Systems for targeted thrombolytic drug delivery - Patents.com

Abstract

Apparatus and method for restoring patency of a catheter. The apparatus may comprise an elongate member configured to be inserted through a catheter. The elongate member may facilitate direct delivery of a chemical agent to a catheter obstruction and / or facilitate agitation of the chemical agent proximate the obstruction. A catheter or catheter system disclosed herein comprises an apparatus for removing an obstruction. The apparatus for removing an obstruction from a catheter may comprise an elongate member configured to be inserted through a catheter lumen, the elongate member defining a proximal end and a distal end, and an agitation actuator coupled to the elongate member adjacent the proximal end, where operation of the actuator causes agitation of fluid adjacent the distal end.

Description

[Technical field]

[0001] The present invention relates to a system for targeted thrombolytic drug delivery. [Background technology]

[0002] Long-term catheters may be prone to blockages or occlusions that reduce or destroy catheter patency. For example, occlusion of central venous catheters has been reported to occur in 14 to 36 percent of patients within 1 to 2 years of catheter placement. Blockage may result from mechanical obstruction, precipitation of medications or parenteral nutrition, or thrombotic causes. Catheters may also become occluded by the formation of a fibrin sheath around the catheter tip, which has been reported to be one of the most common causes of thrombotic occlusion. Intraluminal blood clots account for 5 to 25% of all catheter occlusions and can cause complete catheter occlusion.

[0003] A common approach is to treat suspected thrombotic occlusions with thrombolytic drugs. Current recommendations include administering thrombolytic drugs in the catheter lumen with a residence time of at least 30 minutes, with repeated administration if necessary. Residence times of 120 minutes or more are uncommon. Summary of the Invention [Problem to be solved by the invention]

[0004] The systems, devices, and methods described herein may aid in the removal of catheter occlusions and restore catheter patency. More specifically, these systems, devices, and methods may aid in the administration of a thrombolytic drug at the location of the occlusion, aid in the penetration of the occlusion, prevent loss of the thrombolytic drug into the bloodstream, and / or increase the surface area of ​​the occlusion in contact with the thrombolytic drug. [Means for solving the problem]

[0005] Briefly summarized, disclosed herein is an apparatus for removing obstructions from a catheter, such as an intravenous catheter, comprising an elongate member configured for insertion into a catheter lumen, the catheter lumen having an elongate member defining a proximal end and a distal end, and an agitation actuator coupled to the elongate member adjacent the proximal end, the agitation actuator causing agitation of a fluid adjacent the distal end of the elongate member.

[0006] The distal end of the elongate member may be disposed within the lumen and the fluid may be disposed adjacent to the occlusion in the catheter. The fluid may include a chemical configured to break down the occlusion, the chemical including a thrombolytic drug. The occlusion may be disposed within the lumen and agitation of the fluid may occur within the lumen. In some embodiments, such as when the occlusion includes a fibrin sheath, the occlusion may extend beyond the distal tip of the catheter and the occlusion may completely occlude the catheter.

[0007] The agitation actuator may be an electromechanical device, and the agitation may include longitudinal and / or lateral vibration of the distal end of the elongate member. In some embodiments, the vibration may have an ultrasonic frequency. The elongate member may include one or more protrusions at the distal end that extend away from the elongate member.

[0008] Also disclosed herein is a device for removing an obstruction from a catheter, which may be an intravenous catheter. The device includes a pressure actuator coupled to the catheter at a proximal end of the catheter such that the pressure actuator is in fluid communication with the catheter lumen. The pressure actuator generates a varying fluid pressure along the lumen causing agitation of fluid adjacent the obstruction in the catheter. The fluid includes a chemical configured to break down the obstruction, and the chemical may include a thrombolytic drug. The agitation of the fluid may occur within the lumen.

[0009] The pressure actuator may be an electromechanical device. Operation of the pressure actuator may define a positive and / or negative pressure within the lumen. Operation may also cause pressure fluctuations within the lumen between positive and negative pressures.

