System for targeted thrombolytic drug delivery

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 Art

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

[0003] A common method is to treat suspected thrombotic occlusion with a thrombolytic drug. Current recommendations include administering the thrombolytic drug into the catheter lumen with a dwell time of at least 30 minutes and, if necessary, repeating the administration. A dwell time of more than 120 minutes is not common.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The systems, devices, and methods described herein can assist in removing catheter occlusions and restoring catheter patency. More specifically, these systems, devices, and methods can assist in administering a thrombolytic drug at the location of the occlusion, assist in penetrating the occlusion, prevent loss of the thrombolytic drug to the bloodstream, and / or increase the surface area of the occlusion in contact with the thrombolytic drug.

Means for Solving the Problems

[0005] In short, this specification discloses a device for removing occlusions from catheters such as intravenous catheters. The device comprises an elongated member configured to be inserted into the catheter lumen, the catheter lumen having an elongated member defining a proximal end and a distal end, and a stirring actuator coupled to the elongated member adjacent to the proximal end. The stirring actuator causes stirring of the fluid adjacent to the distal end of the elongated member.

[0006] The distal end of the elongated member may be positioned within the lumen, and the fluid may be positioned adjacent to the occlusion of the catheter. The fluid may contain chemicals configured to break down the occlusion, and these chemicals may include thrombolytic agents. The occlusion may be positioned 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 end of the catheter, and the occlusion may completely occlude the catheter.

[0007] The stirring actuator may be an electromechanical device, and the stirring may include longitudinal and / or lateral vibration of the distal end of the elongated member. In some embodiments, the vibration may have an ultrasonic frequency. The elongated member may have one or more projections extending away from the elongated member at its distal end.

[0008] This specification also discloses a device for removing an occlusion from a catheter, which may be an intravenous catheter. The device comprises a pressure actuator, which is coupled to the catheter at its proximal end such that the pressure actuator is in fluid communication with the catheter lumen. The pressure actuator generates a fluid pressure that fluctuates along the lumen, causing agitation of the fluid adjacent to the occlusion in the catheter. The fluid contains a chemical configured to break down the occlusion, and the chemical may contain a thrombolytic agent. The agitation of the fluid may occur within the lumen.

[0009] A pressure actuator may be an electromechanical device. The operation of the pressure actuator can define positive and / or negative pressure within a lumen. The operation can also induce pressure fluctuations within the lumen between positive and negative pressure.

[0010] This specification also discloses a catheter which may be an intravenous catheter. This catheter comprises an outer elongated tubular member defining an outer lumen, the outer lumen extending between the proximal and distal ends of the outer member, and an inner elongated tubular member defining an inner lumen, the inner lumen extending between the proximal and distal ends of the inner member. The inner member comprises a plurality of side ports arranged along a ported portion of the inner member, which are in fluid communication with the inner lumen. The inner member is positioned within the outer lumen and is displaceable between a distal and 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 positioned between the distal and proximal positions, and the inner member may be detachable from the outer member. The inner lumen may also be open at the distal end, allowing for fluid exchange with the patient through the inner lumen.

[0011] During use, the chemical can be administered through the inner lumen toward the occlusion in the catheter and come into contact with it. The fluid may contain a chemical configured to break down the occlusion, and the chemical may contain a thrombolytic agent. During further use, the inner member is displaced distally relative to the outer member to expose the side port, and the chemical can be administered through the side port and come into contact with the occlusion outside the inner member. The chemical can also come into contact with the occlusion extending beyond the distal end of the inner member and / or with the occlusion extending proximal along the outer surface of the inner member. The chemical administered through the side port can also come into contact with the occlusion along its outer surface.

[0012] This specification also discloses another device for removing an occlusion from a catheter, which may be an intravenous catheter. This device comprises an elongated member configured to be inserted through the catheter lumen, the elongated member having a proximal end and a distal end. An inflatable balloon is coupled to the elongated member adjacent to the distal end, and the balloon is in fluid communication with a first lumen extending between the balloon and the proximal end of the elongated member. A plurality of side ports are arranged along the ported portion of the elongated member, and the side ports are in fluid communication with a second lumen extending between the side ports and the proximal end of the elongated member.

