Body fluid exchange system and related methods

Abstract

To provide a body fluid exchange system configured to prevent or remove blockages of a multi-lumen catheter used for targeted body fluid exchange.SOLUTION: A body fluid exchange system may include: a control unit comprising a processor; a tube set attachment removably connected to the control unit, the tube set attachment comprising a tube set fluidly connected to a body fluid source and to a drainage receptacle; a catheter fluidly connected to the tube set; and at least one sensor positioned on at least one of the control unit and the tube set attachment. The control unit may be configured to supply the body fluid to a patient through the tube set and drain the body fluid from the patient via the tube set. The control unit may be configured to receive measurements from the at least one sensor to adjust the supply of the body fluid to the patient and the drainage of the body fluid from the patient.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 473,303, filed March 17, 2017, the disclosure of which is incorporated herein by reference in its entirety. This application is also related to U.S. Provisional Patent Application No. 62 / 470,711, filed March 13, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to fluid exchange systems for medical applications, and more particularly to fluid exchange systems configured to prevent or remove blockages in multi-lumen catheters used for targeted fluid exchange. [Background technology]

[0003] This disclosure addresses a major medical need: the treatment of cerebral vasospasm after subarachnoid hemorrhage (SAH) due to aneurysm rupture or any other cause of SAH. Angiographic cerebral vasospasm is observed in 30–70% of patients with aneurysmal SAH, and more than one-third of these patients develop clinically significant vasospasm, which is the major morbidity and mortality factor in this pathology. It is widely accepted that blood breakdown products are a causative factor in vasospasm. Because the amount of subarachnoid blood correlates with the risk of vasospasm, reducing the burden of subarachnoid blood clots during surgery reduces the risk of vasospasm. It is also well known that removing blood from the subarachnoid cistern during surgery reduces the incidence and severity of vasospasm. However, removing subarachnoid blood from the cistern after aneurysm rupture presents technical challenges, making it extremely difficult and invasive to adequately remove all blood.

[0004] Traditionally, neurosurgeons have employed a wide variety of irrigation and drainage methods during the intraoperative and postoperative periods. Each carries its own risks: increased intracranial pressure (ICP), insufficient clearance, and infection. For the treatment of vasospasm in particular, many theories have been proposed, and various therapies have been applied. For example, many local and systemic pharmaceutical approaches via various catheters have been attempted, but improved systems and methods for efficiently removing blood from the subarachnoid space with low risk to the patient remain necessary.

[0005] Various additional unmet needs that cannot be addressed by current fluid exchange systems include a) drainage of hematomas from the intracranial cavity or other locations in the body, with or without the administration of thrombolytic drugs, and b) drainage of abscesses and infected fluids from the intracranial cavity or other locations in the body (e.g., meningitis, peritonitis), with or without the simultaneous administration of antibiotic solutions directly to the lesion. Regarding these unmet needs, previously known drainage systems cannot meet the needs listed in items (a) and (b) because they exhibit continuous obstruction problems that make them unsuitable for direct drug administration, which compromises clinical outcomes. This is effective not only for intracranial hematomas, but also for the collection of peritoneal, thoracic, orthopedic, pathological hematomas, or infected fluids.

[0006] Further unmet needs include direct drug delivery to malignant tumors (liver, lung, pancreas, and prostate cancer, disseminated intraperitoneal carcinomatosis, etc.) or other non-malignant localized lesions within the central nervous system and body, organs, or cavities (osteomyelitis, ascites, spondylitis, etc.) to avoid side effects caused by "wasted drugs" (e.g., drugs that do not reach the therapeutic target but act on healthy tissue) when administered systematically (orally, intravenously, etc.). Existing direct drug delivery systems are unable to maintain therapeutic drug concentrations long enough to achieve therapeutic goals because increasing the amount of administered drug dangerously increases local pressure and / or general toxicity. To date, no known local drug delivery system has actually addressed the clinical need for sufficient drug doses, and all of them rely on the blood circulation and other patient natural systems for the elimination of therapeutically inactive and harmful metabolites of drug-pathological interactions. Additional unmet needs include peritoneal dialysis, which is actually delivered by a device that causes significant changes in intraperitoneal volume over a short period of time, causing discomfort and pain to the patient, but does not ensure a stable biochemical profile in the extracellular space over time. A gentler, continuous fluid exchange system is needed that extends treatment time and eliminates dangerous biochemical fluctuations between treatments without compromising patient mobility and quality of life. Summary of the Invention [Problem to be solved by the invention]

[0007] To meet at least the above-mentioned needs, the present disclosure provides a fluid exchange system, and related methods, including, but not necessarily limited to, the following components or aspects: (1) a multi-lumen catheter, i.e., catheter, also referred to as a catheter probe, that includes multiple lumens, such as a combination of an inner lumen and an outer lumen; (2) a pump system; and (3) a tubing system. [Means for solving the problem]

[0008] In one aspect of the present disclosure, a bodily fluid exchange system may include a control unit including a processor; a tubeset attachment removably connected to the control unit, the tubeset attachment including a tubing set fluidly connected to a bodily fluid source and a drainage container; a catheter fluidly connected to the tubing set; and at least one sensor disposed on at least one of the control unit and the tubeset attachment, wherein the control unit may be configured to supply bodily fluid to a patient through the tubing set and drain bodily fluid from the patient through the tubing set, and the control unit may be configured to receive measurements from the at least one sensor and regulate the supply of bodily fluid to and the drainage of bodily fluid from the patient, and wherein when a difference between a first measurement and a second measurement exceeds a first pressure threshold or is less than a second pressure threshold, the control unit is configured to issue a pressure signal output to indicate that the first pressure threshold has been exceeded or that the difference between the first measurement and the second measurement is less than the second pressure threshold.

[0009] In another aspect of the present disclosure, the at least one sensor may include a pressure sensor, and the at least one sensor may transmit pressure measurements to the control unit. The at least one sensor may be disposed in a cassette of the tubing set attachment. The at least one sensor may transmit intracranial pressure measurements to the control unit. The at least one sensor may include a pressure sensor, and the at least one sensor may be disposed in the control unit, and the at least one sensor may transmit intracranial pressure measurements to the control unit. The control unit may be further configured to initiate drainage of bodily fluid from the patient when a difference between a first measurement and a second measurement from the at least one sensor exceeds a first pressure threshold. The control unit may be further configured to initiate infusion of bodily fluid into the patient when a difference between the first measurement and the second measurement from the at least one sensor falls below a second threshold. The bodily fluid may be a medicinal or therapeutic agent. The measurement received from the at least one sensor may be intracranial pressure. The catheter may include a first lumen having a proximal end and a distal end, a second lumen disposed within the first lumen and having a proximal end and a distal end, a valve disposed within at least one of the first lumen and the second lumen and configured to control the flow of bodily fluid through the catheter, and a sleeve disposed at the distal end of the first and second lumens. At least one opening may be defined in at least one of the first lumen and the second lumen, the sleeve may be axially displaceable relative to the first lumen and the second lumen, and the sleeve may be movable between a first position in which the at least one opening is covered by the sleeve and a second position in which the at least one opening is not covered by the sleeve. At least one opening may be defined in at least one of the first lumen and the second lumen, the sleeve may be rotationally displaceable relative to the first lumen and the second lumen, and the sleeve may be movable between a first position in which the at least one opening is covered by the sleeve and a second position in which the at least one opening is not covered by the sleeve.At least one opening may be defined in at least one of the first lumen and the second lumen, and the sleeve may be rotationally displaceable relative to the first lumen and the second lumen, and the sleeve may be movable between a first position in which the at least one opening is covered by the sleeve and a second position in which the at least one opening is not covered by the sleeve. The tubing set attachment may include a cassette configured to removably connect the tubing set attachment to a control unit. The control unit may include a pump that delivers bodily fluid from a bodily fluid source to the patient via the tubing set. The tubing set may include a first tube fluidly connected at a first end to the bodily fluid source and at a second end to the catheter, and a second tube fluidly connected at a first end to the catheter and at a second end to a drain container. The bodily fluid source may include an infusion bag. The drain container may include a suction bag. The drain container may be connected to the control unit via a graduated measuring band. The drainage container may be vertically adjustable relative to the control unit. The tubing set attachment may include at least one pressure sensor for measuring the pressure of the bodily fluid flowing through the tubing set. The tubing set attachment may be disposable. The tubing set attachment may include a security valve disposed between a portion of the tubing set and a cassette fluidly connected to the tubing set. The control unit may include a graphical user interface including at least a flow rate indicator and an intracranial pressure alarm for monitoring the intracranial pressure level of a patient connected to the fluid exchange system. The intracranial pressure alarm may include a high intracranial pressure threshold alarm and a low intracranial pressure threshold alarm. The control unit may include an air sensor connected to a portion of the tubing set to identify when the bodily fluid source is empty.

[0010] In another aspect of the present disclosure, a computer-implemented method for monitoring intracranial pressure using a fluid exchange system may include receiving, with a processor, a first pressure value in the intracranial cavity; injecting fluid into the intracranial cavity; receiving, with the processor, a second pressure value in the intracranial cavity; calculating, using the processor, a difference between the first and second intracranial pressures; and, if the difference between the first and second intracranial pressures exceeds a first pressure threshold or is less than a second pressure threshold, issuing a pressure signal output via the processor to indicate that the first pressure threshold has been exceeded or that the difference between the first and second intracranial pressures is less than the second pressure threshold.

[0011] In another aspect of the present disclosure, a processor may determine a first time course of pressure corresponding to a first measured pressure valve, and a second time course of pressure corresponding to a second measured pressure valve. The method may further include, via the processor, calculating a first derivative from the first measured pressure valve and a second derivative from the second measured pressure valve. The method may further include, via the processor, determining a first maximum slope value of the first derivative and a second maximum slope value of the second derivative. The method may further include, via the processor, calculating a difference between the first maximum slope value and the second maximum slope value, and, if the difference between the first maximum slope value and the second maximum slope value exceeds a first pressure threshold or is less than a second pressure threshold, issuing a pressure signal output via the processor to indicate that the pressure threshold has been exceeded or that the difference between the first maximum slope value and the second maximum slope value is less than the second pressure threshold. The method may further include activating a fluid exchange system via the processor to withdraw fluid from the intracranial cavity to reduce the intracranial pressure when a first pressure threshold is exceeded. The method may further include activating a fluid exchange system via the processor to infuse additional fluid into the intracranial cavity to increase the intracranial pressure when a difference between the first and second intracranial pressures is less than a second pressure threshold.

[0012] In another aspect of the present disclosure, a catheter for a bodily fluid exchange system may include a lumen including a proximal end and a distal end and a lumen wall extending between the proximal end and the distal end, the lumen wall defining an interior lumen space, at least one opening defining a passageway through the lumen wall into the interior lumen space, and a movable sleeve covering at least a portion of the lumen wall, the sleeve being movable relative to the lumen wall between a first position in which the sleeve covers a first amount of the at least one opening and a second position in which the sleeve covers a second amount of the at least one opening, the second amount being greater than the first amount.

[0013] In another aspect of the present disclosure, the sleeve may be axially displaceable relative to the lumen wall between a first position and a second position. The sleeve may include a sleeve shoulder at least partially disposed within one of the at least one opening, and axial displacement of the sleeve relative to the lumen wall between the first position and the second position may cause the sleeve shoulder to slide within one of the at least one opening to clear debris from one of the at least one opening. The sleeve may include multiple sleeve shoulders, and the catheter may include multiple openings each defining a passageway through the lumen wall into the interior luminal space, each of the sleeve shoulders may be at least partially disposed within one of the multiple openings, and axial displacement of the sleeve relative to the lumen wall between the first position and the second position may cause each of the sleeve shoulders to slide within one of the multiple openings to clear debris from one of the multiple openings. The sleeve may be rotatable relative to the lumen wall between the first position and the second position. The sleeve may include at least one sleeve element, and rotation of the sleeve relative to the lumen wall may cause the at least one sleeve element to pass over the at least one opening to clear debris from the at least one opening. The sleeve may include multiple sleeve elements and multiple openings, each defining a passage through the lumen wall into the interior lumen space, and rotation of the sleeve relative to the lumen wall may cause multiple sleeve extensions to pass over the multiple openings to clear debris from the multiple openings. The first amount may not be equal to any of the at least one opening. The catheter may include a second lumen disposed within the interior lumen space.

[0014] In another aspect of the present disclosure, a catheter for a bodily fluid exchange system may include: a first lumen including a proximal end and a distal end and a lumen wall extending between the proximal and distal ends, the lumen wall defining a first internal lumen space; at least one opening defining a passageway through the lumen wall of the first lumen into the first internal lumen space; a second lumen including a proximal end and a distal end and a lumen wall extending between the proximal and distal ends and defining a second internal lumen space, the second lumen may be disposed within the first internal lumen space, the lumen wall of the second lumen separating the first internal lumen space from the second internal lumen space; and a valve disposed in the lumen wall of the second lumen, the valve adapted to restrict flow of bodily fluid through the first internal lumen space using flow of bodily fluid through the second internal lumen space.

[0015] In another aspect of the present disclosure, the first lumen may be connected to a suction device adapted to aspirate aspirated body fluid through the first internal lumen space, the second lumen may be connected to an infusion device adapted to infuse infused body fluid through the second internal lumen space, the valve may be an opening in a lumen wall of the second lumen, the opening may be positioned proximal to at least one opening, and flow of a portion of the infused body fluid from the second internal lumen space to the first internal lumen space through the opening may limit flow of the aspirated body fluid through the first internal lumen space. The first lumen may be connected to a suction device adapted to aspirate aspirated body fluid through the first internal lumen space, and the second lumen may be connected to an infusion device adapted to infuse infusate body fluid through the second internal lumen space. The valve may be an opening in the lumen wall of the second lumen, and the opening may be located proximal to at least one opening, and flow of a portion of the infusate body fluid from the second internal lumen space to the first internal lumen space through the opening may restrict flow of aspirated body fluid through the first internal lumen space. The valve may include an inflatable balloon valve, and flow of body fluid through the second internal lumen space may cause the balloon valve to expand into the first internal lumen space, thereby restricting flow through the first internal lumen space. The balloon valve may have a porous surface that allows body fluid flowing through the second internal lumen to enter the first internal lumen space. The second lumen may include a check valve that restricts flow through the second lumen, and the check valve may be located between the proximal end of the second lumen and the balloon valve. The valve may include at least one leaflet, and flow of bodily fluid through the second internal luminal space may cause the at least one leaflet to extend into the first internal luminal space, thereby restricting flow through the first internal luminal space. The valve may include multiple leaflets, and flow of bodily fluid through the second internal luminal space may cause each of the multiple leaflets to extend into the first internal luminal space, thereby restricting flow through the first internal luminal space. At least one leaflet may be porous to allow bodily fluid to flow through its thickness.

[0016] In another aspect of the present disclosure, a method of delivering a drug to a patient may include activating a control unit of the fluid exchange system described above, infusing a drug into the patient via a tubing set and a catheter of the fluid exchange system, monitoring measurements received from at least a sensor, and draining fluid from the patient via the catheter and tubing set if the measurements exceed a high threshold. The drug may include a pharmaceutical or therapeutic drug.

[0017] The present invention is also disclosed in the following sections.

