Systems and methods for reducing catheter leakage

Abstract

The systems and methods described herein relate to an intracardiac blood pump system comprising a pump, an elongated multi-lumen catheter, a compartment connected to the catheter, a first lumen, a conduit, and a filter disposed in the conduit. At least one electronic component is located in the compartment. The conduit extends through an interface between the compartment and the conduit. The conduit is configured to allow gas to penetrate from a first end of the conduit through a first opening of the compartment to a second end of the conduit. The second end of the conduit is in fluid communication with a central lumen of the elongated multi-lumen catheter. The filter is configured to prevent liquid from flowing out of the multi-lumen catheter into the compartment after allowing gas to flow from the first end of the conduit through the second end of the conduit and into the multi-lumen catheter.

Description

[0001] Citation of Related Applications

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 700,683, entitled “SYSTEMS AND METHODS FOR REDUCING LEAKS FROM A CATHETER,” filed on July 19, 2018. The entire contents of the above application are incorporated herein by reference. Background Art

[0003] An intracardiac heart pump assembly can be introduced into the heart surgically or percutaneously and is used to move blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the heart, an intracardiac pump can pump blood from the left ventricle of the heart into the aorta, or from the right ventricle to the pulmonary artery. An intracardiac pump can be powered by a motor located outside the patient's body or by a motor located inside the patient's body. Some intracardiac blood pump systems can operate in parallel with the natural heart to supplement cardiac output and partially or completely relieve the heart of its workload. Examples of such systems include Series of devices (Abiomed, Inc., Danvers MA).

[0004] The blood pump system includes a pump and a compartment. One end of the catheter is connected to the pump and the other end is connected to the compartment. The catheter usually includes multiple fluid lumens that carry liquid to the pump in a distal direction. The compartment can be multifunctional. In some modifications, it includes mechanical components and electronics that enable the pump to operate and maintain. Leakage in the lumen of the catheter may reach the compartment and damage the electronic components in the compartment. Leakage may cause, for example, the pump to stop working or the pressure of the entire system to drop. Summary of the invention

[0005] This article describes systems, methods and devices for preventing leakage in intracardiac blood pump systems. Such systems can prevent fluid from flowing out of a catheter into a compartment of a blood pump system containing electronic components while maintaining the function of the pump. A filter as described herein is advantageously placed between the catheter and the compartment of the blood pump system to differentially seal the compartment. For example, the filter allows sterilizing gas to pass through the filter to reach the catheter, but prevents liquid from the catheter (e.g., as a result of a leak) from passing through the filter and entering the compartment.

[0006] In some embodiments, the intracardiac blood pump system includes a pump, a catheter proximal to the pump, a compartment proximal to the catheter, a tube extending through an interface between the compartment and the catheter, and a filter within the tube. For example, the blood pump system may be a Device or any other suitable system. In some embodiments, the controller is configured to facilitate operation of the blood pump system described herein. For example, the controller can be an automated impeller controller (AIC) from Abiomed Corporation. or any other suitable controller that receives input signals and translates them into operating signals to operate the pump.At least one advantage of a standalone controller configured to facilitate operation of an intracardiac blood pump system is precise control of the system and acquisition of data related to the system.

[0007] In some embodiments, the pump includes a housing and a rotor disposed in the housing. The rotor may have at least one blade. Specifically, the rotor may include an impeller blade that is shaped to cause fluid flow when under a rotational force. In some embodiments, the rotor is driven by an implantable motor having a rotor and a stator. The proximal end of the rotor may be coupled to a drive shaft. In some embodiments, the motor is external to the patient and drives the rotor through an elongated mechanical transmission element (such as a flexible drive shaft, a drive cable, or a fluid coupling).

[0008] In some embodiments, the catheter is an elongated multi-lumen catheter with a proximal end, a distal end, and a central lumen. The distal end of the elongated multi-lumen catheter can be adjacent to the pump housing. For example, when the blood pump system is in use, the pump housing is placed inside the patient's heart, and the elongated multi-lumen catheter can extend from the patient's heart and pass through the patient's vascular system, so that the first part of the catheter is in the patient's body, and the second part of the catheter is outside the patient's body. The catheter can include two, three, four, five or any suitable number of lumens. For example, two separate tubes can pass through the central lumen of the catheter, thus defining a total of three lumens--a first central lumen, a lumen passing through the first tube, and a lumen passing through the second tube. Some lumens can extend the entire length of the catheter, while other lumens can only partially extend through the catheter.

[0009] In some embodiments, the compartment is near the proximal end of the catheter. For example, the distal end of the compartment can be located adjacent to the proximal end of the catheter. At least one advantage of positioning the compartment adjacent to the proximal end of the catheter is that the pipe can extend through the compartment and enter the lumen of the catheter. In some examples, the catheter can partially extend in the compartment (for example, to provide structural support at the connection point between the catheter and the compartment). In some examples, the proximal end of the catheter is close to the distal end of the compartment.

[0010] In some embodiments, the blood pump system also includes a connector at the interface between the compartment and the catheter. The first lumen and the conduit can pass through the connector. In some embodiments, the connector has an internal volume, and the filter fills at least 50% of the internal volume of the connector. In some examples, the connector partially extends into the compartment. In some examples, the catheter partially extends into the connector. At least one advantage of providing a connector between the compartment and the catheter is that additional structural stability is provided at the connection point between the two elements. For example, the connector can prevent the catheter from being sharply bent or kinked where it is connected to the compartment.

[0011] In some embodiments, the compartment includes a first opening and one or more side ports. The first opening of the compartment can be located at the distal end of the compartment and connected to the proximal end of the catheter. The one or more side ports of the compartment can be located at the proximal side of the first opening of the compartment. For example, one or two side ports can be provided between the distal end and the proximal end of the compartment. At least one advantage of providing a side port is that the lumen of the fluid transported is allowed to enter the compartment and then extend into the proximal end of the catheter. Specifically, the side port provides a connection to an external fluid source, and the external fluid source can provide fluid to a pump or a patient through a catheter.

[0012] In some embodiments, there is at least one electronic component in the compartment. The at least one electronic component may include a memory, a pressure transducer and / or a pressure sensor. For example, a printed circuit board including a transistor, an inductor, a resistor, a capacitor, a sensor or any other suitable element may be disposed in the compartment. The electronic equipment in the compartment may also allow the pump to be connected to a pump controller. At least one advantage of including a storage element in the compartment is that if the pump is connected to multiple controllers at different time points, the blood pump system can store operating parameters to be used. At least one advantage of including a pressure transducer and / or a pressure sensor in the compartment is that the pump system can "translate" pressure readings (e.g., from a pressure transducer) so that a pressure signal or related parameters can be sent to a controller and displayed to a user.

