JP2004503336A - Apparatus and method for injecting liquid into a catheter - Google Patents

Abstract

The present invention relates to devices (1), methods and kits for use in connection with a catheter, and more particularly to devices for injecting fluid into a catheter, such as, for example, a percutaneous internal access catheter. , Methods and kits. In one aspect, the invention involves injecting a lock solution into an indwelling catheter to prevent occlusion of the catheter and control infection.

Description

[0001]
Description of the related application
This application claims the benefit of a U.S. provisional application entitled "Apparatus and Method for Locking an Indwelling Catheter" filed on July 13, 2001, which is incorporated by reference in its entirety. .
[0002]
Background of the Invention
The present invention relates generally to devices, methods and kits for use in connection with a catheter, and more particularly for injecting liquid into a catheter, such as, for example, a percutaneous body access catheter. Devices, methods and kits. According to one feature, the present invention involves injecting a lock solution into an indwelling catheter to prevent clogging of the catheter and control infection. In another aspect, the invention includes injecting saline solution into an indwelling catheter to flush the contents of the catheter from the distal end of the catheter. The invention is particularly useful when coupled to an intravascular infusion catheter and can also be used in conjunction with a peritoneal dialysis catheter, thoracic duct, urethral catheter, and the like.
[0003]
By way of background, catheters are widely used to treat patients in need of various medical procedures. The catheter can be emergency or temporary for short-term use, or it can be long-term for long-term procedures. Generally, a catheter is inserted into a central vein (such as the vena cava) from a peripheral venous site to provide access to the patient's vasculature. Catheters offer many benefits to patients, such as long-lasting catheters for administering large volumes of fluids, nutrients and drugs without repeated punctures or repeated vascular cannulations. Provides easy access for withdrawing blood in a continuous or discontinuous manner. With respect to the use of catheters for infusion of fluids, examples include infusion of fluids used in drugs, electrolytes or chemotherapy. In chemotherapy, catheters are used to inject drugs on an intermittent basis ranging from daily to weekly. Another example is the use of catheters in overnutrition procedures, where catheters are typically used to inject large volumes of fluid.
[0004]
For hemodialysis, catheters are typically used three times a week to draw blood for the dialysis procedure and quickly return blood to the circulatory system after the procedure. Preferred modes of vascular access to hemodialysis patients include the use of an arteriovenous (AV) fistula or an arteriovenous "bridge" graft (typically utilizing PTFE) in the upper or lower limb. However, the use of these access devices is not always possible or desirable. If neither of these modes of vascular access are available, for example, due to lack of suitable vessels for "AV" bypass formation or established AV bypass formation that does not function optimally, To do so, a catheter with a large bore venous line is typically required. Catheters used for hemodialysis typically include two relatively large diameter lumens (usually one) for aspiration and rapid return of blood needed during the hemodialysis process. Formed as one catheter). One of the lumens of such a catheter is used for aspiration or removal of blood and the other lumen is used for returning blood to the patient's blood stream.
[0005]
Dialyzer tubing, IV line tubing, infusion ports and catheters used to seal the ends of the catheters to protect the sterility of the catheter and prevent fluid loss and / or contamination by particles. Coupling of the catheter, such as coupling of the catheter to the cap, is most often done using luer-type tapered fittings standardized in the medical industry. These mating members, which can be male or female couplings, include tapered ends of standardized dimensions. Coupling is achieved by press-fitting the mating parts. Threaded locking fittings or other types of locking mechanisms are commonly used to ensure press-fit connection of the luer fitting.
[0006]
Catheters, especially long-term venous catheters, have disadvantages. One significant disadvantage is that such catheters can become clogged by thrombus. For example, to prevent clogging of the catheter in the blood vessel between uses, such as during a dialysis procedure, the catheter is essentially non-functional and has a "central" vein (i.e., superior vena cava). When placed inside the vena cava, inferior vena cava, iliac vein, etc.), the lumen of the catheter often contains a concentrated solution of the commonly used anticoagulant, heparin (less than 10,000 units of heparin per catheter lumen). ) Containing a tablet solution. The term "locking solution" as used herein is typically desirable or required to re-access a particular lumen for additional treatment, i.e., infusion or aspiration of fluid. A solution injected or injected into the lumen of a catheter, with the intent that a substantial portion of the tablet solution remain in the lumen and not in the systemic blood circulation. I have. In addition, attention has been focused on the development of alternative lock solutions with the goal of improving the patency of vascular catheters. The tablet solution is preferably capable of remaining in the lumen for a desired period of time lasting from about 1 hour to more than 3 or 4 days.
[0007]
In order to lock the indwelling catheter for dialysis, each lumen of the catheter can be filled with a tablet solution containing an anticoagulant (usually heparin) immediately after each use. The coagulant theoretically stays in the catheter until the catheter is accessed again. The tablet solution must be withdrawn from the catheter by aspiration prior to the next use of the catheter (eg, at the next dialysis period) to prevent large amounts of anticoagulant from flowing into the patient's body. No. In general, due to the large lumen diameter of hemodialysis catheters and the need to prevent clotting in the lumen, the concentration of the anticoagulant is generally lower than that administered to the tissue. Much higher. Thus, even a small amount of an anticoagulant, when placed in a patient at such a high concentration, will cause excessive bleeding and will require a significant amount of anticoagulant to flow into the patient's bloodstream. Attention must be paid. If a significant excess of anticoagulant is infused into the patient's blood during the catheter locking process, or by mistaking the anticoagulant with some other fluid (eg, saline) injected during the dialysis process, May harm the patient. For example, excess heparin can cause excessive non-coagulation of the patient's blood and bleeding from many sites.
[0008]
Therefore, during the catheter locking process, it is important that the “locking” solution be carefully measured to avoid “non-coagulation” in the patient, and the volume of solution injected will be less than the amount of solution in the lumen of the catheter. It is desirable that it be exactly the same as the internal volume of the catheter to prevent clotting. Even when this volume is correctly infused, typically about one-third of the volume of anticoagulant infused remains at the end of the catheter as a result of fluid mixing at the inner end of the catheter. Some hours after the dialysis process, the patient will have some non-coagulable state.
