Wire management for device delivery systems

Abstract

The medical device delivery system includes an elongate member having a main lumen configured to contain a main guidewire and at least one secondary lumen configured to releasably contain a secondary guidewire, the secondary lumen configured to release a first portion of the secondary guidewire when an implantable medical device is advanced along the main guidewire to a first longitudinal position near the first portion of the guidewire and configured to release a second portion of the guidewire when an implantable medical device is advanced along the main guidewire to a second longitudinal position near the second portion of the guidewire.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to Provisional Application No. 63 / 126,982, filed December 17, 2020, which is incorporated herein by reference in its entirety for all purposes.

[0002] The present disclosure relates generally to devices, systems, and methods for managing multiple guidewires within a lumen, and more particularly to devices, systems, and methods for managing multiple guidewires before and during delivery of a device having branches or usable with other devices or components to be positioned within branches of a lumen. [Background technology]

[0003] Treatment of diseased or damaged luminal tissue, e.g., endovascular repair, is routinely performed. For example, aneurysms occur at vascular sites where, due to a patient's age, disease, or genetic predisposition, the strength or resilience of the vessel wall is insufficient to prevent thickening or stretching of the wall as blood passes through it. If an aneurysm is left untreated, the vessel wall may expand and rupture, often resulting in death.

[0004] Various treatments are available for diseased or damaged luminal tissue. For example, to prevent aneurysm rupture, a stent graft can be introduced percutaneously into a blood vessel and deployed across the aneurysmal sac. A stent graft comprises a graft fabric secured to a cylindrical scaffold or framework of one or more stents. The stents provide rigidity and structure to hold the graft open in a tubular configuration, as well as the outward radial force necessary to form a seal between the graft and a healthy portion of the vessel wall and provide migration resistance. By channeling blood flow through the luminal surface of the stent graft, stress on the vessel wall at the location of the aneurysmal sac can be reduced, if not eliminated. The stent graft can reduce the risk of vessel wall rupture at the aneurysm site and allow blood to flow unimpeded through the vessel.

[0005] However, various luminal treatment or repair procedures can be performed at branched sites of a lumen. For example, excluding an aneurysm in or near a branch artery requires that a stent graft be implanted adjacent to the vessel bifurcation. Often, the aneurysm extends into the branch, requiring the stent graft to be placed within the branch. In these cases, a branched stent graft may be necessary. Modular stent grafts with separate body and branch components are often preferred in these procedures due to their ease and precision of deployment. For an example of a modular stent graft with separate body and branch components, see U.S. Patent Application Publication No. 2008 / 0114446 to Hartley et al.

[0006] To properly treat or repair a branched lumen, it may be necessary to access each of the branches. Guidewires and catheters are provided to access the treatment site. Multiple guidewires and catheters may be provided to access each portion of the lumen that contains the branches. Summary of the Invention [Means for solving the problem]

[0007] A wire management device for maintaining guidewires during implantation of a multi-wire device.

[0008] According to one embodiment (embodiment 1), a medical device delivery system includes an elongate member having a main lumen configured to contain a main guidewire and at least one secondary lumen configured to releasably contain a secondary guidewire, the secondary lumen configured to release the first portion of the secondary guidewire when an implantable medical device is advanced along the main guidewire to a first longitudinal position near the first portion of the guidewire, and configured to release the second portion of the guidewire when the implantable medical device is advanced along the main guidewire to a second longitudinal position near the second portion of the guidewire.

[0009] According to another embodiment ("Embodiment 2") in addition to Embodiment 1, the elongated member comprises a radially rigid material.

[0010] According to another embodiment ("Embodiment 3") that is further added to Embodiment 1 or 2, the secondary lumen is formed within the wall of the elongate member.

[0011] According to another embodiment ("Embodiment 4") that is further added to any one of Embodiments 1 to 3, an opening into the secondary lumen is defined within the elongate member along the longitudinal length of the elongate member between the secondary lumen and the main lumen.

[0012] According to another embodiment ("Embodiment 5") further added to any one of Embodiments 1 to 3, an opening into the secondary lumen is defined through the outer radial surface of the elongate member along the longitudinal length of the elongate member.

[0013] According to another embodiment ("Embodiment 6") further added to Embodiment 1 or 2, the medical device delivery system further includes a partition positioned within the main lumen of the elongate member, the partition defining the secondary lumen.

[0014] According to another embodiment ("Embodiment 7") in addition to Embodiment 6, the divider includes a single sheet of material.

[0015] According to another embodiment ("Embodiment 8") further added to any one of Embodiments 1 to 7, the secondary lumen is operable to restrict the secondary guidewire from entangling with the main guidewire along the length of the secondary wire contained by the secondary lumen.