[0013] In some embodiments, the first lumen of the elongated multi-lumen catheter is configured to transport a fluid from an external source. The fluid can be transported to the distal end of the elongated multi-lumen catheter through one or more side ports of the compartment and through the first opening of the compartment. In some embodiments, the first lumen passes through the compartment. For example, the first lumen can be defined by a first endpoint outside the compartment, extending through a portion of the compartment, entering the catheter, and terminating at a second endpoint in the catheter or terminating at the distal end of the catheter. In some embodiments, the first lumen is in the central lumen. At least one advantage of placing the first lumen in the central lumen is that a single tube including all other tubes extending from the compartment is provided to prevent entanglement and / or kinking of the tubes. In addition, by placing the first lumen in the central lumen, the first lumen is protected from external forces (e.g., scratches, etc.) by an extra layer of tube.

[0014] In some embodiments, the fluid is blood, saline, purified fluid, glucose, heparin or any other suitable material or combination thereof. For example, the fluid may include dextrose and heparin. In some embodiments, the fluid includes a purified fluid that flows through the first lumen to reach the rotor to maintain the pump substantially free of blood. At least one advantage of using a purified fluid is that the flow of the purified fluid can provide a barrier to prevent blood from entering the gap between the rotor and the motor stator or pump housing, otherwise the gap may damage the blood (e.g., hemolysis) or damage the motor (e.g., increased friction, overheating and / or getting stuck). For example, the purified fluid may include dextrose and heparin. At least one advantage of using a combination of dextrose and heparin is that the formation of blood clots is prevented (e.g., via anticoagulant heparin) with an appropriate amount of active agent while maintaining biocompatibility and flow.

[0015] In some embodiments, the blood pump system further comprises a second lumen of the elongated multi-lumen catheter. The second lumen may be configured to transport a second liquid. In some examples, the second lumen extends through the compartment. The second fluid may also be transported from an external source through one or more side ports of the compartment and through the first opening of the compartment to the distal end of the elongated multi-lumen catheter. In some examples, the second lumen is a pressure lumen and the second fluid is saline. The second lumen may have an opening located distal to the compartment. At least one advantage of the second lumen is that the second lumen may transport a different fluid from the first lumen and may be provided via different external sources. For example, the first lumen may transport a purified fluid, while the second lumen may transport saline, and the purified fluid and saline may be maintained separate from each other.

[0016] In some embodiments, the pipeline extends through the interface between the compartment and the multi-lumen catheter. The pipeline can include a first end located near the first opening of the compartment and a second end located far from the first opening of the compartment, so that the pipeline spans the first opening of the compartment. Positioning the pipeline in the compartment and the catheter allows liquid or gas to be inserted into the catheter from the compartment, and therefore provides a passage into the central lumen of the catheter. The pipeline is configured to transport gas from the first end of the pipeline through the first opening of the compartment to the second end of the pipeline. The second end of the pipeline can be in fluid communication with the central lumen of the elongated multi-lumen catheter. For example, the proximal end of the pipeline can extend into the compartment over a short distance, and the distal end of the pipeline can extend into the catheter over a short distance. The system can be immersed in an environment filled with gas introduced via an external gas source, and the pipeline can allow gas to penetrate into the inside of the catheter. At least one advantage of delivering gas to the inside of the catheter is that the central lumen of the catheter is sterilized so that any fluid in the catheter (for example, a fluid that may contact the patient) is maintained aseptic.

[0017] In some embodiments, the filter is disposed in the pipeline. The filter can be configured to prevent fluid from flowing out of the multi-lumen catheter into the compartment while allowing gas to flow from the first end of the pipeline through the second end of the pipeline and into the multi-lumen catheter. At least one advantage of placing the filter in the pipeline is that any fluid leaking from the central lumen of the catheter will reach the filter (via the pipeline) before reaching any electronic components in the compartment.

[0018] In some embodiments, the gas carried by the conduit is a sterilizing gas. The sterilizing gas can be used to sterilize the central lumen. For example, the gas can be ethylene oxide, nitrogen dioxide, ozone, vaporized hydrogen peroxide, or any other suitable gas. At least one advantage of using a sterilizing gas is that the central lumen of the catheter is sterilized so that any fluid in the catheter (e.g., fluid that may come into contact with the patient) remains sterile.

[0019] In some embodiments, the filter is configured to prevent liquid leaking from the central lumen from passing through the conduit and reaching the compartment in some cases. During operation of the blood pump system, the first lumen may be damaged, causing liquid to leak from the first lumen into the central lumen of the catheter. For example, the purified fluid may leak from the lumen into the central lumen of the catheter. In the absence of a filter, the leaked liquid would flow from the catheter into the compartment, which would be problematic. However, the filter located in the pipeline prevents the leaked liquid from reaching the interior of the compartment, and thus prevents the fluid from reaching the at least one electronic component. In order to achieve a proper seal but still facilitate disinfection, the filter is configured to provide liquid filtration, so it allows the airflow to be transported through the filter before any liquid contacts. At least one advantage of preventing leakage through the filter is that liquid is prevented from reaching the electronic components in the compartment. For example, if the liquid contacts any exposed electronic components in the compartment, the liquid may cause a short circuit or damage the electronic equipment, thereby causing the operation of the pump to stop or change. At least one advantage of allowing gas to pass through the filter is that the central lumen of the catheter is allowed to be disinfected.

[0020] Positioning the filter can help achieve a liquid seal. In some embodiments, the filter is located proximal to the first opening of the compartment. For example, the filter can be placed completely inside the compartment. In some embodiments, the filter is located distal to the first opening of the compartment. For example, the filter can be placed completely outside the compartment. In some embodiments, the filter extends through the first opening of the compartment. In some embodiments, a portion of the filter extends inside the compartment. For example, the filter may span the first opening of the compartment so that a first portion of the filter is inside the compartment and a second portion of the filter is outside the compartment. At least one advantage of placing the filter so that it extends through or near the opening of the compartment is that the filter can prevent liquid from contacting the interior of the compartment (and the electronic components located therein).

[0021] In some embodiments, the filter includes a hydrogel adhering to the pore wall of a porous matrix. The filter can be, for example, a filter as described in U.S. Patent Publication 2004 / 0052689, which is incorporated herein by reference in its entirety. The hydrogel can be a hydrophilic polyurethane, a hydrophilic polyurea, a hydrophilic polyurea ammonia ester or any suitable material. At least one advantage of using a hydrogel (for example, a hydrophilic polymer) is that the hydrogel swells in an aqueous solution and retains a majority of the aqueous solution to which it is exposed without dissolving. The porous matrix can be a metal, ceramic, glass, organic, non-organic, an organic polymer, an acrylic polymer, a polyolefin or any suitable material or combination thereof. At least one advantage of a porous matrix is ​​that it has a channel through which gas can flow, which is convenient for disinfection. At least one advantage of using a filter including a hydrogel and a porous matrix is ​​that when the filter is placed between the two parts of a pipe, and by preventing the aqueous solution from flowing between the two parts, the filter can prevent the pollution between the two parts.