[0018] Item 1: A bodily fluid exchange system comprising: a control unit including a processor; a tubeset attachment removably connected to the control unit, the tubeset attachment including a tubeset fluidly connected to a bodily fluid source and a drainage container; a catheter fluidly connected to the tubeset; and at least one sensor disposed on at least one of the control unit and the tubeset attachment, wherein the control unit is configured to supply bodily fluid to a patient through the tubeset and drain bodily fluid from the patient through the tubeset; the control unit is configured to receive measurements from the at least one sensor and regulate the supply of bodily fluid to and the drainage of bodily fluid from the patient; and when a difference between a first measurement and a second measurement exceeds a first pressure threshold or is less than a second pressure threshold, the control unit is configured to issue a pressure signal output to indicate that the first pressure threshold has been exceeded or that the difference between the first measurement and the second measurement is less than the second pressure threshold.

[0019] Item 2: The fluid exchange system of item 1, wherein the at least one sensor includes a pressure sensor, and the at least one sensor transmits pressure measurements to the control unit.

[0020] Item 3: A fluid exchange system as described in item 2, wherein at least one sensor is disposed within a cassette of the tube set attachment.

[0021] Item 4: A fluid exchange system as described in Item 2 or 3, wherein at least one sensor transmits intracranial pressure measurements to the control unit.

[0022] Clause 5: A fluid exchange system described in any of clauses 1 to 4, wherein at least one sensor includes a pressure sensor, the at least one sensor is located in the control unit, and the at least one sensor transmits intracranial pressure measurements to the control unit.

[0023] Clause 6: A fluid exchange system described in any of clauses 1 to 5, wherein the control unit is further configured to initiate drainage of fluid from the patient when a difference between a first measurement value and a second measurement value from at least one sensor exceeds a first pressure threshold.

[0024] Clause 7: A fluid exchange system described in any of clauses 1 to 6, wherein the control unit is further configured to start injecting fluid into the patient when the difference between the first measurement value and the second measurement value from at least one sensor falls below a second threshold.

[0025] Item 8: A bodily fluid exchange system described in any one of items 1 to 7, wherein the bodily fluid includes a medicine or therapeutic agent.

[0026] Clause 9: A fluid exchange system described in any of clauses 1 to 8, wherein the measurements received from at least one sensor include intracranial pressure.

[0027] Clause 10: A bodily fluid exchange system described in any of clauses 1 to 9, wherein the catheter includes a first lumen having a proximal end and a distal end, a second lumen disposed within the first lumen and having a proximal end and a distal end, a valve disposed within at least one of the first lumen and the second lumen and configured to control the flow of bodily fluid through the catheter, and sleeves provided at the distal ends of the first and second lumens.

[0028] Clause 11: A bodily fluid exchange system as described in clause 10, wherein at least one opening is defined in at least one of the first lumen and the second lumen, the sleeve is axially displaceable relative to the first lumen and the second lumen, and the sleeve is movable between a first position in which the at least one opening is covered by the sleeve and a second position in which the at least one opening is not covered by the sleeve.

[0029] Clause 12: A bodily fluid exchange system described in clause 10 or clause 11, wherein at least one opening is defined in at least one of the first lumen and the second lumen, the sleeve is rotationally displaceable relative to the first lumen and the second lumen, and the sleeve is movable between a first position in which the at least one opening is covered by the sleeve and a second position in which the at least one opening is not covered by the sleeve.

[0030] Clause 13: A bodily fluid exchange system described in any of clauses 1 to 12, wherein the tube set attachment further includes a cassette configured to removably connect the tube set attachment to the control unit.

[0031] Item 14: A fluid exchange system as described in any of items 1 to 13, wherein the control unit further includes a pump for supplying fluid from the fluid source to the patient via the tubing set.

[0032] Item 15: A bodily fluid exchange system described in any of items 1 to 14, wherein the tubing set includes a first tube fluidly connected at a first end to a bodily fluid source and at a second end to a catheter, and a second tube fluidly connected at a first end to the catheter and at a second end to a drainage container.

[0033] Item 16: A fluid exchange system described in any one of items 1 to 15, wherein the fluid source includes an infusion bag.

[0034] Item 17: A bodily fluid exchange system described in any one of items 1 to 16, wherein the drainage container includes a suction bag.

[0035] Item 18: A bodily fluid exchange system described in any one of items 1 to 17, wherein the drainage container is connected to the control unit via a graduated measuring band.

[0036] Item 19: A bodily fluid exchange system described in any one of items 1 to 18, wherein the drainage container is vertically adjustable relative to the control unit.

[0037] Clause 20: A bodily fluid exchange system described in any of clauses 1 to 19, wherein the tube set attachment further includes at least one pressure sensor for measuring the pressure of bodily fluid flowing through the tube set.

[0038] Item 21: A fluid exchange system described in any one of items 1 to 20, wherein the tube set attachment is disposable.

[0039] Item 22: A fluid exchange system described in any of items 1 to 21, wherein the tube set attachment includes a security valve positioned between a portion of the tube set and a cassette fluidly connected to the tube set.

[0040] Clause 23: A fluid exchange system described in any of clauses 1 to 22, wherein the control unit further includes a graphical user interface including at least a flow rate indicator and an intracranial pressure alarm for monitoring the intracranial pressure level of a patient connected to the fluid exchange system.

[0041] Item 24: A fluid exchange system as described in Item 23, wherein the intracranial pressure alarm includes a high intracranial pressure threshold alarm and a low intracranial pressure threshold alarm.

[0042] Clause 25: A fluid exchange system as described in any one of clauses 1 to 24, wherein the control unit further includes an air sensor connected to a portion of the tubing set and configured to identify when the fluid source is empty.

[0043] Clause 26: A computer-implemented method for monitoring intracranial pressure using a fluid exchange system, the computer-implemented method including the steps of receiving, with a processor, a first pressure value in the intracranial cavity; infusing fluid into the intracranial cavity; receiving, with the processor, a second pressure value in the intracranial cavity; calculating, using the processor, a difference between the first and second intracranial pressures; and, if the difference between the first and second intracranial pressures exceeds a first pressure threshold or is less than a second pressure threshold, issuing a pressure signal output via the processor to indicate that the first pressure threshold has been exceeded or that the difference between the first and second intracranial pressures is less than the second pressure threshold.

[0044] Clause 27: The computer-implemented method of clause 26, wherein the processor determines a first time course curve of pressure corresponding to a first measured pressure valve, and the processor determines a second time course curve of pressure corresponding to a second measured pressure valve.

[0045] Clause 28: The computer-implemented method of clause 26 or clause 27, further comprising the step of calculating, via the processor, a first derivative from the first measured pressure value and a second derivative from the second measured pressure value.

[0046] Clause 29: The computer-implemented method of clause 28, further comprising determining, via the processor, a first maximum slope value of the first derivative and a second maximum slope value of the second derivative.

[0047] Clause 30: The computer-implemented method of clause 29, further comprising: calculating, via the processor, a difference between the first maximum slope value and the second maximum slope value; and, if the difference between the first maximum slope value and the second maximum slope value exceeds a first pressure threshold or is less than a second pressure threshold, issuing, via the processor, a pressure signal output to indicate that the pressure threshold has been exceeded or that the difference between the first maximum slope value and the second maximum slope value is less than the second pressure threshold.

[0048] Clause 31: A computer-implemented method described in any of clauses 26 to 30, further comprising the step of activating a fluid exchange system via the processor to aspirate fluid from the intracranial cavity to reduce intracranial pressure when a first pressure threshold is exceeded.

[0049] Clause 32: A computer-implemented method described in any of clauses 26 to 31, further comprising the step of activating a fluid exchange system via the processor to inject additional fluid into the intracranial cavity to increase the intracranial pressure when the difference between the first intracranial pressure and the second intracranial pressure is less than a second pressure threshold.

[0050] Clause 33: A catheter for a body fluid exchange system, the catheter comprising: a lumen including a proximal end and a distal end; a lumen wall extending between the proximal end and the distal end, the lumen wall defining an interior lumen space; at least one opening defining a passageway through the lumen wall into the interior lumen space; and a movable sleeve covering at least a portion of the lumen wall, the sleeve being movable relative to the lumen wall between a first position in which the sleeve covers a first amount of the at least one opening and a second position in which the sleeve covers a second amount of the at least one opening, the second amount being greater than the first amount.

[0051] Clause 34: The catheter of clause 33, wherein the sleeve is axially displaceable relative to the lumen wall between a first position and a second position.

[0052] Clause 35: The catheter described in clause 34, wherein the sleeve further includes a sleeve shoulder at least partially disposed within one of the at least one opening, and wherein axial displacement of the sleeve relative to the lumen wall between the first position and the second position causes the sleeve shoulder to slide within one of the at least one opening to clear debris from one of the at least one opening.

[0053] Clause 36: A catheter as described in clause 35, wherein the sleeve includes a plurality of sleeve shoulders, and the catheter includes a plurality of openings each defining a passageway through the lumen wall into the interior lumen space, each of the sleeve shoulders being at least partially disposed in one of the plurality of openings, and wherein axial displacement of the sleeve relative to the lumen wall between a first position and a second position causes each of the sleeve shoulders to slide within one of the plurality of openings to clear debris from one of the plurality of openings.

[0054] Clause 37: A catheter described in any of clauses 33 to 36, wherein the sleeve is rotatable relative to the lumen wall between a first position and a second position.

[0055] Clause 38: A catheter as described in clause 37, wherein the sleeve includes at least one sleeve element, and rotation of the sleeve relative to the lumen wall passes the at least one sleeve element over the at least one opening to remove debris from the at least one opening.

[0056] Clause 39: A catheter as described in clause 38, wherein the sleeve includes a plurality of sleeve elements and a plurality of openings each defining a passageway through the lumen wall into the interior lumen space, and wherein rotation of the sleeve relative to the lumen wall causes the plurality of sleeve extensions to pass over the plurality of openings to clear debris from the plurality of openings.

[0057] Item 40: A catheter described in any one of items 37 to 39, wherein the first amount is not equal to any of the at least one opening.

[0058] Clause 41: A catheter according to any one of clauses 33 to 40, wherein the catheter further comprises a second lumen disposed within the internal lumen space.

[0059] Clause 42: A catheter for a body fluid exchange system, comprising: a first lumen including a proximal end and a distal end and a lumen wall extending between the proximal and distal ends, the lumen wall defining a first internal lumen space; at least one opening defining a passageway through the lumen wall of the first lumen into the first internal lumen space; a second lumen including a proximal end and a distal end and a lumen wall extending between the proximal and distal ends and defining a second internal lumen space, the second lumen being disposed within the first internal lumen space, the lumen wall of the second lumen separating the first internal lumen space from the second internal lumen space; and a valve disposed in the lumen wall of the second lumen, the valve adapted to restrict flow of body fluid through the first internal lumen space using flow of body fluid through the second internal lumen space.

[0060] Clause 43: A catheter as described in clause 42, wherein the first lumen is connected to a suction device adapted to aspirate aspirated body fluid through the first internal lumen space, the second lumen is connected to an injection device adapted to inject infused body fluid through the second internal lumen space, the valve being an opening in the lumen wall of the second lumen, the opening being positioned proximal to at least one opening, and the flow of a portion of the infused body fluid from the second internal lumen space to the first internal lumen space through the opening restricts the flow of aspirated body fluid through the first internal lumen space.

[0061] Item 44: A catheter described in Item 42 or 43, wherein the valve includes an inflatable balloon valve, and flow of bodily fluid through the second internal lumen space causes the balloon valve to inflate into the first internal lumen space, thereby restricting flow through the first internal lumen space.

[0062] Clause 45: A catheter as described in clause 44, wherein the balloon valve has a porous surface that allows bodily fluid flowing through the second internal space to enter the first internal lumen space.

[0063] Item 46: A catheter as described in Item 45, wherein the second lumen includes a check valve that restricts flow through the second lumen, the check valve being located between the proximal end of the second lumen and the balloon valve.

[0064] Clause 47: A catheter described in any of clauses 42 to 46, wherein the valve includes at least one valve leaflet, and flow of body fluid through the second internal lumen space causes the at least one valve leaflet to extend into the first internal lumen space, thereby restricting flow through the first internal lumen space.

[0065] Clause 48: A catheter as described in clause 47, wherein the valve includes a plurality of valve leaflets, and flow of bodily fluid through the second internal lumen space causes each of the plurality of valve leaflets to extend into the first internal lumen space, thereby restricting flow through the first internal lumen space.

[0066] Clause 49: A catheter as described in clause 47 or 48, wherein at least one valve leaflet is porous to allow bodily fluid to flow through the leaflet in its thickness direction.

[0067] Clause 50: A method of delivering a drug to a patient, comprising the steps of: activating a control unit of a fluid exchange system according to claim 1; infusing the drug into the patient via a tubing set and a catheter of the fluid exchange system; monitoring measurements received from at least a sensor; and draining fluid from the patient via the catheter and tubing set if the measurements exceed a high threshold.

[0068] Item 51: The method of item 50, wherein the drug includes a pharmaceutical or therapeutic agent.

