Patent Grant
9005163
Embodiments of the present disclosure generally relate to a balloon catheter having an external delivery tube.
The delivery of therapeutic agents to the inner lining of vessel walls can be very effective to address various types of vascular injury. A key consideration for such procedures is the precise delivery of a predetermined amount of therapeutic agent. Some methods of delivery present challenging manufacturing processes in order to control the amount of therapeutic agent on the delivery device. For example, dip coated catheter balloons (percutaneous transluminal angioplasty (PTA) catheter balloons) can present several drawbacks during manufacturing. Application of a uniform coating can be difficult when using the dipping process as the process may be very labor intensive and time consuming.
Further, in other devices fluids are metered through weeping orifices within an inflatable balloon to provided localized delivery of the fluid (e.g., therapeutic agents or contrast media). This configuration requires filling the inflatable balloon with the infused fluid. In some examples, the infused fluid is a toxic substance with localized therapeutic benefits to the vessel. It is difficult to meter the flow of the infused fluid through weeping orifices that expand and contract to some degree with deployment and storage of the balloon through inflation. For example, a specified pressure must be maintained to inflate the balloon. The specified pressure for inflation may administer the infused fluid at too great a flow rate to the vessel with attendant risks (e.g., overdosing of the infused fluid, delivery of supplemental infused fluid downstream from the desired treatment site and the like).
Additionally, with smaller weeping orifices the infused fluid may plug the orifices and prevent the precise delivery of the desired dose of the fluid. Further still, where expensive agents, such as pharmaceuticals, are used it is expensive to use the agent as the media for inflation of a balloon, a relatively large volume, as compared to the small volume of agent required for delivery to the desired treatment location. The volume of agent used to inflate the balloon is often not recoverable thereby greatly enhancing the cost of the procedure.
In general, various embodiments of the present disclosure are directed to a balloon catheter having an external delivery tube. In one embodiment, a catheter (e.g., a catheter body) having at least a balloon, a catheter shaft, and a delivery tube extending over at least a portion of the balloon is disclosed.
In various embodiments, a catheter having a connector assembly with an inflation channel, a guidewire channel, and a delivery channel; a strain relief connected at a proximal end to a distal end of the connector assembly; a catheter shaft connected at a proximal end to a distal end of the strain relief; a trilumen tube extending from the connector assembly to a distal end of the catheter shaft and having an inflation lumen that is in fluid communication with the inflation channel, a guidewire lumen configured for disposition of a guidewire therein and in fluid communication with the guidewire channel, and a delivery lumen in fluid communication with the delivery channel; a delivery tube in fluid communication with the delivery lumen at the distal end of the catheter shaft; a stem portion connected at a proximal end to the distal end of the catheter shaft and having a stem guidewire lumen configured for disposition of the guidewire therein and in fluid communication with the guidewire lumen; a tip connected at a proximal end to a distal end of the stem portion and having a tip guidewire lumen configured for disposition of the guidewire therein and in fluid communication with the stem guidewire lumen; and an inflatable balloon (part of an inflatable balloon assembly) positioned substantially around the exterior of the stem portion, having proximal and distal ends, and in fluid communication with the inflation lumen, wherein the delivery tube extends over at least a portion of the inflatable balloon is disclosed.
Methods of delivering a therapeutic or other solution to a target site using the catheter having an external delivery tube set forth herein are also disclosed.
Those and other details, objects, and advantages of the present disclosure will become better understood or apparent from the following description and drawings showing embodiments thereof.
The accompanying drawings illustrate examples of embodiments of the disclosure. In such drawings:
In all of its embodiments, the present disclosure relates to an agent delivery catheter 10 (e.g., a balloon catheter), such as for example and without limitation a PTA catheter, having an external delivery tube 12. See
In another embodiment, the catheter 10 (e.g., a catheter body) has a manifold assembly 18 (e.g., a connector assembly configured to couple with one or more fluid sources and instruments) with an inflation channel 20, a guidewire channel 22, and a delivery channel 24. See
The channels 20, 22, and 24 of the manifold assembly 18 may be separated by adhesive 28, such as an epoxy or other hardenable material, that is added through adhesive openings 30 in the manifold assembly 18. In an example, a Teflon® rod stock is placed in one or more trilumen openings 32 of a trilumen tube 34 at the base of the inflation channel 20 and the delivery channel 24. Adhesive is then added and the rod stock is removed after the adhesive hardens to maintain the opening during construction. As shown, for instance in
The trilumen tube 34 has an inflation lumen 36, a delivery lumen 38, and a guidewire lumen 40. See
The guidewire lumen 40 is in fluid communication with the guidewire channel 22 and is configured for disposition of a guidewire (or other instrument) therein. The guidewire channel may have a guidewire seal 42, such as a deformable seal member used in a touhy fitting. The connector assembly 18 may also have a cap 44, such as a threaded or rotating cap.
