Valvuloplasty device with satellite expansion means

• US 4,878,495 A
• Filed: 05/15/1987
• Issued: 11/07/1989
• Est. Priority Date: 05/15/1987
• Status: Expired due to Term

• Current Assignee: Joseph Grayzel
• Original Assignee: Joseph Grayzel
• Inventors: Grayzel, Joseph
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US07/050,741
• Time in Patent Office: 907 Days
• Field of Search: 128/10, 128/344, 128/348.1, 604/96-103
• US Class Current: 606/193
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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 valvuloplasty device having a plurality of expandable chambers for valvuloplasty such that the arrangements and disposition of the expandable chambers conforms to the anatomy of the valve to be treated, thereby increasing the likelihood that inflation of the balloons will restore the valve more closely to its original anatomy and function. The expandable chambers can be expanded in various combinations or sequences in order to provide improved results from the treatment. The present invention also provides a method of performing valvuloplasty in which a plurality of expandable chambers having a fixed geometric relationship to each other are positioned within the valve to be treated and the expandable chambers are expanded in combination and/or in sequence to provide improved anatomical structure and function of the valve treated by the method.

Claims

1. A balloon catheter for valvuloplasty comprising:

a catheter portion having a plurality of flow passages therein;

primary expandable means coupled to a source of pressurized liquid;

auxiliary expandable means coupled to a source of pressurized liquid;

said auxiliary expandable means mounted circumferentially adjacent said primary expandable means with the axis of said primary and auxiliary expandable being displaced and capable of being expanded under control of said liquid supply separately and independently of the expansion of said primary expandable means and in substantially parallel relation to the primary expandable means said auxiliary expandable means being displaced laterally from the axis of said primary expandable means upon expansion of said primary expandable means.

2. The device of claim 1 wherein each of said expandable means communicates with separate fluid paths in said catheter portion of said catheter.

3. The device of claim 1 wherein said auxiliary expandable means consisting of at least one separately expandable chamber.

4. The device of claim 1 wherein said auxiliary expandable means consisting of two separately expandable chambers.

5. The device of claim 1 wherein said auxiliary expandable means consisting of three separately expandable chambers.

6. The device of claim 1 wherein said first expandable means further comprises a large expansible end portion adapted to expand to an area greater than the area of the remaining portion of the first expandable means to act as a retaining means for the device when properly positioned for valvuloplasty.

7. The device of claim 1 wherein said auxiliary expandable means comprise partition means within said expandable means to shape said auxiliary expandable means when in the expanded state.

8. The device of claim 7 wherein said partition means shape said auxiliary expandable means to produce a relatively narrow rounded edge of said auxiliary exandable means.

9. The device of claim 7 wherein said partition means separate said auxiliary expandable means into separate and distinct compartments which can be independently expanded.

10. The device of claim 1 further comprising guide means extending through one of said expandable means to enable said device to be moved along said guide means to position said device.

11. The device of claim 10 wherein said guide means extend through said first expandable means.

15. The device of claim 1, 12 or 13 wherein said first expandable means is centrally located.

12. A balloon catheter valvuloplasty device comprising:

a central catheter portion;

a plurality of liquid glow paths in said central section;

a guide passage in said central catheter portion;

first expandable means connected to said central catheter portion and communicating with one of said liquid flow paths to expand upon introduction of pressurized liquid therein;

auxiliary expandable means comprising a plurality of separately expandable chambers mounted circumferentially adjacent to and in substantially parallel relation to the primary expandable means;

each of said separately expandable chambers communicating with a separate fluid path in said central section;

said first expandable means including an enlarged end section adapted to expand larger than the area of a valve to be treated to position and anchor the device during a valvuloplasty proceeding;

at least one of said separately expandable chambers comprising a plurality of partition means;

said partition means shaping said separately expandable chamber to produce a relatively narrow rounded edge thereof; and

guide means extending through said central means and through said first expandable means for housing a guide wire for positioning of said catheter.

