Attachment device for sheath hub with angled suture pad and strain relief - Patent Application 20070122997

Abstract

The attachment device (170) for coupling to the hub (120) includes a base having a proximal end (173), a distal end (171), and a lumen (174) extending along a longitudinal axis between the proximal and distal ends, a first extension (180) coupled to the base, the first extension having legs (182) and a base portion (184), the base portion including at least one opening (186), and a second extension (180) coupled to the base, the second extension having legs (182) and a base portion (184), the base portion including at least one opening (186). Each of the legs of the first extension and the legs of the second portion are angled relative to the longitudinal axis of the base, and the base is constructed from an elastomeric material to provide strain relief at both the proximal and distal ends.

Description

[Technical Field]

[0001] The present disclosure relates to attachment means for securing a sheath hub to a patient's skin. More particularly, the present disclosure relates to an attachment device coupled to the hub of an introducer or repositioning sheath, the attachment device having a suture pad for coupling the attachment device to the patient's skin. [Background technology]

[0002] In various procedures for delivering intravascular medical devices, an introducer sheath is percutaneously 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 vasculature. In various examples, the medical device includes a catheter or other device, such as a blood pump. A hub may be incorporated into the proximal end of the introducer sheath to reduce blood leakage when the device is inserted, positioned, manipulated, and removed. The introducer sheath may be removed and replaced with a repositioning sheath, which may also incorporate a hub for maintaining hemostasis. During these procedures, it may be desirable for the sheath and hub to be secured to the patient's skin to ensure that the hub and sheath maintain a desired position. However, during this time, a medical device may be delivered through the introducer sheath and / or coupled with a repositioning sheath to reposition it, or the sheath and / or hub may need to be repositioned. Improved attachment means for securing a hub and associated sheath to a patient are needed. Summary of the Invention

[0003] In Example 1, an attachment device configured to couple to a hub of a sheath for delivering a medical device includes: a base having a proximal end, a distal end opposite the proximal end, and a lumen extending along a longitudinal axis between the proximal end and the distal end; a first extension coupled to the base, the first extension having legs and a base portion, the base portion including at least one opening; and a second extension coupled to the base, the second extension having legs and a base portion, the base portion including at least one opening. The attachment device further includes: each of the legs of the first extension and the legs of the second portion angled relative to the longitudinal axis of the base; and the base constructed from an elastomeric material, whereby the attachment device is configured to provide strain relief.

[0004] In Example 2, the mounting device of Example 1 further includes: the elastomeric material is comprised of silicone or rubber. In Example 3, the mounting device of Example 1 or Example 2 further includes: the base includes a narrowed portion and a cylindrical portion.

[0005] In Example 4, the mounting device of Example 3 further includes: the narrow portion defined by a length; the cylindrical portion defined by a length; and the length of the narrow portion is less than the length of the cylindrical portion.

[0006] In Example 5, the mounting device of Example 3 further includes the narrow portion defined by a length, the cylindrical portion defined by a length, and the length of the narrow portion approximately equal to the length of the cylindrical portion.

[0007] In Example 6, the mounting device of any one of Examples 1 to 5 further includes an angle at which the legs of the first extension portion extend and an angle at which the legs of the second extension portion extend are substantially equal.

[0008] In Example 7, the mounting device of Example 6 further includes the angle having a value ranging from about 30 degrees to about 90 degrees. In Example 8, the attachment device of any one of Examples 1-7 further includes at least a portion of the hub being received within the lumen of the attachment device.