[0069] These and other features and characteristics of the fluid exchange system, as well as the method of operation and function of the associated elements of the fluid exchange system, will become more apparent upon consideration of the following description and the appended claims, with reference to the accompanying drawings, all of which form a part of this specification, and like reference numerals indicate corresponding parts in the various drawings. It is to be expressly understood, however, that the drawings are for purposes of illustration and description only and are not intended as a definition of the limits of the present disclosure. As used in the specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. [Brief explanation of the drawings]

[0070] [Figure 1] 1 is a perspective view of a bodily fluid exchange system according to one aspect of the present disclosure. [Figure 2] 2 is a left perspective view of the control unit of the bodily fluid exchange system of FIG. 1. FIG. [Figure 3] FIG. 3 is a right perspective view of the control unit of FIG. 2. [Figure 4] FIG. 3 is a rear view of the control unit of FIG. 2. [Figure 5A] FIG. 2 is a front view of the tube set attachment of the fluid exchange system of FIG. 1. [Figure 5B] FIG. 5B is a rear view of the tubeset attachment of FIG. 5A. [Figure 6] FIG. 2 is a schematic diagram of the operating system of the bodily fluid exchange system of FIG. 1. [Figure 7] FIG. 3 is a front view of the front panel of the control unit of FIG. 2. [Figure 8] FIG. 3 is a diagram of a home screen of the graphical user interface of the control unit of FIG. 2. [Figure 9] FIG. 9 is a diagram of the graphical user interface of FIG. 8, in which a patient fluid flow indicator indicates the infusion process. [Figure 10] FIG. 9 is a diagram of the graphical user interface of FIG. 8, in which a patient fluid flow indicator indicates the aspiration process. [Figure 11] FIG. 9 is a view of the graphical user interface of FIG. 8, showing the patient fluid flow indicator showing no fluid flow. [Figure 12] 2 is a flow chart illustrating different treatment states of the fluid exchange system of FIG. 1. [Figure 13] FIG. 1 is a perspective view of a catheter according to one aspect of the present disclosure. [Figure 14] FIG. 14 is a cross-sectional view of the catheter of FIG. 13 taken along line AA. [Figure 15] FIG. 14 is another cross-sectional view of the catheter of FIG. 13 taken along line BB. [Figure 16] FIG. 14 is a cross-sectional view of the distal tip of the catheter of FIG. 13 taken along line BB. [Figure 17] FIG. 1 is a perspective view of a distal tip of a catheter according to one aspect of the present disclosure. [Figure 18] FIG. 18 is a cross-sectional view of the distal tip of the catheter of FIG. 17 taken along line BB. [Figure 19] FIG. 1 is a perspective view of a distal tip of a catheter according to one aspect of the present disclosure. [Figure 20] FIG. 20 is a cross-sectional view of the distal tip of the catheter of FIG. 19. [Figure 21] FIG. 1 is a partial cross-sectional view of a distal tip of a catheter including a valve according to one embodiment of the present disclosure taken along line BB. [Figure 22] FIG. 10 is a partial cross-sectional view of a distal tip of a catheter including a valve according to another aspect of the present disclosure taken along line BB. [Figure 23] FIG. 10 is a partial cross-sectional view of a distal tip of a catheter including a valve according to another aspect of the present disclosure taken along line BB. [Figure 24] FIG. 10 is a diagram of a GUI date and time setting screen of the present disclosure. [Figure 25] FIG. 10 is a diagram of a setup screen for the GUI of the present disclosure. [Figure 26] FIG. 10 is a diagram of a priming sequence screen of the GUI of the present disclosure. [Figure 27] FIG. 10 is a diagram of the GUI action log screen of the present application. [Figure 28]FIG. 10 is a diagram of a transfer screen of the GUI of the present disclosure. [Figure 29] FIG. 10 is a diagram of a language selection screen of the GUI of the present disclosure. [Figure 30] FIG. 10 is a diagram of a touchscreen help screen for the GUI of the present disclosure. [Figure 31] FIG. 10 is a diagram of a software version screen of the GUI of the present disclosure. [Figure 32] FIG. 10 is a diagram of an ICP warning level screen of the GUI of the present disclosure. [Figure 33] FIG. 10 is a diagram of a treatment time reset screen of the GUI of the present disclosure. [Figure 34] FIG. 10 is a diagram of the infusion rate and bolus screen of the GUI of the present disclosure. [Figure 35] FIG. 10 is a diagram of a preset mode screen of the GUI of the present disclosure. [Figure 36] FIG. 5B is a cross-sectional view of the tubeset attachment of FIG. 5A. [Figure 37] FIG. 2 is a perspective view of a pump used in the control unit of the present disclosure. [Figure 38] FIG. 1 is a perspective view of a pinch valve used in the control unit of the present disclosure. [Figure 39] FIG. 1 is a perspective view of a security valve used in the tubing set of the present disclosure. [Figure 40] FIG. 40 is another perspective view of the security valve of FIG. 39. DETAILED DESCRIPTION OF THE INVENTION

[0071] For purposes of the following description, terms such as "up," "down," "right," "left," "vertical," "horizontal," "top," "bottom," "sideways," "longitudinal," and derivatives thereof, shall refer to the disclosed apparatus as shown in the figures. However, it should be understood that the disclosed apparatus may assume alternative variations and step sequences, unless expressly stated otherwise. It should also be understood that the specific systems and processes illustrated in the accompanying drawings and described in the following specification are merely illustrative examples of the apparatus disclosed herein. Accordingly, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered limiting.

[0072] As used herein, the terms "communication" and "communicating" refer to the receipt, transmission, or transfer of one or more signals, messages, commands, or other types of data. One unit or device communicating with another unit or device means that the one unit or device can receive and / or transmit data from the other unit or device. Communication may use direct or indirect connections and may be wired and / or wireless in nature. Additionally, two units or devices may be communicating with each other even if the transmitted data is modified, encrypted, processed, routed, etc. between the first and second units or devices. It will be appreciated that numerous arrangements are possible. Any known electronic communication protocol and / or algorithm may be used, such as, for example, UDP, TCP / IP (including HTTP and other protocols), WLAN (including 802.11 and other radio frequency-based protocols and methods), analog transmission, cellular networks, etc.

[0073] Referring to the drawings, wherein like numerals refer to like parts throughout the several views of the drawings, the present disclosure is directed generally to fluid exchange systems for medical applications, and more particularly to fluid exchange systems configured to prevent or remove blockages in multi-lumen catheters used for targeted fluid exchange.

[0074] Referring to FIG. 1 , a fluid exchange system 2 (hereinafter “System 2”) according to the present disclosure is shown and described. In one aspect, System 2 is an intracranial pressure (ICP) drainage system intended for use by professional medical personnel and those experienced in neurological / neurosurgical care. Through use of System 2, a patient's ICP is maintained at a safe level by draining excess intracranial fluid. As described in more detail below, System 2 includes, among other components, an infusion support mechanism used to flush System 2 in the event of blockage. The infusion support mechanism functions by generating bolus pulses using short periods of high flow (i.e., flow pulses). System 2 is intended for fixed use in hospitals for the purpose of monitoring ICP and draining intracranial fluid to control a patient's ICP, facilitate patient diagnosis, and identify recommended follow-up or continuing treatment.

[0075] In one embodiment, the system 2 includes a control unit 4, a tubing set attachment 8, a fluid source 10, and a drain container 12 connected to an IV pole 6 or other support structure. The IV pole 6 may include a plurality of wheels on its bottom end to allow a healthcare professional to move the system 2. The top end of the IV pole 6 may include at least one hook for holding the fluid source 10. The control unit 4, the drain container 12, and the fluid source 10 may be connected to the IV pole 6 using any suitable connection means for securing the control unit 4 and the drain container 12 to the IV pole 6. The fluid source 10 and the drain container 12 are fluidly connected to the tubing set attachment 8. In one embodiment, the fluid source 10 is an infusion bag. In one embodiment, the drain container 12 is a suction bag. The fluid source 10 may be positioned on the tubing set attachment 8 and directs fluid into the tubing set attachment 8. A drainage container 12 may be positioned below the tube set attachment 8 to receive bodily fluids drained from the patient through the tube set attachment 8. Each component of the system 2 is described in more detail below.

[0076] 2-4, the control unit 4 of system 2 is shown and described in more detail. Control unit 4 may be, for example, a computer-based management system that utilizes software and / or firmware to enable pump and sensor control and to enable proper delivery of therapeutic fluid to a patient, body cavity, or tissue of a patient. The software and / or firmware may include algorithms in the form of programming instructions stored on a non-transitory machine-readable medium associated with system 2. The programming instructions may be executed by a processor associated with control unit 4 to enable control unit 4 to perform the various tasks and methods described herein.

[0077] The control unit 4 may include a pump 66 configured to direct bodily fluid through the tube set attachment 8. The pump 66 may be configured to direct bodily fluid from the bodily fluid source 10 through the tube set attachment 8 to the patient. The pump 66 may also be configured to drain bodily fluid from the patient, through the tube set attachment 8, and into the drain container 12 by generating or creating a negative pressure within the tube set attachment 8. Pumps suitable for use in the present disclosure are generally known. In one embodiment, the pump 66 is a peristaltic pump. The control unit 4 may also include a pinch valve 64 (shown in FIG. 38 ) for controlling the flow of bodily fluid through the tube set attachment 8. The pump 66 and the pinch valve 64 may be retained within the housing 14 of the control unit 4. The control unit 4 may also include a connection port 16 for receiving the tube set attachment 8.

[0078] The control unit 4 may further include a graphical user interface (GUI) 18 for displaying control options, alarm indications, and system parameters related to the system 2 to a patient or medical professional. In one embodiment, the GUI 18 includes an LCD touchscreen display that allows a medical professional to operate the control unit 4. The control unit 4 also includes a central processing unit (CPU) configured to operate a pump 66 housed within the control unit 4. The CPU may also communicate with sensors provided in the system 2 to measure and record system operating parameters and alarm indications for the control unit 4.

[0079] System 2 may also include flow sensors, algorithms, and associated methods for controlling pump motor function to achieve precise control of bolus injections, e.g., both in volume, flow rate, duration, post-injection pause period, and pressure measurement interval, to deliver pharmaceutical agents, modify tissue effects and responses, achieve desired therapeutic effects, meet safety requirements, manage clogs in catheter 44 and tubing set 36, and achieve desired flow characteristics. The flow sensors may be, for example, MEMS-based flow sensors or impeller-driven flow meters.

[0080] Referring to FIG. 4 , the rear panel of the control unit 4 may include a mains input 20 for a power cable, a memory socket 22 for connecting a USB memory stick or other removable memory device, an IV pole clamp 24 for connecting the control unit 4 to an IV pole 6, and a handle 26 for carrying and holding the control unit 4. A healthcare professional may insert a USB memory stick or other removable memory device into the memory socket 22 to record data measured by the control unit 4. The memory device may be used to transfer measurement data from the control unit 4 to another computer for saving and importing into a spreadsheet report. A transfer log screen on the GUI 18 of the control unit 4 allows a healthcare professional to select files to transfer to the memory device. The IV pole clamp 24 may include a tightening knob 28 for loosening or tightening the IV pole clamp 24 to remove or secure the control unit 4 on the IV pole 6, respectively. The control unit 4 may also include an air sensor 30 located on one side of the housing 14. The air sensor 30 is positioned and configured to receive tubing connected to the body fluid source 10. In one embodiment, air sensor 30 is an air bubble detection sensor configured to identify when bodily fluid source 10 has run dry. Air sensor 30 is in communication with the CPU of control unit 4 to measure and record information regarding the run dry of bodily fluid source 10. In one embodiment, air sensor 30 is configured to send a signal to the CPU of control unit 4 indicating that bodily fluid source 10 has run dry and that an alarm should be issued by control unit 4 to notify medical personnel of this condition.

[0081] Continuing with reference to FIG. 4 , the control unit 4 can also include a drain container hanger 32 configured to hold the drain container 12. In one embodiment, the drain container 12 is a suction bag. The drain container hanger 32 can include a graduated measuring band 34 connected at one end to the control unit 4 and at the opposite end to the drain container 12. The graduated measuring band 34 allows the drain container 12 to be vertically adjusted relative to the control unit 4. The graduated measuring band 34 can also indicate the vertical distance between the control unit 4 and the drain container 12. Once the drain container 12 is vertically adjusted relative to the control unit 4, a healthcare professional can determine the vertical distance between the drain container 12 and the control unit 4, or in another embodiment, the vertical distance between the drain container 12 and a patient's head positioned adjacent to the system 2. In one embodiment, the graduated measuring band 34 includes a measurement (inches, centimeters, etc.) provided thereon that identifies the vertical distance between the drain container 12 and the control unit 4.

[0082] The positioning of the control unit 4, fluid source 10, and drainage container 12 relative to the patient can play a role in achieving the desired fluid flow rate and pressure necessary to deliver the intended therapy. Accordingly, the control unit 4 can include methods and devices that enable and facilitate positioning of the control unit 4 relative to the patient, the specific patient anatomy, the user, specific instrumentation and equipment, as well as general positioning, e.g., level and height. For example, the system 2 can include a leveling system 29. The leveling system 29 can be an optical laser attached to the control unit 4 and using a counterweight to provide automatic leveling. In this embodiment, the laser indicates the position of the control unit 4 relative to the patient by marking the position or height of the control unit 4 relative to the intended body cavity or patient limb. Alternatively, pressure or position sensors can be included in the control unit 4 and / or along the length of the system's tubing set 36 and catheter 44. These sensors can be secured (e.g., by adhesive or sutures) to the patient's skin or anatomical structures at the desired anatomical level and can be used to detect the position or height of system components relative to the patient and communicate with control unit 4 to properly manage fluid flow and detect and deliver the correct relative pressure despite patient movement.

[0083] Referring to FIG. 5 , the tubeset attachment 8 of the system 2 is shown and described in more detail. In one embodiment, the tubeset attachment 8 includes a single-use, disposable, sterile tubing set 36 attached to and routed through a housing 38 of the tubeset attachment 8. At one end, the tubeset 36 may be connected to a catheter 44 for infusion and aspiration of bodily fluids from a patient. Details of the catheter 44 are described in more detail below. The tubeset 36 and catheter 44 can be connected and disconnected using, for example, a Luer lock connection. The tubeset attachment 8 also includes a cassette 40 that connects to the connection port 16 of the control unit 4, a pressure sensor calibration knob 42 on its front face, and a security valve 41 (shown in FIGS. 39 and 40 ). The cassette 40 allows the tubeset attachment 8 to be removably attached to the control unit 4. Thus, after use of the tubeset attachment 8 is complete, a medical professional can easily remove the tubeset attachment 8 from the control unit 4 for disposal. A pressure sensor calibration knob 42 is provided on the tubeset attachment 8 for calibrating and adjusting the pressure sensor included in the tubing set 36 and / or catheter 44. A medical professional can calibrate the pressure sensor to ensure that accurate measurements of fluid pressure through the tubing set 36 are recorded by the pressure sensor. In one embodiment, the pressure sensor communicates with the control unit 4 to transmit and record pressure measurements, and in one embodiment, intracranial pressure measurements. In one embodiment, a security valve 41 is positioned between the connecting spike of the fluid source 10 and the cassette 40. Typically, during operation of the system 2, when the cassette 40 is properly attached to the control unit 4, a pump 66 (shown in FIG. 37 ) on the control unit 4 closes the fluid source line when not directing fluid through the tubing set 36. If the cassette 40 is unintentionally removed from the control unit 4 while still connected to the patient, or if the pump 66 begins to leak, the security valve 41 prevents the free flow of fluid from the fluid source 10 to the patient's brain.

[0084] Referring to FIG. 6 , the operating system configuration of system 2 is shown and described according to one non-limiting embodiment. Control unit 4 can communicate with various data sources, including a keypad and / or touchscreen 46 of GUI 18, a pressure sensor calibration knob 42, a real-time clock calendar 48, flash memory 50, a USB host 52, and a service port 54. In one aspect, control unit 4 also communicates with at least one pressure sensor 56 configured to record measurements of bodily fluid pressure within system 2. In one aspect, pressure sensor 56 may be located on at least one of control unit 4, tube set attachment 8, and catheter 44. In another aspect, control unit 4 also communicates with a safety module 58. Control unit 4 can handle patient treatment, GUI 18 processing, data logging, and external communications. Safety module 58 can monitor control unit 4 to ensure it is functioning as intended. Safety module 58 may be located remotely from control unit 4. The safety module 58 may also communicate with a pressure sensor 60 provided on at least one of the control unit 4, the tubing set attachment 8, and the catheter 44. The control unit 4 and the safety module 58 both communicate with an audible alarm 62, a pinch valve 64, a pump 66, an air sensor 30, and a main battery 68 that powers the control unit 4 and the safety module 58.

[0085] 7, an exemplary front panel 70 of the control unit 4 is shown and described in detail. The front panel 70 includes an LED indicator 72 that illuminates when a power connection to the control unit 4 is established, a power button 74 that turns the control unit 4 on and off, a start / stop button 76 that begins and ends the treatment process performed by the control unit 4, and a bolus button 78 that begins the bolus process using the control unit 4.

