Antimicrobial obturator for use with vascular access devices

• US 9,789,279 B2
• Filed: 04/23/2014
• Issued: 10/17/2017
• Est. Priority Date: 04/23/2014
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Burkholz, Jonathan Karl, Shevgoor, Siddarth K.
• Primary Examiner(s): Schmidt, Emily
• Application Number:
  US14/260,071
• Publication Number:
  US 20150306345A1
• Time in Patent Office: 1,273 Days
• Field of Search: 604262, 604264, 604265, 604523, 604533, 604539
• CPC Class Codes: A61L 2/00 Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for contact lenses A61L12/00; atomisers for disinfecting agents A61M; sterilisation of packages or package contents in association with packaging B65B55/00; treatment of water, waste water, sewage or sludge C02F; disinfecting paper D21H21/36; disinfecting devices for water closets E03D; articles having provision for disinfection, see the relevant subclasses for these articles, e.g. H04R1/12
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 9/00 Disinfection, sterilisation or deodorisation of air body deodorants A61Q15/00; purifying air by respirators A62B, A62D9/00; separating dispersed particles from gases or vapours B01D45/00 - B01D51/00, B03C3/00; chemical or biological purification of waste gases B01D53/34; production of ozone C01B13/10; air-conditioning systems incorporating sterilisation F24F3/16, F24F8/20
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 39/20 Closure caps or plugs for connectors or open ends of tubes

Abstract

An obturator can include antimicrobial features which assist in sterilizing or maintaining the sterility of fluid contained within a vascular access device while the device is not being used for infusion or other access to the patient'"'"'s vasculature. These antimicrobial features include antimicrobial coatings applied to various surfaces of an obturator and antimicrobial components bonded or otherwise secured to an obturator. Various combinations of antimicrobial coatings and/or components can be used on an obturator as necessary to provide a desired amount of antimicrobial agents within a particular enclosed volume of a vascular access device.

Claims

1. A vascular access system, the vascular access system comprising:

a vascular access device comprising a catheter extending from a distal end of the vascular access device; and

an obturator, comprising;

a catheter portion, wherein when the obturator is secured to the vascular access device, the catheter portion extends through a lumen of the vascular access device and into a proximal end of the catheter of the vascular access device, wherein the catheter portion includes a first outer diameter;

a middle portion positioned within the lumen of the vascular access device when the obturator is secured to the vascular access device, wherein the middle portion includes a second outer diameter;

a base portion that seals the lumen when the obturator is secured to the vascular access device, wherein the base portion includes a third outer diameter, wherein the second outer diameter is less than the third outer diameter and greater than the first outer diameter, wherein the base portion is inserted into the lumen of the vascular access device;

an antimicrobial ring positioned around the middle portion and configured to release an antimicrobial agent, wherein the antimicrobial ring is configured to be positioned within the lumen while the catheter portion is inserted into the catheter, wherein the antimicrobial agent is contained within a material of the antimicrobial ring or on a surface of the material, wherein an inner diameter of the antimicrobial ring is approximately equal to the second outer diameter, wherein an outer diameter of the antimicrobial ring is less than the third outer diameter; and

a cap portion configured to secure the obturator to the vascular access device.

2. The vascular access system of claim 1, wherein the catheter portion includes an antimicrobial coating, wherein antimicrobial coating comprises a dissolvable coating.

3. The vascular access system of claim 2, wherein the antimicrobial coating comprises a base material matrix that elutes the antimicrobial agent.

4. The vascular access system of claim 3, wherein the base material matrix is cured onto the catheter portion.

5. The vascular access system of claim 2, wherein the antimicrobial coating is contained on a length of the catheter portion that is positioned within the catheter.

6. The vascular access system of claim 5, wherein the length of the catheter portion also extends into the lumen of the vascular access device.

7. The vascular access system of claim 1, wherein the third outer diameter is substantially the same as the diameter of the lumen of the vascular access device.

8. An obturator for a vascular access device, the obturator comprising:

a catheter portion configured to be inserted through a lumen of the vascular access device and into a proximal end of a catheter of the vascular access device while the catheter is placed intravenously within a patient, wherein the catheter portion includes a first outer diameter, wherein the catheter portion further includes an antimicrobial component configured to release an antimicrobial agent into fluid contained within the vascular access device;

a middle portion configured to be positioned within the lumen of the vascular access device while the catheter portion is inserted into the catheter, wherein the middle portion includes a second outer diameter that is constant along at least a portion of the middle portion, wherein a distal end of the middle portion proximate the catheter portion is tapered;

a base portion that seals the lumen when the obturator is secured to the vascular access device, wherein the base portion includes a third outer diameter, wherein the second outer diameter is less than the third outer diameter and greater than the first outer diameter, wherein the base portion is inserted into the lumen of the vascular access device, wherein the base portion is inserted into the lumen of the vascular access device, wherein a distal end of the base portion proximate the middle portion is tapered;

a cap portion proximal to the base portion and configured to secure the obturator to the vascular access device;

a ring positioned around the middle portion, wherein the ring is configured to be positioned within the lumen while the catheter portion is inserted into the catheter; and

an antimicrobial coating disposed on a surface of the ring.

9. The obturator of claim 8, wherein the ring comprises a base material matrix that elutes the antimicrobial agent.

10. The obturator of claim 9, wherein the base material matrix forms the antimicrobial coating on the surface of the ring.

11. The obturator of claim 8, wherein the antimicrobial component includes an antimicrobial coating configured to release the antimicrobial agent into the fluid contained within the vascular access device.

12. The obturator of claim 11, wherein the antimicrobial coating is dissolvable.

13. The obturator of claim 11, wherein the antimicrobial coating comprises a base material matrix that elutes the antimicrobial agent.

14. The obturator of claim 8, further comprising:

a base portion having a diameter substantially the same as the diameter of the lumen, the base portion configured to seal the lumen when the obturator is secured to the vascular access device.