[0009] In Example 9, the mounting device of any one of Examples 1-8 further includes: the at least one opening in each base portion includes two openings. In Example 10, a delivery system for delivering at least one medical device into a blood vessel includes a sheath having a proximal end and a distal end and configured to be inserted through a blood vessel, and a hub engaged with the proximal end of the sheath, the hub coupled to an attachment device at the distal end of the hub. The attachment device includes a base having a proximal end, a distal end opposite the proximal end, and a lumen extending along a longitudinal axis between the proximal end and the distal end, a first extension coupled to the base, the first extension having legs and a base portion, the base portion including at least one opening, and a second extension coupled to the base, the second extension having legs and a base portion, the base portion including at least one opening. The attachment device further includes: each of the legs of the first extension and the legs of the second portion angled relative to the longitudinal axis of the base; and the base constructed from an elastomeric material such that the attachment device is configured to provide strain relief at both the proximal end and the distal end during engagement with the hub.

[0010] In Example 11, the delivery system of Example 10 further includes: the hub includes a cylindrical portion coupled to a narrowed portion, the cylindrical portion being defined by an outer wall. In Example 12, the delivery system of Example 11 further includes: a wall of the lumen of the base includes a groove extending circumferentially around the lumen.

[0011] In Example 13, the delivery system of Example 12 further includes: the outer wall of the cylindrical portion includes a rib extending around the outer wall, the rib configured to engage the groove when the hub is coupled with the mounting device.

[0012] In Example 14, the delivery system of any one of Examples 10-13 further includes the elastomeric material of the base being silicone or rubber. In Example 15, the delivery system described in any one of Examples 10 to 14 has an angle at which the legs of the first extension portion extend in a range of about 30 degrees to about 90 degrees, and an angle at which the legs of the second extension portion extend in a range of about 30 degrees to about 90 degrees.

[0013] In Example 16, an attachment device configured to couple to a hub of a sheath for delivery of a medical device includes: a base having a proximal end, a distal end opposite the proximal end, and a lumen extending along a longitudinal axis between the proximal end and the distal end; a first extension coupled to the base, the first extension having legs and a base portion, the base portion including at least one opening; and a second extension coupled to the base, the second extension having legs and a base portion, the base portion including at least one opening. The attachment device further includes: each of the legs of the first extension and the legs of the second portion angled relative to the longitudinal axis of the base; and the base constructed from an elastomeric material, whereby the attachment device is configured to provide strain relief at both the proximal end and the distal end during engagement with the hub.

[0014] In Example 17, the attachment device of Example 16 further includes, wherein the elastomeric material is comprised of silicone or rubber. In Example 18, the mounting device of Example 16 or Example 17 further includes: the base includes a narrowed portion and a cylindrical portion.

[0015] In Example 19, the mounting device of Example 18 further includes: the narrow portion defined by a length; the cylindrical portion defined by a length; and the length of the narrow portion is less than the length of the cylindrical portion.

[0016] In Example 20, the mounting device of Example 18 further includes the narrowed portion defined by a length, the cylindrical portion defined by a length, and the length of the narrowed portion approximately equal to the length of the cylindrical portion.

[0017] In Example 21, the mounting device of Example 16 further includes an angle at which the legs of the first extension extend and an angle at which the legs of the second extension extend are approximately equal. In Example 22, the mounting device of Example 21 further includes the angle having a value ranging from about 30 degrees to about 90 degrees.

[0018] In Example 23, the attachment device of Example 16 further includes at least a portion of the hub being received within the lumen of the attachment device. In Example 24, the mounting device of Example 16 further includes: the at least one opening in each base portion includes two openings.

[0019] In Example 25, an attachment device configured to couple to a hub of a sheath for delivery of a medical device includes a base having a proximal end, a distal end opposite the proximal end, and a lumen extending along a longitudinal axis between the proximal end and the distal end, the base including a cylindrical portion and a narrow portion, a first suture pad coupled to the base having at least one opening, and a second suture pad coupled to the base having at least one opening, the attachment device further including each of the first suture pad and the second suture pad being inclined at an angle ranging from about 30 degrees to about 90 degrees relative to the longitudinal axis of the base, the cylindrical portion having a length of about 10 mm, and the narrow portion having a length of about 12 mm.

