Patent Description:
Catheter type devices are typically long tubular structures with an inner lumen suitable for a guidewire used to navigate the vasculature, inject contrast or therapeutic materials, aspirate thrombus, or provide a means to deliver other devices or therapies to a target site within the vasculature or other body lumen. Catheter type devices are typically inserted through a small opening in the skin or another opening under visual guidance tracked to the target location within the body.

<CIT> discloses a medical device including a catheter with an expandable tip for use with at least two different sizes of wire guides. The catheter includes a wire guide lumen sized to receive a first wire guide of a first diameter. The catheter may also include a tip lumen that extends in a distal direction from a first opening in communication with the wire guide lumen to a second opening. The first opening is sized to receive the first wire guide, and the second opening is sized to receive a second wire guide of a smaller diameter than the first wire guide. The catheter also includes one or more longitudinal expansion features capable of radially expanding the tip lumen to receive a wire guide of a diameter up to the first diameter through the second opening.

<CIT> discloses an adapter assembly for connecting a catheter assembly to a tunneler having a generally tubular body having a first end, a second end and a longitudinal axis extending there through between the first end and the second end. The first end of the adapter is constructed to engage the proximal end of a trocar. The second end of the adapter is constructed to releasably engage at least one catheter lumen. A slider is disposed about the adapter and is longitudinally slidable along the adapter. When the slider is slid towards the second end of the adapter, the slider engages a plurality of legs on the adapter and biases the plurality of legs toward each other and the longitudinal axis of the adapter.

<CIT> discloses coupler assemblies to be used with a catheter to connect a proximal end of the catheter to extracorporeal medical equipment. An exemplary coupler assembly includes a spherical linkage coupler for a catheter. The coupler comprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter. The coupler also comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion. The two link arms connect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.

<CIT> describes a guidewire extension system which connects and disconnects the wires. The system includes a guidewire and an extension wire. Each wire has distal and proximal ends and a longitudinal axis therebetween. The distal end of the extension wire is adapted to be releasably connected to the proximal end of said guidewire or vice-versa. The system further has a coiled spring mounted the distal end of the extension wire. The spring is adapted to receive the proximal end of the guidewire so that as the wires are pulled apart, the spring constricts and grips the guidewire. The system also includes a tube disposed over the coiled spring. The tube is attached to the extension wire so that it slides along its longitudinal axis. The tube is adapted to engage and expand the spring as it is slid open, towards said proximal end of the extension wire, thereby releasing the guidewire wire.

<CIT> describes an apparatus for sealing a puncture through tissue including an introducer sheath sized for introduction into a puncture, cartridge sized for insertion into the introducer carrying a sealant, and a locking element for coupling the introducer sheath to the cartridge. When the cartridge is advanced into the introducer sheath, the locking element couples the introducer sheath to the cartridge such that subsequent retraction of the cartridge causes the introducer sheath to retract, thereby deploying the sealant from the cartridge within the puncture beyond the introducer sheath. <CIT> describes catheter connectors in which a catheter is attached to a threaded connector that is inserted into the lumen of the catheter. When the connector is inserted into the lumen of the catheter, the elastically compressible inner lumen conforms to the shape of the threaded outer surface of the connector to form a fluid-tight seal between the lumen and the connector.

It is desirable to provide an improved adapter designed with features that expand, augment, or modify the configuration or intended use of a medical device. The adapter including geometry, mechanical and/or thermal properties to expeditiously attach to the medical device, which is a catheter. In one embodiment, the adapter provides conversion of the medical device from a single guidewire device to a two guidewire device.

In accordance with the present invention, an adapter for a medical device is defined as in claim <NUM>. The adapter is constructed to have a proximal portion that interfaces with the internal lumen of a medical device and a distal portion that modifies, augments or extends the configuration or intended use of the medical device. The medical device is a catheter. The proximal portion of the adapter, and in particular a coil of an attachment mechanism that is positioned at this proximal portion and further includes a tube coaxial with the coil, interfaces with a portion of the internal lumen of the medical device in a manner to secure the adapter to the medical device during use. The distal portion of the adapter is generally outside the lumen of the catheter , and in particular extends beyond the distal portion end of the inner lumen of the medical device. The distal portion of the adapter is designed with features that expand, augment, or modify the configuration or intended use of the medical device.

The proximal portion of the adapter, and in particular the attachment mechanism positioned at this proximal portion, is designed to provide an interference fit of the coil with the internal lumen of the medical device such that during subsequent use the adapter remains secure. The proximal portion is additionally designed to be easily inserted into the internal lumen of the medical device. In one embodiment, the coil is a coil structure having geometry and mechanical/thermal properties such that the structure is slightly smaller than the internal lumen to fit within the internal lumen in the operating room environment temperature and then expands to a larger size to secure the adapter to the internal lumen of the medical device when it is in-vivo closer to body temperature. For example, the coil structure can be formed of nitinol at a predetermined austenitic finish (AF) temperature less than body temperature but greater than the temperature typically expected in an operating room or catheter lab. Alternatively, the coil structure can be physically restrained to have a size smaller than the internal lumen in the operating room environment and then expands to interface with the internal lumen of the medical device once the adapter is seated with the medical device and the physical restraint is removed. Alternatively, the coil structure can be configured to compress as it is inserted into the internal lumen of the medical device and provide securement.

The proximal portion can include an internal lumen to preserve a path for a guidewire, or for contrast injection for example. The proximal portion can include a braided structure or slotted tube stent-like geometry which can be compressed to a smaller size and then expanded to secure the adapter to the internal lumen of the catheter or other device.

The distal portion of the adapter can be used to modify the configuration of the medical device, for example, to convert a medical device from a single guidewire device to a two (<NUM>) guidewire device.

The foregoing description, as well as further objects, features, and advantages of the present invention will be understood more completely from the following detailed description of presently preferred, but nonetheless illustrative embodiments in accordance with the present invention, with reference being had to the accompanying drawings, in which:.

Reference will now be made in greater detail to preferred embodiments of the invention, examples of which is illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings and the description to refer to the same or like parts.

<FIG> illustrate one embodiment of adapter <NUM> coupled to distal end <NUM> of medical device <NUM>. According to the invention, the medical device <NUM> is a catheter. Adapter <NUM> includes distal portion <NUM> and proximal portion <NUM>. Proximal portion <NUM> is predominately or entirely inside lumen <NUM> of target medical device <NUM>. Distal portion <NUM> of adapter <NUM> is predominately outside of target medical device <NUM>. Adapter <NUM> is co-axial with medical device <NUM> as shown by longitudinal axis <NUM>. Proximal portion <NUM> of adapter <NUM> includes coil <NUM>. Preferably, coil <NUM> can be made of nitinol. Coil <NUM> is comprised of wire with a cross-sectional size wound to form a general coil shape.

Coil <NUM> interfaces with lumen <NUM> of medical device <NUM> in a manner that secures adapter <NUM> to medical device <NUM>. Adapter <NUM> is secured to medical device <NUM> by an interference fit of coil <NUM> with lumen <NUM>. Coil <NUM> can have an austenitic finish temperature (Af) less than body temperature, such as an average of <NUM> of normal body temperature. and greater than a temperature typically expected in an operating room or catheter lab, for example about <NUM> degrees to about <NUM> degrees C. Coil <NUM> can be twisted and or elongated to reduce a size or diameter of coil <NUM> such that coil <NUM> has a smaller size or diameter than a size or diameter of lumen <NUM> to facilitate positioning adapter <NUM> inside medical device <NUM>. As adapter <NUM> warms to body temperature during use in-vivo, coil <NUM> can expand to provide additional securement to medical device <NUM>.