[0009]
Another important disadvantage of intravascular catheters is that they can increase the patient's risk of infection, even when careful attention is paid. Great care must be taken in placing and using catheters over long periods of time to prevent infection of the patient at the access site or within the vascular system. When catheters are inserted into a vein or artery, they bypass the protective dermis layer and provide direct access to the patient's blood flow. This may inadvertently transfer the infectious agent into the vein or artery at the catheter placement site during placement of the catheter or during the placement of the catheter within the patient and across the patient's dermis. . The heterogeneous surface of the catheter can form a smooth surface on which bacteria can grow and white blood cells cannot surround or "phagocytize" the bacteria. Long-term venous catheters include a DACRON cuff, which is typically attached to the catheter and placed under the skin to promote ingrowth of fibrous tissue and to position the catheter in place. Secure and minimize the occurrence of bacterial penetration around the catheter from outside the catheter into the systemic circulation.
[0010]
Such catheters are used to pass substances, such as dialysed blood, nutrients, drugs, etc., into the patient's bloodstream, and thus come into contact with the substance being injected and the catheter to inject the same. It can be readily appreciated that great care must be taken to ensure that the device is sterile. Catheters, particularly intravenous catheters, are often accessed by a syringe or uncapped and connected directly to an IV line.
[0011]
This problem applies equally to lock solutions placed in the catheter during periods of non-use and devices for introducing the lock solution into the catheter. For example, heparin does not have antibacterial properties when used as an anticoagulant in catheter lock solutions, and in fact, actually "biofilms" proteins on the surface of the catheter. It may promote bacterial growth in the stratum (protamine has the opposite effect). "Biofilm" proteins on the catheter surface can protect bacteria from antibiotics and the bactericidal properties of leukocytes. If there is bacteremia (a disease in which bacteria are present in the blood vessels), then the surface of the catheter in the vein or artery can become inoculated with the bacteria. In each case, the patient develops sepsis (infection in the blood) and becomes severely ill. These patients often have to be hospitalized and given antibiotics by intravenous injection. Despite such precautions, patients often remain severely ill until the infected catheter is removed. Since catheters have a tendency to become contaminated, and contamination can have disastrous consequences, great care must be taken to prevent bacterial invasion into the patient's body or contact with indwelling catheters. Must.
[0012]
For the reasons mentioned above, the risk of thrombus or non-coagulation and the risk of infection when injecting drugs, nutrients, etc. into the catheter and when "locking" the catheter between uses. Great care must be taken to minimize the risks associated with indwelling catheters, including sex. Syringes are typically used to administer after a given use. For example, at the end of the dialysis phase, the tablet solution is typically introduced into both lumens of the dialysis catheter, and eventually caps are placed at both the inflow and outflow openings of the catheter. The process of locking the catheter should be performed by an aseptic method, but the need to quickly "turn" the patient in most dialysis units complicates the method, thereby increasing infection. Risk may increase. Aseptic methods of "clothing" or "undressing" hemodialysis patients are often at risk, thereby causing bacteremia / sepsis associated with catheters plagued today's dialysis units. . This is because the number of accesses to the catheter has increased sharply in recent years. Also in the last few years, the level of education for dialysis personnel has generally declined, due to lower salaries and the need to increase the already "rigorous" margins required by state dialysis institutions.
[0013]
In connection with the above problems, there is a continuing need for advances in catheter locking techniques, devices and methods to improve the safety and effectiveness of the catheter locking process and overall patient care. . In particular, there is a need for a proposal for a locking technique for indwelling dialysis catheters, including improved devices and techniques to reduce the incidence of infection or non-coagulation in patients. Similarly, there is a continuing need for proposals for techniques, devices and methods for injecting other types of liquids into percutaneous catheters. The present invention is such a proposal and offers a wide range of benefits and advantages.
[0014]
Summary of the Invention
In one form of the invention, a device used to "lock" an indwelling catheter between uses and for injecting a predetermined amount of another type of liquid into the catheter. An apparatus is provided. The device has a connector with a structure suitable for connecting to the outer end of an indwelling catheter, holds a lock solution, connects the device to the catheter, and allows the health care provider or other user to access the container. A collapsible container configured to squeeze the solution into the catheter.
[0015]
Another aspect of the invention is to lock an indwelling catheter between uses and to inject a predetermined amount of another type of liquid into the catheter between uses. Provide a method. The method includes securing a device of the present invention containing a predetermined amount of a locking solution to the outer end of an indwelling catheter by engaging a connector with the end of the catheter and applying the locking solution to the catheter. Crushing the container of the device for injection into the lumen. Another embodiment further includes aspirating the tablet solution from the catheter ready for subsequent use. In another form of the present invention, the device of the present invention is used to inject a rinse solution comprising saline into a catheter.
[0016]
One object of the present invention is to provide a multifunctional cap that eliminates the need to correctly measure and administer a catheter lock solution or other liquid via a syringe.
[0017]
Another object of the present invention is to reduce the occurrence of improper (also dangerous) non-coagulation phenomena and the occurrence of improper underfilling of the catheter leading to clogging and subsequent improper dialysis treatment. It is to provide techniques, devices and methods.
[0018]
It is yet another object of the present invention to provide a technique, apparatus and method for reducing the possibility of infection of a patient due to contamination of the catheter during the process of locking the catheter or injecting another liquid.
[0019]
Still other aspects, embodiments, objects, features and aspects of the present invention will become apparent from the description contained herein.
Detailed Description of the Preferred Embodiment
For the purposes of promoting an understanding of the principles of the invention, reference will be made to the embodiments described herein, and specific language will be used to describe the same. However, it will be understood that no limitation of the scope of the invention is thereby intended. Any alternatives and further modifications in the methods, devices and apparatus described herein, and any other uses for the principles of the present invention described herein, are generally contemplated by those skilled in the art to which the present invention pertains. .
[0020]
To prevent clotting of the catheter between uses, the catheter is typically filled with a tablet solution containing an anticoagulant and sometimes additional compounds. The device and method of the present invention for injecting a liquid into a catheter has one advantage when injecting a lock solution into an indwelling catheter, such as, for example, an indwelling percutaneous hemodialysis catheter. For purposes of illustrating the present invention, techniques, devices and methods for locking a dialysis catheter will be described in detail. However, the use of the present invention is not intended to be limited to locking dialysis catheters, and the present invention also provides advantageous methods of locking a wide range of other indwelling catheters. It is intended to have. Furthermore, it is not intended that the present invention be limited to injecting tablet solutions, the present invention also provides a wide range of other liquids, such as, for example, nutrients, drugs, saline, etc., in various catheters. It is also intended to have advantageous use for injecting into.