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

[0014] When in use, the elongated member can be coupled at its proximal end to the first fluid device so that the first fluid device is in fluid communication with the first lumen. The first fluid device is configured to inflate and deflate the balloon.

[0015] During use, the elongated member can be coupled at its proximal end to a second fluid device so that the second fluid device is in fluid communication with the second lumen. The second fluid device is configured to administer a chemical through the second lumen. During use, the chemical is administered through the side port and can come into contact with the occlusion, including the proximal and distal ends, along the ported portion. During use, the second fluid device can be operated to aspirate and re-administer the chemical through the side port to agitate the chemical, and the device is displaced longitudinally within the lumen to agitate the chemical.

[0016] During use, the device may be displaced proximal to the lumen to bring the occlusion into contact with the balloon and / or displace one or more portions of the occlusion proximal to the catheter lumen. This specification also discloses a method for restoring the patency of a catheter. This method includes administering a chemical through the catheter lumen, the chemical being configured to break down an obstruction in the lumen, and agitating the chemical to enhance the breakdown of the obstruction.

[0017] Agitation of chemicals may include inserting a long member into the catheter lumen, or displacing the distal end of the long member to induce agitation. Agitation may also include vibrating the distal end of the long member.

[0018] In some embodiments of this method, the elongated member may be provided with a member lumen, and administering a chemical may include administering the chemical through the member lumen. The elongated member may be provided with a plurality of side ports, and administering a chemical may include administering the chemical through the side ports. Administering a chemical through the side ports may also include administering the chemical proximal and distal to the occlusion.

[0019] In some embodiments of this method, inserting an elongated member may involve piercing the blockage with the distal end of the elongated member. In some embodiments, stirring the chemicals may involve varying the pressure of the chemicals.

[0020] This specification also discloses a catheter system comprising a catheter defining a catheter lumen extending between a proximal and distal end, and an elongated member configured to be inserted through the catheter lumen, the elongated member defining the proximal end and the distal end. The elongated member is configured to perform one or more actions for removing an occlusion from the catheter.

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

[0022] The operation may include administering a chemical through the 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 operation includes administering the chemical through the side ports. The operation may further include administering the chemical distally of the obstruction.

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

[0024] A more specific description of the present disclosure is made by reference to the specific embodiments thereof shown in the accompanying drawings. It is to be understood that these drawings show only typical embodiments of the invention and are, therefore, not to be considered as limiting its scope. Exemplary embodiments of the invention are described and explained in further detail through the use of the accompanying drawings.

Brief Description of the Drawings

[0025] [Figure 1] A side cross-sectional view of a first embodiment of a medical device for use in removing a catheter obstruction, according to some embodiments. [Figure 2] A side cross-sectional view of a second embodiment of a medical device for use in removing a catheter obstruction, according to some embodiments. [Figure 3] A side cross-sectional view of a catheter having features for obstruction removal, according to some embodiments. [Figure 4A]Side cross-sectional view of a third embodiment of a medical device for use in removing a catheter occluder, according to some embodiments. [Figure 4B] Detailed cross-sectional view of a portion of the medical device of FIG. 4A, according to some embodiments. **DETAILED DESCRIPTION OF THE INVENTION**

[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 can be easily separated from the specific embodiments and may optionally have features that can be combined with or substituted for features of any of several other embodiments disclosed herein. <{

