A medical balloon dilation system, a method of producing of the same

Abstract

A medical balloon dilation system (MBD) for anatomic passageways that are accessible through natural openings in the body of a person and method for producing the system. The system comprising a pump assembly (PA) containing at least one liquid (LI) in a pump reservoir (PR), a balloon catheter (BC) comprising a catheter shaft (CS), and a balloon (BA), wherein said pump assembly is mechanically connected or mechanically connectable to said balloon catheter, wherein said pump assembly is fluidly connected or fluidly connectable to said balloon catheter, wherein said pump assembly and said balloon catheter is enclosed in a sealed packaging (PACK), and wherein said pump assembly and said balloon catheter has been sterilized.

Description

A MEDICAL BALLOON DILATION SYSTEM, A METHOD OF PRODUCING AND AUSE OF THE SAMEField of the invention

[0001] The present invention relates to a medical balloon dilation system, a method of manufacturing a medical balloon dilation system and a use of a medical balloon dilation system.Background of the invention

[0002] Balloon dilation of an anatomic passageway of a person e.g., the Eustachian tube is a treatment for Eustachian Tube Dysfunction (ETD). This disease is characterized by the inability of the Eustachian tube to ventilate the middle ear. Consequently, patients report multiple symptoms such as a plugged feeling in the ears, ears feeling like they are filled with water, tinnitus, or ringing in the ear, muffled hearing or partial hearing loss, ticking or popping sounds, pain, and tenderness around the ear, a tickling or tingling sensation and trouble with balance. Additionally, ETD can lead to other more severe middle ear diseases. The potential patient population is huge with prevalence of ETD being reported as high as 4.6% among the background population, which makes this a widespread disease by definition. Barometric related problems such as when flying or diving exists in as many as 10% of cases. The socioeconomic burden of this disease should not be underestimated. Studies have reported that medical care visits associated with ETD exceed 4 million per annum in the US alone.

[0003] A challenge related to known equipment for such balloon dilation is that such systems may be either complex to use and / or difficult to use for e.g., the practitioner or exerciser in real life environment and with real persons in a reliable and safe manner.Summary of the invention

[0004] The inventors have identified the above-mentioned problems and challenges related to balloon dilation, and subsequently made the below-described invention which may may help practitioner and exerciser in their daily work.

[0005] The invention relates to a medical balloon dilation system for dilating of anatomic passageways that are accessible through natural openings in the body of a person comprising: a pump assembly containing at least one liquid in a pump reservoir, a balloon catheter comprising: a catheter shaft, and a balloon, wherein said pump assembly is mechanically connected or mechanically connectable to said balloon catheter, wherein said pump assembly is fluidly connected or fluidly connectable to said balloon catheter, wherein said pump assembly and said balloon catheter is enclosed in a sealed packaging, and wherein said pump assembly and said balloon catheter has been sterilized.

[0006] Thereby is provided an advantageous medical balloon dilation system. The present system is advantageous for a number of reasons which will be described here below.

[0007] The term pump assembly may be understood as an assembly with a pumpelement and a reservoir. The pump reservoir may be understood as a container, bladder, tube, pump reservoir, or any other part for storing and / or containing a liquid. The liquid in the pump reservoir may then pumped by the pump-element from the pump reservoir to a balloon in a balloon catheter. The pump-element may be any kindof pump, actuator, plunger, or the like for pumping a liquid, where an operator may use the pump to push the liquid. The pump may be directly in contact with the liquid like a plunger in a syringe. The pump may be placed on the outside of a reservoir where the pump pushes, pumps or squeezes from the outside to move the liquid from the reservoir. The pump working on the outside may be a peristaltic pump pushing the liquid by pushing / squeezing a reservoir or a tube connected to the reservoir. The word pump and pump-element is used in this application interchangeable and will thus refer to a pump-element of a pump assembly unless otherwise noted.

[0008] The pump assembly may be understood as a syringe assembly, where a syringe comprising a cylindrical barrel and a plunger. The plunger may be used to push any kind of liquid or fluid out of the barrel through an opening in the opposite end of the plunger. The plunger may fit to be pushed into the barrel to push out liquid while the head of the plunger may prevent the liquid from leaking at the other end.

[0009] The term balloon catheter may be understood as a medical device which may be inserted into a human body. For a balloon catheter a balloon may typically be located at one end of a catheter, where the end with balloon located is to be inserted into the human body. The catheter may be made of both a soft and / or a stiff material depending on where in the body the catheter is inserted. When the balloon catheter has been inserted into the body the balloon may be expanded for dilation of a passageway in the body. The ballon may be collapsed before the balloon catheter is removed again from the passageway and from the body.

[0010] The catheter may be understood as a shaft, pipe, tube or any kind of embodiment for guiding a ballon. The catheter may have a guiding effect for the balloon but is also fluidly connecting the balloon to the pump reservoir with the liquid used for inflating the balloon.

[0011] The term mechanically connected may be understood as a connection between a pump assembly and a balloon catheter. The mechanical connection may be a direct coupling between the pump assembly and the balloon catheter of the medical ballon dilation system. The mechanical connection may also be facilitated by a tube orpipe between the pump assembly and the balloon catheter. The mechanical connection may typically be arranged to facilitate a fluidly connection between the pump assembly and the balloon catheter. The fluidly connection may be directly between the two parts or provide by flexible tube or pipe connected in between. The mechanical connection may be with glue, a snap lock, one or more clips or any other part for connection a pump assembly and a balloon catheter.

[0012] The term balloon may be understood as an expandable item used to be inserted into the body of a human for dilation of an anatomic passageway. The balloon may typically be non-compliant or semi-compliant and may typically have a cylindrical shape with tapered or rounded ends, with a diameter of 2- 10mm and a cylindrical length of 8-40mm.

[0013] It is advantageous to have a medical balloon dilation system where a liquid has been prefilled before enclosing and sealing the pump assembly and the balloon catheter. When the medical balloon dilation system has been prefilled it is easily and quickly used when being opened from the packaging. Any person using the medical balloon dilation system may use the dilation system immediately after being unpacked with no need for assembling any parts and / or filling water into the pump reservoir. When the system is prefilled with a liquid of the correct volume and preassembled from manufacturing, the risk of incorrect filling and incorrect assembly may be reduced. The overall procedure time can be reduced, when the no system preparation is needed.

[0014] A sealed packaging may be understood as a packaging which has been sealed to exclude any bacteria or particles to enter. The packaging may typically be understood as a packaging where gas can be filled in to sterilize the internal parts and afterwards let the gas out without letting unintended things in like bacteria. The packaging may be with a permeable membrane to allow for a sterilizing gas to enter through the membrane and for keeping the contents of the packaging sterile by preventing bacteria, fungi, vira, etc. to enter through the membrane. The sealing of the packaging may be a sealing which is not capable of closing or sealing again after beingbroken. Once the sealed packaging is opened the sealing is broken and cannot be closed again.

[0015] It may be advantageous to seal the packaging in order to be sure that the parts being enclosed inside are sterile until the packaging is being opened. In some embodiment that packaging may be suitable for being sterilized with radiation so that the packaging may be sealed and afterwards sterilized. When being sterilized by radiation the packaging may be made of materials suitable for not breaking when being either radiated with gamma, electrons or larger particles. The packaging may be understood as a blister packaging.

[0016] According to an embodiment of the invention, said pump assembly has been sterilized by radiation.

[0017] According to an embodiment of the invention, said pump assembly has been sterilized by gas-sterilization

[0018] According to an embodiment of the invention, said pump assembly has been sterilized by heat.

[0019] According to an embodiment of the invention, said pump reservoir and said at least one liquid has been sterilized by radiation.

[0020] According to an embodiment of the invention, said balloon catheter has been sterilized by radiation.

[0021] According to an embodiment of the invention, said balloon catheter has been sterilized by gas-sterilization

[0022] According to an embodiment of the invention, said balloon catheter has been sterilized by heat.

[0023] According to an embodiment of the invention, said pump assembly, said balloon catheter and said one liquid has been sterilized together by radiation while being inside the sealed packaging.

[0024] According to an embodiment of the invention, said pump assembly and said balloon catheter has been sterilized together by gas while being inside the sealed packaging and while containing the said one liquid.

[0025] According to an embodiment of the invention, said pump assembly and said balloon catheter has been sterilized together by gas while being inside the sealed packaging, and while the said at least one liquid is partly in said pump reservoir and partly in said balloon catheter.

[0026] It may be advantageous to have a pump reservoir containing a liquid where both the pump assembly and the liquid has been sterilized prior to being used. If a leakage occurs or a balloon may break it is advantageous to have a sterilized liquid floating out especially if the medical balloon dilation system is leaking inside a person.

[0027] It may be advantageous to have liquid filled into the balloon catheter from manufacturing to reduce the amount of compressed air in the balloon. Under conventional filling of prior art systems by an operator, an air-filled balloon is connected to a waterfilled syringe and a water filled fluid connection tube. The air in the balloon catheter is pushed to the distal expandable part of the balloon when liquid is pumped to the balloon. As a result, the compressed air in the balloon may suddenly and violently escape the balloon in case of balloon rupture.

[0028] It may be advantageous to use radiation to sterilize a pump reservoir containing a liquid when the liquid is enclosed. The radiation may be any kind of radiation like gamma, electron or alpha radiation. The radiation may be ionized or nonionized radiation. The radiation may be used to both sterilize the pump assembly, the liquid and the balloon assembly simultaneously.

[0029] According to an embodiment of the invention, said pump assembly has been sterilized prior to being filled with said at least one liquid.

[0030] The term sterilized may be understood as a process for “cleaning” a device 100% for microorganisms. The sterilization may be done either by gas, radiation, boiling, autoclaving or any other known process for sterilizing a device or product.

[0031] According to an embodiment of the invention, said pump assembly has been sterilized by gas-sterilization prior to filling said pump reservoir with said at least one liquid.

[0032] According to an embodiment of the invention, said pump assembly has been sterilized by radiation while being enclosed in said sealed packaging.

[0033] According to an embodiment of the invention, said balloon catheter has been sterilized by radiation while being enclosed in said sealed packaging.

[0034] It is advantageous to sterilize a pump assembly after enclosing it in a sealed packaging to ensure the pump assembly is sterile when it is being unpacked from the packaging.

[0035] According to an embodiment of the invention, said pump assembly has been sterilized prior to being mechanically connected to said balloon catheter.

[0036] According to an embodiment of the invention, said balloon catheter has been sterilized prior to being mechanically connected to said pump assembly.

[0037] According to an embodiment of the invention, said sterilization is by radiation while containing said at least one liquid.

[0038] It is advantageous to sterilize an enclosed liquid by radiation. In that way it may be possible to sterilize a liquid without opening a device or product. The liquid may be any liquid which is prefilled to a pump reservoir and afterwards sterilized by radiation along with the pump assembly and the balloon catheter.