[0020] In Example 26, the attachment device of Example 25 further includes: the base is formed from an elastomeric material, whereby the attachment device is configured to provide strain relief at both the proximal end and the distal end during engagement with the hub.

[0021] In Example 27, the attachment device of Example 26 further includes, wherein the elastomeric material is comprised of silicone or rubber. In Example 28, the attachment device of Example 25 further includes: each of the first suture pad and the second suture pad includes at least two openings.

[0022] In Example 29, the attachment device of Example 25 further includes that the first suture pad and the second suture pad each include legs extending from the base and attached to base portions of the first suture pad and the second suture pad.

[0023] In Example 30, a delivery system for delivering at least one medical device into a blood vessel includes a sheath having a proximal end and a distal end and configured to be inserted through a blood vessel, a hemostatic valve hub engaged with the proximal end of the sheath, the hemostatic valve hub coupled to an attachment device at the distal end of the hemostatic valve hub, the attachment device including: a base having a proximal end, a distal end opposite the proximal end, and a lumen extending along a longitudinal axis between the proximal end and the distal end, a first extension coupled to the base, the first extension having legs and a base portion, the base portion including at least one opening, and a second extension coupled to the base, the second extension having legs and a base portion, the base portion including at least one opening. The attachment device further includes: each of the legs of the first extension portion and the legs of the second portion being inclined relative to the longitudinal axis of the base; and the base being constructed from an elastomeric material, whereby the attachment device is configured to provide strain relief at both the proximal end and the distal end during engagement with the hemostasis valve hub.

[0024] In Example 31, the delivery system of Example 30 further includes: the hemostasis valve hub includes a cylindrical portion coupled with a narrowed portion, the cylindrical portion being defined by an outer wall. In Example 32, the delivery system of Example 31 further includes: a wall of the lumen of the base includes a groove extending circumferentially around the lumen.

[0025] In Example 33, the delivery system of Example 32 further includes: the outer wall of the cylindrical portion includes a rib extending around the outer wall, the rib configured to engage with the groove when the hemostasis valve hub is coupled with the attachment device.

[0026] In Example 34, the delivery system of Example 30 further includes, wherein the elastomeric material of the base is silicone or rubber. In Example 35, the delivery system of Example 30 further includes an angle at which the legs of the first extension portion extend in a range of about 30 degrees to about 90 degrees, and an angle at which the legs of the second extension portion extend in a range of about 30 degrees to about 90 degrees. [Brief explanation of the drawings]

[0027] [Figure 1] FIG. 1 shows a side view of an introducer sheath extending into a blood vessel, according to elements of the present disclosure. [Figure 2] FIG. 2 shows a cross-sectional view of a medical device positioned within a blood vessel according to an embodiment of the present disclosure. [Figure 3] FIG. 3 illustrates a side view of a portion of an introducer sheath with an attachment device and hub attached to the introducer sheath according to an embodiment of the present disclosure. [Figure 4] FIG. 4 illustrates a top left perspective view of a mounting apparatus according to an embodiment of the present disclosure. [Figure 5] FIG. 5 shows a cross-sectional view of the mounting device of FIG. [Figure 6] FIG. 6 illustrates a top left perspective view of a mounting apparatus according to an embodiment of the present disclosure. [Figure 7] FIG. 7 shows a cross-sectional view of the mounting device of FIG. [Figure 8] FIG. 8 is an exploded view of a mounting device and a hub according to an embodiment of the present disclosure. [Figure 9] FIG. 9 is a cross-sectional view of an attachment device coupled with a hub according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0028] FIG. 1 shows a side cross-sectional view of a blood vessel V with an introducer sheath 100 at least partially inserted therein. While the disclosure herein is primarily made with reference to the introducer sheath 100, the disclosure may also be applied to a repositioning sheath or various other applicable types of sheaths. 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 described further herein, through the introducer sheath 100 and into the blood vessel V. Accordingly, 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 (not shown) adjacent the proximal end 106 and a distal opening 109 adjacent the distal end 108. The introducer sheath 100 has a body portion 110 extending between a proximal end 106 and a distal end 108, and the body portion 110 defines 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.

