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WO2014004498A1 - Citrate anticoagulant underloaded syringe for catheter locking - Google Patents

Citrate anticoagulant underloaded syringe for catheter locking Download PDF

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Publication number
WO2014004498A1
WO2014004498A1 PCT/US2013/047604 US2013047604W WO2014004498A1 WO 2014004498 A1 WO2014004498 A1 WO 2014004498A1 US 2013047604 W US2013047604 W US 2013047604W WO 2014004498 A1 WO2014004498 A1 WO 2014004498A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
volume
citrate
solution
locking
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2013/047604
Other languages
French (fr)
Inventor
Michael Basta
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medical Components Inc
Original Assignee
Medical Components Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medical Components Inc filed Critical Medical Components Inc
Publication of WO2014004498A1 publication Critical patent/WO2014004498A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • 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
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/21—Acids
    • 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
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • 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 is directed generally to catheter flushing and locking; and more particularly to a method and apparatus for locking a catheter using a citrate anticoagulant underloaded syringe.
  • the present invention is directed generally to catheter flushing and locking. Flushing assesses catheter capability and removes prior infused medication. Locking a catheter closes respective lumens to prevent blood from entering the lumen.
  • flushing is used to clear a catheter lumen of prior medications.
  • Medication incompatibility can produce drug precipitate that occludes the catheter lumen. Flushing with saline between each medication can prevent contact between incompatible drugs and prevent the formation of this occluding precipitate. This concern about drug incompatibility extends to heparin lock solution, used for interluminal anticoagulation.
  • the volume of heparin necessary to lock a catheter depends on the catheter's priming volume (i.e., total internal volume of the catheter). Standards or practice call for a minimum priming volume normally equal to twice the internal volume of the catheter (all lumens, extensions sets, other accessories). Accordingly, catheter overflow during locking always exists, and is necessary to ensure complete filling of the entire catheter system. The overfill amounts, however, may have negative aspects. In recent years other products have entered into use to act as an anticoagulant and as an antibacterial agent. Highly concentrated trisodium citrate and citrate derivatives are examples. Citrate can effectively prevent, eliminate, or at least reduce, biofilm production on the catheter lumen surface. However, citrate has a serious drawback - citrate binds with circulating calcium buffer, sometimes causing significant side effects such as cardiac rhythmic disturbances.
  • the present invention is directed generally to catheter flushing and locking, and to a method and apparatus for locking a catheter using a citrate anticoagulant underloaded syringe.
  • a method of flushing and locking a catheter involves flushing the catheter, then aspirating the catheter to determine catheter priming volume, then flushing the catheter with a volume equal to at least the catheter priming volume, and finally locking the catheter with a citrate solution having a volume equal to 20% - 80% of the catheter priming volume, wherein the concentration of citrate by volume, relative to the catheter priming volume, is within known lethal pathogenic concentrations, whereby the specific gravity of the citrate solution provides that the citrate solution will effectively mix within and lock the entire catheter priming volume.
  • the catheter can be a PICC catheter, the catheter can be flushed with a saline solution, and/or the citrate solution can include 30% - 46.7% citrate by volume.
  • citrate is recognized as an effective anticoagulant and antibacterial agent, capably preventing, reducing or eliminating biofilm on a catheter lumen surface.
  • Catheter overfill volumes of citrate can have negative consequences; accordingly, the present invention provides a method and apparatus for catheter locking that avoids citrate overfill.
  • the priming volume of a catheter is provided with the catheter by the catheter manufacturer. It is this volume, as provided, that is drawn into a syringe and locked into the catheter (e.g., a routine practice with hemodialysis catheters).
  • many PICC and CVC catheters are cut to length by the clinician during insertion.
  • the catheters are provided with markings, making calculated adjustments to the provided priming volumes possible, based upon the length cut from the catheter during insertion, a later clinician might not be aware of the prior catheter insertion procedure, and/or whether there was a length adjustment, thereby making it impossible for that clinician to know the actual inserted catheter priming volume. Accordingly, the method of the present invention effectively provides for the locking of a total internal volume of a catheter with a solution, without requiring catheter overflow volumes of the solution that could possibly result in negative consequences.
  • catheter locking is contemplated using a preloaded syringe containing a citrate solution calibrated at a significant volume between 20% - 80% of the respective catheter priming volume (e.g., a PICC or CVC catheter).
  • the catheter is first filled with saline or similar material suitable for flushing.
  • the catheter is topped off with a locking solution of citrate and saline (or similar material suitable for flushing).
  • the locking solution will include citrate in high concentration, within the lethal pathogenic concentrations known, as selected by the clinician.
  • the clinician may select a lower overall volume of citrate solution (e.g., 20% of the respective catheter priming volume).
  • a further factor in a clinician selection process is the overall priming volume of the respective catheter, so that the clinician can ensure that the overall citrate concentration by volume relative to the priming volume of the catheter is within a lethal pathogenic concentration.
  • a catheter is first flushed entirely with a saline solution. Then, the catheter is injected (locked) with a citrate solution having a volume equal to 20% - 80% of the total internal volume of a catheter.
  • the citrate solution selected for injection (locking) will ensure that a total concentration of citrate by volume, relative to the total internal volume of the catheter, is within known lethal pathogenic concentrations for citrate (e.g., 30% - 46.7%).
  • the specific gravity of the citrate solution provides that the citrate solution will effectively mix within and lock the entire total internal volume of the catheter.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

