Flexible safety connection of multiple guide wires
By using a selective connection method with perforated flexible sutures and flexible cannulas in medical devices, the problems of weak and insufficiently flexible guide suture connections in existing technologies are solved, enabling stable connections of multiple guide sutures and flexible connections that penetrate the body during transcatheter surgery.
Patent Information
- Application Number
- CN202180014866.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-02-16
- Filing Date
- 2021-02-16
- Publication Date
- 2025-12-16
- Estimated Expiration
- 2041-02-16
AI Technical Summary
Existing methods and devices for end-to-end connection of guide wires have problems such as being unstable, not flexible enough, having an excessively large diameter, or being unsuitable for insertion into the body during transcatheter surgery, especially in transcatheter ventricular suspension or papillary muscle suspension implantation surgery where effective connection is difficult.
A selectively connectable medical device is provided, comprising a first flexible wire having an opening at its distal end and a flexible cannula surrounding the first flexible wire, wherein the opening is switched between open and closed positions by movement of the flexible cannula, and the device is connected to the first flexible wire via an grippable area of a second flexible wire, thereby achieving flexible connection and locking.
It enables flexible end-to-end connection of multiple guide wires outside the body and can safely pass through the body's lumen, making it suitable for various transcatheter navigation surgeries, especially ventricular suspension or papillary muscle suspension implantation, providing a stable connection method.
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Figure CN115103728B_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This application is based on and claims priority to U.S. Provisional Patent Application No. 62 / 977271, filed February 16, 2020, which is incorporated herein by reference in its entirety. Technical Field
[0003] Some applications of this disclosure relate to methods and apparatus for flexible, secure connections of multiple guide wires. More specifically, some applications of this disclosure relate to methods and apparatus for connecting guide wires in medical devices used for intra-catheter navigation, such as the implantation of transcatheter ventricular suspensions or papillary muscle suspensions. Background Technology
[0004] In some transcatheter procedures, such as the implantation of transcatheter ventricular or papillary muscle suspensions, it may be advantageous to flexibly connect multiple sutures end-to-end. For example, in the case of implantation of a transcatheter ventricular or papillary muscle suspension, one suture is first placed through the ventricular trabeculae and then connected to another suture used to pull the implant into place. In this exemplary application, the connecting sutures must pass through the body.
[0005] Existing methods and devices for end-to-end connection of guide wires have many limitations, making them unsuitable for some transcatheter procedures, such as the implantation of transcatheter ventricular or papillary muscle ligation. For example, some methods for connecting guide wire extensions are not strong enough to allow the connected guide wire to be inserted into the body and are only intended for use during catheter changes when the guide wire itself is not manipulated, as manipulation of the guide wire can cause these types of connections to break. Other types of guide wire connections are either too stiff or too large in diameter to be used in some transcatheter procedures where the wire diameter may be as thin as 0.35 mm and must be flexible enough to pass smoothly through ventricular anatomy. Furthermore, in some procedures, it is necessary to grasp the distal end of the wire with a snare, pull it out of the body, and then attach that same distal end of the wire to the end of another wire.
[0006] Therefore, it is advantageous to have a line connection mechanism that can be configured to attach to a flexible end of a line suitable for being gripped. Summary of the Invention
[0007] The presently disclosed embodiments recognize that there is a need for improved devices and methods for wire connection mechanisms in medical devices for transcatheter navigation to a cavity in the body. Embodiments of the present disclosure include methods and devices for flexible connection of multiple guide wires in a medical device for transcatheter navigation to a cavity in the body, for example to a heart chamber. Advantageously, some example embodiments provide methods and devices for flexible connection of multiple wires in a medical device end-to-end outside the body and then threading the wires through a lumen in the body.
[0008] Consistent with some embodiments of the present disclosure, a selectively connectable medical device is provided. The medical device can include a first flexible wire having an aperture at a distal end thereof and a flexible sleeve surrounding the first flexible wire. The flexible sleeve can be movable along the first flexible wire to a first position exposing the aperture and a second position extending over the aperture.
