Cutting balloon assembly and method of manufacturing thereof

• US 20110082483A1
• Filed: 10/01/2009
• Published: 04/07/2011
• Est. Priority Date: 10/01/2009
• Status: Active Grant

• Current Assignee: Nordson Corporation
• Original Assignee: Cardioniti Ltd. (Nordson Corporation)
• Inventors: DIAMANT, Valery, DANENBERG, Haim, YASKO, Nadezda, LOTAN, Chaim
• Granted Patent: US 8,992,553 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A cutting balloon assembly and a method for fabrication of the assembly is described. The cutting balloon assembly comprises a delivery catheter, an expandable balloon mounted on the catheter distal end, and a scoring mesh disposed around the expandable balloon. The scoring mesh comprises interlacing filaments that extend from a mesh proximal end towards a mesh distal end, form distal filament loops at said mesh distal end, and then return to the mesh proximal end. At least a part of the interlacing filaments forms one or more permanent links with neighboring filaments between the mesh proximal end and the mesh distal end.

Claims

1. A cutting balloon assembly, comprising:

a delivery catheter having a catheter proximal end, a catheter distal end, and at least one catheter lumen extending between the catheter proximal and distal ends;

an expandable balloon having a balloon proximal end and a balloon distal end, said expandable balloon mounted on the catheter distal end; and

a scoring mesh disposed around the expandable balloon, said scoring mesh comprising interlacing filaments that interweave between a mesh proximal end and a mesh distal end and form at least distal filament loops at said mesh distal end;

at least a part of the filament of said interlacing filaments intertwines with neighboring filaments to form at least one permanent link.

2. The cutting balloon assembly of claim 1, wherein said scoring mesh is connected to the balloon proximal and distal ends.

3. The cutting balloon assembly of claim 1 comprising at least one distal string wound round the balloon distal end and passing through openings in the distal filament loops, thereby to tie said distal filament loops of the scoring mesh to the balloon distal end.

4. The cutting balloon assembly of claim 1, wherein said interlacing filaments also form proximal filament loops at the mesh proximal end.

5. The cutting balloon assembly of claim 4 comprising at least one proximal string wound round the balloon proximal end and passing through the openings in the proximal filament loops, thereby to tie said proximal filament loops of the scoring mesh to the balloon proximal end.

6. The cutting balloon assembly of claim 1 comprising at least one distal string wound round the delivery catheter after the balloon distal end in relation to an operator using the cutting balloon assembly, said at least one string passes through the openings in the distal filaments loops, thereby to tie said scoring mesh to said delivery catheter.

7. The cutting balloon assembly of claim 1 comprising at least one proximal string wound round the delivery catheter before the balloon proximal end in relation to an operator using the cutting balloon assembly, thereby to tie the filaments at the mesh proximal end to said delivery catheter.

8. The cutting balloon assembly of claim 1, wherein the scoring mesh includes scoring elements.

9. The cutting balloon assembly of claim 8, wherein the scoring elements are formed by twisted turns of the intertwined filaments forming said at least one permanent link.

10. The cutting balloon assembly of claim 8, wherein the scoring elements are dedicated elements attached to or placed around the filaments forming the scoring mesh.

11. The cutting balloon assembly of claim 1, wherein the filaments of the scoring mesh are radiopaque.

12. The cutting balloon assembly of claim 1, wherein at least a part of the scoring mesh comprises an active pharmacological agent that can inhibit inflammation and smooth-muscle cell growth.

13. The cutting balloon assembly of claim 1 comprising a guiding catheter including a lumen for housing the delivery catheter, the lumen having sufficient size for receiving the distal end of the delivery catheter therethrough together with the locator unit in a contracted condition.

14. The cutting balloon assembly of claim 1 comprising at least one guide wire.

24. The cutting balloon assembly of claim 11 configured for a simulation of an optimal position for deployment of a stent.

25. The cutting balloon assembly of claim 24, wherein said simulation comprises:

advancing said balloon assembly, by using fluoroscopy, over a guidewire within the cardiovascular system of a patient so that to place the balloon adjacent a stenotic lesion inside a stenosed region;

inflating the balloon; and

taking angiograms of the radioopaque scoring mesh.

26. The cutting balloon assembly of claim 25, wherein said simulation further comprises processing and analyzing an image of the radioopaque scoring mesh on said angiograms so as to obtain said optimal position for deployment of the stent.

15. A method for fabrication of a cutting balloon assembly, comprising:

(a) providing a predetermined number of filaments having predetermined properties, diameter and length;

(b) fabricating a scoring mesh from said filaments, comprising;

providing a weaving jig having a cylindrical structure including a plurality of pins disposed circumferentially about the surface of the structure in rows and extending outwardly therefrom;

placing the filaments between the pins and interlacing the filaments to form a scoring mesh having a mesh proximal end and a mesh distal end;

said interlacing the filaments comprising interweaving the filaments between the mesh proximal end and the mesh distal end, and intertwining at least a part of filament of said interlacing filaments to form at least one permanent link with neighboring filaments;

forming at least distal filament loops at said mesh distal end;

annealing the scoring mesh;

(c) providing a delivery catheter having a catheter proximal end, a catheter distal end, and at least one catheter lumen extending between the catheter proximal and distal ends;

(d) providing an expandable balloon having a balloon proximal end and a balloon distal end, said expandable balloon mounted on the catheter distal end; and

(e) mounting said scoring mesh on said expandable balloon.

16. The method of claim 15, wherein said fabricating of the scoring mesh includes providing scoring elements on the filaments forming the scoring mesh.

17. The method of claim 15, wherein said fabricating of the scoring mesh includes providing an active pharmacologic agent within the scoring mesh.

18. The method of claim 17, wherein said providing of the active pharmacologic agent includes coating at least a portion of a surface of the filaments with a material including said agent.

19. The method of claim 15, wherein said mounting of said scoring mesh on said expandable balloon includes connecting said scoring mesh to the balloon proximal and distal ends.

20. The method of claim 15, wherein said mounting of said scoring mesh on said expandable balloon includes connecting said scoring mesh to said delivery catheter after the balloon distal end and before the balloon proximal end in relation to an operator using the cutting balloon assembly.

21. The method of claim 15, wherein said mounting of said scoring mesh on said expandable balloon includes winding at least one distal string around the balloon distal end and passing through openings in said distal filament loops, thereby to tie said distal filament loops of the scoring mesh to the balloon distal end.

22. The method of claim 15 further comprising forming proximal filament loops at the mesh proximal end.

23. The method of claim 15, wherein said mounting of said scoring mesh on said expandable balloon includes winding at least one proximal string around the balloon proximal end and passing through the openings in the proximal filament loops, thereby to tie said proximal filament loops of the scoring mesh to the balloon proximal end.