[0021]
Filling or "locking" the hemodialysis catheter after the hemodialysis procedure is completed involves a series of steps, many of which involve contact with the lumen of the catheter or device or the lumen of the catheter. The exposed fluid is exposed to possible infection. The steps of the method include, for example, clamping the catheter body, removing the catheter's luer connector from the blood of the dialyzer, placing a cap on the catheter, and placing a predetermined amount of chain on the syringe as directed by the catheter manufacturer. Filling the tablet solution, inserting the tip of the syringe needle into the lumen of the catheter through the cap, unclamping the catheter body, injecting the lock solution from the syringe into the catheter, catheter body Re-clamping and withdrawing the needle from the catheter. Another method involves placing a cap with a "needleless hole" known in the art at the end of the catheter. The method of using such a cap also involves a series of steps in which the lumen of the catheter is exposed to possible infection. Another method of "locking" the catheter after use is to clamp the catheter body, remove the fluid connection from the luer connector, and attach a syringe containing the locking solution and configured to connect to the luer connector. Unclamping the catheter, injecting the locking solution, clamping the catheter, removing the syringe and attaching a "locking member" or non-pierceable cap.
[0022]
It is easily understood that these types of methods have a number of disadvantages. For example, blood in the catheter begins to clot shortly after distribution, stops at the end of the dialysis procedure, and delays in the process may cause unwanted thrombi. In addition, the method involves the placement of many foreign materials and surfaces, including catheter caps, syringe needles, etc., that are in direct contact with the lumen of the catheter. Each contact point increases the risk of infecting the catheter with bacteria. These methods require a number of steps during which the outer end of the catheter is uncapped or otherwise exposed to possible infection.
[0023]
In one aspect, the invention provides a pre-filled device for "locking" an indwelling catheter between uses. By using the infusion device of the present invention, the need for many steps during the catheter locking process is advantageously eliminated, minimizing the time blood remains in the lumen of the catheter after the dialysis procedure is completed, and It minimizes the time that must be left exposed from the outer end of the catheter before and after the process takes place, and reduces the number of foreign substances that come into contact with the lumen of the catheter. One embodiment of the present invention is illustrated in FIG. 1, in which the device 1 comprises a collapsible container 20 and a connector 10 adapted to hold a lock solution or other liquid. And The connector 10 can be connected to the proximal end (outer end) of an indwelling catheter in such a way that the solution can be dispensed from the container into the catheter when the provider or other user manually crushes the container. It has a structure.
[0024]
Most common catheters are configured to receive a cap or other coupling member in a relative relationship, commonly referred to as a Luer lock connection. In one embodiment of the present invention, connector 10 has a luer locking structure that can be attached to most common catheters. It will be appreciated that the connector may have alternative configurations apparent to those skilled in the art, for example, for engaging a catheter having a different design or mode of attachment.
[0025]
The collapsible container 20 forms a cavity 25 and a port 30 through which the cavity is in fluid communication with the outside of the container, such as an orifice or valve. It will be appreciated that in embodiments featuring a valve, the cavity is in fluid communication with the exterior of the container only when the valve is open. When the valve is closed, the cavity is sealed and is not in fluid communication with the outside of the container.
[0026]
The connector 10 is fixed to the container 20 such that the connector 10 covers the port 30. In other words, the connector 10 provides a structure such that when the connector 10 mates with the proximal end of the catheter, the connector 10 provides a sealed connection in which the cavity 25 is in fluid communication with the lumen of the catheter via the port 30. To the container 20 around the port. When the device 1 is connected to the catheter by the engagement of the connector 10 with the proximal end (outer end) of the catheter, a port 30 is positioned between the cavity 25 and the lumen of the catheter, whereby the cavity 25 , A port 30, the lumen of the catheter and the vascular tissue of the patient are provided to form a closed system.
[0027]
In one embodiment, the connector is configured to be connectable to a catheter having a proximal end having a mating member configured to mate with the connector. In one embodiment, the mating member is one of a male luer coupling or a female luer coupling, and the connector is a male luer coupling or a female luer coupling. Including the other of them. In this embodiment, the connector is fixed to the catheter by press-fitting the fitting member and the connector. In another embodiment, the connector includes a fastening member for maintaining the connection between the mating member and the connector. A wide variety of fastening members conceived by those skilled in the art are available for such applications. In one embodiment, the proximal end of the catheter forms a flange or thread and the fastening member cooperates with the flange or thread of the catheter to maintain connectivity between the mating member and the connector. Forming a working flange or thread.
[0028]
In one embodiment of the present invention, port 30 is a valve. As those skilled in the art will appreciate, a wide range of valves can be used in accordance with the present invention. In one embodiment, the valve is a one-way valve such as, for example, a "duck bill valve". The duckbill valve is such that in the absence of external action, fluid passes through the valve in a first direction in response to a pressure gradient across the valve, but is prevented from flowing through the valve in the opposite direction. It is preferable to have a simple structure. A moderate threshold pressure is required to cause the fluid to flow in the first direction. In another embodiment, the valve may be manually actuated to open the valve and allow fluid flow in either direction depending on the pressure gradient across the valve. It has a structure. In another embodiment, port 30 is a cock valve, and various cock valves are readily available commercially. A wide variety of duckbill valves, manually actuated valves, cock valves and other structures are commonly known to those skilled in the art and are readily available commercially.
[0029]
By way of example, in embodiments using a duckbill valve, pressure in the cavity, for example, provided by a health care provider manually crushing the container causes fluid to flow from the container through the valve in a first direction. Until the solution is held in the cavity. Thus, once the device of this embodiment is brought into contact with the catheter, the container can be manually crushed and the lock solution can flow into the catheter via the valve. As the locking solution flows into the catheter, the one-way valve blocks flow in the second direction, ensuring that the solution is not withdrawn too early from the catheter.
[0030]
This embodiment of the invention is particularly useful when the catheter being locked does not include a clamp at or near the outer end of the catheter. Although most catheters used for dialysis include such clamps, some do not, and for catheters without clamps, this type of valve would be During the lock period (ie, when not in use), it is useful to prevent fluid from flowing from the catheter.