[0009] In some embodiments, the device can further include a second flexible wire having a graspable region at an end thereof. The aperture of the first wire can be sized to allow the graspable region of the second wire to pass through the aperture when the aperture is exposed. The flexible sleeve can be configured to move to the second position when the graspable region of the second flexible wire passes through the aperture, causing the graspable region of the second flexible wire to bend around an edge of the aperture and simultaneously cover the aperture of the first wire and at least a portion of the graspable region of the second wire, thereby locking the second wire to the first wire.
[0010] Additional objects and advantages of the embodiments will be set forth in part in the description which follows, and in part will be obvious from the description, or can be learned by practice of the embodiments. The objects and advantages of the embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
[0011] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claims. BRIEF DESCRIPTION OF DRAWINGS
[0012] Figure 1 An example flexible wire having an aperture at a distal end thereof consistent with some embodiments of the present disclosure is shown.
[0013] Figure 2 An example flexible wire having a graspable region at an end thereof consistent with some embodiments of the present disclosure is shown.
[0014] Figure 3A A configuration of an example selectively connectable medical device consistent with some embodiments of the present disclosure is shown.
[0015] Figure 3B Another configuration of an example selectively connectable medical device consistent with some embodiments of the present disclosure is shown.
[0016] Figure 3C Another configuration of an exemplary selectively connectable medical device is shown, consistent with some embodiments of the present disclosure.
[0017] Figure 3D Another configuration of an exemplary selectively connectable medical device is shown, consistent with some embodiments of the present disclosure.
[0018] Figure 3E Another configuration of an exemplary selectively connectable medical device is shown, consistent with some embodiments of the present disclosure.
[0019] Figure 4 An exemplary flexible wire including a protrusion thereon is shown, consistent with some embodiments of the present disclosure. DETAILED DESCRIPTION
[0020] The present disclosure relates to methods and devices for flexible secure connection of multiple guide wires. While the present disclosure provides examples of connecting guide wires in the context of implanting a transcatheter ventricular sling or papillary muscle sling, it should be noted that aspects of the present disclosure are not limited in their broadest sense to devices for implanting a transcatheter ventricular sling or papillary muscle sling. Rather, it is contemplated that the foregoing principles can be applied to other devices for transcatheter navigation to any lumen in the body.
[0021] Exemplary embodiments are described with reference to the accompanying drawings. The drawings are not necessarily to scale. While examples and features of disclosed principles are described herein, modifications, adaptations and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Also, the words "comprise," "comprises," "comprising," "including," "includes," "contain," "containing," "have," "has," "having," or the like are used inclusively, in that a
[0022] In the following description, for purposes of explanation, numerous working examples are set forth. It should be noted, however, that the present disclosure can be practiced in the absence of one or more of these details.
[0023] The present disclosure is provided to facilitate a basic understanding of some of the exemplary embodiments described herein and is not therefore completely defining or limited to the scope of the disclosure. The present disclosure is not an all-inclusive exposition of all contemplated embodiments and neither is it intended to identify key or essential elements of all embodiments nor to delineate the scope of any or all aspects. Its sole purpose is to present some features of one or more embodiments in a simplified form as a prelude to the more detailed description that is taken up later. For convenience, the term "embodiments of the disclosure" or "exemplary embodiments" can be used herein to refer to a single embodiment of the present disclosure or multiple embodiments of the present disclosure.
[0024] According to the present disclosure, exemplary embodiments can include selectively connectable medical devices. Exemplary selectively connectable medical devices can include a plurality of flexible wires selectively connectable end-to-end. The flexible wires can be constructed of one or more flexible metallic materials, such as stainless steel, cobalt-chrome alloy, titanium, and nickel-titanium alloy (nitinol). Additionally or alternatively, the flexible wires and their constituents can also be constructed of one or more ceramics, polymers, composites, or any other biocompatible material. The flexible wires can refer to a cable of single-stranded material or multi-stranded material, such as braided, stranded, or other multi-stranded arrangements.
