巴西专利BR112014012689B1 CATHETER ASSEMBLY

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专利摘要:
assembly and method of using a catheter and method of administering an antimicrobial composition this application describes examples of antimicrobial compositions that can be used alone or in combination with catheters and catheter insertion sites. in another aspect, the application describes catheters that may employ one or more protective devices, such as cleaning plugs, protective plugs, or both.
公开号:BR112014012689B1
申请号:R112014012689-5
申请日:2012-11-28
公开日:2022-01-04
发明作者:Patrick O. Tennican
申请人:Hyprotek, Inc.；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDER
[0001] This application claims priority over Provisional Patent Application No. US 61/564,206, filed on November 28, 2011, entitled “Medical Devices and Techniques for Antiseptic, Immunomodulatory and Antineoplastic Therapies” - “Medical Devices and Techniques for Antiseptic, Immunomodulatory and Antineoplastic Therapies”, which is hereby incorporated by reference in its entirety. FUNDAMENTALS
[0002] Infections are still a real problem in the medical industry today. Infections are often caused by contamination of intravascular (IV) pathways (eg, intravenous, intraarterial, etc.), contamination of an injection site or blood draw site (eg, from a vein, artery, or capillary vessel), urinary catheters, wounds, incision sites and numerous other sources of infection in medical care units. For example, in the United States alone, central venous catheters cause an estimated 80,000 cases of catheter-related bloodstream infections per year, resulting in up to 28,000 deaths among patients in intensive care units. O'Grady NP, Alexander M, Dellinger EP et al., Guidelines for the prevention of intravascular catheter-related infections. MMWR Recomm Rep 2002; 51:1-29. These figures do not include infections caused by contamination of injection sites, blood draw sites, catheters or any of the numerous sources of contamination in healthcare facilities. Infections are an even bigger problem in developing nations, where syringes, IV lines and other equipment are routinely used and reused by a multitude of different patients. BRIEF SUMMARY OF THE INVENTION
[0003] This application describes approaches to reducing and/or preventing infections. In one aspect, the application describes examples of antimicrobial compositions that can be used alone or in combination with catheters and catheter insertion sites. In another aspect, the application describes catheters that may employ one or more protective devices, such as cleaning plugs, protective plugs, or both. This summary is not intended to identify the essential characteristics of the claimed object, nor should it be used to limit the scope of the claims.
[0004] A first embodiment of the invention involves the assembly of a catheter comprising a housing containing a catheter and at least one cleaning device. The cleaning device can be a cleaning plug, a protective plug, or both. In addition, the catheter may have at least one hole.
[0005] Another embodiment involves a method for obtaining a urine sample comprising providing a catheter assembly, such catheter assembly comprising a housing containing a catheter and at least one cleaning plug, wherein the catheter has at least at least one hole; opening the housing for removing the cleaning plug; catheter placement at a urological catheter insertion site; cleaning said orifice with an orifice cleaning device; and obtaining a urine sample through the orifice. The catheter and at least one protective plug are individually sealed in separate compartments of the housing.
[0006] Yet another embodiment involves a method for administering an antibacterial compound to a urological site, comprising providing a catheter assembly, the catheter assembly comprising a housing containing a catheter and at least one cleaning plug, wherein the catheter has at least one hole; opening the housing for removing the cleaning plug; installing the catheter into a urological catheter insertion site, said catheter having at least one orifice; cleaning said orifice with an orifice cleaning device; and administering an antimicrobial composition through the orifice. The catheter and at least one cleaning plug are individually sealed in separate compartments of the housing. BRIEF DESCRIPTION OF THE FIGURES
[0007] FIG. 1 shows an assembly of a catheter;
[0008] FIGs. 2A and 2B show details of an example cleaning device; and
[0009] FIG. 3A-3C show details of several examples of cleaning devices. DETAILED DESCRIPTION
[0010] FIG. 1 illustrates an example catheter device and assembly that may, although need not necessarily, be used in connection with the antimicrobial compositions described herein. When used with the antimicrobial compositions described herein, in any case, the catheter device may provide disinfecting and/or therapeutic effects.
[0011] As shown in FIG. 1, a housing 100 including one or more spot cleaning devices 102 coupled to a catheter 104. The housing 100 may comprise a transparent, flexible, polymeric housing, allowing the user to view and inspect the contents of the housing prior to use. Cleaning devices 102 and catheter 104 may be individually sealed in separate compartments of housing 100, or may be sealed together in a common compartment of housing 100. Cleaning devices 102 may be used to clean a catheter insertion site prior to insertion of catheter 104. In one embodiment, the cleaning device may be a piece of material, such as a piece of tissue, a cotton swab, or a sponge. In one embodiment, the cleaning devices 102 may be cleaning plugs, protective plugs, or both, as described in more detail below.