Alternatively, coil <NUM> can be designed to be physically restrained or constrained to have a size or diameter smaller than internal lumen <NUM> of medical device <NUM> in an operating room environment and coil <NUM> can expand to interface with the internal lumen <NUM> of the target catheter <NUM> when the physical restraint is removed, once the adapter <NUM> is seated within medical device <NUM>. Coil <NUM> is shown with a constant round cross-section, alternatively the coil <NUM> can have a rectangular cross-section of a flat wire coil design. A flat wire design provides the benefit of a lower profile coil <NUM> but still sufficient securement through an interference fit with lumen <NUM>. The cross-section can be variable along the length of coil <NUM>. A variable cross-section coil <NUM> design provides the advantage of biased securement either towards one of ends of adapter <NUM>. Coil <NUM> can have variable flexibility and bending about longitudinal axis <NUM>.

In one embodiment, coil <NUM> provides additional reinforcement of medical device <NUM> to improve the kink resistance. Adapter <NUM> includes tube <NUM> coupled to distal portion <NUM> of adapter <NUM> and is co-axial with coil <NUM>. Tube <NUM> has funnel portion <NUM> located at proximal end <NUM> of adapter <NUM>. Funnel portion <NUM> can facilitate tracking of a guide wire from a proximal end (not shown), of medical device <NUM> to distal portion <NUM> of adapter <NUM>. Tube <NUM> preferably is a polymer tube and can include braiding or other reinforcement. Coil <NUM> includes proximal end <NUM> that is coupled, bonded or otherwise attached near proximal end <NUM> of tube <NUM>. Proximal end <NUM> of coil <NUM> can be retained to a size smaller than a size of lumen <NUM> to facilitate loading of adapter <NUM> into medical device <NUM> in use. Distal end <NUM> of coil <NUM> can be retained to a size smaller than a size of lumen <NUM>. For example, proximal end <NUM> or distal end <NUM> can be heat shaped or formed to a smaller size than the size of lumen <NUM>.

Distal end <NUM> provides a location on coil <NUM> that can be grabbed or held in order to twist and or elongate coil <NUM> to make it smaller in size to facilitate positioning the adapter <NUM> inside medical device <NUM>. Distal portion <NUM> of adapter <NUM> is preferably made from a thermoplastic elastomer. Example thermoplastic elastomers or soft polymers include, polyether urethane and polyether block amide, such as for example -40D PEBAX manufactured by Arkema.

In this embodiment, distal portion <NUM> is designed to modify medical device <NUM> that has a single guidewire access to have a two guidewire access. Distal portion <NUM> includes first lumen <NUM> for a first guidewire and second lumen <NUM>. Second lumen <NUM> connects to lumen <NUM> of medical device <NUM> by way of tube <NUM> of adapter <NUM>. This allows the user extra flexibility, for example to exchange guidewires, or administer contrast or medications through the target catheter lumen <NUM>. The path of a first guidewire illustrated by first lumen centerline <NUM> and the path of a second guidewire is illustrated by the second lumen centerline <NUM>. Accordingly, the path of lumen centerline <NUM> is outside of device <NUM>.

Distal portion <NUM> includes reduced size portion <NUM> at proximal end <NUM> of distal portion <NUM> which is designed through choice of materials, for example thermoplastic elastomers or soft polymers and geometry to interface with lumen <NUM> of medical device <NUM>. A slight interference fit between reduced size portion <NUM> and lumen <NUM> provides a stable structure during introduction of the coupled adapter <NUM> and medical device <NUM> into a body cavity or vessel. Adapter <NUM> can include a tapered distal end <NUM> of distal portion <NUM> which facilitates tracking the medical device <NUM> with attached adapter <NUM> inside a body lumen.

<FIG> illustrates adapter <NUM> in a configuration where coil <NUM> has been reduced to a smaller size by elongating coil <NUM>. <FIG> illustrates adapter <NUM> in a configuration where the coil <NUM> has been reduced to a smaller size by rotating or twisting coil <NUM>. An alternate embodiment of adapter <NUM> is where a combination of coil <NUM> twisting and elongating reduces the size of coil <NUM> such that it can fit within medical device <NUM>. Distance Ds2 between distal end <NUM> of coil <NUM> and proximal end <NUM> of distal portion <NUM> in <FIG> is smaller than distance Ds1 between distal end <NUM> of coil <NUM> and proximal end <NUM> of distal portion <NUM> as illustrated in <FIG>. In an alternate embodiment of adapter <NUM>, if the user twists and or elongates coil <NUM> such that distal end <NUM> of coil <NUM> is within a predetermined distance of proximal end <NUM> of distal portion <NUM> then the user would know adapter <NUM> is safe to insert into medical device <NUM>. For example, tube <NUM> can be marked to indicate the appropriate location of distal end <NUM> of coil <NUM>.

<FIG> illustrates an alternate embodiment of the present invention, adapter <NUM>. Adapter <NUM> has distal portion <NUM> and proximal portion <NUM> similar to distal portion <NUM> and proximal portion <NUM> of adapter <NUM> as shown in <FIG>. Adapter <NUM> includes tube <NUM> with funnel portion <NUM> located at proximal portion <NUM> of adapter <NUM>. Tube <NUM> is coupled to distal portion <NUM>. Coil <NUM> is also coupled to distal portion <NUM> and interfaces with lumen <NUM> of medical device <NUM> in a manner that secures adapter <NUM> to medical device <NUM>. Securement can be achieved in a similar manner as previously described for adapter <NUM>.

<FIG> illustrates an alternate embodiment of the present invention, adapter <NUM>. Adapter <NUM> has distal portion <NUM> and proximal portion <NUM> similar to distal portion <NUM> and proximal portion <NUM> of adapter <NUM> as shown in <FIG>, Adapter <NUM>, which is similar to adapter <NUM>, except portion <NUM> of coil <NUM> that interfaces with lumen <NUM> has a larger pitch than that of adapter <NUM>. For example, the pitch can be in the range of about <NUM> to about <NUM> times the size of the coil-sectional size of the wire of coil <NUM>. Adapter <NUM> also includes proximal end <NUM> of coil <NUM> which is similar to distal end <NUM> of adapter <NUM> in both use and form, except coil <NUM> is elongated and or twisted toward the proximal portion <NUM> of adapter <NUM> to make the size of coil <NUM> smaller to facilitate insertion of adapter <NUM> into medical device <NUM>.

<FIG> illustrates an alternate embodiment of the present invention, adapter <NUM>. Adapter <NUM> has distal portion <NUM> and proximal portion <NUM> similar to distal portion <NUM> and proximal portion <NUM> of adapter <NUM> as shown in <FIG>, as well as other similar features. Proximal portion <NUM> includes coil <NUM> which has a reduced sized portion <NUM> such that it grips tube <NUM>. Coil <NUM> can be heat shaped or formed with a portion that interfaces with lumen <NUM> of medical device <NUM>. Reduced sized portion <NUM> has an inside diameter dia1 smaller than outside diameter dia2 of tube <NUM> to contact and grip tube <NUM> during use. Reduced diameter portion <NUM> of coil <NUM> can be bonded, glued, heat reflowed to tube <NUM> to further couple coil <NUM> to proximal portion <NUM>.

