Device for disinfecting and cleaning catheter and method thereof

Abstract

A device (100) for disinfecting a catheter (302) and a method thereof are described. The device (100) includes a rod (102) and an expandable member (104) secured at a front portion of the rod (102). The expandable member (104) is wetted with a disinfectant. The sheath assembly (106) accommodates the rod (102) and the expandable member (104) and includes a front end (106-1) and a plurality of slots (108) located proximate the front end (106-1). The slot (108) allows the expandable member (104) to expand outward when the expandable member (104) is pushed toward the front end (106-1) by the operating lever (102). When the sheath assembly (106) is inserted into the catheter (302) and the expandable member (104) is brought outward by being pushed by the rod (102), the expandable member (104) is in contact with an inner surface of the catheter (302) to sterilize the catheter (302).

Description

Technical Field

[0001] The present invention relates generally to the field of catheters used in medical applications, and more particularly to a device for sterilizing and cleaning catheters. Background Art

[0002] It should not be considered that the subject matter discussed in the background section is prior art simply because the subject matter is mentioned in the background section. Likewise, it should not be considered that the problems associated with the subject matter mentioned in the background section have been previously recognized in the prior art. The subject matter in the background section merely represents different approaches, which themselves may also correspond to implementations of the claimed technology.

[0003] Catheters are thin, flexible tubes with varying levels of stiffness depending on their application. Catheters are inserted into body cavities, ducts, blood vessels, skin, or fatty tissue to treat disease or perform surgical procedures. By modifying the structure and materials of the catheter, catheters can be customized for cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic applications. Catheters allow drainage, administration of fluids or gases, or access to body cavities.

[0004] Central venous catheters (CVCs), peripherally inserted central catheters (PICCs), and peritoneal dialysis (PD) catheters are integral devices used extensively in medical practice, especially in critically ill patients, cancer patients, and patients receiving intravenous infusions. These catheters allow for rapid infusion of concentrated medications, fluids, or blood products that would otherwise be impossible to administer into a peripheral vein via a standard intravenous probe.

[0005] While these catheters (CVC, PICC, and PD catheters) provide essential vascular access, they also put patients at risk for serious infections, which can be life-threatening. Most catheter-related bloodstream infections (CRBIs) are associated with contamination and subsequent colonization of the lumen of the catheter during long-term use. For example, PD catheters are susceptible to developing biofilms, fibrin sheaths, bacterial accumulation, and scarring at the inner diameter due to the continued presence of fluid. Catheters subject to such factors can lead to thrombosis and peritonitis in patients. Generally speaking, catheters become contaminated when microorganisms attach to their outer surfaces through contact with the patient's or operator's skin, tracheostomy secretions, wounds, etc. Contaminated catheters can lead to central line-associated bloodstream infections (CLABSIs), which are serious infections that occur when pathogens (usually bacteria or viruses) enter the patient's bloodstream through a contaminated catheter. This infection also requires the unplanned removal of the contaminated catheter.

[0006] In the past, attempts have been made to sterilize catheters using strict infection control measures. Some of these strict infection control measures include using fluids to sterilize the catheter after each use. A typical example is the Citra-lock TM , which is a solution pre-filled into the catheter after each surgery as an antibacterial, anticoagulant and anti-biofilm fluid. However, such technology is not effective in sterilizing and disinfecting harmful microorganisms that colonize the catheter and biofilms that are deposited in the catheter.

[0007] Currently available catheters are primarily designed to ensure a tight connection to intravenous tubing, but are not specifically designed to prevent contamination, for example, to prevent microbial colonization of the intraluminal catheter.

[0008] Therefore, there is a need for techniques and devices that are effective in removing microbial contamination from catheters. The present invention satisfies this need and is also expected to provide related advantages.

[0009] Purpose of the Invention

[0010] An object of the present invention is to provide a device and method for sterilizing and cleaning a catheter.

[0011] Another object of the present invention is to provide a device and method for preventing bloodstream infection in patients.

[0012] Another object of the present invention is to provide a device and method for sterilizing the inner surface of a catheter and removing microbial contamination.