[0016] According to one embodiment ("Embodiment 9"), a medical device delivery system includes an elongate member having a main lumen configured to contain a main guidewire; and a partition removably positioned within the elongate member, the partition forming at least one secondary lumen within the main lumen, the partition configured to contain a secondary guidewire along at least a portion of the longitudinal length of the elongate member, the partition configured to sequentially collapse along the longitudinal length of the elongate member to free the secondary guidewire from the secondary lumen when the elongate member is removed from around the partition and as an implantable medical device is advanced along the main guidewire, the partition including a collapsible seam.

[0017] According to another embodiment ("Embodiment 10") further adding to Embodiment 9, a portion of the partition is configured to release a portion of the secondary guide wire into the lumen of the medical device when the portion of the partition is collapsed.

[0018] According to another embodiment ("Embodiment 11") that is further added to embodiment 9 or 10, the partition further divides the main lumen to include at least two secondary lumens.

[0019] According to another embodiment ("Embodiment 12") further added to any one of Embodiments 9 to 11, the divider includes a sheet of material.

[0020] According to another embodiment ("Embodiment 13") further added to any one of Embodiments 9 to 12, the partition is folded to form a secondary lumen.

[0021] According to another embodiment ("Embodiment 14") further added to any one of Embodiments 9 to 13, the partition includes an adhesive for releasably coupling a first edge of the partition to a second edge of the partition.

[0022] According to one embodiment ("Embodiment 15"), a medical device delivery system includes an elongate member having a wall and a main lumen, the main lumen configured to contain a main guidewire, the wall having an inner surface and an outer surface, the elongate member having at least one secondary lumen at least partially defined between the inner and outer surfaces of the wall, the at least one secondary lumen configured to releasably contain the secondary guidewire.

[0023] According to another embodiment ("Embodiment 16") further adding to Embodiment 15, the at least one secondary lumen is configured to sequentially release the secondary guidewire.

[0024] According to another embodiment ("Embodiment 17") further added to Embodiment 15 or 16, the at least one secondary lumen is configured to release the first portion of the secondary guidewire when the implantable medical device is advanced along the main guidewire to a first longitudinal position near the first portion of the guidewire, and to release the second portion of the guidewire when the implantable medical device is advanced along the main guidewire to a second longitudinal position near the second portion of the guidewire.

[0025] According to another embodiment ("Embodiment 18") further added to any one of Embodiments 15 to 17, an opening into the at least one secondary lumen is defined through the inner surface of the wall along the longitudinal length of the elongate member.

[0026] According to another embodiment ("Embodiment 19") further added to any one of embodiments 15 to 17, an opening into the at least one secondary lumen is defined through the outer surface of the wall along the longitudinal length of the elongate member.

[0027] According to one embodiment ("Embodiment 20"), a method of delivering a medical device includes advancing an elongate member to a target site, the elongate member having a main lumen and a partition positioned within the main lumen of the elongate member, the partition defining at least one secondary lumen, the elongate member having a main guidewire positioned within the main lumen and a secondary guidewire positioned within the at least one secondary lumen; retracting the elongate member from the target while the partition, main guidewire, and secondary guidewire are retained at the target site; and advancing a main device along the main guidewire, the main device permanently collapsing the partition along its longitudinal length, thereby releasing the secondary guidewire from the at least one secondary lumen of the partition.

[0028] The preceding embodiments are examples only and should not be read to limit or narrow the scope of any of the inventive concepts otherwise provided by this disclosure. While numerous examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description. The following detailed description illustrates and describes. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

[0029] The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the disclosure. [Brief explanation of the drawings]

[0030] [Figure 1] FIG. 1 is a diagram illustrating a wire management device according to one embodiment.

[0031] [Figure 2] FIG. 2 illustrates a wire management device in use in conjunction with an implantable device and delivery system according to one embodiment.

[0032] [Figure 3] FIG. 3 illustrates a wire management device and an implantable device according to one embodiment.

[0033] [Figure 4] FIG. 4 is a cross-sectional view of a wire management device according to one embodiment.

[0034] [Figure 5] FIG. 5 is a side view of a wire management device with a guidewire sheath according to one embodiment.

[0035] [Figure 6] FIG. 6 is a schematic diagram illustrating an example method for preparing a partition of a wire management device according to one embodiment.

[0036] [Figure 7] FIG. 7 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 8] FIG. 8 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 9] FIG. 9 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 10] FIG. 10 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 11] FIG. 11 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 12] FIG. 12 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 13] FIG. 13 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 14] FIG. 14 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 15] FIG. 15 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 16] FIG. 16 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 17]FIG. 17 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment. [Figure 18] FIG. 18 illustrates an example method of implementing a wire management device when used in conjunction with an implantable device and delivery system, according to one embodiment.

[0037] [Figure 19] FIG. 19 illustrates an embodiment of a wire management device with a secondary lumen having an access portion through the exterior surface of the wall, according to one embodiment.

[0038] [Figure 20] FIG. 20 illustrates an embodiment of a wire management device with a secondary lumen having an access portion through the interior surface of the wall, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0039] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a restrictive manner. For example, the terms used in this application should be read broadly in light of the meaning that one of ordinary skill in the art would ascribe to such terms.

