Catheter flush fixture

Abstract

The present disclosure relates to a flushing fixture (300) for flushing the lumen of a catheter, the flushing fixture comprising a housing (302) having a catheter entry port (304) and a catheter exit port (306), the catheter entry port being arranged to receive at least a distal portion of a catheter (320), wherein the housing defines a flushing chamber (308) at least partially fillable with a liquid so as to thereby immerse the distal portion of the catheter (320), wherein the catheter exit port (306) comprises a deformable exit opening (312) shaped to conform to a distal tip (324) of the catheter in such a way that the distal tip of the catheter covers the opening in a liquid-tight manner when in use.

Description

Background Technology

[0001] If a gaseous substance enters the bloodstream, surgery involving the blood vessels connected to the brain's vascular system may expose the patient to the risk of brain damage.

[0002] It is standard practice to flush medical devices with a flushing fluid (such as medical-grade saline) before intravenous procedures to remove air from the device and reduce the risk of air entering the bloodstream.

[0003] In EP 3 367 978 A1, it is proposed to flush stent grafts with a solution that preferentially absorbs air (such as a perfluorocarbon solution or a degassed solution). In addition to venting air, such flushing solutions also absorb air pockets that would otherwise be trapped and cannot be removed by flushing with conventional flushing fluids alone.

[0004] While such methods improve the removal of air from medical devices, the danger posed by even a tiny volume of air means there remains a need for improved flushing methods and systems, particularly those that ensure no air re-enters during or after flushing. Summary of the Invention

[0005] Various aspects of this disclosure provide methods for rinsing fixation devices and rinsing medical devices as described in the appended claims.

[0006] According to a first aspect of this disclosure, a flushing and fixing device for flushing the lumen of a catheter is provided, the flushing and fixing device comprising a housing having a catheter inlet port and a catheter outlet port, the catheter inlet port being arranged to receive at least a distal portion of the catheter, wherein the housing defines a flushing chamber at least partially fillable with liquid to thereby submerge the distal portion of the catheter, and wherein the catheter outlet port includes a deformable exit opening shaped to conform to the distal tip of the catheter such that, in use, the distal tip of the catheter liquid-tightly covers the opening.

[0007] The deformable exit opening can have a roughly conical shape when it is not deformed.

[0008] In another embodiment, the size of the deformable exit opening is determined to provide an interference fit with the distal tip of the catheter when in use.

[0009] In another embodiment, the catheter inlet port includes a deformable inlet opening shaped to conform to the outer diameter of the catheter.

[0010] In another embodiment, the deformable inlet opening is configured to provide an interference fit with the outer diameter of the conduit when in use, particularly wherein the deformable inlet opening of the conduit outlet port has a diameter smaller than the diameter of the conduit.

[0011] In another embodiment, when the openings are not deformed, the deformable entry opening has a diameter greater than the diameter of the deformable exit opening.

[0012] In another embodiment, the flushing fixation device includes an exit port bracket that is removably attached to a catheter exit port and configured to prevent the catheter from being pushed through the exit opening when the exit port bracket is attached to a deformable exit opening.

[0013] In another embodiment, the exit port stent includes a weakened portion for removing the exit port stent from the catheter exit port.

[0014] In another embodiment, the exit port support is annular and configured to surround the outer periphery of the catheter exit port.

[0015] In another embodiment, the exit port support includes a collar configured to surround the outer circumference of the catheter exit port, particularly a funnel-shaped collar.

[0016] In another embodiment, the flushing fixation device includes an exit port bracket that is rigidly attached to the catheter exit port and configured to prevent the catheter from being pushed through the exit opening when the exit port bracket is attached to the deformable exit opening.

[0017] In another embodiment, the exit port support is configured to permanently increase the diameter of the exit opening when the exit port support is removed from the catheter exit port.

[0018] In another embodiment, the exit port support includes a pull wire or cord tightly coupled to the catheter exit port, the pull wire or cord being configured to cause the catheter exit port to rupture upon removal of the pull wire or cord.

[0019] In another embodiment, the exit port support includes a platform configured to support the chamber on a working surface.

[0020] In another embodiment, the flushing fixture includes a frame configured to support the chamber on a working surface, the frame being integrated into the housing of the flushing fixture.

[0021] In another embodiment, the flushing fixture includes a platform configured to support the chamber on a working surface, the platform including a fluid reservoir for flushing fluid.

[0022] In another embodiment, the flushing fixture includes one or more suction cups for removably attaching the flushing fixture to the work surface.

[0023] In another embodiment, the chamber has an inner diameter larger than the diameter of the catheter.

[0024] In another embodiment, the deformable exit opening is configured to provide an interference fit with the tip of the catheter when in use, particularly wherein the deformable exit opening of the catheter has a diameter smaller than the diameter of the catheter.

[0025] In another embodiment, the flushing fixation device includes one or more weak lines, preferably easily cracked weak lines, such that the flushing fixation device can be separated along one or more weak lines.

[0026] In another embodiment, the flushing fixation device includes a pull ring for assisting the flushing fixation device to separate along one or more weak lines.

[0027] In another embodiment, the flushing fixation device is slidable along the longitudinal range of the conduit.

[0028] In another embodiment, the flushing fixture is formed of a flexible material. The flexible material can be an elastomer.

[0029] According to another aspect, a method for flushing a catheter within a flushing fixation device is provided, the flushing fixation device comprising a housing having a catheter inlet port, a catheter outlet port, and a flushing chamber extending between the inlet port and the outlet port, the catheter outlet port including a deformable exit opening shaped to conform to a distal tip of the catheter, wherein the method comprises: inserting the distal tip of the catheter into the flushing chamber until the distal tip is received in the deformable exit opening of the catheter outlet opening and deformed therein; filling the flushing chamber at least partially with liquid to immerse the distal tip of the catheter in the liquid; and flushing the lumen of the catheter with a flushing fluid while the distal tip of the catheter is immersed in the liquid.

[0030] In another embodiment, the method includes pushing the catheter through a deformable exit opening after flushing has been completed.

[0031] In another embodiment, the flushing fluid is a flushing liquid, and the method further includes flushing the cavity with a flushing gas before flushing with the flushing liquid.

[0032] In another embodiment, the flushing gas is carbon dioxide.

[0033] In another embodiment, the lumen is flushed from the proximal end of the catheter.

[0034] According to another aspect of the invention, a flushing and fixing device for flushing the lumen of a catheter is provided, the flushing and fixing device comprising: a chamber having a catheter inlet port arranged to receive a tip of the catheter, wherein the chamber is at least partially filled with liquid to immerse the tip of the catheter; and a one-way valve arranged to allow fluid to drain from the chamber while the lumen is being flushed.

[0035] When flushing a catheter with a flushing fluid that absorbs (or dissolves) air / ambient gases (such as degassed saline), any volume of air absorbed by the flushing fluid must be replaced by the flushing fluid. However, this may create a partial vacuum within the catheter, potentially drawing air back into the catheter lumen through the tip.

[0036] This invention overcomes this problem by utilizing a one-way valve connected to a chamber that can be filled with liquid. In this way, when the air pocket inside the catheter is absorbed by the flushing fluid, liquid (rather than air) is drawn into the tip of the catheter. Furthermore, the one-way valve allows air displaced by the flushing fluid during flushing to escape from the chamber, but prevents air from re-entering the chamber, thereby further reducing the risk of air being drawn into the tip of the catheter.

[0037] The tip of the catheter is the distal end of the catheter. The distal end is the end of the catheter that is inserted into the patient, and the proximal end of the catheter is the end that is connected to, for example, a control system.

[0038] The catheter can be a multi-lumen catheter, and flushing can involve flushing all lumens (excluding cannulas used for guidewire access).

[0039] The chamber can be a closed / sealed chamber and can also be called a flushing chamber.

[0040] Preferably, the opening pressure of the check valve is higher than 101.325 kPa. Also known as the standard pressure, 101.325 kPa equals one atmosphere, which is approximately equal to the atmospheric pressure at sea level. Setting the opening pressure of the check valve to a value higher than the standard pressure increases the pressure of the flushing fluid within the conduit when it is flushed.

[0041] The increased pressure of the flushing fluid enhances its ability to absorb trapped air pockets within the conduit, which is particularly useful when flushing with flushing fluids that have high air solubility, such as degassed solutions and perfluorocarbon solutions. Furthermore, flushing at higher pressures reduces the size of air bubbles within the conduit. This makes it easier for bubbles to escape from the conduit and any devices encased within it, such as packaged grafts or any other devices in a shrink-fit configuration prior to deployment, thereby improving the effectiveness of the flushing.

[0042] The opening pressure of the one-way valve is preferably below 1000 kPa, and more preferably below 800 kPa.

[0043] Optionally, the opening pressure of the check valve can be adjustable.

[0044] Preferably, the one-way valve is arranged to vent gas, and the flushing fixture further includes a pressure regulator arranged to vent liquid.

[0045] Optionally, the pressure regulator may include an electronically controllable valve. The flushing fixture may also include a pressure sensor. The pressure sensor can provide feedback to the pressure regulator to maintain an appropriate pressure within the chamber.

[0046] Alternatively, the pressure regulator may include a capillary. A capillary may also be referred to as a microfluidic tube or conduit. The narrow orifice of the capillary restricts the flow of fluid through it, thereby creating back pressure in the chamber during flushing. As mentioned earlier, this produces enhanced absorption of air pockets trapped within the conduit that would otherwise not be removed by flushing alone.

[0047] Preferably, the flushing fixation device further includes a catheter exit port. This allows the catheter to be pushed through the flushing fixation device during deployment rather than being withdrawn, meaning the catheter tip does not need to be exposed to air before insertion into the patient (e.g., the exit port can be directly coupled to the sheath introducer). The catheter exit port can be (directly) opposite the inlet port (i.e., on the opposite side of the flushing fixation device).

[0048] The catheter exit port can be fragile. That is, when in use, when sufficient force is applied to the catheter exit port, for example through the tip of the catheter, the catheter exit port may break.

[0049] The irrigation fixation device may further include one or more weak lines, allowing the irrigation fixation device to be detached along one or more weak lines. This detachability allows the fixation device to be removed from the catheter (e.g., by tearing or splitting it), thereby increasing the length of the catheter that can be inserted into the patient during the procedure. Available catheter length is extremely valuable, and a few extra centimeters of catheter can be crucial during the procedure.

[0050] Optionally, the catheter exit port is fracturable, such that when sufficient force is applied to the mating surface of the exit port through the tip of the catheter, the exit port breaks open, and optionally, the breaking of the exit port (in use) triggers the separation of the flushing fixture along one or more weak lines.

[0051] Preferably, the flushing fixing device further includes one or more pull tabs or pull rings for assisting the flushing fixing device in separating along one or more weak lines.

[0052] Preferably, the outer surface of the catheter exit port is conformal and / or may be puncturable by the catheter. When manual force is applied to engage the surface, the conformal nature of the exit port allows it to seal against a suitable, similar adjacent entry surface of the introducer device (such as an introducer sheath). The manual force required to maximize catheter advancement can be the same as the manual force required to fit the conformal outer surface of the exit port to the entry port of the introducer sheath, and the manual force required to puncture / rupture the exit port of the chamber.

[0053] Alternatively, puncturing or rupturing the catheter exit port with the catheter can trigger the separation (e.g., rupture) of the fixation device along one or more weak lines.

[0054] The flushing fixation device may further include a catheter guide for aligning the catheter within a cavity between the catheter inlet and outlet ports. The catheter guide may be shaped such that it does not create any new cavity within the flushing fixation device.

[0055] The catheter guide may optionally be rotatable within the chamber. For example, the catheter guide may be at least partially magnetic and can be rotatable using a magnet, for example by moving a magnet around the outer surface of the flushing fixture and / or the chamber. Rotating the catheter guide within the chamber agitates the fluid within the chamber and causes air bubbles trapped on the surface within the flushing fixture to be displaced, making it easier to remove the air bubbles.

[0056] Preferably, the flushing fixing device is slidable along the longitudinal range of the conduit.

[0057] Preferably, the flushing fixture further includes an inlet port for filling the chamber with liquid.

[0058] Preferably, the flushing and fixing device further includes a guidewire sleeve plug (or alternatively, a center sleeve plug) for sealing the guidewire sleeve of the catheter.

[0059] Optionally, the chamber can be an inner chamber, and the flushing fixture can further include an outer chamber surrounding the inner chamber.

[0060] Preferably, the inner chamber is separable from the outer chamber, allowing the inner chamber to be removed from the outer chamber while the catheter tip remains submerged in liquid. Alternatively, the guidewire plug can be removably connected to the outer chamber, allowing the guidewire plug to be removed from the outer chamber simultaneously with the inner chamber. For example, the connection between the guidewire plug and the outer chamber can be a push-in / push-in fit, interference fit, mechanical clamping, or any other locking mechanism.

[0061] Preferably, the flushing fixture further includes one or more gas collection areas. These are areas / volumes of the flushing fixture shaped to allow gas to preferentially accumulate therein. For example, the gas collection area may be a funnel-shaped area in the top portion of the flushing fixture. The gas collection area may also function to guide / collect gas, for example, toward one or more one-way valves in the gas collection compartment.

[0062] Alternatively or additionally, the flushing fixture may further include a gas collection compartment, wherein the gas collection compartment includes a one-way valve, and wherein the gas collection compartment is fluidly connected to the chamber via one or more valves. The gas collection compartment allows gas (and possibly some fluid) to be diverted from the chamber by closing the valve.

[0063] One or more valves may include a rotatable perforated disc, wherein, in the open position, by rotating the perforated disc, one or more holes on the perforated disc can be aligned with one or more holes in the outer surface of the chamber.

[0064] Preferably, the inlet port of the flushing fixture includes an iris valve.

[0065] Optionally, the check valve of the flushing fixture can be connected to a water trap. For example, the water trap can be an S-bend or a P-bend, etc. This facilitates the separation and removal of gas from the chamber.