[0086] Referring to FIG. 8 , an exemplary embodiment of the GUI 18 of the control unit 4 is shown and described in detail. The GUI 18 can include a graphical layout of various operating modes arranged in an appropriate order and logic to provide a desired level of ease of use, patient benefit, treatment protocol management, and safety. The GUI 18 provides both system performance data and patient data in textual, pictorial, and graphical formats to facilitate data interpretation and therapy delivery decision-making. Information provided to the user by this system 2 includes graphical data of therapy-related parameters such as fluid flow through the catheter, pressure, general sensor data, and protocol prompts and alarms. The GUI 18 further provides information regarding device setup, treatment protocols, safety controls, alarm and error message management, and instructions for device use and therapy delivery. The GUI 18 enables and facilitates patient data and status monitoring, treatment parameter control and modification, and user decision-making regarding appropriate therapy delivery and patient safety.

[0087] The home screen of the GUI 18 includes a battery indicator 80 for displaying the battery charge status and generating an alarm when the control unit 4 needs to be connected to a power source. If a treatment process cannot be performed due to low battery power, the control unit 4 can generate a higher intensity alarm for a period of time, such as 3-5 minutes, to notify medical personnel. When the battery is depleted, the control unit 4 stops displaying ICP information and terminates the treatment process. The home screen of the GUI 18 can also include a date and time indicator 81 for displaying the current date and time to medical personnel. The home screen of the GUI 18 also includes an equipment status indicator 82 that displays text providing user prompts and warnings regarding the use of the system 2. In one embodiment, the home screen of the GUI 18 also includes an alarm status indicator 84 that displays alarm status to medical personnel. The alarm status includes a visual indication that a specific alarm condition in the system 2 has been activated. In one embodiment, the alarm status may be displayed as red, indicating a high level of alarm, yellow, indicating different levels of high level alarm, or blue, indicating a low level of alarm. In one embodiment, the alarm status is gray, indicating that no alarms are currently active. The home screen of GUI 18 may also include an ICP indicator 86 that displays the patient's current ICP value. The ICP value is updated every monitoring cycle, which can be set by a healthcare professional. The monitoring cycle may be every few seconds, every few minutes, or every hour. The home screen of GUI 18 may also include a current pressure indicator 88 that displays the patient's current ICP pressure, which is continually updated and displayed in real time for the healthcare professional to review.

[0088] In one embodiment, the home screen of the GUI 18 also includes a patient fluid flow indicator 90 that displays the direction of fluid flow relative to the patient. In one embodiment, the patient fluid flow indicator 90 displays a diagram of a portion of the patient's body, such as a head, with an arrow indicating the direction of fluid flow to and from the patient. In one embodiment, as shown in FIG. 9 , the patient fluid flow indicator 90 displays a blue arrow pointing toward the diagram of the patient's head to indicate that fluid is being infused into the patient. In another embodiment, as shown in FIG. 10 , the patient fluid flow indicator 90 displays an orange arrow pointing away from the diagram of the patient's head to indicate that fluid is being aspirated from the patient's head. In another embodiment, as shown in FIG. 11 , the patient fluid flow indicator 90 displays a green bar to indicate that no infusion or aspiration is occurring on the patient. It should be understood that alternative colors and shapes can be used with the patient fluid flow indicator 90 to indicate these fluid flow statuses. The home screen of the GUI 18 may also include a treatment time indicator 92 that displays the duration of the patient's treatment.

[0089] The home screen of the GUI 18 may also include function selection buttons 94 that allow a healthcare professional to select functions within the GUI 18. The home screen of the GUI 18 may also include an alarm clear button 96 that the healthcare professional uses to reset alarms on the control unit 4. In one embodiment, the home screen of the GUI 18 includes indicators for displaying high and low ICP alarms to the healthcare professional. A high ICP alarm indicator 98 is provided on the GUI 18 to indicate that a patient's high ICP setting or limit has been reached. The high ICP setting can be selected and adjusted by the healthcare professional based on the patient's condition. If the control unit 4 determines that the patient's ICP has exceeded the high ICP setting, the control unit 4 may generate an alarm, such as an audible and / or visual alarm, to alert the healthcare professional. If the patient's ICP exceeds the high ICP setting, a suction process may be initiated by the control unit 4 to drain fluid from the patient's intracranial cavity. A low ICP alarm indicator 100 is also provided on the GUI 18 to indicate that a patient's low ICP setting or limit has been reached. The low ICP setting can be selected and adjusted by a medical professional based on the patient's condition. If the control unit 4 determines that the patient's ICP has fallen below the low ICP setting, the control unit 4 may generate an alarm, such as an audible and / or visual alarm, to alert the medical professional. If the patient's ICP falls below the low ICP setting, the control unit 4 initiates an infusion process to deliver substitution fluid to the patient's intracranial cavity. The high and low ICP alarm indicators 98, 100 may be displayed in millimeters of mercury. The control unit 4 may have different types of alarms to indicate different ICP settings. In one embodiment, the control unit 4 includes a low ICP warning that triggers an alarm when the ICP is less than the low ICP setting. This alarm is cleared when the ICP exceeds the low ICP setting. This alarm setting includes an audible signal that beeps every 20 seconds and a visual signal on the home screen of the GUI 18 that includes a cyan circle symbol. In one embodiment, the control unit 4 includes a high ICP warning that triggers an alarm when the ICP exceeds the high ICP setting. This alarm can be cleared when the pressure drops below the high ICP setting.During the high ICP warning, the control unit 4 allows aspiration and infusion. This alarm setting may include an auditory beep every few seconds, e.g., every 7.5 seconds, e.g., every 5-10 seconds, and a visual signal on the home screen of the GUI 18 that includes a yellow circle. In one embodiment, the control unit 4 also includes a high ICP warning that triggers an alarm when the ICP exceeds the high ICP setting by more than 3 mmHg. This warning setting initiates an aspiration process that continues for a predetermined time to drain fluid from the patient's intracranial cavity. The control unit 4 does not return to the normal treatment process until a healthcare professional acknowledges the alarm by touching the home screen of the GUI 18. This alarm setting may include an auditory beep every few seconds, e.g., every 1-4 seconds, e.g., every 2.5 seconds, and a visual signal on the home screen of the GUI 18 that includes a red circle.

[0090] The home screen of the GUI 18 may also include a flow rate indicator 102 that displays a selected flow rate of fluid to the patient. The selected flow rate is displayed in milliliters per second. The flow rate of fluid may be selectable and adjustable by a healthcare professional based on the patient's condition.

[0091] 24-35 are examples of additional screens in the GUI 18 that identify and present information to the healthcare professional when using the system 2. Each of these screens can be accessed directly or indirectly through the GUI 18. As shown in FIG. 24, a date and time setting screen 200 can be accessed by pressing or selecting the date and time indicator 81 on the GUI 18. The date and time setting screen 200 presents the healthcare professional with buttons for adjusting and changing the date and time settings on the control unit 4. In one embodiment, the date and time setting screen 200 includes an increment button 202 and a decrement button 204 for adjusting the year, month, and / or day of the date on the control unit 4, as well as the hour, minute, and / or second settings of the time on the control unit 4. The increment button 202 can increase the value of a particular date or time setting, and the decrement button 204 can decrease the value of a particular date or time setting. After the date and / or time setting is adjusted by the healthcare professional, an accept button 205 can be selected to change the date and / or time setting. A return button 206 can be selected to return the control unit 4 to the GUI 18.

[0092] 25, a setup screen 208 is shown and described. The setup screen 208 may be accessed by selecting the function selection button 94 on the GUI 18. The setup screen 208 may include several different function buttons that lead to additional screens for adjusting specific functions of the control unit 4. The setup screen 208 may include a prime sequence button 210 that directs the GUI 18 to a priming sequence screen 212, which is described in more detail below. The setup screen GUI 208 may also include a treatment log button 214 that directs the GUI 18 to a treatment log screen 216, which is described in more detail below. The setup screen 208 may also include a language selection button 218 that directs the GUI 18 to a language selection screen 220, which is described in more detail below. The language selection button 218 may include a label representing the current language (e.g., English, French, Spanish, German, etc.) currently set for the GUI 18. The setup screen 208 may also include a treatment time reset button 222 that instructs the control unit 4 to reset the amount of treatment time for the patient. The setup screen also includes a set clock button 223 that directs the GUI 18 to the set date and time screen 200. The setup screen 208 also includes a return button 226 for returning to the home screen of the GUI 18.

[0093] 26, the priming sequence screen 212 is shown and described. The priming sequence screen 212 may include a warning message 228 that indicates to the medical professional that the priming sequence should not be initiated while the catheter 44 is connected to a patient. This warning message 228 serves as a reminder to the medical professional that the catheter 44 should be disconnected from the patient before the priming sequence is initiated by the control unit 4. The priming sequence screen 212 may also include a start priming sequence button 230 that the medical professional can select to initiate the priming sequence of the control unit 4. In one embodiment, the start priming sequence button 230 must be pressed and held by the medical professional to initiate the priming sequence. In another embodiment, the start priming sequence button 230 must only be pressed by the medical professional to initiate the priming sequence. The priming sequence screen 212 may also include a return button 232 for returning to the home screen of the GUI 18.

[0094] Referring to FIG. 27 , a procedure log screen 216 is shown and described. The procedure log screen 216 allows a medical professional to select and transfer data files to a USB drive, a computing device connected to the control unit 4, a phone, a remote computer server, or any other type of data receiving device. The procedure log screen 216 includes a column of procedure log files 234 identified by the specific date on which the procedure log was recorded. Each specific date may include a selectable check box button 236 located adjacent to the specific date so that the medical professional can select the specific date of the procedure log file to transfer. The procedure log screen 216 may also include a column of selectable check box buttons 238 next to each specific date so that the medical professional can select to transfer all pressure data files for that specific date. The procedure log screen 216 may also include a transfer button 240 that the medical professional can select after selecting the specific pressure data or procedure log file to be transferred from the control unit 4. After the transfer button 240 is selected by the medical professional, the control unit 4 moves to a transfer screen 242, as shown in FIG. 28 . The transfer screen 242 may include a rising bar indicator 244 that shows the healthcare professional the percentage of the procedure log file or pressure data that has currently been transferred. The transfer screen 242 may also include an estimated remaining transfer time indicator 246 to show the healthcare professional the time remaining until the procedure log file or pressure data is completely transferred. The transfer screen 242 may also include a cancel button 248 that the healthcare professional can select to cancel the transfer process on the control unit 4. Upon selecting the cancel button 248 or upon completion of the transfer process, the transfer screen 242 returns to the procedure log screen 216. The procedure log screen 216 may also include a return button 250 to return to the home screen of the GUI 18.

[0095] 29, a language selection screen 220 is shown and described. The language selection screen 220 can be accessed by selecting the language selection button 218 on the setup screen 208. The language selection screen 220 may include several different language buttons 252. Each language button 252 may include a label depicting a different language (e.g., English, German, French, and Spanish) that may be selected by a healthcare professional. By selecting a particular language button 252, the control unit 4 changes the language displayed by the GUI 18 to correspond to the selected language. The language selection screen 220 may also include a return button 254 that can be selected to return to the home screen of the GUI 18.

[0096] Referring to FIG. 30 , a touchscreen help screen 224 is shown and described. The touchscreen help screen 224 can be accessed by selecting the touchscreen help button 222 on the setup screen 208. The touchscreen help screen 224 may show the GUI 18 touchscreen area 256 and additional function buttons 258 accessible to the healthcare professional. The function buttons 258 may include a “Set Time” button, a “Set ICP Limit” button, a “Chart” button, a “Set Flow Rate” button, and / or a “Reset” button. Thus, instead of selecting a particular icon on the home screen of the GUI 18, the healthcare professional can select one of the function buttons 258 on the touchscreen help screen 224 to access a particular screen. The touchscreen help screen 224 may also include a return button 260 for returning to the home screen of the GUI 18. As shown in FIG. 31 , the software version screen 262 may also include a touchscreen help button 264 that directs the GUI 18 to the touchscreen help screen 224.

[0097] 32, an ICP warning level screen 266 is shown and described. The ICP warning level screen 266 may be accessed by selecting at least one of the high ICP alarm indicator 98 and the low ICP alarm indicator 100 on the GUI 18. The ICP warning level screen 266 may allow a healthcare professional to adjust the high and low ICP level thresholds of the system 2. The ICP warning level screen 266 may display the current settings of the high and low ICP level thresholds. In one embodiment, the high and low ICP level thresholds are displayed in mmHg. The ICP warning level screen 266 may include an increase button 268 and a decrease button 270 that can be selected by a healthcare professional to adjust the high and low ICP level thresholds. By selecting the increase button 268, the respective high and low ICP level thresholds can be increased by a predetermined increment (e.g., 1 mmHg, 5 mmHg, 10 mmHg, etc.) per selection of the button 268. By selecting the decrease button 270, the respective high and low ICP level thresholds can be decreased by a predetermined increment (e.g., 1 mmHg, 5 mmHg, 10 mmHg, etc.) with each selection of the button 270. After the healthcare professional has set the high and low ICP level thresholds at the desired settings, the return button 272 can be selected on the ICP warning level screen 266 to return to the home screen of the GUI 18.

[0098] 33, a procedure time reset screen 274 is shown and described. The procedure time reset screen 274 may be accessed by selecting the procedure time indicator 92 on the home screen of the GUI 18. The procedure time reset screen 274 may include a reset button 276 and a cancel button 278. By selecting the reset button 276, the healthcare professional can reset the procedure time indicator 92 to zero and restart the procedure time counter. By selecting the cancel button 278, the procedure time reset screen 274 returns to the home screen of the GUI 18. A return button 280 may also be provided on the procedure time reset screen 274 to return to the home screen of the GUI 18.

[0099] Referring to FIG. 34, an infusion rate and bolus screen 282 is shown and described. The infusion rate and bolus screen 28 may be accessed by selecting the patient fluid flow indicator 90 or the flow rate indicator 102 on the home screen of the GUI 18. The infusion rate and bolus screen 282 may include an infusion button 284 that may be selected by a healthcare professional to direct the GUI 18 to the infusion rate and bolus screen 282. The infusion rate and bolus screen 282 may also include an aspiration screen button 285 to direct the GUI 18 to an aspiration screen 286, as shown in FIG. 35. The aspiration screen 286 may include an increase button 288 and a decrease button 290 for changing an aspiration level threshold 292. The aspiration level threshold 292 corresponds to a patient's ICP level threshold that must be exceeded before the control unit 4 can initiate an aspiration process to alleviate the patient's ICP level. A healthcare professional can adjust the aspiration level threshold 292 by pressing the increase button 288 and the decrease button 292. The aspirate screen 286 may also include an increase button 291 and a decrease button 293 for adjusting the bolus amount on the control unit 4. The healthcare professional may adjust the bolus amount by pressing the increase button 291 and the decrease button 293. The aspirate screen 286 may also include a return button 294 for returning to the home screen of the GUI 18.

[0100] The Infusion Rate & Bolus screen 282 may also include an Infusion Rate indicator 296 that displays the current infusion rate of the control unit 4. The Infusion Rate & Bolus screen 282 may also include a Cycle Time indicator 298 that shows the healthcare professional's current cycle time setting. The cycle time corresponds to the infusion and aspiration cycles of the system 2. The Cycle Time indicator 298 may include an Increase button 300 and a Decrease button 302 to allow the healthcare professional to adjust the cycle time according to the patient's needs. The cylinder time may be increased or decreased by a specific time allotment (e.g., 1 second, 10 seconds, 15 seconds, 30 seconds, etc.) each time the Increase button 300 or the Decrease button 302 is pressed. The Infusion Rate & Bolus screen 282 may also include an Infusion / Bolus Volume indicator 304. The Infusion / Bolus Volume indicator 304 displays the current volume setting for the bolus volume that will be delivered through the system 2 when the healthcare professional activates a bolus procedure. The bolus volume may be adjusted by the healthcare professional by selecting the Increase button 306 or the Decrease button 308. The bolus amount can be increased or decreased by a specific amount allotted (eg, 1 mL, 5 mL, 10 mL, etc.) each time the increase button 306 or decrease button 308 is pressed.