13. A balloon catheter valvuloplasty device comprising:

a primary expandable chamber;

at least one satellite expandable chamber circumferentially adjacent and in substantially parallel relation to the primary expandable means with the axis of said primry and auxiliary expandable means being displaced;

a central catheter portion having flow passage means therein;

said flow passage means communication with a source of pressurized fluid for expanding said primary and satellite expandable chambers;

said primary and satellite expandable chambers communicating with said flow passage means;

said primary and satellite expandable means in fixed position with relation to each other; and

said auxiliary expandable means being displaced laterally from the axis of said primary expandable means upon expansion of said primary expandable means.

14. The device of claim 13 wherein said flow passage means communicating with a source of pressurized fluid for expanding said primary and satellite expandable chambers consisting of a single flow passage communicating with the primary and satellite expandable chamber means.

16. A method of performing valvuloplasty on a valve associated with the heart comprising the steps of:

placing a valvuloplasty device adjacent a valve to be treated by valvuloplasty said valvuloplasty device having a primary expandable chamber and at least one auxiliary expandable chamber mounted circumferentially adjacent to said primary expandable chamber and adapted to expand parallel to the primary expandable chamber;

a positoning the valvuloplasty device across the plane of the valve;

expanding expandable chamber and at least one auxiliary expandable chamber associated with said valvuloplasty device of flex or open the segments of the valve to be treated;

contracting the expandable chambers; and

removing the valvuloplasty device from the valve.

17. The method of valvuloplasty according to the method of claim 16 wherein the step of placing a valvuloplasty device adjacent a valve to be treated by valvuloplasty includes the stept of guiding the valvuloplasty device along a guide passing through the valve to be treated.

18. The method of valvuloplasty according to the method of claim 16 wherein said valvuloplasty device includes an enlarged forward section and further comprising after the step of positoning the valvuloplasty device, the step of securing the valvuloplasty device by expanding the enlarged forward section of an expandable chamber associated with the valvuloplasty device beyond the valve.

19. The method of valvuloplasty according to the method of claim 16 wherein the step of positioning the valvuloplasty device includes the step of auxiliary positioning the valvuloplasty device by means of inflating an enlarged forward section of the main expansion balloon.

20. The method of valvuloplasty according to the method of claim 16 wherein the step of positioning the valvuloplasty device includes the step of rotationally positioning the valvuloplasty device by inflating an auxilary expandable chamber before inflating the primary expandable chamber.

21. The method of valvuloplasty according to the method of claim 16 wherein the step of expanding the main expandable chamber and at least one auxiliary expandable chamber includes the steps of sequentially expanding the auxiliary expandable chamber prior to expansion of the primary expansion chamber so that expansion of the primary chamber will drive the auxiliary expansion chamber into the commissures or narrow portions of the valve to be expanded.

22. The method valvuloplasty according to the method of claim 16 wherein the step of expanding the main expandable chamber and at least one auxiliary chamber includes the step of expanding auxiliary and primary expansion chambers together.

23. The method valvuloplasty according to the method of claim 16 wherein the step of expanding the main expandable chamber and at least one auxilariy chamber includes the step of expanding the primary expansion chamber before the auxiliary expansion chamber.

24. A method of performing valvuloplasty on a valve associated with the heart comprising the steps of:

placing a valvuloplasty device adjacent a valve to be treated by valvuloplasty by guiding the valvuloplasty device along a guide passing through the valve to be treated said valvuloplasty device having a plurality expandable chamber and at least one auxiliary expandable chamber mounted circumferentially adjacent said primary expandable chamber and adapted to expand parallel to the primary expandable chamber;

axially positioning the valvuloplasty device across the plane of the valve by means of inflating an enlarged forward section of the primary expansion chamber;

rotationally positioning the valvuloplasty device within the plane of the valve by at least partially expanding an auxiliary expandable chamber before inflating the primary expandable chamber; and

expanding the primary and auxiliary expandable chamber in sequence to flex or open the segments of the valve to be treated by sequentially expanding one of the auxiliary expandable chambers or the primary chamber prior to the other chamber to drive the auxiliary expandable chamber into the commissures or narrow portions of the valve to be expanded when both primary and auxiliary balloons are expanded.