[0039] According to an embodiment of the invention, said pump assembly is a syringe assembly.

[0040] It is advantageous to have a syringe assembly when using a balloon catheter to pump and fill up the balloon with a liquid. Typically a syringe assembly comprising a barrel and a plunger with sealing elements may be used to connect to a balloon catheter.

[0041] According to an embodiment of the invention, said pump reservoir is a syringe barrel.

[0042] According to an embodiment of the invention, said syringe assembly comprises: a syringe barrel, and a plunger.

[0043] According to an embodiment of the invention, said plunger is configured for sliding inside said syringe barrel.

[0044] According to an embodiment of the invention, said plunger is configured for pumping a part of said at least one liquid into said balloon.

[0045] The term syringe barrel and plunger may be understood as any kind of syringe, where a plunger is used to pump any kind of liquid or gas out of the syringe barrel. The diameter of the syringe barrel may vary accordingly with the diameter of the plunger in order to have one end of the syringe sealed from leaking liquid or gasses.

[0046] According to an embodiment of the invention, said pump assembly comprises an actuator for pumping a part of said at least one liquid from said pump reservoir to said balloon.

[0047] According to an embodiment of the invention, said pump assembly comprises a fluid barrier keeping said at least one liquid enclosed in said pump reservoir.

[0048] Fluid barrier may be understood as any kind of object for enclosing a liquid in a reservoir. The fluid barrier may be a membrane or a valve. The fluid barrier may be an irreversible barrier which as soon as it is broken won’t be able of enclosing the liquid anymore. The fluid barrier may be reusable e.g., a valve which may be opened and closed. The fluid barrier may be any kind of valve like an overpressure valve, ball valve, butterfly valve, globe valve, needle valve, pinch valve or plug valve.

[0049] According to an embodiment of the invention, said fluid barrier is a membrane.

[0050] According to an embodiment of the invention, said fluid barrier is a valve.

[0051] According to an embodiment of the invention, said pump reservoir is configured for fluidly connecting to said balloon by opening said fluid barrier.

[0052] According to an embodiment of the invention, said fluid barrier is a one-time- use.

[0053] According to an embodiment of the invention, said fluid barrier is irreversible.

[0054] It may be advantageous to have separated the balloon and the pump reservoir by a fluid barrier like a membrane or valve in order to control where the liquid is. The fluid barrier may be opened upon the medical balloon dilation system has to be used. The fluid barrier may be an irreversible part of the pump assembly so when the fluid barrier has been opened it can’t be closed again. It may be a destructive part of the fluid barrier which is to be broken to open the fluid barrier. It may also be a valve which is configured for opening and closing of the fluid connection to the pump reservoir. The fluid barrier may also be an overpressure valve which is configured for opening a fluid connection when e.g., a plunger or pump is pushing on the liquid in the pump reservoir.

[0055] The membrane may be understood as any wall, diaphragm, film, layer or the like to divide the volume inside a pump reservoir containing a liquid from a balloon catheter. The membrane may be suitable for containing the liquid and not leaking, evaporating or sweating any volume of the liquid out of the reservoir.

[0056] According to an embodiment of the invention, said pump assembly and said balloon is fluidly preconnected before being enclosed in said sealed packaging.

[0057] According to an embodiment of the invention, said mechanical connection between said pump assembly and said balloon catheter is click and lock-solution.

[0058] According to an embodiment of the invention, said pump assembly is directly mechanically and fluidly connected to said balloon catheter.

[0059] According to an embodiment of the invention, a tube is mechanically and fluidly connecting said pump assembly to said balloon catheter.

[0060] According to an embodiment of the invention, said one or more mechanical connections in said medical balloon dilation system between any part of the medical balloon dilation system is a permanent connection.

[0061] According to an embodiment of the invention, all fluid connections of said medical balloon dilation system are permanent fluid connections.

[0062] According to an embodiment of the invention, the connections mechanically and fluidly connecting said pump assembly and said balloon catheter are permanent.

[0063] According to an embodiment of the invention, said connections are established by means of glue.

[0064] According to an embodiment of the invention, said permanent connections are established by forming at least a part of the pump assembly and at least a part of the balloon catheter in one monolithic piece.

[0065] According to an embodiment of the invention, all mechanical connections are glued together.

[0066] According to an embodiment of the invention, all fluid connections are glued together.

[0067] According to an embodiment of the invention, said mechanical connection between said pump assembly and said balloon catheter is a permanent connection.

[0068] The tube may be any kind of tube which may be stiff or flexible depending on what kind of use the medical balloon dilation system is used for. The tube may typically be made of flexible plastic material which has also been sterilized before use.

[0069] It may be advantageous to have permanent mechanical connections between parts in a medical balloon dilation system to enclose sterilized liquid. A permanent connection makes it difficult for an operator to add more liquid to the pump reservoir or balloon and further for gas to get into the system. That may be advantageous in keeping the exact level of pressure inside the balloon when the liquid is being pumped to the balloon.

[0070] It may be advantageous to have a tube or pipe between a pump assembly and a balloon catheter when being assisted by another person by holding the pump assembly. It may be more comfortable to hold the pump assembly when separated by a tube or pipe from the balloon catheter.

[0071] It may be advantageous to provide fluid connections that are not meant for being disconnected and reconnected when the system is already filled with the correct amount of liquid. Opening of said fluid connection may result in loss of liquid and entry of gas into the system which may cause failures in the system. It may be advantageous to make the system and all the fluid connection tamper proof, such that any opening of the fluid connections or any opening of the pump assembly will show visible damage.

[0072] According to an embodiment of the invention, at least a part of said at least one liquid is partly in said balloon catheter when said balloon catheter is enclosed in said sealed packaging.

[0073] According to an embodiment of the invention, at least a part of said at least one liquid is partly in said balloon shaft and / or said balloon when said balloon catheter is enclosed in said sealed packaging.

[0074] According to an embodiment of the invention, said at least one liquid is contained in said pump reservoir and said balloon catheter at the same time while being enclosed in said packaging.

[0075] It may be advantageous to have the entire system filled with a liquid or to at least maximize the amount of liquid in the inner volume compared to the gas. Byhaving less gas in the inner volume of the system the pump may be more efficient when avoiding the compressible effect of the gas. The more liquid in the system may facilitate a better reaction from a pump or plunger when starting to pump the liquid toward the balloon in the system.

[0076] According to an embodiment of the invention, said pump assembly comprises a valve, wherein said valve when being opened is fluidly connecting said pump reservoir to surroundings.

[0077] It may be advantageous to have a valve configured for fluidly connecting a pump reservoir to surroundings. The valve may be opened to let out gas from the inner volume of e.g., the pump reservoir and the balloon catheter. Typically, a person may squeeze the ballon when holding the medical balloon dilation system with the valve up and open to push out gas from the inner volume.

[0078] According to an embodiment of the invention, said medical balloon dilation system is enclosed in an outer packaging.

[0079] It is advantageous to have a medical balloon dilation system enclosed in an outer packaging to have all smaller packaging enclosed in the outer packaging.

[0080] According to an embodiment of the invention, a manual is enclosed in said outer packaging.

[0081] According to an embodiment of the invention, said medical balloon dilation system has been sterilized while being enclosed in said outer packaging.

[0082] The outer packaging may be sterilized by e.g., gas. The outer packaging may typically be made of a weaker material compared to a packaging only enclosing parts which has to be sterilized.

[0083] Additionally, the outer packaging may be further sterilized.

[0084] According to an embodiment of the invention, said outer packaging has been sterilized while containing said packaging.

[0085] According to an embodiment of the invention, said outer packaging has been sterilized by radiation while containing said packaging.

[0086] According to an embodiment of the invention, said outer packaging has been sterilized by gas while containing said packaging.

[0087] According to an embodiment of the invention, said at least one liquid in said pump reservoir is either water or oil.

[0088] It may be advantageous to have oil in a pump reservoir as the oil may typically comprise a higher evaporations temperature which may be advantageous to maintain the same pressure inside both the pump assembly and balloon catheter. It may be advantageous to use a liquid with a low viscosity to reduce the hydraulic resistance in the system. It may also be advantageous not to have too low viscosity of the liquid as this may result in leakages across seals of the system.

[0089] According to an embodiment of the invention, said at least one liquid in said pump reservoir has an evaporation temperature of at least 60°C, at least 70°C, at least 80°C, at least 90°C, at least 100°C, at least 110°C or at least 120°C.

[0090] According to an embodiment of the invention, said at least one liquid in said pump reservoir has a viscosity of more than 0.9cP and less than 75cP.

[0091] According to an embodiment of the invention, said at least one liquid in said pump reservoir has a viscosity of more than 2cP and less than 50cP.

[0092] According to an embodiment of the invention, said at least one liquid in said pump reservoir comprises anti-bacteria material.

[0093] It may be advantageous to add antimicrobial additive to avoid a growth of bacteria in the liquid so the medical balloon dilation system has a longer lifespan. The avoiding of bacteria-growth may also prevent generation of gases inside the liquid which is advantageous. The antimicrobial additive may be bactericide, fungicide, algaecide or any kind of additive that prevents biological growth.

[0094] According to an embodiment of the invention, a volume of said at least one liquid in said pump reservoir is more than 70% of an inner volume of said pump reservoir, such as more than 75% of an inner volume of said pump reservoir, such as more than 80% of an inner volume of said pump reservoir, such as more than 85% of an inner volume of said pump reservoir, such as more than 90% of an inner volume of said pump reservoir.

[0095] According to an embodiment of the invention, a volume of said at least one liquid in said pump reservoir and said balloon catheter is more than 70% of an inner volume of said pump reservoir and said balloon catheter, such as more than 75% of an inner volume of said pump reservoir and said balloon catheter, such as more than 80% of an inner volume of said pump reservoir and said balloon catheter, such as more than 85% of an inner volume of said pump reservoir and said balloon catheter, such as more than 90% of an inner volume of said pump reservoir and said balloon catheter.

[0096] According to an embodiment of the invention, said inner volume of said pump reservoir is less than 30% gas, such as less than 25% gas, such as less than 20% gas, such as less than 15%, such as less than 10%, such as less than 5%, such as less than 2%.

[0097] It may be advantageous to ensure that only a certain amount of the inner volume of a pump reservoir is gas for a more efficient flow of liquid from the reservoir to a balloon. Especially when a compressible gas is enclosed in the inner volume it may be advantageous to minimize the amount of gas to minimize the compressible factor of the gas.

[0098] It may be advantageous to have little or no compressed gas in the balloon when the balloon is pressurized while inserted into a human, since bursting of the balloon would cause a sudden and violent release and expansion of the compressed air which may cause damage to the surrounding tissue of the human, such as an eardrum.

