CATHETER WITH MULTIPLE BRAID LAYERS

Embodiments herein relate to catheters including multiple braid layers. In an embodiment, a catheter is included having a catheter body, the catheter body can include a proximal end portion; a distal end portion; an inner liner; and a braided structure, the braided structure can include an inner braid layer, the inner braid layer can include a first set of inner wires; and a second set of inner wires; an outer braid layer, the outer braid layer can include a first set of outer wires; and a second set of outer wires; wherein the braided structure is disposed over the inner liner; wherein the first set of inner wires are larger than the second set of inner wires; and wherein the first set of outer wires are larger than the second set of outer wires. Other embodiments are also included herein.

FIELD

Embodiments herein relate to catheters including multiple braid layers.

BACKGROUND

Catheters have many applications in the context of medical treatment. Microcatheters are those with a relatively small diameter that make them ideal for navigating complex vasculature within the human body.

Desirable properties of catheters can include pushing capabilities (sometimes referred to as “pushability”) such that force provided by a clinician to the proximal end of the catheter can be transmitted sufficiently through the catheter to advance it to a particular site. Desirable properties of catheters can also include torque transmission properties, such that torque applied to the proximal end of the catheter can be transmitted to the distal end.

SUMMARY

Embodiments herein relate to catheters including multiple braid layers. In a first aspect, a catheter can be included having a catheter body. The catheter body can include a proximal end portion, a distal end portion, an inner liner, and a braided structure. The braided structure can include an inner braid layer. The inner braid layer can include a first set of inner wires and a second set of inner wires. The braided structure can include an outer braid layer. The outer braid layer can include a first set of outer wires and a second set of outer wires. The braided structure can be disposed over the inner liner. The first set of inner wires can be larger than the second set of inner wires and the first set of outer wires can be larger than the second set of outer wires.

In a second aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of inner wires wrap around the inner liner in a direction that can be opposite to a direction that the first set of outer wires wrap around the inner liner.

In a third aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the outer braid layer extends farther toward the distal end portion than the inner braid layer.

In a fourth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the outer braid layer extends farther toward the distal end portion than the inner braid layer by 5 to 8 millimeters.

In a fifth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the catheter body can include a jacket layer, wherein the jacket layer can be disposed over and penetrates into the braided structure.

In a sixth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the jacket layer can include a thermoplastic polymer.

In a seventh aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the jacket layer can include reflowed PEBAX.

In an eighth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the jacket layer can include a proximal jacket portion, a distal jacket portion, and a tip portion. The tip portion can be formed of a polymer having a different Shore hardness than a polymer forming the distal jacket portion.

In a ninth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the catheter body can include a lubricious outer coating, wherein the lubricious outer coating can be disposed over an outside of the catheter body.

In a tenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the lubricious outer coating can include a hydrophilic polymer.

In an eleventh aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner liner can define a lumen, wherein the lumen can be configured to receive a guidewire.

In a twelfth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner liner can define a lumen, wherein the lumen can be configured to receive a guidewire having a diameter from 0.014 to 0.035 inches.

In a thirteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner liner can include a hydrophobic polymer.

In a fourteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner liner can include polytetrafluoroethylene.

In a fifteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner braid layer can have a braid angle that can be less than the outer braid layer.

In a sixteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner braid layer can have a braid angle from 25 to 45 degrees and the outer braid layer can have a braid angle from 45 to 65 degrees.

In a seventeenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner braid layer can have a braid angle from 30 to 40 degrees and the outer braid layer can have a braid angle from 50 to 60 degrees.

In an eighteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner braid layer can have a braid angle that can be greater than the outer braid layer.

In a nineteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner braid layer can have a braid angle from 45 to 65 degrees and the outer braid layer can have a braid angle from 25 to 45 degrees.

In a twentieth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the inner braid layer can have a braid angle from 45 to 65 degrees and the outer braid layer can have a braid angle from 30 to 40 degrees.

In a twenty-first aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of inner wires and the second set of inner wires can be at least partially flat wires.

In a twenty-second aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of inner wires and the second set of inner wires can be at least partially flat stainless steel wires.

In a twenty-third aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of inner wires and the second set of inner wires each include from 6 to 10 wires.