[0012] The catheter 104 may comprise a urinary catheter or any type of catheter. In the event that catheter 104 is a urinary catheter, the catheter may be either a Foley-type, extended-use catheter, or a single-use, straight, straight catheter. In either case, the catheter 104 would include an antimicrobial gel lubricant 106 applied to and/or contained in a housing tip area compartment 100. The housing 100 may include a restrictor 108 (e.g., a portion of the housing fused near a exterior of the catheter midway along the length of the catheter) to prevent covering the entire exterior of the catheter 104 by the gel lubricant. One or more cleaning devices 102, being arranged in one or more compartments in front of the catheter tip 104, serve as a reminder to the user to clean and disinfect the catheter insertion site prior to catheter insertion. Once the site is clean, the catheter 104 can be inserted by pulling back the housing 100 to expose the tip side of the catheter and holding the catheter through the housing 100. In this way, the user does not even need to touch the catheter 104 during insertion, providing a “No Touch Catheter” technique that further reduces the risk of contamination and infection.
[0013] Additionally, in some embodiments, the lumen of catheter 104 may be pre-filled with an antimicrobial composition such as those described herein.
[0014] Once the catheter 104 is in place, in some embodiments, the catheter may be used to obtain sterile, uncontaminated urine samples through a urological catheter orifice. In this case, orifice cleaning and protection devices can be used to clean and protect the catheter orifice. Catheter port plugs may use the same or different antimicrobial compositions from those used for cleaning the IV port and protective plugs.
[0015] FIGS. 2A, 2B, and 3A-3C illustrate details of several examples of orifice cleaning and protective plugs. Each of the plugs can be made from materials such as, but not limited to, polyethylene, polypropylene, and/or copolymer materials. Buffers may also comprise a UV protective material or agent to preserve the integrity of the hydrogen peroxide during storage, transport, etc. The tampons themselves may additionally or alternatively be kept in a wrapper containing UV-protective materials to inhibit the breakdown of hydrogen peroxide.
[0016] FIGS. 2A and 2B illustrate an example of an IV orifice protective plug 200 designed to be threaded into a threaded orifice, such as a female Luer® connector, in order to provide a physical barrier against recontamination. As demonstrated by FIG. 2A, protective cap 200 is hermetically sealed by protective cap 202. Protective cap 202 may be removably fused or bonded to protective cap 200 through sonic welding, heat fusion, or other bonding techniques. Protective cover 202 may be made of the same material or a different material than that of protective cap 200. In order to facilitate sealing of protective cover 202 to protective cap 200, as shown in FIG. 2B, the protective cap includes an energy director 204 disposed on an upper surface of a rim 206 or flange around an opening of the protective cap 200. The energy director 204 comprises a rib or raised edge of material having a relatively small cross-section. to the rim 206 of the protective cap 200. The small cross-section of the energy director 204 allows the energy director to melt faster and fuse with the protective cap 202 with less energy than is required to melt the entire rim 206 of the protective cap 200. The power driver 204 also allows the fusing of the protective cap 202 to the protective cap 200 over a relatively thin region, thus making the protective cover 202 easier to remove from the protective cap 200 than if it were fused to the entire area of the rim 206 of the protective cap 200.
[0017] The rim 206 is designed as a “no-touch rim”, which extends radially from the perimeter of the central body of the protective cap 200, thus minimizing the likelihood that a wearer's fingers will come into contact with the surfaces. inside the protective cap during use. In the illustrated embodiment, the energy director 204 is radially disposed towards the outside of an opening of the protective cap, but towards the inside of an outer edge of the rim 206. This ensures that the portion of the rim 206 inside the energy director. energy 204 remains sterile prior to use. Touchless rim 206 increases the likelihood that the portion of rim 206 within energy director 204 will remain sterile during use. In other embodiments, the energy director may be disposed anywhere on the rim 206 (eg, centrally, as shown, on an interior perimeter of the rim near the opening, or on an exterior perimeter of the rim).
[0018] As demonstrated in FIG. 2B, the protective cap 200 also includes an applicator material 208 (shown in exploded perspective in this illustration for clarity). In the illustrated example, the applicator material comprises a cylindrical foam material having an open cell region 210 around the circumference of the sides of the cylinder and a closed cell region 212 at one or both axial ends of the cylinder. The open cell region 210 allows the applicator material 208 to absorb and load an antimicrobial composition such as those described above. The closed cell region 212 functions at least partially as a cover and seal of an end of an IV orifice to prevent leakage from the orifice and to prevent substantial amounts of the antimicrobial composition from entering the IV orifice. Both the open cell 210 and closed cell 212 regions can have a certain amount of roughness in texture to scrub the IV hole.
[0019] Also, while the applicator material 208 is illustrated as being a generally cylindrical piece, in other embodiments the applicator material can assume other shapes and/or sizes. Furthermore, the applicator material 208 may include different surface treatments (eg, grooving, cutting, etc.), surface finishes (eg, macro, micro, or nanostructures, etc.) and/or contours (eg, rounded, fluted, protrusions, fingers etc.).
[0020] FIGs. 3A-3C illustrate several variations of the 300A, 300B, and 300C IV Protective Plugs, respectively (collectively referred to as the 300 Protective Plugs), for use with Varied Outer Diameter (OD) orifice IV connectors, such as male Luer® connectors. Protective Plugs 300 of these embodiments are slim fit plugs that are designed to fit easily and closely into IV orifice connectors of various ODs, as not all orifice connectors have a standardized OD.
