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WO2013049033A1 - Procédé et composition d'irrigation de cathéter de vessie - Google Patents

Procédé et composition d'irrigation de cathéter de vessie Download PDF

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Publication number
WO2013049033A1
WO2013049033A1 PCT/US2012/057065 US2012057065W WO2013049033A1 WO 2013049033 A1 WO2013049033 A1 WO 2013049033A1 US 2012057065 W US2012057065 W US 2012057065W WO 2013049033 A1 WO2013049033 A1 WO 2013049033A1
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Prior art keywords
composition
irrigation
irrigation composition
bladder
catheter
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PCT/US2012/057065
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English (en)
Inventor
Douglas D. Cary
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir

Definitions

  • the present invention relates to methods of pretreating, irrigating or flushing a catheter inserted into the bladder using an irrigation composition comprising a carrier, an anticoagulant and a viscosity-increasing agent.
  • the compositions useful in the present invention may also be hypertonic and exhibit a density and viscosity greater than the blood of the subject with the catheter.
  • Catheters represent an important and common procedure performed in daily medical practice. Catheters are flexible tubular surgical instruments that are inserted into a body cavity to withdraw or introduce fluids.
  • a type of catheter that is inserted into the bladder is a Foley catheter.
  • a Foley catheter consists of a tube which is inserted through the urethra of a subject to drain urine from the subject's bladder. The tube consists of two separate lumens: one lumen is open at both ends to allow urine to drain out into a collection bag; the other lumen has a valve at one end and a balloon at the other, which is inflated once inside the bladder to prevent the catheter from slipping out.
  • Foley catheters are routinely flushed with an irrigation solution to prevent clotted blood from clogging the catheter lumen or to flush blood from the bladder following a medical procedure such as surgery on the kidney, prostate, or bladder.
  • saline i.e., sodium chloride in solution
  • a significant disadvantage of saline is that it must be administered frequently, e.g., the catheter must be flushed every 4-8 hours to prevent blockage. This frequency of administration represents a considerable labor effort for healthcare providers.
  • flushing a bladder catheter using saline increases the risk of introducing bacteria to the bladder or urethra.
  • bladder catheters are often contribute to urinary tract infections when bacteria travel up the catheter to the bladder. Also, over time, bladder catheters can become coated with a biofilm or encrusted with solids which obstructs drainage and further contributes to causing urinary tract infections. Therefore, a further disadvantage of using saline to flush bladder catheters is that saline does not prevent bacterial infections or biofilm build-up because it does not possess antimicrobial properties.
  • the present invention is a method for pretreating and/or irrigating a bladder catheter, such as a Foley catheter, using an irrigation composition comprising a carrier, a viscosity increasing agent and an anticoagulant.
  • the methods of the present invention can also be employed to flush the bladder during bladder surgery.
  • the irrigation composition should be a hypertonic composition compared to a subject's blood plasma and should exhibit a density and viscosity greater than a subject's blood.
  • the irrigation composition comprises a carrier, such as water, in an amount of about 25% to about 70%, preferably about 40% to about 60%) and most preferably about 45% to about 55%, a viscosity-increasing agent, such as glycerol, in an amount of about 25% to about 70%>, preferably about 35% to about 60% and most preferably about 40% to about 55%, and an anticoagulant, in an amount of about 1% to about 25%o, preferably about 2% to about 8% and most preferably about 3% to about 6%, wherein the anticoagulant is not heparin and the composition is free of alcohols.
  • a carrier such as water
  • a viscosity-increasing agent such as glycerol
  • an anticoagulant in an amount of about 1% to about 25%o, preferably about 2% to about 8% and most preferably about 3% to about 6%, wherein the anticoagulant is not heparin and the composition is free of alcohols.
  • the method of irrigating a bladder catheter of the present invention comprises the steps of: inserting a bladder catheter into the urethra of a subject, preferably a mammal such as a dog, cat, horse, pig or cow and most preferably a human; inserting the irrigation composition of the present invention into the open-ended lumen of the bladder catheter; and withdrawing the irrigation composition back out through the bladder catheter. It is contemplated that an amount of the irrigation composition may remain in the subject's bladder due to its high viscosity.
