Low cost low profile inflatable bone tamp

• US 9,554,840 B2
• Filed: 04/08/2011
• Issued: 01/31/2017
• Est. Priority Date: 04/08/2011
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Druma, Calin, Chabansky, Bruce
• Primary Examiner(s): Ramana, Anu
• Assistant Examiner(s): Weiss, Jessica
• Application Number:
  US13/082,781
• Publication Number:
  US 20120259375A1
• Time in Patent Office: 2,125 Days
• Field of Search: 606 79- 86 R, 606/99, 606/191, 606192-196, 623 1711- 1716, 604/544, 604/96.01
• US Class Current: 1/1
• 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 device for performing a surgical procedure, the device comprising:

an elongate shaft comprising an inner surface defining a lumen, the elongate shaft comprising a primary region having a first diameter and a secondary region having a second diameter, the first diameter being greater than the second diameter, the elongate shaft comprising a transition region that is tapered continuously between the primary region and the secondary region, the elongate shaft comprising a smooth outer surface along an entire length of the shaft;

an inflatable structure including a proximal end region coupled to a distal end region of the primary region and a distal end region coupled to the secondary region such that the secondary region and the transition region each extend at least partially within an inflatable chamber of the inflatable structure; and

a stylet movably positioned within the lumen and configured to provide additional rigidity to the secondary region,

wherein a distal end region of the secondary region comprises a distal end surface that defines a completely closed distal end of the shaft that is configured to prevent unwanted material ingress into the lumen, the distal end surface defining a distal stop for the stylet such that a tip of the stylet engages the distal end surface.

2. The device of claim 1, wherein the lumen is in communication with the chamber such that an inflation material may be moved through the lumen and into the inflatable chamber to increase a volume of the inflatable chamber.

3. The device of claim 2, wherein the distal end region of the inflatable structure is coupled to the distal end region of the secondary region.

4. The device of claim 3, wherein the secondary region comprises at least one opening defining a flow path between the lumen and the inflatable chamber.

5. The device of claim 4, wherein:

the elongate shaft extends along a longitudinal axis between the primary region and the secondary region; and

the secondary region comprises at least one opening extending perpendicular to the longitudinal axis that is in communication with the lumen.

6. The device of claim 1, wherein the elongate shaft consists of stainless steel.

7. The device of claim 1, wherein the stylet comprises nitinol.

8. The device of claim 1, wherein a portion of the distal end region of the inflatable structure is flush with an end surface of the closed distal end.

9. The device of claim 1, wherein when inflated, a proximal half of the inflatable structure has a maximum interior volume that is less than that of a distal half of the inflatable structure.

10. The device of claim 9, wherein the proximal half of the inflatable structure has a maximum radial diameter that is less than that of the distal half of the inflatable structure when the inflatable structure is inflated.

11. The device of claim 1, wherein when inflated, the inflatable structure has an outwardly tapering expansion profile that allows an inflation force to be more effectively directed toward endplates of vertebrae.

12. The device of claim 1, wherein when inflated, the inflatable structure 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 inflatable structure.

13. A system for performing a surgical procedure, the system comprising:

a cannula comprising an inner surface defining a lumen; and

an inflatable bone tamp, the inflatable bone tamp comprising a shaft having a primary region and a reduced diameter region, the shaft comprising a transition region that is tapered continuously between the primary region and the reduced diameter region, the inflatable bone tamp comprising an inflatable structure including a proximal end region being coupled to a distal end region of the primary region of the shaft and a distal end region of the inflatable structure being coupled to the reduced diameter region such that at least a portion of the transition region and the reduced diameter region extend within an inflatable chamber of the inflatable structure, the shaft comprising spaced apart ports extending through inner and outer surfaces of the shaft such that the ports extend perpendicular to an axis defined by the shaft, the shaft comprising a smooth outer surface along an entire length of the shaft, the inflatable bone tamp comprising a stylet movably positioned within a lumen of the shaft, wherein the distal end region comprises a distal end surface that defines a completely closed distal end of the shaft that is configured to prevent unwanted material ingress into the lumen of the shaft, the distal end surface defining a distal stop for the stylet such that a tip of the stylet engages the distal end surface, and further wherein the inflatable structure, when deflated about the reduced diameter region, is sized to, fit through the lumen of the cannula.

14. The system, of claim 13, wherein the stylet is configured to provide additional rigidity to the reduced diameter region.

15. The system of claim 13, wherein the ports are each in communication with the inflatable chamber such that an inflation material may be moved from the lumen and into the inflatable chamber to increase a volume of the inflatable chamber.

16. The system of claim 15, further comprising a connector coupled to the primary region, the stylet extending through the connector, the stylet comprising a cap having threads that engage threads on the connector to secure and seal the stylet to the connector.

17. The system of claim 13, further comprising:

a second cannula defining a second access lumen; and

a second inflatable bone tamp, the second inflatable bone tamp comprising a shaft having a second primary region and a second reduced diameter region, and a second inflatable structure, wherein the second inflatable structure surrounds at least a portion of the reduced diameter region, and further wherein the second inflatable structure, when deflated about the second reduced diameter region, is sized to fit through the second access lumen.

18. The device of claim 13, wherein a portion of the distal end region of the inflatable structure is flush with an end surface of the closed distal end.

19. A method comprising:

establishing an access path to a bone;

driving an inflatable structure through the access path using an elongate shaft, wherein the shaft includes a smooth outer surface along an entire length of the shaft, a primary region and a reduced diameter region positioned at least partially within the inflatable structure, a proximal end region of the inflatable structure being coupled to a distal end region of the primary region and a distal end region of the inflatable structure being coupled to the reduced diameter region, the elongate shaft comprising a transition portion between the primary region and the reduced diameter region, the transition portion being tapered continuously between the primary region and the reduced diameter region, the distal end region comprising a completely closed distal end configured to prevent unwanted material ingress into a lumen defined by an inner surface of the elongate shaft;

inserting a stylet into the lumen and moving the stylet distally until a tip of the stylet engages the closed distal end;

inflating the inflatable structure to manipulate the bone;

deflating the inflatable structure about the reduced diameter region; and

withdrawing the inflatable structure through the access path.