[0099] The invention further relates to a method of packing a ready-to-use medical balloon dilation system comprising:providing:- a pump assembly having a pump reservoir and- a balloon catheter, mechanically and fluidly connecting said pump assembly to said balloon catheter, enclosing and sealing said ballon catheter and said pump assembly in a packaging, wherein said pump reservoir includes at least one liquid when enclosed and sealed in said packaging, sterilizing said pump assembly and said balloon catheter prior to and / or subsequent to enclosing said pump assembly and said balloon catheter in said packaging.

[0100] It is advantageous to have a method for packing a ready -to-use medical ballon dilation system where a pump assembly and balloon catheter has been sterilized and is ready to use when a packaging is opened.

[0101] According to an embodiment of the invention, said method comprises a step of filling said pump reservoir of said pump assembly with at least one liquid.

[0102] According to an embodiment of the invention, said method comprises a step of filing said balloon catheter with a part of said at least one liquid.

[0103] According to an embodiment of the invention, said method comprises a step of filing a balloon comprised in said balloon catheter with a part of said at least one liquid.

[0104] According to an embodiment of the invention, said balloon catheter includes a part of said at least one liquid when being enclosed and sealed in said packaging.

[0105] According to an embodiment of the invention, said method comprises a step of filing said pump reservoir of said pump assembly and said balloon catheter with said at least one liquid.

[0106] According to an embodiment of the invention, said step of filling said pump reservoir is prior to enclosing and sealing said packaging.

[0107] According to an embodiment of the invention, said step of mechanically and fluidly connecting said pump assembly to said balloon catheter is prior to filling said pump reservoir and / or said balloon catheter with said at least one liquid.

[0108] It may be advantageous to have mechanically connected a pump assembly and a balloon catheter prior to filling the pump reservoir in the pump assembly with a liquid.

[0109] According to an embodiment of the invention, said step of filling said pump reservoir is prior to mechanically and fluidly connecting said pump assembly to said balloon catheter.

[0110] It may be advantageous to have filled a pump reservoir in a pump assembly with a liquid before mechanically connecting the pump assembly to a balloon catheter.

[0111] According to an embodiment of the invention, said pump assembly having said pump reservoir is provided with said pump reservoir filled with at least one liquid.

[0112] According to an embodiment of the invention, said step of sterilizing is a sterilization by radiation.

[0113] According to an embodiment of the invention, said step of sterilizing is a sterilization by gas.

[0114] According to an embodiment of the invention, said method comprises an additional step of enclosing said packaging in an outer packaging.

[0115] It may be advantageous to have an outer packaging containing the packaging and eventually a manual or other additional parts. The outer packaging may typicallybe understood as a container made of a cheaper and weaker material since the outer packaging may not have to be sterilized. The outer packaging may typically be made of cardboard box, paper, carton, recycled material, any other paper like material or any combination of the previous mentioned elements.

[0116] According to an embodiment of the invention, said additional step of enclosing said packaging in said outer packaging is done prior to said step of sterilizing said pump assembly and said balloon catheter.

[0117] According to an embodiment of the invention, said step of sterilizing is done subsequent to said step of enclosing said packaging in said outer packaging.

[0118] It may be advantageous to sterilize the outer packaging since all the other parts in the medical balloon dilation system have been sterilized and to keep the total packaging including the contained parts cleaner.

[0119] According to an embodiment of the invention, said method comprises a step of reducing the amount of gas contained inside said pump reservoir and said balloon catheter.

[0120] According to an embodiment of the invention, said step of reducing the amount of gas contained inside said pump reservoir and said balloon catheter is reduced by a valve.

[0121] According to an embodiment of the invention, said medical balloon dilation system is a medical balloon dilation system as described above.

[0122] The invention further relates to a use of a medical balloon dilation system according to the above describes medical balloon dilation system comprising:

[0123] unpacking a sterilized pump assembly and a sterilized balloon catheter,

[0124] inserting at least a part of said sterilized balloon catheter into an anatomic passageway that is accessible through natural openings in the body of a person,

[0125] pumping at least a part of said at least one liquid from said pump reservoir into said balloon.

[0126] According to an embodiment of the invention, said anatomic passageway may be any one of a eustachian tube or sinus drain channel.

[0127] According to an embodiment of the invention, said use of said medical balloon dilation system comprises the following steps:

[0128] removing at least a part of said at least one liquid from said balloon, and

[0129] subsequently extracting said balloon catheter from said anatomic passageway.

[0130] Thereby facilitating a smart and responsible use and / or re-use of an medical balloon dilation system which is safe for a patient and easy to handle for an exerciser or practitioner.

[0131] A use of a medical balloon dilation system may also be understood as a method of balloon dilating one or more anatomic passageways of a person.

[0132] According to an embodiment of the invention, a step of opening said fluid barrier for fluidly connecting said pump reservoir to said balloon is done prior to said step of inserting.

[0133] According to an embodiment of the invention, said inserting is performed without further preparation after said unpacking.

[0134] According to an embodiment of the invention, said method comprises a step of testing said balloon expansion prior to inserting said ballon catheter by pumping at least a part of said at least one liquid from said pump reservoir into said balloon.

[0135] According to an embodiment of the invention, said method comprises an additional step of final testing said balloon after extracting said ballon catheter from said anatomic passageway.

[0136] It is advantageous to make a final testing of said balloon after having used a balloon catheter to ensure liquid has not been leaked during procedure. A final testing of the balloon after having used the balloon one or more times on the same person is typically advantageous to see if the balloon may have leaked.

[0137] According to an embodiment of the invention, said step of inserting at least a part of said sterilized balloon catheter into an anatomic passageway that is accessible through natural openings in the body of a person, and said step of pumping at least a part of said at least one liquid from said pump reservoir into said balloon is performed on the same person in relation to two or more different anatomic passageways of said person.

[0138] It may be advantageous to use a medical balloon dilation system more than one time one the same patient when e.g., examining more than one of a person’s anatomic passageways. The medical balloon dilation system may be used on e.g., more than one or a person’s sinus passageway and thereby saving one or more medical balloon dilation system.

[0139] It is advantageous to use the medical balloon dilation multiple times on the same person as no other bacteria or the like may occur. The medical balloon dilation system may therefore be used for more than one time for the same person at the same procedure check.

[0140] According to an embodiment of the invention, said medical ballon dilation system comprises a tube.

[0141] According to an embodiment of the invention, said tube is mechanically connected to said pump assembly.

[0142] According to an embodiment of the invention, said tube is fluidly connected to said pump assembly.

[0143] According to an embodiment of the invention, said tube is mechanically preconnected to said pump assembly in said packaging.

[0144] According to an embodiment of the invention, the total volume of said at least one liquid is between 0,1 and 10ml, such as between 0,1 and 5ml, such as between 0,1 and 3 ml.

[0145] It may be advantageous to have a minimum amount of liquid to inflate the ballon in the ballon catheter. The amount of liquid may be optimized according to sterilization of the medical ballon dilation system e.g., when sterilized by radiation. The amount of liquid may also be required to prevent damage of the ballon while being radiated. Similarly at the amount of liquid may have a maximum amount which may be defined by the internal volumes inside the pump reservoir, ballon catheter and optional a tube. The maximum amount of liquid used in the system may also require a larger amount of radiation which could then damage the ballon, therefore the amount of liquid may also be limited by the ballon material, ballon thickness and things related to the ballon.

[0146] Water is difficult to sterilize by irradiation, and the sterilization of the water itself in a system will likely determine the required radiation dose. The balloon on the balloon catheter will have a wall thickness of less than 0.1 mm, the material will be a thermoplastic, most likely a nylon type, and must in some instances withstand a pressure of more than 10 bar. Too high a radiation dose with gamma for sterilizing the ballon can alter the material of the ballon, and it will be important to reduce the amount of water in the system as much as possible to reduce the radiation dose, so that the balloon does not suffer too much damage. The radiation dose should preferably not exceed 50 kGy to ensure that the balloon is not damaged. To ensure effective sterilization of the liquid in the system at 50 kGy, the total liquid volume in the system should not exceed 10 ml. It will be particularly advantageous if the liquid volume is less than 5 ml, and optimally if the liquid volume can be less than 3 ml, as a lower liquid volume may reduce the necessary radiation dose and thereby reduce the radiation damages to the balloon material.

[0147] According to an embodiment of the invention, said pump assembly comprises a first fluid port configured for fluidly connecting said pump assembly with said balloon catheter upon activation.

[0148] According to an embodiment of the invention, said tube comprises a first fluid port configured for fluidly connecting said pump assembly with said ballon catheter upon activation.

[0149] According to an embodiment of the invention, said balloon catheter comprising a second fluid port, wherein said second fluid port is configured for fluidly connecting said balloon catheter with ambient atmosphere in the packaging.

[0150] According to an embodiment of the invention, said balloon catheter comprising a second fluid port, wherein said second fluid port is configured for fluidly connecting said balloon catheter with said pump assembly.

[0151] According to an embodiment of the invention, said second fluid port (SFP) is located at the opposite end of the balloon catheter than said ballon.

[0152] According to an embodiment of the invention, the first fluid port is closed while the system is enclosed in said packaging thereby completely sealing said at least one liquid inside the pump assembly and / or tube.

[0153] According to an embodiment of the invention, the second fluid port is open while the medical balloon dilation system is enclosed in said packaging thereby connecting ambient atmosphere in the packaging to internal parts of the balloon catheter.

[0154] According to an embodiment of the invention, the first fluid port and second fluid port are configured to be operably dependent, such that opening of the first fluid port can happen only after closing of the second fluid port to said ambient atmosphere.

[0155] According to an embodiment of the invention, said first fluid port and second fluid port are configured to be operably dependent and wherein the first fluid port and the second fluid port can be fluidly connected only after closing off any said ambient fluid port.

[0156] According to an embodiment of the invention, a lock is configured to prevent the second fluid port from being re-opened after fluidly connecting the pump assembly to the balloon catheter.

[0157] According to an embodiment of the invention, said medical ballon dilation system comprises a fluid barrier.

[0158] According to an embodiment of the invention, said fluid barrier is a valve.

[0159] According to an embodiment of the invention, said valve is connected to the first fluid port and the second fluid port, wherein said valve comprises an ambient fluid port configured for fluidly connecting said ambient surroundings inside the enclosed packaging with said second fluid port.

[0160] According to an embodiment of the invention, said valve comprises a first state inside said packaging, where the first fluid port is closed, the second fluid port is connected to surroundings inside the enclosed packaging through said ambient fluid port.

[0161] According to an embodiment of the invention, said valve comprises a second state, where the first fluid port is fluidly connected to the second fluid port and where the ambient fluid port is closed.