[0101] The preparation, installation, and operation of the system 2 will now be described in more detail. The control unit 4 is initially placed in a vertical position on the IV pole 6 using the tightening knob 28 and IV pole clamp 24. The zero line 31 of the control unit 4 can be positioned horizontally at the same level as the patient's ear canal. The control unit 4 can then be activated by pressing the power button 74. In one embodiment, the control unit 4 can prompt the healthcare professional to set the date and time on the control unit 4. A bodily fluid source 10 may also be placed on the IV pole 6.

[0102] After the control unit 4 is attached to the IV pole 6 and the control unit 4 is activated, the tubing set attachment 8 may be connected to the control unit 4. The cassette 40 of the tubing set attachment 8 is inserted into the connection port 16 of the control unit 4 to connect the tubing set attachment 8 thereto. The tubing of the body fluid source 10 is then connected to the tubing set 36 of the tubing set attachment 8. In one embodiment, the male luer connector of the tubing set of the body fluid source 10 is connected to the female luer connector of the tubing set 36 of the tubing set attachment 8. In one embodiment, the drainage container 12 may be pre-connected to the tubing set 36 of the tubing set attachment 8.

[0103] Prior to using the system 2, the tubing set 36 of the tubing set attachment 8 can be primed. With the tubing set 36 connected to the fluid source 10 and the drain container 12, the calibration knob 42 of the cassette 40 is moved to the operating position. A healthcare professional can then use the control unit 4 to initiate a priming sequence, directing fluid from the fluid source 10 through the tubing set attachment 8 and into the drain container 12. This priming sequence continues until the entire tubing set 36 is filled with fluid. Alternatively, the tubing set 36 of the tubing set attachment 8 can be manually primed using a syringe. After the priming sequence is complete, a portion of the tubing set 36 is inserted into the air sensor 30 of the control unit 4 to monitor whether the fluid source 10 has been depleted. The drain container 12 can then be hung on the drain container hanger 32 of the control unit 4. The vertical position of the drain container 12 can be adjusted by adjusting the length of the graduated measuring band 34. Lowering the drain container 12 is expected to increase the aspiration flow of the system 2. Raising the drainage container 12 is expected to reduce the aspiration flow of the system. The aspiration flow of the system 2 is gravity flow.

[0104] After the drainage container 12 is properly positioned, the system 2 can be calibrated. The calibration knob 42 on the control unit 4 can be turned to calibration mode. In calibration mode, the pressure sensors 56, 60 are connected to atmospheric pressure and the pressure signal is set to a zero value. Once the calibration knob is set to calibration mode, the healthcare professional waits until the ICP value reaches zero. At this point, the pressure sensor is calibrated. The calibration knob 42 can then be turned to operation mode, and the tubing set attachment 8 can be positioned for treatment.

[0105] After the tube set attachment 8 is calibrated, the catheter 44 is inserted into the patient's intracranial cavity using any method known in the art. The catheter 44 is then connected to the tubing set 36 of the tube set attachment 8. The control unit 4 should then be configured to initiate the desired treatment process. First, the medical professional must set the desired upper and lower pressure alarm limits. Depending on the patient's condition and the desired treatment, the medical professional can set the high and low ICP pressure settings that should be monitored by the control unit 4. The medical professional must also set the desired flow rate using the control unit 4. After this information is set, the treatment process can be initiated by pressing the start / stop button 76. The treatment processes initiated by the control unit 4 are described in detail below. The medical professional can periodically start and stop the treatment process using the start / stop button 76. In one embodiment, the treatment process may need to be stopped so the patient can be separated from the system 2 for an MRI or CT scan.

[0106] At any point during the treatment process, the medical professional can change the flow rate setting by pressing the flow rate indicator 102, which causes the GUI 18 to allow the medical professional to increase or decrease the flow rate of the system 2. In the preset mode of the treatment process, no patient infusion occurs, and aspiration occurs only if the measured ICP is greater than the high ICP setting. A high flow rate setting can be used when draining bleeding. A lower flow rate setting can be used for ICP monitoring and drainage of clearer fluids from the intracranial cavity.

[0107] The healthcare professional has the option to flush the catheter 44 and tubing set 36 before or after the treatment process. By pressing the bolus button 78 on the GUI 18, a bolus injection from the fluid source 10 is directed through the catheter 44 and tubing set 36. When flushing the system 2, no suction is performed. The bolus function can be used at the discretion of the treating healthcare professional.

[0108] The treatment process performed by system 2 includes the use of a drug or drug combination to treat the human or animal body by surgery or therapy in which the catheter 44 of the present disclosure is used. In one embodiment, the drug or drug combination is administered to a patient by the catheter 44 or system 2 of the present disclosure. In one embodiment, the drug combination includes at least two drugs. In another embodiment, a drug or drug combination is disclosed for use in a diagnostic method performed on the human or animal body utilizing the catheter 44 or system 2 of the present disclosure. In one embodiment, the bodily fluid administered by system 2 is a physiological solution. That is, physiological solutions such as, but not limited to, NaCl 0.9% or Ringer's lactate solution (generally, and as known to those skilled in the art) can be administered (and optionally aspirated) by the catheter 44 of the present disclosure. In other embodiments, the bodily fluid is a nutrient solution.

[0109] Generally, as used herein, "at least one drug" may refer to one drug. In other aspects herein, "at least one drug" may refer to "at least two drugs." In other aspects herein, the terms "at least one drug" and "at least two drugs" may refer to two, three, four, five, or six drugs, preferably two, three, or four drugs, preferably three drugs, and preferably two drugs. In certain aspects, drugs such as "at least two drugs" as used herein are incompatible. Incompatible drugs are not particularly limited and are readily known to those skilled in the art, for example, from standard handbooks on injectable drugs. In certain embodiments, incompatible drugs are incompatible with multi-site injection and / or single-syringe injection. In exemplary aspects herein, "at least two drugs" are administered simultaneously. In other aspects herein, "at least two drugs" are administered sequentially. In certain aspects herein, the at least one drug or at least two drugs may be any combination of drugs described herein.

[0110] System 2 manages the flow of infused and aspirated fluids through catheter 44. As described above, control unit 4 is a software-based management system that uses pump and sensor control and specific algorithms to enable proper delivery of therapy to the patient, body cavity, or tissue. Management of infusion and aspirated flows can be performed by valve functions that alternately restrict and allow fluid flow, and thus fluid pressure, to the tubing, catheter, distal lumen, distal port, target tissue, and body cavity. In the present disclosure, valves can be used to manage aspirated fluids, while infused fluids are managed by pump functions. Valve functions are controlled by control unit 4 according to an algorithm and desired therapy; in this case, the protocol executed by the controller, pump, and valves includes a programmed, alternating sequence of infusion, aspirate, and pause with the appropriate combination of therapy. During any of these flow phases, control unit 4 activates pump 66 and valves to determine flow rate, fluid pressure within the system, and body cavity pressure. The valve is configured to act on the tubing set 32 as a pinch valve 64, allowing the tubing set 32 to be inserted, threaded, or fed through the valve into the control unit 4. The valve itself is configured, for example as a linear solenoid, to function as a pinch valve 64 by axial displacement relative to the tubing. The valve may also be configured as a cantilever mechanism, a roller mechanism, a wedge, or a tube deflection mechanism.

[0111] The CPU of the control unit 4 controls the treatment process of the system 2 and, in one embodiment, is organized as a finite state machine. The CPU can operate in various states, with various events determining when and how transitions between states occur. With reference to FIG. 12, exemplary states and the events that cause transitions between states are shown and described. The CPU may be held in a ready state, during which the system 2 remains idle. The system 2 may require certain conditions to be met before entering a programmed treatment state and / or calibration state. For example, before entering a programmed treatment state, the system 2 may first verify that the cassette 40 is connected to the control unit 4, the pressure sensors 56, 60 are calibrated, the air sensor 30 indicates the presence of fluid in the tubing set 36, periodic monitoring tests are cleared, and / or the start / stop button 76 has been pressed by a medical professional to initiate the treatment process programmed in the system 2.

[0112] Another state is the Calibrate state, which can be reached from the Ready state or the Treat state. The Calibrate state is used to ensure that the system 2 and its components are properly calibrated. The control unit 4 can enter the Calibrate state, for example, by moving the Calibrate knob 42 on the control unit 4 to the Calibrate position. Once in the Calibrate state, a zero offset value for each pressure sensor 56, 60 can be determined. To determine the zero offset value, a minimum 500 ms delay is initiated to allow the raw signals to set. Next, an average of the raw pressure measurement samples is taken over a short period, such as one second or less. The average value is then stored as the zero offset value for each pressure sensor 56, 60.

[0113] After calibration is complete, the control unit 4 can move to a programmed treatment state. However, in some embodiments, such as when the system has been recently calibrated, it is not necessary to first complete the calibration process before entering a programmed treatment state. A programmed treatment state can be used to infuse and / or aspirate bodily fluids to or from a patient. While in a treatment state, the control unit 4 can cycle through different treatment parameters selected by the user to move between different infusion and aspiration states. During the infusion state, the control unit 4 is configured to supply and direct bodily fluids from the bodily fluid source 10 to the patient, such as the patient's intracranial cavity, through the tubing set 36. During the aspiration state, the control unit 4 is configured to drain bodily fluids, for example, from the intracranial cavity through the tubing set 36 to the drain container 12. The pump 66 of the control unit 4 can create positive pressure in the tubing set 36, or a particular lumen thereof, to pump bodily fluids into the patient during the infusion state, and can create negative pressure in the tubing set 36, or a particular lumen thereof, to drain bodily fluids from the patient during the aspiration state. Exemplary infusion and aspiration programs include those described in U.S. Pat. No. 8,398,581 and U.S. Patent Application Publication No. 2015 / 0224284, the disclosures of which are incorporated herein by reference.

[0114] The control unit 4 may be preprogrammed to switch between the infusion and suction states based on a desired outcome from a healthcare professional. In another embodiment, the control unit 4 may switch between the infusion and suction states based on pressure measurements recorded by the pressure sensors 56, 60. In particular, the pressure sensors 56, 60 can send ICP measurements to the control unit 4, which monitors the patient's ICP level. If the ICP measurements are within a desired range, the control unit 4 continues to execute the preprogrammed treatment process. If the ICP measurements exceed a high ICP level setting, the control unit 4 may be configured to initiate a suction state to drain fluid from the patient's intracranial cavity and reduce the ICP. After a sufficient amount of fluid has been drained from the intracranial cavity and the ICP level has fallen between the high ICP level settings, the control unit 4 may be configured to resume the preprogrammed treatment process. In another embodiment, if the ICP measurements fall below a low ICP level setting, the control unit 4 may be configured to initiate an infusion state to direct additional fluid into the patient's intracranial cavity. After fluid is introduced into the intracranial cavity and the measured ICP increases above the low ICP level setting, the control unit 4 may be configured to resume the preprogrammed treatment process. In another embodiment, a treatment stop event in the control unit 4 returns the system 2 to the ready state. The treatment stop event may be initiated by a medical professional pressing the start / stop button 76. It is also contemplated that the control unit 4 may automatically return to the ready state in the event of an emergency situation involving the control unit 4 and / or the patient.

[0115] In one embodiment, the control unit 4 can transition between the infusion state and the aspiration state using several different techniques. In one embodiment, the pressure sensors 56, 60 can measure a first pressure value within the intracranial cavity and transmit this measurement to the control unit 4. Infusion of bodily fluid into the intracranial cavity can then be initiated by the control unit 4. After the infusion state, the pressure sensors 56, 60 can measure a second pressure value within the intracranial cavity and transmit this measurement to the control unit 4. The CPU of the control unit 4 can then calculate or determine the difference between the first and second pressure measurements from the pressure sensors 56, 60. If the difference between the first and second pressures exceeds a high threshold level, the control unit 4 can issue a high-pressure signal output. The control unit 4 can then initiate an aspiration state to reduce the ICP. If the difference between the first and second pressures falls below a low threshold level, the control unit 4 can issue a low-pressure signal output. The control unit 4 can then initiate an infusion state to increase the ICP.

[0116] System 2 may use measurements of "compliance" and "elasticity" to adjust the treatment process. Generally, the skull of adult vertebrates is a rigid structure. The primary intracranial contents are the brain, blood, and cerebrospinal fluid (CSF). Because intracranial volume remains constant, the introduction of intracranial mass requires compensation through a reciprocal reduction in venous blood and CSF volume. This is known as the Monro-Kelly-Burroughs principle. To maintain pressure within physiological ranges, the patient's venous system readily collapses, squeezing venous blood from the jugular or draining veins and scalp veins. Similarly, CSF can move through the foramen magnum into the spinal subarachnoid space. When these compensatory mechanisms are exhausted, even small changes in volume cause a sudden increase in pressure (e.g., in the range of 1–5 ml depending on the timing involved).

[0117] Compliance (dV / dP) is the observed change in volume for a given change in pressure. It represents the intracranial space's ability to accommodate. If the cranial cavity can accommodate a large mass with a very small change in pressure, compliance is high. However, in clinical practice, elastance (dP / dV), the inverse of compliance, is typically measured. It is the observed change in pressure for a given change in volume. It represents the resistance to outward expansion of the intracranial mass. Elastance can be measured at the bedside, for example, by injecting 1 ml of sterile saline through a ventricular catheter and observing the change in pressure. An increase of less than 2 mmHg indicates low elastance and high compliance. However, the high risk of infection associated with this procedure prevents its routine implementation as a pressure measurement method.

[0118] In one embodiment, the control unit 4 can measure compliance after each injection of 1 ml (or less) without risk of infection, for example, by analyzing the generated pressure curve, thus providing valuable information about the patient's actual and expected ICP values. If compliance values tend to rise or fall, medical personnel are alerted to act early and modify treatment accordingly for the patient's benefit. The same concept may be applied to monitoring local pressure and compliance of body organs and tissues during treatment, for example, to protect organs from malfunction or rupture.

[0119] Compliance and elastance measurements according to the present disclosure can be accomplished in any of a variety of suitable ways. For example, compliance measurements according to the present disclosure can be described as an ex vivo method for determining cerebral compliance in the intracranial cavity of a patient.

[0120] An example of compliance measurement by the control unit 4 is described below. In one embodiment, by measuring a first pressure in the intracranial cavity, the control unit 4 can provide a first time course curve of pressure corresponding to the first measured pressure value. By measuring a second pressure in the intracranial cavity, the control unit 4 can provide a second time course curve of pressure corresponding to the second measured pressure value. In one embodiment, a first derivative can be determined by the control unit 4 from the first measured pressure value. A second derivative can be determined by the control unit 4 from the second measured pressure value. The control unit 4 can then determine a first maximum slope value of the first derivative and a second maximum slope value of the second derivative. The control unit 4 can then determine the difference between the first maximum slope value and the second maximum slope value. Based on the difference between the first maximum slope value and the second maximum slope value, the control unit 4 may determine a cerebral compliance value. The measured cerebral compliance value can be compared to a previously measured cerebral compliance value. If the cerebral compliance value exceeds a threshold value, a signal output can be issued by the control unit 4 to notify medical personnel. The control unit 4 can then determine whether to administer the fluid infusion immediately after a predetermined time interval has elapsed, which may be a time interval that allows cerebral compliance to decrease below a threshold value.

