Low cost low profile inflatable bone tamp

• US 10,405,907 B2
• Filed: 01/04/2017
• Issued: 09/10/2019
• Est. Priority Date: 04/08/2011
• Status: Active Grant

• Current Assignee: Medtronic Holding Company Sarl (Medtronic Plc)
• Original Assignee: Medtronic Holding Company Sarl (Medtronic Plc)
• Inventors: Druma, Calin, Chabansky, Bruce
• Primary Examiner(s): Coley, Zade
• Assistant Examiner(s): Weiss, Jessica
• Application Number:
  US15/398,402
• Publication Number:
  US 20170112556A1
• Time in Patent Office: 979 Days
• Field of Search: 606 79- 86 R, 606 99, 606191-196, 606108, 604544, 604 9601
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

An inflatable bone tamp for performing a minimally invasive surgical procedure includes a shaft having a primary region and a reduced diameter region, and an inflatable structure surrounding at least a portion of the reduced diameter region. The reduced diameter region of the shaft allows the deflated size of the inflatable structure to be minimized, while at the same time eliminating the need for the conventional dual lumen balloon catheter construction.

Claims

1. A surgical device comprising:

a shaft comprising an inner surface defining a lumen, the shaft extending along a longitudinal axis between a proximal end and a distal end comprising a primary region having a first diameter, a secondary region having a reduced second diameter and a transition region that is tapered continuously from the primary region to the secondary region;

a balloon comprising a proximal end that is coupled to the primary region and a distal end that is coupled to the secondary region; and

a stylet comprising a rod that is movably positioned within the lumen, the rod having a maximum outer diameter that is equal to or greater than a maximum inner diameter of the secondary region, the stylet being movable between a first configuration in which the rod is spaced apart from the inner surface and a second configuration in which rod engages the inner surface to seal the secondary region,

wherein the secondary region comprises a port that is in communication with the lumen and a chamber of the balloon such that an inflation material may be moved through the lumen and into the chamber through the port when the stylet is in the first configuration to increase a volume of the chamber.

2. A surgical device as recited in claim 1, wherein the surgical device is configured to prevent the inflation material from moving into the lumen through the port when the stylet is in the second configuration.

3. A surgical device as recited in claim 1, wherein the stylet further includes at least one feature that engages the inner surface to seal off the secondary region when the stylet is in the second configuration.

4. A surgical device as recited in claim 1, wherein the maximum outer diameter of the rod is equal to the maximum inner diameter of the secondary region.

5. A surgical device as recited in claim 1, wherein the maximum outer diameter of the rod is greater than the maximum inner diameter of the secondary region.

6. A surgical device as recited in claim 1, wherein the shaft has a smooth outer surface along an entire length of the shaft.

7. A surgical device as recited in claim 1, wherein the port includes two spaced apart ports on one side of the shaft.

8. A surgical device as recited in claim 1, wherein the port comprises a plurality of ports that are spaced apart from one another.

9. A surgical device as recited in claim 1, wherein the rod comprises nitinol.

10. A surgical device as recited in claim 1, further comprising a connector coupled to the primary region, the rod extending through the connector, the stylet further comprising a cap that is coupled to the rod, the cap having threads that engage threads on the connector to secure and seal the stylet to the connector.

11. A surgical device as recited in claim 1, wherein when inflated, a proximal half of the balloon has a maximum interior volume that is less than that of a distal half of the balloon, the proximal half of the balloon having a maximum radial diameter that is less than that of the distal half of the balloon when the balloon is inflated.

12. A surgical device as recited in claim 1, wherein when inflated, the balloon has a dual-lobed, peanut shaped configuration comprising a proximal lobe and a distal lobe, the distal lobe having a larger maximum radial diameter than the proximal lobe upon inflation of the balloon.

13. A surgical device as recited in claim 1, wherein an inner diameter of the secondary region remains constant along an entire length of the secondary region as the stylet moves between the first and second configurations.

14. A surgical device as recited in claim 1, wherein an outer diameter of the secondary region remains constant along an entire length of the secondary region as the stylet moves between the first and second configurations.

15. A kit comprising:

the surgical device recited in claim 1;

a cannula sized to receive the surgical device; and

instructions for use.

16. A method comprising:

providing the surgical device recited in claim 1;

establishing an access path to a bone;

moving the shaft through the access path until the distal end of the balloon is positioned adjacent to the bone;

moving the rod through the lumen such that the stylet is in the first configuration;

moving the rod through the lumen such that the stylet moves from the first configuration to the second configuration; and

inflating the balloon when the stylet is in the first configuration to manipulate the bone.

17. A method as recited in claim 16, further comprising moving a material through the lumen and out of an opening in the distal end of the shaft when the stylet is in the first configuration such that the material irrigates the bone.

18. A method as recited in claim 16, further comprising aspirating a material adjacent to the bone such that the material moves through an opening in the distal end of the shaft and into the lumen when the stylet is in the first configuration.

19. A surgical device comprising:

a shaft comprising an inner surface defining a lumen, the shaft extending along a longitudinal axis between a proximal end and a distal end comprising a primary region having a first diameter and a secondary region having a reduced second diameter;

a connector coupled to the primary region;

a balloon comprising a proximal end that is coupled to the primary region and a distal end that is coupled to the secondary region; and

a stylet comprising a cap and a rod that extends from the cap, the cap having threads that engage threads on the connector to secure the stylet to the connector, the rod being movably positioned within the lumen, the rod having a maximum outer diameter that is equal to or greater than a maximum inner diameter of the secondary region, the stylet being movable between a first configuration in which the rod is spaced apart from the inner surface and a second configuration in which the rod engages the inner surface to seal a distal end of the secondary region,

wherein the surgical device is configured to allow material in the lumen to move into a chamber of the balloon when the stylet is in the first configuration,

and wherein the stylet is configured to prevent material in the lumen from moving into the chamber when the stylet is in the second configuration.

20. A surgical device comprising:

a shaft comprising an inner surface defining a lumen, the shaft extending along a longitudinal axis between a proximal end and a distal end comprising a primary region having a uniform first diameter, a secondary region having a reduced uniform second diameter and a transition region that is tapered continuously from the primary region to the secondary region;

a connector coupled to the primary region;

a balloon comprising a proximal end that is coupled to the primary region and a distal end that is coupled to the secondary region; and

a stylet comprising a cap and a rod that extends from the cap, the cap having threads that engage threads on the connector to secure the stylet to the connector, the rod being movably positioned within the lumen, the rod having a maximum outer diameter that is equal to or greater than a maximum inner diameter of the secondary region, the stylet being movable between a first configuration in which the rod is spaced apart from the inner surface and a second configuration in which the rod engages the inner surface to seal a distal end of the secondary region,

wherein when the stylet is in the first configuration, the lumen is in communication with a chamber of the balloon, and

wherein when the stylet is in the second configuration, the lumen is not in communication with the chamber.