In a twenty-fourth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of inner wires and the second set of inner wires can each include 8 wires.

In a twenty-fifth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of outer wires and the second set of outer wires can be at least partially flat wires.

In a twenty-sixth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of outer wires and the second set of outer wires can be at least partially flat stainless steel wires.

In a twenty-seventh aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of outer wires and the second set of outer wires each include from 6 to 10 wires.

In a twenty-eighth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first set of outer wires and the second set of outer wires each include 8 wires.

In a twenty-ninth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the catheter further can include a flexible strain relief device, wherein the flexible strain relief device can be disposed over the proximal end portion of the catheter body.

In a thirtieth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the catheter further can include a hub, wherein the hub engages a flexible strain relief device.

In a thirty-first aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the distal end portion can define a tapered tip.

In a thirty-second aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the catheter body can include a metal marker band, wherein the metal marker band can be disposed within the tapered tip.

DETAILED DESCRIPTION

As referenced above, desirable properties of catheters can include pushability as well as torque transmission. Such properties can be challenging to provide in the context of small diameter microcatheters. However, embodiments herein include catheters, and specifically microcatheters, that have excellent pushability and torque transmission properties while also exhibiting a significant degree of resistance to kinking.

In an embodiment here, a catheter is included having a catheter body. The catheter body can include a braided structure including an inner braid layer and an outer braid layer. The inner braid layer can include a first set of inner wires and a second set of inner wires. The outer braid layer can include a first set of outer wires and a second set of outer wires. The first set of inner wires can be larger than the second set of inner wires. Further, the first set of outer wires can be larger than the second set of outer wires.

Referring now toFIG.1, a schematic view of a catheter100is shown in accordance with various embodiments herein. The catheter100is shown with a hub106and a flexible strain relief device108. The hub106can serve as a point of attachment or engagement with other components such as a cap structure or other components. The hub106can be formed of various materials. In some embodiments, the hub106can be formed of a thermoplastic or thermoset polymers. As a specific example, in some embodiments, the hub106can be formed of a polymer such as a polycarbonate. In some embodiments, the hub106can be substantially rigid. The hub106can engage the flexible strain relief device108directly or indirectly. In some embodiments, the hub106can directly engage the flexible strain relief device108using a snap fit connection mechanism.

The flexible strain relief device108can serve to prevent the formation of kinks in the catheter due to the application of force by the clinician. The flexible strain relief device108can take on various shapes and configurations and can be formed of various materials including thermoplastic and thermoset polymers. In some embodiments, the flexible strain relief device can be formed of an elastomeric polymer material. The flexible strain relief device can be formed of a polymer that is flexible and relatively soft. As a specific example, in some embodiments the flexible strain relief device can be formed of a polyether block amide polymer (PEBA or PEBAX).

The catheter100also includes a catheter body110. The catheter body110includes a proximal end portion102and a distal end portion104. The distal end portion104can define a tapered tip112. The flexible strain relief device108can be disposed at least partially over the proximal end portion102of the catheter body110.

As will be described more fully herein, the catheter100can include a braided structure disposed over an inner liner, the braided structure can include an inner braid layer and an outer braid layer. As described below, both the inner braid layer and the outer braid layer can have asymmetric torque transmission properties with respect to the direction (clockwise or counterclockwise) of applied torque.

Referring now toFIG.2, a schematic view of a distal end portion104of a catheter is shown in accordance with various embodiments herein. As before, the catheter includes a catheter body110. The catheter body110includes the distal end portion104that, in turn, defines a tapered tip112. As before, a braided structure (not visible inFIG.2) can include an inner braid layer and an outer braid layer. As will be described further below, in various embodiments, the inner braid layer extends farther toward the distal end portion104than the outer braid layer.

In some embodiments, the beginning of the tapered tip112can coincide with where the inner braid layer extends outward beyond the end of the outer braid layer. In some embodiments, the tapered tip112can have a length of less than about 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 millimeters, or an amount falling within a range between any of the foregoing.

Referring now toFIG.3, a cross-section view of a distal end portion104as taken along line3-3′ ofFIG.2is shown in accordance with various embodiments herein. As previously described, the catheter includes a catheter body110with a distal end portion104defining a tapered tip112.