[0010] Also disclosed herein is a catheter, which may be an intravenous catheter, comprising an outer elongated tubular member defining an outer lumen, the outer lumen extending between a proximal end and a distal end of the outer member, and an inner elongated tubular member defining an inner lumen, the inner lumen extending between a proximal end and a distal end of the inner member. The inner member includes a plurality of side ports disposed along a ported portion of the inner member, the ports being in fluid communication with the internal lumen. The inner member is disposed within the outer lumen, the inner member being displaceable between a distal position and a proximal position relative to the outer member. When the inner member is in the proximal position, the ports are covered by the outer member, and when the inner member is in the distal position, the ports are exposed. The inner member may be continuously positionable between the distal and proximal positions, and the inner member may be removable from the outer member. The inner lumen may also be open at the distal end so that fluids may be exchanged with the patient through the inner lumen.

[0011] In use, a chemical agent may be administered through the inner lumen towards the occlusion of the catheter to contact the occlusion. The fluid may include a chemical agent configured to break down the occlusion, and the chemical agent may include a thrombolytic drug. In further use, the inner member is displaced distally relative to the outer member to expose the side port, and a chemical agent may be administered through the side port to contact the occlusion outside of the inner member. The chemical agent may also contact the occlusion extending beyond the distal end of the inner member and / or extending proximally along the outer surface of the inner member. The chemical agent administered through the side port may also contact the occlusion along the outer surface of the occlusion.

[0012] Also disclosed herein is another device for removing obstruction from a catheter, which may be an intravenous catheter. The device includes an elongate member configured to be inserted through a catheter lumen, the elongate member defining a proximal end and a distal end. An inflatable balloon is coupled to the elongate member adjacent the distal end, the balloon in fluid communication with a first lumen extending between the balloon and the proximal end of the elongate member. A plurality of side ports are disposed along the ported portion of the elongate member, the side ports in fluid communication with a second lumen extending between the side ports and the proximal end of the elongate member.

[0013] The ported portion is disposed proximally from the balloon. The distal end of the elongate member is configured to extend through the occlusion of the catheter such that, in use, (i) the occlusion is disposed between the proximal and distal ends of the ported portion, (ii) one or more side ports are disposed distal to the occlusion, and / or (iii) one or more side ports are disposed proximal to the occlusion. In some embodiments, the balloon spans across the catheter lumen when inflated.

[0014] In use, the elongate member can be coupled at a proximal end to a first fluid device such that the first fluid device is in fluid communication with the first lumen, the first fluid device configured to inflate and deflate the balloon.

[0015] In use, the elongate member can be coupled at the proximal end to a second fluidic device such that the second fluidic device is in fluid communication with the second lumen. The second fluidic device is configured to administer a chemical through the second lumen. In use, the chemical can be administered through the side port and contacted along the ported portion with an occlusion that includes a proximal end portion and a distal end portion. In use, the second fluidic device can be operated to aspirate and re-administer the chemical through the side port to agitate the chemical, and the instrument is displaced longitudinally within the lumen to agitate the chemical.

[0016] In use, the device can be displaced proximally within the lumen to bring the occlusion into contact with the balloon and / or to displace one or more portions of the occlusion proximally along the catheter lumen. Also disclosed herein is a method of restoring patency to a catheter, the method including administering a chemical agent through a catheter lumen, the chemical agent configured to dissolve an obstruction in the lumen, and agitating the chemical agent to enhance dissolution of the obstruction.

[0017] Agitating the chemical may include inserting an elongate member into the catheter lumen and may include displacing a distal end of the elongate member to cause agitation. Agitating may include vibrating the distal end of the elongate member.

[0018] In some embodiments of the method, the elongate member may include a member lumen and administering the chemical may include administering the chemical through the member lumen. The elongate member may include a plurality of side ports and administering the chemical may include administering the chemical through the side ports. Administering the chemical through the side ports may also include administering the chemical proximal and distal to the obstruction.