[0025] In some embodiments, the selectively connectable medical devices can include at least one first flexible wire and at least one second flexible wire that are selectively connectable and / or disconnectable. As discussed below with reference to some exemplary embodiments, the first and second metallic wires can be configured to engage one another at their ends to form or break a flexible connection. For example, the first flexible wire can include a hole configured to engage a graspable region on the second flexible wire to connect the two wires. In some embodiments, the connection can be sufficiently flexible for certain aspects of transcatheter navigation, such as smoothly traversing ventricular anatomy or any other intraluminal movement.
[0026] By way of example, according to some embodiments of the present disclosure, Figure 1 An exemplary flexible wire 100 having a hole 112 is shown, Figure 2 An exemplary flexible wire 200 having a graspable region 210 at its end is shown. As Figures 3A-3E As shown, the flexible wire 100 and the flexible wire 200 can be positioned relative to one another in a variety of configurations to selectively connect or disconnect one another end-to-end.
[0027] Exemplary selectively connectable medical devices can include a first flexible wire having a hole at its distal end. The hole can be composed of any biocompatible material and can be moved between open and closed positions through mechanical interaction and / or through the use of a pre-biased material such as a resilient metal or a shape memory alloy (e.g., Nitinol). Although exemplary embodiments are discussed with reference to a hole having a closed loop configuration, it should be understood that the hole can include any open or closed configuration of biocompatible material that can be moved between an open position and a closed position. For example, Figure 1 An exemplary flexible wire 100 is shown having a hole 112 at its distal end 110 in an open position. Figures 3A-3E A hole 112 is also shown in a variety of configurations, wherein Figure 3A A configuration of a flexible wire 100 and 200 is shown with a hole 112 in a fully open configuration, while Figure 3E A configuration of a flexible wire 100 and 200 is shown with a hole 112 (not shown) in a fully closed configuration and covered by a flexible sleeve 120.
[0028] Exemplary selectively connectable medical devices can include a flexible sleeve that surrounds a first flexible wire. In some embodiments, the flexible sleeve can be moved along the first flexible wire to a first orientation that exposes the hole and a second orientation that extends over the hole. The flexible sleeve and its components can be composed of one or more metals, ceramics, polymers, composites, or any other biocompatible material and can be in the form of a lumen having one or more inner diameters configured to fit over the first flexible wire and / or the hole. In some embodiments, the flexible sleeve can be configured such that the inner diameter is smaller than the width of the hole, such that when the flexible sleeve is moved in a distal direction relative to the first flexible wire, the flexible sleeve compresses the hole to a closed position. In some embodiments, the length of the flexible sleeve can be less than half the length of the first flexible wire, although any length suitable for the intended use of the disclosed medical device can be used. For example, the length of the flexible sleeve can be less than 10 centimeters.
[0029] For example, Figures 3A-3E A variety of orientations of a flexible sleeve 120 relative to a flexible wire 100 and 200 are shown, between which the flexible sleeve 120 can be moved. For example, Figure 3A One orientation of the flexible sleeve 120 is shown in which the flexible sleeve 120 covers a proximal portion of the flexible wire 100 relative to the hole 112, while the hole 112 remains exposed. Alternatively, Figure 3E One orientation of the flexible sleeve 120 is shown in which the flexible sleeve 120 extends over a portion of the flexible wire 100 and the hole 112, such that the hole 112 is covered by the flexible sleeve 120. When the flexible sleeve 120 is moved from Figure 3A to Figure 3EIn the illustrated orientation, the flexible sleeve 120 can exert a compressive force on the aperture 112, causing the aperture 112 to move from the open position to the closed position.