[0022] In some embodiments, the filter can self-seal when exposed to liquid. For example, the filter may self-seal when exposed to an aqueous medium. In some embodiments, the filter is breathable. In some embodiments, the self-sealing filter responds quickly (i.e., seals) when exposed to liquid, hardly or not at all contaminates the liquid solution in contact with it, and can withstand high back pressure (e.g., greater than about 7psi) before allowing gas or liquid to pass again. In some embodiments, the filter is biocompatible. At least one advantage of the self-sealing filter is that the response time is short, the aqueous solution in contact with them is hardly or not at all contaminated, and can withstand high back pressure.

[0023] In some embodiments, the filter is in the shape of a narrow cylinder, and the size and shape of the filter are designed to fit in the pipeline. In some embodiments, the pipeline can be a narrow tube. The outer diameter of the filter can be equal to the inner diameter of the pipeline, so that the filter fits tightly in the pipeline. In some embodiments, the filter is in the shape of a truncated cone, and the size and shape of the filter are designed to fit in the pipeline. The filter can have a first outer diameter equal to the inner diameter of the pipeline, so that the filter fits tightly in the pipeline at the first end, and then tapers to follow the shape of the pipeline. At least one advantage of designing the shape and size of the filter to fit tightly in the pipeline is that any gas or liquid passing through the pipeline will contact the filter, and therefore the filter can prevent liquid from flowing from one end of the pipeline to the other end (for example, from the central lumen of the catheter to the inside of the compartment). The filter can have any other shape (for example, disc-shaped, prismatic, etc.) that adapts to the shape of the pipeline.

[0024] In some embodiments, the filter for a blood pump system (e.g., a system described herein) is manufactured including a filter medium of a support material coated with a hydrogel. For example, the filter medium can be a fiber, a particle, a powder, or any other suitable substance. At least one advantage of using a filter including a hydrogel and a filter medium is that when placed between two parts of a pipeline, the filter allows gas flow between the two parts to allow disinfection in one of the parts, and if an aqueous solution attempts to flow between the two parts, liquid contamination can be prevented. The blood pump system includes a catheter that defines at least one lumen with a lumen cross section. The coated filter medium can be assembled to form a self-sealing filter, the size and shape of the self-sealing filter being designed to have a cross section equal to the lumen cross section. At least one advantage of assembling the filter in this way is to ensure that the filter fits tightly in the lumen so that it can block or prevent any gas or liquid from passing through the pipeline. The self-sealing filter can be positioned at the distal end of a sealed compartment. The elongated conduit (which defines the lumen) is positioned so that the self-sealing filter extends between a portion of the elongated conduit and the sealed compartment. The filter can thus prevent liquid from flowing from one end of the conduit to the other end (e.g., from the central lumen of the catheter to the interior of the compartment). The sterilizing gas is delivered to the elongated catheter via the hollow tube extending through at least a portion of the sealed compartment. At least one advantage of using a sterilizing gas is that the central lumen of the catheter is sterilized so that any fluid within the catheter (e.g., fluid that may come into contact with a patient) remains sterile.

[0025] In some embodiments, gas is allowed to penetrate the tubing to disinfect the central lumen of the multi-lumen catheter. The tubing is positioned across the first opening of the compartment. The compartment is positioned adjacent to the proximal end of the catheter. Fluid passes from an external source through the first lumen to the distal end of the multi-lumen catheter. The self-sealing filter prevents fluid from flowing out of the multi-lumen catheter into the compartment while allowing gas to flow from the first end of the tubing to the second end of the tubing. At least one advantage of preventing leakage through the filter is that liquid is prevented from reaching the electronic components in the compartment. If liquid contacts any exposed electronic components in the compartment, the liquid may cause a short circuit or damage the electronic components, causing the operation of the pump to stop or change. At least one advantage of allowing gas to pass through the filter is that it allows the central lumen of the catheter to be disinfected. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 shows an illustrative blood pump system according to certain embodiments;

[0027] Figure 2 shows a compartment with a side port according to certain embodiments;

[0028] Figure 3 shows a compartment with two side ports according to certain embodiments;

[0029] FIG. 4A to FIG. 4C Shown are self-sealing filters that allow sterilizing gas to pass through and self-sealing filters that prevent liquid flow according to certain embodiments;

[0030] Figure 5 shows a lumen within a compartment according to certain embodiments;

[0031] Figure 6 A flowchart showing the manufacture of an intracardiac blood pump system with leak protection according to certain embodiments; and

[0032] Figure 7 A flow chart is shown for preventing leakage from a catheter of an intravascular blood pump in accordance with certain embodiments. DETAILED DESCRIPTION

[0033] In order to provide an overall understanding of the systems, methods, and devices described herein, certain illustrative embodiments will be described. Although the embodiments and features described herein are specifically described for use in conjunction with a percutaneous blood pump system, it should be understood that all of the components and other features outlined below can be combined with each other in any suitable manner and can be adapted and applied to other types of cardiac therapy and cardiac assist devices, including cardiac assist devices implanted using surgical incisions, etc. In addition, although the application of the pump element has been described herein with respect to a blood pump, it should be understood that the pump element can be applied to other pumps for which any type of fluid flow sent to the distal side can flow proximally and damage electronic components. For example, a pump used in an acidic or other corrosive environment may require a purge flow to prevent the ingress of acid, which can damage pump components. Although the embodiments and features described herein are specifically described as being used in conjunction with an intracardiac blood pump system, it should be understood that a blood pump system according to the embodiments and features described herein can be used in any vascular system and / or in conjunction with other systems. For example, the filter systems and placement described below can be used in: urethral or bladder catheterization systems; right heart cardiac support systems; intra-aortic balloon pumps; extracorporeal membrane oxygenation devices; left ventricular assist devices; renal support systems, such as cardiac assist devices used to regulate kidney autoregulation; infusion systems; central venous catheters; or any other suitable system.

[0034] Figure 1 An intracardiac blood pump system 150 is shown for use with filters (e.g., filters 216 and 316), which will be discussed below in conjunction with Figure 2 and Figure 3Further description. System 150 includes an elongated catheter body (also referred to as an elongated multi-lumen catheter) 110, a pump 140, a compartment 100, a purge side arm 120, and a pressure side arm 130. The purge side arm 120 includes a fitting 122, a pressure accumulator 124, an infusion filter 128, and a tube 126. The pressure side arm 130 includes a tube 136. The pump 140 includes a pump housing 134, a motor housing 102, a cannula 173, a suction head 174, and a flexible protrusion 176. The pump 140 can be inserted into a patient by a variety of methods.