CITRATE ANTICOAGULANT UNDERLOADED SYRINGE
FOR CATHETER LOCKING
FIELD OF THE INVENTION
The present invention is directed generally to catheter flushing and locking; and more particularly to a method and apparatus for locking a catheter using a citrate anticoagulant underloaded syringe.
BACKGROUND OF THE INVENTION
The present invention is directed generally to catheter flushing and locking. Flushing assesses catheter capability and removes prior infused medication. Locking a catheter closes respective lumens to prevent blood from entering the lumen.
As stated, flushing is used to clear a catheter lumen of prior medications. Medication incompatibility can produce drug precipitate that occludes the catheter lumen. Flushing with saline between each medication can prevent contact between incompatible drugs and prevent the formation of this occluding precipitate. This concern about drug incompatibility extends to heparin lock solution, used for interluminal anticoagulation.
The volume of heparin necessary to lock a catheter depends on the catheter's priming volume (i.e., total internal volume of the catheter). Standards or practice call for a minimum priming volume normally equal to twice the internal volume of the catheter (all lumens, extensions sets, other accessories). Accordingly, catheter overflow during locking always exists, and is necessary to ensure complete filling of the entire catheter system. The overfill amounts, however, may have negative aspects. In recent years other products have entered into use to act as an anticoagulant and as an antibacterial agent. Highly concentrated trisodium citrate and citrate derivatives are examples. Citrate can effectively prevent, eliminate, or at least reduce, biofilm production on the catheter lumen surface. However, citrate has a serious drawback - citrate binds with circulating calcium buffer, sometimes causing significant side effects such as cardiac rhythmic disturbances.
Therefore, what is needed in the art is a method to effectively lock a total internal volume of a catheter with a solution, without requiring catheter overflow volumes of the solution that could possibly result in negative consequences.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is directed generally to catheter flushing and locking, and to a method and apparatus for locking a catheter using a citrate anticoagulant underloaded syringe.
In one aspect, a method of flushing and locking a catheter is provided that involves flushing the catheter, then aspirating the catheter to determine catheter priming volume, then flushing the catheter with a volume equal to at least the catheter priming volume, and finally locking the catheter with a citrate solution having a volume equal to 20% - 80% of the catheter priming volume, wherein the concentration of citrate by volume, relative to the catheter priming volume, is within known lethal pathogenic concentrations, whereby the specific gravity of the citrate solution provides that the citrate solution will effectively mix within and lock the entire catheter priming volume. In this aspect, the catheter can be a PICC catheter, the catheter can be flushed with a saline solution, and/or the citrate solution can include 30% - 46.7% citrate by volume. In the present invention, citrate is recognized as an effective anticoagulant and antibacterial agent, capably preventing, reducing or eliminating biofilm on a catheter lumen surface. Catheter overfill volumes of citrate can have negative consequences; accordingly, the present invention provides a method and apparatus for catheter locking that avoids citrate overfill.