[0030] In some disclosed embodiments, the flexible sleeve can include a distal region, a middle region, and a proximal region. In some embodiments, the inner diameter of the distal region and the proximal region can be smaller than the inner diameter of the middle region. For example, in some embodiments, the distal region and the proximal region can be more tightly constricted against the first wire than the middle region because of their smaller inner diameter. By way of example, in Figure 1 and Figure 3A In -E, the flexible sleeve 120 can include a proximal region 122 and a distal region 126 having an inner diameter that is smaller than the inner diameter of the middle region 124.
[0031] In some disclosed embodiments, the flexible sleeve can include at least two regions having different mechanical properties. For example, in some embodiments, the distal tip of the flexible sleeve can be made of a more elastic material than the adjacent regions of the flexible sleeve, thereby enabling the distal tip to stretch over the aperture and the flexible graspable region when the sleeve is moved from the first orientation to the second orientation. By way of example, as illustrated in Figure 1 and Figure 3A In -E, the flexible sleeve 120 can include a proximal region 122 and a distal region 126 having an inner diameter that is smaller than the inner diameter of the middle region 124.
[0032] In some disclosed embodiments, the first flexible wire can include at least one protrusion thereon configured to be located within the middle region of the sleeve. The protrusion can refer to a portion of the first flexible wire having an outer diameter that is different than the diameter of the first flexible wire and can be located on the flexible wire at a proximal position relative to the aperture. The protrusion can be included as a part of the first flexible wire or it can be attached to the first flexible wire as an additional component. The outer diameter of the protrusion can be smaller than the inner diameter of the middle region of the flexible sleeve and larger than the inner diameter of the proximal region and the distal region. In some embodiments, this configuration can at least partially prevent the proximal region of the flexible sleeve from moving distally past the protrusion or the distal region of the flexible sleeve from moving proximally past the protrusion. By way of example, Figure 4 An exemplary first flexible wire 100 having a protrusion 400 thereon is illustrated.
[0033] In some disclosed embodiments, the flexible sleeve may include a lock configured to secure the sleeve in a second position. The lock may refer to a mechanism, such as one or more protrusions or components located on the inner surface of the flexible sleeve, configured to interact with a first flexible line to lock the flexible sleeve in place relative to the first flexible line. In some embodiments, the lock may be configured to engage with a protrusion on the first flexible line to secure the sleeve in a second position. For example, in Figure 1 In this case, the lock 130 may be located inside the flexible sleeve 120 and may be configured to engage with the protrusion 400 (not shown) to secure the flexible sleeve 120 in place.
[0034] In some disclosed embodiments, the lock may include at least one resilient fork projecting inwardly from the flexible sleeve. For example, at least one resilient fork may be configured to cross a protrusion on the first flexible line and engage distally with the protrusion when the sleeve moves to a second orientation, thereby preventing proximal movement of the flexible sleeve. The resilient fork may be included as part of the flexible sleeve, or it may be attached to the flexible sleeve as an additional component. For example, in Figure 1 In this design, lock 130 may include at least one resilient fork 132. The resilient fork may be made of plastic, metal, or other suitable material. The elasticity and mechanical configuration of the resilient fork 132 allow lock 130 to pass over the protrusion 400 (not shown) of flexible line 100 in the distal direction, but not in the proximal direction. Therefore, when lock 130 passes over protrusion 400 in the distal direction, it prevents flexible sleeve 120 from moving proximally.
[0035] In some disclosed embodiments, the orifice can be selectively adjusted between an open position and a closed position and is biased to the open position. For example, as described above, the orifice can be made of a pre-biased material, such as a resilient metal or shape memory alloy (e.g., nitinol), such that the orifice is biased into a shape corresponding to the open position. In some embodiments, the flexible sleeve can be configured to allow the orifice to expand to the open position when the flexible sleeve is in a first orientation and to compress the orifice to the closed position when the flexible sleeve moves from the first orientation to a second orientation. As described above, in some embodiments, the flexible sleeve can apply a compressive force to the orifice, at least because the inner diameter of the flexible sleeve is smaller than the width of the orifice. In some embodiments, the orifice can be a compressible loop, although other configurations are possible. The compressible loop can be formed from a single wire or stranded or braided cable. The compressible loop can be formed from a metal, polymer, or any other biocompatible thread with suitable tensile strength and flexibility.