[0035] The method by which the pump 140 can be inserted into the patient's body includes, but is not limited to, using an over-wire technique and a side-rigger technique. For example, a first guide wire is inserted into the patient's vascular system, and then a guide catheter is screwed onto the first guide wire. The first guide wire is then removed, allowing a second guide wire to be introduced into the guide catheter. For example, the second guide wire is harder than the first guide wire to facilitate backloading the pump onto the guide wire. Once the harder guide wire is in place, the pump can be screwed onto the wire using a standard over-wire technique or a side-rigger technique. Before the pump is operated, the guide wire is removed. Alternatively, the guide wire is not removed before operation. Alternatively, the pump can be backloaded onto a guide wire inserted through the free space of the pump impeller. In one embodiment, an easy-catheter lumen 132, such as described in U.S. Pat. Nos. 8,814,776, 9,402,942, and 9,750,861 (which are incorporated herein by reference in their entirety), can be used in conjunction with a guidewire to more easily pass the guidewire through the free space of the impeller to backload the pump without damaging the impeller. Prior to operating the pump, the easy-catheter lumen 132 is removed, just like the guidewire. In another embodiment, the pump is backloaded on the guidewire without using an easy-catheter lumen.

[0036] In some embodiments, a purge fluid is delivered to the rotor in the pump 140 to maintain the pump substantially free of blood. As described in more detail below, at least one advantage of using a purge fluid is that the flow of the purge fluid can provide a barrier to prevent blood from entering the gap between the rotor and the motor stator or pump housing, which could otherwise damage the blood (e.g., hemolysis) or damage the motor (e.g., increased friction, overheating, and / or seizure). The purge fluid can be delivered to the elongated catheter body 110 through the first lumen (e.g., by the elongated catheter body 110). Figure 5 The first lumen of the elongated catheter body 110 supplies the purge fluid from a fluid reservoir (not shown) to the pump 140 via the purge side arm 120. The first lumen of the elongated catheter body 110 is partially defined by the tube 126. The first lumen passes through the compartment 100 (e.g., at Figure 2 , Figure 3 and Figure 5compartments 200, 300 and 500) and into the elongated catheter body 110 and may include connectors or accessories.

[0037] In some embodiments, the motor is "onboard", such as Figure 1 173 , and it can be located inside the patient's body during operation of the pump and is configured with electrical leads that transmit electricity to the motor for driving the pump. As previously described, the motor can alternatively be located outside the patient's body and can actuate the rotor via a drive shaft, drive cable, or drive train. For example, the motor can be located within a handle of the pump system (e.g., connected to compartment 100). In some examples, the drive cable can extend through the elongated catheter body 110 to reach the rotor located near the proximal end of the cannula 173. In some embodiments, the drive shaft, drive cable, or drive train is connected to a purification fluid delivery system described herein (e.g., via Figure 5 Tube 512) in the combined operation.

[0038] The purge fluid flows through the pump to prevent blood cells from entering the pump. Alternatively or additionally, the purge fluid can be used as a lubricant for the bearings (not shown) of the pump or as a coolant to dissipate the heat generated by the electromagnetic motor coils of the motor stator. The purge fluid can be a lubricant, a coolant, a drug, or any suitable blood-compatible fluid. For example, the purge fluid can be saline, Ringer's solution, a glucose solution, heparin, or any other suitable fluid. The purge fluid prevents blood from entering the motor housing 102 during operation of the pump 140. The purge fluid can also prevent blood from entering the elongated catheter body 110. In some embodiments, a high viscosity purge fluid (e.g., a glucose solution) is used to lubricate the bearings inside the pump 140. In other embodiments, the drug is used as a purge fluid to purify the blood pump and perform medical purposes. For example, the purge fluid can include heparin to prevent blood from clotting. The purge fluid flows through the first lumen of the elongated catheter body 110 and flows out of the pump 140 at the outlet opening near the proximal portion of the pump 140. The purge fluid is safely dispersed into the patient's bloodstream.

[0039] Another lumen of the elongated catheter body 110 (e.g., Figure 5The pump can be supplied with pressurized fluid via a pressure side arm 130 (defined by tube 516 of the side arm 130). The pressure side arm 130 provides fluid to a fluid-filled pressure lumen having an inlet at the proximal end of the motor housing 102. The fluid-filled pressure lumen in combination with the electronic components located in the compartment 100 can be used to determine the placement of the pump relative to the patient's aortic valve. For example, the electronic component can be a pressure transducer that "translates" the pressure from the pressure lumen into a value that can be output to an external system or display. In some embodiments, a second fluid reservoir or pressure bag (not shown) is connected to the proximal end of the pressure side arm 130 to provide pressurized fluid. The pressure fluid can be the same as or different from the purification fluid. For example, the pressure fluid can be saline, Ringer's solution, glucose, heparin, or any blood-compatible fluid.

[0040] In some embodiments, the blood pump system 150 includes an optical pressure sensor (e.g., a Fabry-Perot optical pressure sensor) located distally of the motor. An optical fiber extends proximally from the optical pressure sensor along the catheter. The optical pressure sensor includes a cavity terminated by a thin pressure-sensitive glass membrane. Light emitted from the optical fiber is reflected by the glass membrane and enters the optical fiber. The reflected light is transmitted along the length of the optical fiber to an electronic control element (e.g., in the compartment 100 or in a connection console), which determines a pressure signal based on an interference pattern in the reflected light.

[0041] The side ports of compartment 100 allow for fluid connections to compartment 100, as described below with respect to Figure 5 The purge side arm 120 and the pressure side arm 130 are respectively provided at a first side port (eg, Figure 5 tube 526) and a second side port (e.g., Figure 5 The first lumen (defined in part by tube 126) and the second lumen (defined in part by tube 136) extend through the compartment 100 to enter the elongated catheter body 110. In some embodiments, the tube 126 is connected to the tube (e.g., tube 524) in the compartment 100 at a glue joint at or near the first side port. Figure 5 100) such that the first lumen extends through tube 126, through compartment 100, and through elongated catheter body 110 to deliver the purge fluid to pump 140. In some embodiments, tube 136 is similarly connected to a different tube (e.g., Figure 5 516) is connected so that the second lumen extends through the tube 136, through the compartment 100 and through the slender catheter body 110 to deliver pressurized fluid to the pump 140.

