Systems and methods for correcting and preventing catheter blockages

Abstract

The present invention discloses a patency device for a catheter assembly and other elongate tubular devices for establishing access to a portion of a patient's body. The patency device establishes and maintains the patency of one or more lumens defined by the catheter assembly by providing a positive pressure pulse to a fluid disposed within a lumen of the catheter assembly. In one embodiment, the patency device includes a fluid reservoir and a pressure input portion configured to provide a fluid path to at least one lumen of the catheter assembly. The pressure input portion is configured to provide a pressure for one or more positive pressure pulses to the fluid disposed within the lumen. The pulses are configured to displace an obstruction that may have formed within the lumen. A negative pressure may then be provided to the lumen to aspirate the obstruction.

Description

[0001] Divisional Information

[0002] This application is a divisional application of the patent application for invention with application number 201780044411.2, titled "Systems and Methods for Correcting and Preventing Occlusion in a Catheter", filed on June 9, 2017.

[0003] Cross - reference to Related Patent Applications

[0004] This patent application claims the benefit of U.S. Provisional Patent Application 62 / 348,082, titled "Systems and Methods for Correcting and Preventing Occlusion in a Catheter", filed on June 9, 2016, the entire disclosure of which is incorporated herein by reference. Summary of the Invention

[0005] Briefly, embodiments of the present invention relate to a patency device for a catheter assembly and other elongated tubular devices for establishing access to a portion of a patient's body. The patency device establishes and / or maintains the patency of one or more lumens defined by the catheter assembly by providing a positive pressure pulse to the fluid disposed within the lumen of the catheter assembly.

[0006] In one embodiment, the patency device includes a fluid reservoir and a pressure input portion configured to provide fluid (or establish a fluid path) to at least one lumen of the catheter assembly. The pressure input portion is configured to provide a pressure of one or more positive pressure pulses to the fluid disposed within the lumen. The pulses are configured to displace an obstruction that may have formed within the lumen. A negative pressure may then be provided to the lumen to aspirate the obstruction and remove it from the catheter assembly.

[0007] These and other features of embodiments of the present invention will become more apparent from the following description and the appended claims, or may be learned by practice of the embodiments of the invention as shown below. Brief Description of the Drawings

[0008] A more particular description of the present disclosure will be given by reference to specific embodiments of the disclosure shown in the drawings. It should be appreciated that these drawings only show typical embodiments of the invention and should not be considered as limiting its scope. The exemplary embodiments of the invention will be described and illustrated more specifically and in detail by using the drawings, in which:

[0009] Figure 1 is a simplified view of a catheter assembly and a patency device attached thereto according to one embodiment;

[0010] Figure 2 is a graph showing the pressure curve of a patency device; Figure 1

[0011] Figure 3 is a block diagram of a patency device according to an embodiment;

[0012] Figure 4A and Figure 4B is Figure 3 a schematic diagram of a valve assembly of a patency device;

[0013] Figure 5 is a block diagram of a patency device according to an embodiment;

[0014] Figure 6 is a block diagram of a patency device according to an embodiment;

[0015] Figure 7 is a block diagram of a patency device according to an embodiment;

[0016] Figure 8 is a pressure curve of a patency device according to an embodiment;

[0017] Figure 9 is a pressure curve of a patency device according to an embodiment;

[0018] Figure 10 is a pressure curve of a patency device according to an embodiment; and

[0019] Figure 11 is a block diagram of a patency device according to an embodiment. DETAILED DESCRIPTION

[0020] Reference is now made to the accompanying drawings, in which like structures will have like reference numerals. It should be understood that the drawings are illustrative and schematic of exemplary embodiments of the present invention and are not limiting of the present invention and are not necessarily drawn to scale.

[0021] For clarity, it should be understood that the term "proximal" refers to the direction relatively closer to the clinician using the device to be described herein, and the term "distal" refers to the direction relatively farther from the clinician. For example, the end of a catheter placed within a patient's body is considered the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. Additionally, as used herein (including in the claims), the terms "comprising," "having" shall have the same meaning as the term "including."