[0066] The flushing fixture may include two rotatable elements connected to each other by a threaded connection, wherein the two rotatable elements are rotatable relative to each other, thereby adjusting the internal volume of the flushing fixture. One element may be internally threaded, while the other may be externally threaded with mating threads. This allows the pressure inside the chamber to increase or decrease, and allows fluid to be forced out of the chamber by rotating the parts relative to each other.

[0067] Optionally, one of the two rotatable elements may be coupled to the catheter, such that the relative rotation of the two rotatable elements advances the catheter tip within the chamber. The catheter tip may be advanced toward and through the exit port. The rotatable element may be coupled to the catheter, for example, via a seal, such that the catheter is held in place relative to the rotatable element.

[0068] The irrigation fixation device can be formed of a flexible material, such as an elastomer. The flexible material can be compressible / stretchable. When the fixation device is slidable, its flexibility allows it to press against the control / handle at the proximal end of the catheter (this allows for the insertion of a further portion of the catheter into the patient during the procedure).

[0069] Alternatively, the flushing fixture may have one or more stabilizing elements, such as one or more pressure feet or outriggers. Since tubing is typically relatively long and bulky, this "hands-free" configuration allows the operator to use their hands to perform other tasks, such as controlling the flushing fluid.

[0070] Alternatively or additionally, the rinsing fixture may have one or more suction cups for removably attaching the rinsing fixture to a surface. For example, the suction cups may be located at the respective base of one or more of the stabilizing elements. This reduces the risk of the rinsing fixture 2200 being unintentionally moved during the rinsing process.

[0071] According to another aspect of the invention, a method for flushing a catheter is provided, the method comprising: inserting a distal end of the catheter into a flushing chamber; filling the flushing chamber at least partially with a liquid so as to immerse the distal end of the catheter in the liquid; and flushing the lumen of the catheter with a flushing fluid while the distal end (i.e. the tip) of the catheter is immersed in the liquid.

[0072] When flushing a catheter with an air-absorbing flushing fluid (such as degassed saline), any volume of air absorbed by the flushing fluid must be replaced by the flushing fluid. However, this can create a partial vacuum within the catheter, potentially drawing air back into the catheter lumen through the catheter tip. This invention overcomes this problem by immersing the distal end or tip of the catheter in liquid while it is being flushed. In this way, as the air pocket inside the catheter is absorbed by the flushing fluid, liquid (rather than air) is drawn into the catheter tip.

[0073] Fluid flows through the inner cavity.

[0074] Preferably, the method further includes adjusting the pressure within the chamber when flushing with liquid.

[0075] For example, the pressure can be adjusted to a value higher than 101.325 kPa. Also known as standard pressure, 101.325 kPa equals one atmosphere, which is approximately equal to the atmospheric pressure at sea level. Adjusting the pressure to a value higher than the standard pressure increases the pressure of the flushing fluid inside the conduit when it is flushed.

[0076] This increases the flushing fluid's ability to absorb trapped air pockets within the conduit that would otherwise be impossible to remove by flushing alone, which is particularly useful when flushing with flushing fluids that have high air solubility, such as degassed solutions and perfluorocarbon solutions. Furthermore, flushing at higher pressures reduces the size of air bubbles within the conduit. This makes it easier for bubbles to escape from the conduit and any devices encased within it, such as packaged grafts or any other devices in a shrink-fit configuration prior to deployment, thus improving the effectiveness of flushing.

[0077] The pressure is preferably adjusted to a value below 1000 kPa, more preferably below 800 kPa.

[0078] The pressure can be adjusted by the opening pressure of a check valve. Alternatively, the pressure can be adjusted, for example, by a capillary tube or by an electronically controlled pressure regulator.

[0079] Optionally, filling the flushing chamber at least partially with liquid may include filling the flushing chamber through the lumen of a catheter, for example, during or as part of the flushing step.

[0080] Alternatively, filling the flushing chamber at least partially with liquid may include filling the flushing chamber through a fluid inlet.

[0081] Preferably, the flushing fluid is a flushing liquid, and the method further includes flushing the cavity with a flushing gas before flushing with the flushing liquid.

[0082] The flushing gas can be carbon dioxide.

[0083] The flushing fluid may include physiological saline or perfluorocarbon solution. The flushing fluid may optionally be a buffer solution and / or pH adjusted. The flushing fluid may be degassed.

[0084] Fluid can be introduced through the lumen from the proximal end of the catheter.

[0085] Optionally, the catheter may be a multi-lumen catheter, and the method may involve flushing one or more lumens of the multi-lumen catheter with a flushing fluid while the distal end of the catheter is immersed in a liquid.

[0086] Preferably, the lumen is flushed from the proximal end of the catheter. That is, flushing fluid is introduced at or near the proximal end of the catheter.

[0087] According to another aspect, a catheter flushing and fixing device is provided, comprising an inlet port shaped to receive a distal end of a catheter, wherein the size of the inner surface of the inlet port is determined to form an interference fit with the outer surface of the catheter when the catheter is inserted into an outlet port, thereby blocking a fluid outlet on the outer surface of the catheter.

[0088] An interference fit means that (before inserting the catheter into the inlet port) the inner diameter of the inlet port is smaller than the outer diameter of the catheter (i.e., the outer diameter of the catheter at the point where the fluid outlet is located).

[0089] Those skilled in the art will understand that catheters are available in a variety of sizes, and that the necessary inlet port size can be readily deduced from the size of the catheter to be used in the procedure in question.

[0090] A blockage at the outlet port impedes or restricts the flow of fluid through the outlet port; however, the blockage does not completely stop the flow. This flow restriction leads to an increase in the pressure of the flushing fluid within the conduit during flushing, which improves the absorption of gas into the flushing fluid.

[0091] To facilitate insertion of the conduit into the outlet port, the outlet port may optionally be deformable. For example, the outlet port may be formed of an elastomeric material.

[0092] In some examples, the flushing fixture can be a pipe, and the inlet port can be the open end of the pipe.

[0093] Optionally, the flushing fixation device may include at least one weak line, such that during use, the flushing fixation device can be removed from the catheter by tearing at least one weak line. One or more pull tabs may also be provided to assist in tearing at least one weak line.

[0094] The catheter flushing fixation device may also include an outlet port positioned opposite the inlet port. Positioning the outlet port opposite the inlet port allows the catheter to be pushed through the catheter flushing fixation device and into the introducer sheath once flushing is complete, which reduces air ingress into the catheter. When the flushing fixation device is a tube, the outlet port may be a second open end of the tube.

[0095] According to another aspect, a kit is provided, comprising: a catheter; and the catheter flushing and fixing device described above.

[0096] According to another aspect, a method for flushing a catheter is provided, the method comprising: placing the tip of the catheter inside the catheter flushing fixation device of the aforementioned aspect to block the fluid outlet of the catheter; and allowing flushing fluid to flow through the catheter while the fluid outlet is blocked by the catheter flushing fixation device.

[0097] Optionally, the method may further include raising the tip of the catheter while flushing fluid passes through it.

[0098] The method may further include, after flushing, pushing the catheter tip through an outlet port of the flushing retainer arranged opposite the inlet port. For example, the catheter tip may be pushed through the outlet port and directly into the introducer sheath, thereby reducing air ingress into the catheter tip between flushing the catheter and insertion into the introducer sheath.

[0099] Within the scope of this application, it is expressly intended that the various aspects, embodiments, examples, and alternatives listed in the preceding paragraphs, as well as the claims and / or the following description and drawings (and in particular their various features), may be adopted independently or in any combination. That is, all embodiments and all features of any embodiment may be combined in any manner and / or combination unless such features are incompatible. The applicant reserves the right to amend any initially filed claim or accordingly file any new claim, including the right to modify any initially filed claim to rely on and / or incorporate any feature of any other claim, although not originally claimed in this way. Attached Figure Description

[0100] Examples of the invention will now be described with reference to the accompanying drawings, in which:

[0101] Figure 1A A schematic diagram of a flushing fixing device according to an embodiment of the present disclosure is shown;

[0102] Figure 1B It shows Figure 1A An example of a catheter with full insertion;

[0103] Figure 2A A flushing fixing device according to an embodiment of the present disclosure is shown;

[0104] Figure 2B It shows Figure 2A A flushing and fixing device with corresponding conduits;

[0105] Figure 3A An exploded view of a flushing fixing device according to an embodiment of the present disclosure is shown;

[0106] Figure 3B It shows Figure 3A A schematic cross-section of an embodiment in an assembled state is shown;

[0107] Figure 4A A flushing fixing device according to an embodiment of the present disclosure is shown;

[0108] Figure 4B It shows Figure 4A The cross-section of the embodiment shown;

[0109] Figure 5A A flushing fixing device according to another embodiment of the present disclosure is shown;

[0110] Figure 5B It shows Figure 5A The cross-section of the embodiment shown has the corresponding conduit;

[0111] Figure 6 A cross-section of a flushing fixing device according to an embodiment of the present disclosure is shown;

[0112] Figure 7 A side view of a flushing fixing device according to another embodiment of the present disclosure is shown;

[0113] Figure 8 A side view of a flushing fixing device according to another embodiment of the present disclosure is shown;

[0114] Figure 9 A flowchart of a method for flushing a catheter according to an embodiment of the present disclosure is shown;

[0115] Figure 10 A flowchart of a method for flushing a catheter according to an embodiment of the present disclosure is shown;

[0116] Figure 11 Another exemplary flushing fixing device is shown;

[0117] Figure 12It shows Figure 11 The removable chamber and guidewire sleeve plug of the flushing and fixing device in the middle;

[0118] Figure 13A and Figure 13B It shows the relationship with Figure 11 A pressure regulator used in conjunction with a flushing fixture;

[0119] Figure 14A and Figure 14B A flushing fixture with a gas collection compartment is shown;

[0120] Figures 15A to 15D An alternative embodiment of the gas collection compartment is shown;

[0121] Figure 16A and Figure 16B An alternative guidewire plug is shown;

[0122] Figure 17 An alternative flushing fixture is shown;

[0123] Figure 18A and Figure 18B Another alternative flushing fixation device is shown;

[0124] Figure 19 This demonstrates yet another alternative flushing fixture;

[0125] Figure 20 The catheter guide is shown;

[0126] Figure 21A and Figure 21B An example input port is shown;

[0127] Figure 22 Another method for flushing the catheter is shown;

[0128] Figure 23 Another flushing fixing device is shown; and

[0129] Figure 24 It shows the use of Figure 23 A method of flushing the conduit using a flushing fixation device. Detailed Implementation

[0130] Figure 1A A schematic diagram of a flushing fixing device according to an embodiment of the present disclosure is shown. The flushing fixing device 100 includes a housing 102. The housing 102 defines a flushing chamber 108, which is configured to contain flushing fluid in a leak-free manner, even when the flushing fluid is pressurized. The type of flushing fluid used will be described in more detail below. In one example, the housing 102 may be made of a flexible material such as silicone.

[0131] The housing 102 of the flushing fixture 100 includes a conduit inlet port 104 and a conduit outlet port 106. The conduit inlet port 104 is disposed at the opposite end of the conduit outlet port 106. The conduit inlet port 104 and the conduit outlet port 106 are coaxially aligned. In other words, both the conduit inlet port 104 and the conduit outlet port 106 extend about a common longitudinal axis L of the housing 102. As will be described in more detail below, the longitudinal axis L is also the axis along which the conduit 120 is inserted into the flushing fixture 100 and ultimately pushed through the flushing fixture.

[0132] The size of the catheter inlet port 104 is determined to receive the catheter 120. Therefore, the catheter inlet port 104 may have a diameter substantially the same as the diameter of the catheter body portion 122. In some embodiments, the catheter inlet 104 may have a diameter smaller than the diameter d of the catheter body 122. In this embodiment, the catheter inlet port may include a deformable inlet opening. The deformable inlet opening may be configured to be widened when the catheter body 122 is inserted into the housing 102 of the flushing retainer 100 via the inlet port 104.

[0133] The catheter exit port 106 may have an opening with a diameter smaller than the diameter d of the catheter body 122. The exit opening of the catheter exit port 106 may be deformable and shaped to conform to the distal tip 124 of the catheter 120 such that when the catheter is pushed toward the exit port 106 of the flushing fixation device 100, the distal tip of the catheter covers the opening in a liquid-tight manner.

[0134] Figure 1B It shows Figure 1A The schematic diagram of the illustrated embodiment shows the conduit 120 now fully inserted into the housing 102 of the flushing fixation device 100. In this case, the tip of the conduit 124 is received within the exit opening of the conduit exit port 106. The (distal) conduit body 122 is received within the opening of the conduit inlet port 104. In this embodiment, the size and shape of both openings of the conduit inlet port 104 and the conduit exit port 106 are determined to conform to their respective portions of the conduit 120. In particular, the exit opening of the conduit exit port 106 is deformable to conform to the shape of the tip 124 of the conduit 120. Similarly, the size and shape of the inlet opening of the conduit inlet port 104 can be determined to conform to the body 122 of the conduit 120. It should be understood that the size and shape of the openings of the conduit inlet port 104 and the conduit exit port 106 of the flushing fixation device 100 are determined taking into account the dimensions of the conduit 120. In other words, the two openings are designed such that when the conduit 120 is fully inserted into the housing 102 of the flushing fixture 100, both openings are liquid-tight relative to the conduit 120.

[0135] Once the openings of the two ports 104, 106 are covered by the conduit 120, the chamber 108 of the housing 102 can be filled with liquid such that the conduit 120 is completely submerged in the liquid. It should be understood that it is not necessary to fill the entire chamber 108 to submerge the conduit 120. However, in some examples, the entire chamber 108 of the housing 102 will be filled with a corresponding fluid, for example, via the fill / drain port 110. Alternatively, the chamber 102 can be filled with one or more added liquids via the inner lumen of the conduit 120. In either case, the inner housing 102 is filled with a volume of fluid sufficient to completely submerge the conduit 120 disposed within the housing 102.