[0162] The valve may be a valve which may be configured to only turn one way and not return to a first position. Meaning that the valve may be configured to open and not close again to ensure a user that the valve has not been open prior to use.

[0163] According to an embodiment of the invention, said valve is lockable in said second state.

[0164] According to an embodiment of the invention, a lock prevents the valve from returning to the first state.

[0165] According to an embodiment of the invention, said valve comprises a third state, wherein the second fluid port is blocked.

[0166] It may be advantageous to prevent leakage of liquid to the surrounding inside the enclosed packaging (atmosphere in packaging). It may be advantageous with a lock on the valve to avoid unintended opening and loss of water from the system during use. It may be advantageous to have a lock to keep the valve in an open configuration during use. It may be advantageous to be able to lock and hold the pressure in the balloon by blocking the fluid connection to the balloon catheter.

[0167] According to an embodiment of the invention, said first fluid port has a septum membrane configured to seal the pump reservoir.

[0168] According to an embodiment of the invention, said second fluid port comprises a hollow needle.

[0169] According to an embodiment of the invention, said pump assembly is mechanically connected to said balloon catheter and said pump assembly is fluidly connectable to said balloon catheter.

[0170] According to an embodiment of the invention, said pump assembly is mechanically connected to said balloon catheter and said pump assembly is fluidly coupled through said first fluid port and through said second fluid port to said balloon catheter.

[0171] To avoid evaporation of liquid through the balloon, it may be advantageous to provide the prefilled pump with a closed port and wherein the balloon catheter is not fluidly connected to the pump while in the pack. It may be advantageous that a port of the balloon catheter is open and provides an open gas connection between the internal sides of the balloon catheter and the ambient air in the pack as this may allow for gas to enter into the balloon catheter as part of a sterilization or packaging process.

[0172] It may be advantageous to avoid spillage of liquid and contamination during fluidly connecting of the balloon catheter to pump. It may be beneficial if it is impossible or difficult for an operator to open the port of the pump to ambient atmosphere. It may be advantageous, if the pump port can only be opened after beingconnected to the balloon catheter port and after the balloon catheter port has been closed off to the surroundings.

[0173] According to an embodiment of the invention, a tube is mechanically connecting and fluidly connecting said pump assembly to said balloon catheter.

[0174] According to an embodiment of the invention, said tube is mechanically connectable to said ballon catheter.

[0175] According to an embodiment of the invention, said tube is fluidly connectable to said ballon catheter.

[0176] According to an embodiment of the invention, a part of said at least one liquid is also in said tube.

[0177] It may be understood that a part of said at least one liquid may be at least 50% of said total amount of said at least one liquid, such as at least 60 % of said total amount of said at least one liquid, such as least 70% of said total amount of said at least one liquid, such as least 80 % of said total amount of said at least one liquid.

[0178] According to an embodiment of the invention, an internal volume of said tube contains more than 50% liquid, such as more than 70% or more than 90% liquid.

[0179] According to an embodiment of the invention, an internal volume of said tube contains less than 5ml gas, such as less than 3ml or less than 1ml of gas.

[0180] According to an embodiment of the invention, said tube is a flexible tube.

[0181] The term flexible tube may be understood as a tube that is soft.

[0182] According to an embodiment of the invention, said tube comprises a fluid barrier configured for preventing the at least one liquid from entering into said balloon until after the packaging has been opened.

[0183] According to an embodiment of the invention, said fluid barrier is located at the end of the tube furthest away from said pump assembly when said tube is mechanically connected to said pump assembly.

[0184] According to an embodiment of the invention, said fluid barrier is a valve configured to be opened by an operator.

[0185] According to an embodiment of the invention, said fluid barrier is a membrane configured for being broken.

[0186] The internal volume of a tube between the pump and the balloon catheter may be significantly greater than the inner volume of the balloon, It may be advantageous to have water prefilled inside the tube to avoid trapped air in the tube being filled into the balloon catheter.

[0187] According to an embodiment of the invention, said at least one liquid has a viscosity of 0,2cP to 5cP.

[0188] According to an embodiment of the invention, said at least one liquid is a silicone oil.

[0189] According to an embodiment of the invention, a non-permeable foil pouch is part of the packaging.

[0190] According to an embodiment of the invention, said foil pouch has a portion that is impermeable and a portion that is permeable and wherein the permeable portion of the pouch is closed after gas sterilization.

[0191] According to an embodiment of the invention, packaging consists of several layers and wherein a first packaging layer is a permeable pouch and wherein a second packaging layer is a non-permeable foil pouch.

[0192] Having a prefilled medical balloon dilation system may introduce a risk of evaporation of liquid during storage which may result in insufficient liquid when used. It may be advantageous to have the system packed in a gas-tight foil pouch such as analu foil pouch or any other pouch with a metallic layer to prevent gasses from passing. It may be advantageous to have vacuum inside the foil pouch to reduce the internal volume of air into which liquid from the system can evaporate. To allow gas sterilization it may be advantageous to have one portion of the pouch with a permeable membrane such as a Tyvek membrane to allow gas to enter during gas sterilization and where the permeable portion may be closed off after sterilization to leave the pouch gas-tight during storage to thereby avoid evaporation. It may be advantageous to first pack the Medical balloon dilation system in a permeable pouch such as a Tyvek pouch to allow gas sterilization and thereafter to secondly pack it into a non-permeable pouch such as an alu pouch to avoid evaporation.

[0193] According to an embodiment of the invention, said pump assembly and said ballon catheter have been preassembled mechanically and / or fluidly.

[0194] According to an embodiment of the invention, the medical balloon dilation system is configured for dilation of the Eustachian tube.

[0195] According to an embodiment of the invention, the medical balloon dilation system is configured for dilation of a passageway of a sinus.

[0196] According to an embodiment of the invention, the medical balloon dilation system is configured for access through a nostril.

[0197] According to an embodiment of the invention, the balloon has a cylindrical portion with a diameter of 3-8mm and a length of 10-30mm.The drawings

