Patent Description:
Catheters are commonly used in medicine for delivery of fluids, therapeutics and implants as well as in sampling tissues and bodily fluids. Catheters can be constructed with balloons or other tools to dilate tissue, block fluid flow or isolate segments of the anatomy. A relatively common use for a catheter is the delivery of drugs to a target tissue using blood vessels as a means of access. When a balloon is used, the vascular compartment distal to the balloon is isolated from the vascular compartment proximal to the balloon and perfusion of diagnostic, therapeutic or embolic agents is localized and concentrated. Transvascular catheters, especially in the peripheral blood circulation, need to have a small diameter to allow access into small vessels.

One common use for a microcatheter is the delivery of embolic agents and anticancer drugs to a tumor.

According to the NIH, <NUM>,<NUM> people were diagnosed with primary liver cancer (hepatocellular carcinoma, HCC) and <NUM>,<NUM> people were diagnosed with colorectal cancer in the US in <NUM>. Seventy five percent of these will metastasize to the liver. Liver resection and transplant are the only curative means; however, only small numbers of patients are eligible. Systemic Chemotherapy for primary and metastatic tumors in the liver is ineffective, having a response rate of about <NUM>% and a survival benefit of <NUM> months vs. <NUM> months over symptomatic care.

Trans-Arterial Embolization therapy is the transvascular access for injection of drug and/or embolic agents directly into, or in the vicinity of, the tumor vasculature using a microcatheter. Embolization therapy causes a shutdown of blood flow and, when drug or radioactivity is present, simultaneous release of high concentrations of drug or radioactivity. The technique is also noted for its very low level of toxicity. Chemoembolization was established as a standard of care for intermediate stage hepatocellular carcinoma in <NUM>. Numerous studies have demonstrated transarterial embolization to be effective on a number of primary cancers and to have better performance than chemotherapy for both HCC and metastatic colorectal cancers in the liver.

Various prior art references provide guidance on aspects of medical catheter construction. For example, <CIT> describes a coaxial catheter whereby a balloon is bonded to an elongated outer tube to prevent the balloon from telescopingly buckling when the balloon is being pushed across a narrow passage. <CIT> describes a coaxial coronary angioplasty catheter whereby an anchor joint is configured to allow distal movement of the inner tube and to prevent proximal movement. <CIT> describes a catheter with a pair of spaced apart balloons that define an intra-balloon space. A lumen passes through the catheter and exits within the intra-balloon space allowing injection of drugs, emulsions, fluids and fluid/solid mixtures. A perfusion lumen or bypass extends from a location proximal to the proximal balloon and to the distal tip to allow shunting of blood past the inflated balloons. <CIT> describes a two balloon catheter that is designed for treating a solid tumor. The balloons are positioned to isolate the blood flow into the tumor and allow injection of a vaso-occlusive collagen material to block the tumor blood supply. <NPL> describes a two balloon catheter for the treatment of lung carcinoma. The four lumen catheter includes a lumen for independent injection in the space between the balloons. <NPL> describes a balloon catheter device for delivering anticancer drugs into the liver. See also <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>;<CIT>; <CIT>; <CIT>and <CIT>.

<CIT> relates to medical vascular catheters adapted to be inserted into a blood vessel from an incision through the skin of a patient for introducing other devices or fluids for diagnostic or therapeutic purposes into the patient's vasculature. <CIT> relates to an angiographic catheter has a relatively stiff though flexible shaft and a soft tip. <CIT> relates to an improved apparatus and method to catheterize passages. <CIT> relates to a soft tip guiding catheter for atraumatic insertion into delicate, tortuous coronary vessels and introduction of an angioplasty balloon catheter therethrough. The guiding catheter includes a main tubular portion and a soft tubular tip with respective, matching external and internal tapers for increasing the contact area of the thermal bond. <CIT> relates to catheters and related methods for supporting a guidewire or delivering an agent through a vessel stenosis or other tortuous anatomy. <CIT> relates to a balloon catheter assembly provided with an outer catheter, an inner catheter, an outer adapter and a balloon, and is configured such that the balloon resides entirely within a predetermined volume having an outer diameter substantially equal to or less than the outside diameter of the distal end of the outer catheter when the balloon is in a deflated configuration. <CIT> relates to a catheter assembly, including an outer catheter and an inner catheter capable of being inserted into the outer catheter. <CIT> relates to a variable stiffness guidewire that comprises a outer body including a plurality of coil windings that are oriented in a first direction. <CIT> relates to a tubular member for manufacture of medical devices insertable into body lumens.