<FIG> illustrates adapter <NUM> in a configuration where coil <NUM> has been reduced to a smaller size by elongating and or twisting coil <NUM>, similarly illustrated in <FIG>. Adapter <NUM> has distal portion <NUM> and proximal portion <NUM> similar to distal portion <NUM> and proximal portion <NUM> of adapter <NUM> as shown in <FIG>. Distal portion <NUM> includes single lumen tip <NUM>, co-axial with longitudinal axis <NUM>. Single lumen tip <NUM> has been reinforced with reinforcement section <NUM>. For example, reinforcement section <NUM> can be a coil or braid. Reinforcement section <NUM> includes proximal coil portion <NUM> which extend past the proximal end of single lumen tip <NUM>. Proximal coil portion <NUM> provides a slight interference fit with lumen <NUM> and a stable interface during initial insertion of adapter <NUM> into medical device <NUM> by the user. Reinforcement section <NUM> reinforces distal portion <NUM> and can facilitate tracking medical device <NUM> through a tight lesion.

<FIG>, <FIG> illustrate an alternate embodiment of the present invention, adapter <NUM>. Adapter <NUM> has distal portion <NUM> and proximal portion <NUM>. Proximal portion <NUM> includes coil <NUM>. Coil <NUM> is wound from wire <NUM> and has multiple diameters along its length. In one embodiment, wire <NUM> is flat with a rectangular or square cross-section. For example, coil <NUM> can have a wound length A <NUM> at a diameter øA <NUM> at proximal end of coil <NUM>. The wound pitch of wire <NUM> along wound length A <NUM> is variable, not constant, and changes from a pitch that is approximately twice the width <NUM> of flat wire <NUM> at proximal end of the wound length A <NUM> to a pitch that is approximately equal to a width of flat wire <NUM>, such that wire <NUM> is close wrapped, at distal end of wound length A <NUM>. A variable pitched wound length has advantages in that the farther spaced pitched coil can be more flexible and the close wrapped coil can be stiffer and stronger in torsion or bending. A variable pitched wound length also has advantages in that the farther spaced pitched coil can also provide a better bonding geometry such that a bonding agent or adhesive can flow between wraps of coil <NUM>. As wire <NUM> is wound distally to form coil <NUM> the diameter of the coil <NUM> transitions from a size øA <NUM> to a larger size øB <NUM> over length transition <NUM>. Wire <NUM> is wound over length B <NUM> at a size øB <NUM>. The wound pitch of wire <NUM> along wound length B <NUM> is variable, not constant, and changes from a pitch that is approximately equal to width <NUM> of wire <NUM>, such that wire <NUM> is close wrapped, to a significantly wider pitch that is approximately more than <NUM> times the close wrapped pitch. A dramatic or rapid change in pitch from close wrapped to more than <NUM> times width <NUM> of flat wire <NUM> is advantageous because it creates a wedge when coil <NUM> is constrained within internal lumen <NUM> of medical device <NUM> during use and can improve the interference fit and retention properties of adapter <NUM> within medical device <NUM>. Typically, øA <NUM> would be dimensionally smaller than lumen <NUM> of the target medical device <NUM> and øB <NUM> would be dimensionally larger than lumen <NUM> of the medical device <NUM>. As wire <NUM> is wound distally to form coil <NUM> the diameter of coil <NUM> transitions from a size øB <NUM> to a smaller size øD <NUM> over length transition <NUM>. The wound pitch of wire <NUM> along wound length transition <NUM> is approximately uniform.

In an alternate embodiment, the wound pitch of wire <NUM> along wound length transition <NUM> is variable. Wire <NUM> is wound distally from length transition <NUM> to continue to form coil <NUM> at a size øD <NUM> over a wound length D <NUM>. Typically, øD <NUM> would be dimensionally smaller than lumen <NUM> of medical device <NUM>. A portion of wound length D <NUM> of coil <NUM> at a size øD <NUM> is within cavities <NUM> and <NUM> of distal portion <NUM> of adapter <NUM>. Cavity <NUM> is sized to interface with a distal end of medical device <NUM> and cavity <NUM> is sized to accommodate the coil <NUM> at a size øD <NUM>. Cavity <NUM> is sized to allow wound length D <NUM> of coil <NUM> to move freely within cavity <NUM> when there is not an external mechanism gripping, pinching or clamping proximal end of distal portion <NUM> in the area of cavity <NUM>. When there is an external mechanism gripping, pinching or clamping the proximal end of distal portion <NUM> in the area of cavity <NUM>, cavity <NUM> is sized to prevent a portion of coil <NUM> in wound length D <NUM> from rotating or moving, holding coil <NUM>, which has been previously rotated/twisted to a smaller size state to facilitate insertion of proximal portion <NUM> of adapter <NUM> into medical device <NUM>.

Coil <NUM> can be made from Nitinol and have an austenitic finish temperature (Af) approximately equal to or less than an ambient temperature of the operating room or catheter lab environment so coil <NUM> will expand when released from a smaller size state after insertion into medical device <NUM>. Alternatively, coil <NUM> can be made from Nitinol and have an austenitic finish temperature (Af) less than body temperature but greater than the temperature typically expected in an operating room or catheter lab, for example about 25C-30C, except in zone T <NUM> where coil <NUM> has been selectively heat treated to have an austenitic finish temperature (Af) approximately equal to or less than an ambient temperature operating room or catheter lab environment, for example less than about ~18C, to enable zone T <NUM> of Nitinol coil <NUM> to expand when released from a smaller size state after insertion into medical device <NUM> in the catheter lab environment. Coil <NUM> having multi-zone or variable thermal properties has advantages in that it can be easier to insert adaptor <NUM> into medical device <NUM> with some of coil <NUM> having a higher Af temperature. The selectively heat treated portion of coil <NUM> in zone T <NUM> is biased to engage internal lumen <NUM> of medical device <NUM> more than the rest of coil <NUM> to facilitate creating the wedge, as described above, after coil <NUM> is released from a smaller size state and constrained within internal lumen <NUM> of medical device <NUM>. As adapter <NUM> warms to body temperature during use in-vivo the zone T is <NUM> of coil <NUM> provides additional securement and structure to adapter <NUM>. Zone T <NUM> as shown includes portion of length A <NUM>, transition <NUM> and portion of length B <NUM>. Alternatively, zone T <NUM> can include just a portion of transition <NUM> and a portion of length B <NUM> or other combinations.

Coil <NUM> is coupled to, bonded to or otherwise attached to central tube <NUM> of central lumen <NUM> of adapter <NUM> at part or all of the wound length A <NUM> at øA <NUM>. Proximal end <NUM> of proximal portion <NUM> of adapter <NUM> includes inner element <NUM> and outer element <NUM>. Inner element <NUM> and outer element <NUM> can form a funnel shape. Outer element <NUM> can be radiopaque or partially radiopaque to provide a landmark for proximal end <NUM> of adapter <NUM> when used in-vivo. The funnel shape of proximal end <NUM> of the adapter <NUM> can facilitate the back loading of a guidewire through the medical device <NUM> and adapter <NUM> during use. Proximal end <NUM> of adapter <NUM> is coupled, bonded or otherwise attached to the central tube <NUM>. In one embodiment, central tube <NUM> can be unitary with inner element <NUM>.

