Spiral balloon catheter

• US 7,766,871 B2
• Filed: 03/27/2008
• Issued: 08/03/2010
• Est. Priority Date: 03/27/2007
• Status: Active Grant

• Current Assignee: Intratech Medical Ltd.
• Original Assignee: Intratech Medical Ltd.
• Inventors: Yaron, Hila, Hirszowicz, Eran
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/078,191
• Publication Number:
  US 20080306440A1
• Time in Patent Office: 859 Days
• Field of Search: 604/101.02, 604/103.07
• US Class Current: 604/103.07
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The present invention provides a balloon catheter system comprising one or more conduits to which are attached a compliant balloon having a non-helical shape in its deflated state, wherein said balloon is constructed such that is capable of adopting a spiral or helical conformation upon inflation. In addition, the present invention also provides methods for using said balloon catheter system.

Claims

1. A balloon catheter system comprising one or more conduits to which is/are attached a compliant balloon having a non-helical shape and surrounding the one or more conduits in a non-spiral manner in its deflated state, wherein said balloon is constructed such that is capable of adopting a spiral or helical conformation upon inflation based upon an intrinsic ability of the balloon.

2. The balloon catheter system according to claim 1, wherein the relative values of the length of the balloon in the deflated state, the elongation fraction and the inner diameter of said balloon in the deflated state are chosen, such that said balloon is capable of adopting a spiral or helical conformation upon inflation.

3. The balloon catheter system according to claim 1, wherein the balloon is attached to a single catheter conduit.

4. The balloon catheter system according to claim 1, wherein the distal neck of the balloon is attached to one catheter conduit while the proximal neck thereof is attached to a second conduit, wherein said first and second conduits are arranged such that at least a portion of the shaft of one of the conduits is disposed within the lumen of the other conduit.

5. The balloon catheter system according to claim 4, further comprising at least one side aperture that connects the lumen of the inner conduit with the space surrounding the outer conduit.

6. The balloon catheter system according to claim 1, further comprising an aspiration tube, the distal end of which is located close to, and on the proximal side of, the proximal neck of the balloon.

21. The balloon catheter system of claim 1, wherein the intrinsic ability is a function of one or more of materials used in construction of said balloon, dimensions of said balloon, and attachment of said balloon at each of its ends to a catheter shaft.

7. A method for removing particulate matter from a body passage in a patient in need of such treatment, comprising the steps of:

a) providing a catheter fitted with a compliant balloon and an aspiration element, wherein said balloon is constructed such that it has a non-spiral shape when deflated and adopts a spiral conformation when inflated;

b) introducing said catheter into a peripheral blood vessel and advancing same until said balloon is located in the region of the particulate matter to be removed;

c) inflating said balloon such that it adopts a spiral conformation, thereby causing said particulate matter to enter said spiral channel thus formed in the external surface of the balloon, and to becomes squeezed and elongated between said balloon and said blood vessel wall;

d) aspirating said squeezed particulate matter into said aspiration element, wherein said aspiration may be performed continuously or intermittently;

e) optionally partially or completely deflating the balloon and re-locating the catheter such that said balloon becomes located in another region of particulate matter to be removed, and repeating steps (c) and (d);

f) completely deflating the balloon and withdrawing the catheter from the patient'"'"'s vasculature.

8. The method according to claim 7, wherein the particulate matter to be removed is thrombotic material.

9. A method for removing thrombotic material from a body passage in a patient in need of such treatment, comprising the steps of:

a) providing a catheter fitted with a compliant balloon, as disclosed hereinabove, wherein said balloon is constructed such that it has a non-spiral shape when deflated and adopts a spiral conformation when inflated;

b) introducing said catheter into a peripheral blood vessel and advancing same until said balloon is located in the region of the thrombotic material to be removed;

c) inflating said balloon such that it adopts a spiral conformation having a spiral channel winding around the external surface of said balloon, thereby causing said thrombotic material to enter said spiral channel and to becomes squeezed and elongated between said balloon and said blood vessel wall;

d) deflating said balloon, thereby creating a space between the deflated balloon and the squeezed thrombotic material, into which a thrombolytic agent may be introduced, thereby enhancing thrombo-dissolution;

e) rapidly repeating steps (c) and (d); and

f) completely deflating the balloon and withdrawing the catheter from the patient'"'"'s vasculature.

