Triple-tube type reconfiguration sheet

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 specifically, the present disclosure relates to a repositioning sheath having at least two tubes disposed therein for receiving at least two medical devices.

Background Art

[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 the medical device is inserted into the introducer sheath for introduction into the patient's vascular system. In various cases, the medical device includes other devices such as a catheter or a blood pump. After delivery of the medical device, it may be desirable to replace the introducer sheath with a repositioning sheath that allows repositioning of the delivered medical device but is smaller in size than the introducer sheath. By replacing the introducer sheath with a repositioning sheath, blood flow can be increased, thereby reducing the potential for ischemia within the blood vessel. In these examples, it may be desirable for the repositioning sheath to receive at least two medical devices simultaneously. There is a need for an improved repositioning sheath that can receive two medical devices simultaneously.

Summary of the Invention

[0003] In Example 1, a repositioning sheath for use in delivering a medical device percutaneously 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 and disposed within the lumen of the outer body, and a second tube defining a second lumen and 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 relocation 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.

[0005] In Example 4, in any one of the relocation sheaths from Examples 1 to 3, the second tube and the first tube are arranged such that the first tube and the second tube are in contact with each other.

[0006] In Example 5, any one of the relocation sheaths from Examples 1 to 4 further includes having a first tube with an inner diameter of approximately 0.094 inches (approximately 2.4 mm) and an outer body of approximately 0.110 inches (approximately 2.8 mm), and a second tube with an inner diameter of approximately 0.039 inches (approximately 0.991 mm) and an outer diameter of approximately 0.043 inches (approximately 1.092 mm).

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

[0008] In Example 7, in any one of the repositioning sheaths from Examples 1 to 6, the tapered distal tip is made of a polyether block amide with a durometer hardness of 40. In Example 8, a delivery system for placing at least one medical device intravascularly includes a repositioning sheath having an outer body extending between a proximal and distal end, the outer body defining a lumen, and the repositioning sheath is configured for intravascular insertion, further including a first tube defining a first lumen and located within the lumen of the outer body, and a second tube defining a second lumen and located 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 the first tube being radially spaced away from the inner wall surface of the outer body, and optionally, the second tube being radially spaced away from the inner wall surface of the outer body.

[0010] In Example 10, the delivery system of Example 8 or Example 9 further includes the fact that a hub is formed together with the proximal end of the repositioning sheath by thermoforming such that the axial and radial arrangement of the first tube and the second tube is fixed at the proximal end of the repositioning sheath.

[0011] In Example 11, any one of the delivery systems from Examples 8 to 10 further includes a tapered distal tip formed from a molded polymer material such that the distal end of the repositioning sheath is fixed at the distal end in the axial and radial arrangement of the first and second tubes.

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

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

[0014] In Example 14, any one of the delivery systems in Examples 8-13 further comprises a tapered distal tip made of a polyether block amide with a durometer hardness of 50. In Example 15, any one of the delivery systems in Examples 8-14 further comprises the outer body of the repositioning sheath being made of a polyether block amide with a durometer hardness of 55.

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

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

[0017] In Example 18, the relocation sheath of Example 16 further includes the fact that the outer body of the relocation sheath has an inner diameter of approximately 0.166 inches (approximately 4.2 mm) and an outer diameter of approximately 0.206 inches (approximately 5.2 mm).

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

[0019] In Example 20, the repositioning sheath of Example 16 further includes a tapered distal tip having a length of approximately 3 cm at the distal end of the repositioning sheath. In Example 21, the repositioning sheath of Example 20 further comprises a tapered distal tip made of a polyether block amide with a durometer hardness of 40.

[0020] In Example 22, the repositioning sheath of Example 16 further comprises the outer body of the repositioning sheath being made of a polyether block amide with a durometer hardness of 55. In Example 23, a delivery system for placing at least one medical device intravascularly includes a repositioning sheath having an outer body extending between a proximal and distal end, the outer body defining a lumen, and the repositioning sheath configured for insertion into a blood vessel, further including a first tube defining a first lumen and positioned within the lumen of the outer body, and a second tube defining a second lumen and positioned 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. The delivery system further includes a hemostatic valve hub engaged with the proximal end of the repositioning sheath.

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

[0022] In Example 25, the delivery system of Example 24 further includes a tapered distal tip formed from a molded polymer material such that the distal end of the repositioning sheath has a tapered distal tip formed from a molded polymer material such that the axial and radial arrangement 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 having a tapered distal tip that is approximately 3 cm long. In Example 27, the delivery system of Example 23 further includes the fact that the outer body of the repositioning sheath has an inner diameter of approximately 0.166 inches (approximately 4.2 mm) and an outer diameter of approximately 0.206 inches (approximately 5.2 mm).

[0024] In Example 28, the delivery system of Example 23 further includes that 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 that 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).