  • the irrigation composition can be inserted into, and withdrawn from, the lumen of the bladder catheter by a syringe. It is preferred that a syringe prefilled with the irrigation composition is packaged with the bladder catheter.
  • the bladder catheter may be packaged immersed in the composition of the present invention or pre-soaked with the composition of the present invention. If the bladder catheter is not packaged in the irrigation composition, the bladder catheter may be pretreated prior to insertion into a patient by immersing the bladder catheter in the irrigation composition for at least 15 minutes, preferably at least 30 minutes, and most preferably at least one hour.
  • the prefilled syringe also contains an appropriate amount, i.e., a predetermined and premeasured amount of the irrigation composition.
  • a predetermined and premeasured amount of the irrigation composition For example, 60 ml if the subject is a human.
  • the irrigation composition may be provided in a standard glass or plastic container such as a bottle, vial or bag.
  • the container may contain single or multiple doses of the irrigation composition. Appropriately measured amounts of the composition may be removed from the container and inserted into the lumen of the bladder catheter.
  • Another embodiment of the present invention is a kit comprising a container comprising the irrigation composition and an instruction set describing the use of the irrigation composition.
  • the container may comprise about 1 ml to about 2,000 ml of the irrigation composition or other appropriate amount of the irrigation composition such as 10, 20, 25, 50, 100, 500 or 1,000 ml.
  • the kit may further comprise a bladder catheter and a syringe for filling and evacuating the bladder catheter with the irrigation composition once the bladder catheter has been inserted into the urethra of a subject.
  • the container comprising the irrigation composition and the syringe may be the same component and contain a premeasured amount of the composition for filling the lumen of the bladder catheter once inserted into the urethra of the subject.
  • the container or syringe is discarded. It should be appreciated that once the irrigation composition is inserted into the catheter and accordingly the patient's bladder, the irrigation composition will become diluted by the fluid present in the patient's bladder. The in situ dilution in the patient's bladder should not adversely affect, i.e., negate, the anticoagulant and/or antimicrobial properties of the irrigation composition.
  • Another embodiment of the present invention is a novel blood-compatible, anticoagulant citrate-glycerol solution suitable for use in bladder catheters.
  • embodiments of this aspect of the invention are aqueous solutions comprising about 1% to about 25%, preferably about 2% to about 8% and most preferably about 3% to about 6%, of a sodium citrate and about 25% to about 70%>, preferably about 35%> to about 60%> and most preferably about 40% to about 55% of glycerol.
  • a further embodiment of the present invention described herein is a blood-compatible, anticoagulant composition consisting essentially of water, about 2%> to about 6%>, preferably about 3% to about 5%, of a citrate and about 35% to about 60%, preferably about 40% to about 55%, of glycerol.
  • This embodiment is preferably free of heparin and alcoholic compounds, especially Ci to C 12 alcohols.
  • This embodiment may be prepared by dissolving the sodium citrate and citric acid in water and then adding glycerol.
  • This embodiment may be sterilized after preparation, and is compatible with a subject's blood and prevents coagulation (clotting) of the blood or blood products.
  • a still further embodiment of the present invention includes a method for manufacturing the irrigation compositions comprising the steps of combining the viscosity increasing agent with an aqueous mixture of the citrate.
  • the pH of the combination may be adjusted by the addition of pharmaceutically acceptable acids or bases until a range of about 5.8 to about 6.8, preferably about 6.0 to about 6.5, is obtained.
  • a preferred pH adjusting agent is citric acid.
  • the bladder catheter may further comprise a flow regulating device, such as a clamp, valve or plug, on the exterior portion of the bladder catheter which will prevent the irrigation composition from exiting the patient's bladder and bladder catheter.
  • a flow regulating device such as a clamp, valve or plug
  • An appropriate amount of the irrigation composition can be inserted into the patient's bladder and remain in the patient's bladder for an appropriate or predetermined amount of time.
  • the irrigation composition will prevent and/or hinder the blood entering the patient's bladder from coagulating and thereby clogging the lumen of the catheter.
  • the irrigation composition also prevents biofilm or encrustation of the catheter tip or lumen.
  • the flow regulating device is opened and the irrigation composition and accumulated urine is removed from the patient's bladder and bladder catheter.
