Balloon with scoring member

• US 8,348,987 B2
• Filed: 12/22/2009
• Issued: 01/08/2013
• Est. Priority Date: 12/22/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Eaton, Elizabeth A.
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): TANNER, JOCELIN C
• Application Number:
  US12/645,122
• Publication Number:
  US 20110152905A1
• Time in Patent Office: 1,113 Days
• Field of Search: 606/194, 606/192, 606/191, 606/198, 606/195, 606/108, 606/159, 606/167, 606/170, 606/127, 606/128, 623/1.15, 623/1.16, 623/1.22, 623/1.11, 623/1.18, 623/1.2, 623/1.12, 623/1.14, 623/1.3, 623/1.19, 604/509, 604/920, 604/22, 604/915, 604/916, 604/96.01, 60410305-10308, 604/99.01, 604/97.01, 604/97.02, 604/103.11, 604/103, 604/913, 428/36.9
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A circumferentially and longitudinally continuous scoring structure having a diameter in an initial unrestrained state that is smaller than a deflated diameter of the balloon is disposed around an outer surface of the balloon in an expanded configuration. The scoring structure continually exerts a radially inward compressive force against the balloon such that when the balloon is expanded from a deflated configuration to an inflated configuration, the scoring structure expands in a radially outward direction and remains in continuous compressive contact with at least a portion of the balloon as the balloon unfolds. The scoring structure may be entirely free of attachment to the balloon and catheter, and may extend substantially a length of a working region of the balloon. The scoring structure may include a plurality of circumferentially compressible members connecting longitudinal members.

Claims

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

a balloon having a distal portion, and a proximal portion, and a working region disposed therebetween, said working region being sized to dilate a vessel wall;

a catheter having a distal end and a proximal end, said balloon being mounted on a distal portion of said catheter, wherein said catheter further comprises an inflation lumen extending therethrough in fluid communication with an interior region of said balloon, said balloon being expandable between a deflated configuration having a first diameter in which said balloon is folded and an inflated configuration having a second diameter in which said balloon is unfolded, said second diameter being greater than said first diameter;

a circumferentially and longitudinally continuous metallic scoring structure having a diameter in an initial unrestrained relaxed state that is smaller than said first diameter of said balloon, wherein said scoring structure is disposed around an outer surface of said balloon in an expanded state, said scoring structure thereby continually exerting a radially inward compressive force against said balloon, such that when said balloon is expanded and contracted between said deflated configuration at said first diameter and said inflated configuration at said second diameter, said scoring structure expands and contracts in a radial direction and remains in continuous compressive contact with at least a radially outermost portion of said balloon as said balloon is inflated and deflated, said scoring structure returning toward its initial unrestrained relaxed state upon deflation of said balloon, said scoring structure thereby not being capable of being implanted to support said vessel wall;

wherein said scoring structure is entirely free of attachment to said balloon and said catheter, said scoring structure comprising a plurality of structural members having an atraumatic radially inner surface in compressive contact with said balloon, and a radially outer surface shaped to engage and score a vessel wall when said balloon is expanded to said inflated configuration, said structural members of said scoring structure being connected in an undulating pattern forming a plurality of ring structures, each of said ring structures having a substantially cylindrical shape, and a plurality of longitudinal members extending between and connecting each of said ring structures in a continuous uninterrupted manner.

2. The balloon catheter of claim 1, wherein said scoring structure is formed of a super elastic material.

3. The balloon catheter of claim 2, wherein said super elastic material is nitinol.

4. The balloon catheter of claim 1, wherein said radially outer surface of said scoring structure has at least one point of stress concentration.

5. The balloon catheter of claim 1, wherein said radially outer surface of said scoring structure tapers from a first width to a second width, said first width being disposed radially inward of said second width, and wherein said first width is greater than said second width.

6. The balloon catheter of claim 1, wherein said longitudinal members extend along said outer surface of said balloon and parallel to a central axis thereof in both said inflated and deflated configurations.

7. The balloon catheter of claim 1, wherein said longitudinal members have a helical shape extending longitudinally and circumferentially along at least a portion of a length and a circumference of said balloon in said inflated configuration.

8. The balloon catheter of claim 1, wherein said scoring structure extends substantially an entire length of said working region.

9. The balloon catheter of claim 1, wherein said scoring structure is formed from a metallic cannula having super elastic and/or shape memory properties.

10. The balloon catheter of claim 1, wherein said outer surface of said balloon has a first structure and said atraumatic inner surface of said scoring member has a second structure, said first and second structures frictionally engaging each other, thereby maintaining a longitudinal position of said scoring structure relative to said balloon as said scoring structure expands due to said expansion of said balloon to said inflated configuration.