The catheter body110includes a braided structure including an outer braid layer302and an inner braid layer304. The inner braid layer304extends farther toward the distal end portion104than the outer braid layer302by a distance308. The distance308can be 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 millimeters or more, or an amount falling within a range between any of the foregoing. In various embodiments, the inner braid layer304extends farther toward a distal end portion104than an outer braid layer302by 5 to 8 millimeters. However, in various embodiments, the outer braid layer302extends farther toward a distal end portion104than an inner braid layer304. For example, in various embodiments, the outer braid layer302extends farther toward a distal end portion104than an inner braid layer304by 5 to 8 millimeters.

The catheter body110also includes a jacket layer306. In various embodiments, the jacket layer306can be disposed over and/or penetrate into the braided structure. In some embodiments, the jacket layer306can be an extrusion. After placement of the jacket layer306over the braided structure, the jacket layer306can be reflowed such that it is disposed over the braided structure as well as at least partially within interstices of the braided structure. In some embodiments, after reflowing, the jacket layer306can be disposed over the braided structure as well as at least partially within interstices of both the inner braid layer304and the outer braid layer302of the braided structure.

In this specific example, the catheter body110also includes a metal marker band310. In various embodiments, the metal marker band310can be disposed within a tapered tip. Various metals can be used to form the metal marker band310. In some embodiments, the metal marker band310can be formed of a platinum iridium alloy. In some embodiments, the metal marker band310can be disposed over a distal end of the inner braid layer304. In some embodiments, the metal marker band310can be crimped in place. In some embodiments, the metal marker band310can be swaged down onto the outer braid layer302, such as swaged down onto an end of the outer braid layer302.

In various embodiments, the inner braid layer304has a braid angle that is less than an outer braid layer302. In various embodiments, the inner braid layer304has a braid angle from 25 to 45 degrees and an outer braid layer302has a braid angle from 45 to 65 degrees. In various embodiments, the inner braid layer304has a braid angle from 30 to 40 degrees and an outer braid layer302has a braid angle from 50 to 60 degrees.

In various embodiments, the inner braid layer304has a braid angle that is greater than an outer braid layer302. In various embodiments, the inner braid layer304has a braid angle from 45 to 65 degrees and an outer braid layer302has a braid angle from 25 to 45 degrees. In various embodiments, the inner braid layer304has a braid angle from 45 to 65 degrees and an outer braid layer302has a braid angle from 30 to 40 degrees. In various embodiments, the inner braid layer304has a braid angle of about 55 degrees and an outer braid layer302has a braid angle of about 35 degrees.

In various embodiments, the inner braid layer304can have a higher pick count (which can be expressed as picks per inch or PPI which refers to the number times the wire crosses for every inch of shaft length) than the outer braid layer302. For example, in various embodiments, the inner braid layer304can have a braid with 120 to 180 PPI (or 145 to 155 PPI) and the outer braid layer302can have a braid with 45 to 85 PPI (or 55 to 75 PPI). In various embodiments, the inner braid layer304can have a braid with about 150 PPI and the outer braid layer302can have a braid with about 65 PPI. However, in some embodiments, the inner braid layer304can have a lower pick count or PPI than the outer braid layer302.

In some embodiments, the pick count or pic count can be consistent along the length of the catheter for the inner braid layer304, the outer braid layer302, or both. However, in some embodiments, the pick count can vary along the length of the catheter for the inner braid layer304, the outer braid layer302, or both. Varying the pick count along the length of the catheter in either layer is a technique that can be used herein to provide optimal characteristics at different points along the length of the catheter. Generally speaking, all things being equal, higher torque can be achieved with a higher pick count, but this can reduce the flexibility of the resulting shaft. While lower pick count tends to orient the wires more in parallel to the longitudinal axis of the catheter, which improves pushability and flexibility. As such, varying the pick count can provide different functional properties at different points along the length of the catheter. In some embodiments, the inner braid layer304and/or the outer braid layer302can include a first portion and a second portion wherein the pick count or PPI varies between the two portions by at least 5, 10, 15, 20, 25, 30, 40, 50, 75, 100, 200 percent or more, or an amount falling within a range between any of the foregoing.