Medical catheters often are advanced through torturous vasculature, requiring a flexible distal section that can easily follow the vessel and a stiff proximal section that can support longitudinal advancement of the catheter as it twists and turns through the blood vessels. It is also desirable, in certain applications, that the catheter can transmit torque throughout its length, from the proximal end to the distal tip. This is particularly true when a shaped catheter tip is used. Shaped catheter tips are common and used to direct a guidewire and/or a catheter around acute angles and into branch vessels. A <NUM>-degree shape is among the favored tip configurations. In use, the catheter tip is rotationally oriented so that the angled tip is pointed toward the desired direction of travel and then the guidewire is further advanced into the vasculature. However, tracking a catheter through tortuous vasculature remains a challenging and time consuming process.

Accordingly, there remains an unmet medical need for an improved catheter having a shaped tip that facilitates navigation through tortuous vasculature.

In some embodiments of the present disclosure, a vascular catheter system is provided with a flexible main body and a flexible shaped tip. The flexible main body extends along a generally straight longitudinal axis when in a relaxed state and has a proximal end and a distal end. The main body also has a lumen therethrough configured to slidably receive a guidewire. The flexible shaped tip is located at the distal end of the main body. The shaped tip has a lumen therethrough that is in communication with the lumen of the main body and is configured to slidably receive a guidewire. The shaped tip has at least a portion configured to deviate from the longitudinal axis when in a relaxed state and configured to move towards alignment with the longitudinal axis when a guidewire is extended through the lumen of the shaped tip. The shaped tip is no longer than <NUM> and comprises at least three sections including a first, a second and a third section. The second section is located distally from the first section and the third section is located distally from the second section. The second section includes a first material having a first durometer and a second material having a second durometer lower than the first durometer. The second material includes a polymer and tungsten. The first section includes the first material without the second material, and the third section includes the second material without the first material.

In some of the above embodiments, the portion of the shaped tip configured to deviate from the longitudinal axis extends through an angle of at least <NUM> degrees. The portion of the shaped tip configured to deviate from the longitudinal axis may extend through an angle of between about <NUM> and about <NUM> degrees. In some embodiments, the portion of the shaped tip configured to deviate from the longitudinal axis extends through an angle of between about <NUM> and about <NUM> degrees.

Some embodiments of the system further include a guidewire configured to be received through the main body and the shaped tip to guide a distal end of the shaped tip through torturous vasculature. A distal region of the guidewire may increase in stiffness when moving from its distal end towards its proximal end. The system may further include an inflatable balloon located near the distal end of the main body.

In some embodiments, the shaped tip includes a single bend. In other embodiments, the shaped tip includes at least two bends. The shaped tip may include a curved portion having an inner bend radius no greater than about <NUM> (<NUM> inches). The shaped tip may include a curved portion having an inner bend radius no greater than about three times an outside diameter of the shaped tip.