11. The balloon catheter of claim 10, wherein said first and second structures are a series of grooves and protrusions extending around a circumference of said balloon and said scoring structure, respectively.

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

a balloon having a distal portion, and a proximal portion, and a working region disposed therebetween, said working region being sized to dilate a vessel wall;

a catheter having a distal end and a proximal end, said balloon being mounted on a distal portion of said catheter, wherein said catheter further comprises an inflation lumen extending therethrough in fluid communication with an interior region of said balloon, said balloon being expandable between a deflated configuration having a first diameter in which said balloon is folded and an inflated configuration having a second diameter in which said balloon is unfolded, said second diameter being greater than said first diameter;

a circumferentially and longitudinally continuous metallic scoring structure having a diameter in an initial unrestrained relaxed state that is smaller than said first diameter of said balloon, said scoring structure extending substantially an entire length of said working region, wherein said scoring structure is disposed around an outer surface of said balloon in an expanded state, said scoring structure thereby continually exerting a radially inward compressive force against said balloon, such that when said balloon is expanded and contracted between said deflated configuration at said first diameter and said inflated configuration at said second diameter, said scoring structure expands and contracts in a radial direction and remains in continuous compressive contact with at least a radially outermost portion of said balloon as said balloon is inflated and deflated;

said scoring structure returning toward its initial unrestrained relaxed state upon deflation of said balloon, said scoring structure thereby not being capable of being implanted to support said vessel wall;

wherein said scoring structure comprises a plurality of longitudinal members connecting circumferentially compressible members, each of said circumferentially compressible members comprising one of a plurality of ring structures, each ring structure forming an undulating pattern substantially cylindrical in shape, said longitudinal members and said circumferentially compressible members having an atraumatic radially inner surface in compressive contact with said balloon, and a radially outer surface having a scoring portion and an atraumatic portion, said scoring portion being shaped to engage and score a vessel wall when said balloon is expanded to said inflated configuration.

13. The balloon catheter of claim 12, wherein said atraumatic portion of said radially outer surface is fluoroscopically distinguishable from said scoring portion.

14. The balloon catheter of claim 12, wherein said circumferentially compressible members and longitudinal members of a first portion of said scoring structure corresponding to said atraumatic portion of said radially outer surface are arranged in a first pattern and said circumferentially compressible members and longitudinal members of a second portion of said scoring structure corresponding to said scoring portion of said radially outer surface are arranged in a second pattern, said second pattern being different and fluoroscopically distinguishable from said first pattern.

15. The balloon catheter of claim 12, wherein a first ring structure of said plurality of ring structures is disposed at a proximal end of said working region of said balloon and a second ring structure is disposed at a distal end of said working region of said balloon, and wherein said plurality of longitudinal members extend between and connect said first and second ring structures in a continuous uninterrupted manner.

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

a balloon having a distal portion, and a proximal portion, and a working region disposed therebetween, said working region sized to dilate a vessel wall;

a catheter having a distal end and a proximal end, said balloon being mounted on a distal portion of said catheter, wherein said catheter further comprises an inflation lumen extending therethrough in fluid communication with an interior region of said balloon, said balloon being expandable between a deflated configuration having a first diameter in which said balloon is folded and an inflated configuration having a second diameter in which said balloon is unfolded, said second diameter being greater than said first diameter;

a circumferentially and longitudinally continuous metallic scoring structure having a diameter in an initial unrestrained relaxed state that is smaller than said first diameter of said balloon, wherein said scoring structure is disposed around an outer surface of said balloon in an expanded state, said scoring structure thereby continually exerting a radially inward compressive force against said balloon, such that when said balloon is expanded and contracted between said deflated configuration at said first diameter and said inflated configuration at said second diameter, said scoring structure expands and contracts in a radial direction and remains in continuous compressive contact with at least a radially outermost portion of said balloon as said balloon is inflated and deflated, said scoring structure returning toward its initial unrestrained relaxed state upon deflation of said balloon, said scoring structure thereby not being capable of being implanted to support said vessel wall;

wherein said scoring structure is entirely free of attachment to said balloon and said catheter, said scoring structure extending only partially along a length of said working region, said scoring structure having a radially inner surface in compressive contact with said balloon, and a radially outer surface shaped to engage and score a vessel wall when said balloon is expanded to said inflated configuration, said scoring structure comprising a plurality of ring structures each forming an undulating pattern substantially cylindrical shape, and a plurality of longitudinal members extending between and connecting each of said ring structures in a continuous uninterrupted manner.

17. The balloon catheter of claim 16, wherein said scoring structure has at least one sharp outer edge, wherein said longitudinal members and said ring structures have an atraumatic radially inner surface in compressive contact with said balloon.