[0021] FIG. 3A illustrates a staggered inner surface protective plug 300A, including a first inner surface 302 and a second inner surface 304, the second inner surface 304 having a smaller average diameter than the first inner surface. The first and second interior surfaces 302 and 304 may have diameters chosen to match common market hole ODs, market maximum and minimum hole ODs, or be based on other criteria. Furthermore, both the first and second inner surfaces 302 and 304 may be conical (having an exit angle θ), so that the diameter of the first and second inner surfaces is the largest near an opening of the protective plug 300A and decreases closest to the lower closed end of the protective cap. An exit angle of the first inner surface 302 can be the same, greater or less than the exit angle of the second inner surface 304. When the protective plug 300A is placed in an IV hole, the protective plug 300A will fit over the hole. IV until an OD of the IV port contacts and seals against the inner surface of the protective plug 300A at the first inner diameter 302 (in the case of an IV port with a relatively large OD), or at the second inner diameter 304 (in the case of an IV port with a relatively large OD). of an IV orifice with a relatively small OD).
[0022] FIGS. 3B and 3C illustrate alternative embodiments of snap-on protective caps 300B and 300C, respectively, which have smooth, continuous internal structures. Instead of being staggered, as in the embodiment of FIG. 3A, the 300B and 300C protective caps have smooth, continuous internal surfaces. Like the interior surfaces of the staggered plug 300, the interior surfaces of the 300B and 300C plugs are tapered to accommodate IV holes of varying ODs. However, in order to accommodate IR holes having a wide spectrum of ODs, the exit angle θ of the protective plugs needs to be larger (eg a more pronounced cone), as in the case of the 300C protective plug.
[0023] Additional details of examples of orifice cleaning and protection devices can be found in Patent Application No. 11/745,843, filed May 8, 2007, to Tennican, which is incorporated herein by reference.
[0024] Additionally or alternatively, a rinse syringe can be used to introduce a rinse solution to flush the catheter lumen, bladder, urethra, renal pelvis or other parts of the urinary tract. The rinsing solutions used may vary depending on where they need to be applied, eg. catheter lumen, bladder, renal pelvis. In some examples, liquid antimicrobial compositions such as those described herein may be used as a rinse.
[0025] According to one embodiment, the catheter assembly includes an antimicrobial composition. Exemplary antimicrobial compositions that can be used in connection with the approaches described herein may include those described, for example, in US Patent Application No. 12/874,188, filed September 2010, to Tennican et al., which is incorporated herein. by reference. In that case, the antimicrobial compositions may include water (H2O), a potent and non-toxic chelating agent such as ethylenediaminetetraacetic acid (EDTA) (e.g. disodium EDTA, calcium disodium EDTA, magnesium EDTA, gallium EDTA) or sodium citrate (or acids, salts, derivatives or other forms of EDTA or sodium citrate), a short-chain monohydric alcohol (e.g. ethanol with a molecular formula C2H5OH and an empirical formula C2H6OH) and a potent molecule oxidizing agent small, such as hydrogen peroxide (H2O2). In a specific example, the compounds may consist essentially of water, EDTA, ethanol and hydrogen peroxide. However, in other examples, other antimicrobial compositions may be used in combination with the devices described in this application.
[0026] Antimicrobial compositions can be in liquid or gel form, and can be combined with one or more carriers or diluents, depending on the needs of a specific application. For example, in applications where the antimicrobial composition is used as a hand sanitizer, the antimicrobial composition may be in a gel. As another example, if the antimicrobial composition is used as a cleaning agent, a rinse or an irritant, the antimicrobial composition may be in a liquid form. In that case, the concentration of the various constituents may depend, for example, on a desired level of disinfection, whether the composition is being applied directly to living tissue or to a medical device, and/or in order to avoid irritation of the tissue on which the compound will be applied directly or indirectly (eg via a medical device to which the compound is or has been applied). In yet another example, the antimicrobial compositions can include or be combined with a lubricant (eg glycerin), surfactant or emulsifier (eg glycerol monolaurate (GML)) or the like and be applied to a catheter, tracheal tube, lens , to an instrument or other device to be inserted into a patient's body.
[0027] In other embodiments, for the therapeutic treatment of localized infections and/or malignant and pre-malignant lesions in the urethra, bladder, ureter or renal pelvis, antimicrobial compositions such as those described herein may be administered via a catheter or direct observations using a cystoscope or ureteroscope or a nephrostomy lens.
[0028] In still other embodiments, antimicrobial compositions such as those described herein can be used as an irrigant for rinsing a catheter to prevent biofilm formation and/or break up stone formation.
[0029] Although the application describes modalities possessing specific structural characteristics and/or methodological acts, it should be understood that the claims are not necessarily limited to the specific characteristics described. The specific features and acts are, rather, merely illustrative of some modalities that fall within the scope of the application's claims.