The trilumen tube 34 runs through a strain relief fitting 46 connected at a proximal end to a distal end of the connector assembly 18 and at a distal end to a proximal end of a catheter shaft 16. See
During manufacture, a stem portion 47 of the catheter 10 is connected at a proximal end to the distal end of the catheter shaft 16 (e.g., the trilumen tube 34) and has a stem guidewire lumen configured for disposition and sliding of the guidewire therein and in fluid communication with the guidewire lumen 40. See
Optionally, a tip 48 is connected at a proximal end of the tip to a distal end (e.g., distal portion) of the stem portion 47 of the catheter 10 and has a tip guidewire lumen configured for disposition and sliding of the guidewire therein and in fluid communication with the stem guidewire lumen such that the guidewire may run through the entire length of the catheter 10 (e.g., the catheter body). In one example, the tip 48 is constructed with an atraumatic material or feature including, but not limited to, polyurethane, a coil, rubber and the like.
As shown in
The inflatable balloon 14, in one example is constructed with, but not limited to, non-compliant (but flexible) materials such as polyesters (e.g., polyethylene terephthalate (PET) or Dacron), Pebax® resin (available from Arkema, Inc.), nylon, blends of the same and the like. In another example, the inflatable balloon 14 is constructed with, but not limited to, compliant materials, such as polyethylene, silicone or latex. In still another example, the inflatable balloon 14 is constructed with, but not limited to, semi-compliant materials (capable of some amount of stretching relative to non-compliant materials), such as Pebax® resin, nylon, blends of the same and blends including polyesters.
As shown in
The balloon catheter 10 may also have marker bands 50 at the proximal and distal ends of the inflatable balloon 14. In an example, the catheter shaft 16 may be constructed of trilumen Pebax® resin, the stem portion 47 may be constructed of polyimide, and the tip 48 may be constructed of molded Pebax® resin. In another example, the lumens 36, 38, and 40 of the trilumen tube 34 may comprise the catheter shaft 16, the stem portion 47, and the tip 48 as described above such that the guidewire lumen 40 extends through the length of the catheter 10.
Referring again to
The length of the delivery tube 12 is sized according to the balloon 14 in one example. In one embodiment, the delivery tube 12 has a small profile to minimize drug leakage at the vessel contact site. For instance, by providing a delivery tube 12 with a small profile, the balloon 14 is able to readily wrap around the delivery tube and engage with the vessel wall and substantially seal any openings between the delivery tube, the balloon 14 and the vessel wall. In another example, one or more of the balloon 14 and the delivery tube 12 are constructed with pliable materials that readily deform (while maintaining the delivery tube open for agent delivery) and provide a seal between the delivery tube 12 and the balloon 14. In yet another embodiment, the delivery tube 12 is incorporated into the sidewall of the balloon 14 and is thereby substantially flush or within the outer perimeter of the balloon 14 including the proximal shoulder 52.
In various embodiments the delivery tube 12 is secured into the delivery lumen 38 at the distal end of the catheter shaft 16. The delivery tube 12 may be secured, for example without limitation, by bonding, such as with cyanoacrylate, or heat welding. The delivery tube 12 may also be secured, for example by bonding, to the balloon 14 in at least one location. In one embodiment, at least the tip of the delivery tube 12 is secured to the balloon 14.