[0019] In some embodiments of this method, inserting the elongate member can include penetrating the obstruction with a distal tip of the elongate member, hi some embodiments, agitating the chemical includes varying a pressure of the chemical.

[0020] Also disclosed herein is a catheter system including a catheter defining a catheter lumen extending between a proximal end and a distal end, and an elongate member configured to be inserted through the catheter lumen, the elongate member defining a proximal member end and a distal member end, the elongate member configured to perform one or more operations to clear the catheter.

[0021] The operation may include agitating a chemical disposed adjacent to the obstruction, where agitating the chemical includes displacing the distal member end and / or vibrating the distal member end.

[0022] The action may include administering the chemical agent through a first member lumen of the elongate member. In some embodiments, the elongate member includes a plurality of side ports extending along the ported portion of the elongate member, and the action includes administering the chemical agent through the side ports. The action may further include administering the chemical agent distal to the obstruction.

[0023] In some embodiments of this method, the elongate member includes an inflatable balloon at a distal end, and the act includes inflating the balloon distal to the obstruction. These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon consideration of the following description and accompanying drawings, which describe in more detail certain embodiments of such concepts.

[0024] A more particular description of the present disclosure will be made by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It is to be understood that these drawings depict only typical embodiments of the invention, and therefore are not to be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0025] [Figure 1] 1 is a side cross-sectional view of a first embodiment of a medical device for use in catheter obstruction removal, according to some embodiments. [Diagram 2] 1 is a side cross-sectional view of a second embodiment of a medical device for use in catheter obstruction removal, according to some embodiments. [Diagram 3] 1 is a side cross-sectional view of a catheter with obstruction removal features, according to some embodiments. [Figure 4A]13 is a side cross-sectional view of a third embodiment of a medical device for use in catheter obstruction removal, in accordance with some embodiments. FIG. [Figure 4B] 4B is a detailed cross-sectional view of a portion of the medical device of FIG. 4A, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other several embodiments disclosed herein.

[0027] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment that includes such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and are not intended to suggest, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative positions, orientations, or directions. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. The words "including," "has," and "having" have the same meaning as the word "comprising" when used herein, including the claims. Furthermore, the terms "or" and "and / or" when used herein shall be construed to mean inclusive or any one or any combination. As an example, "A, B, or C" or "A, B, and / or C" means "any of the following: A only, B only, C only, A and B, A and C, B and C, and A, B, and C." Exceptions to this definition occur only when combinations of elements, components, features, steps, or acts are in some way essentially mutually exclusive.

[0028] The phrases "connected to" and "coupled to" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, signal, communication (including wireless), and thermal interaction. Two components may be connected or coupled to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component.

[0029] Any method disclosed herein includes one or more steps or acts for implementing the described method. Method steps and / or acts may be interchanged with one another. In other words, unless a specific order of steps or acts is required for proper operation of an embodiment, the order and / or use of specific steps and / or acts may be changed. Furthermore, only subroutines or portions of the methods described herein may be independent methods within the scope of the present disclosure. Stated otherwise, some methods may include only some of the steps described in a more detailed method.

[0030] The directional terms "proximal" and "distal" are used herein to refer to opposite locations on a medical device. The proximal end of the device is defined as the end of the device that is closest to an end user when the device is in use by the end user. The distal end is the end of the device opposite the proximal end along the length of the device, or the end that is furthest from the end user.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1 illustrates a first exemplary embodiment of a medical instrument 100 for removing an obstruction 20 blocking a catheter 10. The instrument 100 includes an elongate shaft 110 configured to (i) be inserted through a lumen 13 of the catheter 10, and (ii) extend between a proximal end 12 and a distal end 11 of the catheter 10. The catheter 10 may be an intravenous catheter.