[0031]
In another embodiment of the present invention, port 30 is an orifice. In the device of this embodiment, the orifice is preferably large enough to hold the fluid in the container during normal processing and until pressure is exerted on the fluid during normal processing and pressure on the fluid. In this regard, tablet solutions have been provided which include a thickening agent to increase the viscosity of the solution. An example of such a composition is described in International Application No. WO-A-98 / 086, entitled "Method for Enhancing Patency of Catheter Using Citrate Catheter Lock Solution." US Provisional Application No. PCT / US99 / 19307 (International Publication No. WO 00/10385), filed May 10, 2000, entitled "Catheter Locking Solution Containing Photooxidant". International Application No. 60 / 203,358, filed May 10, 2001 and entitled "Catheter Locking Solution Containing Photo-Oxidizing Agent". PCT / US01 / 15177, each of which is incorporated herein by reference in its entirety. The thickener prevents the lock solution from being pushed out by the blood in the intravascular catheter over time so that most of the lock solution stays in the catheter between uses. Included in such a tablet solution is to have a sufficiently high viscosity to minimize. Other tablet solutions that can be used in combination with the present invention have much lower viscosities. In this regard, it is understood that the desired size of the orifice in the device of the present invention may depend on the viscosity of the tablet solution therein.
[0032]
In a preferred embodiment, the orifice has a generally circular shape and is about 0.25 mm to about 2 mm in diameter. In another embodiment, the diameter of the orifice is between about 0.75 mm and about 1 mm. In another embodiment, the diameter of the orifice is about 0.5 mm. Embodiments having an orifice most commonly have an outer end or outer end to prevent fluid flow into and out of the catheter after the lock solution has been injected. It will be appreciated that it may be used with catheters having clamps or other devices near the device.
[0033]
Further, the device may include a plug 15 configured to connect to the connector 10 in a manner similar to connection to the outer end of the catheter. An embodiment showing the plug 15 is shown in FIG. The plug 15 can have a wide variety of structures as would occur to those skilled in the art, and can resemble a catheter cap if the cap has a mating member configured to engage the connector. The plug 15 can be advantageously connected to the filled device to prevent the lock solution from leaking out of the container during transport, storage, handling, etc. The presence of a plug is particularly useful in embodiments having an orifice rather than a valve. Just before the device is used to lock the catheter, the plug 15 can be removed to allow the device to freely connect to the catheter. Such a plug can also be used advantageously in a device having a valve as described above.
[0034]
It is readily understood that container 20 can have a wide range of sizes, shapes, and configurations. For example, indwelling catheters can have lumens with widely varying volumes, most dialysis catheters have a lumen volume of about 1.4 cc to about 2.1 cc, and most Long-term intravenous catheters have a lumen volume of about 0.5 cc to 1.5 cc. In one embodiment, the locking device of the present invention used to lock a given catheter has an internal volume corresponding to the lumen volume of the catheter to be locked. The use of the term "corresponds to" is intended to refer to the volume selected by a health care provider to lock a given volume of catheter between uses. It is generally understood that the volume of the tablet solution introduced into the lumen of the catheter is preferably about 80% to about 100% of the volume of the lumen of the catheter. An advantage of the present invention is that the device of the present invention can be manufactured to accommodate a specific volume of catheter, thereby requiring the careful measurement of the lock solution during the lock process and associated with such measurements. The risk of mistakes is eliminated.
[0035]
In another embodiment, the device of the present invention has an internal volume that is greater than the internal volume of the catheter to be locked. It will be appreciated that in certain embodiments, the container will not be filled to maximum capacity prior to use, but rather will contain a predetermined amount of a tablet solution corresponding to the catheter. The container is preferably free of air or other gas, and is therefore preferably prepared to have an initial partially collapsed structure. In this regard, it is common to aspirate more than the internal volume of the catheter when aspirating from a locked catheter, thereby ensuring that substantially all of the lock solution is recovered. Is a proper way. The device of this embodiment aspirates such a larger volume in the container at the end of the lockout period without the need to remove the device or access the container through a needled or needleless syringe. It is advantageous because it is used for In one embodiment, the device has an internal volume of about 0.5 to 3.5 cc. In another embodiment, the device has an internal volume of about 1 to about 3 cc. In yet another embodiment, the device has an internal volume of about 2.5 cc.
[0036]
In addition to size variations, the devices of the present invention can have a wide range of structures. In one embodiment of the present invention illustrated in FIG. 3, the container is a shape memory crushable sphere configured to return to its original shape when the external force is removed. An advantage of such a shape memory container is that after the container is locked by crushing the container and thereby introducing the locking solution into the catheter, the container creates a negative pressure, which is At the end of the lock period when the catheter is being prepared for subsequent use, the lock solution can be used to aspirate into the container. Of course, when such a shape memory container is used, the device or catheter being locked may require a clamp, valve or other device to prevent the lock solution from being pulled out of the catheter prematurely. It is understood that the device must be included.
[0037]
In another embodiment of the invention illustrated in FIG. 4, the container is a stretchable accordion-type container 220 that is flexible and has a bellows configuration. Thus, in this embodiment, upon contraction of the bellows, the container causes the lock solution to flow through the port, and upon extension of the bellows, the container draws the lock solution through the port. The structure of the container 220 in this embodiment is referred to herein as "straight bellows".
[0038]
As shown in FIG. 4, the container also includes a cap 40 configured to engage the connector 10 when the device is in a contracted condition (ie, after the lock solution has been introduced into the catheter). Also included. The advantage of this structure is that once the lock solution is introduced into the lumen, the device is compressed to a small size and not bulky. This configuration is advantageous because the device can remain connected to the catheter for an extended period of time. Due to the crushable nature of the device, the device according to this embodiment can be made to have a size similar to a conventional locking cap.
[0039]
In another embodiment shown in FIGS. 5 and 6, the container 320 has a flexible and expandable fan-shaped bellows structure. In this embodiment, contraction of the bellows (i.e., "closing the fan") causes the container to allow the locking solution to flow through the port and into the lumen of the catheter (when the device is connected to the catheter). ), The extension of the bellows causes a pressure gradient across the port, which can be used to draw the locking solution back through the port and into the container. In this embodiment, the bellows portion may be hinged about a fixed point adjacent the connector 10. This embodiment is shown in FIG. 5 in an extended state and in FIG. 6 in a partially contracted state.
[0040]
In another embodiment shown in FIGS. 7 and 8, the container 420 has a flexible disk shape. FIG. 8 depicts an end view of this embodiment and one or more flanges or threads on the proximal end of the catheter (or one or more flanges or threads on the plug, if present). 4) shows a Luer locking structure including a threaded fastening member 12 featuring a screw 13 configured to engage with the lug. By way of example, the flange 14 shown on the catheter shown in FIG. 9 is adapted to receive a thread 13 to retain the connector 10 on the catheter, thereby maintaining the luer connection integrity. I have. Connector 10 also includes a male luer coupling 11 configured to mate with a corresponding female luer coupling of the catheter. In an alternative embodiment, the male coupling 11 can be replaced by a female coupling or other mateable member, and the threaded fastening member 12 can be a catheter having various configurations. Of course, an alternative fastening mechanism could be substituted to provide an alternative device that is structured to be able to be coupled. Such substitutions are well within the purview of those skilled in the art.