Central tube <NUM> connects proximal end of coil <NUM>, in the area of Length A <NUM> and proximal end <NUM> to distal portion <NUM>. Distal portion <NUM> of adapter <NUM> has an outer body <NUM> that is typically cylindrical or a revolved shape. Alternatively, outer body can have a non-revolved profile in portions or entirely. Outer body <NUM> can be made from a polymer. Outer body can be reinforced with metal, polymer or ceramic fibers, wire, laser cut hypotube and the like. Outer body <NUM> can be a laminated structure which can include multiple tube elements or materials. Outer body <NUM> can have a stepped tapered shape with first outside diameter <NUM> and second outside diameter <NUM> connected by tapered portions. Distal portion <NUM> has first exit lumen <NUM> of central lumen <NUM> and second exit lumen <NUM> of central lumen <NUM> at opposite each other in outer body <NUM>. First exit lumen <NUM> is angled at angle A1 toward proximal portion <NUM> of adapter <NUM> from the central axis of central lumen <NUM>. An angle in a direction of angle A1 can be advantageous when a guidewire is tracked through central lumen <NUM> starting at distal tip <NUM> of distal portion <NUM>, exiting through first exit lumen <NUM>. Second exit lumen <NUM> is angled at angle A2 toward distal end of adapter <NUM> from the central axis of central lumen <NUM>. An angle in a direction of angle A2 can be advantageous when a guidewire is tracked through central lumen <NUM> at proximal end <NUM> of proximal portion <NUM>, exiting through second exit lumen <NUM>. Central tube <NUM> terminates proximal to distal tip <NUM> such that a portion of central lumen <NUM> is formed only by outer body <NUM>. Alternatively, central tube <NUM> could extend to distal tip <NUM> or terminate at a more proximal location within outer body <NUM>. Central tube <NUM> can form central lumen <NUM> for a majority of the length of distal portion <NUM> to add strength and rigidity if required, for example if central tube <NUM> was a braided or wire reinforce structure.

In one embodiment, coil <NUM> has been rotated or twisted about the longitudinal axis of coil <NUM> and central tube <NUM> while central tube <NUM> and portion of wound length A <NUM> at øA <NUM> attached to central tube <NUM> are held fixed to decrease its size, specifically in transition <NUM>, length B <NUM>, and transition <NUM>. After coil <NUM> has been rotated or twisted to decrease the size of transition <NUM>, length B <NUM>, and transition <NUM>, a portion of distal end <NUM> of coil <NUM>, length D <NUM>, which is already at a small diameter can be held and fixed relative to distal portion <NUM> and coupled central tube <NUM> such that the coil <NUM> will remain at a reduced diameter. When a portion of distal end <NUM> of coil <NUM>, length D <NUM> that was held is released coil <NUM> will expand back from the small size state to its unconstrained size state and this expansion will tend to happen starting at unattached distal end <NUM>, length D <NUM> as coil <NUM> starts to expand/unwind from the distal end and progressively expands/unwinds moving proximal. In one embodiment, coil <NUM> progressively expands/unwinds from distal end <NUM> to proximal end of coil <NUM>, distal elements of coil <NUM> do not substantially inhibit the expansion and engagement of the portion transition <NUM> and Length B <NUM> to internal lumen <NUM> of medical device <NUM>, facilitate creating the wedge.

<FIG>, <FIG>, <FIG> illustrate an alternate embodiment of the present invention, adapter <NUM>. Adapter <NUM> is similar to adapter <NUM> and has distal portion <NUM> and proximal portion <NUM>. Proximal portion <NUM> includes coil <NUM> which is similar to coil <NUM>. Coil <NUM> is wound from wire <NUM> and has multiple diameters along the length of coil <NUM>. Coil <NUM> as shown has a wound length A <NUM> at a diameter øA <NUM> at proximal end <NUM> of coil <NUM>. The wound pitch of wire <NUM> along wound length A <NUM> is variable, not constant, and changes from a pitch that is approximately twice the width <NUM> of flat wire <NUM> at the proximal end of the wound length A <NUM> to a pitch that is approximately equal to the width <NUM> of wire <NUM>, such that wire <NUM> is close wrapped, at the distal end of wound length A <NUM>. A variable pitched wound length has advantages that the farther spaced pitched coil can be more flexible and the close wrapped coil can be stiffer and stronger in torsion or bending. A variable pitched wound length can have advantages in that the farther spaced pitched coil can also provide an improved bonding geometry such that a bonding agent or adhesive could flow between wraps of coil <NUM>. As wire <NUM> is wound distally to form coil <NUM> the diameter of the coil <NUM> transitions from a size øA <NUM> to a larger size øB <NUM> over length transition <NUM>. Wire <NUM> is wound over a length B <NUM> at a size øB <NUM>. The wound pitch of wire <NUM> along wound length B <NUM> is variable, not constant, and changes from a pitch that is approximately equal to width <NUM> of wire <NUM>, such that wire <NUM> is close wrapped, to a significantly wider pitch that is approximately more than <NUM> times width <NUM> of the flat wire <NUM>. A dramatic or rapid change in pitch from close wrapped to more than <NUM> times the width <NUM> of wire <NUM> as shown is advantageous because it creates a wedge when coil <NUM> is constrained within internal lumen <NUM> of medical device <NUM> during use and can improve the interference fit and retention properties of adapter <NUM> within the catheter <NUM>. Typically, øA <NUM> would be dimensionally smaller than lumen <NUM> of medical device <NUM> and øB <NUM> would be dimensionally larger than lumen <NUM> of the medical device <NUM>. As wire <NUM> is wound distally to form coil <NUM> the diameter of coil <NUM> transitions from size øB <NUM> to a smaller size øC <NUM> over length transition <NUM>, the wound pitch of wire <NUM> along wound length transition <NUM> is substantially uniform. Alternatively, wound pitch of wire <NUM> along wound length transition <NUM> is variable. Wire <NUM> is wound distally from length transition <NUM> to continue to form coil <NUM> at a size øC <NUM> over wound length C <NUM>. øC <NUM> can be dimensionally similar to or slightly smaller than lumen <NUM> of medical device <NUM> so that as coil <NUM> was unconstrained from a small size state in use to secure adapter <NUM> to internal lumen <NUM>, wound length C <NUM> of coil <NUM> at size øC <NUM> would be less likely to inhibit wound length B <NUM> of coil <NUM> at size øB <NUM> from engaging and securing coil <NUM> to internal lumen <NUM> of medical device <NUM>. As wire <NUM> is wound distally to form coil <NUM> the diameter of coil <NUM> transitions from size øC <NUM> to a smaller size øD <NUM> over length transition <NUM>, the wound pitch of wire <NUM> along wound length transition <NUM> is substantially uniform. Alternatively, wound pitch of wire <NUM> along wound length transition <NUM> is variable. Wire <NUM> is wound distally from length transition <NUM> to continue to form coil <NUM> at a size øD <NUM> over wound length D <NUM>. Typically, øD <NUM> would be dimensionally smaller than lumen <NUM> of medical device <NUM>. A portion of the wound length D <NUM> of coil <NUM> at a size øD <NUM> is within cavities <NUM> and <NUM> at proximal end <NUM> of distal portion <NUM> of adapter <NUM>. Cavity <NUM> is sized to interface with distal end (not shown) of medical device <NUM> and cavity <NUM> is sized to accommodate coil <NUM> at a size øD <NUM>.