[0040] Those skilled in the art will appreciate that various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform their intended functions. It should be noted that the accompanying drawings referred to herein are not necessarily to scale and may be exaggerated to illustrate various aspects of the present disclosure. In that regard, the drawings should not be construed as limiting.

[0041] Certain relative terms are used to refer to the relative positions of components and features. For example, the words "top," "bottom," "upper," "lower," "left," "right," "horizontal," "vertical," "upward," and "downward" are used in a relative sense (e.g., how components or features are positioned relative to one another) and not in an absolute sense unless specifically stated otherwise. Similarly, throughout this disclosure where processes or methods are shown or described, they may be performed in any order or simultaneously, unless it is clear from the context that the method is dependent on some particular act being performed first.

[0042] With respect to terms expressing imprecision, the terms "about" and "approximately" may be used to refer to measurements that include the stated measurement and also include any measurement that closely approximates the stated measurement. A measurement that closely approximates a stated measurement deviates from the stated measurement by a fairly small amount that would be understood and easily ascertained by one of ordinary skill in the art. Such deviations may be attributable to measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, performance and / or structural parameters that take into account differences in measurements relative to other components, particularly fine-tuning made to optimize a performance scenario, imprecise adjustment and / or manipulation of objects by humans or machines, and / or the like.

[0043] As used herein, "coupling" means to join, connect, attach, adhere, affix, or bond, whether directly or indirectly, and whether permanently or temporarily.

[0044] Description of Various Embodiments Those skilled in the art will appreciate that various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform their intended functions. It should be noted that the accompanying drawings referred to herein are not necessarily to scale and may be exaggerated to illustrate various aspects of the present disclosure. In that regard, the drawings should not be construed as limiting.

[0045] The device shown in Figure 1 is provided as an example of various embodiments of wire management devices. Combinations of these illustrated embodiments are clearly within the scope of the present invention, but the examples and their descriptions are not intended to suggest a limitation of the inventive concepts provided herein to fewer, additional, or alternative embodiments, such as to one or more of these embodiments, as shown in Figures 8 and 9.

[0046] As shown in FIG. 1 , a delivery device 10 is illustrated that includes a wire management device 20. The wire management device 20 is operable to maintain and manage the wire as it is advanced and positioned within the patient's anatomy. For example, in addressing damaged or diseased tissue, a patient's branched vasculature can be accessed for treatment and / or to deliver a device to a target site. In one example, the branched vasculature can include the aortic arch. The aortic arch is a portion of the aorta that includes branches extending into the brachiocephalic trunk, left common carotid artery, and left subclavian artery. Other example branches can include the renal arteries, mesenteric arteries, iliac arteries, etc. Additionally, branches can be located in other arteries, veins, or other lumens, such as within the lymphatic system, CSF passageways, etc. A device that can be delivered using the delivery device 10 (e.g., an implantable device, e.g., a stent, graft, etc.) can include a main body and device branches, the device branches corresponding to some or all of the branches of the lumens to which the device is delivered. The device branches can be coupled to, extend from, or positionable with the device. The device may be, for example, an implantable device 100 that can be delivered to the aortic arch. In one particular example, the implantable device 100 includes a first branch 102, a second branch 104, and a third branch 106. These branches correspond to the brachiocephalic artery, the left common carotid artery, and the left subclavian artery, respectively (see, e.g., FIG. 2 ). To position the implantable device 100 within the aortic arch and each of the branches 102 (e.g., 102a, 102b, 102c) within the corresponding arteries, multiple guidewires 110 (e.g., 102a, 102b, 102c) are used to guide each element to their target sites.

[0047] To minimize interaction of each of the multiple guidewires with one another and with other components of the delivery device 10, the wire management device 20 is provided to limit or prevent the guidewires from entangling, binding, or interfering with one another and with other components of the delivery device 10, which would impede the advancement of a device along the guidewire. The wire management device 20 maintains each of the guidewires in a predetermined position. The wire management device 20 is operable to release portions of the guidewire as the device is advanced along the longitudinal length of the wire management device 20, allowing the device and its branches to be advanced through the patient's lumen. For example, the delivery system 10 may include a wire management device 20 that releasably contains multiple guidewires (e.g., a primary guidewire 110a and a secondary guidewire 110b). Wire management device 20 may be configured to release a first portion of at least one of primary and secondary guidewires 110a, 110b when the device is advanced along primary guidewire 110a to a first longitudinal position near a first portion of guidewires 110a, 110b, and to release a second portion of one of guidewires 110a, 110b when the device is advanced along primary guidewire 110a to a second longitudinal position near a second portion of guidewires 110a, 110b. Thus, wire management device 20 gradually (also referred to as stepwise, gradual, or sequential) releases the guidewire as the device is advanced relative to delivery device 10. This allows the guidewire to be properly positioned to interact with the device (e.g., enter the internal lumen of the device) as the device is delivered.