[0022] ​Embodiments of the present invention generally relate to catheter assemblies and other elongated tubular devices for establishing access to a portion of a patient's body. An example of such a catheter assembly is a peripherally inserted central catheter ("PICC"). Specifically, the present invention discloses solutions and methods for establishing and maintaining the patency of one or more lumens defined by a catheter assembly. According to the specific embodiments discussed below, the present invention discloses examples of patency devices that can be employed.

[0023] Referring first to Figure 1 , which generally depicts various details of a catheter assembly ("catheter", generally designated 10) and a patency device, to be further described below, according to one embodiment. As shown, catheter 10 includes an elongated catheter body 12 that defines a lumen 14 extending between a proximal end 12A and a distal end 12B of the catheter body. A luer connector 22 or other suitable connector is included at the proximal end 12A of the catheter body 12. In other embodiments, the catheter may include a bifurcated hub at the proximal end of the catheter body, with one or more extending legs extending proximally from the bifurcated hub.

[0024] Although shown herein as defining a single lumen 14, in other embodiments, catheter 10 may define two or more lumens. Moreover, although shown as a PICC, in other embodiments, the catheter may include other catheter types, such as dialysis, CVC, PIV, urinary, arterial, balloon catheters, etc. Thus, the discussion herein is not intended to be limiting.

[0025] Figure 1 Details of a patency device 30, according to one embodiment, are also shown, which is configured to be operably connected to catheter 10 temporarily and provide patency to catheter lumen 14. Generally speaking, patency device 30 includes a fluid reservoir 34 and a pressure input section 38, which together are configured to provide one or more relatively short-duration high-pressure fluid pulses (also referred to herein as positive pressure pulses) to lumen 14 of catheter body 12. When performed periodically, such pulses are configured to prevent the formation of thrombi or other obstructions in lumen 14, particularly at its distal end. These short-duration high-pressure pulses can also be used to clear the lumen after an obstruction has formed in the lumen.

[0026] More specifically, the pressure input portion 38 of the patency device 30 includes a mechanical input, such as a manually or motor-controlled plunger-type syringe, to apply pressure pulses to the fluid contained in the fluid reservoir 34. The fluid reservoir 34 is configured to hold a quantity of fluid that can be directed into the lumen 14 of the catheter body 12 either before or in conjunction with the pressure pulses generated by the pressure input portion 38. In one embodiment, as shown below, the fluid reservoir 34 serves as a hydraulic accumulator to store the pressurized fluid before it is released into the lumen 14 by the pressure input portion 38.

[0027] It should be noted that other types of pressure input portions can be used to provide high-pressure fluid pulses, including, for example, electro- and piezo-actuators, voice coil actuators, linear actuators, piezoelectric motors, vibrating drums, and membranes.

[0028] Including a catheter connector interface 40 that defines a lumen 42 to enable the patency device 30 to be operably connected to the luer connector 22 (or other portion) of the catheter 10 and to provide a conduit through which high-pressure fluid can be transferred from the fluid reservoir 34 to the lumen 14 of the catheter body 12. Note that in one embodiment, the connector interface 40 is a sterile article to bridge between the non-sterile patency device 30 and the catheter 10. In this way, the connector interface 40 can be manufactured as a disposable sterile article while the patency device 30 can be reused.

[0029] In operation, the patency device 30 emits periodic, relatively short-duration, relatively high-pressure bursts or pulses in the distal direction through the fluid-filled lumen 14 of the catheter body 12. These pulses are generated by the pressure input portion 38 in combination with the pressure portion 34 and are transmitted through the lumen 42 of the patency device 30 via the connector interface 40 to the luer connector 22 and into the catheter lumen 14. It should be understood that the pressure of the pulses, the pulse duration, the rest period between pulses, the frequency of successive pulses, etc. can be adjusted and varied according to the specific patency procedure being performed on the catheter 10.