Cavity <NUM> is sized to allow wound length D <NUM> of coil <NUM> to move freely within cavity <NUM> when there is not an external mechanism gripping, pinching or clamping proximal end <NUM> of distal portion <NUM> in the area of cavity <NUM>. When there is an external mechanism gripping, pinching or clamping proximal end <NUM> of distal portion <NUM> in the area of cavity <NUM>, cavity <NUM> sized to prevent a portion of coil <NUM> in wound length D <NUM> from rotating or moving, holding coil <NUM>, which has been previously rotated/twisted to a smaller size state to facilitate insertion of proximal portion <NUM> of adapter <NUM> into medical device <NUM>.

Coil <NUM> is coupled to, bonded to or otherwise attached to second tube element <NUM> forming a portion of second lumen <NUM> of adapter <NUM> at or along part or all of the wound length <NUM> at øA <NUM>. It may be advantageous for wound length <NUM> to be attached to second tube element <NUM> predominately close to transition <NUM> such that an uncoupled portion of wound length <NUM> could extend proximally to add more structure and support to adapter <NUM> and medical device <NUM>. Proximal end <NUM> of adapter <NUM> is attached to second tube element <NUM> in a similar manner as proximal end <NUM> of adapter <NUM> is attached to central tube <NUM>.

Distal portion <NUM> of adapter <NUM> has outer body <NUM> that is typically cylindrical or a revolved shape. Alternatively, distal portion <NUM> of adapter <NUM> has outer body <NUM> that has a non-revolved profile in portions or all, similar to outer body <NUM> of adapter <NUM> shown in <FIG>. Second tube element <NUM> is attached or coupled to outer body <NUM>, thereby connecting proximal end of coil <NUM>, in the area of Length A <NUM> and proximal end <NUM> to distal portion <NUM>. Distal portion <NUM> has first tube element <NUM> which forms a portion of first lumen <NUM>. As shown, first tube element <NUM> terminates proximal to distal tip <NUM> such that a portion of first lumen <NUM> is formed only by the outer body <NUM>. First tube element <NUM> could extend to distal tip <NUM> or terminate at a more proximal location within outer body <NUM>. Second lumen <NUM> and first lumen <NUM> exit outer body <NUM> in a manner similar to second exit lumen <NUM> and first exit lumen <NUM>. Second tube element <NUM> and first tube element <NUM> are shown extending to edge <NUM> of outer body <NUM> of distal portion <NUM>. Alternatively, second tube element <NUM> and first tube element <NUM> can terminate before edge <NUM> and such that a portion of second lumen <NUM> and first lumen <NUM> can be formed by outer body <NUM> of distal portion <NUM>.

<FIG>, <FIG> illustrate an alternate embodiment of the present invention, adapter <NUM>. Adapter <NUM> is similar to adapter <NUM> and has distal portion <NUM> and proximal portion <NUM>. Proximal portion <NUM> includes coil <NUM> located closer to distal portion <NUM> and coil <NUM> located closer to proximal end <NUM>. Coil <NUM> is a left handed helix and coil <NUM> is a right handed helix. Coil <NUM> has been described as part of adapter <NUM>. Coil <NUM> is similar to coil <NUM>. Coil <NUM> is wound from wire <NUM> and has multiple diameters along the length of the coil <NUM>. Wire <NUM> can be a flat wire. Coil <NUM> as shown has a wound length E <NUM> at a diameter (ø) øE <NUM> at the proximal end of coil <NUM>. As wire <NUM> is wound distally to form coil <NUM> the diameter of coil <NUM> transitions from a size øE <NUM> to a larger size øF <NUM> over a length transition <NUM>. Wire <NUM> is wound over a length F <NUM> at a size øF <NUM>. The wound pitch of <NUM> along wound length F <NUM> is variable, not constant, and changes from a pitch that is approximately equal to the width of wire <NUM>, such that wire <NUM> is close wrapped, to a significantly wider pitch that is approximately more than <NUM> times the width of wire <NUM>. A dramatic or rapid change in pitch from close wrapped to more than <NUM> times the width of wire <NUM> is advantageous because it creates a wedge when coil <NUM> is constrained within internal lumen <NUM> of medical device <NUM> during use and can improve the interference fit and retention properties of adapter <NUM> within medical device <NUM>. Typically, øE <NUM> would be dimensionally smaller than lumen <NUM> of medical device <NUM> and the øF <NUM> would be dimensionally larger than lumen <NUM> of medical device <NUM>.

Adapter <NUM> includes coaxial tube elements, central tube <NUM> and reinforcing tube member <NUM>. Central tube <NUM> forms a portion of central lumen <NUM> of adapter <NUM>. Proximal end <NUM> of adapter <NUM> is attached or coupled to the central tube <NUM>. Proximal end <NUM> is comprised of funnel element <NUM>. Central tube <NUM> and funnel element <NUM> can be unitary such that funnel element <NUM> is a flared end of central tube <NUM>. Funnel element <NUM> is advantageous in that it can facilitate back loading a guide wire through the medical device <NUM> and adapter <NUM>. Central tube <NUM> and reinforcing tube member <NUM> are both attached, bonded or coupled to distal portion <NUM> of adapter <NUM>. As shown, reinforcing tube member <NUM> terminates proximally to central tube <NUM> which terminates proximal to distal end <NUM> of proximal portion <NUM> of adapter <NUM>. An alternate embodiment or configuration can have reinforcing tube member <NUM> attached to distal portion <NUM> and central tube <NUM> attached to reinforcing tube member <NUM> to form adapter <NUM>. This embodiment has advantages if reinforcing tube member <NUM> were to terminate closer to distal tip <NUM> to include features to optimize the tip performance, for example as a crossing support device, while central tube <NUM> predominately provides a more optimized central lumen <NUM> for a guide wire as an example. In this embodiment, reinforcing tube member <NUM> and central tube <NUM> can terminate approximately together or central tube <NUM> can be more proximal than reinforcing tube member <NUM>.

Coil <NUM> is attached, bonded or otherwise coupled to the reinforcing tube member <NUM> at all or a portion of length E <NUM>. This could be accomplished using an adhesive to attach a portion of length E <NUM> to reinforcing tube member <NUM>. In a similar manner as previously described, a portion or all of the length A <NUM> of coil <NUM> is bonded or attached to reinforcing tube member <NUM>.

The inside diameter of coil <NUM> at a size of øD <NUM> is typically larger than the outside diameter of second tube element <NUM> or central tube <NUM> or reinforcing tube member <NUM>.

<FIG> illustrate adapter <NUM> while coil <NUM> has been rotated or twisted in a manner that wraps or winds it down to a smaller diameter øB <NUM>. Coil <NUM> has been rotated or twisted such transition <NUM>, wound length B <NUM> and transition <NUM> have been made to be held in a state at a smaller diameter øB <NUM> over a combined wound length of transitions <NUM> and length B <NUM>. Diameter øB <NUM> is approximately equal to or smaller than internal lumen <NUM> of medical device <NUM> to facilitate inserting adapter <NUM>. Temporary constraining element <NUM> is positioned around this portion of coil <NUM> to secure coil <NUM> at smaller diameter øB <NUM>. Temporary constraining element <NUM> is advantageous to allow coil <NUM> to be held in smaller diameter øB <NUM> without the need to hold or restrain from moving length D <NUM> section of coil <NUM>. Length D <NUM> is not attached or coupled to reinforcing tube member <NUM>.