[0041]
The device of the present invention can be made of various materials including, but not limited to, for example, silicone, polyurethane, polyvinyl, silicone or silastic elastomer. Although it is desirable to be made of a generally rigid material such as, for example, polycarbonate, polypropylene or high density polyurethane, the container may be made of a flexible material such as, for example, polyvinyl chloride (PVC) or low density polyurethane. It is preferably made by a polymerizable composition. In a preferred aspect of the invention, the device of the invention is made of a connector made of polycarbonate and a container made of PVC. The device is made by blow molding using a method wherein the selected polymer in the container portion of the device is made in a thin and flexible layer and the polymer in the connector portion of the device is made in a thicker and more rigid device. be able to. In addition, a movable fastening member, such as a threaded threaded locking member for a luer locking connector, is a separate fastener made of polycarbonate and formed to snap into place with the connector. It can be made as a molded piece.
[0042]
In one embodiment, the composition of the containers 20, 120, 220, 320, 420 is transparent or translucent, such that a user can see the color of the fluid in the container. . For example, a lock solution used in combination with this device is described in US Provisional Application No., entitled "Catheter Lock Solution Containing Photo-Oxidizing Agent," filed May 10, 2000. International Application No. 60 / 203,358, filed May 10, 2001 and entitled "Catheter Locking Solution Containing Photo-Oxidizing Agent". It can have a unique color, as described in PCT / US01 / 15177, each of which is incorporated herein by reference in its entirety. By using a transparent or translucent material for the container 20, simply by looking at the solution through the container, a health care provider or other user can determine whether such a solution is contained in the device. You can check. Further, the device of the present invention can be used to aspirate a lock solution from a catheter prior to subsequent use of the catheter or infusion of a new lock solution, as described in further detail below. The transparency or translucency of the container will allow the user to determine whether blood has entered the container during aspiration of the tablet solution.
[0043]
In certain embodiments of the invention, the device 1 is characterized in that it is pre-filled and thus contains a liquid in the cavity 25, for example a lock solution. The locking solutions used to lock hemodialysis catheters can have a wide range of formulations, many of which are commercially available. The solution preferably contains an anticoagulant, including but not limited to a coagulant including citrate, heparin, urokinase, tissue plasminogen activation (tPA) and mixtures thereof. It is well known to those skilled in the art. Provisional application no. International Application No. 60 / 203,358, filed May 10, 2001 and entitled "Catheter Locking Solution Containing Photo-Oxidizing Agent". As described in PCT / US01 / 15177, the tablet solutions can also include a photooxidant. The solution can also include various additives. For example, in certain preferred embodiments, the tablet solution also contains an antimicrobial or antimicrobial agent. Such antimicrobial and antimicrobial agents are well known to those of skill in the art and can include, for example, without limitation, gentamicin, vancomycin, and mixtures thereof.
[0044]
The viscosity of a tablet solution can be varied by including a thickening agent. Thus, in certain embodiments of the present invention, the tablet solutions also include a thickening agent. It is well known that catheters are manufactured to have various structures and lumen diameters. For example, a catheter can have one or two lumens. The two lumens can be adjacent to each other and fused or concentric. The lumen can have a varying cross-sectional area and shape ranging from approximately circular to approximately oval. A phenomenon common to most tablet solutions described above is that a portion of the solution at the end of the lumen diffuses into the patient's bloodstream and is replaced by blood in the catheter. While not intending to be bound by any theory, the diffusivity of the tablet solution from the lumen is affected by the cross-sectional shape and area of the particular lumen, the density of the tablet solution, and the viscosity of the tablet solution. receive. Typically, high density tablet solutions, such as relatively high concentrations of citrate, tend to fall out of the lumen of the catheter to allow blood to enter the lumen.
[0045]
A tablet solution that can be used to advantage with the present invention is such that it has a viscosity and density such that a substantial portion of the tablet solution does not diffuse or flow out of the lumen of the catheter over a period of days. Can be made. Thickeners useful in the present invention include pharmaceutically acceptable substances that are known or commonly used in the treatment of animals, including humans. Examples include, but are not limited to, dextran, polyethylene glycol, glycerin, polygenes and non-metabolizable sugars such as sorbitol and mannitol, and mixtures thereof. It will be appreciated that the optimum viscosity and density will depend on the particular lumen shape and size, but those skilled in the art will appreciate, without undue experimentation, the particular catheter in view of the description herein. The desired density and viscosity for can be easily determined. It is of course also understood that the viscosity of the tablet solution used with the device of the present invention having an orifice port should be considered in determining the preferred size of the orifice, as described above. Determining an appropriate size for a given use is well within the purview of those skilled in the art.
[0046]
Tablet solutions can also be made to contain various other pharmaceutically acceptable substances. For example, a tablet solution can include salts such as, for example, sodium chloride or other sodium salts. "Pharmaceutically acceptable" means that the tablet solution and any salts and other additives contained therein are free of undue toxicity, irritation, allergic reactions, etc., within the scope of sound medical judgment. Suitable for use in contact with human and lower animal tissues, and corresponding to a legitimate benefit / risk ratio. For example, pharmaceutically acceptable salts are described, for example, in J. Am. Pharmaceutical @ Science, 66: 1-19, 1977. M. As is found in Berge et al., They are well known in the art.
[0047]
An example of an excellent lock solution for use in accordance with the present invention is described in International Application No. WO-A-98 / 08697, entitled "Method for Enhancing Patency of Catheter Using Citrate Catheter Lock Solution. US Provisional Application No. PCT / US99 / 19307 (International Publication No. WO 00/10385), filed May 10, 2000, entitled "Catheter Locking Solution Containing Photooxidant". International Application No. 60 / 203,358, filed May 10, 2001 and entitled "Catheter Locking Solution Containing Photo-Oxidizing Agent". PCT / US01 / 15177, each of which is incorporated herein by reference in its entirety.
