Device and methods for delivery and transfer of temporary radiopaque element

• US 8,828,040 B2
• Filed: 07/06/2010
• Issued: 09/09/2014
• Est. Priority Date: 07/07/2009
• Status: Active Grant

• Current Assignee: Thomas G. Goff
• Original Assignee: Thomas G. Goff
• Inventors: Goff, Thomas G.
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): LOUIS, RICHARD G
• Application Number:
  US12/831,048
• Publication Number:
  US 20110009818A1
• Time in Patent Office: 1,526 Days
• Field of Search: 606/1, 606191-192, 600/467, 604/265, 604/103.1, 604/103.02, 623/2.11
• US Class Current: 606/194
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device for the transfer of radiopaque material within the body comprises a valvuloplasty or other balloon coated with the radiopaque material. The balloon is inflated in the aortic valve for marking the site of an aortic annulus to enable accurate placement of prosthetic valves under fluoroscopic imaging.

Claims

1. A method for marking a valve structure in a heart, said method comprising:

providing an expandable member having a radiopaque material releasably carried on an external surface thereof;

expanding the expandable member within the valve structure in the heart to transfer at least a portion of the radiopaque material to an implantation site in the valve structure prior to implanting a prosthetic valve at the implantation site;

removing the expandable member from the valve structure after the radiopaque material has been transferred to the implantation site; and

fluoroscopically imaging the transferred radiopaque material on the valve structure, wherein the radiopaque material delineates the implantation site on the valve structure prior to implantation of the prosthetic valve.

2. A method as in claim 1, wherein the valve structure comprises an aortic valve site and the implantation site includes at least one of an aortic root, aortic valve, and aortic valve annulus.

3. A method as in claim 2, further comprising:

implanting the prosthetic aortic valve at the implantation site.

4. A method as in claim 3, wherein expanding the expandable member comprises inflating a balloon within the aortic valve site.

5. A method as in claim 4, wherein said balloon inflation opens the valve leaflets and breaks calcification present on or between the leaflets.

6. A method as in claim 5, wherein the balloon is inflated to a pressure in the range from 0.1 atmosphere to 20 atmospheres.

7. A method as in claim 1, wherein the radiopaque material is coated over at least a portion of the surface of the expandable member.

8. A method as in claim 1, wherein the radiopaque material is disposed in a porous structure of the expandable member.

9. A method as in claim 1, wherein the radiopaque material is disposed in wells found on the external surface of the expandable member.

10. A method as in claim 1, wherein the radiopaque material is present on the external surface as a plurality of microdots.

11. A method as in claim 1, wherein the radiopaque material is present on the external surface under a membrane.

12. A method as in claim 1, wherein the valve structure comprises mitral valve chordae.

13. A method as in claim 1, further comprising removing expandable member prior to fluoroscopically imaging the valve structure.

14. A method as in claim 13, further comprising performing an intervention at the target site while fluoroscopically imaging the valve structure after the expandable member has been removed.

15. A method as in claim 14, wherein performing an intervention comprises placing a prosthetic valve at the target site.