[0198] Various embodiments of the invention will in the following be described with reference to the drawings where fig. 1 illustrates a side view of a human head and a medical balloon dilation system, fig. 2 illustrates an anatomic passageway with a balloon catheter, fig. 3a-b illustrates a medical balloon dilation system, fig. 4 illustrates a medical balloon dilation system with a tube, fig. 5a-b illustrates a packaging for a medical balloon dilation system, fig. 6 illustrates a medical balloon dilation system, fig. 7 illustrates a medical balloon dilation system with a valve, fig. 8 illustrates a method of balloon dilating an anatomic passageway of a person, fig. 9a-c illustrates a medical ballon dilation system, fig. lOa-b illustrates a medical ballon dilation system.Detailed descriptionFig. 1 illustrates a side view of a human patent’s head HE where a balloon catheter BC has been inserted into the head HE of the human. The balloon catheter comprises a balloon (not shown) and a part of a balloon shaft BS. The balloon catheter BC is a part of a medical balloon dilation system MBD, where the medical balloon dilation system MBD further comprises a pump assembly PA. The balloon catheter BC has been inserted into an anatomic passageway (not shown) where the anatomic passageway typically may be the eustachian tube. The pump assembly PA is mechanically and fluidly connected to the balloon catheter BC. The pump assembly PA comprises a pump reservoir PR and a pump PU, where the pump reservoir contains a part of a liquid (not shown). The liquid is contained within said pump reservoir PR, balloon catheter BC including the balloon shaft BS and the balloon. A small amount of gas may also be contained in the same volume as the liquid but may typically be minimised to keep the balloon catheter efficient.The balloon catheter BC is illustrated with two parts for holding the balloon shaft BS and a part for sliding the balloon (not shown) forward. The medical balloon dilation system MBD may typically be guided by a camera or endoscope ES along with the balloon catheter BC. The use of pump assembly PA, balloon catheter BC and endoscope ES may typically require more than one person to handle all three parts. The pump PU is illustrated as a screwing part for the pump assembly PA but may in other embodiments be a syringe, actuator or peristaltic pump. The mechanical and fluid connection between the pump assembly PA and the balloon catheter BC is shown as a flexible tube TU but may in other embodiments of the inventions be a stiffer / smoother tube or pipe. The mechanical and fluid connection between the pump assembly PA and the balloon catheter BC may in another embodiment be a direct coupling of the two parts.Fig. 2 shows a partial vertical sectional view through the left-side nasal passageway AP on a human head HE and depicts an optional balloon catheter insertion instrument housing the balloon catheter BC and configured for advancement of the balloon out from the tip of the guiding tube of the insertion instrument and an endoscope ES. Aballoon shaft BS is hidden inside the insertion tube ITU of the balloon catheter BC is located partly with the nose of a human along with the endoscope ES to reach the opening of the eustachian tube ET. The balloon catheter BC is mechanically and fluidly connected with a pump assembly (not shown) outside of the human head at the opposite end of the ballon shaft BS closest to the eustachian tube ET. It may also be defined as a distal end where the balloon end towards the patient and a proximal end towards the operator. The balloon catheter comprises a balloon (not shown) at the end of the balloon shaft BS illustrated closest to the eustachian tube ET. The medical balloon dilation system MBD shown in fig. 1 and fig. 2 may be any of the embodiments described in description below. It some embodiments of the invention the insertion tube may be understood as being a part of the balloon catheter.The balloon dilation system may or may not include a balloon insertion instrument. A balloon insertion instrument may be an integrated part of a disposable balloon dilation system or alternatively, a disposable balloon dilation system with a balloon catheter and pump assembly made of mainly plastic parts may be used together with a multiuse and autoclavable balloon insertion instrument made from mainly steel parts.Fig. 3a illustrates a medical balloon dilation system MBD that comprises a pump assembly PA and a balloon catheter BC. The balloon catheter BC and pump assembly PA is mechanically and fluidly connected to each other at one of their respective ends. The mechanically connection is illustrated as the balloon catheter BC being approximately perpendicular on the pump assembly PA. In other embodiments of the invention the mechanical connection between the balloon catheter BC and the pump assembly PA may be any other angle e.g., 180 degrees with the two parts parallel or a pointed angle. The balloon catheter BC comprises a balloon shaft BS and a balloon BA, where the balloon BA is located at the opposite end of the mechanical connection to the pump assembly PA. The ballon shaft BS may in some embodiments be understood or referred to as a catheter shaft. The pump assembly PA is shown with a pump reservoir PR containing a liquid (not show) or a part of a liquid (not shown) and a pump PU with a sealing element SEAL to enclose the liquid. The pump PU may in some embodiments also be referred to as a plunger PL when said pump reservoir is abarrel of a syringe. The pump PU is shown in a resting position ready for being pushed and thereby pump liquid from the pump reservoir PR to the balloon BA. The balloon is shown in an unflated state which typically corresponds to the resting position of the pump PU. A part of the liquid (not shown) may be located in both the balloon shaft BS and the balloon BA even though the pump PU has not been pushed away from a resting position. The inner volume of the pump reservoir PR, the balloon shaft BS and the balloon BA may further contain an amount of gas (not shown). The mechanical and fluid connection between the pump assembly and the ballon catheter may be an irreversible process when broken, where the medical balloon dilation system can’t be connected back together.The medical balloon dilation system MBD illustrated in fig. 3 has been enclosed in a packaging PACK. The packaging may be a blister packaging, a medical tray or a TYVEK pouch, which are typically used when ensuring a sterile environment but is not limited to the specific packaging. The medical balloon dilation system MBD shown in fig. 3a has been sterilized (not shown). The sterilization may be done by radiation, heat, gas or any other method for sterilizing a medical device. The sterilizing of the pump assembly PA and the balloon catheter BC may have been done prior to or subsequently to mechanically and fluidly connecting the two parts. The sterilization may also have been done prior to or subsequently to filling the liquid (not shown) into the pump reservoir PR and optionally the ballon shaft BS and the balloon BS without inflating the balloon.Fig. 3b shown a similar embodiment of the invention as fig. 3a. Fig. 3b illustrates a different location of the pump PU in the pump reservoir PR where the pump PU has been pushed to a using location and thereby pumping a part of the liquid (not shown) to the balloon shaft BS and into the balloon BA. The balloon BA is shown in an inflated state where the balloon BA has been unfolded due to being filled with a part of the liquid.The medical balloon dilation system MBD in fig. 3b has been unpacked from the packaging PACK illustrated in fig. 3a. As the medical balloon dilation system has been unpacked the dilation system may be ready to use immediately after unpacking withoutfurther preparation. The balloon BA may also be tested as the first part after the dilation system has been unpacked to ensure that the balloon BA e.g., is not leaking when being filled with liquid.Fig. 4a illustrates a medical balloon dilation system MBD comprising a pump assembly PA mechanically and fluidly connected to a balloon catheter BC, where the balloon catheter BC comprises a balloon BA and a balloon shaft BS. The pump assembly PA is illustrated as a syringe assembly with a plunger PL and a pump reservoir PR, where the pump reservoir PR may contain at least a part of a liquid LI which is contained in the medical balloon dilation system MBD. The plunger PL is illustrated as has been pushed forward into the pump reservoir PR and has thereby pumped and pushed a part of the liquid LI from the pump reservoir PR to the balloon catheter BC including the balloon BA and the balloon shaft BS. The balloon BA is illustrated as being inflated with liquid LI like when being used in an anatomic passageway (not shown) or a testing-state. A tube TU is mechanically connected to the pump assembly PA with a snap-lock coupling which facilitates a fluid connection between the tube TU and the pump assembly PA, where the tube TU contains a part of the liquid LI. The mechanical connection between the tube TU and the pump assembly PA may not be limited to a snap-lock. The mechanical connection may in another embodiment of the invention be any kind of mechanical connection like a screwing part, glue, click-lock or any other mechanical connections which facilitates a fluid connection between the tube TU and the pump assembly PA. The tube TU is illustrated as being mechanically connected with glue in the opposite end to the balloon catheter BC which thereby facilitates the fluid connection between the pump assembly PA and the balloon catheter BC. It may be advantageous to provide fluid connections that are not meant for being disconnected and reconnected when the system is already filled with the correct amount of liquid. Opening of said fluid connection may result in loss of liquid and entry of gas into the system which may causes failures in the system. It may be advantageous to make the system and all the fluid connection tamper proof, such that any opening of the fluid connections or any opening of the pump assembly will show visible damages.The liquid may be contained in both pump reservoir PR and balloon catheter BC from beginning including the balloon shaft BS and the balloon BA.The embodiment illustrated in fig. 4a and 4b have been sterilized (not shown). The sterilization of the medical balloon dilation system MBD may have been with radiation, gas, heat or any other form of sterilizing. The process of sterilizing the medical balloon dilation system MBD may have been done prior to enclosing the medical balloon dilation system MBD in a sealed packaging (not shown) or done subsequently to enclosing the medical balloon dilation system MBD in a packaging (not shown). When sterilizing the pump reservoir, it may be done with or without a contained liquid inside of the pump reservoir. The liquid contained in the pump reservoir may be sterilized simultaneously with pump reservoir and pump assembly by radiation. In another embodiment of the invention the liquid inside the pump reservoir has not been sterilized either prior to or after being enclosed in the pump reservoir.4b illustrates the same technical features as shown in fig. 4a. In fig. 4b the pump PU has been pushed to a position where the liquid (not shown) has been pumped into the balloon catheter BC and into the balloon BA. The balloon BA is shown in an inflated state like when the balloon BA and a part of the balloon catheter BC has been inserted into an anatomic passageway (not shown).Fig. 5a illustrates a medical balloon dilation system MBD placed in a packaging PACK either after the packaging PACK has been opened or before the packaging PACK is being sealed. The medical balloon dilation system MBD shown in fig. 5a is similar to the medical balloon dilation system illustrated in fig. 4a and / or 4b but may by any embodiment of the invention.The packaging PACK shown in fig. 5a is illustrated as a blister packaging but may any kind of packaging to enclose a pump assembly PA and a balloon catheter BC of the medical balloon dilation system MBD. The packaging may typically be sealed to enclose the medical balloon dilation system to prevent bacteria, virus or other unintended particles in the sterilized environment in the packaging PACK. Thepackaging PACK may be vacuum sealed with no or a bare minimum of gas located inside the packaging.The packaging PACK may in an embodiment of the invention be made of a material where a sterilization is possible without breaking or opening the sealed packaging. The sterilization may in an embodiment be with a gas, where the gas can penetrate the packaging to kill bacteria and where the packaging at the same time can prevent further bacteria to enter the inside of the sealed packaging. In another embodiment of the invention the packaging may be made of a material which does not break when being exposed for radiation. The same packaging may at the same time allow radiation to penetrate the packaging to sterilize the pump assembly, balloon catheter and any liquid being contained inside the pump assembly and / or the balloon catheter.In fig. 5b is an outer packaging OP ACK illustrated for a packaging PACK which may be similar to the packaging shown in fig. 5a. The outer packaging may in an embodiment of the invention be used to include the packaging and e.g., a manual for using the medical balloon dilation system. The outer packaging OP ACK may in an embodiment of the invention facilitate a sterilization of the medical balloon dilation system when being enclosed in the packaging and the packaging being enclosed in the outer packaging.Fig. 6 illustrates an embodiment of the invention seen in a cross-sectional view where a medical balloon dilation system MBD comprises a pump assembly PA and a balloon catheter BC. The pump assembly PA and the balloon catheter BC are mechanically and fluidly connected. The balloon catheter BC comprises a balloon BA located at the end of a balloon shaft BS. The balloon BA is illustrated as being in an inflated state similar to when being used in an anatomic passageway (not shown). The balloon shaft BS may be directly mechanically coupled to the pump assembly PA or may be connected via a tube, pipe or similar for facilitating a fluid connection between the pump assembly PA and the balloon catheter BC.The pump assembly PA in fig. 6 is illustrated with a peristaltic pump PU and a pump reservoir PR. The peristaltic pump PU is mechanically coupled with an actuator ACT,where the peristaltic pump PU is controlled by turning the actuator ACT. By rotating the actuator ACT the peristaltic pump PU is rotated and liquid LI is being pumped from the pump reservoir PR to the balloon catheter BC and especially the balloon BA, where the balloon BA may be folded out.In another embodiment of the invention the pump assembly may be any kind of actuator or pump configured for pumping / pushing liquid from a reservoir to a balloon catheter. The pump PU may be a diaphragm pump with a first and a second checkvalve wherein an actuator is operably coupled to push the diaphragm down to push liquid LI out from the diaphragm volume, through the second-check valve and into the balloon catheter BC, and wherein the diaphragm when pulled back up, will pull liquid LI from the pump reservoir PR through the first check valve. One or multiple diaphragm movements may be needed to fully inflate the balloon BA. A release valve may allow liquid LI to return from the balloon BA to the pump reservoir PR or alternatively, the diaphragm pumping direction may be inverted with other valves, to pump the liquid LI from the balloon BA back into the pump reservoir PR. The pump PU may be a squeeze-pump wherein the pump reservoir PR is compressible such as a compressible bladder or bellows and wherein an actuator is operably coupled to squeeze the pump reservoir for pumping liquid LI from the pump reservoir PR and into the ballon BA. The flexible pump reservoir PR may have a resilient nature and return to its shape upon release of the actuator such that the liquid LI is pulled back into the pump reservoir from the balloon BA.The medical balloon dilation system MBD illustrated in fig. 6 may be enclosed in a packaging (not shown) similar to fig. 5a, where the packaging may be a blister packaging, Tyvek pouch, a medical tray or any other suitable packaging.In another embodiment of the invention the pump assembly may include an additional valve fluidly connected to the pump reservoir for filling liquid into the system and / or to release some internal gas from e.g., the pump reservoir or balloon catheter.Fig. 7 illustrates an embodiment of the invention seen in a cross-sectional view of a medical balloon dilation system MBD. The medical balloon dilation system MBD isshown with a pump assembly PA with a pump reservoir PR and a valve VS. The valve VS may be used to fill more liquid into the system or to drain gas from the system. The valve is located next to the pump reservoir but may in another embodiment of the invention be located at the balloon catheter, the connection between the balloon catheter and the pump assembly, or any other location where the valve may be suited for releasing gas from the system.Fig. 8 illustrates a method of using a medical balloon dilation system like the one of embodiments describes relating to fig. 1-7. The method of balloon dilating one or more anatomic passageways of a person is shown with following steps. SI illustrates a first step of unpacking a medical balloon dilation system comprising a sterilized pump assembly and a sterilized balloon catheter. The pump assembly and optionally the balloon catheter is prefilled with a liquid used for inflating the balloon. The unpacking may be done by the operator, exerciser or practitioner which is about to use the medical balloon dilation system.In a second step S2 of the method at least a part of the balloon catheter is inserted into an anatomic passageway through a natural opening in the body of a person. The second step of the method may be done immediately after the operator has unpacked the medical balloon dilation system. The insertion into the person may be done without any further preparation of the medical balloon dilation system. The medical balloon dilation system is ready -to-use when the first step SI of unpacking has been done. The operator may in some cases run a testing step of the balloon dilation system prior to inserting by testing e.g., the pump and balloon. The testing may be to ensure that liquid is being pumped to the balloon and that the balloon inflates during that procedure. The operator may also test if any leakage is occurring from the system, pump assembly, balloon catheter and / or especially from the balloon.In a third step S3 of the method a pumping of the liquid from the pump reservoir to the balloon catheter and into the balloon to inflate the balloon. The inflation of the balloon inside the anatomic passageway may typically be done while an endoscope is used to see if the balloon is inflated at the correct location of the anatomic passageway.The method may further comprise additional steps (not shown) where the liquid in the balloon is pumped back into the pump reservoir to un-flate the balloon. After unflating the balloon, a step of removing the part of the balloon catheter from the anatomic passageway may be carried out. The removing of the balloon catheter may typically be done without liquid in the balloon or a bare minimum of liquid in the balloon, and therefore the step of removing is typically done subsequently to removing a part of the liquid from the balloon by pumping.A further additional step (not shown) of the method may be another step of testing especially the balloon to see if the balloon has been damaged in the previous steps and therefore could be leaking. The additional step of testing may ensure that liquid has not been leaked while a part of the balloon catheter has been inserted into a person.Further additional steps (not shown) of the method may be steps of reusing the balloon catheter on the same person in different anatomic passageways. The reusing may include inserting into a second anatomic passageway, pumping liquid into the balloon, removing the liquid from the balloon and subsequently extracting the balloon catheter from the anatomic passageway and the person.

