Expandable Support Frame and Medical Device

• US 20180055635A1
• Filed: 11/06/2017
• Published: 03/01/2018
• Est. Priority Date: 02/11/2013
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Krieger, Joshua, Chambers, Sean, Berwick, Zachary, Kassab, Ghassan
• Granted Patent: US 11,406,495 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded

Abstract

Support frames and medical devices are described. An example medical device comprises an expandable support frame with first and second leaflets attached to the support frame. Each of the first and second leaflets defines a domed radius that is equal to or less than the radius of the expandable support frame when the expandable support frame is in an expanded configuration and the leaflets are subjected to fluid pressure sufficient to affect closure of the valve orifice.

Claims

1. A medical device for regulating fluid flow through a body vessel of a patient, comprising:

an expandable support frame having a longitudinal axis, an outer circumference, an unexpanded configuration, the support frame comprising;

a first connector segment comprising substantially parallel first and second struts and a first connecting bar extending between and joining the first and second struts;

a second connector segment disposed substantially opposite the first connector segment with respect to said longitudinal axis, the second connector segment comprising substantially parallel third and fourth struts and a second connecting bar extending between and joining the third and fourth struts;

a third connector segment disposed circumferentially adjacent the first and second connector segments;

a fourth connector segment disposed substantially opposite the third connector segment with respect to said longitudinal axis;

a proximal portion defining a first circumferential serpentine path joined to the first, second, third, and fourth connector segments; and

a distal portion defining a second circumferential serpentine path joined to the first, second, third, and fourth connector segments and comprising a first connector strut extending between and joining the first and third connector segments, a second connector strut extending between and joining the second and third connector segments, a third connector strut extending between and joining the first and fourth connector segments, and a fourth connector strut extending between and joining the second and fourth connector segments, each of the connector struts comprising a curvilinear strut that includes a straight portion;

a first leaflet attached to the support frame along an attachment pathway extending along the first and second connector struts and along a first portion of the first connector segment and a first portion of the second connector segment, the first leaflet having a first free edge and a first inner surface; and

a second leaflet attached to the support frame along a second attachment pathway extending along the third and fourth connector struts and along a second portion of the first connector segment and a second portion of the second connector segment, the second leaflet having a second free edge and a second inner surface;

wherein the first and second free edges cooperatively define a valve orifice.

2. The medical device of claim 1, wherein the first portion of the first connector segment is about ¼

^th the height of the first connector segment.

3. The medical device of claim 2, wherein the first portion of the second connector segment is about ¼

^th the height of the second connector segment.

4. The medical device of claim 3, wherein the first connecting bar is positioned on a first transverse axis of the support frame that orthogonally intersects the first connector segment at a point that is about ¼

^th the height of the first connector segment; and

wherein the second connecting bar is positioned on a second transverse axis of the support frame that orthogonally intersects the second connector segment at a point that is about ¼

^th the height of the second connector segment.

5. The medical device of claim 1, further comprising a third connecting bar extending between the first and second struts.

6. The medical device of claim 5, further comprising a fourth connecting bar extending between the third and fourth struts.

7. The medical device of claim 1, wherein the support frame is free of additional struts between the first connector segment and the third connector segment.

8. The medical device of claim 7, wherein the support frame is free of additional struts between the second connector segment and the third connector segment.

9. The medical device of claim 8, wherein the support frame is free of additional struts between the first connector segment and the fourth connector segment.

10. The medical device of claim 9, wherein the support frame is free of additional struts between the second connector segment and the fourth connector segment.

11. The medical device of claim 1, wherein the first and second leaflets comprise a natural material.

12. The medical device of claim 11, wherein the natural material comprises a bioremodelable material.

13. The medical device of claim 12, wherein the bioremodelable material comprises an extracellular matrix material.

14. The medical device of claim 13, wherein the extracellular matrix material comprises small intestine submucosa.

15. The medical device of claim 13, wherein the extracellular matrix material is selected from the group consisting of stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater.