[0027] With regard to the terminology used herein, it should be understood that the terms are for the purpose of describing certain specific embodiments and do not 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 processes within a group of features or processes and do not provide a sequential or numerical limitation. For example, the “first,” “second,” and “third” features or processes do not necessarily have to appear in that order, and a particular embodiment containing such features or processes is not necessarily limited to three features or processes. Labels such as “left,” “right,” “up,” “down,” “front,” and “back” are used for convenience and are not intended to suggest any particular fixed position, orientation, or direction, for example. Instead, such labels are used to reflect a relative position, orientation, or direction, for example. The singular forms “a,” “an,” and “the” include plural references unless otherwise explicitly indicated in the context. The terms “including,” “has,” and “having” have the same meaning as “comprising” when used herein, including in the claims. Furthermore, the terms “or” and “and / or” are to be interpreted as encompassing or any one or any combination thereof when used herein. For example, “A, B or C” or “A, B and / or C” means “i.e., A only, B only, C only, A and B, A and C, B and C, and any one of A, B and C.” An exception to this definition arises only if the combination of elements, components, functions, processes, or actions is in any way essentially mutually exclusive.

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

[0029] Any method disclosed herein includes one or more steps or actions for carrying out the described method. The method steps and / or actions are interchangeable. In other words, the order and / or use of any particular steps and / or actions may be changed unless a particular order of steps or actions is required for the proper operation of the embodiment. Furthermore, only a subroutine or part of a method described herein may constitute an independent method within the scope of this disclosure. In other words, some methods may include only a portion of the steps described in a more detailed method.

[0030] The directional terms "proximal" and "distal" are used herein to refer to opposite positions in a medical device. The proximal end of the device is defined as the end of the device closest to the end user when the device is being used by the end user. The distal end is the end of the device opposite the proximal end along its longitudinal direction, or the end furthest from the end user.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Figure 1 shows a first exemplary embodiment of a medical device 100 for removing an occlusion 20 blocking a catheter 10. The device 100 comprises (i) an elongated shaft 110 that is inserted through the lumen 13 of the catheter 10 and (ii) extends between the proximal end 12 and the 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 located 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 proximal along the outside of the catheter 10, and the occlusion 20 may include, for example, a fibrin sheath. The occlusion 20 may consist of a fluid precipitate or may result from the formation of a thrombus within the lumen 13 or adjacent to the distal end 11.

[0033] The apparatus 100 is configured to define the agitation 131 of a chemical 30 placed in the lumen 13 in close proximity to the blockage 20. The shaft 110 is coupled to an agitation actuator 120 (actuator) at its proximal end 112. The actuator 120 causes agitation motion of the distal end 111 of the shaft 110. The agitation may include oscillating motion of the distal end 111 in the longitudinal and / or lateral directions. In some embodiments, the agitation may include rotation of the shaft 110. The shaft 110 may have one or more projections 114 to assist in the agitation 131 of the chemical 30. The projections 114 may be columns, fins, flaps, or any other projections that are appropriately shaped to assist in agitation 131 when the distal end 111 is displaced.

[0034] The actuator 120 may be an electromechanical device. In some embodiments, the stirring motion may include vibration of the shaft 110, and the vibration may have a frequency within the ultrasonic range (i.e., a frequency above about 20 kilohertz). In some embodiments, the actuator 120 may be configured to be manually operated. Thus, the actuator 120 may be equipped with a plunger, a crank, or any other suitable physical interface to facilitate the stirring motion of the shaft 110, which is manually defined by a clinician.

[0035] The chemical 30 may be configured to dissolve, decompose, or otherwise destroy the solid nature of the obstruction 20. Thus, the decomposition of the obstruction 20 can be facilitated by a chemical reaction of the chemical 30 in close proximity to the surface of the obstruction 20. The rate of the chemical reaction (i.e., the decomposition rate) may be limited by the diffusion rate of the chemical 30 to the obstruction 20. In some cases, the decomposition rate may decrease over time due to a decrease in the diffusion of the chemical 30 in close proximity to the surface of the obstruction 20. Thus, stirring the chemical 30 in close proximity to the surface of the obstruction 20 can restore, maintain, or otherwise increase the diffusion rate of the chemical 30 in close proximity to the surface of the obstruction 20, thereby increasing the decomposition rate of the obstruction 20. In summary, stirring the chemical 30 in close proximity to the obstruction 20 131 can reduce the time required to remove the obstruction 20 and restore the patency of the catheter 10. In some embodiments, stirring 131 can physically break (e.g., fragment) the blockage 20, further enhancing the decomposition process.