[0136] A multi-stage flushing process, such as that described in EP 3 367 978 A1, can be used to flush conduit 120. For example, a first flushing stage may involve flushing one or more cavities of the conduit with a flushing gas such as carbon dioxide (CO2), which may optionally be performed before the inner housing is filled with liquid. The CO2 and the air replaced by CO2 can exit the conduit body 122 at a vent port 126, as... Figure 1A and Figure 1B As shown schematically. Therefore, CO2 and air leaving the conduit 102 via the vent port 126 will then be introduced into the chamber 108 of the housing 102.

[0137] exist Figure 1A and Figure 1B In some embodiments, the displaced gas can be removed from the housing via the fill / vent port 110. In one embodiment, the fill / vent port 110 may simply be an opening that allows the housing 102 to be filled with the liquid described above and allows the flushing gas to escape from the housing 102 at a later stage. Alternatively, the fill / vent port 110 of the housing 102 may be provided with various different valves to achieve liquid filling and gas venting. In yet another example, the housing 102 may be provided with two different ports, one for filling with liquid and the other for venting flushing gas. In some variations, the vent port may be provided with a pressure relief valve that only allows flushing gas to leave the chamber 108 when the opening pressure is exceeded within the chamber 108.

[0138] After flushing catheter 120 with flushing gas, catheter 120 may be flushed with one or more flushing liquids, such as physiological saline. The flushing liquid may optionally be a buffer solution and / or a pH-adjusted solution, and may optionally be degassed such that it preferentially absorbs air as it travels through the lumen of catheter 120. Alternatively, the flushing liquid may be a perfluorocarbon solution that preferentially absorbs air.

[0139] During the flushing process, the flushing fluid can absorb air pockets trapped within the conduit 120. Any air pockets absorbed by the flushing fluid are replaced by the flushing fluid, which effectively creates a partial vacuum within the conduit 120 as the flushing fluid is drawn into the previously air-occupied volume. This causes a corresponding volume of fluid to be drawn from the chamber 108 into the conduit 120 when the distal portion of the conduit 120 (including the vent port 126) is immersed in the fluid within the housing 102, thereby preventing further air from being drawn into the conduit 120.

[0140] Once the flushing process is complete, the catheter 120 can then be removed from the flushing fixation device 100 and inserted into an introducer device (such as an introducer sheath) for insertion into the patient's vascular system.

[0141] exist Figure 1A and Figure 1B In this embodiment, the catheter 120 can be removed from the flushing retainer 100 by pushing the catheter through the catheter exit port 106. When the catheter 120 is pushed toward the catheter exit port 106 with sufficient force, the exit opening of the catheter exit port 106 will be deformed by the catheter tip 124. In particular, the tip 124 of the catheter 120 will widen the exit opening of the catheter exit port 106 until the exit opening has the same diameter as the body portion 122 of the catheter 120, thereby allowing the catheter 120 to be pushed out of the retainer 100 via the exit port 106.

[0142] Figure 2A and Figure 2B Another embodiment of a flushing fixation device for flushing the lumen of a catheter is shown. Figure 2A and Figure 2B The flushing and securing device 200 shown includes a housing 202 having a catheter inlet port 204 and a catheter outlet port 206. Between the catheter inlet port 204 and the catheter outlet port 206, the housing 202 defines a chamber 208 that can be at least partially filled with liquid for immersing the distal portion of the catheter.

[0143] The housing 202 can be a single-piece structure. Alternatively, the housing 202 can be made of two or more individual pieces that can be released or permanently connected together. Figure 3A and Figure 3B Details of this type of two-piece housing are shown, in which the front and rear portions of the housing are manufactured separately and then permanently attached to each other. This will be described in more detail below.

[0144] The catheter inlet port 204 includes a deformable inlet opening 210. The inlet opening 210 is generally configured to correspond with the corresponding catheter body (222, Figure 2B The outer diameter is conformal. In this particular example, the size of the inlet opening 210 is determined to be slightly smaller than... Figure 2B The diameter of the catheter body 222 is shown. Therefore, as the catheter 220 is introduced into the new catheter inlet port 204 and extends through the deformable opening 210, the deformable opening 210 is widened by the outer diameter of the catheter body 222. The material surrounding this deformed inlet opening 210 thus forms a liquid-tight seal around the outer surface of the catheter body 222.

[0145] Figure 2A and Figure 2B The inlet opening 210 shown is arranged substantially centrally within the flushing chamber 208. The inlet opening 210 is also coaxially aligned with the catheter exit opening 212 of the catheter exit port 206, which will be described in more detail below. In other words, both the inlet opening 210 and the exit opening 212 extend about a common axis L2.

[0146] The catheter inlet port 204 includes a funnel-shaped portion 214 disposed proximally relative to the inlet opening 210. The funnel-shaped portion 214 reduces the diameter of the inlet port from the diameter of the flushing chamber 208 to the diameter of the inlet opening 210. The funnel-shaped portion 214 acts as a guide for inserting the catheter 220 into the flushing fixation device 200. The catheter is guided into the catheter inlet port 204 by the wall of the funnel-shaped portion 214 toward the inlet opening 210.

[0147] The catheter exit port 206 of this embodiment includes a nozzle-shaped protrusion. The nozzle-shaped protrusion defines a catheter exit opening 212. The nozzle-shaped protrusion of the catheter exit port 206 is made of a flexible material, making the opening 212 a deformable opening. The exit opening 212 is generally conical in shape to facilitate... Figure 2B The catheter tip 224 shown is conformally shaped. However, similar to the inlet opening 210, the outlet opening 212 is slightly smaller than the catheter tip 224. Therefore, when the catheter tip 224 is inserted into the outlet opening 212 of the catheter outlet port 226, the material surrounding the outlet opening 212 (i.e., the nozzle-shaped protrusion) will be widened by the catheter tip 224 and thus form a liquid-tight seal around the catheter tip 224.

[0148] The catheter exit port 206 includes a funnel-shaped portion 215 disposed proximally relative to the exit opening 212. The funnel-shaped portion 215 reduces the diameter of the entry port 206 from the diameter of the flushing chamber 208 to the diameter of the exit opening 212. The funnel-shaped portion 215 acts as a guide for inserting the catheter tip 224 into the exit port 206. The catheter 220, guided by the wall of the funnel-shaped portion 215 toward the exit opening 212, is pushed through the flushing chamber 208.

[0149] The flushing fixture 200 includes a fill / vent port 216. The fill / vent port 216 is connected to a chamber 208 of the housing 202. The fill / vent port 216 is positioned at the top of the housing 202 to prevent liquid from leaving the chamber 208 via the fill / vent port 216. Simultaneously, the fill / vent port 216 allows gas to vent from the flushing chamber 208 of the housing 202. Figure 2A and Figure 2B In this embodiment, the fill / drain port is always open. However, it should be understood that in use, the fill / drain port may be equipped with one or more valves, or connected to one or more fluid reservoirs.

[0150] The rinsing fixture 200 includes a frame for positioning the rinsing fixture 200 on a workbench surface. Figure 2A In one embodiment, the platform includes a front support leg 217 and a rear support leg 218. When the rinsing fixture 200 is placed on a horizontal work surface, the platform (front support leg 217 and rear support leg 218) is configured to have a longitudinal axis L2 arranged in the horizontal direction.

[0151] The flushing fixture may include tools for releasably securing the flushing fixture to a work surface, such as... Figure 2A The suction cup 219 is shown schematically. When the conduit 220 is inserted into the housing 202, such a tool will prevent the flushing fixture 200 from moving across the table or workbench surface.

[0152] Special Reference Figure 2B This will be described in more detail. Figure 2A The functionality of the flushing fixture 200 shown. Figure 2B The insertion device 200 and the corresponding catheter 220 are shown. Figure 2B The conduit 220 is fully inserted into the flushing fixation device 200. In other words, the conduit 220 has been pushed through the inlet opening 210 of the conduit inlet port 204 and inserted into the outlet opening 212. At this stage, the tip 224 of the conduit 220 is received in the outlet opening 212 such that the material of the outlet port 206 (i.e., the nozzle-shaped protrusion) forms a liquid-tight seal around the tip 224 of the conduit. The distal portion of the conduit body 222 is received in the inlet opening 210. The material forming the inlet opening 210 of the inlet port 204 is enlarged by the conduit 220 and forms a liquid-tight seal around the conduit body 222 in this state.

[0153] exist Figure 2BIn this configuration, both the inlet opening 210 and the outlet opening 212 are liquid-tightly sealed by the catheter. Therefore, except for the open fill / exit port 216, the flushing chamber 208 of the housing 202 is completely sealed. At this stage, the fill / exit port 216 can be used to introduce sterile fluid (such as saline) into the flushing chamber 208. The flushing chamber 208 will be filled with fluid until the portion of the catheter 220 disposed within the chamber 208, between the inlet port 204 and the outlet port 206, is completely submerged in the fluid. Once the catheter 220 is completely submerged, one or more lumens of the catheter 220 are flushed with flushing fluid. The purpose of flushing is to remove as much air as possible from the catheter lumen. The lumen is flushed by pumping or otherwise forcing flushing fluid through the catheter 220 from the proximal end toward the distal end received within the housing 202.

[0154] The flushing fluid can be a gas, such as carbon dioxide, or it can be a liquid, such as saline or perfluorocarbon. Such flushing fluid introduced at the proximal end of catheter 220 will exit the lumen of the catheter at the distal catheter exit 226. When catheter 220 is inserted into the flushing fixation device 200, the distal catheter exit port 226 is positioned between the inlet opening 210 and the exit opening 212.

[0155] Flushing fluid exiting the conduit vent port 226 can be removed from the chamber 208 of the housing 202 via the fill / vent port 216. If the flushing solution is a gas, both the flushing solution and the air removed from the conduit's interior by the flushing solution will be released through the fill / vent port 216. If the flushing solution is a liquid, this liquid may remain in the chamber 208 after exiting from the conduit vent port 226. However, gas trapped in this flushing liquid can still be released through the fill / vent port 216.

[0156] Flushing the inner cavity of the conduit with the distal portion submerged in the housing 202 of the flushing fixture 200 ensures that no air is drawn back into the conduit cavity through the vent port 226. This is especially important when flushing the conduit with an air-absorbing flushing fluid, as this could cause fluid to be drawn back into the conduit cavity through the vent port 226, at which point trapped air bubbles may be reabsorbed.

[0157] Once catheter 220 has been flushed, it remains submerged in the fluid held in chamber 208 and can be pushed through exit opening 212 for direct insertion into an introducer device for catheter insertion into a patient. To facilitate removal of the catheter from the flushing fixation device 200 via exit port 206, exit port 206 may include a weakened portion. The weakened portion at exit port 206 may be configured to allow a nozzle-shaped protrusion to split, thereby allowing the entire catheter body 220 to fit through exit opening 212. However, it should be understood that the weakened portion should not rupture immediately upon insertion of the catheter tip prior to flushing. Instead, the weakened portion should only rupture when additional force is applied to push the catheter through exit opening 212.

[0158] Figure 3A and Figure 3B Another embodiment of the flushing fixing device according to the present disclosure is shown. Figure 3A An exploded view of the flushing fixture is shown. Figure 3B A schematic cross-sectional view of a flushing fixation device 300 with an inserted conduit 320 is shown. Figure 3A and Figure 3B The embodiments shown are related to Figure 2A and Figure 2B The parts corresponding to the parts in the illustrated embodiments are marked with corresponding reference numerals enlarged to "100".

[0159] Figure 3A and Figure 3B The flushing fixture 300 shown includes a housing 302 comprising a catheter inlet port 304, a catheter outlet port 306, and a flushing chamber extending between ports 304 and 306. The housing 302 is a two-part housing. A first distal portion 302a of the housing 302 includes a flushing chamber 308, an outlet port 306, and a fill / drain port 316. A second proximal portion 302b of the housing 302 includes the catheter inlet port 304. The two portions 302a and 302b of the housing 302 can be manufactured separately and then joined together. The two portions 302a and 302b can be permanently or removably connected to each other. Figure 3A and Figure 3B In one embodiment, the proximal portion 302b of the housing 302 is permanently attached to the distal portion 302a of the housing 302, for example, by an adhesive.

[0160] Similar to Figure 2A and Figure 2BIn the illustrated embodiment, the inlet port 304 includes an inlet opening 310 and a funnel-shaped portion 314 disposed proximally relative to the inlet opening 310. The proximally disposed portion 302b of the housing includes the inlet port 304 and a collar 330. The collar 330 has a proximally attached end to the distal end of the funnel-shaped portion 314. The distal end of the collar 330 extends partially beyond the funnel-shaped portion 314. The collar 330 has an inner diameter greater than the outer diameter of the flushing chamber 308. Therefore, the proximally disposed portion 302b of the forming conduit inlet port 304 of the housing 302 can be fitted onto the proximally disposed end of the wall of the flushing chamber 308. The proximally disposed end of the wall of the flushing chamber 308 is then received within an annular cavity formed between the collar 330 and the funnel-shaped portion 314. The two portions of the housing 302 can then be permanently secured to each other, for example by applying an adhesive or welding between the inner surface of the collar 330 and the outer surface of the wall of the flushing chamber 308.

[0161] The distal portion of housing 302 includes a reference Figure 2A and Figure 2B The described catheter exit port 206 is substantially the same as catheter exit port 306. Therefore, catheter exit port 306 includes a substantially conical deformable exit opening 312. However, Figure 3A and Figure 3B The exit opening 312 is not defined by a nozzle-shaped protrusion. Instead, the exit opening is formed between the front outrigger 317 and the pull ring 332, which will be described in more detail below.