In some embodiments of the present disclosure, a method of manufacturing a vascular catheter system is provided. The method may include the steps of providing a flexible main body, and forming and bonding a flexible shaped tip to the distal end of the main body. The flexible main body may extend along a generally straight longitudinal axis when in a relaxed state. The main body has a proximal end and a distal end and may have a lumen therethrough configured to slidably receive a guidewire. The shaped tip may be provided with a lumen therethrough in communication with the lumen of the main body and configured to slidably receive a guidewire. In some embodiments, the shaped tip has at least a portion configured to deviate from the longitudinal axis when in a relaxed state and configured to move towards alignment with the longitudinal axis when a guidewire is extended through the lumen of the shaped tip. In some embodiments, the shaped tip is no longer than <NUM> and comprises at least three sections including a first, a second and a third section. The second section is located distally from the first section and the third section is located distally from the second section. The second section may include a first material having a first durometer and a second material having a second durometer lower than the first durometer. The second material may include a polymer and tungsten. In some embodiments, first section includes the first material without the second material, and the third section includes the second material without the first material.

In some of the above embodiments, the first durometer is 35D and the second durometer is 25D. The forming and bonding step may include placing a first tube made of the first material partially over the distal end of the main body and heating the first tube such that it reflows onto the main body and bonds therewith. The forming and bonding step may further include placing a second tube made of the second material partially over a distal end of the first tube and heating the first tube and second tube such that they reflow and bond together. In some embodiments, the first tube and the second tube are each no longer than about <NUM>. In some embodiments, the first tube overlaps with the main body no more than about <NUM> and the second tube overlaps with the first tube no more than about <NUM>.

In some exemplary embodiments, the forming and bonding step further includes placing a tube made of heat shrink material over at least one of the first tube and the second tube, heating the heat shrink material until it shrinks and causes a diameter of at least one of the first tube and the second tube to shrink, and then removing the heat shrink material. The forming and bonding step may further include forming a taper on a distal end of the second tube by placing a tube made of heat shrink material over the distal end of the second tube, heating the heat shrink material until it shrinks and causes a diameter of distal end of the second tube to shrink more than a diameter of a proximal portion of the second tube, and then removing the heat shrink material.

The exemplary methods may further include a step of changing the shape of the first and second tubes after they have been reflowed together. This step may include using a mandrel or mold to hold the first and second tubes in a non-straight position while heating the first and second tubes to a temperature that is lower than a temperature that was used to reflow the first and second tubes together. This non-straight position may include a curve extending more than <NUM> degrees.

The novel features of the disclosure are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:.

Described herein are catheter designs that allow a shaped tip to be more easily navigated through tortuous vasculature. Termination of the catheter at a flexible, soft tip is desirable to minimize vessel trauma. The added support of a rigid section in proximity to the distal tip further aides in catheter tracking as a flexible section (without support or reinforcement) would be prone to kink and excessive flexing.

As shown in <FIG>, an exemplary vascular catheter system <NUM> constructed according to aspects of the present disclosure includes a Y-hub <NUM>, an inner catheter <NUM>, a strain relief <NUM>, a proximal outer catheter section <NUM>, a distal outer catheter section <NUM>, an inflatable balloon <NUM>, a marker band <NUM>, and a distal tip segment <NUM>. Y-hub <NUM> is shown separated from strain relief <NUM> for clarity in <FIG>, but normally is connected thereto. Proximal outer catheter section <NUM> extends from inside Y-hub <NUM> to a junction point <NUM> with distal outer catheter section <NUM>. Distal outer catheter section <NUM> extends from junction point <NUM> to the proximal end of balloon <NUM>, and the proximal end of balloon <NUM> is fluidically sealed with the distal end of the distal outer catheter section <NUM>. Proximal outer catheter section <NUM> may be joined to distal outer catheter section <NUM> with a butt joint weld at junction point <NUM> such that the outer catheter is fluid pressure tight. Inner catheter <NUM> extends from within Y-hub <NUM>, through proximal outer catheter section <NUM>, distal outer catheter section <NUM>, balloon <NUM>, marker band <NUM>, and into the proximal end of distal tip segment <NUM>. In this exemplary embodiment, the distal end of balloon <NUM> is fluidically sealed near the distal end of inner catheter <NUM>. With this arrangement, a first generally annular volume (not shown) remains between an outer diameter of the inner catheter <NUM> and an inner diameter of the proximal outer catheter section <NUM>. Similarly, a second generally annular volume (not shown) remains between the outer diameter of the inner catheter <NUM> and an inner diameter of the distal outer catheter section <NUM>. These first and second generally annular volumes are in fluid communication with one another at junction point <NUM>. In some embodiments, inner catheter <NUM> may be generally free to move laterally inside proximal outer catheter section <NUM> and distal outer catheter section <NUM>. As such, inner catheter <NUM> may contact these outer catheter sections (as depicted in <FIG>), and the generally annular volumes may become crescent shaped. What is meant by "generally annular volume" in the claims appended hereto is the space between inner catheter <NUM> and outer catheter sections <NUM> and <NUM>, regardless of whether it always has an annular shape.