16. The medical device of claim 11, wherein the natural material comprises lung ligament.

17. The medical device of claim 11, wherein the natural material comprises visceral pleura.

18. The medical device of claim 11, wherein the natural material comprises fixed tissue.

19. A medical device for regulating fluid flow through a body vessel of a patient, comprising:

an expandable support frame having a longitudinal axis, an outer circumference, an unexpanded configuration, the support frame comprising;

a first connector segment comprising substantially parallel first and second struts and a first connecting bar extending between and joining the first and second struts on a first transverse axis that orthogonally intersects the first connector segment at a point that is about ¼

^th the height of the first connector segment;

a second connector segment disposed substantially opposite the first connector segment with respect to said longitudinal axis, the second connector segment comprising substantially parallel third and fourth struts and a second connecting bar extending between and joining the third and fourth struts on a second transverse axis that orthogonally intersects the second connector segment at a point that is about ¼

^th the height of the second connector segment;

a third connector segment disposed circumferentially adjacent the first and second connector segments;

a fourth connector segment disposed substantially opposite the third connector segment with respect to said longitudinal axis;

a proximal portion defining a first circumferential serpentine path joined to the first, second, third, and fourth connector segments; and

a distal portion defining a second circumferential serpentine path joined to the first, second, third, and fourth connector segments and comprising a first connector strut extending between and joining the first and third connector segments, a second connector strut extending between and joining the second and third connector segments, a third connector strut extending between and joining the first and fourth connector segments, and a fourth connector strut extending between and joining the second and fourth connector segments, each of the connector struts comprising a curvilinear strut that includes a straight portion;

a first leaflet attached to the support frame along an attachment pathway extending along the first and second connector struts and along a first portion of the first connector segment to the first connecting bar and a first portion of the second connector segment to the second connecting bar, the first leaflet having a first free edge and a first inner surface; and

a second leaflet attached to the support frame along a second attachment pathway extending along the third and fourth connector struts and along a second portion of the first connector segment to the first connecting bar and a second portion of the second connector segment to the second connecting bar, the second leaflet having a second free edge and a second inner surface;

wherein the first and second free edges cooperatively define a valve orifice.

20. A medical device for regulating fluid flow through a body vessel of a patient, comprising:

an expandable support frame having a longitudinal axis, an outer circumference, an unexpanded configuration, the support frame comprising;

a first connector segment comprising substantially parallel first and second struts and a first connecting bar extending between and joining the first and second struts on a first transverse axis that orthogonally intersects the first connector segment at a point that is about ¼

^th the height of the first connector segment;

a second connector segment disposed substantially opposite the first connector segment with respect to said longitudinal axis, the second connector segment comprising substantially parallel third and fourth struts and a second connecting bar extending between and joining the third and fourth struts on a second transverse axis that orthogonally intersects the second connector segment at a point that is about ¼

^th the height of the second connector segment;

a third connector segment disposed circumferentially adjacent the first and second connector segments;

a fourth connector segment disposed substantially opposite the third connector segment with respect to said longitudinal axis;

a proximal portion defining a first circumferential serpentine path joined to the first, second, third, and fourth connector segments; and

a distal portion defining a second circumferential serpentine path joined to the first, second, third, and fourth connector segments and comprising a first connector strut extending between and joining the first and third connector segments, a second connector strut extending between and joining the second and third connector segments, a third connector strut extending between and joining the first and fourth connector segments, and a fourth connector strut extending between and joining the second and fourth connector segments, each of the connector struts comprising a curvilinear strut that includes a straight portion;

a first leaflet attached to the support frame along an attachment pathway extending along the first and second connector struts and along a first portion of the first connector segment to the first connecting bar and a first portion of the second connector segment to the second connecting bar, the first leaflet comprising fixed natural tissue comprising visceral pleura and having a first free edge and a first inner surface; and

a second leaflet attached to the support frame along a second attachment pathway extending along the third and fourth connector struts and along a second portion of the first connector segment to the first connecting bar and a second portion of the second connector segment to the second connecting bar, the second leaflet comprising fixed natural tissue comprising visceral pleura and having a second free edge and a second inner surface;

wherein the first and second free edges cooperatively define a valve orifice.