[0030] Figure 2A graph depicting the pressure curve 80 (including fluid pressure and time) generated by the patency device 30 during operation. The pressure curve 80 includes time on the x-axis and pulse pressure on the y-axis for the operation of the patency device 30. As shown, the patency device 30 provides short-duration, relatively high-pressure pulses through the fluid present in the catheter lumen 14, and the pulses are interspersed in relatively long negative baseline pressure quiescent periods 84 provided to the catheter lumen. The negative baseline pressure present between the pulses enables any obstructing objects displaced by the pulses to be aspirated proximally up into the catheter lumen 14 and removed therefrom, thereby preventing the displaced obstructing objects from entering the bloodstream from the distal end 12B of the catheter body 12. Note that in other embodiments, the quiescent period may include a reduction to neutral pressure or lower (but still positive) pressure or a pressure that varies over time as needed.

[0031] Figure 2 Also shown are successive pulse peaks 82 representing short-duration high-pressure fluid pulses plotted on the graph of the pressure curve 80. In this embodiment, each of the pressure peaks 82 is characterized by a rise time phase of approximately 30 milliseconds, a hold high pressure phase of approximately 200 milliseconds, and a pressure reduction phase of approximately 40 milliseconds. It should be understood that these phases of the pressure peaks 82 may differ from the values given herein, and the phase characteristics of each pressure peak may differ from those of previous and / or subsequent peaks. Moreover, the amplitude and duration of the pulses may differ from those described herein and from each other.

[0032] In one embodiment, the pressure peaks 82 are modified by the controller of the patency device 30 for customization by the user. The quiescent periods 84 between the high-pressure fluid pulses (represented by the pressure peaks 82) may also vary in duration, baseline pressure, etc.

[0033] In this embodiment, the maximum pressure achieved by the pulses is approximately 400 psi, but this may vary depending on the desired application, catheter lumen design, type or size of the obstructing object, catheter body length, etc. In one embodiment, it should be understood that in one embodiment, the maximum pressure of the pulses may exceed the burst pressure rating of the catheter body 12, but due to the relatively short duration of the pulses, the catheter 10 will not rupture or fail.

[0034] As described above, high-pressure fluid pulses travel from the patency device 30 and enter the catheter 10 to travel downward along the fluid-filled lumen 14 of the catheter body 12. In one embodiment, the fluid that fills the fluid path of the patency device and the catheter lumen 14 is a 0.9% saline solution, but other fluids are also acceptably used. It should be noted that using other fluids may require changing the pulse characteristics (e.g., pulse pressure, pulse duration, dwell period duration, etc.). As described above, the high-pressure fluid pulse impacts an obstruction (such as a clot or fibrin sheath) or other obstruction formed in the lumen 14 (usually at or near the distal end 12B of the catheter body 12). The obstruction is displaced by the high-pressure pulse, which is strong enough to displace the obstruction but not long enough to push it out of the distal end 12B of the catheter body 12. In one embodiment, a subsequent negative pressure dwell period after each pulse can be used to prevent the clot from escaping from the catheter body 12. Additionally, a suction process can be performed through the patency device 30 to aspirate the clot proximally from the catheter body 12 and the catheter 10 and into the patency device, where it can be disposed of. In this way, any clot or obstruction present in the catheter 10 can be acceptably removed.

[0035] Figure 3 A patency device 30 according to one embodiment is depicted. As shown, the patency device 30 includes a hydrostatic pump 138 that serves as a pressure input portion 38 for providing hydraulic pressure to a fluid that is contained and held at pressure in a hydraulic accumulator (“accumulator”) 134 that serves as a fluid reservoir 34. A two-way normally closed (“N.C.”) valve 140 is provided at its fluid inlet and is operatively connected via a fluid line to the fluid outlet of the accumulator 134. A pressure sensor 144 is operatively interposed between the fluid outlet of the N.C. valve 140 and a Luer connector 22 or other suitable inlet of the catheter. As described above, in this and other embodiments, a connector interface 40( Figure 1 ) can be used to operatively connect the patency device 30 to the catheter 10. It should be noted that the fluid lines between the various components discussed herein can include lines for fluid conveyance or other suitable modalities.

