Variable Stiffness Balloon Catheter and Related Systems and Methods

• US 20160114125A1
• Filed: 10/26/2015
• Published: 04/28/2016
• Est. Priority Date: 10/27/2014
• Status: Abandoned Application

• Current Assignee: QXMedical, LLC
• Original Assignee: QXMedical, LLC
• Inventors: Di Caprio, Fernando, Panarello, Gianfranco
• Application Number:
  US14/922,736
• Publication Number:
  US 20160114125A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• 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: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/19 the layers being joined at their edges
• CPC Class Codes: B29C 48/2692 Material change
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

The various embodiments herein relate to balloon catheters, and more specifically to balloon catheters having variable stiffnesses.

Claims

1. A balloon catheter comprising:

(a) a catheter shaft comprising;

(i) a proximal segment of the catheter shaft having a first predetermined stiffness;

(ii) a distal segment of the catheter shaft having a second predetermined stiffness; and

(iii) a transition zone disposed between the proximal segment and the distal segment, wherein the transition zone comprises a stiffness that varies gradually along a length of the zone; and

(b) an expandable balloon operably coupled to the catheter shaft;

2. The balloon catheter of claim 1, wherein the second predetermined stiffness is lower than the first predetermined stiffness.

3. The balloon catheter of claim 1, wherein the first and second predetermined stiffnesses are higher than any portion of the stiffness of the transition zone.

4. The balloon catheter of claim 1, wherein the transition zone comprises proximal, middle and distal portions, wherein the proximal and distal portions are stiffer than the middle portion.

5. The balloon catheter of claim 1, wherein the transition zone comprises a proximal portion and a distal portion, wherein the proximal portion is stiffer than the distal portion.

6. The balloon catheter of claim 1, further comprising a second transition zone disposed distally of the distal segment, wherein the second transition zone comprises a proximal portion and a distal portion, wherein the proximal portion is more flexible than the distal portion.

7. The balloon catheter of claim 6, further comprising a second distal segment distal to the second transition zone, wherein the second distal segment has a predetermined stiffness.

8. The balloon catheter of claim 1, wherein the gradual variation in the stiffness is caused by a gradual variation in a composition of the transition zone.

9. The balloon catheter of claim 8, wherein the gradual variation in the composition comprises a gradual variation in amounts of at least two different components.

10. The balloon catheter of claim 1, wherein a proximal portion of the transition zone comprises a stiffness substantially similar to the first predetermined stiffness and a distal portion of the transition zone comprises a stiffness substantially similar to the second predetermined stiffness.

11. A method for performing a medical procedure, the method comprising:

inserting a balloon catheter over a guidewire into a blood vessel through an entry site, the balloon catheter comprising;

(a) a catheter shaft comprising;

(i) a proximal segment of the catheter shaft having a predetermined stiffness;

(ii) a distal segment of the catheter shaft having a predetermined stiffness that is lower than the proximal segment; and

(iii) a transition zone disposed between the proximal segment and the distal segment, wherein the transition zone comprises a stiffness that varies gradually along a length of the zone; and

(b) an expandable balloon operably coupled to the catheter shaft;

positioning the balloon within an anatomical structure;

inflating the balloon;

deflating the balloon; and

retracting the balloon catheter from the blood vessel.

12. The method of claim 11, wherein the medical procedure is an endovascular aortic repair procedure, wherein the blood vessel is an aorta or neighboring vessel, wherein the inflating the balloon further comprises expanding a stent or improving apposition of the stent.

13. The method of claim 11, wherein the medical procedure is vessel occlusion.

14. The method of claim 11, wherein the medical procedure is sizing of the blood vessel or another anatomical structure.

15. The method of claim 11, wherein the medical procedure is vessel or structural remodeling.

16. A method for performing a medical procedure, the method comprising:

inserting a balloon catheter over a guidewire into a blood vessel through an entry site, the balloon catheter comprising;

(a) a catheter shaft comprising;

(i) a proximal segment of the catheter shaft having a predetermined stiffness;

(ii) a distal segment of the catheter shaft having a predetermined stiffness that is lower than the proximal length; and

(iii) a middle segment disposed between the proximal segment and the distal segment; and

(b) an expandable balloon operably coupled to the catheter shaft;

positioning the balloon within an anatomical structure;

inflating the balloon;

deflating the balloon; and

retracting the balloon catheter from the blood vessel.