Referring now toFIG.4, a schematic view of a braided structure400is shown in accordance with various embodiments herein. As before, the braided structure400includes an outer braid layer302. The braided structure400also includes an inner braid layer304. In this example, the outer braid layer302terminates and the inner braid layer304extends outward beyond the end of the outer braid layer302. However, in various embodiments, the outer braid layer can overlap the ends of the inner braid layer. For example, the outer braid layer can overlap a proximal end of the inner braid layer and/or overlap a distal end of the inner braid layer. As such, in some embodiments, the outer braid layer can extend along a greater length of the catheter than the inner braid layer. In other embodiments the inner braid layer and the outer braid layer can be substantially coterminous.

In some embodiments, one or both of the outer braid layer302and the inner braid layer304can include welded terminations. In some embodiments, the terminations of the outer braid layer302and the inner braid layer304can be etched or electropolished.

The ends of a braid layer can be secured to the other components of the catheter in various ways including using various types of fastening elements, adhesives, other structures, or the like. In some embodiments, a layer of a heat shrink tubing (including, but not limited to a PET heat shrink tubing material or another type of polymeric heat shrink tubing) can be disposed over an end (proximal end, distal end, or both) of a braid layer in order to secure it down to other catheter components.

Various braid patterns can be utilized herein. In some embodiments, the braid pattern can be a one wire under two wires, then over two wires braid pattern (sometimes referred to as a full load braid pattern) or one over two, under two. Such a braid pattern can be used for the inner braid layer304and/or the outer braid layer302. However, other braid patterns can also be used herein. For example, in some embodiments, a diamond braid pattern, a one over one pattern, a chase wire pattern, or the like could be used. In some embodiments, an inner braid layer can have one type of braid pattern while the outer braid layer can have another type of braid pattern. However, in some embodiments, both the inner braid layer and the outer braid layer can have the same braid pattern. In various embodiments the braid can have a right hand lay. In various embodiments, the braid can have a left hand lay. In some embodiments, an inner braid layer herein can have one type of lay while the outer braid layer can have another type of lay. For example, in some embodiments, the inner braid layer can have a right hand lay while the outer braid layer can have a left hand lay. Various systems can be used to form braid structures described herein including braiding systems commercially available from Steeger USA, Inman, S.C. and Kyoritsu Co. Ltd., as well as others.

In some embodiments, catheters herein can specifically lack a coil pattern arrangement of wires. Coil pattern arrangements of wires can offer kink resistance, but may lack sufficient pushability. Embodiments of catheters herein can offer desirable levels of kink resistance even without a coil. However, in other embodiments, a coil pattern of wires can also be included.

Referring now toFIG.5, a cross-sectional view of an inner braid layer304is shown in accordance with various embodiments herein. The inner braid layer304includes a first set of inner wires502. The inner braid layer304also includes a second set of inner wires504. The first set of inner wires502and the second set of inner wires504can have various shapes in cross-section and can be the same or different from one another. In some embodiments, the cross-sectional shape can be circular, square, rectangular, ovoid, polygonal, of the like. In various embodiments, the first set of inner wires502and a second set of inner wires504are at least partially flat wires. In various embodiments, the first set of inner wires502and a second set of inner wires504are at least partially flat metal wires. Various metals can be used including, but not limited to, pure elemental metals and alloys such as stainless steel, nitinol, and the like. In various embodiments, the first set of inner wires502and a second set of inner wires504are at least partially flat stainless-steel wires.

The wires of the first set of inner wires502and the wires of the second set of inner wires504can be different in size, shape, and/or material from one another. For example, in some embodiments, the first set of inner wires502can be larger than the wires of the second set of inner wires504, or vice versa. With smaller wires, generally flexibility is good but pushability and torque transmission go down. With larger wires, generally pushability and torque transmission are good, but flexibility go down. It has been found herein that optimal properties can be achieved by combining larger and smaller wires together.