[0032] The occlusion 20 may define a partial or complete occlusion of the catheter lumen 13. In some embodiments, the occlusion 20, or a portion thereof, may be disposed within the catheter lumen 13. In other embodiments, the occlusion 20 may cover the distal end 11. In some embodiments, the occlusion 20 may extend proximally along the exterior of the catheter 10, where the occlusion 20 may comprise, for example, a fibrin sheath. The occlusion 20 may consist of fluid deposits or may result from the formation of a thrombus within the lumen 13 or adjacent the distal end 11.

[0033] The instrument 100 is configured to define agitation 131 of the chemical 30 disposed within the lumen 13 adjacent to the obstruction 20. The shaft 110 is coupled to an agitation actuator 120 (actuator) at a proximal end 112 of the shaft 110. The actuator 120 induces an agitating motion of the distal end 111 of the shaft 110. The agitation may include an oscillatory motion of the distal end 111 in a longitudinal and / or later direction. In some embodiments, the agitation may include a rotation of the shaft 110. The shaft 110 may include one or more protrusions 114 to assist in the agitation 131 of the chemical 30. The protrusions 114 may include posts, fins, flaps, or any protrusions appropriately shaped to assist in the agitation 131 when the distal end 111 is displaced.

[0034] The actuator 120 may be an electromechanical device. In some embodiments, the agitation motion may include vibration of the shaft 110, and the vibration may have a frequency in the ultrasonic range (i.e., a frequency greater than about 20 kilohertz). In some embodiments, the actuator 120 may be configured to be manually operated. Thus, the actuator 120 may comprise a plunger, crank, or any other suitable physical interface to facilitate an agitation motion of the shaft 110 that is manually prescribed by a clinician.

[0035] The chemical agent 30 may be configured to dissolve, dissolve, or otherwise destroy the solid nature of the obstruction 20. Thus, dissolution of the obstruction 20 may be facilitated by a chemical reaction of the chemical agent 30 proximate the surface of the obstruction 20. The rate of the chemical reaction (i.e., the rate of dissolution) may be limited by the diffusion rate of the chemical agent 30 to the obstruction 20. In some instances, the rate of dissolution may decrease over time due to a decrease in diffusion of the chemical agent 30 proximate the surface of the obstruction 20. Thus, agitation of the chemical agent 30 proximate the surface of the obstruction 20 may restore, maintain, or otherwise increase the diffusion rate of the chemical agent 30 proximate the surface of the obstruction 20, thereby increasing the rate of dissolution of the obstruction 20. In summary, agitation 131 of the chemical agent 30 proximate the obstruction 20 may reduce the time required to clear the obstruction 20 and restore patency of the catheter 10. In some embodiments, agitation 131 can physically disrupt (eg, disrupt) obstructions 20, further enhancing the disintegration process.

[0036] In use, the clinician may administer chemical agent 30 to obstruction 20 through lumen 13 of catheter 10. The clinician may then insert instrument 100 (or more specifically shaft 110) into lumen 13 of catheter 10 and advance shaft 110 such that distal end 111 of shaft 110 is positioned proximate obstruction 20. The clinician may then manipulate actuator 120 to cause agitation 131 until obstruction 20 is adequately broken down. The clinician may then withdraw shaft 110 from catheter 10.

[0037] In some embodiments, the distal end 111 of the shaft 110 has a chemical agent 30 deposited thereon (e.g., in the form of a powder or gel). In embodiments in which the chemical agent 30 is deposited on the distal end 111 in powder form, the powder may mix with and / or dissolve in the fluid administered into the lumen 13.

[0038] The instrument 100 may define a stand-alone device for use with the catheter 10. In other embodiments, the instrument 100, or one or more components thereof, may be combined with the catheter 10 to define a catheter system.

[0039] 2 illustrates a second exemplary embodiment of a medical instrument (or device) 200 for removing obstruction 20 from catheter 10. Instrument 200 includes a pressure actuator 220 (e.g., a hydraulic driver) coupleable to catheter 10 at proximal end 12 of catheter 10 via pressure port 221.