[0013] Still another object of the present invention is to provide a device and method for preventing the formation of a fibrin sheath in a catheter. Summary of the invention

[0014] One aspect of the present invention relates to a device for disinfecting and cleaning the inner surface of a catheter to remove microbial contamination and prevent the formation of a fibrin sheath in the catheter. The device includes a rod and an expandable member fixed at the front of the rod, and the expandable member is moistened with a disinfectant. The device also includes a sheath assembly that accommodates the rod and the expandable member. The sheath assembly includes a closed front end and a plurality of grooves near the front end.

[0015] When the expandable member is pushed toward the front end by the rod, the plurality of grooves allow the expandable member to expand outward, and when the expandable member is pushed away from the front end by the rod, the plurality of grooves allow the expandable member to move inward. When the sheath assembly is inserted into the catheter and the expandable member is brought outward by being pushed by the rod, the expandable member moistened with the disinfectant contacts the inner surface of the catheter, thereby sterilizing the catheter.

[0016] In one aspect, the expandable member is selected from the group consisting of sponge, foam, and cotton.

[0017] In one aspect, the front end is a sheath cover that is removably secured to the body of the sheath assembly.

[0018] In one aspect, the rod is rotated while being pushed toward the leading end to allow the expandable member to expand outwardly through the plurality of slots, thereby thoroughly cleaning the inner surface of the catheter by removing any biofilm and killing harmful microorganisms.

[0019] In one aspect, the front end is coated with an anticoagulant.

[0020] Another aspect of the present invention relates to a method for sterilizing the inner surface of a catheter. The method includes inserting a device for sterilizing a catheter into the catheter, pushing an expandable member toward a front end by an operating rod to allow the expandable member to expand outwardly through a plurality of grooves when the expandable member reaches the front end, and pulling the device out of the catheter when the expandable member is in an outwardly expanded form, thereby sterilizing the catheter.

[0021] In one aspect, the method includes rotating the device while pulling the device out of the catheter. Inserting the device into the catheter includes inserting the sheath assembly into either the arterial line or the venous line of the catheter. The method also includes flushing the arterial line and the venous line of the catheter with saline solution before inserting the device into the catheter, and removing residual saline solution from the arterial line and the venous line after pulling the device out of the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The accompanying drawings constitute a part of the specification and are used to provide a further understanding of the present invention. The accompanying drawings illustrate exemplary embodiments of the present disclosure and together with the description serve to explain the principle of the present disclosure.

[0023] Figure 1A and Figure 1B Cross-sectional side views of an apparatus for sterilizing a catheter according to an embodiment of the present invention are shown in an inactive state and an active state, respectively.

[0024] Figure 2A and Figure 2B A perspective side view of a device for sterilizing a catheter according to an embodiment of the present invention is shown in an inactive state and an active state, respectively.

[0025] Figure 3A and Figure 3B Side views showing a device for sterilizing a catheter according to an embodiment of the present invention inserted into an arterial line and a venous line of a catheter, respectively.

[0026] Figure 4 A perspective side view showing a device for sterilizing a catheter fully inserted into the arterial line of a catheter in accordance with an embodiment of the present invention.

[0027] Figure 5 A device for sterilizing a catheter according to an embodiment of the present invention is shown in a sterile package.

[0028] Figure 6 A flow chart of a method for sterilizing an inner surface of a catheter according to an embodiment of the present invention is shown. DETAILED DESCRIPTION

[0029] The detailed description set forth below in conjunction with the accompanying drawings is intended to illustrate various embodiments of the present invention, but is not intended to represent the only embodiment in which the present invention can be practiced. Each embodiment described in this disclosure is only an example or illustration of the present invention, and should not be interpreted as being preferred or advantageous over other embodiments. The detailed description includes specific details in order to provide a thorough understanding of the present invention. However, it will be appreciated by those skilled in the art that the present invention can be practiced without these specific details.

[0030] As used in the description herein, unless the context clearly dictates otherwise, the meanings of “a”, “an” and “the” include plural references. In addition, as used in the description herein, unless the context clearly dictates otherwise, the meaning of “in” includes “in” and “on”.

