapered distal tip.

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

8. 1. A delivery system for placing at least one medical device in a blood vessel, 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 for insertion into the blood vessel, the repositioning sheath comprising: a first tube defining a first lumen, the first tube being disposed within the lumen of the outer body; the repositioning sheath further including a second tube defining a second lumen, the second tube being disposed within the lumen of the outer body; a hub engaged with the proximal end of the repositioning sheath.

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

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

11. 11. The delivery system of claim 8, wherein the distal end of the repositioning sheath includes a tapered distal tip formed from a molded polymeric material such that the axial and radial alignment of the first tube and the second tube is fixed at the distal end.

12. 12. The delivery system of claim 8, wherein the first tube has a first inner diameter and the second tube has a second inner diameter, the first inner diameter being larger than the second inner diameter.

13. 13. The delivery system of claim 12, wherein the first inner diameter is about 2.4 mm and the second inner diameter is about 1 mm.

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

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

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