[0040] The pressure actuator 220 is configured to define an fluctuating / oscillating pressure 225 along the lumen 13 of the catheter 10. The fluctuating pressure 225 causes agitation 231 of the chemical agent 30 proximate the obstruction 20. The pressure actuator 220 may also be configured to displace and / or dispense a fluid, such as the chemical agent 30, distally along the catheter lumen 13 to deliver the chemical agent 30 proximate the obstruction 20.

[0041] In some embodiments, the pressure actuator 220 may be configured to be manually operated by a clinician to generate pressure variations. Thus, the pressure actuator 220 may comprise a plunger, a crank, or any other suitable physical interface to allow the clinician to manually generate the pressure variations 225. For example, the pressure actuator 220 may be a syringe, and the manual operation may include pushing and / or pulling the plunger of the syringe. In other embodiments, the actuator 220 may be an electromechanical device, such as, for example, a reciprocating plunger in a cylinder. The pressure variations 225 may occur over (i) a positive pressure range (i.e., a pressure range above atmospheric pressure), (ii) a negative pressure range (i.e., a pressure range below atmospheric pressure), or (iii) both a positive pressure range and a negative pressure range.

[0042] Similar to the agitation 131 described above, agitation 231 of the chemical 30 proximate the surface of the obstruction 20 can restore, maintain, or otherwise enhance the rate of degradation. In summary, agitation 231 of the chemical 30 proximate the obstruction 20 can reduce the time required to clear the obstruction 20 and restore patency of the catheter 10. In some embodiments, agitation 231 can induce localized fluid flow 226 adjacent the surface of the obstruction 20 to physically disrupt (e.g., disrupt) the obstruction 20, thereby further enhancing the degradation process.

[0043] In use, a clinician may administer chemical agent 30 to obstruction 20 through lumen 13 of catheter 10. The clinician may then couple pressure actuator 220 to catheter 10 at proximal end 12. The clinician may then actuate pressure actuator 220 to cause agitation 231 until obstruction 20 is adequately broken down. The clinician may then disconnect pressure actuator 220 from catheter 10.

[0044] 3 illustrates an exemplary embodiment of a catheter 300 with features and functionality for removing an obstruction 20 therein. The catheter 300 comprises an inner tubular member 310 defining a lumen 313 extending between a distal end 311 and a proximal end 312. The catheter 300 further comprises an outer tubular member 320 (e.g., an outer catheter) defining an outer lumen 323 extending between a distal end 321 and a proximal end 322 of the outer member 320. The inner member 310 is slidably disposed within the lumen 323 of the outer member 320 such that the outer member 320 is continuously displaceable between a distal position and a proximal position relative to the inner tubular member 310.

[0045] In some embodiments, the outer member 320 can be configured to function as a stand-alone catheter. In other words, the outer member 320 can be a catheter, such as a central venous catheter. In such embodiments, the inner tubular member 310 can be a separate device that is inserted into the outer tubular member.

[0046] The inner member 310 includes a plurality of side ports (or channels) 330 extending along the ported portion 314 of the inner member 310. The side ports 330 extend through the tubular wall 315 of the inner member 310. The ported portion 314 is positioned relative to the outer member 320 such that (i) when the outer member 320 is disposed in a distal position, the distal end 322 extends distally beyond the ported portion 314 such that the side ports are closed / occluded by the outer member 320, and (ii) when the outer member 320 is disposed in a proximal position, the distal end 322 is positioned proximal to the ported portion 314 such that the side ports 330 are open (i.e., not covered by the outer member 320). In summary, the outer member 320 may occlude all of the side ports 330 when disposed in a distal position. As the outer member 320 is retracted from the distal position, more and more side ports 330 become uncovered / open until the outer member 320 is disposed in the proximal position, at which point all of the side ports 330 may become uncovered / open. Alternatively, the inner member 310 may be inserted successively such that more and more side ports 330 become uncovered / open.