The delivery tube 12 may be used to deliver any therapeutic agent or other solution, such as, for example without limitation, saline. The therapeutic agent or other solution may be a liquid, dispersion, slurry, viscous fluid, etc. As used herein, “therapeutic agent” includes, but is not limited to, any therapeutic, for example drugs, genetic material, and biological material. Genetic material includes, for example and without limitation, DNA or RNA, viral vectors and non-viral vectors. Biological material includes, for example and without limitation, cells, bacteria, proteins such as growth factors, peptides, lipids, and hormones. Drugs include, for example and without limitation, anti-thrombogenic agents, anti-proliferative agents, anti-inflammatory agents, anti-neoplastic agents such as epothilone and its derivatives, antimiotic agents, antioxidants, anti-coagulants, immunosuppressants such as sirolimus and its derivatives, vascular cell growth promoters, vascular cell growth inhibitors, antibiotic agents, angiogenic substances, restenosis-inhibiting agents, and drugs for heart failure. The “therapeutic agent” may include a combination of one or more therapeutics. Particular embodiments include restenosis-inhibiting agents such as Taxol, paclitaxel, paclitaxel analogues, derivatives, and mixtures thereof, such as Abraxane® pharmaceutical composition (available from Abraxis Bioscience, Inc.). In an example, carriers may be used with the therapeutic, such as, for example and without limitation, bioabsorbable agents, fibrin glue, sugar, honey, microspheres, microtubes, and physiologically compatible non-reactive drug transfer, contrast, or radio opaque agents, such as urea, iopromide, iopamidol, cremophore EL, vitamin E, Tocopheryl Polyethylene Glycol Succinate (TPGS), etc. In an example, the therapeutic is a drug solution consisting of: 0.3 cc Tween® surfactant solution (0.1 cc Tween® surfactant added to 2 cc saline), 0.5 cc Fibrin (Tisseel® adhesive minus thrombin), 0.3 cc Isovue® contrast agent, and 5 cc Abraxane® pharmaceutical composition (5 mg/cc).
In various embodiments, the inflatable balloon 14 may have a proximal shoulder 52 and a distal shoulder 53 creating a well 54 for localized delivery of the therapeutic or other solution. See
Referring again to
As discussed above, and shown in
Referring now to
As shown in
Referring again to
As shown in
The delivery assembly 102 provides a mechanism to deliver the agent fluid to the well 54 formed by the balloon 14 without otherwise using the agent fluid to inflate or maintain the balloon 14 in the inflated deployed configuration. Instead, the delivery assembly 102 is operated independently to ensure precise measured delivery of a dose of the agent fluid. The delivery assembly 102 cooperates with the occlusions provided by the inflatable balloon assembly 100 (e.g., at the proximal and distal shoulders 52 and 53) to retain the dose of the agent fluid in intimate proximate contact with a designated portion of the vessel wall without dilution of the specified concentration of the agent fluid through mixing with fluids within the vessel. The separation of the delivery assembly 102 from the inflatable balloon assembly 100 ensures that the desired inflation pressure is maintained in the balloon 14 without otherwise requiring weeping of the agent through weep holes as in other balloons. Further, filling of the relatively large volume of the inflatable balloon 14 (relative to the well 54) is similarly avoided. Instead, a small volume of the agent fluid fills the space of the well 54 (e.g., between the shoulders 52 and 53, the well portion 72 and the vessel wall). Discarding of agent fluid, such as an expensive therapeutic fluid, used only for inflation of the relatively large volume of the balloon 14, but not otherwise administered is thereby avoided.
Optionally, the inflatable balloon 14 has a plurality of spacing projections 56, including, but not limited to, raised portions, bumps, spirals and the like that aid in delivery or maintaining the well in another example. See
In one example, the spacing projections 56 are integrally formed with the balloon 14. For instance, the spacing projections 56 are co-molded with the balloon 14. In another example, the spacing projections are applied to the balloon 14, such as with adhesive and the like.
In other embodiments, the balloon catheter 10 may be used with other devices, such as, for example and without limitation, balloon expandable stents. In the example of a balloon expandable stent, the delivery tube 12 infuses the therapeutic or other solution at the stent site. In another example, the balloon catheter 10 may deliver a stent and then bathe the site with a therapeutic or other liquid solution. Optionally, the balloon catheter 10 with the balloon 14, as described herein, is used in an angioplasty procedure and may supply agent fluids to the treated vessel (e.g., between the shoulders 52 and 53) at one or more of before, after and during the angioplasty procedure. As discussed herein, the agent fluid is supplied to the well 54 at a separate controlled pressure relative to the inflation pressure of the balloon 14.
Methods of using the balloon catheter 10 are also embodied herein. In one embodiment, the balloon catheter 10 is advanced to the site or location requiring treatment. The balloon 14 is inflated, followed by infusion of the therapeutic agent through the delivery tube 12 at the treatment site. The balloon 14 may remain inflated for a period of time to ensure adequate delivery. After treatment, the balloon 14 is deflated and the catheter 10 may be either relocated to another location requiring treatment with the same or different therapeutic agent or the catheter 10 may be removed from the patient.