[0121] 12, while in a programmed treatment state, the control unit 4 can initiate a bolus state. The bolus state can be initiated when the healthcare professional presses the bolus button 78 on the GUI 18 while in a programmed treatment state. In the bolus state, the control unit 4 is configured to deliver a bolus injection through the tubing set 36.

[0122] During a programmed treatment state, the control unit 4 can issue a high ICP warning. This high ICP warning initiates a high pressure state in the control unit 4. This state of the control unit 4 can wait to verify that natural ICP fluctuations from the patient's heart rate are present and that the ICP is within user-set limits. After these conditions are met, the control unit 4 returns to the programmed treatment state, and the treatment sequence resumes. For example, while aspirating the brain at high pressure, there is a risk of ventricular collapse. This means that most or all of the fluid is expelled from the cavity in which the catheter 44 sits. The ventricle wall then acts as a check valve, allowing fluid in but not out, preventing the pressure sensors 56, 60 from measuring the correct ICP. The system 2 could find itself in a situation where fluid is infused into the brain with a high ICP. When the naturally occurring ICP fluctuations in the patient's intracranial cavity resume, the system realizes that fluid has settled around the catheter 44 and is measuring the correct ICP.

[0123] If an irrecoverable device failure is detected during a programmed treatment state or other state, the control unit 4 can automatically enter a fault state. In one embodiment, irrecoverable device failures include an internal software error, a monitored voltage outside of an acceptable range, the safety module 58 not responding to commands, and the safety module 58 detecting an irrecoverable error. Upon entering the fault state, the pinch valve 64 of the control unit 4 is closed, the pump 66 is stopped, and a message is displayed on the GUI 18 instructing the medical professional that the control unit 4 should be restarted.

[0124] The control unit 4 also manages the pressure within the system 2 by operating the pump motor functions to apply or reduce pressure within the tubing set 36, catheter 44, or body cavity. The pump 66 can be advanced to apply incremental pressure and similarly progressively retracted to reduce pressure. The control unit's interpretation of the system 2 pressure differential and pressure waveforms enables management of the pump functions to deliver or modify the intended therapy, provide feedback to the user, or activate an alarm. The same data also provides feedback regarding system function, including restriction or occlusion of the catheter 44 or tubing set 36. Data is obtained from a combination of sensors 56, 60 within the catheter 44, the tubing set 36, the fluid container, and a combination of motor and sensor functions. An occlusion of the catheter 44 can be detected, for example, by applying a sudden burst of pressure from the pump 66 to initiate a pressure wave. Sensors 56, 60 in the catheter lumen and / or catheter tip can be used to detect fluid reflexes as a result of the induced pressure wave, thereby detecting the presence of restricted or occluded fluid flow through the lumen. Similarly, pump motor operating parameters such as current, power consumption, motor position etc. are monitored by the control unit 4 to manage system function.

[0125] 13 and 14, a catheter 44 for use in system 2 is shown and described. Catheter 44 can include various features focused on achieving the desired infusion and aspiration functions of system 2. Some of these features are shown and described in U.S. Patent Application Publication No. 2015 / 0224284, the disclosure of which is incorporated herein by reference in its entirety. For purposes of this disclosure, the tip of catheter 44 that is inserted into biological material, e.g., a patient's body, will be referred to as the distal tip or end of catheter 44, and the tip that remains outside the biological material will be referred to as the proximal tip or end of catheter 44.

[0126] As shown in FIGS. 14 and 15 , the catheter 44 may be a dual-lumen catheter. The catheter 44 may include an infusion lumen 104 and an aspiration lumen 106, each formed by one or more lumen walls extending generally from the proximal end of the catheter 44 to the distal tip 108. It should be understood that certain lumens, i.e., the infusion lumen 104 and the aspiration lumen 106, may be switched. In one embodiment, the infusion lumen 104 may function as the outer catheter body. In one embodiment, the infusion lumen 104 and the aspiration lumen 106 diverge from each other at an intermediate location on the catheter 44. In one embodiment, the aspiration lumen 106 may be defined within the infusion lumen 104 along the length of the catheter 44 where the infusion lumen 104 and the aspiration lumen 106 converge. In one embodiment, infusate from the fluid source 10 is directed through the infusion lumen 104. In one embodiment, fluid aspirated from the intracranial cavity into the drainage container 12 is directed through the aspiration lumen 106. However, each of the infusion lumen 104 and the aspiration lumen 106 is structurally configured such that infusion or aspiration occurs therein depending on the particular flow direction enabled by the device attached to its proximal end.

[0127] As shown in FIG. 16 , the distal tip 108 of the catheter 44 can include multiple openings 110 and / or have porosity, commonly described as openings or ports. These openings 110 are designed to achieve desired performance for infusion of therapeutic fluids and evacuation of target tissues and fluids and solids of various characteristics, which may occur in connection with the treatment of disease or delivered therapy. The openings 110 perform a multifaceted role, allowing for optimal rates of both fluid infusion and fluid aspiration while maintaining free and unimpeded flow through the system 2. Specific design factors that affect the performance of the openings 110 in the distal tip 108 include, for example, the size of the openings 110, their location on the length or tip 108 of the catheter, their location relative to the target or surrounding tissue during use, their location relative to the aspiration lumen 106 of the catheter 44, the direction of fluid flow into and out of the aspiration lumen 106 relative to the openings 110, and the cross-sectional flow area of the openings 110 relative to the flow area of the aspiration lumen 106. These characteristics, among other things, affect the ability of catheter 44 to perform its infusion and aspiration functions as specified and desired.

[0128] The present disclosure can also include numerous additional catheter functions. For example, the catheter 44 may be configured to realize a multifunctional, self-regulating endoscopic system that includes one or more of the following components (by way of example only): an optical fiber for observation and / or video recording; an additional outer lumen for guiding a biopsy stylet, microforceps, or the like for biopsy or local tissue manipulation; one or more electrodes for monopolar or bipolar coagulation; a microdialysis catheter for biochemical and pharmacokinetic monitoring; one or more sensors within or associated with the catheter 44 (e.g., pressure, temperature, pH, specific molecule or compound sensors, etc.); a local irradiation probe; and an ultrasound probe for imaging and energy delivery, respectively, to aid in clot monitoring and dissolution. For example, the endoscopic system described above may simultaneously perform, for example, ultrasound treatment and / or microdialysis processes, followed by drug injection while, for example, pressure and temperature measurements and fluid drainage are performed. Furthermore, instead of simply expelling a substance, it may also be possible to collect tissue or fluid samples while administering a drug to the body or target tissue. For example, as a specific example of such a system for the treatment of solid malignant tumors, such an endoscopic system may be introduced into the interior of a pancreatic tumor under radiological control.

[0129] The catheter 44 of the present disclosure may include one or more of the following features. a large lumen, e.g., including a stylet for introducing the catheter 44 into the pancreatic tumor through a small incision in the patient's abdominal wall under radiological and / or imaging capabilities of its own; an optical fiber, e.g., that can be used for direct inspection of the introduction of the catheter 44 into the tumor and / or video recording of the procedure when radiological inspection is undesirable and / or insufficient for patient safety; an ultrasound probe, e.g., that can be used for direct inspection of the introduction of the catheter 44 into the tumor and monitoring its dimensions throughout treatment (ultrasonic energy may also enhance the efficacy of drug therapy); an injection lumen, e.g., for injecting Ringer's lactate solution, which may be provided inside an aspiration lumen that also includes other features such as the optical fiber described above, which solution may be used to clean the tip of the optical fiber and clear the surgeon's view; a biopsy stylet, e.g., that can be used to biopsy the tumor after introduction, i.e., after withdrawal of the stylet; and a central lumen of the catheter 44, e.g., a microsurgical instrument for manipulating local tissue separate from biopsy (such as microforceps for tissue dissection). the catheter 44 may be used for example through a central lumen, e.g., electrodes provided around the catheter 44, which may be used for example for bipolar coagulation of bleeding during the introduction of the catheter 44; electrodes, which may be used for example during surgical manipulation and / or during withdrawal from the patient's body, or to modify the physiological environment at the treatment site; a combination of three or more infusion lumens introduced into the larger lumen, e.g., after withdrawal of a biopsy stylet, which may be used for example for simultaneous administration of a cytotoxic chemotherapy solution, an analgesic solution, and an isotonic physiological solution for local drug concentration, temperature, pressure, and / or pain control; a combination, e.g., a microdialysis catheter, which may be used for local biochemical and / or pharmacokinetic monitoring; a sensor at the tip of an appropriately connected catheter, which may be used for example for monitoring local physicochemical parameters (temperature, pH value, ICP, etc.); and / or a local irradiation probe, e.g., made at least in part of iridium, which may be used through the central lumen, e.g., for local irradiation of a tumor after chemotherapy and before withdrawal of the catheter 44 from the body.The above-mentioned drugs and / or physiological infusions can be administered over several days and adjusted according to local biochemical and / or physicochemical parameters to enhance the drug's efficacy. Furthermore, additional lumens can be introduced if, for example, administration of antidotes to reverse drug toxicity and / or parallel administration of drugs designed to interact with the pathology for maximum therapeutic potential when administered simultaneously is required. Such information, potentially combined with the biochemical information provided by the microdialysis catheter, can assist physicians in optimizing and individualizing the administered chemotherapy treatment, for example, according to the response of the malignant tissue being treated. If necessary, new biopsy samples of tissue can be extracted and analyzed from time to time. For this purpose, the combination of the three infusion lumens can be temporarily removed, for example, to perform biopsy sampling using an appropriate stylet, microforceps, etc.

[0130] Several embodiments of the multi-lumen catheter may be considered to achieve the best infusion, aspiration, general flow, and / or deblocking performance of the catheter 44. The following description of individual embodiments may include features that may be advantageously included in other enumerated embodiments and are not exclusive to one embodiment, but may be interchangeable by those skilled in the art as needed.

[0131] In one embodiment, openings 110 included in the walls of the various catheter lumens 104, 106 are positioned so that infusate can be used to clear the openings 110 to maintain effective removal of fluid and small particles from the body cavity or tissue. In this design, the alignment of the openings is intended to direct the flow of infusate radially toward the openings 110, thereby improving deocclusion of the openings 110. Openings 110 are also provided in the wall of the infusion lumen 104, which are substantially aligned both axially and radially with the openings 110 provided in the aspiration lumen 106. The aligned openings 110 in the infusion and aspiration lumens 104, 106, may be axially distributed across different cross-sectional planes along the length of the catheter 44, occurring in, for example, a staggered, repeating, or random pattern. Infusion can occur as a steady stream of fluid directed toward the aligned openings 110 or shorter infusions. The catheter 44 may be formed as a multi-lumen extrusion such that the infusion lumen 104 is formed as a co-extrusion in the wall of the outer catheter body formed as a substantially separate lumen attached to the inner surface of the outer catheter body, a separate telescopically disposed lumen, or any combination thereof.

[0132] Apart from the suction function of the main lumen, additional lumens may be used for the aspiration and collection of tissue and fluids from a body cavity. This includes the collection of pathological fluids and tissues, the collection of septic fluids, fluid or blood sampling, drainage, fluid sampling for measurement or treatment monitoring, and / or general tissue sample collection. Additional lumens may be located radially at any point around the circumference of the outer diameter of the catheter 44. The additional lumens may be constructed as separate lumens within the outer catheter body, or as holes in the infusion lumen 104 or the thicker wall of the outer catheter body. The infusion lumen 104 may include openings to both the internal aspiration lumen on the outer diameter of the catheter body or between the infusion lumens. The description of each embodiment may be included in other listed embodiments, and several embodiments may be envisioned that include features not limited to a single embodiment.

[0133] In a further embodiment, the catheter 44 is formed as a multi-lumen extrusion with the aspiration lumen 106 located as a substantially axial hole in the wall of the infusion lumen 104, or as a co-extruded lumen directly adjacent to the wall of the infusion lumen 104. The aspiration lumen 106 may intersect with an opening 110. The opening 110 is formed as a slot, valve, hole, or any shape that provides for evacuation of media from the body cavity or tissue into the aspiration lumen 106 of the catheter 44. The infused bodily fluid is flushed axially over the opening 110 to remove particulates and / or deposits and help keep the port clear and open for bodily fluid flow. In another embodiment, the catheter 44 is formed as a multi-lumen extrusion with the aspiration lumen 106 located as a substantially axial hole in the wall of the infusion lumen 104, or as a co-extruded lumen directly adjacent to the wall of the infusion lumen 104. The aspiration lumen 106 intersects with and passes through the opening 110 to reach the next infusate outlet port on the aspiration lumen 106 or the exterior surface of the infusion lumen 104. In this manner, the opening 110 and the aspiration lumen 106 form a cross-forming intersection substantially within the catheter wall. The intersection between the aspiration lumen 106 and the opening 110 is configured to create a Venturi effect at the intersection by including a narrow portion of the aspiration lumen 106 at the intersection. The Venturi effect creates a suction at the opening 110, for example, to assist in drawing aspirated media from both sides of the catheter body into the aspiration lumen 106 and keep the opening 110 open and unobstructed.

[0134] In a further embodiment, an infusion lumen is included as a hole in the wall of the outer catheter body 104, providing either or both of the suction lumens 106 or ports that allow for the infusion of bodily fluids into the tissue or body cavity surrounding the catheter. The infusion lumens can be designated for specific purposes, such as the infusion of individual fluids or medications. This design can be employed to provide multiple ports of egress for infused bodily fluids, affecting tissues and bodily fluids both internal and external to the catheter 44.

[0135] In another embodiment shown in FIGS. 17 and 18 , the catheter 44 may have a stretchable structure and may include a sleeve 112 that covers the hollow or multi-lumen catheter 44. The sleeve 112 can slide over the outer surface of the catheter 44 so that the catheter 44 is substantially disposed within the sleeve 112. The sleeve 112 and the hollow or multi-lumen catheter 44 can be axially displaced relative to one another to allow debris or obstructions to be removed from an opening 110 in the catheter 44. The sleeve 112 can also be used to restrict flow or close the opening 110, thereby providing a valve function. The sleeve 112 can include at least one sleeve shoulder 113 extending from the inner circumferential surface of the sleeve 112. The sleeve shoulder 113 is received in the opening 110 of the catheter 44. The sleeve shoulder 113 is slidable within the opening 110 to remove debris or obstructions trapped in the opening 110. The catheter 44 can include any interchangeable configuration of single or multiple lumens 104, 106 for infusing and aspirating bodily fluids and for clearing the opening 110 with the infused bodily fluids. The sleeve 112 can move axially in a direction A relative to the catheter 44. The sleeve 112 can move between a first position (shown in FIG. 17 ) in which the opening 110 is closed and a second position (shown in FIG. 18 ) in which the opening 110 is open. The axial movement of the sleeve 112 relative to the catheter 44 can cause the sleeve shoulder 113 to push or guide any debris or obstructions in and out of the opening 110.