In some embodiments, the larger wires (where relatively larger wires are included along with relatively smaller wires) can be flat wires having dimensions of 0.0010 to 0.0020 inches (thickness) by 0.0025 to 0.0035 inches (width) in cross-section and the smaller wires can be flat wires having dimensions of 0.0002 to 0.0008 inches by 0.0025 to 0.0035 inches in cross-section. In some embodiments, the larger wires (where relatively larger wires are included along with relatively smaller wires) can be flat wires having dimensions of approximately 0.0015 inches by 0.003 inches in cross-section and the smaller wires can be flat wires having dimensions of approximately 0.0005 inches by 0.003 inches in cross-section.

In various embodiments, the first set of inner wires502and a second set of inner wires504each comprise from 4 to 12 wires. In various embodiments, the first set of inner wires502and a second set of inner wires504each comprise from 6 to 10 wires. In various embodiments, the first set of inner wires502and a second set of inner wires504each comprise 8 wires.

In some embodiments, the first set of inner wires502can include a portion of wires wound in a first direction and a portion of wires wound in a second direction (such as 4 wires CW and 4 wires CCW, using 8 wires as an example) and the second set of inner wires504can also include a portion of wires wound in a first direction and a portion of wires wound in a second direction (such as 4 wires CW and 4 wires CCW, using 8 wires as an example). However, in other embodiments, all of the wires of the first set of inner wires502can be wound in one direction while all of the wires of the second set of inner wires504can be wound in the opposite direction. In this case, where the first set of inner wires502and the second set of inner wires504are different from one another (in size and/or material), this can result in asymmetric directional torque transmission properties provided by the braid layer.

Referring now toFIG.6, a schematic view of wire directions is shown in accordance with various embodiments herein.FIG.6shows a first direction602.FIG.6shows a second direction604. In some embodiments, the first direction602can correspond to the direction of winding or wrapping of a first set of inner wires502. In some embodiments, the second direction604can correspond to the direction of winding or wrapping of a second set of inner wires504.

WhileFIG.5shows wires of an inner braid layer, certain properties thereof can be provided similarly within an outer braid layer. Referring now toFIG.7, a cross-sectional view of an inner braid layer304and an outer braid layer302is shown in accordance with various embodiments herein. As before, the inner braid layer304includes a first set of inner wires502and a second set of inner wires504.

The outer braid layer302includes a first set of outer wires702. The outer braid layer302also includes a second set of outer wires704. The first set of outer wires702and the second set of outer wires704can have various shapes in cross-section and can be the same or different from one another. In some embodiments, the cross-sectional shape can be circular, square, rectangular, ovoid, polygonal, of the like. In various embodiments, the first set of outer wires702and a second set of outer wires704are at least partially flat wires. In various embodiments, the first set of outer wires702and a second set of outer wires704are at least partially flat metal wires. Various metals can be used including, but not limited to, pure elemental metals and alloys such as stainless steel, nitinol, and the like. In various embodiments, the first set of outer wires702and a second set of outer wires704are at least partially flat stainless-steel wires.

In various embodiments, the first set of outer wires702and a second set of outer wires704each comprise from 4 to 12 wires. In various embodiments, the first set of outer wires702and a second set of outer wires704each comprise from 6 to 10 wires. In various embodiments, the first set of outer wires702and a second set of outer wires704each comprise 8 wires.

The wires of the first set of outer wires702and the wires of the second set of outer wires704can be different in size, shape, and/or material from one another. For example, in some embodiments, the first set of outer wires702can be larger than the wires of the second set of outer wires704, or vice versa. In some embodiments, the larger wires (where relatively larger wires are included along with relatively smaller wires) can be flat wires having dimensions of 0.0010 to 0.0020 inches (thickness) by 0.0025 to 0.0035 inches (width) in cross-section and the smaller wires can be flat wires having dimensions of 0.0002 to 0.0008 inches by 0.0025 to 0.0035 inches in cross-section. In some embodiments, the larger wires (where relatively larger wires are included along with relatively smaller wires) can be flat wires having dimensions of approximately 0.0015 inches by 0.003 inches in cross-section and the smaller wires can be flat wires having dimensions of approximately 0.0005 inches by 0.003 inches in cross-section.