The balloon catheter 10 as disclosed herein may be used in multiple locations with multiple therapeutic agents in various concentrations. In addition, an exact and known amount of therapeutic agent may be accurately delivered. As such, patient treatment may be optimized.
The following discussion illustrates non-limiting examples of embodiments of the present disclosure.
A balloon catheter having an external delivery tube as disclosed herein was constructed by carving back the delivery lumen before a balloon was bonded to the other lumens or the catheter shaft. A polypropylene tube having about a 0.014 inch outer diameter, about a 0.010 inch inner diameter, and about a 1.0 inch length was bonded into the delivery lumen by bonding the tip of the tube to the balloon and bonding of the delivery tube proximal to the delivery orifice along evenly spaced locations, for example three locations, until the tube was secured into the delivery lumen. Bonding of the delivery tube to the balloon occurred via methods as known in the art such as through the use of adhesives, heat bonding, welding and the like.
The balloon catheter having an external delivery tube disclosed herein was used in a chronic porcine stenosis study. The catheter was used to deliver 3 mg/cc of paclitaxel to a target site in a porcine blood vessel. The 24 hour tissue concentration was 2.70 μg/ml.
The agent delivery catheter is shown in
Referring to
Referring now to
In one example, the balloon 14 is constructed with a first polymer material capable of inflation from the stored configuration shown in
After deployment of the balloon 14 into the deployed configuration shown in
With the above described configuration, delivery of the agent fluid, for instance, into the inflatable balloon 14 and thereafter administering the agent fluid through weep holes within the inflatable balloon 14 is not required. Stated another way, inflating the inflatable balloon 14 (with agent fluid) having a larger volume relative to the well 54 defined between the shoulders 52 and 53 and the well portions 72 is avoided. Instead, with the agent delivery catheter 10 the agent fluid is delivered by itself in an isolated manner from the inflatable balloon 14 through the delivery tube 12 to the well 54. Precise metering of a specified dose of agent fluid having a specified concentration is thereby facilitated without having to manage the inflation pressure of the inflatable balloon 14 and the agent fluid. The agent delivery assembly 102 including the delivery tube 12, the delivery lumen 38 and the delivery channel 24 are entirely separated from the inflatable balloon assembly 100 including the inflatable balloon 14, the inflation lumen 36 and the inflation channel 20. That is to say, the inflatable balloon assembly 100 cooperates with the agent delivery assembly 102. For instance, the inflatable balloon assembly 100 inflates the balloon to provide the well 54 configured to receive the agent fluid therein. After inflation of the balloon 14, the agent delivery assembly 102 (entirely separate from the inflatable balloon assembly 100) delivers the agent fluid through the delivery tube 12 into the well 54. The agent fluid is retained within the well 54 through occluding engagement of the shoulders 52 and 53 of the inflated balloon 14 with the vessel wall.
Referring now to
In another example, the spacing projections 56 engage with and mechanically stimulate the vessel wall 402 upon deployment of the balloon 14 from the stored configuration to the deployed configuration shown in
Referring now to
Referring again to
In another example, the delivery tube 12 is occluded during expansion of the cage 602, for instance, through inflation of the inflatable balloon 14. After engagement of the cage 602 with the vessel wall, for instance to abrade and thereby mechanically stimulate the vessel wall, the delivery tube 12 is not operated. After mechanical stimulation of the vessel wall the inflatable balloon 14 is at least partially deflated to provide tolerance between the cage 602 and the balloon 14 to thereby open the delivery tube 12 for delivery of agent fluid through the delivery orifice 70. In one example, the inflatable balloon 14 is retained in a substantially inflated configuration (e.g., less than the expanded configuration used to deploy the cage 602) to ensure sealing engagement of the shoulders 52 and 53 with the vessel wall while agent fluid is delivered through the delivery orifice 70 of the delivery tube 12. That is to say, the inflatable balloon is partially deflated to open the delivery tube 12 for passage of the agent fluid to the at least one agent delivery orifice 70.
