DEVICE FOR PERFORMING A SURGICAL PROCEDURE AND METHOD

• US 20140276572A1
• Filed: 03/15/2013
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Auyoung, Bryan J., Sapida, Warren C.
• Granted Patent: US 9,730,746 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• 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

Abstract

A medical balloon device includes an outer member extending along an axis. An inflatable member has a proximal end extending from a first end of the outer member and a distal end. An inner member is positioned within the outer member and the inflatable member such that a first end of the inner member is coupled to the distal end of the inflatable member. A support member is movably disposed within the inner member and includes a first end configured to removably engage the first end of the inner member. Translation of the support member along the axis causes the inflatable member to move between a first position in which the inflatable member has a first length and a first profile and a second position in which the inflatable member has a second reduced length and a second reduced profile. Methods of use are disclosed.

Claims

1. A device for performing a surgical procedure comprising:

an outer member extending along an elongated axis and comprising an inner surface defining a first passageway;

an inflatable member having a proximal end extending from a first end of the outer member and a distal end, the inflatable member including an inner surface defining a chamber;

an inner member positioned within the first passageway and the chamber such that a first end of the inner member is coupled to the distal end of the inflatable member, the inner member having an inner surface defining a second passageway; and

a support member movably disposed within the second passageway and including a first end configured to removably engage the first end of the inner member,

wherein translation of the support member along the elongated axis in a first direction causes the inflatable member to move between a first position in which the inflatable member has a first length and a first profile and a second position in which the inflatable member has a second length and a second reduced profile, the second length being greater than the first length.

2. A device as recited in claim 1, wherein the first end of the inner member includes a stopper having an opening extending parallel to the axis and the first end of the support member is configured for disposal in the opening of the stopper such that the stopper prevents the first end of the support member from translating through the distal end of the inflatable member.

3. A device as recited in claim 1, wherein:

the first end of the inner member includes a plastic stopper bonded to the inner surface of the inner member, the stopper having an opening extending parallel to the axis; and

a first end of the support member includes a stepped portion configured for disposal in the opening of the stopper.

4. A device as recited in claim 1, wherein the first end of the inner member includes a stopper having an opening extending parallel to the axis and a first end of the support member includes a stepped portion configured for disposal in the opening of the stopper, wherein the opening and the stepped portion each have a configuration configured to engage one another to prevent rotation of the support member within the stopper about the axis.

5. A device as recited in claim 4, wherein rotation of the support member about the axis rotates the stopper which in turn causes the inflatable member to twist about the inner member such that the inflatable member moves between the second position and a third position in which the inflatable member has third profile that is less than the second profile.

6. A device as recited in claim 4, wherein the opening and the stepped portion each have a polygonal configuration, wherein the polygonal configuration of the opening mates with the polygonal configuration of the stepped portion.

7. A device as recited in claim 4, wherein the opening and the stepped portion each have a hexalobe configuration.

8. A device as recited in claim 1, wherein the device includes a distal marker band having an inner surface engaging an outer surface of the inner member.

9. A device as recited in claim 1, wherein a portion of the support member is disposed in an a third passageway defined by an inner surface of an inflation member and a second end of the support member includes a cap having a first locking surface configured to engage a second locking surface of the inflation member to maintain the inflatable member in the second position.

10. A device as recited in claim 9, wherein the first locking surface is a first thread form and the second locking surface is a second thread form.

11. A device as recited in claim 1, wherein:

the device includes a cannula defining a lumen;

the outer member is movably disposed in the lumen; and

the lumen has a diameter that is greater than the first profile and less than the second profile such that the inflatable member is configured for disposal in the lumen when in the second position and is prevented from being disposed in the lumen when in the first position.

12. A device as recited in claim 11, wherein the outer member, the inner member and the inflatable member are made from a material having a lower modulus of elasticity than a material from which the cannula and the support member are made.

13. A device as recited in claim 11, wherein the diameter of the lumen is about 4.0 mm.

14. A device for performing a surgical procedure comprising:

an outer member defining an axis and comprising an inner surface defining a passageway;

an inflatable member having a first end extending from a first end of the outer member, the inflatable member including an inner surface defining a chamber; and

a support member movably disposed within the passageway and the chamber, the support member including a first end that is coupled to a second end of the inflatable member,

wherein translation of the support member along the elongated axis in a first direction causes the inflatable member to move between a first position in which the inflatable member has a first length and a first profile and a second position in which the inflatable member has a second length and a second reduced profile, the second length being greater than the first length, and

wherein rotation of the support member relative to the outer member about the axis causes the inflatable member to twist about the inner member such that the inflatable member moves between the second position and a third position in which the inflatable member has a third profile that is less than the second profile.

15. A method comprising:

providing a device comprising;

an outer member defining an axis and comprising an inner surface defining a first passageway,

an inflatable member having a first end extending from a first end of the outer member, the inflatable member including an inner surface defining a chamber,

an inner member positioned within the first passageway and the chamber such that a first end of the inner member is coupled to a second end of the inflatable member, the inner member having an inner surface defining a second passageway, and

a support member movably disposed within the second passageway;

inflating the inflatable member such that the inflatable member has an inflated height;

deflating the inflatable member such that the inflatable member is in a first position defined by a first height and a first length, the first height being less than the inflated height; and

translating the support member along the axis in a first direction such that the inflatable member moves from the first position to a second position defined by a second height and a second length, the second height being less than the first height and the second length being greater than the first length.

16. The method of claim 15, wherein the device includes a cannula defining a lumen, and the method further comprises translating the outer member relative to the cannula along the axis such that the inflatable member is positioned outside of the lumen before inflating the inflatable member and after providing the device.

17. The method of claim 16, wherein the method includes translating the outer member along the axis relative to the cannula such that the inflatable member is positioned within the lumen after moving the inflatable member from the first position to the second position.

18. The method of claim 15, wherein:

the first end of the inner member includes a stopper having an opening extending parallel to the axis and a first end of the support member includes a stepped portion configured for disposal in the opening of the stopper, the opening and the stepped portion each being configured to engage one another; and

the method comprises;

engaging the stepped portion with the opening to prevent rotation of the support member relative to the stopper, and

rotating the support member about the axis after moving the inflatable member from the first position to the second position and engaging the stepped portion with the opening such that the inflatable member twists about the inner member to move the inflatable member from the second position to a third position in which the inflatable member has profile that is less than a profile of the inflatable member in the second position.

19. The method of claim 15, wherein the support member includes a cap including a first thread form and the method includes:

providing an inflation member having an inner surface defining a third passageway and including a second thread form;

translating the support member along the axis relative to the inflation member after moving the inflatable member from the first position to the second position such that the first thread form is aligned with the second thread form; and

rotating the support member about the axis relative to the inflation member such that the first thread form engages the second thread form to maintain the inflatable member in the second position.

20. The method of claim 19, further comprising delivering a bone filler material into the cavity.