[0047] In use, the chemical agent 30 administered through the side port 330 may contact the occlusion 20 at multiple locations on the occlusion 20. In some examples, the occlusion 20 may extend proximally along the outside of the catheter 300, including the outer member 320 and / or the inner member 310. In such cases, the chemical agent 30 administered through the side port 330 may be directed proximally along the outside of the catheter 300 and contact a portion of the occlusion 20 disposed proximally along the outside of the catheter 300. In some embodiments, the occlusion 20 may extend proximally along the ported portion 314. Thus, the chemical agent 30 administered through the side port 330 may contact the occlusion 20 along an annular inner surface of the occlusion 20.

[0048] In the case of the obstruction 20 of the catheter 300, the catheter 300 (more particularly the inner tubular member 310) may be coupled at the proximal end 312 to a fluid device (e.g., a syringe 340 having a plunger 341) such that the syringe 340 is in fluid communication with the lumen 313, and the syringe 340 may contain a chemical agent 30. In such a case, the clinician may push the plunger 341 to administer the chemical agent 30 through the lumen 313 to the obstruction 20. When the outer tubular member 320 is displaced away from the distal position, the chemical agent 30 may flow out of the lumen 313 through the opened side port 330, exposing the outer surface 21 of the obstruction 20 to the chemical agent 30. Exposing the outer surface 21 may enhance the decomposition of the obstruction 20.

[0049] In some examples, the clinician may retract the plunger to displace the chemical agent 30 proximally within the lumen 313. In further examples, the clinician may repeatedly push and retract the plunger 341 to agitate the chemical agent 30 adjacent the obstruction 20. Agitation may further enhance the rate of decomposition.

[0050] 4A illustrates a third exemplary embodiment of a medical instrument 400 for removing an obstruction 20 in a catheter 10. The instrument 400 comprises an elongate bi-luminal tubular member 410 configured to (i) be inserted through the lumen 13 of the catheter 10 and (ii) extend between the proximal end 12 and the distal end 11 of the catheter 10. The catheter 10 may be an intravenous catheter. The instrument 400 is configured to deliver a chemical agent 30 to the obstruction 20 in the lumen 13. More specifically, the instrument 400 is configured to deliver the chemical agent 30 to both the proximal and distal sides of the obstruction 20.

[0051] 4B is a detailed cross-sectional view of a portion of tubular member 410. With reference to FIGS. 4A and 4B, tubular member 410 defines a distal end 411 and a proximal end 412. A first lumen 413 and a second lumen 414 extend along tubular member 410. Tubular member 410 includes a bifurcation 416 adjacent proximal end 412 to define a first leg 410A and a second leg 410B. First lumen 413 extends along first leg 410A and second lumen 414 extends along second leg 410B. A distal tip 419 of tubular member 410 is configured to pierce occlusion 20 such that tubular member 410 can be extended through opening 21 of occlusion 20.

[0052] The device 400 includes an inflatable balloon 420 coupled to the tubular member 410 adjacent the distal end 411. The device 400 can also include a first fluid device, such as a first syringe 430 with a first plunger 431, coupled to the first leg 410A. The balloon 420 is fluidly coupled to the first fluid device 430 via a first lumen 413. Operation of the syringe 430 results in inflation and deflation of the balloon 420. In an inflated state, the balloon 420 can spread across the catheter lumen 13 and, in some embodiments, can fill a cross-section of the catheter lumen 13. A valve 435 can be disposed along the first leg 410A and collinear with the first lumen 413 to selectively allow and prevent fluid flow through the lumen 413.

[0053] A plurality of side ports 440 extend proximally from the balloon 410 along the ported portion 441 of the tubular member 410. A second fluid device, for example a second syringe 450 with a second plunger 451, can be coupled to the second leg 410B. The side ports 440 are each fluidly coupled to the second syringe 450 via the second lumen 414. Operation of the second syringe 430 results in a flow of fluid through the ports 440. In some embodiments, the second syringe 450 can contain a chemical agent 30, and by depressing the second plunger 451, the chemical agent 30 can be administered through the side ports 440. Because the side ports 440 are located proximally from the balloon 420 and the balloon 420 can expand across the catheter lumen 420, the balloon 420 can prevent the chemical agent 30 from being lost into the patient's bloodstream.