As mentioned, total interluminal catheter space is known as the "priming volume" of a catheter. The priming volume of a catheter is provided with the catheter by the catheter manufacturer. It is this volume, as provided, that is drawn into a syringe and locked into the catheter (e.g., a routine practice with hemodialysis catheters). However, many PICC and CVC catheters are cut to length by the clinician during insertion. Although the catheters are provided with markings, making calculated adjustments to the provided priming volumes possible, based upon the length cut from the catheter during insertion, a later clinician might not be aware of the prior catheter insertion procedure, and/or whether there was a length adjustment, thereby making it impossible for that clinician to know the actual inserted catheter priming volume. Accordingly, the method of the present invention effectively provides for the locking of a total internal volume of a catheter with a solution, without requiring catheter overflow volumes of the solution that could possibly result in negative consequences.
For the locking citrate solution contemplated by the present invention, a range of antibacterial activity of citrate solutions is known and published that lethal pathogenically concentrations range from 30 to 46.7 percent. Therefore, in one aspect of the present invention, catheter locking is contemplated using a preloaded syringe containing a citrate solution calibrated at a significant volume between 20% - 80% of the respective catheter priming volume (e.g., a PICC or CVC catheter). The catheter is first filled with saline or similar material suitable for flushing. The catheter is topped off with a locking solution of citrate and saline (or similar material suitable for flushing). The locking solution will include citrate in high concentration, within the lethal pathogenic concentrations known, as selected by the clinician. For instance, if a higher lethal pathogenic concentration is selected (e.g., 46.7%), the clinician may select a lower overall volume of citrate solution (e.g., 20% of the respective catheter priming volume). Naturally, a further factor in a clinician selection process is the overall priming volume of the respective catheter, so that the clinician can ensure that the overall citrate concentration by volume relative to the priming volume of the catheter is within a lethal pathogenic concentration. Thereby, since citrate is heavier than saline, the citrate will wander through the saline, once locked within the respective catheter, mixing to an average lethal anti-pathogenic concentration relative to the total interluminal catheter space (or volume).
So, in one embodiment, a catheter is first flushed entirely with a saline solution. Then, the catheter is injected (locked) with a citrate solution having a volume equal to 20% - 80% of the total internal volume of a catheter. The citrate solution selected for injection (locking) will ensure that a total concentration of citrate by volume, relative to the total internal volume of the catheter, is within known lethal pathogenic concentrations for citrate (e.g., 30% - 46.7%). The specific gravity of the citrate solution provides that the citrate solution will effectively mix within and lock the entire total internal volume of the catheter.
Accordingly, locking the catheter with citrate solution having a volume equal to 20% - 80% of the total internal volume of a catheter, while also maintaining a concentration of citrate by volume, relative to the total internal volume of the catheter, within known lethal pathogenic concentrations for citrate (e.g., 30%-46.7%), will create and maintain a lethal anti-pathogenic environment within the entire internal volume of the catheter, and will provide for a dilution of the concentration of citrate by volume, relative to the total internal volume of the catheter, so that any loss into the body, from the catheter, will be minimal and will be at a concentration as not to result in a health hazard.