The first annular volume described above is in fluid communication inside Y-hub <NUM> with its lateral port <NUM>. The second annular volume is in fluid communication with the interior of balloon <NUM>. Accordingly, when a balloon inflation pressure is provided at lateral port <NUM>, balloon <NUM> inflates as shown in <FIG>. When the inflation pressure is removed from lateral port <NUM>, balloon <NUM> deflates and returns to a retracted state (not shown) surrounding the distal region of inner catheter <NUM>.

In some embodiments, catheter system <NUM> may have a working length A (i.e. outside of Y-hub <NUM> and strain relief <NUM>) of about <NUM> to about <NUM>. In some embodiments, the length B of distal outer catheter section <NUM> is about <NUM>. In some embodiments, the diameter of balloon <NUM> is about <NUM>, its length is about <NUM>, and the length of distal tip segment <NUM> is about <NUM>. This results in a combined distance C of balloon and tip of about <NUM>, and a total distance B + C distal to junction point <NUM> of about <NUM>. For embodiments having a working length A of <NUM>, this leaves a length D of about <NUM> for the portion of proximal outer catheter section <NUM> that extends from Y-hub <NUM> and strain relief <NUM>. In some implementations, catheter system <NUM> is introduced into the target vasculature through a diagnostic catheter (not shown. ) In some of these implementations, it is desirable to have about <NUM> of flexible catheter section (e.g. B + C) extending from the diagnostic catheter in order to track through tortuous vasculature. Therefore, with the aforementioned dimensions, junction point <NUM> and the distal portion of proximal outer catheter section <NUM> remain inside the diagnostic catheter during a medical procedure.

Referring to <FIG>, cross-sections of inner catheter <NUM>, proximal outer catheter section <NUM>, and distal outer catheter section <NUM> are shown. In this exemplary embodiment, each of these three components comprises an inner layer, a middle layer and an outer layer with the following characteristics:.

Referring to <FIG>, enlarged views showing the distal portion of catheter system <NUM> are provided. <FIG> shows an assembled view of the distal portion, and <FIG> shows an exploded view. Inflated balloon <NUM>' shown in <FIG> has a more rounded profile than that of balloon <NUM> shown in <FIG>. As best seen in <FIG>, distal outer catheter section <NUM> stops just short of the proximal end of balloon <NUM>'. To seal the proximal end of balloon <NUM>' against the distal end of distal outer catheter section <NUM>, a stepped inner sleeve and/or an outer sleeve (neither shown) may be utilized.

As shown in <FIG>, distal tip segment <NUM> may be provided with a preset shape that extends a distal end thereof laterally outward. In this embodiment, the distal end extends outward at a <NUM> degree angle. In other embodiments, the distal end extends outward at an angle of about <NUM> to about <NUM> degrees (see for example <FIG>). In still other embodiments, the tip angle can be between about <NUM> degrees and about <NUM> degrees, or between about <NUM> degrees and about <NUM> degrees (i.e. the tip can double back on itself. ) In some later described embodiments, the tip can include two or more bends (see for example <FIG>) rather than the single bend of the exemplary embodiment shown in <FIG>. This outward angle allows a medical practitioner to rotate the distal tip segment <NUM> towards a branch blood vessel (by rotating Y-hub <NUM> outside of the patient), extend a guidewire (not shown) distally from the distal tip segment <NUM> into the branch blood vessel, and then track the catheter system <NUM> over the guidewire into the branch blood vessel. This may be done repeatedly to track the catheter system <NUM> deep into tortuous vasculature toward target tissue.