17. The method of claim 16, wherein the medical procedure is an endovascular aortic repair procedure, wherein the blood vessel is an aorta or neighboring vessel, wherein the inflating the balloon further comprises expanding a stent or improving apposition of the stent.

18. The method of claim 16, wherein the medical procedure is vessel occlusion.

19. The method of claim 16, wherein the medical procedure is sizing of the blood vessel or another anatomical structure.

20. The method of claim 16, wherein the medical procedure is vessel or structural remodeling.

21. The method of claim 16, wherein the middle segment has a stiffness that is lower than the proximal segment and higher than the distal segment.

22. The method of claim 16, wherein the middle segment has a stiffness that is substantially the same as the proximal segment.

23. The method of claim 16, wherein the middle segment has a stiffness that is substantially the same as the distal segment.

24. A method for performing a medical procedure, the method comprising:

inserting a balloon catheter over a guidewire into a blood vessel through an entry site, the balloon catheter comprising;

(a) a catheter shaft comprising

a transition zone comprising a stiffness that varies gradually along a length of the zone, wherein a proximal portion of the transition zone is stiffer than a distal portion of the transition zone; and

(b) an expandable balloon operably coupled to the catheter shaft;

positioning the balloon within an anatomical structure;

inflating the balloon;

deflating the balloon; and

retracting the balloon catheter from the blood vessel.

25. The method of claim 24, wherein the medical procedure is an endovascular aortic repair procedure, wherein the blood vessel is an aorta or neighboring vessel, wherein the inflating the balloon further comprises expanding a stent or improving apposition of the stent.

26. The method of claim 24, wherein the medical procedure is vessel occlusion.

27. The method of claim 24, wherein the medical procedure is sizing of the blood vessel or another anatomical structure.

28. The method of claim 24, wherein the medical procedure is vessel or structural remodeling.

29. The method of claim 24, wherein the first predetermined stiffness is a higher stiffness, wherein the catheter shaft further comprises a higher stiffness segment distal to the transition zone.

30. The method of claim 24, wherein the catheter shaft further comprises a proximal segment of the catheter shaft having a first predetermined stiffness, wherein the proximal segment is disposed proximally of the transition zone.

31. The method of claim 24, wherein the catheter shaft further comprises a distal segment of the catheter shaft having a second predetermined stiffness, wherein the distal segment is disposed distally of the transition zone.

32. A method for performing a medical procedure, the method comprising:

inserting a balloon catheter over a guidewire through an entry site, the balloon catheter comprising;

(a) a catheter shaft comprising;

(i) first higher stiffness length at a proximal portion of the catheter shaft;

(ii) a first medium stiffness length distal to the first higher stiffness length;

(iii) a higher flexibility length distal to the first medium stiffness length; and

(iv) a second medium stiffness length distal to the higher flexibility length; and

(b) an expandable balloon operably coupled to the catheter shaft;

positioning the balloon within an anatomical structure;

inflating;

deflating the balloon; and

retracting the balloon catheter from the blood vessel.

33. The method of claim 32, wherein the medical procedure is an endovascular aortic repair procedure, wherein the blood vessel is an aorta or neighboring vessel, wherein the inflating the balloon further comprises expanding a stent or improving apposition of the stent.

34. The method of claim 32, wherein the medical procedure is vessel occlusion.

35. The method of claim 32, wherein the medical procedure is sizing of the blood vessel or another anatomical structure.

36. The method of claim 32, wherein the medical procedure is vessel or structural remodeling.

37. The method of claim 32, wherein the catheter shaft further comprises a second higher stiffness length distal to the second medium stiffness length.