[0036] A two-way normally open (“N.O.”) valve 150 is interposed between the N.C. valve 140 and the transducer 144 via a fluid line that is connected to the N.O. valve fluid inlet. A vacuum input portion 160 for providing negative pressure in the patency device 30 is operatively connected to the fluid outlet of the N.C. valve 150. In the present embodiment, a syringe pump 162 serves as the vacuum input portion 160, but other suitable components, such as a vacuum pump, can also be employed. A controller 170 is operatively connected to the aforementioned components of the patency device 30 to manage their operation. In one embodiment, the controller 170 includes a power supply, a printed circuit board including a processor, and the like.

[0037] Figure 4A depicts various details of a valve control assembly 180 associated with an N.C. valve 140 shown in a patency device 30 according to one embodiment. As shown, the valve control assembly 180 includes a relay 182 and a power diode operably interconnected with the N.C. valve 140. A power supply 186 for the N.C. valve 140 and a power supply 188 for the relay 182 are included. Figure 3 depicts various details of a valve control assembly 180 associated with an N.C. valve 140 shown in a patency device 30 according to one embodiment. As shown, the valve control assembly 180 includes a relay 182 and a power diode operably interconnected with the N.C. valve 140. A power supply 186 for the N.C. valve 140 and a power supply 188 for the relay 182 are included. Figure 4B shows a similar configuration of a valve control assembly 180 associated with an N.O. valve 150 of a Figure 3 patency device 30, including a relay 182 and a power diode operably interconnected with the N.O. valve. A power supply 186 for the N.O. valve 150 and a power supply 188 for the relay 182 are included. The valve control assembly 180 for the N.C. valve 140 and the N.O. valve 150 aids in controlling the operation of the N.C. valve and the N.O. valve during operation of the patency device 30. In this embodiment, the N.C. valve 140 and the N.O. valve 150 are gate valve type valves, but it should be understood that other suitable types of valves may be used. In another embodiment, the functionality of the N.C. valve 140 and the N.O. valve 150 may be combined into a single valve, such as a three-way valve, where the fluid lines are arranged to provide such an embodiment. In such a single valve embodiment, a single three-way valve is operated to alternately provide positive pressure pulses and negative baseline pressure / negative pulses.

[0038] When a clinician or catheter user requires a patency procedure (a procedure to clear an obstruction in or prevent the formation of an obstruction in the catheter lumen 14), Figure 3 the patency device 30 is operably attached to the Luer connector 22 of the catheter 10. In operation, the patency device 30 first provides fluid pressure by manual actuation or by automatic / motor mode actuation of a hydrostatic pump 138. Pressurized fluid is received from the pump 138 by an accumulator 134, which stores the fluid in a pressurized state until needed. The N.O. valve 150 remains open at the start and during the procedure to maintain a negative baseline pressure in the system, except at those times when the N.C. valve 140 is open to provide a fluid pulse. The controller 170 or other suitable components may control the opening / closing of the valves.

[0039] The controller 170 determines the number, frequency, dwell time, etc. of the pulses delivered by the patency device 30 to the catheter lumen 14. The N.C. valve 140 opens and closes repeatedly at a predetermined time interval to provide a series of fluid pulses from the accumulator through the N.C. valve and into the lumen 14 of the catheter 10. During each pulse when the N.C. valve 140 is open, the N.O. valve 150 is closed to prevent the pulsed fluid from entering the N.O. valve and being diverted to the syringe pump 162 rather than entering the catheter lumen 14 as needed. The pulses propagate distally along the lumen 14, which is filled with fluid prior to initiation of the patency operation to provide a propagation medium for the pulses.

[0040] Between each pulse and after the end of a series of pulses, the N.C. valve 140 closes and the N.O. valve 150 opens to provide a negative baseline pressure (provided by the syringe pump 162 or other suitable device) in the catheter lumen 14 and to enable any obstruction displaced by the pulses to be withdrawn proximally out of the lumen and aspirated into the syringe pump 162 through the N.O. valve. A suitable capture reservoir or the like may be operably connected to the syringe pump to retain the obstruction and fluid when needed. The controller 170 is used to precisely control the opening / closing of the N.C. valve 140 and the N.O. valve 150 to provide pulses and negative baseline pressure to the lumen 14 as needed.