[0029] Hub 120 is generally included on a proximal opening (not shown) of introducer sheath 100 at proximal end 106. Hub 120, also referred to herein as a hemostatic valve hub, is configured for hemostasis, i.e., to prevent blood from leaking out of introducer sheath 100 during use. More specifically, a medical device, e.g., catheter 155, may be inserted through hub 120 and introducer sheath 100 into blood vessel V, and hub 120 may maintain hemostasis between catheter 155, introducer sheath 100, and the external environment. In some embodiments, catheter 155 may be coupled to a medical device, such as blood pump 150 shown in FIG. 2. After insertion of catheter 155, it may be desirable to secure the axial and radial position of catheter 155 to ensure that catheter 155 (and any coupled medical device) is properly positioned during use. Additionally, in some instances, it may be desirable for the operator to reposition catheter 155 (and any associated medical devices) after insertion. Accordingly, hub 120 may include a built-in fastening port 130, consisting of several components associated with hub 120, that provides fixation of catheter 155 relative to hub 120 and vessel V. It may also be desirable to secure hub 120 to the patient, as described in more detail below.

[0030] FIG. 2 shows a cross-sectional view of the introducer sheath 100 of FIG. 1 after inserting a medical device, illustratively a blood pump 150, into the introducer sheath 100. As mentioned above, in some embodiments, a catheter, such as catheter 155, can be coupled to the proximal end of the blood pump 150 and can 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 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 and forces blood through the blood pump 150. More specifically, impeller 148 directs blood from a blood inlet 151 formed in impeller assembly housing 140, through impeller assembly housing 140, and out a blood outlet 152 formed in impeller assembly housing 140. In some embodiments, impeller shaft 146 and impeller 148 may be integrated, 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 to a distally extending cannula (not shown), which may receive blood and deliver it to inlet 151.

[0031] 2 , the motor housing 142 houses a motor 154, which is 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 in conjunction with the introducer sheath 100 and hemostasis valve hub 120.

[0032] As mentioned above, once the introducer sheath 100 or repositioning sheath is introduced into the blood vessel V, it may be desirable to secure the hemostasis valve hub 120 relative to the patient. For example, as shown in FIG. 3, the hub 120 may have an attachment device 170 coupled thereto. More specifically, the attachment device 170 may be coupled to the distal end 124 of the hub 120. Referring now to FIGS. 4-7, embodiments of the attachment device 170 will be further described herein.

[0033] FIG. 4 shows a top, left-hand perspective view of the attachment device 170. The attachment device 170 includes a base 172 defined by a generally cylindrical configuration. The base 172 can have a distal end 171 opposite a proximal end 173 and a lumen 174 extending therebetween. The lumen 174 extends along the longitudinal axis L ( FIG. 3 ) of the base 172 of the attachment device 170. Additionally, the base 172 includes an outer surface 176 having at least two collars 178 extending around the entire periphery of the outer surface 176 of the base 172. As shown, the attachment device 170 can also include at least two extensions or suture pads 180 extending outward from the base 172. As shown, each of the at least two suture pads 180 is comprised of a connector or leg 182 and a suture pad base 184. More specifically, connector 182 extends from base 172 to suture pad bases 184. As shown, each suture pad base 184 is generally oval-shaped with at least one opening 186 extending therethrough. Other shapes for suture pad bases 184 are possible. Once introducer sheath 100 is inserted into blood vessel V, at least one opening 186 may be configured to pass a suture therethrough and secure at least two suture pads 180 to the patient's skin.