[0036] During use, the clinician may administer a chemical 30 to the occlusion 20 through the lumen 13 of the catheter 10. The clinician may then insert the instrument 100 (or more specifically the shaft 110) into the lumen 13 of the catheter 10 and advance the shaft 110 so that its distal end 111 is positioned close to the occlusion 20. The clinician may then operate the actuator 120 to induce agitation 131 until the occlusion 20 is properly broken down. The clinician may then withdraw the shaft 110 from the catheter 10.

[0037] In some embodiments, the distal end 111 of the shaft 110 is provided with a chemical 30 deposited thereon (for example, in the form of a powder or gel). In embodiments where the chemical 30 is deposited on the distal end 111 in powder form, the powder can be mixed and / or dissolved in a fluid administered into the lumen 13.

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

[0039] Figure 2 shows a second exemplary embodiment of a medical device (or apparatus) 200 for removing an occlusion 20 from a catheter 10. The device 200 comprises a pressure actuator 220 (e.g., a hydraulic actuator) that can be coupled to the catheter 10 at the proximal end 12 of the catheter 10 via a pressure port 221.

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

[0041] In some embodiments, the pressure actuator 220 may be configured to be manually operated by a clinician to generate pressure fluctuations. Thus, the pressure actuator 220 may have a plunger, a crank, or any other suitable physical interface to allow the clinician to manually generate pressure fluctuations 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 a reciprocating plunger in a cylinder. Pressure fluctuations 225 may occur (i) in a positive pressure range (i.e., a pressure range higher than atmospheric pressure), (ii) in a negative pressure range (i.e., a pressure range lower than atmospheric pressure), or (iii) across both positive and negative pressure ranges.

[0042] Similar to the agitation 131 described above, agitation 231 of the chemical 30 adjacent to the surface of the blockage 20 can restore, maintain, or otherwise increase the decomposition rate. In summary, agitation 231 of the chemical 30 adjacent to the blockage 20 can reduce the time required to remove the blockage 20 and restore the patency of the catheter 10. In some embodiments, agitation 231 can induce a localized fluid flow 226 adjacent to the surface of the blockage 20, causing the blockage 20 to physically break (e.g., fragment) the blockage 20, thereby further enhancing the decomposition process.

[0043] During use, the clinician may administer a chemical agent 30 to the occlusion 20 through the lumen 13 of the catheter 10. The clinician may then connect the pressure actuator 220 to the catheter 10 at its proximal end 12. The clinician may then activate the pressure actuator 220 to induce agitation 231 until the occlusion 20 is properly broken down. The clinician may then disconnect the pressure actuator 220 from the catheter 10.

[0044] Figure 3 shows an exemplary embodiment of a catheter 300 having features and functionality for removing an occlusion 20 from the catheter 300. 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), the outer tubular member 320 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 positioned within the lumen 323 of the outer member 320 so that the outer member 320 can be continuously displaced between a distal and proximal position relative to the inner tubular member 310.

[0045] In some embodiments, the outer member 320 may be configured to function as a standalone catheter. In other words, the outer member 320 may be a catheter, such as a central venous catheter. In such embodiments, the inner tubular member 310 may be a separate device 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 positioned distally, the distal end 322 extends distally beyond the ported portion 314, so that the side ports are closed / blocked by the outer member 320, and (ii) when the outer member 320 is positioned proximal, the distal end 322 is positioned proximal to the ported portion 314, so that the side ports 330 are open (i.e., not covered by the outer member 320). In summary, when the outer member 320 is positioned distally, it can block all of the side ports 330. As the outer member 320 is retracted from the distal position, the number of side ports 330 that are left uncovered / open increases until the outer member 320 is positioned proximal, and it is possible that all of the side ports 330 will be left uncovered / open at the proximal position. Alternatively, the inner member 310 may be continuously inserted so that the side ports 330 remain uncovered / open.