[0054] In use, in the case of an occlusion 20 in the catheter lumen 13, the clinician may insert the device 400 (or more specifically the tubular member 410) into the lumen 13 of the catheter 10 and advance the tubular member 410 so that the distal end 411 of the tubular member 410 is positioned proximate to the occlusion 20. The clinician may then advance the tubular member 410 further to pierce the occlusion 20 at the distal tip 419 and advance the tubular member 410 through the occlusion 20. The clinician may position the tubular member 410 so that the balloon 420 is located distal to the occlusion 20. The clinician may further position the tubular member 410 so that the occlusion 20 is positioned along the ported portion 441, i.e., between the proximal and distal ends of the ported portion. The clinician may push the first plunger 431 to inflate the balloon 420 so that the balloon 420 spreads across the catheter lumen 13. With the balloon still inflated, the clinician may close the valve 435 to lock the inflation pressure in the balloon 420. The clinician may then push the second plunger 451 to administer the chemical agent 30 through the side port 440. The administered chemical agent 30 may contact the occlusion 20 proximal and / or distal to the occlusion 20. The chemical agent 30 may also contact the occlusion 20 along the opening 21. After sufficient disintegration of the occlusion 20, the clinician may open the valve 435 and retract the first plunger 431 to deflate the balloon 20. The clinician may withdraw the tubular member 410 from the catheter lumen 13.

[0055] In some embodiments, the clinician may retract the second plunger 451 to aspirate the chemical agent 30 through the side port 440. The clinician may also repeatedly push and retract the second plunger 451 to agitate the chemical agent 30 adjacent the obstruction 20. In further embodiments, the clinician may displace the tubular member 410 longitudinally along the catheter lumen 13 to agitate the chemical agent 30. Agitation may further enhance the rate of dissolution. In some examples, the clinician may displace the tubular member 410 proximally with the balloon 420 inflated to drag any remaining debris or portions of the obstruction 20 out of the catheter lumen 13.

[0056] The instrument 400 may define a stand-alone device for use with the catheter 10. In other embodiments, the instrument 400, or one or more components thereof, may be combined with the catheter 10 to define a catheter system.

[0057] Without further elaboration, it is believed that one skilled in the art can utilize the present invention to its fullest extent using the preceding description. The claims and embodiments disclosed herein are merely illustrative and exemplary and should not be construed as limiting the scope of the present disclosure in any way. It will be apparent to one skilled in the art that, with the aid of the present disclosure, changes can be made to the details of the above embodiments without departing from the basic principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the above description are within the scope of the appended claims. Furthermore, the order of steps or operations of the methods disclosed herein may be changed by one skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or operations is necessary for the proper operation of the embodiment, the order or use of specific steps or operations may be changed. The scope of the present invention is therefore defined by the following claims and their equivalents.

Claims

1. An instrument for removing an occlusion from a catheter lumen, the instrument comprising: a long member configured to be inserted into the catheter lumen; a stirring actuator coupled to the long member adjacent to a proximal end of the long member, wherein operation of the stirring actuator causes stirring of a fluid adjacent to a distal end of the long member.

2. The instrument according to claim 1, wherein the fluid contains a chemical configured to decompose the occlusion and is disposed adjacent to the occlusion in the catheter.

3. The instrument according to claim 2, wherein the chemical contains a thrombolytic agent.

4. The instrument according to claim 1, wherein the occlusion extends beyond a distal end of the catheter lumen.

5. The instrument according to claim 4, wherein the occlusion includes a part of a fibrin sheath.

6. The instrument according to claim 1, wherein the stirring includes displacement of the distal end of the long member in a longitudinal direction or a lateral direction.

