Cutting balloon with connector and dilation element

• US 9,604,036 B2
• Filed: 05/02/2012
• Issued: 03/28/2017
• Est. Priority Date: 03/13/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Burton, David G., Schaeffer, Darin G., Drewes, David A.
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US13/462,458
• Publication Number:
  US 20120215251A1
• Time in Patent Office: 1,791 Days
• Field of Search: 606/159, 60410306-10309, 604/0.14
• US Class Current: 1/1
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: B29C 2049/2017 outside the article
• CPC Class Codes: B29C 49/04 Extrusion blow-moulding
• CPC Class Codes: B29C 49/20 of articles having inserts or reinforcements ; Handling of inserts or reinforcements
• CPC Class Codes: B29K 2067/003 PET, i.e. poylethylene terephthalate
• CPC Class Codes: B29K 2077/00 Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7543 Balloon catheters

Abstract

A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements.

Claims

1. A balloon catheter for dilation of a vessel wall, comprising:

a balloon having a tapered distal portion, and a tapered proximal portion, wherein at least a length of an outer surface of the balloon comprises a working diameter between the distal portion and the proximal portion adapted to dilate the vessel wall;

a shaft having a distal end and a proximal end, the balloon being mounted on the distal end of the shaft, wherein the shaft further comprises an inflation lumen extending therethrough in fluid communication with an interior region of the balloon, the balloon thereby being expandable between a deflated state and an inflated state;

a protuberance continuously extending from the proximal portion to the distal portion and disposed along the outer surface of the balloon, the protuberance being affixed to the outer surface of the balloon at an interface region, the protuberance comprising a dilation element and a connector being formed from a structural element and extension element, respectively, by an expansion of a parison into the balloon, the structural element and extension element being created by extrusion of the parison prior to blow-molding the balloon, the dilation element extending away from the outer surface of the balloon and being characterized by a second effective width, the connector connecting the dilation element to the outer surface of the balloon at the interface region, the connector characterized by a first effective width less than the second effective width of the dilation element

wherein a lower portion of the connector comprises a first polymeric material and an upper portion of the connector comprises a second polymeric material more rigid than the first polymeric material and wherein the balloon also comprises the first polymeric material and the dilation element also comprises the second polymeric material.

2. The balloon catheter of claim 1, wherein the interface region is characterized by a wall thickness greater than a wall thickness of a noninterface region disposed along another portion of the outer surface of the balloon.

3. The balloon catheter of claim 1, wherein the protuberance extends along the working diameter of the balloon.

4. The balloon catheter of claim 1, wherein the protuberance is integral with the balloon.

5. The balloon catheter of claim 1, wherein the outer surface of the balloon in the deflated state comprises a plurality of pleats wrapped about an axis of the balloon.

6. The balloon catheter of claim 5, wherein the protuberance is present multiple times, forming multiple protuberances, and wherein one of the multiple protuberances is disposed along a top of each of the pleats.

7. The balloon catheter of claim 6, wherein the interface region is characterized by a wall thickness greater than a wall thickness of a noninterface region disposed along another portion of the outer surface of the balloon.

8. The balloon catheter of claim 1, wherein the dilation element has a rounded outer edge.

9. The balloon catheter of claim 1, wherein the dilation element has a flattened outer edge.

10. The balloon catheter of claim 1, wherein the dilation element has straight edges inwardly tapered toward an outer edge of the dilation element.

11. The balloon catheter of claim 1, wherein the dilation element is asymmetrical relative to the connector.

12. The balloon catheter of claim 1, wherein the interface region is characterized by a wall thickness greater than a wall thickness of a noninterface region disposed along another portion of the outer surface of the balloon, the protuberance extends along the working diameter of the balloon, the outer surface of the balloon in the deflated state comprises a plurality of pleats wrapped about an axis of the balloon, and the dilation element has a flattened outer edge.