Referring now to
In one example, the plurality of struts 604 include but are not limited to nitinol, stainless steel, cobalt chromium alloys, polymers, composites and the like. The plurality of struts 604 are interconnected at various juncture points in a manner similar to stent construction. For instance, upon inflation of the inflatable balloon 14 the plurality of struts 604 move from a collapsed configuration shown, for instance, in
In operation, the agent delivery catheter 600 is navigated through vasculature in a manner similar to the previously described agent delivery catheters 10 and 500. Upon delivery of the inflatable balloon 14 including the cage 602 thereon to a desired location within the vasculature the inflatable balloon 14 is operated. For instance, the inflatable balloon assembly 100 (separate from the agent delivery assembly 102) delivers inflation fluid to the inflatable balloon 14 and deploys the inflatable balloon 14 into the configuration shown in
In one example, where a recess for the delivery tube 12 is provided in one or more of the cage 602 or the exterior balloon surface 64 the delivery tube 12 is maintained in an open configuration during expansion of the inflatable balloon 14 and the cage 602. Agent fluid is thereafter delivered through the delivery tube 12 to the well 54. As with previous examples, the agent fluid delivered to the well 54 is in close and intimate contact with the vessel wall overlying the well 54. In another example, the cage 602 is expanded and the delivery tube 12 is occluded in the expanded configuration shown, for instance, in
In still another example, the inflatable balloon 14 is partially inflated into a substantially deployed configuration where the plurality of shoulders 52 and 53 engage with the vessel wall. In this configuration, the cage 602 is not fully deployed and tight engagement between the cage 602 and the inflatable balloon is not yet realized. In this configuration the delivery tube 12 is retained in an open configuration. Agent fluid is thereafter delivered through the agent delivery orifice 70 into the well 54. After delivery of the agent fluid into the well 54 the pressure within the inflatable balloon (separate from any pressure used to deliver the agent fluid through the delivery tube 12) is increased to further expand the inflatable balloon 14. Increased expansion of the inflatable balloon correspondingly expands the cage 602 and engages the plurality of struts 604 with the vessel walls previously described. In this example, the additional expansion of the cage 602 squeezes the delivery tube 12 and occludes the delivery tube. However, the agent fluid has been previously delivered to the well 54 and occlusion of the delivery tube 12 does not otherwise frustrate the intimate contact of the agent fluid with the vessel wall. As discussed herein, the agent fluid is delivered to the vessel at one or more times before, after or during a procedure (e.g., to form the well 54 and/or conduct an angioplasty dilation of the vessel).
In the example including the cage 602 as a deployable component of the agent delivery catheter 600 the cage 602 remains coupled with the catheter (e.g., the balloon 14) throughout navigation, deployment and removal of the catheter 600. For instance, the cage 602 is constructed with a shape memory material and heat set according to the stored (folded) configuration of the balloon 14, as shown in
In the example including the cage 602 as a deployable stent of the agent delivery catheter 600, the cage 602 is a stent that is implanted within the vessel through inflation and expansion of the balloon 14. For instance a protective sheath is placed around the catheter 600 including the cage 602 during navigation. The sheath is withdrawn after the balloon 14 and the cage 602 (e.g., stent) are delivered to the desired portion of the vasculature. Inflation of the balloon 14 correspondingly expands and deploys the cage 602 for implantation in the vessel. In one example, the cage 602 includes shape memory materials and is heat set in a configuration corresponding to the diameter of the vessel (e.g., the cage 602 is biased into the deployed configuration). After inflation, the cage 602 remains in the deployed state and engaged with the vessel wall according to the previously described heat setting. The balloon 14 is deflated and stored and the catheter 600 is then withdrawn from the vessel leaving the cage 602 implanted as a stent.