  • the bladder catheter is irrigated with fresh irrigation composition, and depending upon the patient's needs, an appropriate amount of irrigation composition is inserted into the patient's bladder and the flow regulating device is closed and the process started again.
  • the present invention is a method of irrigating bladder catheters.
  • the method comprises the steps of:
  • mammal such as a dog, cat, horse, pig or cow, and most preferably a human;
  • the irrigation composition can be inserted into, and withdrawn from, the lumen of the bladder catheter by a syringe.
  • a syringe that is prefilled with an appropriate amount of the irrigation composition.
  • the prefilled syringe thereby allows the health care provider to quickly insert the bladder catheter into the subject and flush the bladder catheter with the required amount of the irrigation composition. For example, if the subject is a human, the prefilled syringe accompanying the catheter will contain 60 ml of the irrigation composition.
  • the bladder catheter can be packaged immersed in the composition of the present invention or pre-soaked with the composition of the present invention, thus allowing for the composition of the present invention to act as a lubricant to increase patient comfort when the bladder catheter is inserted and removed.
  • the irrigation composition may be provided in a standard glass or plastic container such as a bottle, vial or bag.
  • the container may contain one or more treatment amounts of the irrigation composition. Appropriately measured amounts of the composition may be removed from the container and inserted into the lumen of the bladder catheter.
  • the container may comprise about 1 ml to about 2,000 ml of the irrigation composition or other appropriate amounts of the irrigation composition such as 10, 20, 25, 50, 100, 500 or 1,000 ml.
  • the kit may further comprise a bladder catheter, such as a Foley catheter, and a syringe for filling the bladder catheter with the irrigation composition once the bladder catheter has been inserted into the urethra of a subject.
  • a bladder catheter such as a Foley catheter, for inserting into the urethra of a subject, preferably a human subject, which is optionally pre-soaked or immersed in the irrigation composition of the present invention
  • the irrigation composition aspect of the present invention comprises:
  • a carrier such as water
  • composition should be free of heparin and alcohols, especially Ci to C 12 alcohols.
  • the water that may be used for preparing the irrigation composition of the present invention can be any type of water, such as distilled water commonly used to prepare
  • compositions include, but are not limited to, water for injection, sterile water for inhalation, sterile water for injection, sterile water for irrigation, purified water and sterile purified water.
  • the viscosity-increasing agents useful in the irrigation composition of the present invention include, but are not limited to, glycerol, protein-based colloidal substances, dextrose, dextran and combinations of the forgoing.
  • the preferred viscosity-increasing agent is glycerol. If glycerol is employed as the viscosity-increasing agent, it is believed that the glycerol will impart antibacterial properties to the irrigation composition and thereby reduce the incidence of infections which often accompany the use of bladder catheters.
  • the viscosity-increasing agent should be present in the irrigation composition in an amount from about 25% to about 70%, preferably about 35% to about 60% and most preferably about 40% to about 55%, weight to volume of carrier.
  • the anticoagulant useful in the irrigation composition of the present invention is any anticoagulant commonly known in the pharmaceutical arts such as riboflavin, citrates, ethylenediaminetetraacetic acid, warfarin or combinations of the foregoing. It is preferred that the anticoagulant not be heparin or any animal derivative or byproduct.
  • the anticoagulant is a citrate such as an ester of citric acid, i.e., triethyl citrate, or a citrate salt such as sodium citrate or other pharmaceutically acceptable salt.
  • the anticoagulant should be present in the irrigation composition in an amount from about 1% to about 25%, preferably about 2% to about 8% and most preferably about 3% to about 6%, weight of anticoagulant to volume of carrier.
  • the viscosity of the irrigation composition at room temperature should be about 2 mPa-s to about 10 mPa-s, preferably about 3 mPa-s to about 9 mPa-s and most preferably about 4 mPa-s to about 7 mPa-s.
  • the viscosity can be measured by any means commonly known in the pharmaceutical arts including but not limited to the use of commercially available equipment such as an Ostwald Viscometer, an Hoeppler Viscometer, or a Brookfield Viscometer. A more detailed discussion of methods and apparatus for determining the irrigation composition's viscosity can be found in Chapter 17 of Physical Pharmacy, 4 th ed., by Alfred Martin.