10. A method for removing a thrombus from a body passage in a patient in need of such treatment, comprising the steps of:

a) providing a catheter fitted with a compliant balloon, as disclosed hereinabove, wherein said balloon is constructed such that it has a non-spiral shape when deflated and adopts a spiral conformation when inflated;

b) introducing said catheter into a peripheral blood vessel and advancing same until said balloon is located in the region of the thrombus to be removed;

c) trapping the thrombus within the spiral channel formed by inflation of the balloon

d) withdrawing the catheter through the vasculature and out of the body, together with said entrapped thrombus.

11. A balloon catheter system comprising one or more conduits to which are attached an inner compliant balloon having a non-helical shape and surrounding the one or more conduits in a non-spiral manner in its deflated state, said balloon being enclosed by an outer non-compliant or semi-compliant balloon,

wherein the inner balloon is constructed such that upon inflation, said inner balloon is capable of adopting a spiral or helical conformation based upon an intrinsic ability of the balloon,

and wherein said outer balloon is perforated by a first set of pores along most or all of its surface, and is further perforated by a second set of pores or openings at the proximal neck thereof,

wherein the pores of said second set are significantly fewer in number and larger in diameter than said first set.

12. The balloon catheter system according to claim 11, wherein the inner and outer balloons are attached to a single catheter conduit.

13. The balloon catheter system according to claim 11, wherein the distal necks of the inner and outer balloons are attached to one catheter conduit while the proximal necks thereof are attached to a second conduit, wherein said first and second conduits are arranged such that at least a portion of the shaft of one of the conduits is disposed within the lumen of the other conduit.

14. The balloon catheter system according to claim 11, further comprising an annular layer of an absorbent material surrounding the inner balloon.

15. A method for removing particulate matter from a body passage in a patient in need of such treatment, comprising the steps of:

a) providing a catheter system according to claim 11, wherein the outer balloon of said catheter system is perforated by a first set of pores along most or all of its surface, and is further perforated by a second set of pores or openings at the proximal neck thereof, wherein the pores of said second set are significantly fewer in number and larger in diameter than said first set;

b) introducing said catheter into a peripheral blood vessel and advancing same until the balloons are located in the region of the particulate matter to be removed;

c) partially inflating the inner balloon to a first expanded state such that the inner balloon adopts a spiral conformation and such that a spiral channel is formed between said spiral balloon and the outer balloon, said channel becoming filled with particulate matter that has entered said spiral channel through said second set of pores;

d) further inflating the inner balloon to a second expanded state, such that the proximal coils of the spiral-shaped inner balloon block the second set of pores and reduce the volume of the spiral channel formed in step (c), thereby causing the outward passage of particulate matter of a size smaller than the average diameter of the first set of pores through said pores, but retaining particulate matter of particulate matter of a size larger than said average diameter in the reduced space between the inner and outer balloons;

e) partially deflating the inner balloon to the first expanded state described in step (c), such that further particulate matter may be received in the spiral channel;

f) repeating steps (d) and (e) as required; and

g) completely deflating the inner balloon and withdrawing the catheter from the patient'"'"'s vasculature with the particulate matter trapped between the inner and outer balloons.

16. The method according to claim 15, wherein the particulate matter to be removed is thrombotic material.

22. The balloon catheter system of claim 11, wherein the intrinsic ability is a function of one or more of materials used in construction of said balloon, dimensions of said balloon, and attachment of said balloon at each of its ends to a catheter shaft.

17. A balloon catheter system comprising:

one or more conduits;

a compliant balloon surrounding the one or more conduits, wherein the compliant balloon has a non-helical shape in a deflated state, and wherein an outer surface of the compliant balloon forms a spiral or helical shape in an inflated state;

wherein a surface of the compliant balloon adjacent an outer surface of the one or more conduits extends along a spiral or helical path when the compliant balloon is in the inflated state.

18. The balloon catheter system of claim 17, wherein the compliant balloon forms the spiral or helical shape based upon an intrinsic ability of the balloon.

19. The balloon catheter system of claim 17, wherein the compliant balloon forms the spiral or helical shape in the inflated state without use of ancillary structures.

20. The balloon catheter system of claim 18, wherein the intrinsic ability is a function of one or more of materials used in construction of said balloon, dimensions of said balloon, and attachment of said balloon at each of its ends to a catheter shaft.