At 702, an inflatable balloon assembly 100 is coupled near a catheter distal portion 62 of a catheter body (e.g., a catheter shaft 16 optionally including a manifold assembly 18). Coupling the inflatable balloon assembly 100 includes, in one example, forming an inflation lumen 36 extending through the catheter body, at 704. In another example, coupling the inflatable balloon assembly 100 near the catheter distal portion 62 includes coupling an inflatable balloon 14 near the catheter distal portion 62, at 706. The inflatable balloon 14 is in fluid communication with the inflation lumen 36. In another example, coupling the inflatable balloon 14 near the catheter distal portion 62 includes coupling the inflatable balloon 14 around at least a portion of the catheter body. For instance, the inflatable balloon 14 is wrapped around the stem portion 47 of a trilumen tube 34 including the inflation lumen 36, a delivery lumen 38 and a guidewire lumen 40. As shown in
At 708, an agent delivery assembly 102 is coupled with the catheter body (e.g., the catheter shaft 16) and the inflatable balloon assembly 100. Coupling the agent delivery assembly 102 includes, in one example, forming a delivery lumen 38 extending through the catheter body, at 710. Coupling the agent delivery assembly 102 with the catheter body includes coupling the agent delivery tube 12 along the exterior balloon surface 64, at 712. In one example, coupling the agent delivery tube 12 along the exterior balloon surface 64 includes positioning the agent delivery tube 12 outside the inflatable balloon 14 from the interface with the delivery lumen 38 (e.g., at the deliver interface port 302) to the at least one delivery orifice 70. At 714, at least one delivery orifice 70 of the agent delivery tube 12 is directed outside of the exterior balloon surface (e.g., into the well 54). As described herein, the agent delivery tube 12 is in fluid communication with the delivery lumen 38.
Several options for the method 700 follow. In one example, the method 700 includes forming the inflatable balloon with a proximal and distal shoulders 52 and 53. In another example, the proximal and distal shoulders 52 and 53 each include a shoulder perimeter. In another example, forming the inflatable balloon 14 includes interposing a well portion 72 between the proximal and distal shoulders 52 and 53. The well portion 72 includes a well perimeter less than the shoulder perimeter. For instance, as previously described herein the well portion 72 is recessed relative to the proximal and distal shoulders 52 and 53 to form the well 54. In another example, forming the inflatable balloon 14 includes forming a plurality of spacing features 56 (e.g., spacing projections) extending outwardly from the well portion 72 (e.g., a well portion surface). The plurality of spacing features 56 are configured to space the well portion 72 from a vessel interior surface while the plurality of spacing features 56 are engaged with the vessel interior surface. In still another example, forming the inflatable balloon 14 includes forming a well between the proximal and distal shoulders 52 and 53 and the well portion 72. In still another example, directing the at least one delivery orifice outside of the exterior balloon surface includes positioning the delivery orifice 70 along the well portion 72 so the delivery orifice opens into the well 54.
In yet another example, the method 700 includes coupling an expandable structural cage 602 with the agent delivery catheter 600. The structural cage 602 includes a plurality of struts 604 extending around the inflatable balloon 14 (see
At 806, an agent fluid is delivered to the sealed well 54 through a delivery tube 12 extending along an exterior balloon surface 64. The delivery tube 12 includes at least one delivery orifice 70 directed outside the exterior balloon surface 64 within the well 54. For instance, in one example the delivery tube 12 extends along the outer surface of the exterior balloon surface 64 from a delivery interface port 302 to the one or more agent delivery orifices 70. In still another example, the delivery tube 12 extends along the interior of the exterior balloon surface 64 within the balloon 14. The agent delivery orifice 70 extends out of the balloon 14 by penetrating the exterior balloon surface 64 in the well portion 72. At 808, the method 800 further includes at least partially filling the well between the inflatable balloon 14 and the vessel wall 402 with the agent fluid. The agent fluid is positioned in intimate adjacent contact with the vessel wall 402 according to the positioning of the well adjacent to the vessel wall. Stated another way the well portion 72 and the proximal and distal shoulders 52 and 53 cooperate to position the well 54 in close adjacent proximity to the vessel wall 402. Subsequent delivery of the agent fluid through the delivery assembly 102 thereby correspondingly delivers the agent fluid into close intimate contact with the surrounding vessel wall 402 overlying the well portion 72.
Several options for the method 800 follow. In one example, a cage 602 is provided around the balloon 14. Inflating the inflatable balloon expands the cage 602 into a deployed configuration, as shown in
The agent delivery catheters described herein and the methods for using the same provide systems and methods including an inflatable balloon having a well in close proximity to a specified portion of a vessel wall. The agent delivery catheters further include separate agent delivery assemblies that are fluidly isolated from the inflatable balloon assemblies configured to inflate the balloons. Stated another way, the agent delivery catheters described herein provide dedicated agent fluid delivery systems configured to deliver therapeutic agents to a specified portion of a vessel. The agent delivery assemblies cooperate with the inflatable balloon assemblies to reliably retain the agent fluid in a desired location for a desired residence time. As previously described herein, the inflatable balloon assembly includes, in one example, inflation channels, lumens and the inflatable balloon configured to inflate and provide a well sized and shaped to receive the agent fluid therein. The inflatable balloon assembly provides the well in close proximity to vessel wall designated for treatment. Agent delivery catheters further include the agent delivery assemblies including the delivery channel, the delivery lumen and the delivery tube extending into the well. By providing separate and dedicated inflatable balloon assemblies and agent delivery assemblies the agent delivery catheters described herein provide dilation with the balloon entirely separate from the infusion function of the agent delivery assemblies. Further, the agent delivery assemblies include delivery tubes extending along the exterior balloon surface and configured to deliver the agent fluid into the well formed by the inflatable balloon.