[0042] In some embodiments, the first lumen and the second lumen of the elongated catheter body 110 are maintained separate from each other. The first lumen and the second lumen can extend through the central lumen of the elongated catheter body 110 and are configured to transport fluid while the central lumen of the elongated catheter body 110 remains free of purge and pressure fluid. However, in the event of a leak from the first or second lumen, the central lumen of the elongated catheter body 110 can transport the fluid. For example, during operation of the pump, the first lumen may become kinked or accidentally damaged, causing the purge fluid to leak from the first lumen into the central lumen of the elongated catheter body 110. In the event that the leak reaches the central lumen of the elongated catheter body 110, two potential problematic situations may occur: (1) the leaked fluid may reach the patient (e.g., through an inlet and outlet disposed in the pump 140), and (2) the leaked fluid may reach the interior of the compartment 100.

[0043] In order to reduce or eliminate the chance of a patient being at risk in the event of a fluid leak in the central lumen of the elongated catheter body 110, the central lumen is sterilized using a sterilizing gas. The fluids in the first lumen (the purge fluid) and the second lumen (the pressure fluid) are blood compatible, and therefore a leak from either the first lumen or the second lumen will not in itself present a risk to the patient unless the fluid is contaminated (e.g., via bacteria in the central lumen). Because of this potential risk, the central lumen is sterilized even though fluid does not normally flow through the central lumen to the pump 140.

[0044] To sterilize the central lumen, sterilizing gas is passed through a tube (e.g. Figure 2 Pipeline 214, Figure 3 The conduit 314 of the present invention enters the central lumen of the elongated catheter body 110, and the conduit extends through the opening of the compartment 100 and into the elongated catheter body 110. The conduit includes a proximal end located proximal to the first opening of the compartment 100 and a distal end located distal to the first opening. Prior to final assembly of the blood pump system, the proximal end of the conduit 214 can be accessed, for example, through the interior of the compartment 100. The sterilizing gas reaches the central lumen of the elongated catheter body 110 by inserting the sterilizing gas through the proximal end of the conduit. In the event that a purified fluid or a pressure fluid leaks into the central lumen, the leaked fluid will remain sterile due to the sterilizing gas. At least one advantage of sterilizing the central lumen is that if any leaked fluid reaches the patient (e.g., through the distal end of the intracardiac blood pump system 150), the fluid remains sterile and bacteria will not be introduced into the patient.

[0045] Because the proximal end of the conduit is located inside the compartment 100 and the distal end of the conduit is located inside the central lumen of the elongated catheter body 110, in the event that liquid leaks into the central lumen of the elongated catheter body 110, the leaked liquid may reach the conduit. In order to prevent the leaked liquid from reaching the interior of the compartment 100 (and the electronic components disposed therein) through the conduit, a self-sealing filter (e.g., Figure 2 Filter 216, Figure 3 The filter 316) is placed in the pipeline (e.g., Figure 2 Pipeline 214, Figure 3 The self-sealing filter prevents liquid from flowing through the conduit in at least one direction while allowing gas to flow through the conduit. The self-sealing filter allows gas to flow through the conduit, but prevents liquid from flowing through the conduit in at least one direction by sealing when in contact with the liquid. Thus, the sterilizing gas to which the device is exposed prior to any liquid exposure is allowed to pass through the conduit to the central lumen of the elongated catheter body 110, but any leaking liquid within the central lumen of the elongated catheter body 110 cannot reach the interior of the compartment 100. Figures 2 to 5 Various embodiments of the filter and blood pump assembly are further described.

[0046] Figure 2 A compartment 200 is shown with a side port 228 according to some embodiments. The compartment 200 is similar to Figure 1 The compartment 200 is similar to the compartment 100 of Abiomed, but includes a single side port for purging the side arm instead of the two side arms described above. The compartment 200 is connected to the conduit 210 through a self-sealing filter 216 to prevent fluid leaking from the conduit 210 from reaching the interior of the compartment 200. For example, the compartment may be a The first lumen defined by tubes 226 and 212 extends from outside of compartment 200 and through side port 228. Tube 226 may be, for example, similar to that described above with respect to Figure 1 200 and may be part of a purge side arm similar to purge side arm 120. A first lumen passes through a portion of the interior of compartment 200, extends through a first opening 250 of the compartment, and extends through connector 260 to enter conduit 210. In some embodiments, tube 212 extends through first opening 250 and extends through the length of conduit 210. In some embodiments, connector 260 is a plastic component configured to provide support to the proximal end of conduit 210.

[0047] The conduit 214 extends through the opening 250, through the connector 260 and into the catheter 210. As described above, the conduit 214 can allow gas to penetrate the central lumen of the catheter 210. For example, the gas can be a sterilizing gas configured to sterilize the central lumen of the catheter 210. The conduit 214 is in the shape of a narrow cylinder, and its length is relatively short compared to the length of the catheter 210. The proximal end of the conduit 214 is located within the compartment 200 and proximal to the opening 250. The conduit 214 is located within the catheter 210 and distal to the opening 250. In some embodiments, the conduit 214 is in fluid communication with the central lumen of the catheter 210. The conduit 214 is shown as a cylindrical tube. However, the conduit 214 can be a truncated cone, a narrow cylinder, a curved cylinder, a rectangular prism, or any suitable shape.

[0048] Filter 216 is located within pipe 214. In some embodiments, filter 216 is in the shape of a narrow cylinder. In some embodiments, filter 216 is sized and shaped to completely fill the inner diameter of pipe 214 so that gas or liquid flowing through pipe 214 will encounter filter 216, as described below with reference to Figure 5 Filter 216 allows gas to flow from the proximal end of conduit 214 to the distal end of conduit 214, but prevents liquid from the distal end of conduit 214 from reaching the proximal end of conduit 214. This configuration allows gas (e.g., sterilizing gas) to reach the central lumen of conduit 210 before any exposure to liquid, but prevents liquid (e.g., leaking purge fluid as described above) from reaching compartment 200. Conduit 214 and filter 216 are positioned so that the purge fluid flowing through the first lumen defined by tubes 226 and 212 does not pass through conduit 214, and therefore does not encounter filter 216. Therefore, the purge fluid can still reach the pump (e.g., pump 140) through conduit 210 without being blocked by filter 216.

[0049] At least one electronic component 240 is arranged in the compartment 200. The electronic component 240 may include a pressure sensor, a pump control circuit, a resistor, a capacitor, an inductor, a transistor, a wiring or any other suitable component. Other electronic components (e.g., components such as a printed circuit board (PCB)) may also be arranged in the compartment 200. The proximal end of the compartment 200 (located opposite the opening 250) may, for example, be connected to a power supply configured to power the electronic component 240. If a liquid (e.g., a purified fluid leaking from the first lumen that has reached the central lumen of the catheter 210) enters the interior of the compartment 200, it will short-circuit or damage the electronic component 240. For example, if the electronic component is corroded due to fluid damage, the operation and function of the pump may be damaged or completely stopped, which may be dangerous to the patient. The filter 216 prevents the fluid from reaching the electronic component. In some embodiments, the filter 216 is impermeable to liquid but permeable to gas. Because the size and shape of filter 216 is designed to fill the inner diameter of conduit 214, liquid that might otherwise flow through conduit 214 (e.g., purified fluid that has leaked into the central lumen of conduit 210) will be "blocked" by filter 216. Because filter 216 is within conduit 214 (which extends between conduit 210 and compartment 200), liquid is effectively blocked from reaching the interior of compartment 200 (which houses electronic components 240) via conduit 214.