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

[0027] In Example 32, a delivery system for placing at least one medical device intravascularly 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 being configured for insertion into a blood vessel, the repositioning sheath including a first tube defining a first lumen and disposed within the lumen of the outer body, and a second tube defining a second lumen and disposed within the lumen of the outer body, the repositioning sheath having an inner diameter of about 0.166 inches (about 4.2 mm), the first tube having an outer diameter of about 0.110 inches (about 2.8 mm), the second tube having an outer diameter of about 0.39 inches, 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. The delivery system further includes a hemostatic valve hub engaged with the proximal end of the repositioning sheath.

[0028] In Example 33, the delivery system of Example 32 further includes that the hub is formed by thermoforming together with the proximal end of the repositioning sheath such that the axial and radial arrangements of the first tube and the second tube are fixed at the proximal end of the repositioning sheath.

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

[0030] In Example 35, the delivery system of Example 34 further includes that the tapered distal tip has a length of about 3 cm.

Brief Description of the Drawings

[0031] [Figure 1] FIG. 1 is a side view of an introducer sheath extending intravascularly according to the components of the present disclosure. [Figure 2] FIG. 2 is a cross-sectional view of a medical device disposed intravascularly according to an embodiment of the present disclosure. [Figure 3] [[ID=2))FIG. 3 is a side perspective view of a repositioning sheath attached to a hub according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a cross-sectional view of the repositioning sheath of FIG. 3.

Modes for Carrying Out the Invention

[0032] Figure 1 shows a side cross-sectional view of a blood vessel V in which an introducer sheath 100 is at least partially inserted. In some embodiments, the introducer sheath 100 is used to facilitate the entry of various relatively large medical devices, such as blood pumps, into the blood vessel V through the introducer sheath 100, as will be further described herein. For this purpose, 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 to the proximal end 106. The introducer sheath 100 includes a proximal opening adjacent to the proximal end 106 and a distal opening 109 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 forms the lumen 112 of the introducer sheath 100. The introducer sheath 100 may be formed from various polymer 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] The hub 120 is generally located at the proximal end 106 and on the proximal opening 107 of the introducer sheath 100. The hub 120, also referred to herein as a hemostatic valve hub, is configured for hemostasis, i.e., to prevent blood from leaking from the introducer sheath 100 during use. More specifically, a medical device, such as a catheter 168, may be inserted into a blood vessel V through the hub 120 and the introducer sheath 100, and the hub 120 can maintain hemostasis between the catheter 168, the introducer sheath 100, and the surrounding environment. In some embodiments, the catheter 168 may be connected to a medical device such as a blood pump 150 shown in Figure 2. After insertion of the catheter 168, it may be desirable to fix the axial and radial position of the catheter 168 to ensure that the catheter 168 (and any connected medical device) is in the correct position during use. Furthermore, in some cases, it may be desirable for the operator to reposition the catheter 168 (and any connected medical devices) after insertion. Therefore, in some embodiments, the hub 120 may include a clamping port 130 consisting of several components within the hub 120 for securing the catheter 168 to the hub 120 and the blood vessel V. However, in other embodiments, the clamping port 130 may not be incorporated.

[0034] Figure 2 shows a cross-sectional view of the introducer sheath 100 of Figure 1 after a medical device, exemplary a blood pump 150, has been inserted into the introducer sheath 100. As described above, a catheter, such as a catheter 168, is connected to the proximal end of the blood pump 150 and may 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 may be manufactured integrally or monolithically. The impeller assembly housing 140 houses an impeller assembly 144. 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, the impeller 148 causes blood to flow out from a blood inlet 151 formed on the impeller assembly housing 140, through the impeller assembly housing 140, and out from a blood outlet 152 formed on the impeller assembly housing 140. In some embodiments, the impeller shaft 146 and the impeller 148 may be integrally formed, while in other embodiments, the impeller shaft 146 and the impeller 148 may be separate parts. 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 connected to a distally extending cannula that can receive blood and deliver it to the inlet 151.

[0035] Continuing to refer to Figure 2, the motor housing 142 houses a motor 154, which is configured to rotatably 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 the rotation of a driven magnet 160 connected to the impeller assembly housing 140. More specifically, in embodiments incorporating 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. The introducer sheath 100 is illustrated above in conjunction with the use of a blood pump 150, but various other medical devices may be used with the introducer sheath 100 and the hemostatic valve hub 120.

[0036] The introducer sheath 100 may be used for the initial delivery of a medical device into blood vessel V, but after the delivery of the device, it may be desirable to replace the introducer sheath 100 with a smaller sheath to increase blood flow and thereby reduce the chance of ischemia or blood flow occlusion in blood vessel V. In these cases, the introducer sheath 100 may be removed and replaced with a repositioning sheath having a smaller size, more specifically, a smaller diameter than the introducer sheath 100. As further described herein, the repositioning sheath may have a hub 120 connected to the repositioning sheath. The delivered medical device or a part thereof fits within the repositioning sheath, and the repositioning sheath allows for the placement or repositioning of one or more of the delivered medical devices within the patient's body.