[0041] In one embodiment, it should be understood that the baseline negative pressure period that exists between positive pressure pulses may be replaced or supplemented with negative pressure pulses of relatively short duration to further assist in displacing the obstruction. A subsequent negative baseline pressure may then be used to remove the obstruction from the lumen 14. In one embodiment, the response times of the valve 140 and the valve 150 are fast enough to enable a negative baseline pressure or a negative pressure pulse to rapidly and continuously follow a positive pressure pulse.

[0042] The pressure sensor 144 is used and controlled by the processor 170 to measure the pressure of the pulses delivered by the patency device 30 to the catheter lumen 14. As described above, the pressure level of the pulses can vary or be determined based on a variety of factors, including catheter length, catheter lumen size, burst strength, pulse duration, quiescent period duration, other catheter configurations, etc. In one embodiment, the pressure of each pulse can be selected from the range of about 30 psi to about 120 psi, although other pressures below and above this range are also possible. Additionally, the frequency of the pulses or the pulse frequency can be set according to a predetermined pattern and can vary based on a number of factors such as those just described above, and in one embodiment, can vary in the range of about 1 Hz to about 150 Hz, although other frequency ranges are also possible. In one embodiment, the pulse frequency is set to match the resonant frequency of the catheter 10 itself, thus enabling improved propagation of the pulses distally through the lumen 14. For example, in one example, for a catheter body having a length of about 35 cm to about 55 cm, the resonant frequency of a 3Fr single lumen catheter assembly was found to be about 30 Hz. The resonant frequency will vary based on a number of catheter characteristics. In one embodiment, for example, the resonant frequencies of various catheters vary between about 15 Hz and about 50 Hz, although other frequencies are also possible.

[0043] In one embodiment, the pulse frequency is higher than about 20 KHz and thus is performed as an ultrasonic pulse signal to displace lumen obstructions or maintain lumen patency. These ultrasonic signals have sufficient frequency, intensity, and duty cycle to displace obstructions present in the lumen 14. In one embodiment, the patency device 30 can include an ultrasonic module operatively connected to the luer connector 22 or the extension leg of the catheter 10 and further includes an ultrasonic transducer for providing ultrasonic pulses to the fluid-filled lumen 14. The patency device 30 can also include ports for enabling the injection or aspiration of fluid or other substances (such as antimicrobial agents, etc.) into or from the catheter lumen 14.

[0044] Note that the patency device 30 is externally powered or can include its own power source, such as a battery. Also note that in one embodiment, the controller 170 can enable the user to customize the characteristics of the pulses, quiescent periods, baseline pressure, etc.

[0045] It should be understood that as described herein, regular use of the patency device described herein can also prevent the formation of obstructions by first preventing the initial adhesion and growth of obstructions. In one embodiment, the patency device is self-operating and thus serves as a passive solution for preventing obstructions.

[0046] Note that, in one embodiment, a pressure regulator can be used to provide and / or maintain pressurized fluid in the patency device 30. It should also be noted that it is to be understood that the pressure of the pulse can be adjusted as a function of the distance that the pulse travels distally through the catheter lumen 14 to compensate for pressure loss / attenuation.

[0047] In view of the foregoing, it is to be understood that, in one embodiment, a method for providing patency at the lumen 14 of the catheter assembly 10 includes disposing fluid in the lumen of the catheter body 12 of the catheter; and propagating a plurality of positive pressure pulses through the fluid disposed in the lumen, with the pulses propagating in a predetermined pattern.

[0048] Figure 5 The patency device uses line pinch valves of N.C. valve 140 and N.O. valve 150 instead of the gate valve type of valve. Such valves operate by pinching a portion of the line including the fluid line (such as the high-pressure line 194 shown near the N.O. pinch valve 150) to prevent fluid from flowing therethrough. The valve releases the pinch of the line to enable fluid to flow therethrough again. Thus, these and other valve types are considered.