[0048] Wire management device 20 may include multiple lumens 22 or partial lumens (shown in more detail, e.g., in FIGS. 4 and 5) that may removably contain guidewires 110. In some embodiments, wire management device 20 includes ports 24 (shown in FIG. 1) corresponding to each of lumens 22. Ports 24 may be incorporated directly onto wire management device 20 or may be positioned with wire management device 20, such that each of ports 24 provides access to a corresponding lumen of wire management device 20.

[0049] FIG. 2 shows an exemplary schematic diagram illustrating a delivery device 10 including a wire management device 20 for delivering an implantable device 100. The wire management device 20 includes a first end 26 and a second end. The guidewire 110 is positioned with the wire management device 20 such that the guidewire 110 extends from each of the first end 26 and the second end 28 of the wire management device 20 (see FIG. 1 ). Portions of the guidewire 110 may extend through various portions of the implantable device 100 (see FIG. 2 ). Other portions of the guidewire extend through the wire management device 20. The guidewire 110 may extend from the ends of the wire management device 20 into respective portions of the lumens (e.g., into respective branches of the vascular system, see FIG. 2 ). As the implantable device 100 is advanced along the guidewire 110, portions of the guidewire 110 are released from their anchoring by the wire management device 20. The wire management device 20 may be used with one or more guidewires 110. Figure 3 illustrates a delivery device 10 administering a single guidewire 110 in conjunction with a wire management device 20, for example.

[0050] Various embodiments of the wire management device 20 are shown herein and each will be described in detail separately, however, it will be apparent that features of any one of the following embodiments may be incorporated into any of the other embodiments as appropriate.

[0051] Referring to FIG. 4, a first embodiment of a wire management device 20a includes a sheath 30 and a partition 40 (e.g., a septum or bulkhead). The sheath 30 defines a main lumen 32 along its longitudinal length. The main lumen 32 has a diameter sufficient to accommodate the partition 40, the guidewire 110, and the guidewire sheath 120. The sheath 30 is formed from a semi-flexible material that is rigid enough to be advanced through a biological lumen while being able to bend around bends or curves within the biological lumen. For example, the sheath 30 may be formed from polyethylene, polytetrafluoroethylene, or the like.

[0052] The partition 40 is operable to form multiple secondary lumens 42. Each of the secondary lumens 42 is operable to contain one of the guidewires 110. As the partition 40 is positioned within the main lumen 32, the partition 40 divides the main lumen 32, thereby forming at least one secondary lumen 42. Figures 4 and 5 are shown as having the partition 40 forming four secondary lumens 42. However, any number of secondary lumens 42 may be formed by the partition 40. For example, the partition may form one, two, three, four, five, six or more secondary lumens 42.

[0053] Referring to FIG. 6 , the divider 40 may be formed from a sheet of material. The sheet of material may be folded or formed to form individual lumens (e.g., secondary lumens 42). For example, in FIG. 6 , the divider 40 is shown as having four secondary lumens 42. The divider 40 is folded such that each of the secondary lumens 42 is formed on a first side 44 of the sheet of material. More specifically, the divider 40 includes a first side 44 and a second side 46. Troughs 48 are formed on the first side 44 of the sheet of material. These troughs 48 are separated by tips 49. Each of the tips 49 is then brought together such that each trough 48 forms a secondary lumen 42. Each of the tips 49 can be coupled together (e.g., via adhesive), or the tips may overlap, be positioned adjacent to, or abut one another. However, the side edges 50, 52 of the sheet of material can be secured to one another along the longitudinal length of the divider 40 by applying an adhesive to the side edges 50, 52. The adhesive may be applied to the first side 44 or the second side 46 of the sheet of material, or both, as appropriate. The coupling of the side edges 50, 52 of the sheet of material forms a primary seam 54. The primary seam 54 is collapsible so that the primary seam 54 can be released and the sheet of material can be cut open. Once the primary seam 54 is collapsed, the guidewires 110 can be removed from their corresponding secondary lumens 42.

[0054] In some embodiments, the primary seam 54 represents a location where a tear (e.g., a thinned section of material, a perforation, etc.) through the sheet of material may be formed. Thus, once adhesive is applied and disrupted, or the sheet of material is torn, the primary seam 54 permanently disrupts. This allows the partition 40 to be removed from the delivery device 10 without having to perform additional steps, such as tearing or severing the partition 40 around the guidewire 110 or from the delivery handle (not shown). In embodiments in which adhesive is applied to each of the tips 49, a secondary seam 56 may be formed. However, the secondary seam 56 may be positioned such that, upon disruption, adjacent secondary lumens 42 merge, but at least one secondary lumen 42 remains intact. It is noted that the partition 40 may be folded or formed to define multiple secondary lumens 42 without forming a seal in the partition 40 between each secondary lumen 42.