[0136] In another embodiment, shown in FIGS. 19 and 20 , a sleeve 114 is provided over a hollow or multi-lumen catheter 44. The sleeve 114 can slide over the exterior of the catheter 44 so that the catheter 44 is substantially disposed within the sleeve 114. The sleeve-catheter combination is configured to rotate to clear the opening 110. As the sleeve 114 and catheter 44 are rotated relative to one another, multiple sleeve elements 116 extending from the distal end of the sleeve 114 and positioned adjacent the opening 110 of the catheter 44 pass through the opening 110, clearing debris and obstructions from the opening 110. The sleeve 114 may also be used to restrict flow or close the opening 110, thereby providing a valve function. The catheter 44 can include any configuration of single or multiple lumens 104, 106 for infusion and aspiration of bodily fluids and for clearing the opening 110 with the infused bodily fluids. Sleeve 114 is rotatable in direction B about the longitudinal axis of catheter 44. Sleeve 114 is movable from a first position in which opening 110 is closed and a second position (shown in FIGS. 19 and 20) in which opening 110 is open. The rotational movement of sleeve 114 relative to catheter 44 allows sleeve 114 to push or guide any debris or obstructions away from opening 110.

[0137] For aspirated fluids traveling from the opening 110 to one of the aspiration lumens 106, interchangeably designated for the aspiration of fluids, materials, tissue, or infused materials from the body, the catheter aspiration lumen 106 is designed to minimize resistance, obstruction, or occlusion within the length of the catheter when draining fluids and solids from the body cavity. Specific design elements involved in achieving the desired unimpeded flow may include sizing the catheter and tubing diameter or cross-section according to the characteristics of the fluid being transported, the location or offset of the extruded cannula lumens relative to one another to avoid flow restrictions, cross-sectional dimensions, and length-to-length ratios, as well as the positional relationships between fluid management components to achieve the desired flow characteristics. These components include catheter ports, lumens, tubing, cassettes, antimicrobial or particle or other filters, flow regulators, heating devices, and reservoirs—all sections of the system where flow management can affect overall system performance.

[0138] The catheter 44 and tubing set 36 are designed to avoid kinking and deformation associated with flow obstruction. Kinking can be avoided, for example, through the polymers used in the catheter 44 and tubing set 36, the selection of structural elements such as reinforcements included in the catheter wall, and extrusion designs that separate structural components (such as wires and sheaths) that resist wall and lumen collapse and can be inserted, removed, or stretched to achieve desired mechanical properties. For example, kink resistance can be designed into the extrusion cross-section by including structural web profiles integrated into the lumen or lumen wall, such as an I-beam or other cross-section configuration that resists deflection in several directions, acute angle deflection, kinking, and any combination thereof. Such lumen cross-sections can also be varied or transitioned over the length of the catheter, tubing, or lumen to achieve desired design and use characteristics, such as atraumatic shape, deflection, elasticity, pushability, and kink resistance. Deflection and bending properties, including resistance to specific deformations, can also be achieved through functional components and materials appropriately embedded in the lumen wall. For example, functional components include one or more optical fibers, bipolar electrodes, ultrasound probes, or conductive or signal-transmitting leads such as wires for measuring pressure, temperature, tissue pH, and other properties.

[0139] The catheter 44, tubing set 36, and infusion and aspiration functions of system 2 may also include one or more sensors as part of the electronic control system to achieve the desired functionality and flow. These may include sensors located at the tip of the catheter, on the flow surface inside the lumen, outside the lumen (in contact with the body cavity or surrounding tissue), along the length of the catheter lumen, tubing, cassette, and / or appropriately integrated within the body fluid container to achieve the desired flow control, biophysical feedback, and collect biochemical information from the patient. These sensors may be positioned to monitor pressure, flow rate, pump function, pressure within the body cavity, tissue properties, and pH, among other parameters. For example, pressure sensors may be positioned both inside the catheter 44 and outside the catheter 44 to measure the differential pressure between the body cavity and the infused and / or aspirated body fluid. One or more MEMS-based sensors may also be included to measure the fluid velocity within the catheter 44, allowing for determining whether a higher fluid velocity is needed to break down solids in the aspirated fluid and / or whether a lower velocity is appropriate, for example, for aspirating low-viscosity fluids.

[0140] The catheter 44 may also include one or more lumens or guides that allow for the passage and insertion of instruments up to and beyond the distal tip of the catheter 44. Such instruments allow for directed therapy and diagnosis of tissue within a target body cavity adjacent or proximal to the distal end of the catheter. For example, instruments delivered through the catheter 44 may include microforceps and similar intraluminal tools, visual tools such as fiber optics, delivery tools for implants such as radioactive seeds or probes, drug-eluting implants, markers, adhesives, fasteners, ligation devices, hemostats, electrocautery, microscalpels, dissectors, balloons, and / or instruments for extracting biopsy samples. Additional lumens may also be used for ultrasound devices that allow imaging and visualization and / or energy transmission for thrombus dissolution or tissue dissection. Additional lumens may also be used for tissue dissection with a controlled jet of autoclaved water or physiological fluid.

[0141] The additional lumen also allows for the delivery of drugs or therapeutic agents and antidotes for thrombolysis, coagulation, chemotherapy, infection control, hormone therapy, cell seeding, cell therapy, markers, and / or therapies applied directly to the target pathology and surrounding tissue. Delivery of such agents may be directed to the body fluid within the infusion lumen 104 for the purpose of mixing, dissolving, or altering the properties of the infused or aspirated fluid. Generally, such drugs are not specifically limited to any particular category of medicinal fluid. Drugs suitable for catheter administration are generally known to those skilled in the art, including all drugs suitable for local injection under the skin. The at least one drug or several different drugs may be selected from the group including antibiotics, anti-inflammatory drugs (e.g., corticosteroids, immunoselective anti-inflammatory drugs), analgesics (e.g., nonsteroidal anti-inflammatory drugs, opioids), chemotherapeutic drugs (e.g., alkylating agents, antimetabolites, anthracyclines), and hormones (e.g., insulin, HGH). The catheter 44 or system 2 of the present disclosure can also be used to treat pain. Thus, in certain embodiments, the (at least one) drug is selected from an analgesic. Analgesics as used herein may include narcotics and the like.

[0142] In another embodiment, the catheter 44 or system 2 of the present disclosure is used to treat cancer. Non-limiting examples of cancer include pancreatic tumors, liver tumors, and brain tumors such as gliomas or craniopharyngiomas. Thus, in certain embodiments, the (at least one) drug is selected from chemotherapeutic agents, such as cytostatic and cytotoxic chemotherapeutic agents. Non-limiting examples of such drugs include fluorouracil, methotrexate, purine analogs, nitrosoureas, platinum compounds, alkylating agents, antitumor antibiotics, and the like.

[0143] In certain embodiments, the catheter 44 of the system 2 of the present disclosure is used to remove material, such as unwanted material, from the body. Preferred examples of such material are selected from the group including blood, coagulated blood, blood clots (thrombi), pus, toxic substances, excess drugs, and / or pathological tissue. Other examples of such material include tissue, such as a tissue sample.

[0144] In one embodiment, the catheter 44 or system 2 of the present disclosure is used to treat cerebral vasospasm. In certain embodiments, the catheter 44 of the present disclosure is used to treat subarachnoid hemorrhage (SAH). The latter embodiment may involve the removal of subarachnoid blood and / or administration of at least one drug. Preferred, non-limiting examples of such drugs include papaverine, urokinase, rTPA, and the like. In one embodiment, the catheter 44 or system 2 of the present disclosure is used as a self-regulating system that does not require the presence of a clinician, physician, and / or medical personnel, or that exceeds the human ability to, for example, (rapid) change therapy. In certain embodiments, the catheter 44 of the present disclosure is used in an intensive care unit (ICU). In certain embodiments, the catheter 44 or system 2 of the present disclosure is used to monitor a site within a patient's body, which monitoring may include (by way of example only) observation (direct and / or via closed-circuit or other viewing technology) and / or video recording.

[0145] Flow control within the catheter 44 may be desirable, for example, to provide specific flow protocols, manage infusion and aspiration flows, or optimize the effectiveness of the infusion flow without, for example, losing infusion fluid to the aspiration line. In the present disclosure, flow control may be desirable to optimize the deocclusion of the opening 110 in the catheter body 104, more precisely manage infusion pressure into a body cavity or tissue by controlling pressure relief paths, or create better agitation of the media surrounding the catheter 44. To achieve this type of control, a valve 118 may be integrated as part of the catheter 44, such as a moving or deflecting element 120, a balloon 122, or a fluid resistor 124 may be used to create a functional obstruction or regulator of flow in the aspiration lumen or any lumen. The valve 118 may be actuated by the infusion flow or separately by a mechanism, shape-memory, or shape-guiding element. The valve 118 may also be passively actuated when infusion pressure is introduced into the infusion lumen 104. That is, valve 118 may be actuated solely by controlled fluid infusion rather than by a separate electronic or mechanical valve device (e.g., a door-like cover over the distal opening of the infusion lumen that is deflected by infusion pressure to completely cover aspiration lumen 106 and returns to its original position when infusion stops). The following embodiments may be considered to include valve 118 in catheter 44. The description of individual aspects may include features that may be included in other listed aspects and are not limited to one aspect.

[0146] Generally, and in the interest of safe operation, the control unit 4 or system 2 of the present disclosure may be designed, based on sensor and pressure feedback data, to operate the valve 118 in a high-pressure default open position, in which the valve 118 is opened if the intraoperative pressure (or intracavity pressure) is too high. Similarly, the control unit 4 or system 2 may conversely operate the valve 118 in a low-pressure default closed position, in which the valve 118 is closed if the intraoperative pressure (or intracavity pressure) is too low. The default valve positions, valve functions to meter or limit flow rates, and motor functions to achieve (or respond to) specified flow rates and pressures may be directed by the control unit according to a sequence and appropriate algorithm to execute a desired treatment protocol appropriate for the body cavity, tissue, disease, or condition being treated.

[0147] As shown in FIG. 21 , one embodiment of the valve 118 includes one or more inflatable valve leaflets 120 in the lumens of the multi-lumen catheter 44. The valve leaflets 120 function such that flow through the aspiration lumen 106 is reduced or blocked by the introduction of fluid pressure into the infusion lumen 104 or multiple infusion lumens, causing the valve leaflets 120 to expand, deploy, or deflect. The valve leaflets 120 move from a first, open position to a second, closed position upon filling in response to infusion fluid pressure. The valve leaflets 120 may be elastic or inelastic, porous or non-porous. The valve leaflets 120 can return to an open position opposite the first lumen wall in response to a decrease in pressure, the flow of aspirated fluid, and / or a passive response to the folding memory of the valve leaflet membrane. A valve, such as a check valve, may be provided in the infusion lumen 104 proximal to the valve leaflets 120 to allow infusion fluid to drain through the valve leaflet membrane.

[0148] 22 , one embodiment of the valve 118 provides a valve function by including at least one expandable balloon 122 in a lumen of the catheter 44, such that the introduction of pressure in the infusion lumen 104 reduces or occludes flow in the aspiration lumen 106, causing inflation of the balloon 122. The balloon 122 may be included in the wall of the infusion lumen 104 as an elastic or inelastic membrane between the lumens. The balloon 122 may also be porous or non-porous to allow infusate to enter the aspiration lumen 106 through the porous membrane, separately through the opening 110, or via a separate lumen. A valve, such as a check valve, may be provided in the infusion lumen 104 proximal to the balloon 122 to allow infusate to exit through the balloon membrane. The balloon 122 may expand with an increase in pressure in the infusion lumen 104 and collapse with a decrease in pressure due to a balloon membrane leak, infusion into the aspiration lumen 106, or a pressure change caused by the controller.

[0149] The restriction of aspiration flow by balloon valve 122 allows the infusion flow to be better directed into aspiration lumen 106 without uncontrolled loss of infusate into aspiration lumen 106. This dynamic may be implemented to protect opening 110 from debris, to agitate the media surrounding catheter 44, or to provide a desired flow or pressure to a body cavity or tissue.

[0150] 23 , in one embodiment of the catheter 44, flow within the aspiration lumen 106 of the multi-lumen catheter 44 is reduced or stopped by introducing flow and fluid pressure 124 in the opposite direction from the infusion lumen 104 into the same aspiration lumen 106. Aspiration flow through the aspiration lumen 106 occurs under relatively high frictional flow resistance as a result of the small lumen cross-sectional dimensions over long catheter lengths (e.g., lengths greater than 5 cm). Flow resistance is a function of fluid viscosity, flow area, and length. Thus, if a fluid valve or port 126 allowing infusion flow 124 from the infusion lumen 104 to the aspiration lumen 106 is positioned a relatively long length (e.g., greater than 5 cm) proximally from the opening 110 at the distal tip of the catheter 44, the infusion flow 124 and pressure provided by the infusion lumen 104 at the fluid valve or port 126 will restrict flow within the aspiration lumen 106 in a direction substantially opposite to the aspiration flow. In this manner, a valve 118 can be provided within the catheter 44 or tubing set 36 to provide valve function without mechanical displacement of a flow obstruction within the catheter 44 and without the need to construct or manufacture a mechanical valve structure within the catheter 44.

[0151] Various additional features or functions may also be included in the fluid exchange system 2 of the present disclosure. For example, features may be included in the catheter 44 of the fluid exchange system 2 to facilitate use of the catheter 44 by a clinician or physician, improve the feel of the catheter 44 during use, and provide both patient safety and clinician confidence in low-risk use. These catheter features include an atraumatic distal tip designed to conform to the intended surrounding body tissue and maneuverability of the catheter 44, including the use of one or more guidewires, one or more sheaths, and / or other surgical navigation means and methods for safer and more effective introduction into a body cavity or target tissue.

[0152] In addition to measuring and managing flow, the disclosed system 2 can also include sensors, algorithms, and associated methods of use and their specific placement to characterize either or both the infused and aspirated fluids. Fluid characteristics may include aeration, air bubble content, solid or particulate content, fluid density, particle dispersion in the fluid, color, hemoglobin, biological content, molecular and nanoparticle content (including pharmaceuticals), and additional physical fluid characteristics such as density, pH, radioactivity, and electrical properties. For example, the control unit 4 may include an ultrasonic sensor, typically positioned as a cuff or horseshoe around the tubing set 36, to detect air bubbles and particulates in the aspirated (or infused) fluid. Pressure sensors positioned along any segment or component of the fluid flow can also be used to detect pressure drops or differences, indicating changes in fluid characteristics, air entrapment, or flow restriction. Sensors may also be included in or positioned on the fluid source 10 and / or drainage container 12 to indicate the fluid level in the container and characterize the contained fluid as described above. Load and fluid level sensors may be included to indicate the weight and volume of fluid aspirated, as well as the rate of fluid aspiration and fluid infusion. Optical flow sensors that measure droplets in the drip chambers of the infusion and aspiration containers can also be used to monitor the amount of fluid infused and aspirated.

[0153] System 2 may also include an output device for providing a signal output corresponding to the determined brain compliance. The fluid infusion into the intracranial cavity may include an opium alkaloid antispasmodic, preferably papaverine, or other agent appropriate for the intended treatment.