As depicted in <FIG>, distal outer catheter section <NUM> may be connected to inner catheter <NUM> through at least one discrete connection point <NUM>. In some embodiments, discrete connection point(s) <NUM> may be created by thermal or chemical bonding. For example, laser, radio frequency energy and/or a heated probe such as a soldering iron may be used to melt together the materials of distal outer catheter section <NUM> and inner catheter <NUM> to form a tack or spot weld. By way of another example, a hole may be formed in distal outer catheter section <NUM> and a small amount of glue, adhesive, epoxy or other fluid material may be injected into the hole to bond the two catheters <NUM> and <NUM> together. In the exemplary layout shown in <FIG>, there may be one discrete connection point <NUM> formed between proximal outer catheter <NUM> and inner catheter <NUM>, and three discrete connection points <NUM> formed between distal outer catheter section <NUM> and inner catheter <NUM>. Further details of such discrete connection points <NUM> may be found in applicant's co-pending <CIT> and entitled High Torque Catheter and Methods of Manufacture.

Referring to <FIG>, various exemplary shaped tips are schematically shown. In each of these examples, two or more layers of tubing are combined to create the tip construct. The left side of each figure represents the proximal end of the shaped tip, which is typically connected to the distal end of an inner catheter <NUM> as shown in <FIG>, and the right side of each figure represents the distal end of the shaped tip. Reference letters A-F and W denote discrete pieces of tubing which in some embodiments are each formed from different materials. The base material of tube A is formulated to bond to the main body of the catheter. W denotes a tube comprising tungsten, or in some embodiments another radio opaque material that serves as a location marker under fluoroscopy or other imaging during a surgical procedure. In other embodiments, W may simply denote another material similar to the materials of A-F (i.e. not having any special radio opaque properties. ) The shaped tips disclosed herein may be used at the distal end of catheters with or without balloons.

In the construct depicted in <FIG>, a tube A comprising a first polymeric material (such as a polyether block amide, or PEBA) is placed within a tube B comprising a second polymeric material (which may also be a PEBA. ) In this embodiment, the material of tube B is softer, more flexible and has a lower durometer than the material of tube A. Tube W, comprising tungsten, is placed over the distal end of tube B and located just distal to the middle region where tubes A and B are overlapping.

Tube A may be oversized so that its proximal end slides over the distal end of inner catheter <NUM>. Heating tube A (before or after tubes B and W are added) allows tube A to shrink to fit over inner catheter <NUM>. The three tubes A, B and W may then be heated to melt and bond together and to inner catheter <NUM> using a material reflow process. The multiple layers may be processed in parallel or in series. In the middle section of <FIG> where tubes A and B overlap, the materials of tubes A and B may blend together in the reflow process such that the middle section no longer has discrete layers but rather comprises a blend of materials. Temperature profiles, time and other parameters of the shrink to fit and/or reflow process may vary based on material selection, diameter and thickness. In some embodiments, materials A, B and W each have a different color which may blend together during the reflow process or may remain distinct. With this disclosed fabrication method, material selection and layering can create different bend profiles of the shaped tip, offering transition from rigid to flexible in a gradient rather than abrupt transition(s), which can reduce kinking of the catheter tip. The construct depicted in <FIG> includes the characteristics of having a strong hold to its shape, relatively thick walls, and a radio opaque marker near its distal tip, but can be difficult to manufacture.