[0036] For example, Figures 3A-3E Multiple orientations of the flexible sleeve 120 relative to the flexible lines 100 and 200 are shown, and the flexible sleeve 120 can move between these orientations. For example, in Figure 3AOne orientation of the flexible sleeve 120 is shown in which the flexible sleeve 120 covers the proximal portion of the flexible wire 100 relative to the hole 112, while the hole 112 remains exposed. In some embodiments, the hole 112 is a compressible wire loop in the open position, as it is biased to the open position. However, in Figure 3A some embodiments, the hole 112 is covered by the flexible sleeve 120, and thus compressed to the closed position. For example, as the flexible sleeve 120 is moved from the orientation shown in Figure 3E to the orientation shown in Figure 3A , the flexible sleeve 120 can exert a compressive force on the hole 112, thereby preventing the hole 112 from having a pre-biased open position. Figure 3E
[0037] An example selectively connectable medical device can include a second flexible wire having a graspable region at an end thereof. The graspable region can refer to a portion of the second flexible wire that is configured to engage a hole of the first flexible wire so as to form a connection between the first flexible wire and the second flexible wire. For example, in some embodiments, the hole of the first wire can be sized to allow the graspable region of the second wire to pass through the hole when the hole is exposed. By way of example, Figure 2 An example flexible wire 200 having a graspable region 210 at an end thereof is shown. As Figure 3A shown, the hole 112 of the flexible wire 100 is sized to allow at least a portion of the graspable region 210 to pass through the hole 112.
[0038] In some disclosed embodiments, the graspable region can include at least one of a stainless steel cable, a nitinol wire, a nitinol cable, and a radiopaque material. The graspable region can be composed entirely of at least one of these components and / or materials, or it can be composed of multiple regions and / or components, each composed of one or more combinations of these components and / or materials. For example, the graspable region of the second flexible wire can include an inner metal core and an outer coil of radiopaque material. The inner metal core can be composed of, for example, a stainless steel cable, a nitinol wire, and / or a nitinol cable, while the outer portion of the graspable region can be composed of at least one radiopaque material and / or a coil of radiopaque material. By way of example, Figure 2 An example flexible wire 200 having a graspable region 210 at an end thereof is shown. In some embodiments, the graspable region 210 can include an inner metal core 224, which can be composed of a stainless steel cable, a nitinol wire, and / or a nitinol cable, and an outer portion 222, which can be composed of a radiopaque material and / or a coil of radiopaque material.
[0039] When the graspable region of the second flexible line is passed through the aperture, the example flexible sleeve of the present disclosure can be configured to move to a second orientation, causing the graspable region of the second flexible line to bend around the edge of the aperture and simultaneously cover at least a portion of the aperture of the first line and the graspable region of the second line, thereby locking the second line to the first line. In some embodiments, the flexible graspable region can be configured to be bent by the sleeve when the sleeve is pushed distally through the aperture. For example, when the flexible sleeve moves to the second configuration, the flexible sleeve can push a portion of the graspable region against the distal edge of the aperture, thereby forcing the graspable region to bend. In some embodiments, the flexible sleeve can be configured to cover the entire graspable region in the second orientation, although the sleeve can also be configured to cover only a portion of the graspable region in the second orientation.