[0048]
In order to prepare the device 1 for use, a predetermined amount of the locking solution is emptied until the container 20 is crushed by external force and the locking solution is pushed out of the cavity 25 via the port 30. It is arranged in the cavity 25 so as to be held in the cavity 25. In one method of placing a lock solution in a cavity, a needle is inserted into the cavity and a predetermined amount of the solution is metered into the cavity via the needle. When this filling method is used, the container includes, for example, a "self-healing" injection port 26 as shown in FIG. 9, which is resealed after the needle is withdrawn. be able to. The injection port can include, for example, a rubber membrane well known to those skilled in the art. Such an injection port is not necessary if the body of the container is made of a composition that can be resealed when the needle is withdrawn. Alternatively, the injection port 26 can simply be formed as a thicker region of the container to extend its life. Alternatively, the injection port may be a needleless port for receiving a needleless syringe to provide fluid communication with the cavity, as is well known to those skilled in the art. It can be easily understood that the injection port having a wide range of structures can be arranged at various positions on the container. In one embodiment illustrated in FIG. 9, the injection port 26 is located generally opposite port 30. The cavity may be filled manually using a needle and syringe or a needleless syringe at the intended site of use of the device, or use a machine designed to meter the solution into such a device. It can be understood that it can be performed in a manufacturing facility.
[0049]
In another method of introducing the solution into the device, the solution is metered into the cavity via port 30. The port 30 can also be used in accordance with the present invention to expel air from the cavity if there is air in the cavity. Of course, it can be appreciated that the solution is preferably introduced into the cavity using aseptic techniques. The present invention also contemplates a manufacturing protocol in which the device is sterilized after the solution is introduced to ensure that the device is free of bacteria, for example, using a pressure sterilization method.
[0050]
In embodiments using a one-way valve, the solution causes the solution to flow from the container through the valve in a first direction by pressure in the cavity provided by the healthcare provider manually crushing the container. Until it is held in the cavity. Thus, once the device of this embodiment is connected to the catheter, the container can be manually crushed to allow the locking solution to enter the catheter via the valve. Once the solution enters the catheter, the one-way valve blocks the flow in the second direction, ensuring that the solution is not withdrawn prematurely from the catheter.
[0051]
This embodiment of the invention is particularly useful when the catheter being locked does not include a clamp at or near the proximal end of the catheter. Although most catheters used for dialysis include such a clamp, some catheters do not include a clamp, and for catheters without a clamp, the lock period (ie, It is useful to prevent fluid from flowing out of the catheter during periods of inactivity.
[0052]
When it is desired to reuse the catheter, the device of this embodiment can be used to aspirate the catheter by manually activating the valve to allow fluid flow in both directions. When the valve is actuated, blood pressure in the accessed vein causes fluid in the catheter to pass through the valve and into the container. For catheters used to access other body cavities, such pressure may not be present, in which case it may be necessary to create a negative pressure in the container. It can be understood.
[0053]
To lock an indwelling catheter, the outer end of the catheter to be locked is removed from a cap or conduit that may have been attached during the procedure, and a connector is engaged with the end of the catheter. This secures the device of the invention containing a predetermined amount of the tablet solution. Once engaged, the catheter and device are in a relative relationship such that the port of the device is adjacent to the lumen of the catheter. For example, in embodiments where the port is an orifice, the catheter and device are in a relative relationship such that the cavity of the container is in fluid communication with the lumen of the catheter. In this embodiment, the healthcare provider pushes the container to collapse, thereby allowing the lock solution to enter the lumen of the catheter, while at the same time draining the contents of the lumen into the patient's bloodstream. Push in.
[0054]
The container is kept collapsed by clamping the catheter or closing the valve, if present, until the catheter is used again and the lock solution is withdrawn from the catheter for disposal. . Withdrawal of the lock solution from the catheter is accomplished in certain aspects of the invention by causing the container to return to its original shape, thereby aspirating the lock solution back into the container. Alternatively, if a device comprising a container containing an injection port as described above is used, a syringe or a needle and a syringe are used to connect the syringe to the injection port or to use the injection port. The lock solution is withdrawn by inserting the needle into the container via and by drawing the lock solution into the syringe via the injection port.
[0055]
When using a device that includes a manual valve, the method of using the device differs, of course, in that the valve must be opened before the container collapses. In this embodiment, the healthcare provider opens the valve and then collapses the container, thereby allowing the lock solution to flow into the lumen of the catheter, while at the same time, Push objects into the patient's bloodstream. In this embodiment, the container can be kept collapsed by simply closing the valve. If the catheter is to be used again, withdrawal of the locking solution from the catheter will open the valve and then allow the container to return to its original shape or the syringe or needle and syringe as described above. This is achieved by withdrawing the solution using
[0056]
Once the lock solution is injected into the lumen of the catheter, it can remain until it is desired that the particular catheter or lumen be re-accessed. Particularly for heparin, it is important to unlock the catheter before starting the dialysis process or using the catheter to inject fluid. As mentioned above, it contains methylene blue or other photooxidants or colorants. The great advantage of this tablet solution is that it imparts color to the tablet solution. This color will indicate to the medical professional using the device that the device or catheter is filled with an anticoagulant.
[0057]
Devices according to various embodiments of the present invention have two functions: first, as a method for accurately and efficiently administering a catheter lock solution, and second, as a catheter cap. The use of the device of the present invention not only eliminates the need for pre-filled syringes or the need to carefully weigh and fill the tablet solution and fill the syringes, but also the "attachment" and " At least one step in the "removal" can be eliminated. Although the actual etiology of bacteremia associated with catheters is known, chains with both anticoagulant / antibacterial properties may be due, in part, to the anchoring of the end of the catheter overhang. By using the device of the present invention comprising a tablet solution, it is expected that the occurrence of bacteremia will be significantly reduced. The device can not only administer a tablet solution with anticoagulant / antimicrobial properties, but also prevent the settlement surrounding the dialysis catheter by contact with the solution. The device can also be used for sensitive catheters with a higher incidence of catheter-related bacteremia.
[0058]
The present invention is also intended for use with catheters used to access other body cavities and catheters used to access patient vascular tissue for purposes other than dialysis. It is natural that there is. For example, a catheter is placed in an artery to measure blood pressure or remove arterial blood for analysis of gas reflex lung function. The catheter is placed in the peritoneum (the space surrounded by the peritoneum and outside the organs in the abdomen) to perform peritoneal dialysis and remove fluids and toxins from the patient. Other catheters are placed in the fluid (cerebrospinal fluid) around the nerve tissue to remove or administer this fluid and are placed in the subcutaneous space for administration of various drugs or fluids. . Other catheters are placed in the bladder for intermittent drainage of urine. Such catheters also have infection problems or other problems addressed herein, and the devices of the present invention are advantageous for use in locking such catheters.