[0037] For example, Figure 3 shows a side view of a relocation sheath 170 with a proximal end 171 connected 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 can be received through the relocation sheath 170 and also within the hub 120. As shown in Figure 3, the relocation 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 relocation 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 Figure 4. The outer body 178 may be composed of polymer materials 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 varying levels of stiffness. For example, in some cases, the outer body 178 may be composed of PEBAX® with a durometer hardness of 55. However, various other durometer hardness values ​​may characterize the material constituting the outer body 178, and the examples given above are not intended to be limiting.

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

[0039] In some cases, the hub 120 is thermomoulded on the proximal end 171. In further cases, the hub 120 is glued to the proximal end 171. In this way, the proximal end 171 is molded so that the first tube 180 and the second tube 190, which are placed within the repositioning sheath 170 as further described herein, are fixed to each other at the proximal end 171 and held in place axially and radially. In other embodiments, the first tube 180 and the second tube 190 may be molded within the repositioning sheath 170 before being connected to the hub 120. Thus, even without the hub 120 being attached, the first tube 180 and the second tube 190 can be fixed axially and radially at the proximal end 171 of the repositioning sheath 170. Furthermore, in some embodiments, the distal tip 174 is formed from molten or thermoformed polyamide so that the distal tip 174 is molded and solidified. In this way, the first tube 180 and the second tube 190 can be formed within the repositioning sheath 170 even at the distal end 172. Therefore, the axial and radial arrangement of the first tube 180 and the second tube 190 can be fixed even at the distal end 172 of the repositioning sheath 170.

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

[0041] The characteristics and arrangement of the first tube 180, the second tube 190, and the repositioning sheath 170 will be further described with reference to the cross-sectional view in Figure 4. As shown, the outer body 178 of the repositioning sheath defines a lumen 176, which extends between the proximal end 171 and the distal end 172. The outer body 178 has an outer surface 173 defined by an outer diameter D1. The outer diameter D1 can have a value in the range of approximately 3 mm to approximately 7 mm. For example, in some cases, the value of the diameter D1 is approximately 5.2 mm. Furthermore, the outer body 178 may have an inner surface 175 defined by an inner diameter D2. The inner diameter D2 can have a value in the range of approximately 2 mm to approximately 6 mm. For example, in some cases, the inner diameter D2 can have a value of 4.2 mm.

[0042] The first tube 180 and the second tube 190 are positioned within the lumen 176 of the outer body 178. The first tube 180 is formed by the outer body 182, which further defines the lumen 184. Furthermore, the first tube 180 is defined by an outer diameter D3 and an inner diameter D4. In some embodiments, the value of the outer diameter D3 is approximately 0.082 inches (approximately 2 mm) to approximately 0.230 inches (approximately 5.8 mm). For example, in some cases, the value of the outer diameter D3 is approximately 0.110 inches (approximately 2.8 mm). In further embodiments, the value of the inner diameter D4 is approximately 0.066 inches (approximately 1.7 mm) to approximately 0.214 inches (approximately 5.4 mm). For example, in some cases, the value of the inner diameter D4 is approximately 0.094 inches (approximately 2.4 mm). Furthermore, in some cases, as shown in the cross-sectional view of Figure 4, the first tube 180 may be maintained radially spaced away from the inner surface 175 of the outer body 178 of the repositioning sheath 170. This is at least in part 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 may be configured to contact the inner surface 175 of the outer body 178. In further embodiments, only one of the first tube 180 and the second tube 190 may be in contact with the inner surface 175 of the outer body 178. For example, in some cases, the first tube 180 may be radially spaced away from the inner surface 175 of the outer body 178, while the second tube 190 is in contact with the inner surface 175. In other cases, the first tube 180 may be in contact with the inner surface 175 of the outer body 178, while the second tube 190 is maintained radially spaced away from the inner surface 175 of the outer body 178. Furthermore, the first tube 180 and the second tube 190 may be arranged so that both tubes 180, 190 are in contact with each other. In other embodiments, the first tube 180 is spaced away from the second tube 190. However, various other arrangements of the first tube 180 and the second tube 190 may be used.