[0040] By way of example, Figure 3A -E illustrates various configurations of the flexible line 100 and the flexible line 200, in which the flexible sleeve 120 is positioned in various orientations. In Figure 3A , the flexible sleeve 120 is in a first orientation in which the aperture 112 is exposed, and in which the graspable region 210 has been passed through the aperture. When the flexible sleeve 120 is moved toward Figure 3B and 3C , the aperture 112 and the flexible sleeve 120 exert opposing forces on a portion of the graspable region 210, causing the graspable region 210 to bend back on itself. In some embodiments, the flexible sleeve 120 can be configured to cover the entire graspable region 210 in the second orientation. Figure 3D may correspond to a second orientation of the flexible sleeve 120 in which the flexible sleeve 120 covers only a portion of the graspable region 210. However, additionally or alternatively, Figure 3E may correspond to a second orientation of the flexible sleeve 120 in which the entire graspable region 210 (not shown) is covered by the flexible sleeve 120.
[0041] In some disclosed embodiments, the inner diameter of the distal tip of the flexible sleeve can be less than or equal to the diameter of the second flexible line, such that when the flexible sleeve is in the second orientation, the distal tip engages the second line. Because the inner diameter of the distal tip is less than or equal to the diameter of the second flexible line, the distal tip can engage the line, for example, by a tight fit and / or forming a seal against an outer portion of the second flexible line. By way of example, Figure 3E illustrates a configuration of the flexible line 100 and the flexible line 200, in which the distal tip 126 of the flexible region 120 engages the flexible line 200.
[0042] In some embodiments, the exemplary graspable region can include a locking element proximate an end of the graspable region, where the locking element is configured to rigidify a distal region of the flexible graspable region. The locking element can refer to any portion or element of the graspable region that has particular mechanical and / or geometric properties configured to facilitate engagement of the hole of the first flexible line and the graspable region of the second flexible line. For example, in some embodiments, a high flexibility portion of the graspable region can have a diameter that is less than a diameter of a rigid locking element on a distal end of the graspable region, such that distal movement of the hole relative to the graspable region is at least partially prevented by the rigid locking element having a diameter greater than the high flexibility portion. In some disclosed embodiments, the diameter of the graspable region and / or the locking element can be less than or equal to the diameter of the second line. In some disclosed embodiments, the axial length of the region that is rigidified is greater than the maximum inner diameter of the flexible sleeve.
[0043] By way of example, Figure 2 An exemplary flexible line is shown having a graspable region 210 at an end thereof, where the graspable region 210 includes a high flexibility portion 220 and a distal rigid locking element 230. The high flexibility portion 220 can have a diameter that is less than a diameter of the rigid distal locking element 230, thereby preventing distal movement of the hole 112 relative to the graspable region 210, for example, as shown. Although not shown here, the graspable region can have other geometric and / or mechanical properties suitable to facilitate engagement of the hole of the first flexible line and the graspable region, all of which fall within the scope of the present disclosure. For example, in addition or alternatively, the graspable region 210 can include a coil or can be constructed of a material that can prevent distal movement of the hole 112 by friction or another form of adhesion when the hole 112 becomes engaged with the graspable region 210. Figure 3C
[0044] The disclosed embodiments can include any of the following features, either alone or in combination with one or more other features, whether as a method, device, or system:
[0045] • a selectively connectable medical device;
[0046] • a first flexible line having a hole at a distal end thereof;
[0047] • a flexible sleeve surrounding the first flexible line, the flexible sleeve being movable along the first flexible line to a first position exposing the hole and a second position extending over the hole;
[0048] • a second flexible line having a graspable region at an end thereof;
[0049] • wherein the hole of the first line is sized to allow the graspable region of the second line to pass through the hole when the hole is exposed;
[0050] • wherein the flexible sleeve is configured to move to a second position when the graspable region of the second flexible line is passed through the aperture, causing the graspable region of the second flexible line to bend around the edge of the aperture, and simultaneously covering at least a portion of the aperture of the first line and the graspable region of the second line, thereby locking the second line to the first line;