[0055] 7-18, an exemplary method of using the wire management device 20a of FIGS. 4 and 5 is shown. FIG. 7 illustrates the wire management device 20a. The wire management device 20a includes a sheath 30 defining a main lumen 32 and a partition 40 positioned within the main lumen 32 to define a plurality of secondary lumens 42 (e.g., as shown in FIGS. 4 and 5). The wire management device 20a includes a first guidewire sheath 120a carrying a first guidewire 110a, a second guidewire sheath 120b carrying a second guidewire 110b, a third guidewire sheath 120c carrying a third guidewire 110c, and a fourth guidewire sheath 120d carrying a fourth guidewire 110d. The wire management device 20a can be inserted into a patient (not shown), for example, into the femoral artery, and advanced to the aortic arch. Each of the guidewires 110 can be positioned as desired (e.g., in the brachiocephalic artery, left common carotid artery, left subclavian artery, and aortic arch). In some embodiments, some or all of the guidewire sheaths 120 are steerable. The first ends 112 of the guidewires 110 and / or guidewire sheaths 120 extend from the wire management device 20a (FIG. 8) so that a physician can appropriately steer the second ends 114 (FIGS. 9 and 10) of the guidewires 110 into their respective positions and attach an implantable device (not shown) onto the first ends 112, thereby advancing the implantable device from the first ends 112 toward the second ends 114 of the guidewires 110.

[0056] Referring to Figure 11, in some embodiments, a steerable sheath 120e can be used in combination with a guidewire 110. As shown in Figure 12, the steerable sheath 120e can be inserted around the guidewire 110 at a first end 112 and then advanced toward the second end 114 (Figure 13). Once the steerable sheath 120e is mounted over the guidewire 110, the guidewire 110 can be steered into position (Figure 14).

[0057] Once guidewire 110 is properly positioned, guidewire sheath 120 can be removed from around guidewire 110 and the sheath can be retracted from second end 114 toward first end 112 of guidewire 110. Once guidewire sheath 120 is removed from guidewire 110, guidewire sheath 120 is removed from wire management device 20a (FIG. 15).

[0058] 16 and 17, with all of the guidewires 110 properly positioned, the sheath 30 of the wire management device 20a can be removed from around the partition 40 and the guidewires 110. With reference to FIG. 18, with the sheath 30 removed, the implantable device 100 can be inserted over the first end 112 of the guidewires 110. In some embodiments, a single device is attached over all of the guidewires 110. In some embodiments, the guidewires 110 may be positioned through various separate features of the implantable device 100 (e.g., branches of a branch graft). In other embodiments, various separate portions of the implantable device 100 may be attached over each guidewire 110 (e.g., branches may be attached over a single lumen graft). In these embodiments, the guidewires 110 may extend through a sidewall of the implantable device 100.

[0059] Once the implantable device 100 is mounted on the guidewire 110, the implantable device 100 can be advanced along the guidewire 110. As the implantable device 100 is advanced toward the first end 112 of the guidewire, the implantable device 100 contacts the partitions 40. As the implantable device contacts the partitions 40, the implantable device 100 collapses the seams 56. As the seams 56 collapse, the guidewire 110 is released from these secondary lumens 42 (FIG. 2). As the implantable device 100 is advanced, the seams 56 collapse sequentially along the longitudinal length of the partitions 40. When the seams 56 are collapsed along the entire longitudinal length of the partitions 40, the guidewire 110 is no longer contained by the partitions 40. However, the portions of the partitions 40 where the seams 56 are not collapsed maintain the guidewire 110 within a separate lumen (i.e., the secondary lumens 42). In some embodiments, one or more of the guidewires 110 may not be positioned within the secondary lumen 42 of the partition 40, but instead may be positioned within the main lumen 32, and thus may be released from engagement when the sheath 30 is removed.

[0060] Once the partition 40 is removed, the implantable device 100 is positioned at or near the target site. Because the guidewire 110 is contained during delivery of the implantable device 100, the guidewire 110 does not become tangled, crossed, or otherwise entangled. Such tangled, crossed, or otherwise entangled configurations may result in improper seating of components at the target site, obstruction of advancement of the implantable device 100 along the guidewire 110, dislocation of the guidewire 110 from the target site (e.g., a branch of a lumen), etc. The implantable device 100 is then deployed, and the guidewire 110 is removed from the patient.

[0061] 19, another embodiment of a wire management device 20b is shown. In this embodiment, the wire management device 20b includes an elongate member 21 with a main lumen 32 and at least one secondary lumen 42. In the illustrated embodiment, the main lumen 32 is formed at the center of and through the elongate member 21 along the longitudinal length of the wire management device 20b. The secondary lumen 42 is formed through the elongate member 21 along the longitudinal length of the wire management device 20b. The secondary lumen 42 does not overlap with the main lumen 32 in a cross section transverse to the longitudinal length. In some embodiments, the secondary lumen 42 can be positioned coaxially about the main lumen 32 such that the secondary lumen 42 and the main lumen 32 are separate and do not overlap. Of course, the secondary lumen 42 can be positioned in any arrangement relative to the main lumen 32 such that the secondary lumen 42 is separate from the main lumen 32. Separation can be provided through the body of the elongate member 21 (i.e., the lumens are formed separately from each other within the body of the elongate member 21), or a partition (not shown) is provided to separate the main lumen 32 and the secondary lumen 42.