[0034] Further, still referring to FIG. 4 , the suture pads 180, and more specifically, the connectors or legs 182 of each suture pad 180, are inclined at an angle α relative to the longitudinal axis L of the base 172. In these embodiments, the outer surface 176 of the base 172 extends generally parallel to the longitudinal axis L; therefore, the angle α is also assumed to be relative to the outer surface 176. However, in some embodiments, the outer surface 176 of the base 172 is not parallel to the longitudinal axis L; in these instances, the angle α is not defined relative to the outer surface 176. The angle α has a value that may range from about 30 degrees to about 90 degrees. For example, in some embodiments, the angle α has a value that may range from about 35 degrees to about 85 degrees, from about 40 degrees to about 80 degrees, from about 45 degrees to about 75 degrees, from about 50 degrees to about 70 degrees, or from about 55 degrees to about 65 degrees. In further embodiments, the angle α may have a value of about 45 degrees. In this manner, each of the at least two suture pads 180 is angled relative to the distal end 171 of the base 172 of the attachment device 170 .

[0035] The forward tilt of each of the at least two suture pads 180 relative to the longitudinal axis L provides several advantages. For example, the forward tilt of the legs 182 of each suture pad 180 of the attachment device 170 increases the ease with which the operator can adjust the hub 120 before, during, or after a procedure, compared to a suture pad without a tilted connector. In particular, the operator can more easily actuate the hub 120 upward or downward, allowing for easier insertion of the device into the hub 120. The forward tilt of the legs 182 allows the operator to more easily adjust the hub 120 relative to the skin surface, compared to a suture pad without a tilted connector, because the opening 186 is positioned closer to the distal end 171 of the attachment device 170 than in a non-tilted suture pad. By moving the opening 186, and therefore the connection point between the attachment device 170 and the patient, more distally (compared to a non-tilted suture pad), the proximal end 173 of the attachment device 170 can be more easily lifted from the patient's skin surface. In other words, the hub 120 coupled to the attachment device 170 can be more easily “tented.” As a result, less force is applied to the legs 182 during adjustment of the hub 120, reducing discomfort to the patient. Additionally, the forward tilt of the suture pad 180 helps avoid transmitting tension forward on the introducer sheath 100 due to the ability to more easily adjust and / or “tent” the hub 120. If the legs 182 did not have this forward tilt, when adjustment of the hub 120 was required, the operator would likely need to remove the connection (e.g., sutures) of the aperture 186 to the patient, adjust the hub 120, and re-secure the legs 182 to the patient. Thus, the forward tilt of the legs 182 increases the flexibility with which the hub 120 may be adjusted while maintaining a connection to the patient, reduces discomfort to the patient, reduces the likelihood of re-suturing the suture pad, and helps reduce the force applied to the introducer sheath 100 when delivering devices through the hub 120.

[0036] Base 172 may be defined to have a cylindrical portion 190 and a narrow portion 192. Narrow portion 192 may comprise distal end 171 of base 172, while cylindrical portion 190 may comprise proximal end 173 of base 172. As shown in the cross-sectional view of FIG. 5, narrow portion 192 may have a length L1, and cylindrical portion 190 may have a length L2. In the exemplary embodiment of FIG. 5, length L1 may have a value between about 6 mm and about 8 mm, and length L2 may have a value between about 8 mm and about 11 mm. In these examples, length L1 may be shorter than length L2. However, in other embodiments, length L2 may be approximately equal to length L1 and / or longer than length L1.