[0047] During use, the chemical 30 administered through the side port 330 may come into contact with the occlusion 20 at multiple locations on the occlusion 20. In some examples, the occlusion 20 may extend proximal along the outside of the catheter 300, which includes the outer member 320 and / or the inner member 310. In such cases, the chemical 30 administered through the side port 330 may be guided proximal along the outside of the catheter 300 and come into contact with a portion of the occlusion 20 that is positioned proximal along the outside of the catheter 300. In some embodiments, the occlusion 20 may extend proximal along the ported portion 314. Thus, the chemical 30 administered through the side port 330 may come into contact with the occlusion 20 along the annular inner surface of the occlusion 20.

[0048] In the case of an occlusion 20 of catheter 300, the catheter 300 (more specifically the inner tubular member 310) may be coupled at its 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 30. In such a case, the clinician may push the plunger 341 to administer the chemical 30 to the occlusion 20 through the lumen 313. If the outer tubular member 320 is displaced away from its distal position, the chemical 30 may flow out of the lumen 313 through the open side port 330, exposing the outer surface 21 of the occlusion 20 to the chemical 30. Exposure to the outer surface 21 may enhance the decomposition of the occlusion 20.

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

[0050] Figure 4A shows a third exemplary embodiment of a medical device 400 for removing an occlusion 20 in a catheter 10. The device 400 comprises a long, 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 device 400 is configured to deliver a chemical 30 to the occlusion 20 in the lumen 13. More specifically, the device 400 is configured to deliver the chemical 30 to both the proximal and distal sides of the occlusion 20.

[0051] Figure 4B is a detailed cross-sectional view of a portion of the tubular member 410. Referring to Figures 4A and 4B, the tubular member 410 defines a distal end 411 and a proximal end 412. A first lumen 413 and a second lumen 414 extend along the tubular member 410. The tubular member 410 includes a branch 416 adjacent to the proximal end 412 so as to define a first leg 410A and a second leg 410B. The first lumen 413 extends along the first leg 410A, and the second lumen 414 extends along the second leg 410B. The distal end 419 of the tubular member 410 is configured to penetrate the occlusion 20 so that the tubular member 410 can be extended through the opening 21 of the occlusion 20.

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

[0053] Multiple side ports 440 extend proximal to the balloon 410 along the ported portion 441 of the tubular member 410. A second fluid device, for example, a second syringe 450 equipped with a second plunger 451, may be coupled to the second leg 410B. Each side port 440 is fluid-coupled to the second syringe 450 via a second lumen 414. The operation of the second syringe 430 brings about a fluid flow through the port 440. In some embodiments, the second syringe 450 can contain a chemical 30, and the chemical 30 can be administered through the side port 440 by pushing the second plunger 451. Because the side ports 440 are located proximal to the balloon 420, and the balloon 420 can expand across the catheter lumen 420, the balloon 420 can prevent the chemical 30 from being lost into the patient's bloodstream.

[0054] As for the method of use, in the case of an occlusion 20 in the catheter lumen 13, the clinician may insert the instrument 400 (or more specifically the tubular member 410) into the lumen 13 of the catheter 10 and advance the tubular member 410 so that its distal end 411 is positioned close to the occlusion 20. Next, the clinician may advance the tubular member 410 further so that its distal tip 419 penetrates the occlusion 20 and advances the tubular member 410 through the occlusion 20. The clinician may position the tubular member 410 so that the balloon 420 is positioned 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, that is, 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 expands across the catheter lumen 13. With the balloon still inflated, the clinician may close the valve 435 to lock the inflation pressure inside the balloon 420. The clinician may then push the second plunger 451 to administer the chemical 30 through the side port 440. The administered chemical 30 may come into contact with the occlusion 20 proximal and / or distal to it. The chemical 30 may also come into contact with 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 30 through the side port 440. The clinician may also repeatedly push and retract the second plunger 451 to agitate the chemical 30 adjacent to the occlusion 20. In further embodiments, the clinician may agitate the chemical 30 by displacing the tubular member 410 longitudinally along the catheter lumen 13. Agitation may further increase the rate of decomposition. In some examples, the clinician may displace the tubular member 410 proximal with the balloon 420 inflated to pull any remaining fragments or portions of the occlusion 20 out of the catheter lumen 13.