[0062] At least some of the secondary lumens 42 are accessible along the longitudinal length of the wire management device 20b. This is made possible by forming a slit 60 through a portion of the elongate member 21. The slit connects the exterior of the elongate member 21 to the secondary lumens 42. In other words, the secondary lumens 42 may be formed within the elongate member 21 by a partition 62 integral with the elongate body. The partition 62 provides resistance to outward movement from the secondary lumens 42. The partition 62 is operable to flex or bend away from a neutral position when sufficient force is applied against the partition to remove the guidewire 110 from the secondary lumen 42 and through the slit 60. For example, if the secondary lumen 42 and guidewire 110 have a generally circular profile, the secondary lumen 42 may be formed within the elongate member about a secondary lumen axis.

[0063] The secondary lumen 42 may be surrounded by the elongate member 21 and the integral partition 62 from about 189 to about 359 degrees. The integral partition is the portion of the elongate member 21 that extends more than 180 degrees such that the guidewire 110 is partially surrounded on the second side. The width of the slit 60, and therefore the size of the integral partition 62, may be a function of the desired resistance required to disengage the guidewire 110 from the wire management device 20. Additionally, the material of the elongate member 21 may be varied to provide different resistances by incorporating more flexible or compliant materials or by incorporating stiffer materials. In some embodiments (not shown), the integral partition 62 may be a structural feature of the elongate member 21. The structural feature may mate with or correspond to a feature on the guidewire 110 to retain the guidewire 110 within the secondary lumen 42 (e.g., cap ridge engagement, keyway, etc.). The guidewire 110 is held within the main lumen 32 or the secondary lumen 42 by the wire management device 20b until the guidewire 110 is continuously and selectively removed from the secondary lumen 42 as it passes through the slit 60 and thus disengages from its in-situ engagement with the wire management device 20b.

[0064] The wire management device 20b may be sized so that the implantable medical device 100 may be advanced through a patient lumen adjacent to or surrounding the wire management device 20b. Some of the secondary lumens 42 of the wire management device 20b may be completely enclosed, thus not sequentially releasing the guidewire 110.

[0065] Referring now to FIG. 20 , wire management device 20c is similar to wire management device 20c of FIG. 19 in that a secondary lumen 42 is formed within the body of the elongate member. However, unlike wire management device 20b of FIG. 19 , wire management device 20b of FIG. 20 includes a secondary lumen 42 that is open to main lumen 32. Thus, as guidewire 110 is sequentially released from secondary lumen 42, it is released into the main lumen. In this embodiment, wire management device 20c may include an outer support member (not shown). The outer support member provides radial support (e.g., a film, sheet, material, wire mesh, etc.) around the wire management device, thereby reducing the risk of tearing the wall of elongate member 21. In this embodiment, secondary lumen 42 may be positioned around wire management device 20c (not shown) or may be concentrated around a portion of elongate member 21.

[0066] More specifically, wire management device 20c includes elongate member 21 with a main lumen 32 and at least one secondary lumen 42. In the illustrated embodiment, main lumen 32 is formed centrally and through elongate member 21 along the longitudinal length of wire management device 20c. Secondary lumen 42 is formed through elongate member 21 along the longitudinal length of wire management device 20c. Access to secondary lumen 42 is provided through main lumen 32 along the longitudinal length of elongate member 21. In some embodiments, secondary lumen 42 can be positioned coaxially around main lumen 32. Of course, secondary lumen 42 can be positioned in any arrangement relative to main lumen 32 such that secondary lumen 42 is separated from main lumen 32. Separation can be provided through the body of elongate member 21 (i.e., the lumens are formed separately from one another within the body of elongate member 21), or a partition (not shown) is provided to separate main lumen 32 and secondary lumen 42. In some embodiments, a small portion of main lumen 32 and secondary lumen 42 are configured to open onto one another based on overlap of these lumens 32, 42. In some embodiments, main lumen 32 and secondary lumen 42 do not overlap with main lumen 32 in a cross section across the longitudinal length, but are accessible through a slit or gap.