The inflatable balloon assemblies described herein facilitate precise maintenance of the inflation and dilation of the inflatable balloon throughout operation of the agent delivery catheters. The inflatable balloon reliably retains the agent fluid at the desired location for the desired residence time. Stated another way, the inflatable balloon provides the well according to the inflated configuration of the shoulders and the well portion of the inflatable balloon. Constant maintenance and delivery of inflation fluid to a balloon including weeping holes configured to infuse fluid to the surrounding tissue is thereby avoided. Stated another way, the inflatable balloon assembly is a closed system that does not include drug infusion lumens.
The agent delivery assembly facilitates precise metering of the agent fluid (e.g., a therapeutic agent) into the well formed by the inflatable balloon. That is to say, a precise dose of a therapeutic agent with a specified concentration is administered to the well according to the operation of the agent delivery assembly separate from the inflatable balloon assembly. The provision of a fluidly separate agent delivery assembly avoids the unpredictability of weep holes provided in an inflatable balloon that are otherwise used to infuse therapeutic agents to surrounding tissue. The deformability of the weep holes frustrates the ability to precisely meter a specified dose and specified concentration of the therapeutic agent to the desired tissue.
As described herein, the agent delivery assembly administers the agent fluid into the well provided by inflation of the balloon and thereby substantially ensures the delivery of the agent fluid to the vessel wall overlying the well. The inflated balloon substantially ensures that the agent delivered into the well is in close intimate contact according to the inflation and positioning of the proximal and distal shoulders and the well portion substantially adjacent to the vessel wall. Further, the inflated balloon retains the agent at a desired location with substantially no leakage downstream. Because the inflatable balloon assembly and the agent delivery assembly are separate from each other the inflatable balloon is filled with an inflation fluid that is entirely separate from the therapeutic agent used in the agent delivery assembly. Stated another way, the therapeutic agent fluid is delivered in relatively small volumes to the well formed adjacent to the vessel wall while a relatively large volume of inflation fluid (e.g., a less expensive fluid, such as saline) is delivered to the inflatable balloon having a correspondingly larger volume. Efficient and economical use of the therapeutic agent is thereby realized.
The present disclosure has been described with reference to specific details of particular embodiments thereof. It is not intended that such details be regarded as limitations upon the scope of the disclosure except insofar as and to the extent that they are included in the accompanying claims.
Benefits, other advantages and solutions to problems have been described above with regard to particular examples; however, any benefit, advantage, solution to problems or any element that may cause any particular benefit, advantage or solution to occur or to become more pronounced are not to be construed as critical, required or essential features or components.
As used herein, the terms “comprises”, “comprising”, or any variation thereof, are intended to reference a non-exclusive inclusion, such that a process, method, article, composition or apparatus that comprises a list of elements does not include only those elements recited, but may also include other elements not expressly listed or inherent to such process, method, article, composition or apparatus. Other combinations and/or modifications of the above-described structures, arrangements, applications, proportions, elements, materials or components used in the practice of the present subject matter, in addition to those not specifically recited, may be varied or otherwise particularly adapted to specific environments, manufacturing specifications, design parameters or other operating requirements without departing from the general principles of the same.
The present subject matter has been described above with reference to examples. However, changes and modifications may be made to the examples without departing from the scope of the present subject matter. These and other changes or modifications are intended to be included within the scope of the present subject matter, as expressed in the following claims.