[0199] Fig. 9a illustrates a medical balloon dilation system MBD configured for dilating anatomic passageways accessible through natural openings in the body of a person. The system comprises a pump assembly PA and a balloon catheter BC.

[0200] The pump assembly PA which is shown as a syringe-like component for containing a liquid LI includes a pump reservoir PR. A pump PU is arranged partly within the pump reservoir PR to enable displacement of the liquid LI for inflation of the balloon BA. A valve VS is located between the pump assembly PA and the ballon catheter BC for controlling fluid flow between the pump reservoir PR and the balloon catheter BC. A tube TU provides a fluid connection between the pump assembly PA and the balloon catheter BC when the valve VS is in an open state like in fig. 9b. The valve VS is illustrated with a lock LOK configured to open and / or close the fluid connection between pump reservoir PR and ballon catheter BC. The lock LOK may be configured to only turn one way and therefore after opening the valve VS for lettingliquid flow the lock LOK may not be able to close the valve VS again. In other embodiments the lock LOK may be configured for turning both ways and thereby opening and closing the valve VS depending on the use of the medical ballon dilation system. The lock LOK may be configured to prevent the second fluid port from being re-opened after fluidly connecting the pump assembly to the balloon catheter. In other embodiments, the lock may be configured to prevent the ambient fluid port AFP from being opened after it has been closed.

[0201] In the configuration shown in fig. 9a, the valve VS is in a closed position, such that no fluid connection is currently available between the pump assembly PA and the balloon catheter BC. This prevents unintended transfer of liquid LI and ensures the system remains in a safe state prior to activation. Similarly, the ballon BA is illustrated in a noninflated state in fig. 9a. The liquid LI may in some embodiments be in the pump reservoir PR, the tube TU or in both when the valve VS is in the closed state.

[0202] The balloon catheter BC comprises an elongated ballon shaft BS, also referred to as catheter shaft, terminating in a distal end configured to carry a balloon BA. The balloon BA is adapted to be positioned within an anatomic passageway, such as an Eustachian tube, and inflated by liquid supplied from the pump assembly PA through the fluid connection. The proximal end of the ballon shaft BS is mechanically connected to the valve VS and tube TU for secure coupling.

[0203] In use, the pump assembly PA is actuated by manual displacement of the plunger PL, thereby transferring liquid LI from the pump reservoir PR through the tube TU and valve VS into the balloon BA for dilation of the targeted passageway when the valve VS is in an open state. The valve VS may in some embodiments be a oneway valve which is only configured to be opened and not closed again to ensure that the valve VS has not been opened prior to use. In some embodiments the valve VS may be configured to open and close again depending on when you have to use the medical ballon dilation system and how often you have to use it.

[0204] Fig. 9b illustrates a medical balloon dilation system MBD in an operational state configured for dilating anatomic passageways accessible through natural openings in the body of a person. The system comprises a pump assembly PA and a balloon catheter BC.

[0205] The pump assembly PA includes a pump reservoir PR, shown as a syringelike component containing a liquid LI, such as water. A pump PU, here illustrated as a plunger-element, is arranged within the pump reservoir PR to pump or enable displacement of the liquid LI for inflation of the balloon BA. In other embodiments the device for pumping the liquid may be other embodiments than a plunger. In some instances, the word pump PU may be used to describe an active partial element of a pump such as a plunger. A tube TU provides a fluid connection FC between the pump assembly PA and the balloon catheter BC. A valve VS for controlling fluid flow between pump assembly PA and ballon catheter BC is mechanically coupled between the tube TU and the ballon catheter BC.

[0206] In the configuration shown, the valve VS is in an open position, thereby establishing a fluid connection between the pump assembly PA and the balloon catheter BC. As a result, liquid LI can been transferred from the pump reservoir PR through the tube TU and into the balloon BA, which is shown in a filled and expanded state. This configuration enables dilation of an anatomic passageway, such as an Eustachian tube, when the balloon catheter BC is positioned at the target site. In other embodiments liquid may also be present in the tube TU prior to opening the valve VS.

[0207] The balloon catheter BC comprises an elongated ballon catheter shaft BS, also referred to as ballon shaft or catheter shaft, terminating in a distal end carrying the balloon BA. The proximal end of the catheter shaft CS is mechanically connected to the valve VS and tube TU.

[0208] In use, the pump assembly PA is actuated by manual displacement of the plunger PL, thereby transferring liquid LI from the pump reservoir PR into the balloon BA through the open valve VS, resulting in balloon inflation for dilation of the targeted passageway.

[0209] Fig. 9c shows a cross-sectional view of the medical balloon dilation system (MBD) as illustrated in fig. 9a-b. The medical ballon dilation system comprises a pump assembly PA and a balloon catheter BC, connected by a tube TU providing a fluid connection from said pump assembly PA to said ballon catheter BC.

[0210] The pump assembly PA includes a pump reservoir PR configured as a syringe-like component for containing a liquid LI. A pump PU, here illustrated as a plunger, is arranged partly within the pump reservoir PR and is shown in a position enabling displacement of the liquid LI. The cross-sectional view reveals the internal structure of the pump reservoir PR and the pump PU, including a sealing element SEAL at the first fluid port FFP that prevent leakage of liquid during actuation.

[0211] The medical ballon dilation system comprises a fluid barrier here illustrated as a valve VS. The valve VS is arranged along the fluid path between the pump assembly PA and the balloon catheter BC. In this configuration, the valve VS is shown in a closed state, thereby preventing fluid flowing from the tube TU to the ballon catheter BC. The tube TU comprises a first fluid port FFP configured to fluidly connecting said tube TU and pump assembly PA to said ballon catheter BC. The ballon catheter BC is illustrated with a second fluid port SFP which is fluidly connected with an ambient fluid port AFP of said valve VS. The ballon catheter BC is illustrated in fluid connection with the ambient surroundings in a packaging through said ambient fluid port AFP. Upon turning said valve VS the first fluid port FFP may be fluidly connected with the second fluid port SFP and the ambient fluid port AFP may be blocked (not shown). The valve VS may e.g., be turned or twisted to open the valve VS. In another embodiment, the valve may be configured to block the second fluid port SFP in order to hold a pressure inside the balloon catheter BC for a period of time.

[0212] The balloon catheter BC comprises an elongated ballon shaft BS terminating in a distal end configured to carry the balloon BA. The cross-sectional view illustrates the internal lumen of the ballon shaft BS, which provides a fluid channel for liquid transfer to the balloon BA. The balloon BA is shown in its non-inflated state, surrounding the distal portion of the ballon shaft BS.

[0213] This view highlights the fluid path from the pump reservoir PR through the valve VS and tube TU to the balloon BA, which in this configuration remains blocked due to the closed valve VS.

[0214] Fig. 10a illustrates a medical balloon dilation system MBD comprising a pump assembly PA and a balloon catheter BC in a state where the components are not mechanically connected but are configured to be connected for operation. The medical ballon dilation system MBD further comprises a tube TU wherein the TU has a first fluid port FFP. The ballon catheter is illustrated with a second fluid port SFP.

[0215] The pump assembly PA includes a pump reservoir PR, shown as a syringelike component for containing a liquid LI, and a pump PU, shown as a plunger, arranged within the pump reservoir PR for displacing the liquid. A tube TU extends from the pump reservoir PR and terminates in a fluid barrier, here illustrated as a septum VS. In an alternative embodiment the fluid barrier could also be formed by a valve. The septum VS is configured to mechanically connect with the balloon catheter BC. The septum VS is illustrated with an ambient fluid port AMF. The septum VS is configured for mechanically connecting and fluidly connecting the ballon catheter BC with the pump assembly PA when coupled and the first fluid port FFP and second fluid port SFP is fluid connected.

[0216] The balloon catheter BC comprises an elongated ballon shaft BS carrying a balloon BA in a distal end. The proximal end of the ballon shaft BS includes a mating connector with complementary features for engagement with the valve VS. The two connector parts of the valve VS and the ballon shaft BS may allow secure coupling and fluid communication when assembled. In the configuration shown, the connectors are axially aligned yet separated, indicating that the components are not connected at present. The medical ballon dilation system MBD is illustrated being enclosed in a packaging PACK. The packaging may be sealed and / or sterilized according to one of the packaging described in other figures or embodiments of the invention.

[0217] This arrangement demonstrates the medical ballon dilation system in a not- pre-assembly state, where the pump assembly PA and balloon catheter BC aresterilized and packaged together, and are intended to be connected prior to use for e.g., a dilation of an anatomic passageway. In another embodiment the pump assembly PA and the ballon catheter BC may be separately packed and sterilized.

[0218] Fig. 10b shows an enlarged cross-sectional view of the connection interface between the tube TU connected to the pump assembly (not shown) and the proximal end of the balloon catheter BC. The fig. 10b illustrates a part of the medical ballon dilation system MBD where the tube TU and pump assembly (not shown) are mechanically connected to the ballon catheter BC through the septum VS. The parts are not fluidly connected due to the sealing element SEAL in the septum VS has not been pierced yet.

[0219] The valve VS at the end of the tube TU is shown with a cylindrical cavity and sealing features, including a sealing element SEAL, which ensures fluid-tight engagement when the mating connector of the balloon catheter BC is inserted. The ballon catheter BC is illustrated with a second fluid port SFP which is fluidly connected with an ambient fluid port AFP of the valve VS. Upen piercing (not shown) the second fluid port SFP and the first fluid port FFP of the tube TU are being fluidly connected and the ambient fluid port AFP are being blocked.