权利要求:
Claims (8)
[0001]
1. Assembly of a catheter comprising a housing (100) containing a catheter (104) and a plurality of cleaning devices (102), wherein at least one of the cleaning devices (102) is a cleaning plug, a plug shield (200) or both, wherein said catheter (104) has at least one orifice, wherein said catheter (104) and each of the plurality of cleaning devices (102) are individually sealed in separate housing compartments ( 100), CHARACTERIZED in that each of the plurality of cleaning devices (102) is individually disposed in a compartment ahead of a catheter tip (104).
[0002]
2. Assembly of a catheter, according to claim 1, CHARACTERIZED by the fact that the housing (100) is transparent.
[0003]
3. Assembly of a catheter, according to claim 1 or 2, CHARACTERIZED by the fact that the catheter (104) is a urinary catheter.
[0004]
4. Assembly of a catheter, according to any one of claims 1 to 3, CHARACTERIZED in that the housing (100) further includes an antimicrobial gel lubricant applied and/or contained in an area of the catheter tip (104) .
[0005]
Assembly of a catheter, according to claim 4, CHARACTERIZED in that a portion of the housing (100) is fused close to an exterior of the catheter (104) midway along the length of the catheter (104), in order to prevent migration of the antimicrobial gel lubricant (106) away from the tip area and masking of another area of the catheter (104).
[0006]
6. Assembly of a catheter, according to any one of claims 1 to 5, CHARACTERIZED in that at least a portion of an interior of the catheter (104) contains an antimicrobial composition.
[0007]
Assembly of a catheter, according to any one of claims 1 to 6, CHARACTERIZED in that it further comprises an applicator material (208) contained within the at least one cleaning device (102).
[0008]
8. Assembly of a catheter, according to claim 7, CHARACTERIZED by the fact that the applicator material (208) includes an antimicrobial composition.

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-11-19| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-05-11| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

2021-06-01| B350| Update of information on the portal [chapter 15.35 patent gazette]|

2021-10-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2022-01-04| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/11/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201161564206P| true| 2011-11-28|2011-11-28|

US61/564,206|2011-11-28|

PCT/US2012/066880|WO2013082174A1|2011-11-28|2012-11-28|Catheter devices and techniques|

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