[0049] Figure 6 Details of the patency device 30 according to another embodiment are depicted, where the pressure input section 38 includes an actuator, such as a voice coil actuator 200 configured to provide mechanical motion for forming the desired fluid pressure pulses. A servo driver 214 is operatively connected to the voice coil actuator 200 to assist the actuator function. A piston 202 (or a plunger, etc.) is operatively connected to the voice coil actuator 200, which is in turn operatively connected to the fluid reservoir 34, and then to the syringe 206 containing fluid. In this embodiment, the syringe 206 is a high-pressure syringe. The piston 202 is sized to be received within the proximal end of the syringe 206 so that the piston can transfer the mechanical motion of the voice coil actuator to the fluid present in the syringe, thereby generating the desired pulse. The pulse generated in the fluid of the syringe 206 advances through the valve 210 and into the lumen 14 of the catheter body 12. A hub adapter 208 is included in this embodiment to enable the valve 210 to be operatively connected to the catheter 10.

[0050] The valve 210 is operable, such as by a 170 controller, to selectively open so that the pulses generated by the foregoing components can pass through the catheter lumen 14. During all other times during the patency procedure, the switching valve 210 is enabled to apply a negative baseline pressure to the catheter lumen 14 in a manner similar to the above-described embodiment via the syringe pump 162. In one embodiment, the Figure 6 pressure of the pulses generated by the patency device 30 is measured to be about 60 psi to greater than about 100 psi, but this can vary depending on the system design.

[0051] Figure 7 depicts details of the patency device 30 according to another embodiment, wherein the pressure input section 38 includes a wave generator 220, such as a speaker, to generate the energy for forming the desired fluid pulses. A signal generator 224 generates a voltage waveform or drive signal to actuate the wave generator in the desired pattern of pulses, and the signal of the signal generator is amplified by an amplifier 226. In one embodiment, the pressure of the pulses generated by the Figure 7 patency device 30 is measured to be about 40 psi or less, but this can vary according to the system design.

[0052] A piston, such as a plunger, is operably connected to the movable cone of the speaker of the wave generator 220, and the piston is received within a fluid-containing syringe 206 that serves as the fluid reservoir 34. The operation of the speaker moves its cone according to the drive signal received and amplified by the signal generator 224 and the amplifier 226, and the signal generator and the amplifier in turn move the plunger. The fluid contained within the syringe 106 is moved by the plunger, which generates the desired fluid pulses that propagate distally through the lumen 14 of the catheter 10 via the hub adapter 208. In one embodiment, the Figure 7 pulses generated by the patency device are in the frequency range of about 1 Hz to about 200 Hz, but can also be various other frequencies.

[0053] Thus, the embodiments of the patency device 30 shown and described in connection with Figure 3 、 Figure 5 、 Figure 6 and Figure 7 represent a variety of patency devices that can be used to provide fluid pulses for displacing occlusive material within the lumen of a catheter and / or maintaining the patency of the lumen to be free of obstructions.

[0054] Figures 8 to 10 depicts various operating cycles of the positive pressure pulses generated by the present patency device (e.g., the patency device 30 shown in Figure 6 ). Figure 8 shows a pulse curve 280 that includes a continuous series of equal (in terms of energy, pressure) pulses delivered at a set pulse frequency to the catheter lumen 14 ( Figure 1 ), and returns to the baseline pressure 284 before the start of the next pulse. The frequency can be any one or more of a variety of pulse frequencies, including ultrasonic frequencies (e.g., above 20 KHz).

[0055] In Figure 9shows a series of pulse groups, where the pulse groups are separated by a quiescent period 286 of a nominal baseline pressure 284, such as a low positive pressure, which mode is useful when there is no obstruction but the lumen 14 is kept patent using pulses.

[0056] In Figure 10 shows a series of pulse groups, where the pulse groups are separated by a quiescent period 286 of a negative baseline pressure 284 so as to enable any obstruction displaced by the pulses to be aspirated from the catheter 10, as discussed further above. In these and other examples herein, it should be noted that the number of pulses in each group can vary according to user needs and / or a preset predefined pattern, and the pressure, frequency, etc. can also vary. It should be noted that the frequency of use of the patency device 30 can vary continuously, hourly, daily, weekly, occasionally, etc., depending on whether the intended use is prophylactic or corrective, the amount of obstruction present, etc.