In some embodiments, the first set of outer wires702can include a portion of wires wound in a first direction and a portion of wires wound in a second direction (such as 4 wires CW and 4 wires CCW, using 8 wires as an example) and the second set of outer wires704can also include a portion of wires wound in a first direction and a portion of wires wound in a second direction (such as 4 wires CW and 4 wires CCW, using 8 wires as an example). However, in other embodiments, all of the wires of the first set of outer wires702can be wound in one direction while all of the wires of the second set of outer wires704can be wound in the opposite direction. In this case, where the first set of outer wires702and the second set of outer wires704are different from one another (in size and/or material), this can result in asymmetric directional torque transmission properties provided by the braid layer. In some embodiments, asymmetric directional torque transmission properties provided by the outer braid layer302can be directionally different (clockwise vs. counterclockwise) than the asymmetric directional torque transmission properties provided by the inner braid layer304.

Referring now toFIG.8, a cross-sectional view of a catheter100is shown in accordance with various embodiments herein. The catheter100includes a catheter body110and a braided structure therein. The braided structure includes an outer braid layer302and an inner braid layer304. The catheter body110also includes a jacket layer306. In this example, the jacket layer306is disposed over the braided structure, but also is disposed within the braided structure.

The catheter body also includes an inner liner804. In various embodiments, the inner liner804can include thermoplastic or thermoset polymers. In various embodiments, the inner liner804can include a hydrophobic polymer. In various embodiments, the inner liner804can include polytetrafluoroethylene (PTFE).

The inner liner804defines a lumen802having a diameter810. In various embodiments, the lumen802of the inner liner804can be configured to receive a guidewire. In various embodiments, the lumen802can be configured to receive a guidewire having a diameter from 0.014 to 0.035 inches and thus be sized to be slightly larger than the same. In some embodiments, the lumen802can have a consistent inner diameter all along the catheter body. However, in other embodiments the lumen802can transition to a tapered narrower inner diameter at the distal end portion104of the catheter100.

A lubricious outer layer808or coating can be disposed on the catheter body110. The lubricious outer layer808can include a polymer providing lubricious properties. In various embodiments, the lubricious outer layer808can include a hydrophilic polymer. Exemplary polymers of the lubricious outer layer808are described in greater detail below.

In some embodiments, the jacket layer of the catheter can have different zones or portions. Referring now toFIG.9, a schematic view of a catheter body110including jacket layer306is shown in accordance with various embodiments herein. Jacket layer306can include a proximal jacket portion902, a distal jacket portion904, and a tip portion906. The tip portion906can include the tapered tip112of the catheter.

In various embodiments, the jacket layer306can include a thermoplastic polymer. In various embodiments, the jacket layer306can include a thermoplastic polymer that is reflowed so that it penetrates into the braided structure of the catheter. In various embodiments, the jacket layer306can include a reflowed PEBAX polymer.

Various portions of the jacket layer can be formed of different materials such that different portions of the jacket layer can have different properties than other portions. For example, in various embodiments, the tip portion906can be formed of a polymer having a different Shore hardness than a polymer forming a distal jacket portion904.

As an example, in some embodiments, the tip portion906can be formed of a polymer having a Shore hardness of 68 D to 74 D, the distal jacket portion904can be formed of a polymer having a Shore hardness of 61 D to 65 D, and the proximal jacket portion902can be formed of a polymer having a Shore hardness of 68 D to 74 D. As an example, in some embodiments, the tip portion906can be formed of a polymer having a Shore hardness of about 72 D, the distal jacket portion904can be formed of a polymer having a Shore hardness of about 63 D, and the proximal jacket portion902can be formed of a polymer having a Shore hardness of about 72 D.

The distal end portion104of catheters herein can take on many different configurations. Referring now toFIG.10, a schematic view of a catheter100is shown in accordance with various embodiments herein. As before, the catheter100includes a hub106and a flexible strain relief device108. The catheter100also includes a catheter body110with a proximal end portion102and a distal end portion104.

In this embodiment, the catheter body110includes an angled portion1002at the distal end portion104of the catheter. The angled portion1002can be of various sizes. In some embodiments, the angled portion1002can be about 2, 3, 4, 5, 6, 7, 8, 9, or 10 millimeters in length, or an amount falling within a range between any of the foregoing.