[0162] An open fill / drain port 316 is connected to the upper end of the flushing chamber 308. The distal portion of the housing 302 includes a front support leg 317. The proximal portion of the housing 302 includes a rear support leg 318. The front support leg 317 and the rear support leg 318 can be used to provide stable support on a substantially level working surface.

[0163] Flushing fixing device 300 in Figure 3B The image shows the tube in its assembled state. The catheter 320 is inserted into the flushing and securing device 300 such that the tip 324 of the catheter is received within the exit opening 312 and the distal portion of the catheter body 322 is received within the entry opening (not shown) of the catheter entry port 304. The catheter discharge port 326 is disposed within the chamber 308, between the entry opening 310 and the exit opening 312.

[0164] Figure 3A and Figure 3B The flushing process of the flushing fixing device 300 shown is similar to that of the reference device. Figure 2A and Figure 2BThe flushing process described is the same. In addition, the exit opening 312 of the flushing fixture 300 may also include a weakened portion to facilitate the removal of the conduit 320 from the flushing fixture 300, i.e., by pushing the conduit 320 through the exit opening 312.

[0165] and Figure 2A and Figure 2B The embodiments shown are the opposite. Figure 3A and Figure 3B The flushing retainer 300 shown includes a pull ring 332 for causing the exit port to break along a weakened portion. The pull ring 332 has a first end attached to material surrounding the exit opening 312. A second end of the pull ring is attached to a fill / drain port 316. Once the catheter has been successfully flushed, the operator can use the pull ring 332 to widen the exit opening 312 by causing the weakened portion to break, allowing the catheter 320 to be pushed through the exit opening 312 and moved into the insertion device. In other words, the pull ring 332 can be used to facilitate controlled breaking of the weakened portion. The weakened portion of the flushing retainer 300 can be larger than... Figure 2A and Figure 2B The weakened portion of the flushing retainer 200 shown is more flexible. This is because, by using the pull ring 332, the operator will be able to apply more pressure to the weakened portion than simply pushing the catheter through the opening (see...). Figure 2A and Figure 2B A more resilient weakened section offers the advantage that the operator is less likely to prematurely push the catheter through the exit opening 312, i.e., before the flushing process is complete. Ideally, the flushing retainer 300 (and in particular the exit port 306) is configured such that the weakened section will not break simply by pushing the catheter into the exit port 306. Instead, an external force will be required via the pull ring 332 to open the weakened section, allowing the catheter to be removed from the exit port 306 only when the operator pulls the pull ring 332.

[0166] Figure 4A and Figure 4B Parts of another embodiment of the flushing fixing device according to the present disclosure are shown. Figure 4A and Figure 4B The flushing fixing device 400 shown may include the same parts as the flushing fixing devices 200 and 300 described above. However, for simplicity, from Figure 4A and Figure 4B Some parts, such as the conduit inlet port, have been omitted. Although... Figure 4A and Figure 4B The conduit inlet port is omitted, but it should be understood that an inlet port is required to ensure that the flushing chamber 408 of housing 402 is liquid-tight.

[0167] The housing 402 of the flushing fixture 400 includes a fill / drain port 416 and a catheter exit port 406. Similar to the embodiment described above, the catheter exit port 406 includes a deformable exit opening 412, which can be in the form of a nozzle-shaped protrusion, particularly a conical deformable nozzle. The exit opening 412 is shaped to conform to the shape of the catheter tip 424 such that when the catheter tip 424 is received within the opening 412, the catheter tip 424 slightly widens the exit opening 412, thereby establishing a liquid-tight seal.

[0168] The exit port 406 may include one or more weakened portions that allow the conduit to be pushed through the exit port 406 when the flushing process is complete. Depending on the configuration of the weakened portions, it may be easy to unintentionally push the conduit through the exit port before flushing is complete. To prevent the conduit from prematurely moving through the exit port 406 of the housing 402, Figure 4A and Figure 4B The flushing fixture 400 shown includes a removable exit port bracket.

[0169] exist Figure 4A and Figure 4B In the example, the removable exit port support includes a collar 440 shaped to surround the outer circumference of the catheter exit port 406. Figure 4B In the example, the exit port is a conical nozzle, and therefore the corresponding collar 440 includes a corresponding conical inner surface. Before the conduit 420 is inserted into the flushing fixture 400, the funnel-shaped collar 440 can be fitted onto the conduit exit port 406.

[0170] The collar 440 can be removably attached to the catheter exit port. In some examples, the collar 440 can be attached to the exit port by means of a pressure fit or a snap-fit ​​fit. In other embodiments, the exit port support may include an internal thread compatible with the external thread (not shown) of the exit port nozzle. In still other variations, the collar 440 can be attached to the exit port nozzle by means of co-molding, secondary molding, adhesive bonding, heat fusion, ultrasonic welding, and / or stitching. Such bonding will be designed to be removable and preferably will not permanently alter the catheter exit port (e.g., breakage). For example, a low-tack adhesive, strong enough to hold the support (here, the collar 440) in place during flushing, can be used, and can also be pulled off by the operator without damaging the nozzle-shaped catheter exit port.

[0171] Other examples include a collar 440 permanently attached to the exit port support, for example by means of co-molding, secondary molding, adhesive bonding, heat fusion, ultrasonic welding, and / or suturing. However, in this example, the collar 440 is merely removable if the catheter exit port is permanently altered. "Permanent alteration" can include plastic deformation, cracking, cutting, tearing, breaking, melting, and any suitable method of removing a permanent connection known to a person skilled in the art. For example, it can be done along the proximal end of the collar, such as along… Figure 4A The line 442 shown is the cut conduit exit port.

[0172] The exit port support is made of a rigid material that will not expand by pushing the catheter tip 424 into the exit port 406. Therefore, as long as the exit port support remains in place, the catheter 420 will not be pushed through the flushing retainer 400. Once the flushing process is complete, the operator can remove the collar 440 from the catheter exit port 406, allowing the catheter 420 to be pushed through the catheter exit port 406 and into the corresponding insertion device.

[0173] Turn Figure 5A and Figure 5B This shows parts of another embodiment of the flushing fixing device according to the present disclosure. Similar to Figure 4A and Figure 4B For simplicity, the inlet port of the conduit has been omitted.

[0174] Figure 5A and Figure 5B The flushing fixing device 500 can be used with Figure 2A and Figure 2B The flushing fixtures shown are similar or identical. The flushing fixture 500 includes a housing 502 defining a flushing chamber 508. A fill / drain port 516 is provided at the upper end of the flushing chamber 508. An exit port 506 is provided in the form of a conical nozzle defining an exit opening 512. The exit opening 512 is deformable to allow a conduit to be pushed through the exit port 506 of the flushing fixture 500 once flushing is complete.

[0175] Similar to Figure 4A and Figure 4B In the embodiment described herein, the flushing fixture 500 includes an exit port bracket. Figure 5A and Figure 5B The illustrated exit port support includes an annular support 540. The size of the annular support 540 is determined to fit within the outer diameter of the exit port 506, i.e., the outer diameter of the nozzle-shaped protrusion. The annular support 540 has a diameter smaller than that of the catheter body 522. Therefore, the annular support 540 prevents the catheter from being prematurely pushed through the exit port 506, i.e., before the annular support 540 is removed.

[0176] The annular support 540 includes a pull tab 542. The pull tab 542 can be used to facilitate the removal of the annular support 540 from the exit port 506. In one example, the pull tab 542 may be attached to a weakened portion of the annular support 540. In this example, if the pull tab 542 is pulled by the operator, the annular support 540 may break along its weakened portion, thereby releasing the outer diameter of the exit port nozzle. Alternatively, the pull tab may be used only to pull the annular support 540 away from the exit port nozzle in a distal direction.

[0177] The annular support 540 can be attached to the outer diameter of the exit port nozzle via an interference fit. In other embodiments, the annular support 540 can be permanently attached to the outside of the exit port (e.g., by adhesive) and can be removed only by breaking the annular support 540 via a pull tab 542. Generally, the annular support 540 can be attached to the exit port 506 in the same manner as described above with reference to the collar 440.

[0178] The above description Figures 4A to 5B Two embodiments of a flushing fixation device including removable exit port supports (cuff 440 and annular support 540, respectively) are shown. In most of the described variations, these exit port supports can be removed from the catheter exit port without permanently altering the exit port. In some embodiments, these removable exit supports (e.g., pressure-fitting cuffs) are reusable.

[0179] Figure 6 Parts of an embodiment of a flushing fixation device including a permanently withdrawable port bracket are shown. In other words, Figure 6 The flushing fixing device 600 is rigidly attached to the catheter exit port 606 and cannot be removed from the exit port without permanently altering the exit port 606.

[0180] Figure 6 The flushing and fixing device 600 includes a housing 602 having a flushing chamber 608, a catheter exit port 606, and a filling / draining port 616. For simplicity, from Figure 6 The conduit inlet and support legs are omitted. The housing 602 of the flushing fixture 600 can be connected to... Figure 2A and Figure 2B The shell shown is the same. Figure 6 The exit port support includes a drawstring 640. In some examples, the exit port support may include a draw wire instead of a drawstring 640. The drawstring is permanently attached to the catheter exit port 606. In other words, the drawstring 640 cannot be removed from the catheter exit port without permanently altering the exit port. For example, the drawstring 640 may be tightly fitted to or remolded into the outer wall of a nozzle-shaped protrusion of the exit port 606.

[0181] The drawstring 640 includes at least one loose end 642. The loose end 642 facilitates the removal of the drawstring from the catheter exit port 606. An operator can pull the loose end 642 to remove the drawstring 640, thereby causing the nozzle-shaped catheter exit port to circumferentially break around the outer wall. Therefore, removing the drawstring 640 from the exit port 606 will cause the distal portion of the catheter exit port 606 to break off along the weak line 644.

[0182] because Figure 6 The example shows the conical shape of the exit port 606. Removal of the wire 640 will increase the diameter of the exit opening 612. This increased diameter will ultimately allow the operator to push a catheter (not shown) through the catheter exit port 606 and into the insertion device.

[0183] In some examples, the pull wire 640 or pull cord discussed above can be replaced by a pull strap or any other rigid or semi-rigid support that can be used to partially rupture the exit port 606 when the exit port support is removed (e.g., stripped) to allow the catheter to be pushed through the exit port 606. Such alternative exit port supports can be partially or wholly molded into the exit port in such a way that removal of the exit port support will permanently alter the exit port (e.g., rupture).

[0184] It should be understood that, Figure 6 In this embodiment, both the exit port bracket and the flushing fixing device 600 are non-reusable.

[0185] Parts of another embodiment of the flushing fixing device according to this disclosure are shown in Figure 7 middle. Figure 7 The flushing retainer 700 is shown as including a housing 702, a conduit exit port 706, and a fill / drain port 716. A conduit inlet port (not shown) is disposed within the housing 702. Similarly, the housing of the flushing retainer 700 can be... Figure 2A and Figure 2B The shell shown is basically the same, except that it does not have legs. Figure 7 The flushing and fixing device 700 includes another type of exit port bracket. The exit port bracket includes a collar portion 740 configured to surround the outer circumference of the conduit exit port 706. The collar portion 740 and... Figure 4A and Figure 4B The 440 collar is basically the same. However, Figure 7 The annular portion 740 is integrally formed with the frame 717. The frame 717 may include one or more leg portions 718 for supporting the flushing fixture 700 on a suitable working surface.

[0186] Figure 7The exit port bracket shown has a dual function. First, it prevents accidental breakage of the conduit exit port 706 before the flushing process is complete. Second, it acts as a stabilizing support for the housing 702 of the flushing fixture 700.

[0187] Figure 7 The exit port bracket can be a reusable part that can be used during many flushing operations. In other words, Figure 7 The exit port bracket is a removable exit port bracket, similar to... Figures 4A to 5B The variant shown. However, it should be understood that the housing 702, along with the inlet and outlet ports, may need to be replaced after each flushing process because at least the outlet port 706 may undergo plastic deformation once the catheter is pushed through the outlet opening. In the case of plastic deformation, the outlet port 706 is no longer able to form a liquid-tight seal around the distal tip of the catheter, and therefore the housing 702 needs to be replaced for future flushing operations. In other embodiments, the housing 702 (and in particular the catheter outlet port) undergoes elastic deformation only after flushing when the catheter is pushed through the outlet port. In such embodiments, the housing can be fully reused along with the outlet port support.

[0188] and Figures 4A to 5B Similarly, the conduit 720 can only be pushed through the exit port 706 until the exit port support is removed from the nozzle-shaped protrusion of the exit port 706.

[0189] Turn Figure 8 This illustrates another embodiment of the flushing fixing device according to the present disclosure. Figure 8 The flushing fixing device 800 is Figure 7 The shown is a modified version of the flushing fixture 700.

[0190] Figure 8 The flushing fixture 800 is shown as including a housing 802, a conduit exit port 806, and a fill / drain port 816. The conduit inlet port (not shown) is arranged within the housing 802.

[0191] Figure 8 The exit port bracket is similar to Figure 7 The exit port support includes a collar portion 840 configured to surround the outer circumference of the catheter exit port 806. The collar portion 840 and Figure 4A and Figure 4B The 440 collar is basically the same. However, Figure 8 The annular portion 840 is integrally formed with the platform 817.

[0192] and Figure 7In contrast to the previous embodiment, the bench 817 of this embodiment includes a reservoir for fluid to drain from the flushing chamber via a fill / drain port 816. The reservoir is a cavity within the bench 817.

[0193] A drain line 830 is provided to connect the flushing chamber to the reservoir of the bench 817. The drain line 830 has a first end connected to the fill / drain port 817 and a second end connected to the fluid reservoir via an opening 832 extending through the sidewall of the bench 817.

[0194] exist Figure 8 In this design, the discharge line 817 is schematically represented as a fluid line, which is removably attached at its first end to the fill / vent port 816 and at its second end to the reservoir. However, the fluid line 830 may also be formed as an integrated portion / extension of the fill / vent port 816. In this variant, the fill / vent port 816 may be configured to be directly inserted into the reservoir via the opening 832.