[0154] System 2 may be used for a variety of reasons identified by the medical professional. Because typical hematoma evacuation systems suffer from catheter clogging, the medical professional may want to drain the patient's hematoma in a safe manner that avoids catheter clogging. Because ICP is a good indicator of the patient's current condition, the medical professional may want to monitor the patient's ICP. Because the medical professional needs to see changes in the patient's condition, the medical professional may want to be able to set low and high pressure alarm levels. Because the medical professional knows what is important in intensive care, the medical professional may want to extract a log file containing procedure details from control unit 4 and attach it to the patient's medical record. Because the patient may need to be moved while System 2 is performing the procedure, the medical professional may want to use a device that operates using battery power. Because different patient conditions require different fluid flow rates, the medical professional may want to change the fluid flow rate. Because pressure changes up and down more quickly than an ICP measurement, the medical professional may want to check the current pressure in the patient's brain. Because the system needs to be disconnected from the patient during a CT scan, for example, the medical professional may want to stop the procedure and resume it at a later time. A medical professional may want to avoid infusing air into a patient when the fluid source is empty, as infusing large amounts of air can be harmful to the patient. A medical professional may want to check the battery charge level to determine how long the device can run on the current battery. A medical professional may want to ensure that the time and date are accurate before starting a procedure, as the logs that are extracted and attached to the patient's medical record require accurate dates and times. A medical professional may want to see the current treatment stage, as this accounts for pressure fluctuations in the patient's brain's current pressure. A medical professional may want to check the elapsed treatment time.

[0155] According to a further aspect, the present disclosure relates to a method of treating a patient, comprising administering at least one drug to a patient in need thereof via a catheter 44 or system 2 of the present disclosure. A further aspect herein is a drug or drug combination for use in a method of treating the human or animal body by surgery or therapy, wherein a catheter 44 or system 2 of the present disclosure is used in said method. Preferably, in the latter aspect, the drug or drug combination is administered to the patient via a catheter 44 or system 2 of the present disclosure. Preferably, the drug combination includes at least two drugs. A related aspect herein is a drug or drug combination for use in a diagnostic method performed on the human or animal body, wherein a catheter 44 or system 2 of the present disclosure is used in said method. In a particular aspect, a diagnostic agent is administered to the patient via a catheter 44 or system 2 of the present disclosure.

[0156] Upon reading this disclosure, the many benefits of the present disclosure will become apparent to those skilled in the art. It will be understood that the various components and aspects described herein are merely exemplary embodiments, and that the present disclosure (or its components or aspects) can extend beyond the specific clinical indication of cerebral vasospasm. For example, the fluid exchange system 2 and each of the methods disclosed herein can have broad applicability to other fields of medicine, including, but not limited to, treatments involving the delivery of drugs or therapeutic agents and antidotes for thrombolysis, coagulation, chemotherapy, infection control, hormone therapy, cell seeding, cell therapy, markers, and therapies applied directly to the target surrounding tissue. The fluid exchange system 2 of the present disclosure can serve both all surgical drainage needs and all invasive local drug delivery needs.

[0157] While the above description provides various aspects of a system and a user interface and a method for operating the user interface, those skilled in the art may make modifications and variations to these aspects without departing from the scope and spirit of the present disclosure. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any aspect may be combined with one or more features of any other aspect. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The present invention as described above is defined by the appended claims, and all modifications of the invention that come within the meaning and range of equivalency of the claims are intended to be embraced within their scope.

Claims

1. 1. A bodily fluid exchange system comprising: a control unit including a processor; a tubeset attachment removably connected to the control unit, the tubeset attachment including a tubeset fluidly connected to a source of bodily fluid and a drainage container; a catheter fluidly connected to the tubing set; at least one sensor disposed on at least one of the control unit and the tubeset attachment; Including, the control unit is configured to supply bodily fluid to a patient through the tubing set and drain bodily fluid from the patient through the tubing set; the control unit is configured to receive measurements from the at least one sensor and regulate the supply of the bodily fluid to and the drainage of the bodily fluid from the patient; A bodily fluid exchange system, wherein when a difference between a first measurement value and a second measurement value exceeds a first pressure threshold or is less than a second pressure threshold, the control unit is configured to issue a pressure signal output to indicate that the first pressure threshold has been exceeded or that the difference between the first measurement value and the second measurement value is less than the second pressure threshold.

2. the at least one sensor includes a pressure sensor; The fluid exchange system of claim 1 , wherein the at least one sensor transmits pressure measurements to the control unit.

3. The fluid exchange system of claim 2 , wherein the at least one sensor is disposed within a cassette of the tubeset attachment.

4. The fluid exchange system of claim 2 , wherein the at least one sensor transmits intracranial pressure measurements to the control unit.

5. the at least one sensor includes a pressure sensor; the at least one sensor is disposed in the control unit; The fluid exchange system of claim 1 , wherein the at least one sensor transmits an intracranial pressure measurement to the control unit.

6. 2. The fluid exchange system of claim 1, wherein the control unit is further configured to initiate the drainage of the bodily fluid from the patient when the difference between the first measurement and the second measurement from the at least one sensor exceeds the first pressure threshold.

7. 2. The fluid exchange system of claim 1, wherein the control unit is further configured to initiate infusion of the bodily fluid into the patient when the difference between the first measurement and the second measurement from the at least one sensor falls below the second threshold.

8. The fluid exchange system of claim 1 , wherein the bodily fluid comprises a pharmaceutical or therapeutic agent.

9. The fluid exchange system of claim 1 , wherein the measurements received from the at least one sensor include intracranial pressure.

10. The catheter a first lumen including a proximal end and a distal end; a second lumen disposed within the first lumen, the second lumen including a proximal end and a distal end; a valve disposed within at least one of the first lumen and the second lumen and configured to control the flow of bodily fluid through the catheter; a sleeve disposed at the distal end of the first and second lumens; The bodily fluid exchange system of claim 1 , comprising:

11. at least one opening is defined in at least one of the first lumen and the second lumen; the sleeve is axially displaceable relative to the first lumen and the second lumen; 11. The bodily fluid exchange system of claim 10, wherein the sleeve is movable between a first position in which the at least one opening is covered by the sleeve and a second position in which the at least one opening is not covered by the sleeve.

12. at least one opening is defined in at least one of the first lumen and the second lumen; 11. The bodily fluid exchange system of claim 10, wherein the sleeve is rotationally displaceable relative to the first lumen and the second lumen, and the sleeve is movable between a first position in which the at least one opening is covered by the sleeve and a second position in which the at least one opening is not covered by the sleeve.

13. The fluid exchange system of claim 1 , wherein the tubeset attachment further comprises a cassette configured to removably connect the tubeset attachment to the control unit.

14. The fluid exchange system of claim 1 , wherein the control unit further comprises a pump for supplying fluid from the fluid source to the patient through the tubing set.

15. 2. The fluid exchange system of claim 1, wherein the tubing set includes a first tube fluidly connected at a first end to the fluid source and at a second end to the catheter, and a second tube fluidly connected at a first end to the catheter and at a second end to the drain container.

16. The fluid exchange system of claim 1 , wherein the fluid source comprises an infusion bag.

17. The fluid exchange system of claim 1 , wherein the drainage container comprises a suction bag.

18. The bodily fluid exchange system of claim 1 , wherein the drainage container is connected to the control unit via a graduated measuring band.

19. The bodily fluid exchange system of claim 1 , wherein the drain container is vertically adjustable relative to the control unit.

20. The fluid exchange system of claim 1 , wherein the tubeset attachment further includes at least one pressure sensor for measuring the pressure of the bodily fluid flowing through the tubeset.

21. The fluid exchange system of claim 1 , wherein the tube set attachment is disposable.

22. The fluid exchange system of claim 1 , wherein the tubeset attachment includes a security valve disposed between a portion of the tubeset and a cassette fluidly connected to the tubeset.

23. 10. The fluid exchange system of claim 1, wherein the control unit further comprises a graphical user interface including at least a flow rate indicator and an intracranial pressure alarm for monitoring intracranial pressure levels in a patient connected to the fluid exchange system.

24. 24. The fluid exchange system of claim 23, wherein the intracranial pressure alarms include a high intracranial pressure threshold alarm and a low intracranial pressure threshold alarm.

25. The fluid exchange system of claim 1 , wherein the control unit further comprises an air sensor connected to a portion of the tubing set to identify when the fluid source is empty.

26. 1. A computer-implemented method for monitoring intracranial pressure using a fluid exchange system, comprising: receiving, at a processor, a first pressure value in the intracranial cavity; injecting a fluid into the intracranial cavity; receiving, with the processor, a second pressure value in the intracranial cavity; using the processor to calculate a difference between the first intracranial pressure and the second intracranial pressure; if the difference between the first intracranial pressure and the second intracranial pressure exceeds a first pressure threshold or is less than a second pressure threshold, issuing a pressure signal output via the processor to indicate that the first pressure threshold has been exceeded or that the difference between the first intracranial pressure and the second intracranial pressure is less than the second pressure threshold; A computer-implemented method comprising:

27. the processor determines a first time curve of pressure corresponding to the first measured pressure valve; 27. The computer-implemented method of claim 26, wherein the processor determines a second time course of pressure corresponding to the second measured pressure valve.

28. 27. The computer-implemented method of claim 26, further comprising the step of calculating, via the processor, a first derivative from the first measured pressure value and a second derivative from the second measured pressure value.

29. 30. The computer-implemented method of claim 28, further comprising determining, via the processor, a first maximum slope value of the first derivative and a second maximum slope value of the second derivative.

30. calculating, via the processor, a difference between the first maximum gradient value and the second maximum gradient value; if the difference between the first maximum slope value and the second maximum slope value exceeds the first pressure threshold or is less than the second pressure threshold, issuing a pressure signal output via the processor to indicate that the pressure threshold has been exceeded or that the difference between the first maximum slope value and the second maximum slope value is less than the second pressure threshold; 30. The computer-implemented method of claim 29, further comprising:

31. 27. The computer-implemented method of claim 26, further comprising activating the fluid exchange system via the processor to aspirate fluid from the intracranial cavity to reduce the intracranial pressure when the first pressure threshold is exceeded.

32. 27. The computer-implemented method of claim 26, further comprising activating the fluid exchange system via the processor to infuse additional fluid into the intracranial cavity to increase the intracranial pressure when the difference between the first intracranial pressure and the second intracranial pressure is less than the second pressure threshold.

33. A catheter for a body fluid exchange system, comprising: a lumen including a proximal end and a distal end and a lumen wall extending between the proximal end and the distal end, the lumen wall defining an interior lumen space; at least one opening defining a passageway through the lumen wall into the interior lumen space; a movable sleeve covering at least a portion of the lumen wall; Including, The catheter, wherein the sleeve is movable relative to the lumen wall between a first position in which the sleeve covers a first amount of the at least one opening and a second position in which the sleeve covers a second amount of the at least one opening, the second amount being greater than the first amount.

34. 34. The catheter of claim 33, wherein the sleeve is axially displaceable relative to the lumen wall between the first position and the second position.

35. 35. The catheter of claim 34, wherein the sleeve further includes a sleeve shoulder at least partially disposed within one of the at least one opening, and wherein axial displacement of the sleeve relative to the lumen wall between the first position and the second position causes the sleeve shoulder to slide within one of the at least one opening to clear debris from the one of the at least one opening.

36. the sleeve including a plurality of sleeve shoulders, and the catheter including a plurality of openings each defining a passageway through the lumen wall into the interior lumen space; each of the sleeve shoulders is at least partially disposed in one of the plurality of openings; 36. The catheter of claim 35, wherein axial displacement of the sleeve relative to the lumen wall between the first position and the second position causes each of the sleeve shoulders to slide within the one of the plurality of openings to clear debris from the one of the plurality of openings.

37. the sleeve is rotatable relative to the lumen wall between the first position and the second position.

34. The catheter of claim 33.

38. the sleeve includes at least one sleeve element; 38. The catheter of claim 37, wherein rotation of the sleeve relative to the lumen wall causes the at least one sleeve element to pass over the at least one opening to clear debris from the at least one opening.

39. the sleeve includes a plurality of sleeve elements and a plurality of openings each defining a passageway through the lumen wall into the interior lumen space; 39. The catheter of claim 38, wherein rotation of the sleeve relative to the lumen wall causes the plurality of sleeve extensions to pass over the plurality of openings to clear debris from the plurality of openings.

40. 38. The catheter of claim 37, wherein the first amount is not equal to any of the at least one opening.

41. 34. The catheter of claim 33, wherein the catheter further comprises a second lumen disposed within the interior lumen space.

42. A catheter for a body fluid exchange system, comprising: a first lumen including a proximal end and a distal end and a lumen wall extending between the proximal end and the distal end, the lumen wall defining a first interior lumen space; at least one opening defining a passageway through the luminal wall of the first lumen into the first interior luminal space; a second lumen including a proximal end and a distal end and a lumen wall extending between the proximal end and the distal end and defining a second interior lumen space, the second lumen being disposed within the first interior lumen space, the lumen wall of the second lumen separating the first interior lumen space from the second interior lumen space; a valve disposed in the lumen wall of the second lumen, the valve adapted to restrict flow of bodily fluid through the first internal lumen space using flow of bodily fluid through the second internal lumen space; A catheter comprising:

43. the first lumen is connected to a suction device adapted to aspirate bodily fluid through the first internal lumen space; the second lumen is connected to an infusion device adapted to infuse an infusate through the second internal lumen space; the valve is an opening in the lumen wall of the second lumen; the opening is disposed proximal to the at least one opening; 43. The catheter of claim 42, wherein flow of a portion of the infusate fluid from the second internal lumen space to the first internal lumen space through the opening limits flow of the aspirate fluid through the first internal lumen space.

44. 43. The catheter of claim 42, wherein the valve comprises an inflatable balloon valve, and wherein flow of bodily fluid through the second internal lumen space causes the balloon valve to expand into the first internal lumen space, thereby restricting flow through the first internal lumen space.

45. 45. The catheter of claim 44, wherein the balloon valve has a porous surface that allows bodily fluid flowing through the second interior space to enter the first interior lumen space.

46. 46. The catheter of claim 45, wherein the second lumen includes a check valve that restricts flow through the second lumen, the check valve being located between a proximal end of the second lumen and the balloon valve.

47. 43. The catheter of claim 42, wherein the valve includes at least one leaflet, and wherein flow of bodily fluid through the second internal lumen space causes the at least one leaflet to extend into the first internal lumen space, thereby restricting flow through the first internal lumen space.

48. 48. The catheter of claim 47, wherein the valve includes a plurality of leaflets, and wherein flow of bodily fluid through the second internal lumen space causes each of the plurality of leaflets to extend into the first internal lumen space, thereby restricting flow through the first internal lumen space.

49. 48. The catheter of claim 47, wherein the at least one leaflet is porous to allow bodily fluid to flow through its thickness.

50. 1. A method of delivering a drug to a patient, comprising: activating a control unit of the bodily fluid exchange system of claim 1; infusing the drug into the patient through the tubing set and catheter of the fluid exchange system; monitoring the measurements received from the at least one sensor; draining fluid from the patient via the catheter and tubing set if the measurement exceeds a high threshold; A method comprising:

51. 51. The method of claim 50, wherein the drug comprises a pharmaceutical or therapeutic agent.

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