Referring to <FIG>, a shaped tip similar to the construct shown in <FIG> is provided. In this example, the region of overlap between tubes A and B is longer, the length which tube B extends distally from the overlap region is shorter, and tube W is located proximal to the overlap region rather than distal to it as in the example shown in <FIG>. The construct depicted in <FIG> includes the characteristics of having a good hold to its shape, relatively thick walls, a radio opaque marker away from its distal tip, and is less difficult to manufacture than the tip shown in <FIG>.

Referring to <FIG>, a shaped tip similar to the construct shown in <FIG> is provided. In this example, there are only two tubes used: A and W. Instead of having only a narrow marker band W as shown in <FIG>, the entire distal tube W may comprise a radio opaque material such as tungsten, as shown in <FIG>. In this exemplary embodiment, the material of tube W is softer, more flexible and has a lower durometer than the material of tube A. The construct depicted in <FIG> includes the characteristics of having a good hold to its shape, a radio opaque marker that extends to its distal tip, has less of a flexibility/rigidity gradient, and is fairly easy to manufacture compared with the previously described tips.

Referring to <FIG>, a shaped tip similar to the construct shown in <FIG> is provided. In this example, a forth material C is used. Each of the materials A, B and C gets progressively softer, more flexible and has a lower durometer moving distally. As depicted in <FIG>, there are six regions of the shaped tip of this embodiment (proximal to distal): A, A+B, A+B+C, B+C+W, B+C and C.

Referring to <FIG>, a shaped tip similar to the construct shown in <FIG> is provided. In this example, seven materials are used. Each of the materials A, B, C, D, E, and F gets progressively softer, more flexible and has a lower durometer moving distally. As depicted in <FIG>, there are eight regions of the shaped tip of this embodiment (proximal to distal): A, A+B, A+C, A+D, A+W, A+E, E and F. Tubes B, C and D abut rather than overlap with one another, as do tubes E and F. Since tube A extends only partway through tube E in this embodiment, tubes E and F may be temporarily mounted over a mandrel when fusing them together to ensure proper alignment. The constructs of <FIG> have more of a flexibility/rigidity gradient than the previously described embodiments. Material wall thicknesses may also be varied to further tune performance and behavior of the tip.

In the exemplary embodiments depicted in <FIG>, when there is an overlapping joint rather than a butt joint between two tubes, the more distal of the two tubes slides over the more proximal tube. This is done so that if an edge of the outer (distal) tube remains after the manufacture of the shaped tip is complete, it will not impede the insertion of the tip into a patient's vasculature. If such an outer edge does remain after manufacture, it may increase friction and/or catch on features of tortuous vasculature when the shaped tip is being withdrawn with the catheter from the patient. However, this is less of an issue during removal of the catheter because the catheter is in tension during removal, as opposed to being in compression during insertion when the catheter may tend to buckle rather than advance through the vasculature. In alterative embodiments (not shown), the more proximal of the two tubes may be slid over the more distal tube during manufacture.

Referring to <FIG>, three catheter tips are shown in various stages of manufacture. All three tips are formed using a layering process similar to that shown in <FIG> as previously described. Catheter tip <NUM> uses materials that are generally the same color so that the various layers are not readily apparent after they have been reflowed together. Tip <NUM> uses materials A, W and B that each have a different color. In some embodiments such as this, the material colors remain distinct after the reflow process. In other embodiments (not shown), colors of the various overlapping materials blend together such that the distinct tube materials are no longer readily discernable.

