BREAK-AWAY HEMOSTASIS HUB

• US 20080108976A1
• Filed: 09/25/2007
• Published: 05/08/2008
• Est. Priority Date: 11/08/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kindberg, Thomas L., Johnson, Eric T., Hague, Gary L., Andrews, Christopher C., Becker, Neil M.
• Granted Patent: US 8,105,315 B2
• Time in Patent Office: Days
• US Class Current: 604/535
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/0693 including means for seal penetration

Abstract

A breakaway hemostasis hub for a catheter or introducer sheath includes a splittable or separable housing, a seal within the housing, an actuator partially slidably disposed within the housing, a pair of spring retainer members in the housing each adapted to receive at least one spring, and a pair of actuator retainer members adapted to retain the seal, the actuator, and the spring retainer members in the housing. The actuator is operable to assume a closed position and an open position and includes a dilator member configured to dilate the seal when the actuator is in the open position. The hub is splittable or separable into two generally symmetrical sub-assemblies to facilitate cutting the catheter for retraction from the patient'"'"'s body without displacing its payload.

Claims

1. A hemostasis hub for use with a catheter including a lumen and a proximal end, the hemostasis hub comprising:

a housing including a proximal portion and a distal portion configured to be coupled to the proximal end of the catheter, the housing configured to be splittable or separable into first and second housing elements;

a hemostasis seal in the proximal portion of the housing; and

an actuator partially slidably disposed within the proximal portion of the housing, the actuator including a body portion, a dilator member extending distally from the body portion, and a lumen extending through the body portion and the dilator member,

wherein the actuator is configured to assume a closed position in which the actuator lumen is fluidly isolated from the catheter lumen by the hemostasis seal, and an open position in which the dilator member extends through the hemostasis seal and the actuator lumen is in fluid communication with the catheter lumen.

2. The hemostasis hub of claim 1 wherein the actuator is separable into first and second actuator elements.

3. The hemostasis hub of claim 1 wherein the actuator is configured such that the first and second actuator elements are partially retained, respectively, within the first and second housing elements.

4. The hemostasis hub of claim 1 wherein the seal is a splittable or separable seal including first and second resilient seal elements.

5. The hemostasis hub of claim 1 and further comprising first and second actuator retainer members in the proximal portion of the housing configured to retain the first and second actuator elements, respectively, partially within the first and second housing elements.

6. The hemostasis hub of claim 5 wherein the actuator retainer members are configured to releasably maintain the actuator in the open position.

7. The hemostasis hub of claim 1 wherein the housing is a unitary structure and includes first and second joints connecting the first and second housing elements, the break line configured to facilitate manual separation of the first and second housing elements.

8. The hemostasis hub of claim 7 wherein the first and second joints each include first and second portions, and wherein the first portions of the joints are configured to require more force to be stronger than the second portions of the joints.

9. The hemostasis hub of claim 1 wherein the actuator body portion includes a proximal end positioned proximal to the proximal portion of the housing and a distal end disposed within the proximal portion of the housing.

10. The hemostasis hub of claim 9 and further comprising at least one spring retained within the housing configured to bias the actuator to the closed position.

11. The hemostasis hub of claim 10 wherein the actuator body portion includes at least one channel extending proximally from the distal end of the body portion, and wherein the spring is partially received within the channel.

12. The hemostasis hub of claim 11 and further comprising at least one spring retainer element within the proximal portion of the housing, the spring retainer element including a spring retainer member received by the channel of the actuator body portion, wherein the spring is retained within the channel and the spring retainer member.

13. The hemostasis hub of claim 9 and further comprising a plurality of springs retained within the housing configured to bias the actuator to the closed position.

14. The hemostasis hub of claim 13 wherein the actuator body portion includes a pair of channels extending proximally from the distal end of the body portion in each of the each of the first and second actuator elements, and wherein each of the springs is partially retained within one of the channels.

15. The hemostasis hub of claim 14 and further comprising first and second spring retainer elements within the proximal portion of the housing, each of the spring retainer elements including a pair of spring retainer members each received by one of the channels of the actuator body portion, wherein each of the springs is retained within one of the channels and the spring retainer member received therein.

16. The hemostasis hub of claim 15 and further comprising first and second actuator retainer members in the proximal portion of the housing configured to retain the first and second actuator elements, respectively, partially within the first and second housing elements.

17. The hemostasis hub of claim 16 wherein the first housing element is adapted to contain the first actuator retainer member, the first actuator element, and the first spring retainer element, and further wherein the second housing element is adapted to contain the second actuator retainer member, the second actuator element, and the second spring retainer element when the housing is split along the break line

18. A hemostasis hub for use in combination with a catheter having a proximal end and a lumen extending distally from the proximal end, the hemostasis hub comprising:

a splittable or separable housing having a proximal portion and a distal portion configured to be coupled to the proximal end of the catheter, the housing defining an interior space;

a hemostasis seal within the housing; and

an actuator partially slidably disposed in the interior space and including a dilator member configured to dilate the seal, and an actuator lumen extending through the dilator member.

19. The hemostasis hub of claim 18 wherein the actuator is configured to assume a closed position in which the dilator member is positioned proximal to the hemostasis seal, and an open position in which the dilator member extends through the hemostasis seal such that the actuator lumen is in fluid communication with the catheter lumen.

20. The hemostasis hub of claim 19 and further comprising means within the housing for biasing the actuator to the closed position.

21. A catheter and hemostasis hub assembly comprising:

an elongate catheter including a proximal end and a lumen extending distally from the proximal end; and

a hemostasis hub coupled to the proximal end of the catheter, the hub including;

a housing defining an interior space in fluid communication with the catheter lumen, the housing including a proximal portion and a distal portion coupled to the proximal end of the catheter, the housing further including first and second housing elements;

a resilient seal member within the housing configured to hemostatically isolate the catheter lumen from the open proximal end of the housing; and

an actuator including mating first and second actuator elements partially slidably disposed within the housing configured to dilate the seal for introducing an elongate medical device or instrument into the catheter lumen;

wherein the hub is further configured to be splittable into a first hub subassembly including the first housing element and the first actuator element, and a second hub subassembly including the second housing element and the second actuator element.

22. The assembly of claim 21 wherein the distal portion of the housing includes an open distal end, and wherein the proximal end of the catheter extends into the open distal end of the housing.

23. The assembly of claim 22 wherein the proximal end of the catheter is releasably coupled to the distal portion of the first housing element, and wherein the proximal end of the catheter is fixedly coupled to the distal portion of the second housing element.

24. The assembly of claim 23 wherein the hub is configured such that upon splitting of the hub, the first hub subassembly is decoupled from the catheter so as to expose the proximal end of the catheter, and the second hub subassembly remains fixedly coupled to the catheter.

25. The assembly of claim 24 wherein the second hub element further comprises a distal ferrule configured to stiffen and support the proximal end of the catheter.