[0195] The fluid line 830 can be made of a flexible material, such as the same material as the housing 802 of the flushing fixture 800. The fluid line 830 is configured to be flexible enough to be inserted into the opening 832 after the flushing chamber has been filled with fluid and before the flushing process begins. Therefore, the second end of the fluid line 830 may not initially (e.g., during setup of the flushing fixture) be received within the opening 832 of the fluid reservoir. Instead, a fluid reservoir (e.g., a saline reservoir) may be initially connected to the second end of the fluid line 830. Saline solution can then be guided into the flushing chamber until the catheter 820 is completely submerged in the fluid. The second end of the fluid line 830 can then be disconnected from the fluid reservoir and inserted into the opening 832 of the fluid reservoir.

[0196] During the flushing process, the flushing fluid, i.e., flushing gas or flushing liquid (described in more detail below), is removed from the flushing chamber via fluid line 830 and stored in the fluid reservoir of the stand 817.

[0197] The frame 817 may include one or more leg portions 818 for supporting the flushing fixture 800 on a suitable working surface.

[0198] Figure 8 The exit port bracket shown has a triple function. First, it prevents accidental breakage of the conduit exit port 806 before the flushing process is complete. Second, it acts as a stabilizing support for the housing 802 of the flushing fixture 800. Third, it acts as a fluid reservoir for draining flushing fluid from the chamber during the flushing process.

[0199] Figure 8The exit port bracket can be a reusable part that can be used during many flushing operations. In other words, Figure 8 The exit port bracket is a removable exit port bracket, similar to... Figures 4A to 5B The variant shown. However, it should be understood that the housing 802, along with the inlet and outlet ports, may need to be replaced after each flushing process because at least the outlet port 806 may undergo plastic deformation once the catheter has been pushed through the outlet opening. In the case of plastic deformation, the outlet port 806 is no longer able to form a liquid-tight seal around the distal tip of the catheter, and therefore the housing 802 needs to be replaced for future flushing operations. In other embodiments, the housing 802 (and in particular the catheter outlet port 806) undergoes elastic deformation only after flushing when the catheter is pushed through the outlet port. In such embodiments, the housing can be fully reused along with the outlet port support.

[0200] The method of flushing the catheter is shown in Figure 9 The method is preferably performed using flushing fixtures such as those described above.

[0201] In the first step S902, the distal end or tip of the catheter is inserted into the flushing fixation device. The catheter is inserted into the housing of the flushing fixation device until the distal end tip of the catheter is received in the deformable exit opening of the catheter exit opening and deformed, thereby forming a liquid-tight seal.

[0202] In the next step S904, the chamber defined by the housing of the flushing fixation device is filled with a volume of liquid sufficient to submerge the catheter tip. The liquid is preferably a sterile medical-grade liquid, such as a saline solution. The housing can be filled with liquid through a filling port on the housing, or alternatively, the housing can be filled by forcing liquid through one or more lumens of the catheter (which may be a multi-lumen catheter).

[0203] In step S906, while the catheter tip is immersed in the liquid within the cavity of the housing, one or more lumens of the catheter are flushed with flushing fluid. The catheter should be submerged such that no other fluid besides the liquid in the cavity can enter the catheter lumen through the catheter's drain port. The purpose of flushing is to remove as much air as possible from the catheter lumen.

[0204] The lumen is flushed by pumping or otherwise forcing flushing fluid through the catheter from its proximal end toward its tip. The flushing fluid can be a gas, such as carbon dioxide, or it can be a liquid, such as saline or perfluorocarbon. Optionally, the method may involve flushing the catheter with one or more flushing gases followed by one or more flushing liquids.

[0205] As described later, the flushing fluid may be pH-adjusted and / or a buffer solution. The flushing fluid may optionally be degassed to improve air absorption within the conduit.

[0206] Flushing the catheter with the tip submerged in liquid ensures that no air is drawn back into the catheter lumen through the tip. This is especially important when flushing the catheter with an air-absorbing flushing fluid, as this could cause fluid to be drawn into the catheter tip when trapped air bubbles are absorbed.

[0207] The pressure within the housing can be optionally adjusted to a pressure higher than the standard pressure (i.e., higher than atmospheric pressure). Flushing in this manner increases the pressure within the conduit during flushing and improves the absorption of air by the flushing fluid. The increased pressure within the conduit also reduces the size of air bubbles, making it easier to displace and flush them out of the conduit. The pressure should be adjusted so that the flushing fluid still flows through the conduit, but at a higher pressure.

[0208] Pressure can be adjusted via capillary tubes, check valves (with an opening pressure greater than atmospheric pressure), or any other form of pressure regulator (such as electronically controlled pressure regulators, for example, those with solenoid valves).

[0209] When flushing with multiple flushing fluids, it is advantageous if any residual flushing agent is of the type that can be safely introduced to communicate with other flushing agents used in the flushing procedure and to communicate with the patient's blood flow in a residual amount, provided that no intermediate flushing fluid / agent has been completely removed.

[0210] When performing multi-stage flushing, the conduit is first flushed with a first flushing fluid, which can be a gas, such as, for example, carbon dioxide, sulfur dioxide, and chlorine, all of which are acidic.

[0211] After flushing the catheter with the first flushing fluid, it can be flushed with a second flushing fluid and optionally a third flushing fluid, the second flushing fluid being a buffer solution. For example, the second and / or third flushing fluid can be physiological saline, perfluorocarbon, or an emulsion, as well as a buffer solution of one or more of glycine, lysine, ammonium, borate, TRIS (tris(hydroxymethyl)aminomethane), HEPES (4-(2-hydroxyethyl)-1-piperazine ethanesulfonic acid), phosphate, histidine, or arginine. The pH of the solution can be further adjusted to a desired value, for example, by increasing the pH using sodium hydroxide (NaOH) and decreasing the pH using hydrochloric acid (HCl).

[0212] When acidic flushing gases such as carbon dioxide, sulfur dioxide, and chlorine dissolve in water, they react with hydroxide ions (OH-) to form highly water-soluble charged substances in the equilibrium reaction. The high concentration of OH- ions present in alkaline buffer solutions shifts the equilibrium towards the water-soluble charged substances, thus greatly increasing the gas solubility of the solution. Similarly, when alkaline flushing gases such as ammonia dissolve in water, they react with hydrogen ions (H+) to form highly water-soluble charged substances in the equilibrium reaction. The high concentration of H+ ions present in acidic buffer solutions shifts the equilibrium towards the water-soluble charged substances, thus greatly increasing the gas solubility of the solution.

[0213] Ideally, the pH of the buffer solution should be in the range of 7 to 10.5 to ensure that the acidic gaseous substance equilibrium is pushed far towards the soluble charged substance, but not so alkaline as to potentially damage the medical device. The strength of the buffer is preferably from 0.01 mol to 1.0 mol.

[0214] pH-regulating / alkaline buffers function by inhibiting the formation of carbonic acid (H₂CO₃) at the CO₂-saline interface. When carbonic acid forms at the CO₂-saline interface, it inhibits the saline's ability to dissolve additional CO₂. If the pH of the saline is adjusted to alkalinity, the CO₂ dissolved at the CO₂-saline interface may be forced to form sodium carbonate (Na₂CO₃), the water-soluble sodium salt of carbonic acid, rather than carbonic acid. The formation of sodium carbonate instead of carbonic acid will not saturate the CO₂ / saline interface, thus allowing the saline to dissolve more fully any CO₂ it is exposed to.

[0215] Of the buffers listed above, CO2 flushing gas is particularly effective when used with lysine or glycine flushing gas at pH 9.6 to dissolve the buffer. CO2 is biocompatible in the bloodstream and can be disposed of easily and safely in a clinical setting. Both lysine and glycine are amino acids present in the body and biocompatible in the blood, and also possess pKa values ​​that make them good buffers at pH 9.6. The amino acid salts formed when carbon dioxide is dissolved are also biocompatible. Both the gas and these buffers are also compatible with medical devices such as catheters.

[0216] Any buffer can be used, optionally in a degassed or partially degassed state.

[0217] Before rinsing with the second fluid, the method may additionally include rinsing the medical device with at least one intermediate rinse fluid to mechanically displace the first rinse fluid. The medical device may then be rinsed with the second rinse fluid and optionally a third rinse fluid. Those skilled in the art will understand that the intermediate rinse fluid mechanically displaces the first rinse fluid, while the second and optional third rinse fluids dissolve and mechanically displace any remaining first rinse fluid. Those skilled in the art will understand that the intermediate rinse fluid will not dissolve a significant amount of the first rinse fluid (if any). For example, when the first rinse fluid is a gas, the solubility of the first rinse fluid in the intermediate rinse fluid may be a mole fraction solubility of less than 10⁻⁵, preferably less than 10⁻⁶, at 25°C and a partial pressure of 101.325 kPa (1 atm). Those skilled in the art will be able to select a suitable intermediate rinse fluid based on the selected first rinse fluid, and vice versa. In this example, the first rinse fluid is preferably a gas. The intermediate rinse fluid is also preferably a liquid.

[0218] As discussed, the use of a buffer solution enhances the ability of the second and optional third flushing fluids to dissolve the first flushing fluid. This creates a pressure differential between ambient gases (such as air) and the first flushing fluid near the second flushing fluid, causing ambient fluid to be drawn into the tip of the catheter. The inventors have found that, in this situation, it is advantageous to flush the medical device with an intermediate flushing fluid to mechanically displace the first flushing fluid without causing ambient gases to be drawn into the medical device. The second and optional third flushing fluids are then used to absorb any residual, trace amounts of the first flushing fluid that have not been mechanically displaced. This, combined with immersing the tip of the catheter during flushing, reduces the risk of air being drawn back into the catheter during flushing.

[0219] Suitable combinations of first and intermediate flush fluids include, but are not limited to: acidic gases (such as carbon dioxide, sulfur dioxide, or chlorine) and acidic buffers (such as aqueous sodium bicarbonate solution); and alkaline gases (such as ammonia) and alkaline buffers (such as tris(hydroxymethyl)aminomethane buffer).

[0220] Preferably, the first flushing fluid is carbon dioxide and the intermediate flushing fluid is an aqueous sodium bicarbonate solution. If any carbon dioxide dissolves in the aqueous sodium bicarbonate solution, the acid (such as carbonic acid) formed by the dissolved carbon dioxide is neutralized in the sodium bicarbonate solution, thereby releasing the carbon dioxide and reducing any net change in the volume of carbon dioxide. Therefore, using this combination is particularly advantageous to further reduce the risk of inhaling ambient gases into the conduit.

[0221] Suitable combinations of first, second, optional third, and intermediate flushing fluids include, but are not limited to: acidic gases (such as carbon dioxide, sulfur dioxide, or chlorine) and alkaline buffers (such as glycine, lysine, ammonium, borate, TRIS (tris(hydroxymethyl)aminomethane), HEPES (4-(2-hydroxyethyl)-1-piperazine ethanesulfonic acid), phosphate, histidine, or arginine buffers) as the first flushing fluid; or physiological saline as the second flushing fluid and optional third flushing fluid, and acidic buffers (such as aqueous sodium bicarbonate solution) as intermediate flushing fluids.

[0222] Once step S906 is completed, the catheter is pushed through the exit port in the final step S908. In this step S908, sufficient force can be used to push the catheter toward the exit opening so that the exit opening is deformed wide enough to accommodate the catheter body passing through it. Alternatively, an external handle can be provided to allow the operator to widen the exit port before pushing the catheter through it.

[0223] Figure 10 An alternative method for flushing a conduit within a flushing fixture is shown. Steps S1002 to S1006 are substantially the same as steps S902 to S906 described above, and will not be discussed in detail thereafter.

[0224] Figure 10 The method involves reference Figures 4A to 6 The described flushing fixation device includes a flushing fixation device with an exit port support. Once one or more catheter lumens have been flushed, the method includes step S1008 for removing the exit port support. Removing the exit port support will allow the exit opening of the exit port to be widened sufficiently to fit the catheter body, for example, when the distal tip is forced into the catheter exit port.

[0225] As a final step S1010, the catheter is pushed through the exit port, similar to step S908 described above.

[0226] Figure 11 Another exemplary flushing fixation device 1100 for flushing catheter 1200 is shown. The flushing fixation device shown has an outer wall 1101 defining an outer chamber 1102 therein and an inner wall 1103 defining an inner chamber 1104 therein. The tip 1201 of catheter 1200 is shown retained within the inner chamber 1104, which is filled with a liquid 1105, such as sterile medical-grade saline or another similar liquid suitable for medical applications. The inner wall 1103 is high enough that it keeps the tip 1201 submerged in the liquid 1105 until catheter 1200 is deployed.

[0227] The flushing fixture 1100 has a one-way valve 1106 connected to the top of the outer chamber 1102 (and thus also fluidly connected to the inner chamber). Although the flushing fixture 1100 shown features an inner chamber 1104 and an outer chamber 1102, alternative solutions are conceivable in which the flushing fixture 1100 has only a single flushing chamber that can be filled with liquid and to which the one-way valve 1106 is connected.

[0228] The check valve 1106 is configured to allow fluid to leak from the inner chamber 1104 and the outer chamber 1102 into the surrounding atmosphere once a suitable pressure gradient (referred to as the check valve opening pressure) is applied across the check valve.

[0229] The catheter tip 1201 is shown, wherein the central cannula / guidewire cannula of the catheter 1200 (not visible) is plugged / stopped by a guidewire cannula plug 1107, which prevents fluid 1105 from entering the guidewire cannula of the catheter 1200. As will be described in more detail later, the guidewire cannula plug 1107 shown is removably coupled to (and forms part of) the outer wall 1101.