  • the density of the irrigation composition should be greater than the density of a subject's blood.
  • human blood is known to range (depending upon the temperature and age of the patient) from about 1.02 g/ml to about 1.1 g/ml. Therefore, the irrigation composition of the present invention for use in humans should exhibit a density greater than 1.1 g/ml, preferably greater than about 1.12 g/ml and most preferably greater than 1.13 g/ml.
  • the density can be measured by any means commonly known in the pharmaceutical arts. Some acceptable methods for measuring the density of the irrigation composition are described in United States Patent No. 4,929,242 and on pages 443-446 of Physical Pharmacy, 4 th ed., by Alfred Martin.
  • Embodiments of the present invention employ an irrigation composition with a density of 1.1 g/ml to about 3.0 g/ml, preferably 1.1 g/ml to about 2.5 g/ml and most preferably 1.1 g/ml to 2.0 g/ml.
  • the pH of the irrigation composition should be in the range of about 5.5 to about 8, preferably about 5.8 to about 7.5 and most preferably about 6.0 to about 7.0.
  • the pH of the irrigation composition may be adjusted to the desired level once the appropriate density and viscosity are obtained.
  • the pH may be adjusted by any means commonly known in the pharmaceutical arts such as the addition of a pharmaceutically acceptable acid or base to the irrigation composition.
  • citric acid is added to the irrigation composition to adjust the pH to an appropriate level.
  • the irrigation composition may also optionally employ a buffering agent to assist in controlling and maintaining the desired pH of the irrigation composition. The selection of an appropriate buffering agent is within the skill of the ordinary artisan.
  • the irrigation composition should be an isotonic composition or a hypertonic composition with respect to the subject's blood.
  • the tonicity may also be referred to as a measurement of the osmolality of the irrigation composition.
  • Tonicity or osmolality describes the concentration of solutes in a given solution.
  • An isotonic composition exhibits a tonicity essentially equal to the tonicity of a subject's plasma.
  • an isotonic composition does not cause a significant shift of water between the subject's blood vessels and cells.
  • a hypertonic composition exhibits a tonicity higher than the tonicity of a subject's plasma.
  • a hypertonic composition causes a shift of water toward the hypertonic composition in an effort to equilibrate the solute concentration.
  • the osmolality of the irrigation composition should be greater than the osmolality of human blood.
  • the osmolality of human blood has been reported to range from 275 mOsm/L to 299 mOsm/L.
  • Manuel Zarandona "Case 422 - Neuropathology Case", http://path.upmc.edu/cases/case422.html.
  • the osmolality of the irrigation composition should be greater than 300 mOsm/L, preferably greater than 320 mOsm/L, and more preferably greater than about 350 mOsm/L.
  • Some embodiments of the irrigation composition exhibit an osmolarity between 4,000 mOsm/L and 6,500 mOsm/L, preferably between 4,500 mOsm/L and 6,250 mOsm/L and most preferably between 5,000 mOsm/L and 6,000 mOsm/L.
  • the irrigation composition in accordance with the present invention should be stable to changes in pH and osmolality during long term storage.
  • the irrigation composition should also be resistant to bacterial and microbial growth during long term storage.
  • the irrigation composition in accordance with the present invention should exhibit less than a 1.0 unit change of pH, preferably less than a 0.5 unit change in the pH, after storage at 25°C and 60% relative humidity for at least six (6) months, preferably one (1) year, when the irrigation composition is stored in an appropriate container such as a sterile and sealed syringe or a glass vial.
  • the irrigation composition in accordance with the present invention should exhibit less than a 1.0 unit change of H, preferably less than a 0.5 unit change in the pH, after storage at 40°C and 75% relative humidity for at least one (1) month, preferably three (3) months, when the irrigation composition is stored in an appropriate container such as a sterile and sealed syringe or a glass vial.
  • the irrigation composition in accordance with the present invention should also be sterile and thereby prevent the growth of bacteria and microbes upon storage and, more importantly, during use.
  • An appropriate test for determining if the irrigation composition is sterile is described in test ⁇ 71> of the USP 25.