It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other examples will be apparent to those of skill in the art upon reading and understanding the above description. It should be noted that examples discussed in different portions of the description or referred to in different drawings can be combined to form additional examples of the present application. The scope of the subject matter should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application is the U.S. National Phase of International Patent Application No. PCT/US2011/046402, filed Aug. 3, 2011, which claims priority to U.S. Provisional Patent Application No. 61/370,222, filed Aug. 3, 2010, the disclosures of which are incorporated herein by reference in their entirety.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US2011/046402 | 8/3/2011 | WO | 00 | 1/30/2013 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2012/018899 | 2/9/2012 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 3981299 | Murray | Sep 1976 | A |
| 4824436 | Wolinsky | Apr 1989 | A |
| 5254089 | Wang | Oct 1993 | A |
| 5318531 | Leone | Jun 1994 | A |
| 5336178 | Kaplan et al. | Aug 1994 | A |
| 5342301 | Saab | Aug 1994 | A |
| 5464395 | Faxon et al. | Nov 1995 | A |
| 5558642 | Schweich, Jr. et al. | Sep 1996 | A |
| 5562620 | Klein et al. | Oct 1996 | A |
| 5653689 | Buelna et al. | Aug 1997 | A |
| 5674287 | Slepian et al. | Oct 1997 | A |
| 5713860 | Kaplan et al. | Feb 1998 | A |
| 5716340 | Schweich, Jr. et al. | Feb 1998 | A |
| 5785679 | Abolfathi et al. | Jul 1998 | A |
| 5792106 | Mische | Aug 1998 | A |
| 5810767 | Klein | Sep 1998 | A |
| 5840066 | Matsuda et al. | Nov 1998 | A |
| 5876426 | Kume et al. | Mar 1999 | A |
| 5882335 | Leone et al. | Mar 1999 | A |
| 5902266 | Leone et al. | May 1999 | A |
| 6053900 | Brown et al. | Apr 2000 | A |
| 6063101 | Jacobsen et al. | May 2000 | A |
| 6129706 | Janacek | Oct 2000 | A |
| 6231562 | Khosravi et al. | May 2001 | B1 |
| 6398757 | Varenne et al. | Jun 2002 | B1 |
| 6497721 | Ginsburg et al. | Dec 2002 | B2 |
| 6527790 | Chien et al. | Mar 2003 | B2 |
| 6554801 | Steward et al. | Apr 2003 | B1 |
| 6733474 | Kusleika | May 2004 | B2 |
| 8439890 | Beyar et al. | May 2013 | B2 |
| 8585959 | Burton | Nov 2013 | B2 |
| 20040260239 | Kusleika | Dec 2004 | A1 |
| 20060190022 | Beyar et al. | Aug 2006 | A1 |
| 20070078433 | Schwager et al. | Apr 2007 | A1 |
| 20070250035 | El-Nounou et al. | Oct 2007 | A1 |
| 20090105687 | Deckman et al. | Apr 2009 | A1 |
| 20090112184 | Fierens et al. | Apr 2009 | A1 |
| Number | Date | Country |
|---|---|---|
| 0920882 | Jun 1999 | EP |
| 9618427 | Jun 1996 | WO |
| 9717099 | May 1997 | WO |
| 0119445 | Mar 2001 | WO |
| 2008066610 | Jun 2008 | WO |
| 2009066330 | May 2009 | WO |
| Entry |
|---|
| C. Herdeg et al., Paclitaxel: Chemotheraphy for Restenosis Prophylaxis? Experimental Investigations in vitro and in vivo. Interventional Cardiology. 2000. |
| C. Dommke, et al., Local paclitaxel delivery after coronary stenting in an experimental animal model. Throm Haemost, 98, pp. 674-680. 2007. Schattauer GmbH, Suttgard. |
| C. Herdeg, et al., Successful Local Antiproliferative paclitaxel delivery in a repeatedly restenosed lesion of the right coronary artery after drug eluting-stent implantation. Clin Res Cardiol 97:46-52. 2008. |
| GENIE by Acrostak., A non-traumatic local drug delivery catheter to treat stenosis., Acrostak. |
| Herdeg, et al., GENIE catheter for liquid local drug delivery. Eurolntervention. 2007;3:286-288. |
| The the International Search Report, International Preliminary Report on Patentability and Written Opinion from corresponding PCT Application No. PCT/US2011/046402. |
| Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies. Clinical Trial. University Hopsital Tuebingen. (http://clinicaltrials.gov/ct2/show/NCT00396929). |
| Number | Date | Country | |
|---|---|---|---|
| 20130131594 A1 | May 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61370222 | Aug 2010 | US |