After a straight catheter tip is formed, such as previously described, it may be shaped into a non-straight configuration. For example, tip <NUM> shown in <FIG> may be used in its straight configuration while tip <NUM> may be formed into a curved tip <NUM> as shown. A low temperature may be used to set the material to a desired shape after the reflow process described above. Holding the material in the desired shape while at a temperature that is below the reflow temperature, such as <NUM> (<NUM> degrees F) for approximately <NUM>-<NUM> seconds for a layered construct of PEBA tubes, can change the overall shape of the tip without altering its dimensional aspects. These temperature and time parameters work for a convection based technique after a shaping mandrel having the desired shape is inserted through the distal end of the central lumen of the tip. An outer mold or tool with the desired shape may be used instead of or in conjunction with the mandrel. If the tip is in contact with media other than air, the temperature may need to be adjusted to ensure no dimensional changes occur during the shape changing process. For example, if the tip is held in a glass or aluminum fixture, etc., a temperature of <NUM>-<NUM> (<NUM>-150F) may be needed, and it may be held at this temperature for less time. As shown in <FIG>, the shaped tip <NUM> of this exemplary embodiment has a straight distal portion <NUM> configured to deviate from the longitudinal axis of the main body <NUM> of the catheter when tip <NUM> is in its relaxed state. The straight distal portion <NUM> extends through an angle of about <NUM> degrees from the longitudinal axis. A curved portion <NUM> may be provided between straight distal portion <NUM> and main body <NUM> as shown. In this exemplary embodiment, curved portion <NUM> has an inside bend radius of about <NUM> (<NUM> inches), or about <NUM> times the outside diameter of the tubing forming the tip <NUM>. This tight bend radius allows the catheter tip to be maneuvered through tighter turns in the vasculature. In other embodiments, the bend radius may be smaller or larger. In some embodiments, the bend radius is no smaller than about <NUM> (<NUM> inches), as a bend radius smaller than this in a tube of the same diameter is difficult to traverse with a guidewire.

Referring to <FIG>, three more examples of shaped catheter tips are schematically shown. Tip <NUM> is similar to tip <NUM> in <FIG>, but has a sharper bend <NUM>. Tip <NUM> includes three bends <NUM>, <NUM> and <NUM>. First bend <NUM> has a bend radius that becomes increasingly smaller towards the distal tip. Second bend <NUM> has a tighter bend radius in the same direction as first bend <NUM>. Together, bends <NUM> and <NUM> turn tip <NUM> about <NUM> degrees, forming a hook shape. Third bend <NUM> has a bend radius that is larger than those of bends <NUM> and <NUM>, and bends in the opposite direction. Tip <NUM> includes two sharp bends <NUM> and <NUM>, each bending in opposite directions and separated by a straight section <NUM>. Various other combinations of single or multiple bend shaped tips are possible using the manufacturing techniques disclosed herein. For example, a J-shaped tip similar to tip <NUM> may have a single, continuous bend of constant radius and may extend <NUM> degrees, between <NUM> and <NUM> degrees, or other angle.

Referring to <FIG>, a series of images are provided showing shaped tip <NUM> progressively straightened by advancing a guidewire through it. As previously described, the catheter and shaped tip <NUM> are provided with a central lumen configured to receive a flexible guidewire <NUM>. <FIG> shows shaped tip <NUM> in a relaxed state and having a deflection angle of <NUM> degrees. When the distal tip of guidewire <NUM> is passed through shaped tip <NUM> as shown in <FIG>, the stiffness of guidewire <NUM> causes tip <NUM> to move towards a straighter configuration (i.e. to have an angle of deviation of less than <NUM> degrees from the longitudinal axis of the main body <NUM>), such as <NUM> degrees in this case. A guidewire may be used that increases in stiffness moving from its distal end towards its proximal end. When such a guidewire <NUM> is advanced further through tip <NUM>, it causes tip <NUM> to further straighten towards the longitudinal axis of the catheter. In this exemplary embodiment, a <NUM> extension of guidewire <NUM> through tip <NUM> causes it to straighten to <NUM> degrees as shown in <FIG>, an extension of <NUM> causes an angle of <NUM> degrees as shown in <FIG>, and an extension of <NUM> causes an angle of <NUM> degrees as shown in <FIG>. A surgeon can thus steer tip <NUM> through turns in a patient's vasculature by adjusting the angle of the tip with the depth of guidewire <NUM>.