[0220] The proximal connector of the balloon catheter BC comprises a threaded portion configured to engage with the valve VS. The cross-sectional view reveals the internal fluid channel extending through the catheter shaft CS toward the balloon (not shown). The sealing element SEAL is positioned between the two components to prevent leakage during fluid transfer. In other embodiments the sealing element SEAL may be any kind of sealing element for preventing liquid to come out of the tube and pump assembly. The sealing element illustrated in the figure may in some embodiments be referred to as a fluid port or a fluid barrier.

[0221] This configuration demonstrates the structural arrangement that allows the pump assembly PA and balloon catheter BC to be securely connected, providing both mechanical stability and a continuous fluid path for inflating the balloon BA during use.

[0222] List of reference signs:ACT ActuatorAFP Ambient fluid portAP Anatomic PassagewayBA BalloonBC Balloon CatheterBS Ballon shaftES EndoscopeET Eustachian tubeFB Fluid barrierFC Fluid connectionFFP First fluid portHE Head / human headITU Insertion tubeLOK LockMBD Medical balloon dilation systemMC Mechanical connectionOP ACK Outer packagingPA Pump arrangementPACK PackagingPL PlungerPR Pump reservoir'PU PumpSEAL Sealing elementSFP Second fluid portTU TubeVS Valve

Claims

Claims1. A medical balloon dilation system (MBD) for dilating of anatomic passageways that are accessible through natural openings in the body of a person comprising: a pump assembly (PA) containing at least one liquid (LI) in a pump reservoir (PR), a balloon catheter (BC) comprising: a catheter shaft (CS), and a balloon (BA), wherein said pump assembly (PA) is mechanically connected or mechanically connectable to said balloon catheter (BC), wherein said pump assembly (PA) is fluidly connected or fluidly connectable to said balloon catheter (BC), wherein said pump assembly (PA) and said balloon catheter (BC) is enclosed in a sealed packaging (PACK), and wherein said pump assembly (PA) and said balloon catheter (BC) has been sterilized.

2. A medical balloon dilation system (MBD) according to claim 1, wherein said pump assembly (PA) has been sterilized by radiation.

3. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) has been sterilized by gas-sterilization4. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) has been sterilized by heat.

5. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump reservoir (PR) and said at least one liquid (LI) have been sterilized by radiation.

6. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said balloon catheter (BC) has been sterilized by radiation.

7. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said balloon catheter (BC) has been sterilized by gas-sterilization8. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said balloon catheter (BC) has been sterilized by heat.

9. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA), said balloon catheter (BC) and said one liquid (LI) have been sterilized together by radiation while being inside the sealed packaging (PACK).

10. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) and said balloon catheter (BC) have been sterilized together by gas while being inside the sealed packaging (PACK) and while containing the said one liquid (LI).I L A medical balloon dilation system (MBD) according to claim 10, wherein said pump assembly (PA) and said balloon catheter (BC) have been sterilized together by gas while being inside the sealed packaging (PACK), and while the said at least one liquid (LI) is partly in said pump reservoir (PR) and partly in said balloon catheter (BC).

12. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) has been sterilized prior to being filled with said at least one liquid (LI).

13. A medical balloon dilation system (MBD) according to claim 12, wherein said pump assembly (PA) has been sterilized by gas-sterilization prior to filling said pump reservoir (PR) with said at least one liquid (LI).

14. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) has been sterilized by radiation while being enclosed in said sealed packaging (PACK).

15. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said balloon catheter (BC) has been sterilized by radiation while being enclosed in said sealed packaging (PACK).

16. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) has been sterilized prior to being mechanically connected to said balloon catheter (BC).

17. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said balloon catheter (BC) has been sterilized prior to being mechanically connected to said pump assembly (PA).

18. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said sterilization is by radiation while containing said at least one liquid (LI).

19. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) is a syringe assembly (SA).

20. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump reservoir (PR) is a syringe barrel.

21. A medical balloon dilation system (MBD) according to claim 20, wherein said syringe assembly comprises: a syringe barrel, and a plunger (PL).

22. A medical balloon dilation system (MBD) according to any of the claims 20-21, wherein said plunger (PL) is configured for sliding inside said syringe barrel.

23. A medical balloon dilation system (MBD) according to any of the claims 20-22, wherein said plunger (PL) is configured for pumping a part of said at least one liquid (LI) into said balloon (BA).

24. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) comprises an actuator (ACT) for pumping a part of said at least one liquid (LI) from said pump reservoir (PR) to said balloon (BA).

25. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) comprises a fluid barrier (FB) keeping said at least one liquid (LI) enclosed in said pump reservoir (PR).

26. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said fluid barrier (FB) is a membrane (MEM).

27. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said fluid barrier (FB) is a valve (VAV).

28. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump reservoir (PR) is configured for fluidly connecting to said balloon (BA) by opening said fluid barrier (FB).

29. A medical balloon dilation system (MBD) according to claim 28, wherein said fluid barrier (FB) is a one-time-use.

30. A medical balloon dilation system (MBD) according to any of the claim 28-29, wherein said fluid barrier (FB) is irreversible.

31. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) and said balloon (BA) is fluidly preconnected before being enclosed in said sealed packaging (PACK).

32. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said mechanical connection between said pump assembly (PA) and said balloon catheter (BC) is click and lock-solution.

33. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) is directly mechanically and fluidly connected to said balloon catheter (BC).

34. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein a tube (TU) is mechanically and fluidly connecting said pump assembly (PA) to said balloon catheter (BC).

35. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said one or more mechanical connections in said medical balloon dilation system (MBD) between any part of the medical balloon dilation system (MBD) is a permanent connection.

36. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein all fluid connections of said medical balloon dilation system (MBD) are permanent fluid connections.

37. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein the connections mechanically and fluidly connecting said pump assembly (PA) and said balloon catheter (BC) are permanent.

38. A medical balloon dilation system (MBD) according to claim 37, wherein said connections are established by means of glue.

39. A medical balloon dilation system (MBD) according to claim 38, wherein said permanent connections are established by forming at least a part of the pump assembly (PA) and at least a part of the balloon catheter (BC) in one monolithic piece.

40. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein all mechanical connections are glued together.

41. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein all fluid connections are glued together.

42. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said mechanical connection between said pump assembly (PA) and said balloon catheter (BC) is a permanent connection.

43. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein at least a part of said at least one liquid (LI) is partly in said balloon catheter (BC) when said balloon catheter (BC) is enclosed in said sealed packaging (PACK).

44. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein at least a part of said at least one liquid (LI) is partly in said balloon shaft (BS) and / or said balloon (BA) when said balloon catheter (BC) is enclosed in said sealed packaging (PACK).

45. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said at least one liquid is contained in said pump reservoir (PR) and said balloon catheter (BC) at the same time while being enclosed in said packaging (PACK).

46. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said pump assembly (PA) comprises a valve (VS), wherein said valve (VS) when being opened is fluidly connecting said pump reservoir (PR) to surroundings.

47. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said medical balloon dilation system (MBD) is enclosed in an outer packaging (OP ACK).

48. A medical balloon dilation system (MBD) according to claim 47, wherein a manual is enclosed in said outer packaging (OP ACK).

49. A medical balloon dilation system (MBD) according to any of the claims 47-48, wherein said medical balloon dilation system (MBD) has been sterilized while being enclosed in said outer packaging (OP ACK).

50. A medical balloon dilation system (MBD) according to any of the claims 47-49, wherein said outer packaging (OP ACK) has been sterilized while containing said packaging (PACK).

51. A medical balloon dilation system (MBD) according to any of the claims 47-50, wherein said outer packaging (OP ACK) has been sterilized by radiation while containing said packaging (PACK).

52. A medical balloon dilation system (MBD) according to any of the claims 47-51, wherein said outer packaging (OP ACK) has been sterilized by gas while containing said packaging (PACK).

53. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said at least one liquid in said pump reservoir (PR) is either water or oil.

54. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said at least one liquid (LI) in said pump reservoir (PR) has an evaporation temperature of at least 60°C, at least 70°C, at least 80°C, at least 90°C, at least 100°C, at least 110°C or at least 120°C.

55. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said at least one liquid (LI) in said pump reservoir (PR) has a viscosity of more than 0.9cP and less than 75cP.

56. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said at least one liquid (LI) in said pump reservoir (PR) has a viscosity of more than 2cP and less than 50cP.

57. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said at least one liquid (LI) in said pump reservoir (PR) comprises anti -bacteria material.

58. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein a volume of said at least one liquid in said pump reservoir (PR) is more than 70% of an inner volume of said pump reservoir (PR), such as more than 75% of an inner volume of said pump reservoir (PR), such as more than 80% of an inner volume of said pump reservoir (PR), such as more than 85% of an inner volume of said pump reservoir (PR), such as more than 90% of an inner volume of said pump reservoir (PR).

59. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein a volume of said at least one liquid in said pump reservoir (PR) and said balloon catheter (BC) is more than 70% of an inner volume of said pump reservoir (PR) and said balloon catheter (BC), such as more than 75% of an inner volume of said pump reservoir (PR) and said balloon catheter (BC), such as more than 80% of an inner volume of said pump reservoir (PR) and said balloon catheter (BC), such as more than 85% of an inner volume of said pump reservoir (PR) and said balloon catheter (BC), such as more than 90% of an inner volume of said pump reservoir (PR) and said balloon catheter (BC).

60. A medical balloon dilation system (MBD) according to any of the preceding claims, wherein said inner volume of said pump reservoir (PR) is less than 30% gas, such as less than 25% gas, such as less than 20% gas, such as less than 15%, such as less than 10%, such as less than 5%, such as less than 2%.

61. A method of packing a ready -to-use medical balloon dilation system (MBD) comprising: providing:- a pump assembly (PA) having a pump reservoir (PR) and- a balloon catheter (BC),mechanically and fluidly connecting said pump assembly (PA) to said balloon catheter (BC), enclosing and sealing said ballon catheter (BC) and said pump assembly (SA) in a packaging (PACK), wherein said pump reservoir (PR) includes at least one liquid (LI) when enclosed and sealed in said packaging (PACK), sterilizing said pump assembly (PA) and said balloon catheter (BC) prior to and / or subsequent to enclosing said pump assembly (PA) and said balloon catheter (BC) in said packaging (PACK).

62. A method according to claim 61, wherein said method comprises a step of filling said pump reservoir (PR) of said pump assembly (SA) with at least one liquid (LI).

63. A method according to any of claims 61-62, wherein said method comprises a step of filing said balloon catheter (BC) with a part of said at least one liquid (LI).

64. A method according to any of claims 61-63, wherein said method comprises a step of filing a balloon (BA) comprised in said balloon catheter (BC) with a part of said at least one liquid (LI).