[0031] The present invention relates to a device and a method for disinfecting and cleaning the inner surface of a catheter to remove microbial contamination and prevent the formation of a fibrin sheath in the catheter. Figure 1A and Figure 1B A cross-sectional side view of a device 100 for sterilizing a catheter is shown. Figure 2A and Figure 2B Perspective side views of the device 100 in an inactive state and an active state are shown, respectively. The device 100 includes a rod 102 and an expandable member 104 fixed at the front end 102-1 of the rod 102. The expandable member 104 is moistened with a disinfectant (e.g., a povidone-iodine solution, a saline solution, and citric acid). In some implementations, citric acid at a concentration of 0.5-1% can be used as a disinfectant. The expandable member 104 can be selected from a polyurethane flexible foam, which has excellent absorption properties when soaked with a disinfectant. Another criterion for selecting the expandable member 104 can be the flexibility / elasticity of the expandable member 104. The expandable member 104 is selected from a group consisting of sponges, foams, cotton, silicone rubber, polyurethane, or a plastic mesh.

[0032] The device 100 also includes a sheath assembly 106 that accommodates the rod 102 and the expandable member 104. The sheath assembly 106 includes a closed front end 106-1 and a plurality of slots 108 located near the front end 106-1. The front end 106-1 is a sheath cover that is removably fixed to the body of the sheath assembly 106. The front end 106-1 is coated with a suitable anti-thrombotic and antibacterial coating to prevent thrombosis and catheter-related infections. Heparin, silver, chlorhexidine, rifampicin or minocycline can be used to prepare the anti-thrombotic and antibacterial coating. In one implementation, the front end 106-1 can be coated with an anticoagulant, such as heparin.

[0033] The plurality of slots 108 allow the expandable member 104 to expand outwardly when the expandable member 104 is pushed toward the front end 106-1 by the operating rod 102. In addition, after the sterilization operation is completed, the expandable member 104 can be pulled away from the front end 106-1 and brought inwardly to a compressed state for safe handling by the operating rod 102.

[0034] In such Figure 2A In the inactive state shown, the expandable member 104 is in a non-expanded / compressed position, i.e., the expandable member 104 has not expanded out of the slot 108 of the sheath assembly 106. Figure 2B When the rod 102 is moved (as shown by the arrow in the middle), the expandable member 104 moistened with the disinfectant expands in the active state by coming out of the groove 108 of the sheath assembly 106 and contacts the inner surface of the catheter. The device 100 can then be pulled away from the front end 106-1 of the sheath assembly 106 so that the inner surface of the catheter can be disinfected and cleaned. In addition, when the expandable member 104 is in the active state, the expandable member 104 can be rotated clockwise and / or counterclockwise to thoroughly clean the inner surface of the catheter and remove any biofilm. This cleaning method will prevent the formation of a fibrin sheath in the catheter. The rod 102 can be detachably arranged so that the rod 102 is pushed into the sheath assembly 106 only during the procedure for disinfecting the catheter.

[0035] like Figure 3A and Figure 3B As shown, the device 100 can be fully inserted into the arterial line 302-1 or the venous line 302-2 of the catheter 302 (e.g., a high-flow dolphin catheter) to disinfect and clean the arterial line 302-1 or the venous line 302-2. The rod 102 can be pushed toward the front end 106-1 to expand the expandable member 104 moistened with the disinfectant outward and contact the inner surface of the arterial line 302-1. Then, the device 100 can be pulled away from the front end 106-1 to enable the inner surface of the catheter 302 to be disinfected and cleaned.

[0036] While expandable member 104 is in an active state, expandable member 104 may be rotated to thoroughly clean and sterilize the inner surface of arterial line 302-1 and prevent the formation of a fibrin sheath within arterial line 302-1. Figure 3B As shown, the sheath assembly 106 can be inserted into the intravenous line 302-2 of the catheter 302, thereby sterilizing and cleaning the intravenous line 302-2 in a similar manner. While the device 100 is pulled away from the front end 106-1, the device 100 can be rotated to thoroughly clean the inner surface of the catheter 302. This will remove any biofilm and prevent the formation of a fibrin sheath inside the catheter 302.