[0230] The flushing fixture 1100 further includes a three-way valve 1108 connected to the fluid inlet port 1109, a pressure regulator 1110 (which may optionally include a pressure controller 1111), and a pressure sensor element 1112. The three-way valve is connected to the outer chamber 1102 via the pressure sensor element 1112.

[0231] The fluid inlet port 1109 allows fluids such as liquid 1105 to be introduced into the flushing fixture 1109. When the conduit 1200 is removed, the fluid inlet port 1109 can also be used as a drain to empty any liquids from the outer chamber 1102.

[0232] Pressure regulator 1110 allows fluid to drain from flush fixture 1100. In the illustrated embodiment, check valve 1106 is positioned at the top of flush fixture 1100 to allow gas to drain from flush fixture, while pressure regulator 1110 is positioned at the bottom of flush fixture 1100 to allow liquid to drain from flush fixture to discharge outlet (and prevent air bubbles from flowing into pressure regulator). However, alternative solutions are contemplated where there is no separate pressure regulator 1110, and all draining and pressure adjustment are performed by check valve 1106. Check valve 1106 can also be replaced by a functionally similar device, such as a pressure relief valve (i.e., a valve that controls pressure but does not necessarily restrict fluid flow to a single direction).

[0233] In use, the tip 1201 of the conduit 1200 is inserted into the flushing fixture 1100 through an inlet port 1113 (such as an iris valve), which creates an airtight and liquid-tight seal around the conduit 1200. The inner chamber 1104 is filled with liquid 1105 before or once the conduit 1200 is inserted. This can be achieved by filling the flushing fixture 1100 with liquid through the fluid inlet port 1109, or alternatively by filling the inner chamber 1104 with liquid via one or more lumens of the conduit 1200. In either case, the inner chamber 1104 is filled with a volume of fluid sufficient to completely submerge the tip 1201.

[0234] A multi-stage flushing process, such as that described in EP 3 367 978 A1, can be used to flush conduit 1200. For example, a first flushing stage may involve flushing one or more cavities of the conduit with a flushing gas such as carbon dioxide (CO2); this may optionally be performed before filling the cavity 1104 with liquid 1105. The CO2 and the air displaced by the CO2 can be discharged through a one-way valve 1106, which may optionally be in an open configuration while being flushed with CO2 (i.e., allowing fluid to drain without resistance, in other words acting as a conduit rather than a one-way valve) – this can be achieved by setting the opening pressure to atmospheric pressure (or lower) or by opening the valve in some other way.

[0235] After flushing catheter 1200 with flushing gas, it may be flushed with one or more flushing liquids, such as physiological saline. The flushing liquid may optionally be a buffer solution and / or a pH-adjusted solution, and may optionally be degassed to preferentially absorb air. Alternatively, the flushing liquid may be a perfluorocarbon solution that preferentially absorbs air.

[0236] When the duct 1200 is flushed with flushing fluid, the air and flushing gas displaced by the flushing fluid are forced into the flushing fixture from which they can be discharged through a one-way valve.

[0237] During the flushing process, the flushing fluid can absorb air trapped within the conduit 1200. A certain volume of air absorbed by the flushing fluid is replaced by the flushing fluid, which effectively creates a partial vacuum within the conduit 1200 as the flushing fluid is drawn into the volume previously occupied by air. When the conduit tip 1201 is immersed in the liquid 1105 within the flushing fixture, this causes a corresponding volume of liquid 1105 to be drawn from the inner chamber 1104 into the conduit 1200, thereby preventing further air from being drawn into the conduit 1200.

[0238] The effectiveness of flushing can be further enhanced by using a one-way valve 1106 (or pressure relief valve) with an opening pressure greater than atmospheric pressure (i.e., standard pressure, 101.325 kPa). This increases the pressure of the flushing fluid inside the conduit 1200, which improves the air absorption characteristics of the flushing fluid and also reduces the size of air bubbles in the conduit, making them easier to remove.

[0239] Once the flushing process is complete, the catheter 1200 can then be removed from the flushing fixation device 1100 and inserted into an introductory device (such as an introductory sheath).

[0240] Now for reference Figure 12 The guidewire cannula plug 1107 and the inner chamber 1104 are removable from the rest of the irrigation fixation device. This allows the catheter tip 1201 to remain submerged in the liquid 1105 until the catheter tip is deployed, thereby preventing air from re-entering the catheter 1200 after the irrigation procedure has been performed.

[0241] Exemplary pressure regulator 1110 in Figure 13A and Figure 13B As shown in the image. First refer to... Figure 13A The pressure regulator 1110 can be a controllable pressure regulator having a solenoid valve 1301 controlled by a pressure controller 1111 (e.g., a microcontroller), which is pre-programmed to open the valve when the pressure measured by the pressure sensor element 1112 exceeds a predetermined threshold. The solenoid valve 1301 can be linearly actuated continuously between open and closed positions, thereby allowing adjustment of the pressure within the flushing fixture 1100.

[0242] Alternatively, the pressure regulator 1110 may include a capillary tube 1302, such as Figure 13B As shown. In this example, the pressure regulation characteristics are predetermined by the properties of the capillary 1302 (such as its diameter) and a pressure controller is not required (i.e., the pressure regulation is fixed and cannot be adjusted). The narrow orifice of the capillary restricts the flow of fluid through it, thereby generating back pressure in the flushing fixture 1100 during flushing. Figure 13B As shown, capillary tube 1302 can be used in combination with another one-way valve 1303 to prevent air from re-entering the flushing fixture via capillary tube 1302.

[0243] Figure 14A An alternative example of a flushing fixture 1100 is shown, which has a gas collection area 1401 and a gas collection compartment 1404 connected to an outer chamber 1102 via a pair of openings (or conduits) 1402 controlled by a valve 1403. Figure 14B The process of flushing fixture 1400 is shown. Figure 14ACross-sectional view of section line XX (valve 1402 not in) Figure 14B (as shown in the image).

[0244] The gas collection area 1401 is recessed and funnel-shaped to ensure that the gas in the outer chamber 1102 accumulates in the gas collection area 1401 and converges toward the opening 1402. In the example shown, the leftmost valve 1403 is shown in the closed position to prevent gas flow through the leftmost opening 1402, and the rightmost valve 1403 is shown in the closed position to allow gas flow through the rightmost opening 1402 and into the gas collection compartment 1404.

[0245] During flushing, the gas collection compartment 1404 effectively allows gas to be removed from the outer chamber 1102 via the shut-off valve 1403, for example, when the outer chamber 1102 is filled with flushing fluid during conduit flushing. The gas collection compartment 1404 allows a layer of gas to be “cut off” by the shut-off valve. Alternatively, in an example not shown, the valve 1403 can be used to select between openings 1402 of different sizes, such as a larger opening for venting and a smaller opening for flow restriction.

[0246] Figure 15A Another exemplary flushing fixture 1500 with a gas collection area 1401 and a gas collection compartment 1404 is shown. The principle is similar to... Figure 14A The flushing fixture 1400 shown is the same, except that valve 1403 has been replaced by a rotary valve 1501, which can be rotated to open and close opening 1402. Figures 15B to 15D As shown, the rotary valve includes an inner section 1503 with a plurality of protruding teeth 1504 that intersect with a plurality of grooves 1506 on a handle element 1505. The rotary valve has two orifices 1508 that can be aligned with an opening 1402 to allow fluid to flow between an outer chamber 1102 and a gas collection compartment 1404. The flow rate can be controlled by a positioning valve 1501 to control the degree of overlap between the orifices 1507 and the opening 1402.

[0247] Figure 15A The flushing fixture 1500 is shown with a capillary tube 1302 as a pressure regulator. Furthermore, the fluid inlet port 1109 is connected to the flushing fixture via a check valve 1502 instead of 1500, and not via a three-way valve, and there is no pressure sensing element.

[0248] and Figure 11 Similar to the flushing fixing device 1100, the inner chambers 1104 are respectively from... Figure 14A and Figure 15AThe flushing retainers 1400 and 1500 shown are removable. However, the guidewire cannula plug no longer forms part of the outer wall of the flushing retainer, but is instead removed via a different mechanism, such as... Figure 16A and Figure 16B Connect one of the mechanisms shown.

[0249] exist Figure 16A In this process, a push-in fit or an interference fit is used to hold the guide wire sleeve plug 1602 in the recess 1601. Figure 16B In the middle, the guide wire sleeve plug 1602 is held by a pair of clamping arms 1603.

[0250] In all examples, the guidewire cannula plug is preferably inserted into the tip 1201 before the catheter 1200 is inserted into the flushing fixation device 1100, 1400, 1500. The guidewire cannula plug is then received by the flushing fixation device 1100, 1400, 1500 and locked in place during flushing (e.g., via a press-fit, mechanical clamp, or other locking mechanism).

[0251] When catheter 1200 is removed from the tip chamber, the guidewire cannula plug is released from the locking mechanism, and once catheter 1200 is removed, tip 1201 remains submerged in liquid 1105, and then the cannula plug is removed and the guidewire cannula of catheter 1200 can be flushed in the open or in a beaker filled with liquid before being introduced into the patient.

[0252] Figure 17 An alternative flushing fixture 1700 is shown. (Compared to...) Figure 11 Like the flushing fixture 1100, the flushing fixture 1700 is characterized by: an outer wall 1101 that defines a flushing chamber 1102 that can be filled with liquid; a one-way valve 1106; and a catheter inlet port 1113 for receiving a catheter 1200.

[0253] and Figure 11 Unlike the flushing fixture 1100 shown, the flushing fixture 1700 is further characterized by: a conduit exit port 1701, a piston element 1702 with external threads 1703, an inflatable seal 1704, and a conduit guide 1705.

[0254] The catheter exit port 1701 is directly opposite the catheter inlet port 1113 and allows the catheter 1200 to be directly inserted into an adjacent fixation device, such as an inlet sheath (not shown), without having to withdraw the catheter 1200 from the flushing fixation device 1700. The exit port 1701 may be conformal and / or puncture-proof by the catheter 1200, i.e., by pushing the catheter 1200 through the exit port 1701. Being conformal means that the exit port 1701 allows 1701 to seal a suitable, similar adjacent inlet surface of an inlet device (such as an inlet sheath).

[0255] Furthermore, the irrigation fixation device 1700 may feature one or more weak lines (not shown), which allows the irrigation fixation device to be separated into two or more parts and removed from the catheter 1200 without withdrawing the catheter 1200. This allows for the introduction of a larger portion of the catheter 1200 into the patient during the procedure, compared to if the irrigation fixation device 1700 remains on the catheter 1200. The irrigation fixation device 1700 may include one or more pull tabs or loops (not shown) to assist in separating the irrigation fixation device along the weak lines.

[0256] Alternatively, having an inlet and an outlet port means that the irrigation fixation device 1700 is slidable along the length of the catheter 1200, so that the irrigation fixation device can remain in the appropriate position above the catheter during the procedure (albeit at the cost of losing the useful length of the catheter (equivalent to the length of the irrigation fixation device 1700)).

[0257] The external thread 1703 of the piston element 1702 is formed to engage with a corresponding thread on the inner surface of the outer wall 1101 of the flushing fixture. Thus, the volume of the chamber 1102 can be adjusted by rotating the piston element 1702 relative to the rest of the flushing fixture 1700. This allows for increasing or decreasing the pressure inside the chamber 1102 and allows fluid to be forced out of the chamber 1102 by rotating the threaded parts (piston element 1702 and outer wall 1101) relative to each other.

[0258] An inflatable seal 1704 is spirally arranged around the inner surface of the inlet port 1113. In use, once the conduit 1200 has been inserted into the flushing retainer 1700, the inflatable seal 1704 can be used to clamp the conduit 1200 by inflating the inflatable seal 1704. When the conduit 1200 is clamped by the inflatable seal 1704, the conduit 1200 is fixed in place relative to the piston element 1702, such that rotation of the piston element 1702 relative to the outer wall 1101 causes the conduit tip 1201 to advance toward the exit port 1701.

[0259] The catheter guide 1705 is received within chamber 1102 and facilitates proper alignment of the catheter 1200 as it is inserted and passes through flushing diagram 1700. Specifically, the catheter guide 1705 ensures proper alignment between the catheter 1200 and the exit port 1701. Later, relative to... Figure 20 The catheter guide 1705 is described in more detail.

[0260] although Figure 17 The example shown in the text does not have Figure 11 The discrete internal chamber 1104, guide wire sheath plug 1107, three-way valve 1108, fluid inlet port 1109, pressure regulator 1110, or pressure sensing element 1112 shown are not identical to those described above; however, those skilled in the art will understand that these features can be readily combined with… Figure 17 The flushing fixing device 1700 shown and Figure 18A , Figure 18B , Figure 19 and Figure 22 The following example combinations are shown in A and 22B; such combinations are those conceived by the inventors.

[0261] also, Figure 17 The features of the flushing fixing device 1700 may also include Figure 11 In the flushing fixing device 1100. For example, Figure 11 The flushing and fixing device 1100 may have an exit port. This exit port may or may not be used with a guidewire cannula plug. For example, the guidewire cannula plug may be absent, or the catheter 1200 may be inserted through the exit port with the guidewire cannula plug in place (i.e., the guidewire cannula plug is also pushed through the exit port). Furthermore, Figure 11 The flushing fixation device 1100 can be used without the inner chamber 1104 (or with a fixed / immovable inner chamber 1104) and can utilize inflatable seals and / or catheter guides. Figure 11 The flushing fixture 1100 can also have an adjustable internal volume, for example, using a similar... Figure 17 The flushing fixture 1700 has a threaded piston element.

[0262] Figure 18A and Figure 18B Another alternative flushing fixture 1800 is shown, which has a gas collection volume 1102 and a conduit guide 1705 that can be rotated by moving the magnetic element 1802. Figure 18A A catheter 1200 with its tip 1201 located within a chamber 1102 is shown, and Figure 18B A flushing and fixing device is shown, in which the tip 1201 is pushed through the membrane 1801 into the gas collection chamber 1404. The chamber 1102 has a similar... Figure 14A and Figure 15A The gas collection area 1401 shown has a conical / funnel shape.