Exemplary materials for the lubricious outer layer/coating herein can be found in U.S. Publ. Pat. App. No. 2014/0193474. In some embodiments, the lubricious polymer layer/coating includes a vinyl pyrrolidone polymer. As used herein a “vinyl pyrrolidone polymer” refers to polymers including vinyl pyrrolidone monomeric units. The vinyl pyrrolidone polymer can be a vinyl pyrrolidone homopolymer or a vinyl pyrrolidone copolymer including vinyl pyrrolidone and one or more (e.g., two, three, four, five, etc.) other monomeric units that are different than vinyl pyrrolidone. In embodiments, in a poly(vinyl pyrrolidone) copolymer, the vinyl pyrrolidone can be the primary monomer (molar quantity), such as present in an amount of greater than 50% (mol), 55% (mol) or greater, 60% (mol) or greater, 65% (mol) or greater, 70% (mol) or greater, 75% (mol) or greater, 80% (mol) or greater, 85% (mol) or greater, 90% (mol) or greater, 92.5% (mol) or greater, 95% (mol) or greater, 97.5% (mol) or 99% (mol) or greater. In exemplary embodiments, vinyl pyrrolidone is present in the copolymer in the range of about 75% (mol) to about 97.5% (mol), about 85% (mol) to about 97.5% (mol), or about 90% (mol) to about 97.5% (mol).

Other monomers that can be copolymerized with vinyl pyrrolidone to provide the vinyl pyrrolidone polymer include, but are not limited to acrylamide, methacrylamide, acrylic acid, acrylamido-2-methylpropanesulfonate (AMPS), methacrylic acid, methyl acrylate, methyl methacrylate, hydroxyethyl methacrylate, hydroxyethyl acrylate, glyceryl acrylate, glyceryl methacrylate, ethylene glycol, and derivatives of these monomers.

For example, in some embodiments, the lubricious polymer layer/coating includes a vinyl pyrrolidone polymer comprising a photoreactive group (e.g., photo-PVP). Reagents and methods for the preparation of photo-PVP can be found in references such as U.S. Pat. Nos. 4,979,959; 5,002,582; 5,263,992; 5,414,075; 5,512,329; and 5,637,460, the teaching of which are incorporated herein by reference. In some modes of practice, photo-PVP can be formed by the copolymerization of 1-vinyl-2-pyrrolidone and N-(3-aminopropyl (meth)acrylamide), which then can be derivatized with an acyl chloride (such as, for example, 4-benzoylbenzoyl chloride) under Schotten-Baumann conditions. That is, the acyl chloride reacts with the amino group of the N-(3-aminopropyl) moiety of the copolymer. An amide is formed resulting in the attachment of the aryl ketone to the polymer.

A vinyl pyrrolidone polymer comprising a photoreactive group can also be prepared by copolymerizing vinyl pyrrolidone with a monomer derivatized with a photoreactive group. Exemplary monomer derivatives include aryl ketone derivatives of hydrophilic free radically polymerizable monomers such as acrylamide, methacrylamide and AMPS. One exemplary methacrylamide-based monomer with a pendent photoreactive groups is N-[3-(4-benzoylbenzamido) propyl]methacrylamide (BBA-APMA), the synthesis which is described in Examples 1-3 of U.S. Pat. No. 5,858,653 (Duran et al.) Another exemplary methacrylamide-based monomer with a pendent photoreactive group is N-[3-(7-methyl-9-oxothioxanthene-3-carboxiamido)propyl] methacrylamide (MTA-APMA), the synthesis which is described in Examples 1-2 of U.S. Pat. No. 6,156,345 (Chudzik et al.)

As used herein, the recitation of numerical ranges by endpoints shall include all numbers subsumed within that range (e.g., 2 to 8 includes 2.1, 2.8, 5.3, 7, etc.).

The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or otherwise to provide organizational cues. These headings shall not be viewed to limit or characterize the invention(s) set out in any claims that may issue from this disclosure. As an example, although the headings refer to a “Field,” such claims should not be limited by the language chosen under this heading to describe the so-called technical field. Further, a description of a technology in the “Background” is not an admission that technology is prior art to any invention(s) in this disclosure. Neither is the “Summary” to be considered as a characterization of the invention(s) set forth in issued claims.