<FIG> show clamping element <NUM> pinching or holding a portion of Length D <NUM> from rotating such that temporary constraining element <NUM> can be removed and coil <NUM> would still be held in a state that includes smaller diameter øB <NUM>. It may be advantageous to include a temporary constraining element <NUM> such that only temporary constraining element <NUM> holds coil <NUM> in a state at a smaller diameter øB <NUM> in an adapter packaging suitable for terminal sterilization and or shipping, transportation and inventory at the customer site, this would minimize the amount of time the load at the attached portion of coil <NUM> in Length A <NUM> would need to be reacted. When the adapter is ready to be used in an operating room or catheter lab, clamping element <NUM> can be applied and temporary constraining element <NUM> can be removed to allow insertion into medical device <NUM>.

<FIG> illustrate adapter <NUM> after it has been initially inserted into medical device <NUM> while coil <NUM> has been rotated or wound down to a smaller diameter øB <NUM> and held in that position by clamping element <NUM>. Coil <NUM> is shown after it has been inserted in internal lumen <NUM> of medical device <NUM>. As coil <NUM> is inserted the portion of length F <NUM> and transition <NUM> as shown in <FIG> conforms to the size of inner lumen <NUM> of medical device <NUM> and becomes a smaller diameter ø" <NUM> by elongating and or rotating. Similarly to as described previously, a dramatic or rapid increase in pitch from close wrapped to more than <NUM> times the close wrap pitch which is approximately the width of wire <NUM>, as shown is advantageous because it creates a wedge with an angle A <NUM>, equal to or greater than approximately <NUM> degrees, when coil <NUM> is constrained within internal lumen <NUM> of medical device <NUM> during use and can improve the interference fit and retention properties of adapter <NUM> within medical device <NUM>. In the embodiment of adapter <NUM>, coil <NUM> is the leading coil inserted into internal lumen <NUM> of medical device <NUM>. As coil <NUM> is inserted into internal lumen <NUM>, the wraps of wire <NUM> that are at a size approximately equal to internal lumen <NUM>, located within transition <NUM> and length F <NUM>, engage wall <NUM> of internal lumen <NUM> and reduce in size by elongating and rotating (predominately elongating) such that the transition and length F <NUM> is longer than combination of transition <NUM> and length F <NUM> and the entire coil <NUM> can be inserted into medical device <NUM>. This mode of action is different than that of coil <NUM>.

As shown in <FIG> after adapter <NUM> is inserted into target catheter <NUM> and clamping element <NUM> is removed, coil <NUM> will rotate and expand to the size of internal lumen <NUM> to engage the walls <NUM> of internal lumen <NUM>, over a combined wound length of length B <NUM> which includes portions of transition <NUM>, length B <NUM>, and transition <NUM>. Coil <NUM> is designed such that, upon expansion to conform to internal lumen <NUM> as described, within coil <NUM> geometry there is a dramatic or rapid increase in pitch from close wrapped to more than <NUM> times the close wrap pitch which is approximately the width of wire <NUM> which creates a wedge with an angle B <NUM>, equal to or greater than approximately <NUM> degrees. An advantage to the mode of action of coil <NUM> versus the mode of action of coil <NUM> is that by predominantly rotating coil <NUM> to conform to the internal lumen <NUM> instead of predominately elongating coil <NUM> to conform to the internal lumen <NUM>, coil <NUM> will be less likely to have axial re-coil when allowed to expand and the force to insert adapter is removed. Coil <NUM> can be pulled into the lumen <NUM> of medical device <NUM> as adapter <NUM> is inserted into medical device <NUM> via the bonded connection in Length A <NUM> to reinforcing tube member <NUM>. After adapter <NUM> has been inserted into medical device <NUM>, coil <NUM> will tend to axially re-coil toward distal end of adapter <NUM>, whereas coil <NUM> rotates into position without an external pulling force. Including both modes of action in one adapter is advantageous because it provides redundancy in case one mode is less effective than the other in retaining adapter <NUM> in medical device <NUM>. Additionally, coil <NUM> and coil <NUM> are wound in opposite directions such that if adapter <NUM> is placed under an external torsional load, adapter <NUM> optimally reacts in either direction of an external torsional load.

<FIG> illustrate adapter <NUM> after it has been inserted into medical device <NUM> and coil <NUM> has been deployed to engage internal lumen <NUM> securing adapter <NUM>. Adapter <NUM> includes distal portion <NUM> and proximal portion <NUM> very similar to previously described proximal portion <NUM> and proximal portion <NUM>. Distal portion <NUM> of adapter <NUM> has outer body <NUM> that is typically cylindrical or a revolved shape. Alternatively, distal portion <NUM> of adapter <NUM> can have a non-revolved profile in portions or all. Outer body <NUM> has a stepped tapered shape with first outside profile <NUM>, second outside profile <NUM> and third outside profile <NUM> connected by tapered portions. Distal portion <NUM> has first tube element <NUM> which forms a portion of first lumen <NUM>. First tube element <NUM> terminates proximal to distal tip <NUM> such that a portion of first lumen <NUM> is formed only by outer body <NUM>. First tube element <NUM> could extend to distal tip <NUM> or terminate at a more proximal location within outer body <NUM>. Second tube element <NUM>, which forms a portion of second lumen <NUM>, connects coil element <NUM> of proximal portion <NUM> to distal portion <NUM>. Second lumen <NUM> and first lumen <NUM> exit outer body <NUM> in a manner similar to second exit lumen <NUM> and first exit lumen <NUM>. Second tube element <NUM> and first tube element <NUM> are shown partially extending to edge <NUM> of outer body <NUM> of distal portion <NUM> where a portion of second tube element <NUM> and first tube element <NUM> terminate before <NUM> edge of outer body <NUM> such that a portion of second lumen <NUM> and first lumen <NUM> are formed by outer body <NUM> of distal portion <NUM>. Third outside profile <NUM> of outer body <NUM> includes first cavity <NUM> and second cavity <NUM>, as shown in longitudinal cross section and transverse cross section Z-Z. First cavity <NUM> and second cavity <NUM> are shown as open cavities. Alternatively, first cavity <NUM> and second cavity <NUM> can be a closed cavity, such as a circle shaped cavity. First cavity <NUM> and second cavity <NUM> are shown to be <NUM> degrees opposite each other. Alternatively, first cavity <NUM> and second cavity <NUM> can have alternative orientations.