Prior art shaped tips are typically made of a single material and often have lengths between about <NUM> and <NUM> in length. Using the fabrication techniques disclosed herein, similar bend profiles can be achieved in a shorter distance. In some embodiments, the lengths of the inventive tips extending beyond the base catheter are between <NUM> and <NUM>. These shorter lengths allow for the catheter to be maneuvered through tighter turns in the vasculature while minimizing the distance from the distal tip of the catheter to an operational interface such as a balloon. This allows accurate positioning of the operational interface and distal tip for the desired application, such as therapeutic delivery.

In one particular exemplary embodiment, a shaped tip is formed from two Pebax tubes in a starting configuration similar to that shown in <FIG>. Tube A is made of a <NUM> durometer Pebax infused with <NUM>% barium sulfate to increase lubricity. A stabilizer may also be added so the material can withstand higher temperatures for longer periods of time, and longer exposure to ultraviolet/fluorescent light. In this embodiment, the inside diameter of tube A is (<NUM>±<NUM> (<NUM>" ±<NUM>"), the wall thickness is <NUM>±<NUM> (<NUM>" ±<NUM>"), the concentricity is ≥<NUM>% and the length is <NUM>. Tube W is made of <NUM> durometer Pebax infused with <NUM>% tungsten by weight. A stabilizer may also be added to tube W. The inside diameter, wall thickness, tolerances and length for tube W are the same as for tube A.

In this exemplary embodiment, the following steps may be performed to form and bond the distal tip on the end of an inner catheter:.

After the above reflow process, the following steps may be performed to create a taper on the distal tip:.

After the above taper process, the following steps may be performed to shape the distal tip:.

In another embodiment similar to the construct shown in <FIG>, a <NUM> durometer Pebax tube with BaSO<NUM> additive is used as tube A, a <NUM> durometer Pebax tube is used as tube B, and a <NUM> durometer Pebax tube with Tungsten is used as tube W. A temperature approximately <NUM> (<NUM> °F) higher may be needed to process tube A due to its higher durometer.

The shaped catheter tips disclosed herein created by layering or abutting different materials can offer improved bend profiles, transition from rigid to flexible in a gradient rather than abrupt changes which in turn can reduce kinking of the catheter tip, and can provide sharper bends in a shorter length of catheter tip in order to more easily navigate through tight bends in the vasculature.

Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure.

For example, if a device in the FIGS. is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features.

Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present disclosure.

For example, a numeric value may have a value that is +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/-<NUM>% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise.

Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the disclosure as described by the claims. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the disclosure as it is set forth in the claims.

Claim 1:
A vascular catheter system (<NUM>) comprising:
a flexible main body (<NUM>) which extends along a generally straight longitudinal axis when in a relaxed state, the main body (<NUM>) having a proximal end and a distal end, the main body having a lumen therethrough configured to slidably receive a guidewire (<NUM>, <NUM>); and
a flexible tip (<NUM>, <NUM>, <NUM>) coupled to the distal end of the main body such that an outer surface of a proximal end of the flexible tip is disposed radially about a distal region of the main body, the flexible tip having a lumen therethrough in communication with the lumen of the main body and configured to slidably receive a guidewire (<NUM>, <NUM>), the flexible tip having at least a portion configured to deviate from the longitudinal axis when in a relaxed state and configured to move towards alignment with the longitudinal axis when a guidewire (<NUM>, <NUM>) is extended through the lumen of the flexible tip (<NUM>, <NUM>, <NUM>),
wherein the flexible tip (<NUM>, <NUM>, <NUM>) is no longer than <NUM> and comprises at least three sections including a first, a second and a third section, the second section being located distally from the first section and the third section being located distally from the second section, the second section comprising a first material having a first durometer and a second material having a second durometer lower than the first durometer, the second material comprising a polymer and tungsten, the first section comprising the first material without the second material with the first material extending from a proximal end of the first section to a distal end of the first section, and the third section comprising the second material without the first material, wherein the first and second materials extend from a proximal end of the second section to a distal end of the second section.