[0051] • wherein the aperture is selectively adjustable between an open position and a closed position, and is biased to the open position;
[0052] • wherein the flexible sleeve is configured to enable expansion of the aperture to the open position when the sleeve is in a first position, and to enable compression of the aperture to the closed position when the sleeve is moved from the first position to a second position;
[0053] • a locking element proximal to the end of the graspable region, wherein the locking element is configured to render a distal region of the flexible graspable region rigid;
[0054] • wherein the diameter of each of the graspable region and the locking element is less than or equal to the diameter of the second line;
[0055] • wherein the axial length of the region rendered rigid is greater than the maximum inner diameter of the flexible sleeve;
[0056] • wherein the first flexible line and the second flexible line are selectively connectable and disconnectable;
[0057] • wherein the length of the flexible sleeve is less than half the length of the first flexible line; wherein the aperture is a compressible wire loop; wherein the length of the flexible sleeve is less than 10 cm; wherein the flexible sleeve comprises a distal region, an intermediate region, and a proximal region;
[0058] • wherein the inner diameter of the distal region and the proximal region is less than the inner diameter of the intermediate region;
[0059] • wherein the first flexible line further comprises a protrusion thereon configured to be positioned within the intermediate region of the sleeve, the protrusion having an outer diameter that is less than the inner diameter of the intermediate region and greater than the inner diameter of the proximal region and the distal region; wherein the flexible sleeve comprises a lock configured to secure the sleeve in the second position;
[0060] • wherein the lock comprises at least one resilient prong protruding inwardly from the flexible sleeve, the at least one resilient prong being configured to pass over the protrusion on the first flexible line and to engage a distal side of the protrusion when the sleeve is moved to the second position, thereby preventing proximal movement of the flexible sleeve;
[0061] • wherein the flexible sleeve comprises at least two regions having different mechanical properties; wherein a distal tip of the flexible sleeve is made of a material that is more elastic than adjacent regions of the flexible sleeve, thereby enabling the distal tip to stretch over the aperture and the flexible graspable region when the sleeve is moved from the first position to the second position;
[0062] • wherein the inner diameter of the distal tip of the flexible sleeve is less than or equal to the diameter of the second flexible wire such that the distal tip engages the second wire when the flexible sleeve is in the second orientation;
[0063] • wherein the flexible sleeve is configured to cover the entire graspable region in the second orientation;
[0064] • wherein the flexible graspable region is configured to be bent by the sleeve when the sleeve is pushed distally through the hole;
[0065] • wherein the graspable region of the second wire comprises a radiopaque material;
[0066] • wherein the graspable region of the second wire comprises an inner metal core and an outer coil of radiopaque material; and
[0067] • wherein the graspable region comprises at least one of a stainless steel cable, a nitinol wire, and a nitinol cable.
[0068] While the present disclosure is described herein with reference to illustrative embodiments for devices used for particular applications, such as for cardiac repair by ventricular navigation, it is understood that the embodiments described herein are not limited to that particular application. Those having ordinary skill in the art and the benefit of the teachings presented herein will recognize additional modifications, applications, embodiments, and equivalents that fall within the scope of the disclosed embodiments. Accordingly, the disclosed embodiments are not to be considered as limited by the foregoing description or the following description.
[0069] Many of the advantages of the present disclosure are apparent to one of ordinary skill in the art in view of the detailed description that follows, and, accordingly, the appended claims are intended to encompass all such features and advantages of the disclosure. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the present disclosure to the exact construction and operation described herein. Accordingly, all suitable modifications and equivalents should be considered as falling within the scope of the present disclosure.
[0070] Further, those of ordinary skill in the art will recognize that the concepts based on the present disclosure can be readily utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the present disclosure. It is therefore not intended that the present disclosure be limited to the exact constructions and operations described herein and illustrated in the drawings, but rather, that all suitable modifications and equivalents be considered as falling within the scope of the present disclosure.