[0263] Membrane 1801 allows fluid to travel from chamber 1102 into gas collection compartment 1404, but does not allow fluid to return to chamber 1102, thus effectively trapping gas in gas collection compartment 1404. In this example, membrane 1801 thus functions as a one-way valve to prevent air from returning to chamber 1102. Membrane 1801 can be a buoyancy valve.

[0264] As previously mentioned, the catheter guide 1705 can be rotated by moving the magnetic element 1802. To achieve this, at least a portion of the catheter guide 1705 is made of a magnetic material. The circumferential movement of the magnetic element 1802 around the flushing fixture 1800 thus causes the catheter guide 1705 to rotate within the chamber 1102. This agitates the fluid in the chamber 1102 and causes air bubbles trapped on the surfaces within the flushing fixture 1800 to be displaced, making it easier to remove the air bubbles.

[0265] Once catheter 1200 has been adequately flushed, it can be advanced through membrane 1801, as follows. Figure 18B As shown, it passes through the conduit exit port 1701.

[0266] Similarly, those skilled in the art will understand that Figure 18A and Figure 18B The features of the flushing fixing device 1800 shown can be easily combined with Figure 11 and Figure 17 The flushing fixing device 1100 and 1700 are combined.

[0267] Turn now Figure 19 Another exemplary flushing fixture 1900 is shown, which illustrates several additional features that may also be included in the flushing figures 1100, 1700, and 1800 of the previous examples.

[0268] The flushing fixation device 1900 has a one-way exit port 1901 and a one-way in port 1902, which can be, for example, one-way hemostatic valves. These valves are shaped such that when the incident pressure increases, the valves deflect, thereby applying force to the catheter 1200, resulting in a tighter seal on the catheter 1200 and reducing the chance of air infiltration into the chamber 1102.

[0269] The flushing retainer 1900 is further characterized by a soft-molded portion 1903 at the exit port 1701, forming a small reservoir 1906. This soft-molded portion 1903 may be made of an elastic or elastomeric material and facilitates a soft mating with the inlet sheath (not shown) positioned at the exit port 1701. The elastic / elastomeric nature also ensures a leak-proof connection between the inlet sheath and the soft-molded portion 1903.

[0270] Flushing fluid can be collected in reservoir 1906, and reservoir 1906 also helps to trap any air while conduit 1200 is inserted into the inlet sleeve. During the engagement and travel of conduit 1200, fluid in reservoir 1906 will occupy most of the volume, and any infiltrated air will remain in reservoir 1906 and will not enter the inlet sleeve. Drain port 1907 can be used to drain fluid from reservoir 1906.

[0271] and Figure 17 and Figure 18A as well as Figure 18B The flushing fixing device in the 1700 and 1800 is the same. Figure 19 The flushing fixation device 1900 has a catheter guide 1705 to ensure proper alignment of the catheter 1200 within the flushing fixation device 1900. An example of such a catheter guide 1705 is shown in Figure 20 The catheter guide 1705 has a frame shaped to prevent it from forming any new chambers within the flushing fixture 1900.

[0272] The flushing fixing device 1900 is also characterized by a sealable inlet port 1904, which has a similar... Figure 18A and Figure 18B The expandable seal 1905 is shown. The sealable inlet port 1904 is located in... Figure 21A and Figure 21B The diagram is shown in more detail below. The commercially available inlet port 1904 includes: an orifice 2101 through which a conduit 1200 is inserted; an inflation port 2102 through which an inflatable seal 1905 is inflated; and a mounting section 2103 for attachment to the body of the flushing fixture. In use, the conduit 1200 is inserted into the inflatable seal 1905 through the orifice 2101, and then the inflatable seal 1905 is inflated via the inflation port 2102.

[0273] The inflatable seal 1905 may be formed of a soft material such as latex to facilitate movement of the conduit 1200. When inflated, the inflatable seal 1905 forms a tight seal around the conduit 1200, wherein the pressure is distributed along the length of the surface of the conduit 1200 (rather than concentrated on a single line).

[0274] The sealable inlet port 1904 can also be used as a sealable outlet port.

[0275] Various additional features are envisioned to enhance the flushing fixture described above. For example, a one-way valve can be connected to a trap arranged to separate gas and liquid, such as a gooseneck, P-bend, or S-bend. The trap can have a vent valve that can open during flushing to allow air to escape and close once liquid begins to leave the chamber. The vent valve can then be closed to allow adjustment of the pressure inside the chamber.

[0276] Any of the above-described irrigation fixation devices can be made of flexible materials, such as elastic or elastomeric materials, which allows for compression of the irrigation fixation device (e.g., when deploying a catheter). Similarly, any of the above-described irrigation fixation devices can have one or more weak lines, which allows (e.g., by tearing) the irrigation fixation device to be divided into two or more parts. Alternatively, the irrigation fixation device can have slits filled with silicone, for example, silicone that can be cut with a scalpel or the like once irrigation is complete, thereby allowing the irrigation fixation device to be removed from the catheter. The catheter guide can optionally serve as a barrier to prevent the catheter from being damaged by a scalpel.

[0277] The flushing fixture may also have a valve or similar device that allows fluid to be drawn out of the chamber before flushing begins (e.g., by a vacuum source connected to the valve). This reduces the pressure within the chamber and the conduit, making it easier to flush the conduit with a flushing fluid such as carbon dioxide.

[0278] As previously mentioned, it is envisioned that features of each of the exemplary flushing fixation devices be combined into a single flushing fixation device. For example, among other features, each of the flushing fixation devices may also have a one-way valve, a pressure regulator, a pressure sensor, a catheter exit port, a weak wire (with or without a pull tab or pull ring), a catheter guide, a guidewire sheath plug, inner (removable or fixed) and outer chambers (or just a single flushing chamber), a gas collection area and compartment, a fluid inlet port, and / or an adjustable chamber volume.

[0279] As mentioned earlier, the flushing fixation device is intended for use in conjunction with the introducer sheath. That is, the flushing fixation device will be used to flush the catheter before inserting the catheter into the introducer sheath. In examples where the flushing fixation device has an exit port, the flushing fixation device may optionally conform to / mate with the introducer sheath to assist in inserting the catheter from the flushing fixation device into the introducer sheath.

[0280] The method of flushing the catheter is shown in Figure 22 The method is preferably performed using flushing fixtures such as those described above.

[0281] In step 2201, the distal end or tip of the catheter is inserted into the chamber. The chamber can be any open or closed volume, container, or seat capable of holding sufficient fluid to submerge the tip of the catheter. For example, the chamber may optionally be... Figure 11 The inner chamber 1104 of the flushing fixture 1100 shown.

[0282] In step 2202, the flushing chamber is filled with a volume of liquid sufficient to submerge the catheter tip. Step 2202 may optionally be performed before step 2201. That is, the chamber may optionally be filled with liquid before catheter insertion.

[0283] The liquid is preferably a sterile medical-grade liquid, such as a saline solution. The chamber can be filled with liquid through an inlet port on the chamber, or alternatively, the chamber can be filled by forcing liquid through one or more lumens of a catheter (which may be a multi-lumen catheter).

[0284] In step 2203, while the catheter tip is immersed in the fluid in the chamber, one or more lumens of the catheter are flushed with flushing fluid. The catheter tip should be submerged such that no other fluid besides the fluid in the chamber can enter the catheter lumen through the tip. The purpose of flushing is to remove as much air as possible from the catheter lumen.

[0285] The lumen is flushed by pumping or otherwise forcing flushing fluid through the catheter from the proximal end toward the tip.

[0286] The flushing fluid can be a gas, such as carbon dioxide, or it can be a liquid, such as saline or perfluorocarbon. The method may optionally involve flushing the catheter with one or more flushing gases followed by one or more flushing liquids.

[0287] As described later, the flushing fluid may be pH-adjusted and / or a buffer solution. The flushing fluid may optionally be degassed to improve air absorption within the conduit.

[0288] Flushing the catheter with the tip submerged in liquid ensures that no air is drawn back into the catheter lumen through the tip. This is especially important when flushing the catheter with an air-absorbing flushing fluid, as this could cause fluid to be drawn into the catheter tip when trapped air bubbles are absorbed.

[0289] The pressure within the chamber can be optionally adjusted to a pressure higher than the standard pressure (i.e., higher than atmospheric pressure). Flushing in this manner increases the pressure within the conduit during flushing and improves the absorption of air by the flushing fluid. The increased pressure within the conduit also reduces the size of air bubbles, making it easier to displace and flush them out of the conduit. The pressure should be adjusted so that the flushing fluid continues to flow through the conduit, but at a higher pressure.

[0290] Pressure can be adjusted via capillary tubes, check valves (with an opening pressure greater than atmospheric pressure), or any other form of pressure regulator (such as electronically controlled pressure regulators, for example, those with solenoid valves).

[0291] When flushing with multiple flushing fluids, it is advantageous if any residual flushing agent is of the type that can be safely introduced to communicate with other flushing agents used in the flushing procedure and to communicate with the patient's blood flow in a residual amount, provided that no intermediate flushing fluid / agent has been completely removed.

[0292] When performing multi-stage flushing, the conduit is first flushed with a first flushing fluid, which can be a gas, such as, for example, carbon dioxide, sulfur dioxide, and chlorine, all of which are acidic.

[0293] After flushing the catheter with the first flushing fluid, it can be flushed with a second flushing fluid and optionally a third flushing fluid, the second flushing fluid being a buffer solution. For example, the second and / or third flushing fluid can be physiological saline, perfluorocarbon, or an emulsion, as well as a buffer solution of one or more of glycine, lysine, ammonium, borate, TRIS (tris(hydroxymethyl)aminomethane), HEPES (4-(2-hydroxyethyl)-1-piperazine ethanesulfonic acid), phosphate, histidine, or arginine. The pH of the solution can be further adjusted to a desired value, for example, by increasing the pH using sodium hydroxide (NaOH) and decreasing the pH using hydrochloric acid (HCl).

[0294] When acidic flushing gases such as carbon dioxide, sulfur dioxide, and chlorine dissolve in water, they react with hydroxide ions (OH-) to form highly water-soluble charged substances in the equilibrium reaction. The high concentration of OH- ions present in alkaline buffer solutions shifts the equilibrium towards the water-soluble charged substances, thus greatly increasing the gas solubility of the solution. Similarly, when alkaline flushing gases such as ammonia dissolve in water, they react with hydrogen ions (H+) to form highly water-soluble charged substances in the equilibrium reaction. The high concentration of H+ ions present in acidic buffer solutions shifts the equilibrium towards the water-soluble charged substances, thus greatly increasing the gas solubility of the solution.

[0295] Ideally, the pH of the buffer solution should be in the range of 7 to 10.5 to ensure that the acidic gaseous substance equilibrium is pushed far towards the soluble charged substance, but not so alkaline as to potentially damage the medical device. The strength of the buffer is preferably from 0.01 mol to 1.0 mol.

[0296] pH-regulating / alkaline buffers function by inhibiting the formation of carbonic acid (H₂CO₃) at the CO₂-saline interface. When carbonic acid forms at the CO₂-saline interface, it inhibits the saline's ability to dissolve additional CO₂. If the pH of the saline is adjusted to alkalinity, the CO₂ dissolved at the CO₂-saline interface may be forced to form sodium carbonate (Na₂CO₃), the water-soluble sodium salt of carbonic acid, rather than carbonic acid. The formation of sodium carbonate instead of carbonic acid will not saturate the CO₂ / saline interface, thus allowing the saline to dissolve more fully any CO₂ it is exposed to.

[0297] Of the buffers listed above, CO2 flushing gas is particularly effective when used with lysine or glycine flushing gas at pH 9.6 to dissolve the buffer. CO2 is biocompatible in the bloodstream and can be disposed of easily and safely in a clinical setting. Both lysine and glycine are amino acids present in the body and biocompatible in the blood, and also possess pKa values ​​that make them good buffers at pH 9.6. The amino acid salts formed when carbon dioxide is dissolved are also biocompatible. Both the gas and these buffers are also compatible with medical devices such as catheters.

[0298] Any buffer can be used, optionally in a degassed or partially degassed state.

[0299] Before rinsing with the second fluid, the method may additionally include rinsing the medical device with at least one intermediate rinse fluid to mechanically displace the first rinse fluid. The medical device may then be rinsed with the second rinse fluid and optionally a third rinse fluid. Those skilled in the art will understand that the intermediate rinse fluid mechanically displaces the first rinse fluid, while the second and optional third rinse fluids dissolve and mechanically displace any remaining first rinse fluid. Those skilled in the art will understand that the intermediate rinse fluid will not dissolve a significant amount of the first rinse fluid (if any). For example, when the first rinse fluid is a gas, the solubility of the first rinse fluid in the intermediate rinse fluid may be a mole fraction solubility of less than 10⁻⁵, preferably less than 10⁻⁶, at 25°C and a partial pressure of 101.325 kPa (1 atm). Those skilled in the art will be able to select a suitable intermediate rinse fluid based on the selected first rinse fluid, and vice versa. In this example, the first rinse fluid is preferably a gas. The intermediate rinse fluid is also preferably a liquid.

[0300] As discussed, the use of a buffer solution enhances the ability of the second and optional third flushing fluids to dissolve the first flushing fluid. This creates a pressure differential between ambient gases (such as air) and the first flushing fluid near the second flushing fluid, causing ambient fluid to be drawn into the tip of the catheter. The inventors have found that, in this situation, it is advantageous to flush the medical device with an intermediate flushing fluid to mechanically displace the first flushing fluid without causing ambient gases to be drawn into the medical device. The second and optional third flushing fluids are then used to absorb any residual, trace amounts of the first flushing fluid that have not been mechanically displaced. This, combined with immersing the tip of the catheter during flushing, reduces the risk of air being drawn back into the catheter during flushing.