[0057] Figure 11 Details of the patency device 30 including a pressure input portion 38 are depicted, the pressure input portion including a hydrostatic pump or other suitable components as described herein or already understood. A membrane 290 is included and is configured to move / vibrate when acted upon by a positive pressure generated by the pressure input portion 38, thereby generating positive pressure pulses, which positive pressure pulses are propagated through a fluid disposed in a valve 294 (such as a three-way valve) before traveling through the fluid-filled Luer connector 22 and the lumen 14 of the catheter 10 to provide patency. A vacuum input portion 160 is provided to provide a negative baseline pressure / negative pressure pulse to the fluid in the lumen 14 when the valve 294 is actuated to provide fluid communication between the lumens. It should be understood that a fluid reservoir 34 is not included in the present embodiment. In one embodiment, Figure 11 the embodiment shown in

[0058] Embodiments of the present invention may be embodied in other specific forms without departing from the substance of the present disclosure. The embodiments are to be considered in all respects only as illustrative and not restrictive. Thus, the scope of these embodiments is indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A catheter assembly, comprising: a catheter including at least one lumen; and a non-sterile, reusable patency device connectable to the catheter, the non-sterile, reusable patency device comprising: a fluid reservoir designed to be in fluid communication with the at least one lumen; a positive pressure input portion having a distal end connected to the fluid reservoir and designed to provide at least one positive pressure pulse to fluid disposed within the at least one lumen; and an interface portion including a proximal end coupled to the fluid reservoir and a distal end operatively coupled to the at least one lumen, wherein the interface portion is disposable and provides a sterile barrier between the catheter and the non-sterile, reusable patency device, wherein the at least one pulse comprises a series of pulses at a predetermined pulse frequency of at least 20 KHz, wherein the patency device is designed to provide the at least one pulse at a pressure of at least 30 psi.

2. The catheter assembly according to claim 1, wherein the at least one pulse is designed to displace an obstruction disposed within the at least one lumen.

3. The catheter assembly according to claim 1, wherein the patency device further comprises a negative pressure input portion.

4. The catheter assembly according to claim 3, wherein the negative pressure input portion comprises a vacuum device.

5. The catheter assembly according to claim 4, wherein the vacuum device comprises a syringe pump or a vacuum pump.

6. The catheter assembly according to claim 4, wherein the vacuum device comprises a normally open valve.

7. The catheter assembly according to claim 6, wherein the positive pressure input portion comprises a normally closed valve.

8. The catheter assembly according to claim 7, wherein the normally open valve is designed to close when the normally closed valve is opened.

9. The catheter assembly according to claim 1, wherein the positive pressure input portion is designed to provide a plurality of series of pulses in a predetermined pulse pattern, each of the plurality of series including at least one pulse.

10. The catheter assembly according to claim 9, wherein each series of the plurality of series of pulses is separated by a quiescent period.

11. The catheter assembly according to claim 10, wherein the patency device is designed to provide a negative pressure to the fluid disposed within the at least one lumen during each quiescent period.

12. The catheter assembly according to claim 1, wherein the patency device is designed to provide the at least one pulse at a pressure exceeding the burst pressure strength rating of the catheter.

13. The catheter assembly according to claim 1, further comprising a pressure sensor designed to provide data related to the pressure within the fluid line of the patency device.

14. The catheter assembly according to claim 1, further comprising a controller designed to manage the operation of the patency device, the controller including a processor.

15. The catheter assembly according to claim 1, wherein the positive pressure input portion comprises at least one of a hydrostatic pump, an actuator, and a wave generator.

16. The catheter assembly according to claim 1, wherein the fluid reservoir includes at least one of a hydraulic accumulator and a syringe.

17. The catheter assembly according to claim 1, wherein the at least one pulse includes a rise time phase of 30 milliseconds, a high pressure hold phase of 200 milliseconds, and a pressure reduction phase of 40 milliseconds.

Images