Claims
1. A selectively connectable medical device, comprising: a first flexible wire having a hole at its distal end; a flexible sleeve surrounding the first flexible wire, the flexible sleeve being movable along the first flexible wire to a first position exposing the hole and a second position extending over the hole; and a second flexible wire having a graspable region at its end, wherein the hole of the first flexible wire is sized to allow the graspable region of the second flexible wire to pass through the hole when the hole is exposed, and wherein the flexible sleeve is configured to move to the second position when the graspable region of the second flexible wire passes through the hole, causing the graspable region of the second flexible wire to bend around the edge of the hole and simultaneously cover at least a portion of the hole of the first flexible wire and the graspable region of the second flexible wire, thereby locking the second flexible wire to the first flexible wire; wherein the flexible sleeve comprises a distal region, an intermediate region, and a proximal region, wherein the inner diameter of the distal and proximal regions is smaller than the inner diameter of the intermediate region, and wherein the first flexible wire further comprises a protrusion thereon configured to be located within the intermediate region of the sleeve, the protrusion having an outer diameter that is smaller than the inner diameter of the intermediate region and larger than the inner diameter of the proximal and distal regions. the hole is selectively adjustable between an open position and a closed position and is biased to the open position, and wherein the flexible sleeve is configured to allow the hole to expand to the open position when the sleeve is in the first position and to compress the hole to the closed position when the sleeve is moved from the first position to the second position.
2. The apparatus of claim 1, wherein, 3. The device of claim 1, further comprising a locking element proximal to the end of the graspable region, wherein the locking element is configured to rigidify the distal region of the flexible graspable region. the diameter of each of the graspable region and the locking element is less than or equal to the diameter of the second flexible wire.
4. The apparatus of claim 3, wherein, the axial length of the region that is rigidified is greater than the maximum inner diameter of the flexible sleeve.
5. The apparatus of claim 3, wherein, the first and second flexible wires are selectively connectable and disconnectable.
6. The apparatus of claim 1, wherein, the length of the flexible sleeve is less than half the length of the first flexible wire.
7. The apparatus of claim 1, wherein, the hole is a compressible wire loop.
8. The apparatus of claim 2, wherein, the length of the flexible sleeve is less than 10 centimeters.
9. The apparatus of claim 1, wherein, the flexible sleeve comprises a lock configured to secure the sleeve in the second position.
10. The apparatus of claim 1, wherein, the lock comprises at least one resilient prong protruding inwardly from the flexible sleeve, the at least one resilient prong being configured to pass over the protrusion on the first flexible wire and to engage a distal side of the protrusion when the sleeve is moved to the second position, thereby preventing the flexible sleeve from moving proximally.
11. The apparatus of claim 10, wherein, the flexible sleeve comprises at least two regions having different mechanical properties.
12. The apparatus of claim 1, wherein, a distal tip of the flexible sleeve is made of a material that is more elastic than adjacent regions of the flexible sleeve, thereby enabling the distal tip to stretch over the hole and the flexible graspable region when the sleeve is moved from the first position to the second position.
13. The apparatus of claim 12, wherein, the inner diameter of the distal tip of the flexible sleeve is less than or equal to the diameter of the second flexible wire, such that the distal tip engages the second flexible wire when the flexible sleeve is in the second position.
14. The apparatus of claim 13, wherein, the flexible sleeve is configured to cover the entire graspable region in the second position.
15. The apparatus of claim 7, wherein, the flexible graspable region is configured to be bent by the sleeve when the sleeve is pushed distally through the hole.
16. The apparatus of claim 1, wherein, 17. The apparatus of claim 1, wherein, The graspable region of the second flexible wire includes a radiopaque material.
18. The apparatus of claim 17, wherein, The graspable region of the second flexible wire includes an inner metal core and an outer coil of radiopaque material.
19. The apparatus of claim 1, wherein, The graspable region includes at least one of a stainless steel cable, a nitinol wire, and a nitinol cable.
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