Claims

What is claimed is:
1. A method of flushing and locking a catheter, the method comprising the steps of: flushing the catheter;
aspirating the catheter to determine catheter priming volume;
flushing the catheter with a volume equal to at least the catheter priming volume; and
locking the catheter with a citrate solution having a volume equal to 20% - 80% of the catheter priming volume, wherein the concentration of citrate by volume, relative to the catheter priming volume, is within known lethal pathogenic concentrations, whereby the specific gravity of the citrate solution provides that the citrate solution will effectively mix within and lock the entire catheter priming volume.
2. The method of claim 1, wherein the catheter is a PICC catheter.
3. The method of claim 1, wherein the catheter is flushed with a saline solution.
4. The method of claim 1 , wherein the concentration of citrate by volume, relative to the catheter priming volume, is 30% - 46.7% citrate by volume.
5. The method of claim 1, wherein the citrate solution includes 30% - 46.7% citrate by volume.
6. An apparatus providing for the locking of a catheter with a citrate solution, comprising at least one preloaded syringe containing a citrate solution, wherein the citrate solution includes a concentration of citrate by volume, relative to a priming volume of the catheter, of 30% - 46.7% citrate, and wherein the syringe is calibrated to provide the citrate solution in a volume within 20% - 80% of the priming volume of the catheter.
7. An apparatus providing for the locking of a catheter with a citrate solution, comprising:
a preloaded syringe containing a citrate solution, wherein the citrate solution includes a concentration of citrate by volume of 30%;
a preloaded syringe containing a citrate solution, wherein the citrate solution includes a concentration of citrate by volume of 46.7%;
wherein the apparatus provides for a method of locking the catheter, the method comprising the steps of:
aspirating the catheter to determine a catheter priming volume;
flushing the catheter with a flushing solution having a volume equal to at least the catheter priming volume; and
locking the catheter with a citrate solution, selected from one or a combination of both of the preloaded syringes so that the citrate solution is of a volume between 20% - 80% of the catheter priming volume, and so that the concentration of citrate by volume, relative to the catheter priming volume, is within known lethal pathogenic concentrations for citrate, whereby the specific gravity of the citrate solution provides that the citrate solution will effectively mix within and lock the entire catheter priming volume.
8. The apparatus of claim 7, wherein the catheter is a PICC catheter.
9. The apparatus of claim 7, wherein the catheter is flushed with a saline solution.
10. The apparatus of claim 7, wherein known lethal pathogenic concentrations for citrate is 30% - 46.7% by volume.
1 1. The apparatus of claim 7, wherein the concentration of citrate by volume, relative to the catheter priming volume, is between 30% - 46.7% citrate by volume.
PCT/US2013/047604 2012-06-25 2013-06-25 Citrate anticoagulant underloaded syringe for catheter locking Ceased WO2014004498A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261663904P 2012-06-25 2012-06-25
US61/663,904 2012-06-25

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WO2014004498A1 true WO2014004498A1 (en) 2014-01-03

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11045589B2 (en) 2017-09-22 2021-06-29 Becton, Dickinson And Company 4% trisodium citrate solution for use as a catheter lock solution

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020010438A1 (en) * 1999-07-23 2002-01-24 Finch Charles D. Methods and kits for locking and disinfecting implanted catheters
US20060177477A1 (en) * 2005-02-08 2006-08-10 Ash Stephen R Catheter lock solution comprising citrate and a paraben
US20100331277A1 (en) * 2004-11-02 2010-12-30 Prosl Frank R Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020010438A1 (en) * 1999-07-23 2002-01-24 Finch Charles D. Methods and kits for locking and disinfecting implanted catheters
US20100331277A1 (en) * 2004-11-02 2010-12-30 Prosl Frank R Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
US20060177477A1 (en) * 2005-02-08 2006-08-10 Ash Stephen R Catheter lock solution comprising citrate and a paraben

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BAYES, B. ET AL.: "Sodium citrate for filling haemodialysis catheters", NEPHROL. DIAL. TRANSPLANT., vol. 14, no. 10, October 1999 (1999-10-01), pages 2532 - 2533 *
STAS, K. J. ET AL.: "Trisodium citrate 30% vs. heparin 5% as catheter lock in the interdialytic period in twin- or double-lumen dialysis catheters for intermittent haemodialysis", NEPHROL. DIAL. TRANSPLANT., vol. 16, July 2001 (2001-07-01), pages 1521 - 1522 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11045589B2 (en) 2017-09-22 2021-06-29 Becton, Dickinson And Company 4% trisodium citrate solution for use as a catheter lock solution
US12447243B2 (en) 2017-09-22 2025-10-21 Becton, Dickinson And Company 4% trisodium citrate solution for use as a catheter lock solution

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