Vascular access system with connector

• US 9,278,172 B2
• Filed: 09/06/2012
• Issued: 03/08/2016
• Est. Priority Date: 09/06/2011
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Cryolife Incorporated
• Inventors: Herrig, Judson A.
• Primary Examiner(s): Lynch, Robert
• Application Number:
  US13/605,678
• Publication Number:
  US 20130060268A1
• Time in Patent Office: 1,279 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration

Abstract

A connector for fluidly coupling proximal and distal tubular segments of a fluid conduit is provided. In one embodiment, the connector can include a connector body having an outer surface defining a first outer perimeter and an inner surface defining a lumen. The connector can also include a connecting device having an open configuration and a plurality of closed configurations. The connecting device can include first and second members configured to engage each other to secure the fluid conduit to the connector. The connecting device can also include a plurality of closed configurations for securing fluid conduits of different sizes.

Claims

1. A system for providing continuous flow of blood between two locations in a cardiovascular system of a patient, comprising:

a blood conduit having a distal portion and a proximal portion, the distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced therethrough to a location spaced apart from the insertion site; and

a connector comprising;

a tubular body comprising a proximal portion and a distal portion, wherein the distal portion of the tubular body is configured to engage the proximal portion of the blood conduit, and wherein the proximal portion of the tubular body is configured to be inserted into an end of a vascular graft;

a flange extending from the tubular body between the proximal portion of the tubular body and the distal portion of the tubular body; and

a connecting device comprising first and second members pivotably connected together at one end by a hinge mechanism having one axis of rotation mounted to the flange, wherein the first and second members comprise an open configuration and a first closed configuration providing a first gap between an inner surface of the first and second members and an outer surface of the proximal portion of the tubular body and a second closed configuration providing a second gap between the inner surface of the first and second members and the outer surface of the proximal portion of the tubular body;

wherein the first gap accommodates a first vascular graft having an inner perimeter matching the outer perimeter of the proximal portion of the tubular body and a first wall thickness and the second gap accommodates a second vascular graft having an inner perimeter matching the outer perimeter of the proximal portion of the tubular body and a second wall thickness different than the first wall thickness;

whereby continuous flow is provided from grafts of different wall thicknesses through the connector and into the blood conduit.

2. The system of claim 1, wherein the first and second closed configurations are for securing fluid conduits of different sizes and the first and second members have second ends disposed away from the end pivotably connected to the flange.

3. The system of claim 2, wherein the first member has a plurality of notches formed on a surface of the first member adjacent to the second end of the first member, the second end of the second member being configured to engage the notches of the first member.

4. The system of claim 3, wherein the connector has a first configuration in which the second end of the second member engages a first range of notches, the connector also having a second configuration in which the second end of the second member engages a second range of notches including at least one notch between the first range of notches and the first end of the first member.

5. The system of claim 3, wherein the second member comprises a second plurality of notches formed on a surface of the second end of the second member configured to engage at least one notch of the plurality of notches of the first member.

6. A connector for implantation in a cardiovascular system, the connector comprising:

a tubular body comprising a distal tubular body and a proximal tubular body;

a flange extending from the tubular body between the proximal tubular body and distal tubular body; and

a connecting device, comprising;

a first member having a first end pivotably coupled with the flange, a second end disposed away from the first end of the first member, and a plurality of notches formed on a surface of the first member adjacent to the second end of the first member; and

a second member having a first end pivotably coupled with the flange, a second end disposed away from the first end of the second member, and a second plurality of notches formed on a surface of the second end of the second member configured to engage at least one notch of the plurality of notches of the first member to secure an inflow component to the proximal tubular body,

wherein the first end of the first member and the first end of the second member are pivotably connected together by a hinge mechanism having one axis of rotation mounted to the flange,

wherein the connecting device comprises an open configuration and one or more closed configurations comprising a gap between an inner surface of the first and second members and an outer surface of the proximal tubular body.

7. The connector of claim 6, wherein the connecting device further comprises a plurality of closed configurations configured to secure inflow components of different sizes to the proximal tubular body.