[0037] Additionally, the base 172 includes both a narrowed portion 192 and a cylindrical portion 190 of the base 172 to provide strain relief. More specifically, the base 172 may be constructed of a flexible or conformable material. For example, the base 172 may be constructed of an elastomer, including, but not limited to, silicone, rubber, a thermoplastic vulcanizate elastomer, or various other applicable materials. When the distal end 124 of the hub 120 is inserted into the lumen 174 of the attachment device 170, at least a majority of the cylindrical portion 190 receives a portion of the hub 120 inserted therethrough. As shown in FIG. 3 , the narrowed portion 192 receives at least a portion of the introducer sheath 100 extending therethrough. In this manner, if there is a force imparted to the hub 120 due to forcing the hub 120 into the attachment device 170, rotating or tilting the hub 120, or otherwise moving the hub and / or introducer sheath 100 during operation of the introducer sheath 100 and hub 120, the force is imparted to the elastomeric material of the attachment device 170 rather than the rigid material of the hub 120. In this manner, the incorporation of the attachment device 170 provides a strain relief that may protect the life and / or integrity of the hub 120. Furthermore, as the introducer sheath 100 extends from the distal end 171 of the attachment device 170, if there is any force imparted to the introducer sheath 100 towards the distal end 171 of the attachment device 170, the strain and / or force is imparted to the elastomeric material of the attachment device 170 rather than the introducer sheath 100. This may reduce the likelihood of the introducer sheath 100 kinking or breaking. In some embodiments, strain and / or force is applied to the attachment device 170 rather than to the patient's skin, reducing trauma to the patient at the intradermal access site.

[0038] 6 and 7, additional embodiments of the attachment device 170 are shown. As shown, the attachment device 170 includes a base 172 and at least two suture pads 180 extending outward from the base 172. The base 172 has a cylindrical portion 190 and a narrow portion 192. The cylindrical portion 190 is defined by a modified length L2', and the narrow portion 192 has a modified length L1'. In the exemplary embodiment of FIGS. 6 and 7, the narrow portion 192 has a length L1' that is longer than the length L1 shown in the exemplary embodiment of FIGS. 4 and 5. In some embodiments, the length L1' of the narrow portion 192 can be equal to or greater than the length L2' of the cylindrical portion 190. In some embodiments, the value of the length L1' can range from about 12 mm to about 16 mm, and the value of the length L2' can range from about 10 mm to about 12 mm. This may provide several advantages when introducer sheath 100 is inserted into blood vessel V and attachment device 170 is pressed against the patient's skin. For example, this may increase the overall volume of elastomeric material in attachment device 170, which can provide strain relief. Additionally, the increased length of narrowed portion 192 increases the depth to which attachment device 170 can extend into the patient's skin. This may increase the stability of the connection between attachment device 170 and the patient and reduce the chance of attachment means 170 becoming dislodged or dislodged from the patient's incision site. Furthermore, as indicated by length L1′, the increased length of narrowed portion 192 may further increase the ability of hub 120 to seal the insertion site for introducer sheath 100, thus reducing the amount of blood leakage and loss around introducer sheath 100 and hub 120. More specifically, the increased length L1' allows more of the incision site to be occupied by the attachment device 170, reducing the likelihood that blood will seep around the attachment device 170 and out of the incision site.

[0039] FIG. 8 shows an exploded view of the hub 120 and the attachment device 170. As shown, the hub 120 includes a proximal end 122 opposite a distal end 124. The distal end 124 is defined by an engagement portion 194 configured to be received within the lumen 174 of the attachment device 170. With further reference to FIG. 8, the engagement portion 194 is defined as having an outer wall 196 having a generally cylindrical shape. The outer wall 196 includes at least one engagement rib 198 extending therefrom. In these embodiments, the engagement rib 198 is configured to be received in the groove 188 of the lumen 174 of the attachment device 170, for example, as shown in FIGS. 5 and 7. Additionally, the outer wall 196 includes a stop ring 199 extending therefrom and extending circumferentially therearound. As shown in FIG. 9, the stop ring 199 acts as an axial stop when the hub 120 is pushed into the lumen 174 of the attachment device 170, indicating to the user when the hub 120 is fully inserted into the attachment device 170 (i.e., the groove 188 is engaged with the engagement rib 198).

[0040] In this manner, the attachment device 170 can be pushed onto the distal end 124 of the hub 120 until the grooves 188 engage the engagement ribs 198, securing the positioning of the attachment device 170 on the hub 120. FIG. 9 shows a cross-sectional view of the hub 120 with the attachment device 170 fully engaged and positioned on the hub 120. More specifically, the engagement ribs 198 of the hub 120 are engaged within the grooves 188 of the hub 120. In this manner, the engagement between the hub 120 and the attachment device 170 is maintained, so that the hub 120 and the attachment device 170 can still rotate relative to one another.

