SYSTEMS AND METHODS FOR PROVIDING A FLUSHABLE CATHETER ASSEMBLY

• US 20110046570A1
• Filed: 08/20/2009
• Published: 02/24/2011
• Est. Priority Date: 08/20/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Isaacson, S. Ray, McKinnon, Austin Jason, Spinti, Mark, Stout, Marty L.
• Granted Patent: US 8,388,583 B2
• Time in Patent Office: Days
• US Class Current: 604/246
• 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 septum disposed within a portion of the inner lumen;

a ventilation channel interposed between the septum and the inner surface of the catheter adapter;

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

a septum activator disposed within a portion of the inner lumen adjacent to the septum, 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 inner surface of the catheter adapter further comprises a channel for receiving and maintaining a desired position of the septum within the inner lumen of the catheter adapter.

3. 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.

4. The catheter assembly of claim 1, wherein the septum activator further comprises at least one of a flow diversion channel and a flow deflector.

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

6. 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.

7. 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.

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

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

disposing a septum within a portion of the inner lumen;

providing a plurality of ventilation channels on the inner surface of the catheter adapter such that the plurality of ventilation channels are interposed between the septum and the catheter adapter;

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

disposing a septum activator within a portion of the inner lumen adjacent to the septum, 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.

9. The method of claim 8, further comprising providing a channel for receiving and maintaining a desired position of the septum within the inner lumen of the catheter adapter.

10. The method of claim 8, 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.

11. The method of claim 8, further comprising providing a flow diversion channel on a surface of the septum activator.

12. The method of claim 8, further comprising providing a flow director on a surface of the septum activator.

13. The method of claim 8, further comprising providing a luer adapter on a proximal end of the outer surface of the catheter adapter.

14. The method of claim 8, 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.

15. A flushable air ventilation system for a catheter assembly, comprising:

a catheter adapter having a proximal end, a distal end, an inner surface, an outer surface, and an inner lumen, wherein a distal portion of the inner lumen comprises a flashback chamber, and a proximal portion of the inner lumen comprises a fluid chamber;

a septum interposedly positioned within the inner lumen of the catheter adapter between the flashback chamber and the fluid chamber;

a ventilation channel interposed between an outer surface of the septum and the inner surface of the catheter adapter;

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

a septum activator disposed within the fluid chamber of the catheter adapter, 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 fluid chamber of the catheter adapter in a distal direction.

16. The system of claim 15, wherein the inner surface of the catheter adapter further comprises a channel for receiving and maintaining a desired position of the septum within the inner lumen of the catheter adapter.

17. The system of claim 15, wherein the septum activator further comprises at least one of a flow deflector and flow diversion channel.

18. The system of claim 15, 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.

19. The system of claim 15, wherein the septum comprises a split opening having a closed position and an opened position, the opened position being provided upon insertion of the septum activator through the split opening.

20. The system of claim 19, wherein the split opening comprises a leak orifice to permit controlled flow of a fluid from the flashback chamber to the fluid chamber prior to insertion of the septum activator through the split opening.