[0050] Figure 3 A compartment 300 is shown having two side ports according to certain embodiments. Figure 3 Similar to the above Figure 1 and Figure 2 .related Figure 1 , the pressure side arm 330 corresponds to the pressure side arm 130, the purge side arm 320 corresponds to the purge side arm 120, and the conduit 310 corresponds to the elongated conduit body 110. Figure 2 , the electronic component 340 corresponds to 240 , the side port 328 corresponds to the side port 228 , the pipe 314 corresponds to the pipe 214 , and the filter 316 corresponds to the filter 216 . Figure 3 and Figure 2 The difference is that Figure 3 There is an additional side port 332. The side port 332 allows for connection of a pressure side arm 330, such as the one described above with reference to Figure 1 A pressure side arm 130 is depicted.

[0051] FIG. 4A to FIG. 4C A semi-permeable filter according to certain embodiments is shown. Figure 4AA semi-permeable filter 416 is shown that allows the airflow indicated by arrow 412 to pass through the conduit 410 before any contact with liquid. The airflow indicated by arrow 412 enters and passes through the proximal portion 414 of the conduit 410, then passes through the filter 416, and then passes through the distal portion 418 of the conduit 410. Figure 4B Filter 416 is shown preventing liquid flow indicated by arrow 422 from passing through tubing 410. Liquid flow indicated by arrow 422 enters distal portion 418 of tubing 410 and encounters resistance at filter 416 such that the liquid flow is unable to penetrate filter 416 and reach proximal portion 414. Instead, the liquid flow exits tubing 410 through distal portion 418. Liquid flow indicated by arrow 422 does not reach proximal portion 414 of tubing 410 because the material properties of filter 416 cause the elements of filter 416 to swell such that the liquid is unable to pass through the entire length of the filter. Figure 4C Filter 416 is shown, which allows air flow indicated by arrow 412 to pass through pipe 410, while preventing liquid flow indicated by arrow 422 from passing through pipe 410. Figure 4C As shown, in some embodiments, filter 416 can simultaneously allow gas flow while preventing liquid from flowing through pipe 410. In some embodiments, filter 416 is self-sealing when exposed to liquid. In some embodiments, when filter 416 has been sealed in response to encountering liquid, filter 416 is also fully or partially sealed to prevent gas flow. For example, if the filter medium of filter 416 swells to prevent liquid from flowing through pipe 410, the swollen filter medium may also prevent gas from flowing through pipe 410. In some embodiments, filter 416 is permeable to gas, but not permeable to liquid.

[0052] In some embodiments, filter 416 can include a hydrogel that can adhere to the pore walls of a porous matrix. The hydrogel can be a hydrophilic polyurethane, a hydrophilic polyurea, a hydrophilic polyurea ammonia ester or any suitable material. A hydrogel is a material that swells in water and retains a large portion of water and is insoluble in water. The porous matrix can be a metal, ceramic, glass, organic, non-organic, organic polymer, acrylic polymer, polyolefin or any suitable material or combination thereof. The porous matrix from which filter 416 can be made is insoluble in water and contains channels or pores through which one or more gas or liquid molecules can pass. This allows gas to pass through the channel. The hydrogel adheres to the porous matrix. When in contact with a liquid, the hydrogel swells so that the liquid cannot pass through the channel. Once in contact with a liquid, the filter becomes impermeable.

[0053] The mechanical, physical and chemical properties of filter 416 can be adjusted by appropriately selecting substrate and hydrogel material and the process for manufacturing filter material. For example, when rapid self-sealing is needed, a small diameter pore or channel can be used. When the smaller pressure gradient across the self-sealing filter is needed, a large diameter pore or channel can be used. Hydrogel can be selected to consider the porosity and composition of porous matrix. Porous matrix and hydrogel material can also affect the physical properties (for example, intensity, flexibility, durability, corrosion resistance or any other suitable property) of filter 416, and can be selected for the necessary physical properties in a specific application. For example, the material of filter 416 can be selected to match with the flexibility of pipeline 410. In some embodiments, the material of filter 416 can be selected to be easy to realize in small geometric shapes (for example, in pipeline 410). In some embodiments, the material of filter 416 can be selected to be easy to form a complete seal with pipeline 410 during the manufacture of system.

[0054] In some embodiments, filter 416 is selectively permeable. Due to selective attraction of different types of molecules or bonds, filter 416 may swell and, in some cases, seal to the specific material when encountering the specific material. For example, filter 416 can block the flow of dextrose by attracting sugar molecules while allowing the flow of water or gas (e.g., sterilizing gas). In some embodiments, filter 416 can separate mixtures by chromatography (i.e., by allowing one component of the mixture to flow through the filter while preventing or at least greatly delaying another component of the mixture from flowing through the filter).

[0055] Figure 5 The lumen within compartment 500 is shown according to certain embodiments. Figure 5 Similar to Figure 3 , but shows additional details of the tubes within compartment 300 as described below. Compartment 500 corresponds to compartment 300, conduit 520 corresponds to conduit 314, and conduit 510 corresponds to conduit 310. In some embodiments, side connector 502 attaches a pressure side arm (e.g., pressure side arm 330) to compartment 500 through side port 524, and side connector 504 attaches a purge side arm (e.g., purge side arm 320) to compartment 500 through side port 526.

[0056] Compartment 500 may contain sensitive electronics. PCB 540 holds the electronics (e.g., electronics 340) inside compartment 500. Wiring extends from PCB 540 to electronics cable 514. In some embodiments, electronics cable 514 is an insulated cable that includes a PCB configured to provide power to a pump (e.g., Figure 1The electronic device cable 514 extends into the proximal end of the central lumen of the elongated multi-lumen catheter 510. In some embodiments, the electronic device cable 514 extends through the central lumen of the catheter 510 to the distal end of the catheter 510.