65. A method according to any of claims 61-64, wherein said balloon catheter (BC) includes a part of said at least one liquid (LI) when being enclosed and sealed in said packaging (PACK).

66. A method according to any of claims 61-65, wherein said method comprises a step of filing said pump reservoir (PR) of said pump assembly (PA) and said balloon catheter (BC) with said at least one liquid (LI).

67. A method according to claim 66, wherein said step of filling said pump reservoir (PR) is prior to enclosing and sealing said packaging (PACK).

68. A method according to any of claims 66-67 wherein said step of mechanically and fluidly connecting said pump assembly (PA) to said balloon catheter (BC) is prior tofilling said pump reservoir (PR) and / or said balloon catheter (BC) with said at least one liquid (LI).

69. A method according to any of claims 66-68, wherein said step of filling said pump reservoir (PR) is prior to mechanically and fluidly connecting said pump assembly (PA) to said balloon catheter (BC).

70. A method according to any of claims 61-69, wherein said pump assembly (PA) having said pump reservoir (PR) is provided with said pump reservoir (PR) filled with at least one liquid (LI).

71. A method according to any of claims 61-70, wherein said step of sterilizing is a sterilization by radiation.

72. A method according to any of claims 61-71, wherein said step of sterilizing is a sterilization by gas.

73. A method according to any of claims 61-72, wherein said method comprises an additional step of enclosing said packaging (PACK) in an outer packaging (OP ACK).

74. A method according to claim 73, wherein said additional step of enclosing said packaging (PACK) in said outer packaging (OP ACK) is done prior to said step of sterilizing said pump assembly (PA) and said balloon catheter (BC).

75. A method according to any of claims 73-74, wherein said step of sterilizing is done subsequent to said step of enclosing said packaging (PACK) in said outer packaging (OPACK).

76. A method according to any of claims 61-75, wherein said method comprises a step of reducing the amount of gas contained inside said pump reservoir (PR) and said balloon catheter (BC).

77. A method according to claim 76, wherein said step of reducing the amount of gas contained inside said pump reservoir (PR) and said balloon catheter (BC) is reduced by a valve (VS).

78. A method according to any of claims 61-77, wherein said medical balloon dilation system (MBD) is a medical balloon dilation system according to claim 1-60.

79. A use of a medical balloon dilation system according to claim 1-60 comprising: unpacking a sterilized pump assembly (PA) and a sterilized balloon catheter (BC), inserting at least a part of said sterilized balloon catheter (BC) into an anatomic passageway (AP) that is accessible through natural openings in the body of a person, pumping at least a part of said at least one liquid (LI) from said pump reservoir (PR) into said balloon (BA).

80. A use of a medical balloon dilation system according to claim 79, wherein said anatomic passageway (AP) may be any one of a eustachian tube or sinus drain channel.

81. A use of a medical balloon dilation system according to any of the claims 79-80, wherein said use of said medical balloon dilation system (MBD) comprises the following steps: removing at least a part of said at least one liquid (LI) from said balloon (BA), and subsequently extracting said balloon catheter (BC) from said anatomic passageway (AP).

82. A use of a medical balloon dilation system according to any of the claims 79-81, wherein a step of opening said fluid barrier (FB) for fluidly connecting said pump reservoir (PR) to said balloon (BA) is done prior to said step of inserting.

83. A use of a medical balloon dilation system according to any of the claims 79-82, wherein said inserting is performed without further preparation after said unpacking.

84. A use of a medical balloon dilation system according to any of the claims 79-83, wherein said method comprises a step of testing said balloon (BA) expansion prior toinserting said ballon catheter by pumping at least a part of said at least one liquid (LI) from said pump reservoir (PR) into said balloon (BA).

85. A use of a medical balloon dilation system according to any of the claims 79-84, wherein said method comprises an additional step of final testing said balloon (BA) after extracting said ballon catheter (BC) from said anatomic passageway (AP).

86. A use of a medical balloon dilation system according to any of the claims 79-85, wherein said step of inserting at least a part of said sterilized balloon catheter (BC) into an anatomic passageway (AP) that is accessible through natural openings in the body of a person, and said step of pumping at least a part of said at least one liquid (LI) from said pump reservoir (PR) into said balloon (BA) is performed on the same person in relation to two or more different anatomic passageways (AP) of said person.

87. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60, wherein said medical ballon dilation system (MBD) comprises a tube (TU).

88. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87, wherein said tube (TU) is mechanically connected to said pump assembly (PA).

89. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-88, wherein said tube (TU) is fluidly connected to said pump assembly (PA).

90. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-89, wherein said tube (TU) is mechanically preconnected to said pump assembly (PA) in said packaging (PACK).

91. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-90, wherein the total volume of said at least one liquid is between 0,1 and 10ml, such as between 0,1 and 5ml, such as between 0,1 and 3ml.

92. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-91, wherein said pump assembly (PA) comprises a first fluid port (FFP)configured for fluidly connecting said pump assembly (PA) with said balloon catheter (BC) upon activation.

93. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-92, wherein said tube (TU) comprises a first fluid port (FFP) configured for fluidly connecting said pump assembly (PA) with said ballon catheter (BC) upon activation.

94. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-93, wherein said balloon catheter (BC) comprising a second fluid port (SFP), wherein said second fluid port (SFP) is configured for fluidly connecting said balloon catheter (BC) with ambient atmosphere in the packaging (PACK).

95. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-94, wherein said balloon catheter (BC) comprising a second fluid port (SFP), wherein said second fluid port (SFP) is configured for fluidly connecting said balloon catheter (BC) with said pump assembly (PA).

96. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-95, wherein said second fluid port (SFP) is located at the opposite end of the balloon catheter (BC) than said ballon (BA).

97. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-96, wherein the first fluid port (FFP) is closed while the system is enclosed in said packaging (PACK) thereby completely sealing said at least one liquid (LI) inside the pump assembly (PA) and / or tube (TU).

98. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-97, wherein the second fluid port (SFP) is open while the medical balloon dilation system (MBD) is enclosed in said packaging (PACK) thereby connecting ambient atmosphere in the packaging (PACK) to internal parts of the balloon catheter (BC).

99. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-98, wherein the first fluid port (FFP) and second fluid port (SFP) areconfigured to be operably dependent, such that opening of the first fluid port (FFP) can happen only after closing of the second fluid port (SFP) to said ambient atmosphere.

100. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-99, wherein said first fluid port (FFP) and second fluid port (SFP) are configured to be operably dependent and wherein the first fluid port (FFP) and the second fluid port (SFP) can be fluidly connected only after closing off any said ambient fluid port (AFP).

101. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-100, wherein a lock (LOK) is configured to prevent the second fluid port (SFP) from being re-opened after fluidly connecting the pump assembly (PA) to the balloon catheter (BC).

102. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-101, wherein said medical ballon dilation system comprises a fluid barrier.

103. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-102, wherein said fluid barrier is a valve (VS).

104. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-103, wherein said valve (VS) is connected to the first fluid port (FFP) and the second fluid port (SFP), wherein said valve (VS) comprises an ambient fluid port (AFP) configured for fluidly connecting said ambient surroundings inside the enclosed packaging (PACK) with said second fluid port (SFP).

105. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-104, wherein said valve (VS) comprises a first state inside said packaging (PACK), where the first fluid port (FFP) is closed, the second fluid port (SFP) is connected to surroundings inside the enclosed packaging (PACK) through said ambient fluid port (AFP).

106. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-105 wherein said valve (VS) comprises a second state (SES), where the first fluid port (FFP) is fluidly connected to the second fluid port (SFP) and where the ambient fluid port (AFP) is closed.

107. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-106, wherein said valve is lockable in said second state (SES).

108. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-107, wherein a lock (LOK) prevents the valve from returning to the first state.

109. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-108, wherein said valve comprises a third state, wherein the second fluid port (SFP) is blocked.

110. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-109, wherein said first fluid port (FFP) has a septum membrane configured to seal the pump reservoir (PR).

111. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-110, wherein said second fluid port (SFP) comprises a hollow needle (NED).

112. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-111, wherein said pump assembly (PA) is mechanically connected to said balloon catheter (BC) and said pump assembly (PA) is fluidly connectable to said balloon catheter (BC).

113. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-112, wherein said pump assembly (PA) is mechanically connected to said balloon catheter (BC) and said pump assembly (PA) is fluidly coupled through said first fluid port (FFP) and through said second fluid port (SFP) to said balloon catheter (BC).

114. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-113, wherein a tube (TU) is mechanically connecting and fluidly connecting said pump assembly (PA) to said balloon catheter (BC).

115. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-114, wherein said tube (TU) is mechanically connectable to said ballon catheter (BC).

116. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-115, wherein said tube (TU) is fluidly connectable to said ballon catheter (BC).

117. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-116, wherein a part of said at least one liquid is also in said tube (TU).

118. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-117, wherein an internal volume of said tube (TU) contains more than 50% liquid, such as more than 70% or more than 90% liquid.

119. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-118, wherein an internal volume of said tube (TU) contains less than 5ml gas, such as less than 3ml or less than 1ml of gas.

120. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-119 wherein said tube (TU) is a flexible tube.

121. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-120, wherein said tube (TU) comprises a fluid barrier configured for preventing the at least one liquid from entering into said balloon (BA) until after the packaging (PACK) has been opened.

122. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-121 wherein said fluid barrier is located at the end of the tube (TU)furthest away from said pump assembly (PA) when said tube (TU) is mechanically connected to said pump assembly (PA).

123. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-122, wherein said fluid barrier is a valve (VS) configured to be opened by an operator.

124. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-123, wherein said fluid barrier is a membrane configured for being broken.

125. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-124, wherein said at least one liquid (LI) has a viscosity of 0,2cP to 5cP.

126. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-125, wherein said at least one liquid (LI) is a silicone oil.

127. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-126, wherein a non-permeable foil pouch is part of the packaging (PACK).

128. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-127, wherein said foil pouch has a portion that is impermeable and a portion that is permeable and wherein the permeable portion of the pouch is closed after gas sterilization.

129. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-128, wherein packaging (PACK) consists of several layers and wherein a first packaging layer is a permeable pouch and wherein a second packaging layer is a non-permeable foil pouch.

130. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-129, wherein said pump assembly (PA) and said ballon catheter (BC) have been preassembled mechanically and / or fluidly.

131. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-130, wherein the medical balloon dilation system (MBD) is configured for dilation of the Eustachian tube.

132. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-131, wherein the medical balloon dilation system (MBD) is configured for dilation of a passageway of a sinus.

133. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-132, wherein the medical balloon dilation system (MBD) is configured for access through a nostril.

134. A medical balloon dilation system (MBD) according to any of the preceding claims 1-60 and 87-133, wherein the balloon (BA) has a cylindrical portion with a diameter of 3-8mm and a length of 10-30mm.

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