[0037] Figure 4 A perspective side view of the device 100 is shown fully inserted into the arterial line 302-1 of the catheter 302. The length of the sheath assembly 106 of the device 100 may be greater than the catheter 302 into which the device 100 may be inserted. The sheath assembly 106 containing the shaft 102 and the expandable member 104 may be inserted into either the arterial line 302-1 or the venous line 302-2 of the catheter 302 such that the leading end 106-1 of the sheath assembly 106 is proximate to the tip of the catheter 302 to allow the entire length of the catheter 302 to be sterilized and cleaned.

[0038] When the sheath assembly 106 containing the rod 102 and the expandable member 104 is inserted into the catheter 302, the rear portion of the rod 102 can extend beyond the rear portion of the sheath assembly 106 to allow the user to move the rod 102 toward the front end 106-1 of the sheath assembly 106 and gradually pull the device 100 out of the catheter 302 to complete the sterilization procedure. It must be noted that the expandable member 104 cannot be pulled back into the sheath assembly 106 during the sterilization procedure. Return to reference Figure 1A , the front inner surface 110 (adjacent the groove 108) of the sheath assembly 106 can act as a barrier to movement of the expansion member 104 within the sheath assembly 106, which may be caused by accidentally pulling back the expandable member 104 during the sterilization procedure.

[0039] Once the sterilization procedure is complete, the expandable member 104 that is contaminated with biofilm or microorganisms can be forcibly pulled back into the sheath assembly 106 via the groove 108. Pulling the expandable member 104 into the sheath assembly 106 will prevent the expandable member 104 from contacting objects or surfaces outside the catheter 302, thereby preventing the spread of contamination. Bringing the expandable member 104 back into the sheath assembly 106 after the sterilization procedure will help to safely dispose of the device 100, because in some implementations, the device 100 can be developed for single use. In addition, the device 100 can be packaged in a sterile package 502 before being discarded, such as Figure 5As shown. Aseptic packaging 502 can be made of plastic, glass or any other suitable material. Once closed, aseptic packaging 502 can be air-locked and does not allow contaminants to leak out.

[0040] Figure 6 A flow chart of a method for sterilizing a catheter according to an embodiment of the present invention is shown. The method includes: at step 602, inserting a device 100 for sterilizing a catheter 302 into the catheter 302. The device includes a rod 102, an expandable member 104 fixed at the front end 102-1 of the rod 102, and a sheath assembly 106 that accommodates the rod 102 and the expandable member 104. The expandable member 104 is moistened with a disinfectant. When the device 100 is inserted into the catheter 302, the sheath assembly 106 can be inserted into either the arterial line 302-1 or the venous line 302-2 of the catheter 302 (e.g., a dolphin catheter).

[0041] As a precaution, prior to inserting the sheath assembly 106 into the catheter 302 , the catheter 302 may be flushed with saline solution to prevent residual blood that may be present in the catheter 302 from coming into contact with the device 100 .

[0042] The method further includes: at step 604, pushing the expandable member 104 toward the front end 106-1 of the sheath assembly 106 by operating the rod 102 to allow the expandable member 104 to expand outward. A plurality of grooves 108 are located near the front end 106-1 of the sheath assembly 106, which allows the expandable member 104 to expand outward via the grooves 108 when the expandable member 104 is pushed toward the front end 106-1 by the rod 102 and reaches the front end 106-1.

[0043] The method includes: at step 606, when the expandable member 104 is in an active state, that is, in an outwardly expanded form, pulling the device 100 out of the catheter 302. When the expandable member 104 is in an active state, the device 100 is pulled away from the front end 106-1 of the sheath assembly 106 to enable disinfection and cleaning of the inner surface of the catheter 302, so that the inner surface of the catheter 302 is thoroughly disinfected and cleaned, and any residual biofilm present in the catheter 302 is removed. In addition, while the device 100 is pulled away from the front end 106-1, the device 100 can be rotated clockwise or counterclockwise to thoroughly clean the inner surface of the catheter 302 and prevent the formation of a fibrin sheath in the catheter 302.