[0057] Figure 5 The system includes a series of side connectors and lumens connected to the compartment 500, each of which facilitates direct or indirect connection to the catheter 510. The first lumen extends through the side connector 504, the side port 526, a portion of the compartment 500, and extends into the proximal end of the central lumen of the catheter 510. A portion of the first lumen is defined by a tube 512. The tube 512 exits the compartment 500 through the opening 508 and extends through the connector 560 (when within the catheter 510). In some embodiments, the tube 512 extends from the proximal end of the catheter 510 to the distal end of the catheter 510. For example, the tube 512 may terminate at the pump housing (e.g., Figure 1 The pump housing 134) allows the fluid to be delivered to the rotor in the pump housing, as described below with respect to Figure 1 In some embodiments, the tube 512 terminates at an opening proximal to the distal end of the catheter 510. In some embodiments, the tube 512 extends beyond the distal end of the catheter 510. In some embodiments, the first lumen (partially defined by the tube 512) carries a purification fluid. For example, the first lumen can carry glucose, saline, heparin, or any other suitable fluid.

[0058] The second lumen extends through the side connector 502, the side port 524, a portion of the compartment 500, and into the proximal end of the central lumen of the catheter 510. A portion of the first lumen is defined by a tube 516. The tube 516 exits the compartment 500 through the opening 508 and extends through the connector 560 (when within the catheter 510). In some embodiments, the tube 516 extends from the proximal end of the catheter 510 to the distal end of the catheter 510. For example, the tube 516 may terminate at a motor housing (e.g., Figure 1 The motor housing 102) allows the fluid to be delivered to the motor in the motor housing, as described below with respect to Figure 1 In some embodiments, tube 516 terminates at an opening proximal to the distal end of catheter 510. In some embodiments, tube 516 extends beyond the distal end of catheter 510. In some embodiments, the second lumen (partially defined by tube 516) carries a pressurized fluid, as described below with respect to Figure 1 For example, the first lumen can carry glucose, saline, heparin, or any other suitable fluid.

[0059] The proximal end of the conduit 520 is located within the compartment 500. The conduit 520 is a hollow tube extending within the central lumen of the catheter 510 and is in fluid communication with the central lumen of the catheter 510. A cross-section of the proximal end of the catheter 510 will show a central lumen around a first lumen defined by the tube 512, a second lumen defined by the tube 516, an electronic device cable 514, and a third lumen defined by the conduit 520. In some embodiments, the conduit 520 is significantly shorter than the conduit 510. For example, the conduit 520 may extend through one percent, two percent, five percent, ten percent, twenty percent, or any other suitable amount of the length of the conduit 510. In some embodiments, the conduit 520 allows gas to be delivered to the central lumen of the conduit 510, the gas being configured to sterilize the central lumen. For example, the proximal end of the conduit 520 may be exposed to an external source of a sterilizing gas, such as ethylene oxide, nitrogen dioxide, ozone, vaporized hydrogen peroxide, or any other suitable gas.

[0060] As shown in the enlarged portion 506 of the compartment 500, the third lumen defined by the conduit 520 holds a filter 528 (e.g., similar to the filters 416 and 426 of Fig. 4). In some embodiments, the filter 528 is breathable and / or self-sealing when in contact with the liquid. The filter allows the sterilizing gas to pass from the proximal end of the conduit 520 to the distal end. The filter prevents the liquid from the central lumen of the conduit 510 from reaching the interior of the compartment 500 and the electronic components located therein. For example, if the tube 512 or the tube 516 is damaged and the purified fluid or the pressure fluid is leaked into the central lumen of the conduit 510, the filter 528 will prevent the leaked liquid from reaching the compartment via the conduit 520.

[0061] Figure 6 A flow chart for manufacturing an intracardiac blood pump system with leakage protection according to certain embodiments is shown. Process 600 begins at step 602, in which a substrate of a supporting material is coated with a hydrogel. The hydrogel can be a hydrophilic polyurethane, a hydrophilic polyurea, a hydrophilic polyurea ammonia ester, or any suitable material. The supporting material can be a porous substrate, such as a metal, a ceramic, a glass, an organic, a non-organic, an organic polymer, an acrylic polymer, a polyolefin, or any suitable material or a combination thereof.

[0062] Process 600 continues to step 604, where the coated filter media is assembled to form a self-sealing filter. In some embodiments, the coated filter media can be assembled into a narrow cylindrical shape. For example, the coated filter media can be assembled to fit tightly within a hollow tube (e.g., Figure 5 In some embodiments, the coated filter media can be assembled in the shape of a truncated cone. For example, a filter made from the coated filter media can plug a hollow tube (e.g., Figure 5 In some embodiments, the size and shape of the filter are selected to match the size and shape of the hollow tube described below. At least one advantage of adapting the filter to the size of the hollow tube is that the liquid or gas flowing through the hollow tube will pass through the filter. In some embodiments, the filter can fill 20%, 30%, 40%, 50%, 75%, 100% or any other suitable percentage of the length of the hollow tube. In some embodiments, the outer perimeter of the filter cross section can be selected to match the inner perimeter of the cross section of the hollow tube. For example, the filter can be effectively inserted into the hollow tube and form an aqueous liquid seal between one end of the hollow tube and the other end of the hollow tube. In some embodiments, the cross section of the filter matches the cross section of the hollow tube over the entire length of the filter. In some embodiments, the cross section of the filter can match the cross section of the hollow tube at a first position and be different from the cross section of the hollow tube at a second position.

[0063] Process 600 continues to step 606 where a self-sealing filter is positioned within a sealed compartment (e.g., Figure 1 The process 600 continues to step 608, in which the elongated conduit is positioned such that the self-sealing filter is located at a portion of the elongated conduit (e.g., Figure 1 elongated catheter body 110) and a sealed compartment (e.g., Figure 1 Extending between compartments 100).

[0064] Process 600 continues to step 610, where a sterilizing gas is passed through a hollow tube (e.g., Figure 5 In some embodiments, the hollow tube is a narrow hollow cylinder whose length is relatively short compared to the length of the catheter. In some embodiments, the hollow tube is in the shape of a truncated cone. Due to the placement of the self-sealing filter (as described in steps 606 and 608) and the hollow tube, when the sterilizing gas flows through the hollow tube, the gas passes through the filter from the far end of the sealed compartment to the elongated catheter, allowing fluid communication between the compartment and the catheter. However, the filter prevents liquid from passing through the hollow tube while allowing gas to pass through the hollow tube, as described above with respect to Figures 1 to 5 described.

[0065] Although the steps of process 600 are described in a particular order, the steps may be performed in any order.

[0066] Figure 7A flow chart for preventing leakage from a catheter of an intracardiac blood pump according to certain embodiments is shown. Process 700 begins at step 702, in which a conduit is positioned across a first opening of a compartment. The compartment is positioned adjacent to the proximal end of a multi-lumen catheter. In some embodiments, the conduit extends from the interior of the compartment to the central lumen of the catheter. The conduit may have a proximal end and a distal end. For example, the compartment and the catheter may be connected with a conduit extending within and between the two, such that the proximal end of the conduit is within the compartment and the distal end of the conduit is within the catheter.