[0041] Although the embodiments and methods are described with reference to a catheter 155 and a blood pump 150 received by the catheter 155, various other medical devices may be incorporated. Various modifications and additions may be made to the exemplary embodiments described without departing from the scope of the invention. For example, while the above-described embodiments refer to particular features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the above-described features.

Claims

1. 1. An attachment device configured to couple with a hub of a sheath for delivering a medical device, comprising: a base having a proximal end, a distal end opposite the proximal end, and a lumen extending along a longitudinal axis between the proximal end and the distal end; a first extension coupled to the base, the first extension having a leg and a base portion, the base portion including at least one opening; a second extension coupled to the base, the second extension having a leg and a base portion, the base portion including at least one opening; Equipped with each of the legs of the first extension and the second portion is inclined relative to the longitudinal axis of the base; the base being constructed from an elastomeric material, whereby the mounting device is configured to provide strain relief; Mounting device.

2. The mounting device of claim 1 , wherein the elastomeric material is comprised of silicone or rubber.

3. The mounting device of claim 1 or 2, wherein the base includes a narrow portion and a cylindrical portion.

4. 4. The mounting device of claim 3, wherein the narrow portion is defined by a length and the cylindrical portion is defined by a length, the length of the narrow portion being less than the length of the cylindrical portion.

5. 4. The mounting device of claim 3, wherein said narrow portion is defined by a length and said cylindrical portion is defined by a length, said length of said narrow portion being approximately equal to said length of said cylindrical portion.

6. The mounting device according to any one of claims 1 to 5, wherein the angle at which the legs of the first extension portion extend and the angle at which the legs of the second extension portion extend are substantially equal.

7. The mounting device of claim 6 , wherein the angle has a value ranging from about 30 degrees to about 90 degrees.

8. The attachment device of any one of claims 1 to 7, wherein at least a portion of the hub is received within the lumen of the attachment device.

9. A mounting device according to any preceding claim, wherein the at least one opening in each base portion comprises two openings.

10. 1. A delivery system for intravascular delivery of at least one medical device, comprising: a sheath having a proximal end and a distal end and configured to be inserted through a blood vessel; a hub coupled to the proximal end of the sheath, the hub coupled to an attachment device at the distal end of the hub; The mounting device comprises: a base having a proximal end, a distal end opposite the proximal end, and a lumen extending along a longitudinal axis between the proximal end and the distal end; a first extension coupled to the base, the first extension having a leg and a base portion, the base portion including at least one opening; a second extension coupled to the base, the second extension having a leg and a base portion, the base portion including at least one opening; Equipped with each of the legs of the first extension and the second portion is inclined relative to the longitudinal axis of the base; the base is constructed from an elastomeric material such that the attachment device is configured to provide strain relief at both the proximal end and the distal end when the attachment device is coupled with the hub. Delivery system.

11. The delivery system of claim 10 , wherein the hub includes a cylindrical portion coupled to a narrowed portion, the cylindrical portion being defined by an outer wall.

12. The delivery system of claim 11 , wherein the wall of the lumen of the base includes a groove extending circumferentially around the lumen.

13. 13. The delivery system of claim 12, wherein the outer wall of the cylindrical portion includes a rib extending circumferentially therearound, the rib configured to engage the groove when the hub is coupled with the mounting device.

14. A delivery system according to any one of claims 10 to 13, wherein the elastomeric material of the base is silicone or rubber.

15. 14. The delivery system of claim 10, wherein the angle over which the legs of the first extension portion extend is in the range of about 30 degrees to about 90 degrees, and the angle over which the legs of the second extension portion extend is in the range of about 30 degrees to about 90 degrees.

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