[0043] Continuing to refer to Figure 4, the second tube 190 is also shown positioned within the lumen 176 of the repositioning sheath 170. The second tube 190 comprises an outer body 192 defining a lumen 194 extending through the second tube 190. Furthermore, the second tube 190 comprises an inner diameter D5 and an outer diameter D6. The value of the inner diameter D5 can range from approximately 0.018 inches (approximately 0.5 mm) to approximately 0.1 inches (approximately 2.5 mm). For example, in some cases, the value of the inner diameter D5 is approximately 0.039 inches (approximately 0.991 mm). The value of the outer diameter D6 can range from approximately 0.021 inches (approximately 0.5 mm) to approximately 0.11 inches (approximately 2.8 mm). For example, in some cases, the value of the outer diameter D6 is approximately 0.043 inches (approximately 1.092 mm).

[0044] Similar to that described with reference to the first tube 180, the second tube 190 is positioned so as to be radially spaced away from the inner surface 175 of the outer body 178 of the repositioning sheath 170. Furthermore, the second tube 190 is shown radially spaced away 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 may not be in contact with each other or with the inner surface 175 of the outer body 178 of the repositioning sheath 170. Thus, the repositioning sheath 170, the first tube 180, and the second tube 190 are molded together and fixed radially and axially at the distal end 172 and proximal end 171 of the repositioning sheath 170. The first tube 180 and the second tube 190 can be maintained spaced apart from each other and from the inner surface 175 of the outer body 178 when they extend 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, movement or sliding of the first and second tubes 180 and 190 within the outer body 178 is reduced. In other embodiments, the first tube 180 and the second tube 190 may be in contact with each other. In other embodiments, the first tube 180 and / or the second tube 190 may be in contact with the inner surface 175 of the outer body 178 of the repositioning sheath 170.

[0045] As described herein, the first tube 180 and the second tube 190 are configured to receive medical devices extending through them. For example, the first tube 180 may be configured to receive a catheter, blood pump, guidewire, guidecatheter, or small sheath. Furthermore, the second tube 190 may be configured to receive a guidewire, stylet, plug, contrast agent infusion, drug infusion, or other mechanism for flushing with heparin or saline. However, the medical devices and materials listed above are provided merely as examples, and further medical devices or materials may be used with the first tube 180 and / or the second tube 190.

[0046] The above configuration, in which the first tube 180 and the second tube 190 are placed within the repositioning sheath 170 and the repositioning sheath 170 is connected to the hub 120, allows two separate medical devices to extend within or through the hub 120 and within or through the repositioning sheath 170 while remaining separated from each other. This can reduce the possibility of the medical devices damaging or interfering with each other 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 certain features, the scope of the present invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described above.

Claims

1. A repositioning sheath for use when delivering medical devices percutaneously into blood vessels, An outer body having an outer wall surface and an inner wall surface that define the lumens, 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, The repositioning sheath has a distal end opposite to the proximal end, and the distal end of the repositioning sheath is provided with a tapered distal tip formed from a molded polymer material such that the axial and radial arrangement of the first tube and the second tube is fixed at the distal end.

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 claim 2, wherein the second tube is radially spaced apart from the inner wall surface of the outer body.

4. The repositioning sheath according to claim 1 or 2, 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 claim 1 or claim 2, wherein the first tube has a first inner diameter, the second tube has a second inner diameter, and the first inner diameter is larger than the second inner diameter.

6. The repositioning sheath according to claim 1, wherein the tapered distal tip portion is made of a polyether block amide having a durometer hardness of 40.

7. A delivery system for placing at least one medical device into a blood vessel, A repositioning sheath having an outer body extending between a proximal end and a distal end, wherein the outer body defines a lumen, and the repositioning sheath is configured for insertion into the blood vessel, and the repositioning sheath is A first tube defining a first lumen, the first tube being disposed within the lumen of the outer body, The repositioning sheath further includes a second tube defining a second lumen, the second tube being disposed within the lumen of the outer body, The repositioning sheath comprises a hub engaged with the proximal end of the repositioning sheath, A delivery system wherein the distal end of the repositioning sheath has a tapered distal tip formed from a molded polymer material such that the axial and radial arrangement of the first tube and the second tube is fixed at the distal end.

8. The delivery system according to claim 7, wherein the first tube is radially spaced away from the inner wall surface of the outer body, and optionally, the second tube is radially spaced away from the inner wall surface of the outer body.

9. The delivery system according to claim 7, wherein the hub is formed together with the proximal end of the repositioning sheath by thermoforming such that the axial and radial arrangements of the first tube and the second tube are fixed at the proximal end of the repositioning sheath.

10. The delivery system according to any one of claims 7 to 9, wherein the first tube has a first inner diameter, the second tube has a second inner diameter, and the first inner diameter is greater than the second inner diameter.

11. The delivery system according to claim 10, wherein the first inner diameter is approximately 2.4 mm and the second inner diameter is approximately 1 mm.

12. The delivery system according to claim 7, wherein the tapered distal tip portion is made of a polyether block amide having a durometer hardness of 50.

13. The delivery system according to claim 7, wherein the outer body of the repositioning sheath is made of a polyether block amide having a durometer hardness of 55.

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