Systems and methods for providing a flushable catheter assembly

• US 8,388,583 B2
• Filed: 08/20/2009
• Issued: 03/05/2013
• Est. Priority Date: 08/20/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Stout, Marty L., Isaacson, S. Ray, Spinti, Mark, McKinnon, Austin Jason
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/544,625
• Publication Number:
  US 20110046570A1
• Time in Patent Office: 1,293 Days
• Field of Search: 604/164.01, 604/164.02, 60416701-16706, 604/168.01, 604/172, 604/200, 604/246, 604/244, 604/249
• US Class Current: 604/244
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0626 used with other surgical instruments, e.g. endoscope, trocar
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/066 Septum-like element
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 39/0693 including means for seal penetration

Abstract

A flushable catheter assembly having features to enable selective activation of fluid flow through the catheter assembly is disclosed herein. A septum is placed within the catheter adapter of the catheter assembly and includes a pathway that is closed prior to being biased open via a septum activator also positioned within the catheter adapter. A plurality of air vent channels is interposed between the septum and the inner surface of the catheter adapter to permit “flashback” of blood during insertion of the catheter into a patient. The septum activator is advanced through the pathway of the septum as a coupler is attached to a proximal opening of the catheter adapter.

Claims

1. A flushable catheter assembly, comprising:

a catheter adapter having a distal end, a proximal end, an inner surface, an outer surface, and an inner lumen;

a flow path extending through the inner lumen of the catheter adapter;

a groove formed on the inner surface and located within the inner lumen;

a septum entirely disposed within the groove, the septum having an outer surface and a length, the length of the septum being approximately equal to a length of the groove;

a ventilation channel formed in the groove, such that an air flow is interposed between the outer surface of the septum and the ventilation channel along the entire length of the septum;

a coating applied to a surface of the ventilation channel; and

a septum activator entirely disposed within the inner lumen of the catheter adapter, the septum activator having a distal end, a proximal end and a fluid channel, wherein the distal end of the septum activator is positioned adjacent to the septum and the proximal end of the septum activator is positioned adjacent to the proximal end of the catheter adapter, the distal end of the septum activator being configured to bias the septum into an opened position.

2. The catheter assembly of claim 1, wherein the septum activator further comprises a retention tab, and the inner surface of the catheter adapter further comprises a retention groove for receiving the retention tab.

3. The catheter assembly of claim 1, wherein the septum activator further comprises:

a flow deflector that extends outwardly from an outward surface of the septum activator and into the flow path;

an elongate channel providing fluid communication between an inner lumen of the septum activator and the flow path; and

one or more vents positioned on the proximal end of the septum activator, the one or more vents providing fluid communication between the inner lumen of the septum activator and the flow path.

4. The catheter assembly of claim 1, wherein the coating comprises at least one of a hydrophobic material and a swelling polymer material.

5. The catheter assembly of claim 1, further comprising a luer adapter forming a portion of the outer surface of the proximal end of the catheter adapter.

6. The catheter assembly of claim 1, wherein the proximal end of the septum activator further comprises a contact surface for forming an interface with a probe, wherein the probe is inserted into the proximal end of the catheter adapter and contacts the contact surface of the septum activator to bias the septum activator in the distal direction.

7. A method for manufacturing a flushable catheter assembly, the method comprising:

providing a catheter adapter having a distal end, a proximal end, an inner surface, an outer surface, and a flow path extending through an inner lumen of the catheter adapter;

forming a groove on the inner surface of the catheter adapter;

providing a septum having an outer surface and a length, a length of the septum being approximately equal to a length of the groove;

disposing the entire length of the septum within the groove to secure the septum within the groove;

providing a plurality of ventilation channels within the groove, such that an air flow is interposed between the outer surface of the septum and the plurality of ventilation channels along the entire length of the septum;

applying a hydrophobic coating to a surface of the plurality of ventilation channels; and

disposing a septum activator entirely within the inner lumen of the catheter adapter thereby securing the septum within the groove, the septum activator having a distal end, a proximal end and a fluid channel, the distal end of the septum activator being positioned adjacent to the septum and the proximal end of the septum activator being positioned adjacent to the proximal end of the catheter adapter, wherein the distal end of the septum activator biases the septum to an opened position upon translating the septum activator through the inner lumen of the catheter adapter in a distal direction.

8. The method of claim 7, further comprising the steps of providing a retention tab to an external surface of the septum activator, and providing a retention groove on the inner surface of the catheter adapter, wherein the retention groove receives the retention tab to substantially retain the septum activator within the inner lumen of the catheter adapter.

9. The method of claim 7, further comprising providing a flow diversion channel on a surface of the septum activator, the flow diversion channel comprising an elongate channel providing fluid communication between an inner lumen of the septum activator and the flow path.

10. The method of claim 7, further comprising providing a flow deflector on a surface of the septum activator, the flow deflector extending outwardly from an outer surface of the septum activator and into the flow path.

11. The method of claim 7, further comprising providing a luer adapter on a proximal end of the outer surface of the catheter adapter.

12. The method of claim 7, further comprising providing a contact surface on the proximal end of the septum activator for forming an interface with a probe, wherein the probe is inserted into the proximal end of the catheter adapter and contacts the contact surface of the septum activator to bias the septum activator in the distal direction.