Break-away hemostasis hub

• US 8,105,315 B2
• Filed: 09/25/2007
• Issued: 01/31/2012
• Est. Priority Date: 11/08/2006
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Johnson, Eric T., Andrews, Christopher C., Becker, Neil M., Hague, Gary L., Kindberg, Thomas L.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US11/860,854
• Publication Number:
  US 20080108976A1
• Time in Patent Office: 1,589 Days
• Field of Search: 604/164.01, 604/164.02, 604/164.07, 604/167.01, 604/167.02, 604/167.04, 604/167.06, 604/246, 604/256, 604/264, 604/523, 604/533, 604/534, 604/535, 604/537, 604/539, 604/93.01, 604/164.12, 604/170.01, 604/170.02, 604/48, 604/905, 604/158, 604/160, 604/161, 604/164.05, 604/167.03, 604/524
• US Class Current: 604/537
• 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 along at least one housing break line into first and second housing elements each having a distal end, the at least one housing break line extending generally longitudinally through the proximal and distal portions of the housing, the distal end of the second housing element extending distally with respect to the distal end of the first housing element and operable to support the proximal end of the catheter;

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

an actuator including a body portion partially slidably disposed within the proximal portion of the housing, a dilator member extending distally from the body portion, and a lumen extending through the body portion and the dilator member, the actuator being separable along an actuator break line generally aligned with the at least one housing break line;

a spring retainer element disposed within the proximal portion of the housing, the spring retainer element including a tubular spring retainer member; and

a spring at least partially retained within the spring retainer 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,

and wherein the hub is configured such that the spring and the spring retainer element are retained within one of the first and second housing elements upon separation of the housing and the actuator.

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

3. The hemostasis hub of claim 2 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 2 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.

5. The hemostasis hub of claim 4 wherein the actuator retainer members are configured to releasably maintain the actuator in the open position.

6. The hemostasis hub of claim 2 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.

7. The hemostasis hub of claim 6 wherein the spring is configured to bias the actuator to the closed position.

8. The hemostasis hub of claim 7 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.

9. The hemostasis hub of claim 8 wherein the spring retainer member is received by the channel of the actuator body portion, wherein the spring is retained within the channel and the spring retainer member.

10. The hemostasis hub of claim 6 and further comprising a plurality of springs 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 a pair of channels extending proximally from the distal end of the body portion in each of the first and second actuator elements, and wherein each of the springs is partially retained within one of the channels.

12. The hemostasis hub of claim 11 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 members received therein.

13. The hemostasis hub of claim 12 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.

14. The hemostasis hub of claim 13 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 at least one housing break line.

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

16. 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, the housing having at least one predetermined housing break line extending generally longitudinally through the proximal and distal portions such that the housing is splittable or separable into first and second housing elements each having a distal end, the distal end of the second housing element extending distally with respect to the distal end of the first housing element and operable to support the proximal end of the catheter;

a hemostasis seal within the housing;

an actuator including a body portion partially slidably disposed in the interior space, a dilator member extending distally from the body portion configured to dilate the seal, and an actuator lumen extending through the dilator member, the actuator being splittable or separable along an actuator break line generally aligned with the at least one predetermined housing break line;

a spring retainer element disposed in the housing having a tubular spring retainer member; and

a spring disposed within the spring retainer member,

wherein the hub is configured such that the spring and the spring retainer element are retained within a portion of the housing upon separation of the housing and the actuator.

17. The hemostasis hub of claim 16 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.

18. 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 each having a distal end, and at least one predetermined housing break line extending generally longitudinally through the proximal and distal portions, the distal end of the second housing element extending distally with respect to the distal end of the first housing element and operable to support the proximal end of the catheter;

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

an actuator including mating first and second actuator elements defining an actuator body portion partially slidably disposed within the housing and a dilator extending distally from the body portion configured to dilate the seal for introducing an elongate medical device or instrument into the catheter lumen;

first and second spring retainer elements each including a tubular spring retainer member; and

a first spring retained within the spring retainer member of the first spring retainer element, and a second spring retained within the spring retainer member of the second spring retainer element,

wherein the hub is further configured to be splittable along the at least one predetermined housing break line into a first hub subassembly including the first housing element, the first actuator element, the first spring retainer element, and the first spring, and a second hub subassembly including the second housing element, the second actuator element, the second spring retainer element, and the second spring.

19. The assembly of claim 18 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.

20. The assembly of claim 19 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.

21. The assembly of claim 20 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.