  • One embodiment of the irrigation composition of the present invention incorporates high amounts of glycerol which impart antimicrobial and antibacterial properties to the composition and thereby avoids the need for the use of additional or separate antimicrobial agents such as alcohols.
  • the antimicrobial and antibacterial properties of glycerol also help to reduce the incidence of bacterial infections which often accompany the use of bladder catheters.
  • Another embodiment of the present invention allows the irrigation composition to undergo a sterilization step after it is prepared and, more preferably, after it is packaged for use.
  • an embodiment of the present invention consists essentially of water, glycerol and a citrate, preferably sodium citrate.
  • This composition may be inserted into a patient's bladder during bladder surgery or shortly after kidney, bladder or prostate surgery to aid in preventing or reducing blood entering the bladder from clotting and/or coagulating.
  • the irrigation composition is inserted into a patient's bladder via a bladder catheter as described previously.
  • the bladder catheter employs a flow regulating device, such as a clamp, valve or plug, that prevents the irrigation composition from exiting the patient's bladder via the lumen of the catheter.
  • the irrigation composition will prevent and/or hinder the blood entering the patient's bladder from coagulating and thereby clogging the lumen of the catheter.
  • the irrigation composition will also prevent biofilm or encrustation on the catheter tip or lumen.
  • the flow regulating device is opened and the irrigation composition and accumulated urine is removed from the patient's bladder and bladder catheter.
  • the bladder catheter is irrigated with fresh irrigation composition and, depending upon the patient's needs, an appropriate amount of irrigation composition is inserted into the patient's bladder and the flow regulating device is closed and the process started again.
  • the present invention solves longstanding art-recognized problems associated with clotting in bladder catheters.
  • glycerol being a highly viscous product
  • the presence of the citrate prevents coagulation, such as by chelating calcium ions that are cofactors for several enzymes in the clotting cascade.
  • the combination of ingredients in solution will act to prevent clotting in the bladder of the subject, which in turn will reduce the incidence of clotting in the bladder catheter, and thereby reduce the frequency with which the bladder catheter must be flushed; this represents a significant improvement and advantage over the current standard of care involving saline.
  • sodium citrate-glycerol solutions may also present additional advantages.
  • sodium citrate is a well-studied anticoagulant for blood transfusion collection bags and is known to have good compatibility with red blood cells.
  • citric acid and glycerol are known to have antimicrobial properties and thus might provide a synergistic and/or improved benefit for infection prevention, thus solving another significant problem associated with bladder catheters.
  • sodium citrate-glycerol solutions help prevent the biofilm or
  • a further embodiment of the present invention is a method for reducing biofilm or encrustation of a bladder catheter comprising the step of: a) immersing a bladder catheter in an irrigation composition comprising: i) a carrier; ii) about 25% to about 70% w/v of a viscosity- increasing agent; and iii) about 1% to about 25% w/v of an anticoagulant, wherein the anticoagulant is not heparin and the irrigation composition is free of alcohol, for at least 15 minutes, preferably at least 30 minutes and most preferably at least one hour or longer, prior to insertion into a patient; b) the step of packaging the bladder catheter in an amount of the irrigation composition so that the bladder catheter is immersed in the irrigation composition for at least 15 minutes, preferably at least 30 minutes and most preferably at least one hour or longer, prior to use; or c) a combination of step a and b.
  • Glycerol 99.8% (Cognis); Anhydrous sodium citrate (Ruger Chemical) and citric acid (Penta).
  • An irrigation composition in accordance with the present invention was prepared as follows:
  • the osmolality of the composition was calculated to be approximately 5850 mOsm/L.
  • the equation used to calculate osmolarity in solution is: VP
  • the dissociation factor, a, for glycerol employed was 1, since it is a non-electrolyte.
  • the sodium citrate dissociation factor was determined by inserting the osmolarity values reported in Hendry, E.B., "Osmolality of Human Serum and of Chemical Solutions of Biologic Importance", Clinical Chemistry, 1961, 7, pp. 154-164 for a 3.8% w/v solution of sodium citrate dehydrate
  • the osmolarity of the 50% glycerol and 4% sodium citrate irrigation composition was estimated as follows: MW of sodium citrate (Na 3 C 6 H 5 0 7 ) is 257.9728 g/mol.