[0301] Suitable combinations of first and intermediate flush fluids include, but are not limited to: acidic gases (such as carbon dioxide, sulfur dioxide, or chlorine) and acidic buffers (such as aqueous sodium bicarbonate solution); and alkaline gases (such as ammonia) and alkaline buffers (such as tris(hydroxymethyl)aminomethane buffer).

[0302] Preferably, the first flushing fluid is carbon dioxide and the intermediate flushing fluid is an aqueous sodium bicarbonate solution. If any carbon dioxide dissolves in the aqueous sodium bicarbonate solution, the acid (such as carbonic acid) formed by the dissolved carbon dioxide is neutralized in the sodium bicarbonate solution, thereby releasing the carbon dioxide and reducing any net change in the volume of carbon dioxide. Therefore, using this combination is particularly advantageous to further reduce the risk of inhaling ambient gases into the conduit.

[0303] Suitable combinations of first, second, optional third, and intermediate flushing fluids include, but are not limited to: acidic gases (such as carbon dioxide, sulfur dioxide, or chlorine) and alkaline buffers (such as glycine, lysine, ammonium, borate, TRIS (tris(hydroxymethyl)aminomethane), HEPES (4-(2-hydroxyethyl)-1-piperazine ethanesulfonic acid), phosphate, histidine, or arginine buffers) as the first flushing fluid; or physiological saline as the second flushing fluid and optional third flushing fluid, and acidic buffers (such as aqueous sodium bicarbonate solution) as intermediate flushing fluids.

[0304] In any of the above aspects, the first flushing fluid may be a gas and the intermediate flushing fluid may include a viscosity-increasing agent. "Viscosity-increasing agent" means a substance that can increase the viscosity of the intermediate flushing fluid at a given temperature and pressure. As used herein, viscosity is measured using a Brookfield viscometer at 20 ± 1 °C and a shear rate of 10,000 s⁻¹. Those skilled in the art will understand that the viscosity-increasing agent should preferably be biocompatible. Suitable examples of viscosity-increasing agents include, but are not limited to, hydroxyethyl starch, gelatin, and dextran, and combinations thereof. The inventors have found it advantageous to include a viscosity-increasing agent in the intermediate flushing fluid because this enhances the ability of the intermediate flushing fluid to mechanically displace the first flushing fluid without dissolving a significant amount of the first flushing fluid, if any.

[0305] In any of the above aspects, the first flushing fluid may be a gas and the intermediate flushing fluid may include a density-increasing agent. "Density-increasing agent" means an agent that can increase the density of the intermediate flushing fluid at a given temperature and pressure. As used herein, density is measured using a densitometer, such as the Mettler Toledo Easy D30 densitometer, at 20 ± 1 °C. Suitable examples of density-increasing agents include, but are not limited to: salts such as sodium chloride, monosodium phosphate, disodium phosphate, trisodium phosphate, sodium carbonate, sodium bromide, cesium bromide, lithium chloride, and potassium iodide; amino acids such as lysine and glycine; carbohydrates such as mannitol, glucose, sucrose, and dextran; and organic compounds such as urea, propylene glycol, etc.; and combinations thereof. Similar to viscosity-increasing agents, the inventors have found it advantageous to include a density-increasing agent in the second and / or third flushing fluid because this increases the rate of dissolution by the first flushing fluid and can increase the volume of gas dissolved by the second and / or third flushing fluid. Therefore, in a preferred embodiment, the second and / or third flushing fluid includes both a viscosity-increasing agent and a density-increasing agent.

[0306] Figure 23 Another catheter flushing fixation device 2301 is shown. The flushing fixation device 2301 shown is a tube (or sheath), but alternative shapes can be used. One end of the flushing fixation device 2301 serves as an inlet port 2302 for receiving the distal end of the catheter 2304 (including the tip 2305 of the catheter 2304). The size of the inlet port 2302 is determined to form an interference fit with the outer surface of the catheter 2304, i.e., the inlet port 2303 has an inner diameter smaller than the outer diameter of the catheter 2304 (before the catheter 2304 is inserted into the inlet port 2303). To facilitate the insertion of the catheter 2304, the inlet port 2303 is preferably deformable (e.g., it can be made of an elastomeric material).

[0307] The second end of the flushing fixture 2301 serves as an outlet port 2303 through which the distal end of the conduit 2304 is pushed out once flushing is complete.

[0308] The interference fit between the inlet port 2303 and the outer surface of the conduit 2304 means that when the distal end of the conduit is inserted into the inlet port 2303, the fluid outlet 2306 on the outer surface of the conduit 2304 is blocked by the inner surface of the inlet port 2303. This blockage hinders (but does not completely prevent) the flow of flushing fluid through the conduit 2304 during flushing, resulting in an increase in the pressure of the flushing fluid, which in turn increases the absorption of gas within the conduit 2304. The magnitude of the increased pressure (i.e., the tightness of the connection between the inlet port 2303 and the outer surface of the conduit 2304) will depend on the relative size of the inlet port 2302 and the conduit 2304, as well as the elasticity and tensile strength of the material of the inlet port 2302. In other words, the maximum pressure that will occur inside the conduit 2304 can be adjusted by selecting the materials and fit properties. The seal formed between the inlet port 2302 and the conduit 2304 by the interference fit also prevents gas from flowing back into the conduit 2304.

[0309] The flushing fixation device 2301 may optionally have one or more markings to help ensure that the catheter is inserted into the inlet port 2302 in an appropriate amount. The flushing fixation device 2301 may also optionally have one or more weak lines (not shown) to allow the flushing fixation device to be torn and removed after flushing. The weak lines may also be provided with pull tabs to assist in tearing the flushing fixation device 2301.

[0310] Figure 24 It shows the use when using Figure 23 A method for flushing a conduit when using the flushing fixing device 2301. In step 2401, the tip 2305 of the conduit 2304 is placed through the inlet port 2302 to form an interference fit between the conduit 2304 and the inlet port 2302, thereby blocking the fluid outlet 2306 of the conduit 2304 (i.e., the fluid outlet 2306 is blocked by the flushing fixing device). In step 2402, the conduit 2304 is then flushed with flushing fluid while the fluid outlet 2306 of the conduit 2304 is blocked by the flushing fixing device 2301.

[0311] To ensure that the flushing fluid 2307 does not overflow from the flushing fixture 2301, the tip 2305 of the conduit 2304 may optionally be raised during flushing.

[0312] Once the catheter 2304 has been adequately flushed, the tip 2305 of the catheter 2304 can optionally be pushed through the flushing retainer 2301 and out of the outlet port 2303, for example, directly into the introductor sheath (not shown). The flushing retainer 2301 can then be removed (e.g., by tearing it along a weak line) or left around the outside of the catheter 2301 (e.g., pushed against the handle of the catheter 2304).

[0313] The irrigation fixation devices and methods described earlier can be provided as part of a kit. These kits include medical devices (such as catheters) and instructions for use for the medical devices.

[0314] Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require regulated medical devices to provide instructions for use.

[0315] As a general principle, each device must be accompanied by as much information as possible that the operator needs to use it safely, taking into account the training and knowledge of potential users. Specific basic instructions must appear on the label, with a more detailed copy included in the accompanying Instructions for Use (IFU).

[0316] An IFU must include several details, including: the details required on the label; any side effects from the use of the device; and details for its proper use as a general rule, including any specific precautions.

[0317] For certain medical devices, such as intravenous catheters, cleaning and sterilization instructions are crucial as they can affect the safety of using the device. Without proper cleaning, the device cannot be sterilized or disinfected. Cleaning procedures vary depending on the complexity of the device, therefore the IFU (Installation Function Unit) should always provide instructions on how to achieve thorough cleaning. Some instruments have areas that are difficult to clean and may require disassembly. In these cases, the IFU typically includes diagrams for proper disassembly and reassembly. Cleaning chemicals are also included, because not only can materials be damaged if the wrong type of cleaning solution is used, but many materials are only effectively cleaned when, for example, the correct ratio of cleaning chemical to water is used.

[0318] Medical devices with channels, such as intravenous catheters, require channel flushing for cleaning. As described above, proper channel flushing is important for removing gases (e.g., air) from inside these devices. IFUs provide flushing instructions and information on specific accessories (including flushing agents) to be used. Kits containing medical devices and IFUs may also include these accessories, such as flushing agents or flushing equipment. According to the present invention, kits may include these accessories as well as medical devices.

[0319] The description of the methods defined herein is preferably included within the "cleaning" section of the IFU. Therefore, the IFU can be a key component of the kit. They are the technical part of the invention because regulatory agencies require compliance with the IFU. The device cannot be provided or used without following the guidelines in the IFU.

[0320] As used herein, unless otherwise specifically mentioned, references to the state of matter such as gas or liquid mean the state of matter at 25°C and 1 atmosphere.

[0321] It should be understood that the systems and methods described above, as well as the accompanying drawings, are non-limiting examples, and other configurations may also implement the invention.

Claims

1. A flushing and securing device for flushing the lumen of a catheter, the flushing and securing device comprising a housing having a catheter inlet port and a catheter outlet port, the catheter inlet port being arranged to receive at least a distal portion of the catheter. The housing defines a flushing chamber, which is at least partially filled with liquid to immerse the distal portion of the catheter. The catheter exit port includes a deformable exit opening shaped to conform to the distal tip of the catheter in such a way that, when in use, the distal tip of the catheter liquid-tightly covers the deformable exit opening. The flushing fixation device further includes an exit port bracket attached to the catheter exit port and configured to prevent the catheter from being pushed through the deformable exit opening when the exit port bracket is attached to the deformable exit opening.

2. The flushing and fixing device according to claim 1, wherein the deformable exit opening has a generally conical shape when not deformed.

3. The flushing and fixing device according to claim 1 or 2, wherein the size of the deformable exit opening is determined to provide an interference fit with the distal tip of the conduit when in use.

4. The flushing and fixing device according to claim 1, wherein the conduit inlet port includes a deformable inlet opening shaped to conform to the outer diameter of the conduit.

5. The flushing and fixing device of claim 4, wherein the deformable access opening is configured to provide an interference fit with the outer diameter of the conduit when in use.

6. The flushing and fixing device according to claim 4, wherein when the openings are not deformed, the deformable entry opening has a diameter greater than the diameter of the deformable exit opening.

7. The flushing and fixing device according to claim 1, wherein the exit port bracket is removably attached to the catheter exit port.

8. The flushing fixation device according to claim 7, wherein the exit port bracket includes a weakened portion for removing the exit port bracket from the catheter exit port.

9. The flushing and fixing device according to claim 7, wherein the exit port bracket is annular and configured to surround the outer circumference of the conduit exit port.

10. The flushing and fixing device of claim 7, wherein the exit port support includes a collar configured to surround the outer circumference of the catheter exit port.

11. The flushing and fixing device according to claim 1, wherein the exit port bracket is rigidly attached to the catheter exit port.

12. The flushing fixation device of claim 11, wherein the exit port bracket is configured to permanently increase the diameter of the exit opening when the exit port bracket is removed from the catheter exit port.

13. The flushing and fixing device of claim 11, wherein the exit port support includes a wire or cord tightly coupled to the catheter exit port, the wire or cord being configured to cause the catheter exit port to break upon removal of the wire or cord.

14. The flushing fixing device of claim 7, wherein the exit port bracket includes a frame configured to support the chamber on a working surface.

15. The flushing fixture of claim 1, further comprising a frame configured to support the chamber on a working surface, the frame being integrated into the housing of the flushing fixture.

16. The flushing fixture of claim 1, comprising a platform configured to support the chamber on a working surface, the platform including a fluid reservoir for flushing fluid.

17. The flushing fixing device according to claim 1, further comprising one or more suction cups for removably attaching the flushing fixing device to a working surface.

18. The flushing and fixing device according to claim 1, wherein the chamber has an inner diameter larger than the diameter of the conduit.

19. The flushing and fixing device of claim 1, wherein the deformable exit opening is configured to provide an interference fit with the tip of the conduit when in use.

20. The flushing fixing device according to claim 1, further comprising one or more weak lines, such that the flushing fixing device can be separated along the one or more weak lines.

21. The flushing fixing device according to claim 20, further comprising a pull ring for assisting the flushing fixing device in separating along the one or more weak lines.

22. The flushing and fixing device according to claim 1, wherein the flushing and fixing device is slidable along the longitudinal range of the conduit.

23. The flushing and fixing device according to claim 1, wherein the flushing and fixing device is formed of a flexible material.

24. The flushing and fixing device according to claim 23, wherein the flexible material is an elastomer material.

25. A method of flushing a catheter within a flushing fixation device, the flushing fixation device comprising a housing having a catheter inlet port, a catheter outlet port, and a flushing chamber extending between the inlet port and the outlet port, the catheter outlet port including a deformable exit opening shaped to conform to a distal tip of the catheter, wherein the method comprises: Insert the distal end of the catheter into the flushing chamber until the distal tip is received in the deformable exit opening of the catheter exit opening and deformed. The flushing chamber is at least partially filled with liquid so as to immerse the distal end of the catheter in the liquid; While the distal end of the catheter is immersed in the liquid, the lumen of the catheter is flushed with a flushing fluid; as well as An exit port support is attached to the catheter exit port, the exit port support being configured to prevent the catheter from being pushed through the deformable exit opening when the exit port support is attached to the deformable exit opening.

26. The method of claim 25, further comprising pushing the conduit through the deformable exit opening after flushing has been completed.

27. The method of claim 25, wherein the flushing fluid is a flushing liquid, and the method further comprises flushing the cavity with a flushing gas prior to flushing with the flushing liquid.

28. The method of claim 27, wherein the flushing gas is carbon dioxide.

29. The method of claim 25, wherein the lumen is flushed from the proximal end of the catheter.

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