[0044] After the device 100 is pulled out of the catheter 302, any remaining saline solution can be removed from the catheter 302 to remove any remaining traces of biofilm. Thereafter, the inlet port of the catheter 302 can be closed using a new injection line cap.

[0045] Therefore, the present invention provides a device and method for disinfecting and cleaning a catheter. The device is capable of effectively disinfecting the inner surface of the catheter and removing microbial contamination of the catheter to prevent bloodstream infection in patients. The device and method described in the present invention also prevent the formation of fibrin sheaths and biofilm traces in the catheter. After cleaning and disinfecting the catheter, the device or one or more of its components can be replaced and / or discarded to ensure the safety of the disinfection procedure. The device prevents the use of heparin lock solutions that usually add more weight to the catheter and increase its pressure. The device is easy to use and low cost, while reducing the operating time for disinfecting the catheter.

[0046] In the above detailed description, reference is made to the accompanying drawings which form a part of the specification and which illustrate the best mode presently contemplated for carrying out the invention. However, this description should not be considered as any limitation on the scope of the present unit. Therefore, the structure contemplated in this description is susceptible of various modifications and variations, and moreover, all the details may be replaced by elements having technical equivalents.

Claims

1. A device (100) for sterilizing a catheter (302), comprising: Rod (102); an expandable member (104) fixed at the front portion of the rod (102), wherein the expandable member (104) is moistened with a disinfectant; and a sheath assembly (106) accommodating the rod (102) and the expandable member (104), wherein the sheath assembly (106) comprises: A closed front end (106-1); and a plurality of grooves (108) located near the front end (106-1), wherein when the expandable member (104) is pushed toward the front end (106-1) by the rod (102), the plurality of grooves (108) allow the expandable member (104) to expand outwardly, When the sheath assembly (106) is inserted into the catheter (302) and the expandable member (104) is brought outward by being pushed by the rod (102), the expandable member (104) moistened with the disinfectant comes into contact with the inner surface of the catheter (302), thereby disinfecting the catheter (302).

2. The device (100) according to claim 1, wherein: The expandable member (104) is selected from the group consisting of sponge, foam and cotton.

3. The device (100) according to claim 1, wherein: The front end (106-1) is a sheath cover that is detachably fixed to the sheath assembly (106).

4. The device (100) according to claim 1, wherein: The front end (106-1) is coated with an anticoagulant.

5. The device (100) according to claim 1, wherein: The sheath assembly (106) is inserted into any one of the arterial line (302-1) or the venous line (302-2) of the catheter (302) for sterilization.

6. A method for sterilizing a catheter (302), the method comprising: A device (100) for sterilizing the catheter (302) is inserted into the catheter (302), wherein the device (100) comprises: an expandable member (104) fixed at the front of the rod (102) and moistened with a disinfectant; and a sheath assembly (106) housing the rod (102) and the expandable member (104), wherein the sheath assembly (106) includes a closed front end (106-1) and a plurality of slots (108) located near the front end (106-1); pushing the expandable member (104) toward the front end (106-1) by operating the rod (102) to allow the expandable member (104) to expand outwardly through the plurality of grooves (108) when the expandable member (104) reaches the front end (106-1), wherein the expandable member (104) moistened with the disinfectant and in an outwardly expanded form contacts the inner surface of the catheter (302); and When the expandable member (104) is in the outwardly expanded form, the device (100) is withdrawn from the catheter (302), thereby sterilizing the catheter (302).

7. The method according to claim 6, comprising: The device (100) is rotated while being pulled out of the catheter (302).

8. The method (500) of claim 6, wherein: Inserting the device (100) into the catheter (302) includes inserting the sheath assembly (106) into either the arterial line (302-1) or the venous line (302-2) of the catheter (302).

9. The method (500) according to claim 8, comprising: Prior to inserting the device (100) into the catheter (302), flushing the arterial line (302-1) and the venous line (302-2) of the catheter (302) with saline solution; and After the device (100) is pulled out of the catheter (302), the residual saline solution is removed from the arterial line (302-1) and the venous line (302-2).

10. The method (500) of claim 6, wherein: After the sterilization procedure is completed, the expandable member (104) is pulled back into the sheath assembly (106) for safe disposal of the device (100).

Images