8. The connector of claim 6, wherein the connective device has a first closed configuration in which the second end of the second member engages a first range of notches, the connecting device also having a second closed configuration in which the second end of the second member engages a second range of notches including at least one notch between the first range of notches and the first end of the first member.

9. The connector of claim 6, further comprising a spring disposed about the hinge mechanism, in communication with the first and second members, and configured to (i) maintain the connector in an open configuration, and/or (ii) apply a force between at least one notch of the plurality of notches of the first member and at least one notch of the plurality of notches of the second member when in a closed configuration.

10. The connector of claim 6, further comprising a plurality of engagement features disposed on an outer surface of the distal tubular body.

11. The connector of claim 6, further comprising a plurality of engagement features disposed on the outer surface of the proximal tubular body.

12. The connector of claim 6, further comprising shrouds extending out from a portion of each of the first and second members.

13. The connector of claim 12, further comprising a plurality of engagement features disposed on an inner surface of the shrouds.

14. The connector of claim 6, further comprising a first slot positioned adjacent to the second end of the first member, the first slot configured to enable the second end of the first member to deflect away from the second end of the second member by an amount sufficient to enable the first plurality of notches to slide past the second plurality of notches when so deflected.

15. The connector of claim 6, further comprising a second slot positioned adjacent to the second end of the second member, the second slot configured to enable the second end of the second member to deflect away from the second end of the first member by an amount sufficient to enable the second plurality of notches to slide past the first plurality of notches when so deflected.

16. The connector of claim 6, further comprising a strain relief structure configured to couple with an end of the connector to form a slip fit with the inflow component for providing strain relief to the inflow component.

17. The connector of claim 16, wherein the strain relief structure comprises an inner sleeve disposed about a distal end of the inflow component configured to be secured between the connecting device and the proximal tubular body.

18. The connector of claim 16, wherein the strain relief structure comprises an elastomeric distal portion and a resilient proximal portion, the elastomeric distal portion configured to elastically expand to receive at least a portion of the connecting device, the resilient proximal portion configured to reduce or minimize excessive narrowing of the inflow component at least adjacent to the proximal tubular body.

19. A method for coupling tubular segments in a cardiovascular system, the method comprising:

radially expand an end of the inflow component with a tissue graft dilator;

engaging the end of the inflow component with the connector of claim 6 such that a lumen of the connector is in fluid communication with a lumen of the inflow component; and

actuating the connecting device from a disengaged configuration to an engaged configuration such that the inflow component is compressed by the connecting device.

20. The method of claim 19, further comprising:

positioning a strain relief structure about the inflow component for providing strain relief to the inflow component; and

coupling the strain relief structure with an end of the connector.

22. A kit for coupling tubular segments in a cardiovascular system, the kit comprising:

the connector of claim 6; and

a tissue graft dilator configured to radially expand an end of the inflow component.

23. The kit of claim 22, further comprising a strain relief structure configured to couple with an end of the connector to form a slip fit with the inflow component for providing strain relief to the inflow component.

24. The kit of claim 23, further comprising a silicone sleeve disposed within the strain relief structure configured to be positioned about the inflow component.

25. The kit of claim 23, further comprising one or more inflow components and/or outflow components.

21. A connector for fluidly coupling proximal and distal tubular segments of a fluid conduit in a cardiovascular system, the connector comprising:

a connector body comprising a proximal portion and a distal portion, wherein the connector body comprises an outer surface defining a first outer perimeter and an inner surface defining a lumen;

a flange extending from the connector body between the proximal portion of the connector body and the distal portion of the connector body;

a connecting device having an open configuration and a plurality of closed configurations, the connecting device comprising;

first and second members pivotably attached together at one end by a hinge mechanism having one axis of rotation mounted to the flange, wherein the first and second members are configured to engage each other to secure the fluid conduit to the connector;

wherein the plurality of closed configurations comprises a plurality of gaps between an inner surface of the first and second members and the outer surface of the proximal tubular body.