<FIG> illustrate adapter <NUM>, as shown in <FIG> with the addition of first wire <NUM> and second wire <NUM>. Preferably, first wire <NUM> originates with a first end outside the patient (not shown) and extends distally along the outside of medical device <NUM> then through first cavity <NUM> and first lumen <NUM> exiting distal end <NUM> of distal portion <NUM> and extends to second end <NUM> of first wire <NUM>. Preferably, second wire <NUM> originates with a first end outside the patient (not shown) and extends distally through proximal end (not shown) of medical device <NUM> and continues inside lumen <NUM> of medical device <NUM>, through second lumen <NUM> then wrapping to extend back proximally through second cavity <NUM> extending proximally along the outside of medical device <NUM> and extends to second end (not shown) of second wire <NUM>. Second end (not shown) of second wire <NUM> can terminate outside the patient body. Adapter <NUM> can be advantageous when medical device <NUM> is a percutaneous transluminal angioplasty balloon. First wire <NUM> can act a guide wire to track medical device <NUM> which is a percutaneous transluminal angioplasty balloon to the site of an arterial lesion or blockage as well as provide a mechanism to induce a stress concentration into the wall of the artery and lesion preferentially dissecting or disrupting the lesion to improve dilation performance of the balloon at the target lesion. Second end of second wire <NUM> can extend proximally past the balloon in medical device <NUM> such that second wire <NUM> also provides a mechanism to induce a stress concentration similar to first wire <NUM>. Second wire <NUM> can have curve <NUM>. For example, second wire <NUM> can be manufactured from Nitinol and be heat treated to set a shape with curve <NUM>. Alternately, second wire <NUM> can be designed to be readily shaped to curve <NUM>. For example, second wire <NUM> can be manufactured from Nitinol and be heat treated to have an Af temperature such that second wire <NUM> is easily bent to curve <NUM> and stays in that shape during use, for example at an Af temperature above body temperature (37C). Second wire <NUM> can be positioned into adapter <NUM> and medical device <NUM> of a balloon prior to introduction of adapter <NUM> and medical device <NUM> into the patient. After the ballooning procedure is completed, second wire <NUM> can be withdrawn from proximal end (not shown) of medical device <NUM>. Alternatively, second wire <NUM> is tracked through medical device <NUM> and positioned in-vivo.

<FIG> illustrate adapter <NUM> which is similar to adapter <NUM>. Adapter <NUM> includes distal portion <NUM> which includes third outside profile <NUM> of outer body <NUM>. Second wire <NUM> includes first end <NUM> which is coupled or attached to outer body <NUM> at top or edge <NUM> of third outside profile <NUM>. Second wire <NUM> extends proximally from outer body <NUM> and distal portion <NUM> along the outside of medical device <NUM> and extends to second end (not shown) of second wire <NUM>. Second end (not shown) of second wire <NUM> can terminate within the artery or body vessel in a loop or fold to minimize any chance of incidental vessel trauma or extend all the way proximally exiting the patient. As shown in transverse cross section view Z-Z of third outside profile <NUM>, there is no cavity in third outside portion <NUM> for first wire <NUM>. First wire <NUM> alternatively extends distally alongside third outside profile <NUM>.

The size of first outside profile <NUM>, second outside profile <NUM>, and third outside portion <NUM> generally increase in size from first outside profile <NUM> to third outside profile <NUM>. However, third outside profile <NUM> has a reduced size portion <NUM> which is approximately equal in size to second outside profile <NUM>. This can be advantageous in that there would be room for second wire <NUM> to fold back and extend distally as medical device <NUM> and adapter <NUM> is withdrawn from the artery and patient.

<FIG> illustrate adapter <NUM> which is similar to adapter <NUM>. Adapter <NUM> includes distal portion <NUM>. Distal portion <NUM> has outer body <NUM> that is typically made from a soft polymer or elastomeric polymer. Distal portion <NUM> incorporates first tube element <NUM> that forms a portion of first lumen <NUM> in outer body <NUM>. First lumen <NUM> exits outer body <NUM> distally at distal tip <NUM>. First lumen <NUM> is formed partially by first tube element <NUM> and outer body <NUM>. First lumen <NUM> exits outer body <NUM> proximally at exit <NUM> which is proximal to distal exit <NUM> of second lumen <NUM> from outer body <NUM>. Second lumen <NUM> is formed partially by second tube element <NUM> and outer body <NUM>. As shown in section Y-Y, second lumen <NUM> transitions from a closed section as it exits outer body <NUM>. Tube element <NUM> and tube element <NUM> are side by side and overlap for length <NUM> within outer body <NUM>. First lumens <NUM> and second lumen <NUM> overlap for length <NUM>. An alternate embodiment of distal portion <NUM> includes first lumen <NUM> formed entirely by outer body <NUM> without tube element <NUM>. Distal portion <NUM> also includes a hole or passage <NUM> into cavity <NUM> close to distal end <NUM> of cavity <NUM>. Hole <NUM> can be beneficial to facilitate flushing air out of cavity <NUM> prior to use. Hole <NUM> can also provide an additional conduit to deliver fluids or contrast through lumen <NUM> of medical device <NUM>.

<FIG>, <FIG> illustrate an alternate embodiment of coil <NUM> of proximal portion <NUM> of an adapter <NUM> of the present invention. Coil <NUM> has a variable diameter and pitch. Similar to the other coil embodiments, coil <NUM> has a proximal diameter (ø) øE <NUM> and a larger diameter (ø) øF <NUM> at distal end <NUM> of coil <NUM>. Coil <NUM> transitions in diameter from øE <NUM> to øF <NUM>. Coil <NUM> is bonded or otherwise attached to central tube <NUM> that forms a portion of a central lumen <NUM> similar to central tube <NUM> over a length G <NUM>. The unbonded distal portion, Length H1 <NUM>, of coil <NUM> includes a portion at a diameter øE <NUM>, a portion at diameter øF <NUM> and a portion where the diameter transitions between those two diameters. The unbonded distal portion, Length H1 <NUM>, of coil <NUM> is shown with a variable pitch that are not close wrapped, but could include close wrapped pitch. A close wrapped pitch in the unbonded distal portion <NUM> at the smaller diameter and in the transition to the larger diameter can be advantageous as there can be less axial movement of central tube <NUM> under an axial load after the adapter <NUM> is attached to a target medical device <NUM>. <FIG> illustrates coil <NUM> of proximal portion <NUM> of an adapter <NUM> after adapter <NUM> has been inserted and seated into medical device <NUM> with lumen <NUM> as previously described. As coil <NUM> is inserted, the unbonded distal portion elongates to a length H2 <NUM>, such that a portion of coil <NUM> forms an angle A <NUM> as previously described. Proximal portion <NUM> also includes proximal end <NUM> and is comprised of inner element <NUM> that forms a funnel and outer element <NUM>. Outer element <NUM> is similar to outer element <NUM> and could be radiopaque or partially radiopaque to provide a landmark for the proximal end of the adapter in-vivo, but is shorter and doesn't fully cover inner element <NUM>, is longitudinally shorter in length than inner element <NUM>.

<FIG> shows an embodiment of proximal portion <NUM> and coil <NUM> such that after inserting and seating into a target device <NUM> as described and the central tube <NUM> is placed under an axial load F <NUM> the unbonded distal portion, Length H3 <NUM>, of coil <NUM> becomes shorter than the length H2 <NUM> prior to the axial load F <NUM>. Additionally, a portion of the unbonded coil wraps that formed unbonded distal portion length H2 compress together axially under the axial load F <NUM> and touch each other, effectively completing the wedge formed by angel A <NUM>, as illustrated in the enlarged detail view <FIG>.