  • MW of glycerol is 92.03982 g/mol. Volume of solution is 0.1 L
  • the 50% glycerol-4% sodium citrate irrigation composition was tested as follows:
  • Each vessel was visually inspected at time zero (To) and then at To+15 minutes, To+30 minutes, T 0 +45 minutes, T 0 +60 minutes, T 0 +90 minutes and T 0 +120 minutes. The first observation of a visual clot (under a focused light beam) was noted. The content of each vessel was then filtered, under gravity flow, through a paper filter (approximately 20 micron).
  • Control sample Clot observed at the To+30 minute observation point. Filtration was slow and blocked completely with a thin film on the filter after 50% of the urine- blood mixture had passed through the filter paper.
  • compositions in accordance with the present invention were prepared using the same method as in Example 1 and having the following compositions of sodium citrate and glycerol:
  • the artificial urine was then sterilized by filtration through a 0.2 ⁇ filter units and stored at 4°C.
  • Bardex All Silicone Foley Catheters manufactured by Bard Access Inc., were soaked in 5 mL of compositions 2a, 2b, 2c or 2d described above for 2 hours. Each catheter was then placed in either 4 mL of artificial urine or 4 mL of artificial urine with Proteus mirabilis and then placed in a rotary shaker (10 revolutions per minute to 0.5 mL/min physiological flow rate) and incubated at 37 ⁇ 1°C for 2 weeks with urine change outs.
  • the catheters were immersed in 5 mL of 4.0% (v/v) nitric acid (metal oxide semiconductor grade in double-deionized water) in universal containers.
  • the encrustations were disrupted by sonicating for 30 minutes.
  • the crystalline suspensions were left for 24 hours to dissolve before the solutions were analyzed for calcium and magnesium content by atomic absorption spectroscopy (AAS/ICP).
  • Encrustation was scored on a scale of 0-5, with 0 representing no encrustation and 5 representing severe encrustation.
  • the following charts set forth the encrustations scores observed after 10 days of testing:
  • compositions not in accordance with the present invention were prepared using the same method as in Example 1 and having the following compositions of sodium citrate and glycerol:
  • Encrustation was scored on a scale of 0-5, with 0 representing no encrustation and 5 representing severe encrustation.
  • the following charts set forth the encrustations scores observed after 10 days of testing:

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Abstract

La présente invention concerne des procédés de prétraitement, d'irrigation ou de rinçage d'un cathéter de vessie employant des compositions d'irrigation qui contiennent de l'eau, un anticoagulant et un agent augmentant la viscosité et sont dépourvues d'héparine et d'alcool et des kits contenant les compositions d'irrigation.
PCT/US2012/057065 2011-09-26 2012-09-25 Procédé et composition d'irrigation de cathéter de vessie Ceased WO2013049033A1 (fr)

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US201161539047P 2011-09-26 2011-09-26
US61/539,047 2011-09-26

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019060697A1 (fr) * 2017-09-22 2019-03-28 Becton, Dickinson And Company Solution de citrate trisodique à 4 % pour utilisation en tant que solution de verrouillage de cathéter
RU2784778C1 (ru) * 2022-03-01 2022-11-29 Акционерное общество "ГЕОСОФТ ДЕНТ" Устройство для ирригации канала зуба
US12383700B2 (en) 2019-06-13 2025-08-12 Hollister Incorporated Reusable urinary catheter products
US12440644B2 (en) 2019-06-25 2025-10-14 Hollister Incorporated Reusable urinary catheter products

Citations (5)

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CN111278476A (zh) * 2017-09-22 2020-06-12 贝克顿·迪金森公司 用作导管封管液的4%柠檬酸三钠溶液
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AU2018338194B2 (en) * 2017-09-22 2021-07-08 Becton, Dickinson And Company 4% trisodium citrate solution for use as a catheter lock solution
JP7138702B2 (ja) 2017-09-22 2022-09-16 ベクトン・ディキンソン・アンド・カンパニー カテーテルロック溶液としての使用のための４％クエン酸三ナトリウム溶液
CN115990296A (zh) * 2017-09-22 2023-04-21 贝克顿·迪金森公司 用作导管封管液的4%柠檬酸三钠溶液
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