[0059]
In another embodiment of the present invention, the device of the present invention contains saline and is used to inject the saline into a catheter. This embodiment finds advantageous use, for example, when used to deliver a single dose of a drug into a patient. It is readily apparent that when the drug is introduced to the proximal end of the catheter, at least a portion of the dose will remain in the catheter unless washed away by injecting a second fluid into the catheter. Accordingly, the present invention finds an advantageous use as a salt flushing delivery device, whereby a dose of a medicament can be flushed through a catheter using the device of the present invention. Can remain fixed to the catheter as a cap to reduce exposure of the lumen of the catheter to infection.
[0060]
As one skilled in the art will appreciate, one embodiment has described a method for injecting a fluid into a catheter. The method includes: (1) providing a catheter defining a lumen, a proximal end and a distal end, the proximal end including a mating member configured to engage the catheter; and (2) (i). A) a collapsible container defining a cavity and defining a port; and (ii) a liquid contained within the cavity, wherein the volume of the liquid is relative to the lumen volume of the catheter. And (iii) a connector attached to said container around said port, said connector comprising a sealed connection wherein said cavity is in fluid communication with a lumen through said port. Providing a device that includes a connector configured to mate with the mating member to provide: (3) mating the connector with the mating member to connect the device to a catheter. Solid And (4) applying a positive pressure to the liquid such that the liquid exits the cavity through the port and enters the lumen of the catheter at the proximal end. I have.
[0061]
In one embodiment, the ratio is from about 1: 2 to about 2: 1. In yet another embodiment, the ratio is from about 0.8: 1 to about 1: 0.8. In yet another embodiment, the liquid has a volume of about 1 to 5 milliliters. In certain embodiments, the liquid is a catheter lock solution. In other embodiments, the liquid is saline. In another embodiment, wherein the liquid is saline, the method also includes introducing a liquid selected from the group consisting of a dose of a drug and a dose of a nutrient into the catheter prior to attachment. Also included. In still other embodiments, the liquid is selected from the group consisting of a nutrient solution and a drug. In yet another embodiment, the cavity is essentially free of air. In certain embodiments, the catheter is a percutaneous intracorporeal catheter, wherein in this step the distal end is placed inside the patient and the proximal end is placed outside the body. In another embodiment, the catheter is a hemodialysis catheter.
[0062]
In another embodiment of the present invention, the method also includes (1) keeping the device fixed until a hemodialysis procedure is indicated; and (2) applying a negative pressure to the cavity. To allow a predetermined amount of fluid to exit the lumen of the catheter at the proximal end and into the cavity via the port; (3) disconnect the device from the catheter; and (4) perform the dialysis procedure. Connecting one or more hemodialysis conduits to the catheter.
[0063]
In certain embodiments, the mating member is one of a male luer coupling or a female luer coupling, and the connector includes the other of a male luer coupling or a female luer coupling. I have. This connector is attached to the fitting member by press-fitting the fitting member and the connector. In another embodiment, the connector includes a fastening member to maintain the connection between the mating member and the connector. In certain embodiments, the proximal end of the catheter forms a first flange or a first thread, and the fastening member is used to maintain the connection between the mating member and the connector. , Forming a second flange or second thread configured to cooperate with the first flange or first thread.
[0064]
In various embodiments, the container includes a disk-shaped, straight bellows configuration, or a fan-shaped bellows configuration. Further, in various embodiments, the port is a one-way valve, a duckbill valve, a cock valve, a manual valve or an orifice. In certain embodiments, the diameter of the orifice is between about 0.25 and about 2 mm. In another embodiment, the diameter of the orifice is from about 0.75 to about 1 mm. In yet another embodiment, the diameter of the orifice is about 0.5 mm.
[0065]
In another aspect of the invention, there is provided an apparatus for injecting fluid into a catheter, wherein the catheter defines a lumen, a proximal end, and a distal end, wherein the proximal end is , A connector, and a fitting member configured to engage with the device. In one embodiment, the device comprises: (1) a collapsible container defining a cavity and a port; (2) a predetermined ratio to the volume of the catheter lumen contained within the cavity. A volume of liquid, and (3) a connector attached to the container around the port. The connector is configured to mate with a mating member to provide a sealed connection in which the cavity is in fluid communication with the lumen through the port. The port is structured to allow fluid to flow from the cavity to the lumen of the catheter at the proximal end when a positive pressure is applied to the liquid.
[0066]
In one embodiment, the ratio is from about 1: 2 to about 2: 1. In yet another embodiment, the ratio is from about 0.8: 1 to about 1: 0.8. In yet another embodiment, the liquid has a volume of about 1 to about 5 milliliters. In certain embodiments, the liquid is a catheter lock solution. In another embodiment, the liquid is saline. In yet another embodiment, the liquid is selected from the group consisting of a nutrient solution and a drug. In yet another embodiment, the cavity is essentially free of air. In certain embodiments, the catheter is a percutaneous intracorporeal catheter disposed distally within the patient and proximally disposed outside the patient. In another embodiment, the catheter is a hemodialysis catheter.
[0067]
In certain embodiments, the mating member is one of a male luer coupling or a female luer coupling, and the connector is the other of a male luer coupling or a female luer coupling. The connector is fixed to the fitting member by press-fitting the fitting member and the connector. In another embodiment, the connector includes a fastening member to maintain the connection between the mating member and the connector. In certain embodiments, the fastening member is configured to cooperate with a corresponding second flange or second thread of the catheter to maintain connectivity between the mating member and the connector. The first flange or the first thread is formed.
[0068]
In various embodiments, the container comprises a disc-shaped, straight bellows configuration or a fan-shaped bellows configuration. Further, in various embodiments, the port is a one-way valve, a duckbill valve, a cock valve, a manual valve or an orifice. In certain embodiments, the diameter of the orifice is from about 0.25 to about 2 mm. In another embodiment, the diameter of the orifice is from about 0.75 to about 1 mm. In yet another embodiment, the diameter of the orifice is about 0.5 mm.
[0069]
While the invention has been illustrated and described in detail in the drawings and foregoing description, these are merely illustrative and of non-limiting nature, and only show and describe preferred embodiments. It is to be understood that all changes and modifications which come within the spirit of the invention should be protected.
[Brief description of the drawings]
FIG. 1 is a schematic view of one embodiment of an apparatus for injecting a lock solution into a catheter according to the present invention, wherein the catheter is illustrated.
FIG. 2 is a schematic diagram of another alternative embodiment of the present invention.
FIG. 3 is a schematic view of another embodiment of the device according to the invention, wherein the container has a valve structure and the device is shown connected to a catheter.