<FIG> shows yet another embodiment of the proximal portion <NUM> and coil <NUM> such that after inserting and seating into medical device <NUM> as described and the central tube <NUM> is placed under an axial load F <NUM> the unbonded distal portion, Length H4 <NUM>, of coil <NUM> becomes shorter than the length H2 <NUM> prior to the axial load F <NUM>. Additionally, a portion of the unbonded coil wraps that formed unbonded distal portion length H2 <NUM> compress together axially under the axial load F <NUM> and touch each other as well as nest inside or invaginate effectively completing the wedge formed by angel A <NUM>, as illustrated in the enlarged detail view <FIG>. Nested coil wraps as illustrated in <FIG> may be advantageous as it may increase the securement of the adapter.

It could be envisioned that multiple coils similar to coil <NUM> could be bonded to a central tube <NUM> in series to create proximal portion <NUM>. Proximal portion <NUM> of this design can increase the robustness of the securement of the adapter to medical device <NUM>. A multiple coil configuration of this nature can include both left and right hand coils as previously described to minimize a bias or potential securement issue when central tube <NUM> is place under a torsional load.

<FIG> illustrates an embodiment of proximal portion <NUM> of an adapter that includes a coil <NUM> similar to coil <NUM>. Coil <NUM> includes all the elements of coil <NUM> plus a section of unbonded length J <NUM> that transitions from a larger diameter øF <NUM> to a smaller diameter that is preferentially smaller than the diameter of the inner lumen <NUM> of medical device <NUM>, similar to a diameter øE <NUM>. A coil design of this nature can be advantageous as it allows proximal portion <NUM> to be removed from medical device <NUM>. Proximal portion <NUM> can be removed by a user gripping a coil wrap in length J <NUM> and pulling distally elongating and or rotating coil <NUM>, releasing the wedge securement at the inside diameter of lumen <NUM> of target device <NUM>. For example, if a proximal portion <NUM> were coupled to a distal portion similar to <NUM> to form an adapter and a portion of length J <NUM> of coil <NUM> extended into cavity <NUM> after proximal portion <NUM> were inserted and seated into medical device <NUM>, similar to length D <NUM> as shown in <FIG>, effectively extending out the distal end <NUM> of medical device <NUM>, the user could cut distal portion <NUM> at a point along cavity <NUM>, effectively separating distal portion <NUM> from proximal portion <NUM> such that the user can grip and pull distally a coil wrap in length J <NUM>, removing proximal portion <NUM> from medical device <NUM>. It is understood that a length of wire <NUM> or an extension of wire <NUM> extending out of medical device <NUM> is gripped to remove proximal portion <NUM>.

<FIG> show proximal portion <NUM> with coil <NUM> that is similar to coil <NUM>. Coil <NUM> includes a transition <NUM> that varies in diameter and pitch. Coil <NUM> also includes a length K <NUM> at a diameter øB <NUM> that is predominately wider spaced pitch and a variable pitch transition to a diameter øD <NUM>. A design similar to this may have an advantage in securement when inserted into medical device <NUM> as described for coil <NUM>. It is understood that coils constructed similar to coil <NUM> and coil <NUM> can alternatively be inserted into medical device <NUM> similarly to coil <NUM> and still provide securement after insertion.

<FIG> illustrate an alternate embodiment of a distal portion <NUM> of adapter <NUM>. Adapter <NUM> includes distal portion <NUM>. Adapter <NUM> has been inserted into medical device <NUM>. Distal portion <NUM> includes first lumen <NUM>, outer body <NUM>, second tube element <NUM> forming a portion of second lumen <NUM> of adapter <NUM>. First lumen <NUM> exits outer body <NUM> proximally at exit <NUM> which is proximal to distal exit <NUM> of second lumen <NUM> from outer body <NUM>. Outer body <NUM> includes taper portion <NUM> to proximally interface and engage with wall <NUM> of distal inner lumen <NUM> of medical device <NUM>. Taper portion <NUM> interfaces and engages with medical device <NUM> and can reduce the overall size or profile of adapter <NUM>. Distal portion <NUM> includes reinforcing coil <NUM> which spans transition portion <NUM> between medical device <NUM> and distal portion <NUM>. Reinforcing coil <NUM> can reduce the chance of the medical device <NUM> or adapter <NUM> kinking at or near transition <NUM>. Reinforcing coil <NUM> is smaller in size or diameter than inner lumen <NUM> and is partially attached to outer body <NUM> and distal portion <NUM>. Distal portion <NUM> also includes distal tip <NUM>. When attached to a medical device <NUM>, the first lumen <NUM> can be used as a guide for a first guidewire, while the second lumen <NUM> can be used to introduce a second guidewire or other accessory into the patient. For example, an accessory with drill bit like features or characteristics that could be used to penetrate the cap of a completely occluded lesion may be advantageous.

It is to be understood that the above-described embodiments are illustrative of only a few of the many possible specific embodiments, which can represent applications of the principles of the invention. Numerous and varied other arrangements can be readily devised in accordance with these principles by those skilled in the art without departing from the and scope of the invention.

For example, the nitinol coil structure could be replaced by a braided wire structure as it could be readily change size by elongating to facilitate insertion into medical device <NUM>. A braided wire structure can be manufactured from nitinol and have similar thermal-mechanical properties as the nitinol coil or can be made from a more traditional alloy, such as stainless steel and be designed to collapse to a smaller diameter as it is inserted or prior to insertion into medical device <NUM>. A braid structure could be designed to have a similar wedge geometry when inserted into lumen of target catheter.

Instead of the user reducing the size of the nitinol coil or similar, the adapter can be manufactured and delivered to the customer constrain in that shape ready to be inserted into target catheter. This would remove some of the burden from the user and possibly make it easier to use. The coil could also be a more traditional alloy without shape memory or superelastic thermal-mechanical properties such as stainless steel.

Additionally, for configurations where the nitinol coil is coupled to the distal portion of adapter, the tube could be optional.

Although distal portion of adapter is generally shown to be the similar size as the target catheter this is not require, but may be desired.

Claim 1:
An adapter (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) for a medical device, the medical device being a catheter (<NUM>), said adapter (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) comprising:
a proximal portion (<NUM>) and a distal portion (<NUM>); and
an attachment mechanism positioned at the proximal portion (<NUM>) of the adapter (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), said attachment mechanism adapted to couple said adapter (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) to a distal end (<NUM>) of an inner lumen (<NUM>) of the medical device,
wherein the distal portion (<NUM>) of the adapter (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) extends beyond the distal end (<NUM>) of the inner lumen (<NUM>) of the medical device,
characterised in that
the attachment mechanism comprises a coil (<NUM>; <NUM>; <NUM>; <NUM>) and a tube (<NUM>) co-axial with the coil (<NUM>; <NUM>; <NUM>; <NUM>), wherein the coil (<NUM>; <NUM>; <NUM>; <NUM>) comprises a wire, a portion of the coil (<NUM>; <NUM>; <NUM>; <NUM>) is attached to a portion of the tube (<NUM>) and a portion of the coil (<NUM>; <NUM>; <NUM>; <NUM>) interfaces with a portion of the inner lumen (<NUM>) of the medical device, and the tube (<NUM>) is coupled to the distal portion (<NUM>) of the adapter (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), and
wherein said attachment mechanism is adapted to be coupled to said medical device by an interference fit of said coil (<NUM>; <NUM>; <NUM>; <NUM>) with said inner lumen (<NUM>).