[0067] At least some of the secondary lumens 42 are accessible along the longitudinal length of the wire management device 20b. This is made possible by forming a slit 60 through a portion of the elongate member 21. The slit connects the main lumen 32 and the secondary lumen 42. In other words, the lumens 32, 42 can be separated by forming the secondary lumen 42 within the elongate member 21 with a partition 62 that is integral with or extends from the elongate body. The partition 62 provides resistance to movement from the secondary lumen 42 into the main lumen 32. The partition 62 is operable to flex or bend out of a neutral position when sufficient force is applied against the partition to remove the guidewire 110 from the secondary lumen 42 and through the slit 60. For example, if the secondary lumen 42 and the guidewire 110 have a generally circular profile, the secondary lumen 42 may be formed within the elongate member about a secondary lumen axis. The secondary lumen 42 may be enclosed by the elongate member 21 and the integral partition 62 from about 189 to about 359 degrees. The integral partition is the portion of the elongate member 21 that extends more than 180 degrees such that the guidewire 110 is partially enclosed on the second side. The width of the slit 60, and therefore the size of the integral partition 62, may be a function of the desired resistance required to disengage the guidewire 110 from the wire management device 20. Additionally, the material of the elongate member 21 may be varied to provide different resistances by incorporating more flexible or compliant materials or by incorporating stiffer materials.

[0068] In some embodiments (not shown), integral partition 62 may be a structural feature of elongate member 21 that mates with or corresponds to a feature on guidewire 110 to retain guidewire 110 within secondary lumen 42 (e.g., cap-ridge engagement, keyway, etc.). Guidewire 110 is retained within primary lumen 32 or secondary lumen 42 by wire management device 20b until guidewire 110 is sequentially and selectively removed from secondary lumen 42 as guidewire 110 passes through slit 60, thereby disengaging from in situ engagement with wire management device 20b.

[0069] The wire management device 20b is sized so that the implantable medical device 100 can be advanced through the patient lumen while passing through the main lumen 32 of the wire management device 20b. Some of the secondary lumens 42 of the wire management device 20b may be completely enclosed, thus not sequentially releasing the guidewire 110.

[0070] The invention of this application has been described above generally and with reference to specific embodiments. As will be apparent to those skilled in the art, various modifications and changes can be made to the embodiments without departing from the scope of the disclosure. Similarly, various components discussed in the embodiments described herein can be combined. Therefore, it is intended that the embodiments cover modifications and variations within the scope of the present invention. (Aspect) (Aspect 1) 1. A medical device delivery system comprising: 1. A medical device delivery system comprising: an elongate member having a main lumen configured to contain a main guidewire and at least one secondary lumen configured to releasably contain a secondary guidewire, the secondary lumen being configured to release a first portion of the secondary guidewire when an implantable medical device is advanced along the main guidewire to a first longitudinal position near the first portion of the guidewire, and to release the second portion of the guidewire when the implantable medical device is advanced along the main guidewire to a second longitudinal position near the second portion of the guidewire. (Aspect 2) 10. The medical device delivery system of embodiment 1, wherein the elongated member comprises a radially rigid material. (Aspect 3) 3. The medical device delivery system of claim 1 or 2, wherein the secondary lumen is formed within a wall of the elongate member. (Aspect 4) Aspect 4. The medical device delivery system of any one of aspects 1 to 3, wherein an opening into the secondary lumen is defined within the elongate member along the longitudinal length of the elongate member between the secondary lumen and the main lumen. (Aspect 5) Aspect 4. The medical device delivery system of any one of aspects 1 to 3, wherein an opening into the secondary lumen is defined through an outer radial surface of the elongate member along the longitudinal length of the elongate member. (Aspect 6) 3. The medical device delivery system of any one of aspects 1 to 2, further comprising a partition positioned within the primary lumen of the elongate member, the partition defining the secondary lumen. (Aspect 7) 7. The medical device delivery system of embodiment 6, wherein the divider comprises a single sheet of material. (Aspect 8) Aspect 8. The medical device delivery system of any one of aspects 1 to 7, wherein the secondary lumen is operable to restrict the secondary guidewire from entangling with the main guidewire along the length of the secondary wire contained by the secondary lumen. (Aspect 9) 1. A medical device delivery system comprising: an elongate member having a main lumen configured to contain a main guidewire; a partition removably positioned within the elongate member, the partition forming at least one secondary lumen within the main lumen, the partition configured to contain a secondary guidewire along at least a portion of the longitudinal length of the elongate member, the partition configured to collapse sequentially along the longitudinal length of the elongate member to free the secondary guidewire from the secondary lumen when the elongate member is removed from around the partition and as an implantable medical device is advanced along the main guidewire, the partition including a collapsible seam; A medical device delivery system comprising: (Aspect 10) A medical device delivery system as described in aspect 9, wherein a portion of the partition is configured to release a portion of the secondary guidewire into the lumen of the medical device when the portion of the partition is collapsed. (Aspect 11) 11. The medical device delivery system of aspect 9 or 10, wherein the divider further divides the main lumen to include at least two secondary lumens. (Aspect 12) 12. The medical device delivery system of any one of aspects 9 to 11, wherein the divider comprises a sheet of material. (Aspect 13) Aspect 13. The medical device delivery system of any one of aspects 9 to 12, wherein the partition is folded to form a secondary lumen. (Aspect 14) Aspect 14. The medical device delivery system of any one of aspects 9 to 13, wherein the divider comprises an adhesive for releasably coupling a first edge of the divider to a second edge of the divider. (Aspect 15) 1. A medical device delivery system comprising: an elongate member having a wall and a main lumen, the main lumen configured to contain a primary guidewire, the wall having an inner surface and an outer surface, the elongate member having at least one secondary lumen at least partially defined between the inner and outer surfaces of the wall, the at least one secondary lumen configured to releasably contain a secondary guidewire; Medical device delivery systems. (Aspect 16) Aspect 16. The medical device delivery system of aspect 15, wherein the at least one secondary lumen is configured to sequentially release the secondary guidewire. (Aspect 17) A medical device delivery system according to aspect 15 or 16, wherein the at least one secondary lumen is configured to release the first portion of the secondary guidewire when an implantable medical device is advanced along the main guidewire to a first longitudinal position near the first portion of the guidewire, and to release the second portion of the guidewire when an implantable medical device is advanced along the main guidewire to a second longitudinal position near the second portion of the guidewire. (Aspect 18) Aspect 18. The medical device delivery system of any one of aspects 15 to 17, wherein an opening into the at least one secondary lumen is defined through an inner surface of the wall along the longitudinal length of the elongate member. (Aspect 19) Aspect 18. The medical device delivery system of any one of aspects 15 to 17, wherein an opening into the at least one secondary lumen is defined through the outer surface of the wall along the longitudinal length of the elongate member. (Aspect 20) 1. A method of delivering a medical device, comprising: advancing an elongate member to a target site, the elongate member having a main lumen and a partition positioned within the main lumen of the elongate member, the partition defining at least one secondary lumen, the elongate member having a main guidewire positioned within the main lumen and a secondary guidewire positioned within the at least one secondary lumen; retracting the elongate member from the target while the partition, primary guidewire, and secondary guidewire are retained at the target site; advancing a body device along the primary guidewire such that the body device permanently collapses the partition along a longitudinal length thereof, thereby releasing the secondary guidewire from the at least one secondary lumen of the partition; 10. A method of delivering a medical device, comprising:

Claims

1. 1. A medical device delivery system comprising: a catheter defining a lumen; 11. A medical device delivery system comprising: an elongate member configured to be positioned within the lumen of the catheter, the elongate member having a main lumen configured to contain a main guidewire and at least one secondary lumen configured to releasably contain a secondary guidewire, the secondary lumen configured to release the first portion of the secondary guidewire when an implantable medical device is advanced along the main guidewire to a first longitudinal position near the main guidewire and a first portion of the secondary guidewire, and configured to release the second portion of the main guidewire and the secondary guidewire when an implantable medical device is advanced along the main guidewire to a second longitudinal position near the main guidewire and a second portion of the secondary guidewire.

2. The medical device delivery system of claim 1 , wherein the elongate member comprises a radially stiff material.

3. The medical device delivery system of claim 1 or 2, wherein the secondary lumen is formed within a wall of the elongate member.

4. 4. The medical device delivery system of claim 1, wherein an opening into the secondary lumen is defined within the elongate member along the longitudinal length of the elongate member between the secondary lumen and the main lumen.

5. 4. The medical device delivery system of claim 1, wherein an opening into the secondary lumen is defined through an outer radial surface of the elongate member along the longitudinal length of the elongate member.

6. The medical device delivery system of claim 1 or 2, further comprising a partition positioned within the primary lumen of the elongate member, the partition defining the secondary lumen.

7. The medical device delivery system of claim 6 , wherein the divider comprises a single sheet of material.

8. 8. The medical device delivery system of claim 1, wherein the secondary lumen is operable to restrict the secondary guidewire from entangling with the main guidewire along the length of the secondary wire contained by the secondary lumen.

9. 1. A medical device delivery system comprising: an elongate member having a main lumen configured to contain a main guidewire; a partition removably positioned within the elongate member, the partition forming at least one secondary lumen within the main lumen, the partition configured to contain a secondary guidewire along at least a portion of the longitudinal length of the elongate member, the partition configured to collapse sequentially along the longitudinal length of the elongate member to free the secondary guidewire from the secondary lumen when the elongate member is removed from around the partition and as an implantable medical device is advanced along the main guidewire, the partition including a collapsible seam; A medical device delivery system comprising:

10. The medical device delivery system of claim 9 , wherein a portion of the partition is configured to release a portion of the secondary guidewire into the lumen of the medical device when the portion of the partition is collapsed.

11. 11. The medical device delivery system of claim 9 or 10, wherein the divider further divides the main lumen to include at least two secondary lumens.

12. The medical device delivery system of claim 9 , wherein the divider comprises a sheet of material.

13. 13. The medical device delivery system of claim 9, wherein the partition is folded to form a secondary lumen.

14. 14. The medical device delivery system of claim 9, wherein the divider includes an adhesive for releasably coupling a first edge of the divider to a second edge of the divider.

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