FIG. 4 is a perspective view of another embodiment of the present invention, wherein the container has a straight bellows structure.
FIG. 5 is a perspective view of another embodiment of the present invention, wherein the container has a fan-shaped bellows structure and the device is shown in an extended configuration. .
FIG. 6 is a perspective view of the embodiment of FIG. 5, with the device shown in a partially collapsed configuration.
FIG. 7 is a side view of another embodiment of the present invention, wherein the container has a disc-shaped structure.
FIG. 8 is an end view of the embodiment of FIG. 7;
FIG. 9 is a schematic view of another alternative embodiment of the present invention, also illustrating a catheter.

Claims (46)

A method for injecting a fluid into a catheter,
Providing a catheter defining a lumen, a proximal end and a distal end, and including a mating member configured to engage the proximal end with the connector;
A collapsible container forming a cavity and a port;
A liquid contained in the container, the volume of the liquid in a predetermined ratio to the volume of the lumen of the catheter,
A connector attached to the container around the port, the connector engaging the mating member to provide a sealed connection in which the cavity is in fluid communication with the lumen through the port;
Providing an apparatus comprising:
Securing the device to the catheter by mating the connector with the mating member;
Applying a positive pressure to the liquid such that the liquid exits the cavity through the port and enters the lumen of the catheter at a proximal end;
A method that includes The method of claim 1, wherein
The method wherein the ratio is from about 1: 2 to about 2: 1. The method of claim 1, wherein
The method, wherein the volume of the liquid is about 1 to about 5 milliliters. The method of claim 1, wherein
The method wherein the cavity is essentially free of air. The method of claim 1, wherein
The method wherein the catheter is a percutaneous intracorporeal catheter, wherein the distal end is disposed within the patient and the proximal end is disposed outside the patient. The method of claim 1, wherein
The method, wherein the liquid is a catheter lock solution. The method according to claim 6, wherein
The method wherein the ratio is from about 0.8: 1 to about 1: 0.8. The method according to claim 6, wherein
The method wherein the catheter is a hemodialysis catheter. 9. The method according to claim 8, wherein
Leaving the device secured to the catheter until a hemodialysis procedure is indicated;
Applying a negative pressure to the cavity such that a predetermined amount of fluid exits the lumen of the catheter at the proximal end and enters the cavity through a port;
Removing the device from the catheter;
Connecting one or more hemodialysis conduits to the catheter for a dialysis procedure. The method of claim 1, wherein
The method wherein the liquid is a saline rinse. The method according to claim 10, wherein
The method further comprising, prior to said anchoring, introducing a fluid selected from the group consisting of a dose of a drug and a dose of a nutrient into the catheter. The method of claim 1, wherein
The fitting member is one of a male luer coupling and a female luer coupling, and the connector includes the other of a male luer coupling or a female luer coupling; The method, wherein securing comprises press fitting the mating member and the connector. The method according to claim 12, wherein
The method, wherein the connector includes a fastening member for maintaining connectivity between the mating member and the connector. 14. The method according to claim 13, wherein
The proximal end of the catheter forms a first flange or a first thread, and the fastening member is configured to maintain the connection between the fitting member and the connector. A method forming a second flange or a second thread configured to cooperate with the flange or the first thread. The method of claim 1, wherein
The method wherein the container comprises a disc shape. The method of claim 1, wherein
The method, wherein the container comprises a straight bellows structure. The method of claim 1, wherein
The method wherein the container comprises a fan-shaped bellows structure. The method of claim 1, wherein
The method, wherein the port is a one-way valve. The method of claim 1, wherein
The method wherein the port is a duckbill valve. The method of claim 1, wherein
The method wherein the port is a cock valve. The method of claim 1, wherein
The method wherein the port is a manual valve. The method of claim 1, wherein
The method wherein the port is an orifice. 23. The method according to claim 22, wherein
The method, wherein the diameter of the orifice is from about 0.25 to about 2 mm. 23. The method according to claim 22, wherein
The method, wherein the diameter of the orifice is about 0.75 to about 1 mm. 23. The method according to claim 22, wherein
The method, wherein the diameter of the orifice is about 0.5 mm. An apparatus for injecting liquid into a catheter defining a lumen, a proximal end, and a distal end, the catheter including a mating member configured to engage the connector at the proximal end,
A collapsible container forming a cavity and a port;
A volume having a predetermined ratio to the lumen of the catheter, the liquid contained in the cavity,
A connector attached to the connector around the port, the connector configured to mate with the mating member to provide a sealed connection in which the cavity is in fluid communication with the lumen through the port. And
The apparatus wherein the port is configured to permit fluid flow from the cavity at the proximal end into the lumen of the catheter when a positive pressure is applied to the liquid. The device according to claim 26,
The device wherein the ratio is from about 1: 2 to about 2: 1. The device according to claim 26,
The device, wherein the volume of the liquid is about 1 to about 5 milliliters. The device according to claim 26,
The device, wherein the cavity is essentially free of air. The device according to claim 26,
The device wherein the liquid is a catheter lock solution. 31. The device according to claim 30, wherein
The device wherein the ratio is from about 0.8: 1 to about 1: 0.8. The device according to claim 26,
The device, wherein the liquid is a flushing saline solution. The device according to claim 26,
The device wherein the connector comprises a male luer coupling or a female luer coupling configured to sealingly engage a corresponding mating member of the catheter. An apparatus according to claim 33,
The apparatus wherein the connector includes a fastening member for maintaining a connection between the mating member and the connector. The apparatus according to claim 34, wherein
A first flange configured to cooperate with a corresponding second flange or a second thread of a catheter to maintain the coupling between the mating member and the connector; Or the device forming the first thread. The device according to claim 26,
The device wherein the container has a disk shape. The device according to claim 26,
The device wherein the container has a straight bellows structure. The device according to claim 26,
The device wherein the container has a fan-shaped bellows structure. The device according to claim 26,
The device, wherein the port is a one-way valve. The device according to claim 26,
The device wherein the port is a duckbill valve. The device according to claim 26,
The device wherein the port is a cock valve. The device according to claim 26,
The device, wherein the port is a manual valve. The device according to claim 26,
The device wherein the port is an orifice. An apparatus according to claim 43,
The device, wherein the diameter of the orifice is about 0.25 to about 2 mm. An apparatus according to claim 43,
The device, wherein the orifice has a diameter of about 0.75 to about 1 mm. An apparatus according to claim 43,
The device, wherein the diameter of the orifice is about 0.5 mm.

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