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

[0057] Those skilled in the art will likely be able to utilize the present invention to its fullest extent using the foregoing description without further detail. The claims and embodiments disclosed herein are merely descriptive and illustrative, and should be construed as not limiting the scope of this disclosure in any way. It will be apparent to those skilled in the art that, with the help of this disclosure, modifications 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 to the embodiments specifically disclosed herein are within the scope of the appended claims. Furthermore, the order of steps or operations of the methods disclosed herein may be modified by those skilled in the art without departing from the scope of this disclosure. In other words, the order or use of a particular step or operation may be modified unless that particular order of steps or operations is necessary for the proper operation of the embodiment. Accordingly, the scope of the present invention is defined by the following claims and their equivalents. [Note 1] An instrument for removing an obstruction from the lumen of a catheter, the instrument is A long, rectangular member configured to be inserted into the catheter lumen, An apparatus comprising a stirring actuator coupled to the elongated member adjacent to the proximal end of the elongated member, wherein the operation of the stirring actuator causes stirring of the fluid adjacent to the distal end of the elongated member. [Note 2] The fluid comprises a chemical configured to decompose the obstruction, and the device is positioned adjacent to the obstruction in the catheter, as described in Appendix 1. [Note 3] The aforementioned chemicals include thrombolytic agents, as described in Appendix 2. [Note 4] The occluding material is the device described in Appendix 1, which extends beyond the distal end of the catheter lumen. [Note 5] The aforementioned occlusion is the device described in Appendix 4, which includes a portion of the fibrin sheath. [Note 6] The apparatus described in Appendix 1, wherein the stirring includes displacement of the distal end of the elongated member in the longitudinal or lateral direction. [Note 7] The apparatus described in Appendix 1, wherein the stirring includes the rotation of the distal end of the elongated member. [Note 8] The stirring actuator is an electromechanical device, as described in Appendix 1. [Note 9] The stirring includes longitudinal vibration of the distal end, as described in Appendix 8. [Note 10] The stirring includes lateral vibration of the distal end, as described in Appendix 8. [Note 11] The vibration is an ultrasonic frequency, as described in Appendix 9. [Note 12] The apparatus according to Appendix 1, wherein the elongated member is provided with one or more projections extending away from the elongated member at the distal end of the elongated member. [Note 13] The catheter is an intravenous catheter, as described in any one of the items 1 to 12 of the appendix. [Note 14] A device for removing an occlusion from a catheter, wherein the device is A pressure actuator connected to the catheter at its proximal end, comprising a pressure actuator that communicates fluidly with the catheter lumen, The pressure actuator is configured to generate a fluid pressure that fluctuates along the lumen, thereby causing agitation of the fluid adjacent to the occlusion in the catheter. [Note 15] The catheter is an intravenous catheter, as described in Appendix 14. [Note 16] The apparatus according to Appendix 14, wherein the fluid comprises a chemical configured to decompose the blockage. [Note 17] The apparatus described in Appendix 16, wherein the aforementioned chemical substance includes a thrombolytic agent. [Note 18] The agitation of the fluid occurs within the catheter lumen using the apparatus described in Appendix 14. [Note 19] The apparatus according to Appendix 14, wherein the operation of the pressure actuator determines at least one of positive pressure and negative pressure within the catheter lumen. [Note 20] The apparatus as described in Appendix 19, wherein the operation of the pressure actuator defines the pressure fluctuation in the lumen between the positive pressure and the negative pressure. [Note 21] The pressure actuator is an electromechanical device, as described in any one of the appendices 14 to 20. [Note 22] An intravenous catheter, wherein the intravenous catheter is An outer elongated tubular member defining an outer lumen, wherein the outer lumen extends between the proximal and distal ends of the outer member, An inner elongated tubular member defining an inner lumen, wherein the inner lumen extends between the proximal and distal ends of the inner member, A plurality of side ports are arranged along the ported portion of the inner member, and the plurality of side ports are in fluid communication with the inner lumen, The inner member is positioned within the outer lumen and is displaceable between a distal and proximal position relative to the outer member. An intravenous catheter wherein the plurality of side ports are covered by the outer member when the inner member is in the proximal position and exposed when the inner member is in the distal position. [Note 23] The catheter as described in Appendix 22, wherein the inner member can be continuously positioned between the distal position and the proximal position. [Note 24] The catheter as described in Appendix 22, wherein the inner member is removable from the outer member. [Note 25] The catheter according to Appendix 22, wherein the inner lumen is open at the distal end of the inner member so that fluid can be exchanged with the patient through the inner lumen. [Note 26] The catheter according to any one of the appendices 22 to 25, wherein the inner member is configured to be displaced distally to the outer member to expose one or more of the plurality of side ports. [Note 27] An instrument for removing an obstruction from a catheter, wherein the instrument is A long, elongated member configured to be inserted into the lumen of a catheter, comprising a long, elongated member defining a proximal end and a distal end, An inflatable balloon connected to the elongated 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 device comprising a plurality of side ports arranged along the ported portion of the elongated member, the side ports being in fluid communication with a second lumen extending between the plurality of side ports and the proximal end. [Note 28] The catheter is an intravenous catheter, as described in Appendix 27. [Note 29] The device described in Appendix 27, wherein the ported portion is located proximal to the inflatable balloon. [Note 30] The device according to Appendix 27, wherein the distal end is configured to penetrate the occlusion such that the distal end is positioned along the ported portion. [Note 31] The apparatus as described in Appendix 27, wherein the elongated member is configured to be coupled to a first fluid device at its proximal end, and the first fluid device is configured to inflate or deflate the inflatable balloon. [Note 32] The apparatus according to any one of the appendices 27 to 31, wherein the elongated member is configured to be coupled at its proximal end to a second fluid device, the second fluid device being configured to administer a chemical through the second lumen.