7. The instrument according to claim 1, wherein the stirring includes rotation of the distal end of the long member.

8. The instrument according to claim 1, wherein the stirring actuator is an electromechanical device.

9. The instrument according to claim 8, wherein the stirring includes longitudinal vibration of the distal end.

10. The instrument according to claim 8, wherein the stirring includes lateral vibration of the distal end.

11. The instrument according to claim 9, wherein the vibration has an ultrasonic frequency.

12. The instrument according to claim 1, wherein the elongate member comprises one or more protrusions extending away from the elongate member at the distal end of the elongate member.

13. The instrument according to any one of claims 1 to 12, wherein the catheter is an intravenous catheter.

14. A device for removing an occlusion from a catheter, the device comprising: a pressure actuator coupled to the catheter at the proximal end of the catheter and in fluid communication with the catheter lumen, the pressure actuator comprising: The pressure actuator is configured to generate a fluid pressure that varies along the lumen to cause agitation of the fluid adjacent to the occlusion in the catheter.

15. The device according to claim 14, wherein the catheter is an intravenous catheter.

16. The device according to claim 14, wherein the fluid comprises a chemical configured to decompose the occlusion.

17. The device according to claim 16, wherein the chemical comprises a thrombolytic agent.

18. The device according to claim 14, wherein the agitation of the fluid occurs within the catheter lumen.

19. The device according to claim 14, wherein at least one of positive pressure and negative pressure is defined within the catheter lumen by operation of the pressure actuator.

20. The device according to claim 19, wherein a pressure fluctuation within the lumen between the positive pressure and the negative pressure is defined by operation of the pressure actuator.

21. The device according to any one of claims 14 to 20, wherein the pressure actuator is an electromechanical device.

22. An intravenous catheter, wherein the intravenous catheter is An outer elongate tubular member defining an outer lumen, the outer lumen extending between a proximal end and a distal end of the outer member, the outer elongate tubular member; and An inner elongate tubular member defining an inner lumen, the inner lumen extending between a proximal end and a distal end of the inner member, the inner elongate tubular member; and A plurality of side ports disposed along a ported portion of the inner member, the plurality of side ports being in fluid communication with the inner lumen, The inner member is disposed within the outer lumen and is displaceable relative to the outer member between a distal position and a proximal position, The plurality of side ports are covered by the outer member when the inner member is in the proximal position and are exposed when the inner member is in the distal position, the intravenous catheter. **Claim 23** The catheter according to claim 22, wherein the inner member is continuously displaceable between the distal position and the proximal position. **Claim 24** The catheter according to claim 22, wherein the inner member is removable from the outer member. **Claim 25** The catheter according to claim 22, wherein the inner lumen is open at the distal end of the inner member such that fluid can be exchanged with a patient through the inner lumen. **Claim 26** The catheter according to any one of claims 22 to 25, wherein the inner member is configured to be displaced distally relative to the outer member to expose one or more of the plurality of side ports. **Claim 27** An instrument for removing an occlusion from a catheter, the instrument comprising An elongate member configured to be inserted into a catheter lumen, the elongate member defining a proximal end and a distal end, the elongate member; and An inflatable balloon coupled to the elongate member adjacent to the distal end, the inflatable balloon being in fluid communication with a first lumen extending between the inflatable balloon and the proximal end. A plurality of side ports disposed along a ported portion of the elongate member, the side ports being in fluid communication with a second lumen extending between the plurality of side ports and the proximal end. The instrument comprises the plurality of side ports. **Claim 28** The instrument according to claim 27, wherein the catheter is an intravenous catheter. **Claim 29** The instrument according to claim 27, wherein the ported portion is disposed proximal to the inflatable balloon. **Claim 30** The instrument according to claim 27, wherein the distal end is configured to penetrate the occluder such that the distal end is disposed along the ported portion. **Claim 31** The instrument according to claim 27, wherein the elongate member is configured to be coupled to a first fluid device at the proximal end, and the first fluid device is configured to inflate or deflate the inflatable balloon. **Claim 32** The instrument according to any one of claims 27 to 31, wherein the elongate member is configured to be coupled to a second fluid device at the proximal end, and the second fluid device is configured to administer a chemical through the second lumen.

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