[0067] Process 700 continues to step 704, in which sterilizing gas is allowed to pass through the pipeline. The sterilizing gas sterilizes the central lumen of the multi-lumen catheter. In some embodiments, the multi-lumen catheter is a main tube having a first diameter and defining a central lumen, wherein at least one secondary tube extends through the length of the main tube in the central lumen, and the secondary tube has a second diameter less than the first diameter. The sterilizing gas can be supplied through the pipeline so that it enters the central lumen of the catheter (defined by the main tube). In some embodiments, the pump is exposed to the sterilizing gas by being immersed in a gas-saturated environment. The gas can then penetrate the proximal end of the pipeline that can be located in the compartment. Therefore, the sterilizing gas is delivered to the interior of the catheter to sterilize the central lumen.

[0068] Process 700 continues to step 706, in which a fluid is flowed through a first lumen. The fluid may enter the first lumen from an external source. The first lumen extends through the compartment and reaches the distal end of the multi-lumen catheter. For example, the fluid may pass from an external source through the first lumen to the distal end of the multi-lumen catheter.

[0069] Process 700 continues to step 708, in which the filter prevents liquid from flowing out of the multi-lumen catheter into the compartment while allowing gas to flow from the first end of the conduit to the second end of the conduit. For example, the filter may allow sterilizing gas to reach the central lumen of the catheter, but may prevent any liquid in the central lumen from reaching the compartment after sterilization.

[0070] Although the steps of process 700 are described in a particular order, the steps may be performed in any order. In some embodiments, gas permeation must occur before the filter is contacted with a liquid.

[0071] The foregoing is merely illustrative of the principles of the present disclosure, and the devices may be practiced in other aspects than those described, which are presented for purposes of illustration and not limitation. It should be understood that the devices disclosed herein, although shown for percutaneous insertion of blood pumps, may be applied to devices in other applications requiring hemostasis.

[0072] Variations and modifications will occur to those skilled in the art after reviewing this disclosure. The disclosed features may be implemented in any combination and subcombination (including multiple dependent combinations and subcombinations) with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. In addition, certain features may be omitted or not implemented.

[0073] Examples of changes, substitutions, and alterations are ascertainable by those skilled in the art and may be made without departing from the scope of the information disclosed herein.All references cited herein are incorporated herein by reference in their entirety and become a part of this application.

Claims

1. An intracardiac blood pump system, comprising: A pump comprising a housing and a rotor disposed within the housing; an elongated multi-lumen catheter having a proximal end, a distal end, and a central lumen, wherein the distal end is adjacent to the pump housing; a compartment comprising a first opening and one or more side ports, the first opening of the compartment being connected to the proximal end of the elongated multi-lumen catheter, the one or more side ports of the compartment being located proximal to the first opening of the compartment; at least one electronic component within the compartment; a first lumen of the elongated multi-lumen catheter configured to convey a fluid from an external source through the one or more side ports of the compartment and through the first opening of the compartment to the distal end of the elongated multi-lumen catheter; a conduit extending through an interface between the compartment and the elongated multi-lumen catheter, the conduit including a first end proximal to the first opening and a second end distal to the first opening, the conduit being configured to carry gas from the first end of the conduit through the first opening of the compartment to the second end of the conduit, the second end of the conduit being in fluid communication with the central lumen of the elongated multi-lumen catheter; and A filter is disposed within the conduit, wherein the filter is configured to prevent the liquid from flowing out of the elongated multi-lumen conduit into the compartment.

2. An intracardiac blood pump system according to claim 1, wherein the filter is configured to allow the gas to flow from the first end of the conduit through the second end of the conduit and into the elongated multi-lumen catheter, while preventing the liquid from flowing out of the elongated multi-lumen catheter into the compartment.

3. An intracardiac blood pump system according to any of the preceding claims, wherein the first lumen passes through the compartment, and wherein the filter is configured to prevent fluid leaking from the central lumen from passing through the conduit and reaching the compartment.

4. An intracardiac blood pump system according to claim 1, wherein the filter is located proximal to the first opening of the compartment.

5. The intracardiac blood pump system of claim 1, wherein the filter is located distal to the first opening of the compartment.

6. The intracardiac blood pump system of claim 1, wherein the filter extends through the first opening of the compartment.

7. The intracardiac blood pump system of claim 1, wherein a portion of the filter extends within the compartment.

8. The intracardiac blood pump system of claim 1, wherein the fluid comprises at least one of: blood, saline, purge fluid, heparin, and glucose.

9. The intracardiac blood pump system of claim 1, wherein the liquid comprises a purge fluid and the purge fluid flows through the first lumen to the rotor to maintain the pump free of blood.

10. The intracardiac blood pump system of claim 1, wherein the filter self-seals when exposed to a liquid.

11. The intracardiac blood pump system of claim 1 , wherein the filter is gas permeable prior to fluid exposure.

12. The intracardiac blood pump system of claim 1, wherein the filter comprises a hydrogel adhered to pore walls of a porous matrix.

13. The intracardiac blood pump system of claim 1, wherein the at least one electronic component comprises at least one of: a circuit board, wires, soldered or surface mounted electrical connections, resistors, capacitors, inductors, copper electrical connections, a memory, a pressure transducer, and a pressure sensor.

14. The intracardiac blood pump system of claim 1, wherein the gas carried by the conduit is a sterilizing gas.

15. The intracardiac blood pump system of claim 1, further comprising a connector at the first opening between the compartment and the catheter, wherein the first lumen and the filter pass through the connector.

16. The intracardiac blood pump system of claim 15, wherein the connector has an interior volume and the filter fills at least 50% of the interior volume of the connector.

17. The intracardiac blood pump system of claim 1, wherein the filter is sized and shaped to fit within the conduit.

18. The intracardiac blood pump system of claim 1, wherein the filter is in the shape of a frustum of a cone or a narrow cylinder.

19. The intracardiac blood pump system of claim 1, wherein the first lumen is within the central lumen.

20. A method of preventing leakage in an elongated multi-lumen catheter for use in an intracardiac blood pump system according to any one of claims 1-19, the method comprising: allowing sterilizing gas to pass through a first end of a conduit, through a first opening of a compartment, to a second end of the conduit to sterilize a central lumen of an elongated multi-lumen catheter, wherein the conduit is positioned across the first opening of the compartment, and wherein the compartment is positioned adjacent a proximal end of the elongated multi-lumen catheter; as well as A liquid is passed from an external source through the first lumen to the distal end of the elongated multi-lumen catheter, wherein a filter prevents the liquid from flowing out of the elongated multi-lumen catheter into the compartment.

21. The method of claim 20, wherein the filter prevents the liquid from flowing out of the elongated multi-lumen conduit into the compartment after allowing gas to flow from the first end of the conduit to the second end of the conduit.

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