Claims

1. An instrument for removing an obstruction from the lumen of a catheter, the instrument is A long shaft configured to be inserted into the catheter lumen, The system comprises a stirring actuator coupled to the elongated shaft adjacent to its proximal end, wherein the operation of the stirring actuator causes stirring motion at the distal end of the elongated shaft. The distal end of the elongated shaft contains a chemical substance deposited thereon, the chemical substance being configured to dissolve, decompose, or destroy the blockage.

2. The apparatus according to claim 1, wherein the chemical substance includes a thrombolytic agent.

3. The apparatus according to claim 1, wherein the chemical is in powder form.

4. The apparatus according to claim 3, wherein the chemical can be mixed and / or dissolved in the fluid administered into the catheter lumen.

5. The apparatus according to claim 1, wherein the stirring motion includes longitudinal or lateral displacement of the distal end of the elongated shaft.

6. The apparatus according to claim 1, wherein the stirring motion includes vibration of the distal end of the elongated shaft.

7. The apparatus according to claim 1, wherein the stirring motion includes the rotation of the distal end of the elongated shaft.

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

9. The apparatus according to claim 8, wherein the stirring motion includes vibration of the elongated shaft.

10. The apparatus according to claim 9, wherein the stirring motion includes longitudinal vibration of the distal end of the elongated shaft.

11. The apparatus according to claim 9, wherein the stirring motion includes lateral vibration of the distal end of the elongated shaft.

12. The apparatus according to claim 9, wherein the vibration has an ultrasonic frequency.

13. The apparatus according to claim 1, wherein the elongated shaft is provided with one or more protrusions.

14. The apparatus according to claim 13, wherein one or more projections extend away from the elongated shaft at the distal end of the elongated shaft.

15. The apparatus according to any one of claims 1 to 14, wherein the stirring actuator is configured to be operated manually.

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