Low cost inflatable bone tamp

• US 9,668,796 B2
• Filed: 09/16/2015
• Issued: 06/06/2017
• Est. Priority Date: 03/07/2013
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Druma, Calin
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): GIBSON, ERIC SHANE
• Application Number:
  US14/856,124
• Publication Number:
  US 20160000492A1
• Time in Patent Office: 629 Days
• Field of Search: 606 63, 606 90, 606 92- 94, 606 99, 606105, 606191-200, 60416401-17003
• CPC Class Codes: A61B 17/8808 with sealing collar for bone cavity
• 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 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855

Abstract

A surgical system and method for correction of a bone injury or disorder are provided. The device includes an elongated shaft that extends between a proximal end and a distal end and defining an interior lumen. A valve disposed with the proximal end of the elongated shaft and including a membrane. An inflatable structure is coupled to the distal end of the elongated shaft. A stylet is configured for insertion through the membrane and is removably disposed in the interior lumen of the elongated shaft such that the stylet provides strength to the elongated shaft.

Claims

1. A balloon catheter comprising:

a catheter extending between opposite proximal and distal ends, the catheter comprising an inner surface defining a lumen, the distal end comprising an opening that is in communication with the lumen, the proximal end comprising a valve, the valve including a membrane;

a balloon having a distal end coupled to the distal end of the catheter such that a distal end surface of the balloon is flush with a distal end surface of the catheter; and

a stylet extending through the membrane such that the stylet is removably disposed in the lumen to provide strength to the catheter, the stylet having a length that prevents a distal tip of the stylet from being positioned distal to the distal end surface of the balloon,

wherein the stylet has a maximum diameter that is less than that of the lumen and the opening such that a material in the lumen may be passed around the stylet and exit the lumen through the opening.

2. A balloon catheter as recited in claim 1, wherein the lumen is in communication with an interior volume of the balloon.

3. A balloon catheter as recited in claim 1, wherein the catheter comprises a port that is continuous with the lumen such that a material can be moved through the port and into an interior volume of the balloon to inflate the balloon.

4. A balloon catheter as recited in claim 1, wherein the stylet remains within the catheter during inflation of the balloon and is moveable to allow inflation material to pass into the balloon.

5. A balloon catheter as recited in claim 1, wherein the catheter comprises 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 stylet being configured to be positioned within the secondary region.

6. A balloon catheter as recited in claim 5, wherein a proximal end of the balloon is coupled to the primary region and a distal end of the balloon is coupled to the secondary region.

7. A balloon catheter as recited in claim 5, wherein:

the catheter comprises a transition region that is continuously tapered from the primary region to the secondary region; and

a proximal end of the balloon is coupled to the transition region and a distal end of the balloon is coupled to the secondary region.

8. A balloon catheter as recited in claim 1, wherein the stylet includes a length such that the stylet extends an entire length of the catheter and into a portion of the catheter that is surrounded by the balloon.

9. A balloon catheter as recited in claim 1, wherein the catheter has a uniform diameter.

10. A balloon catheter as recited in claim 1, wherein the stylet is confined between a distal tip of the balloon and the proximal end.

11. A balloon catheter as recited in claim 1, wherein the catheter comprises a flexible material and the stylet comprises a rigid material.

12. A balloon catheter as recited in claim 1, wherein the catheter comprises a material selected from a group consisting of silicone, polyvinyl chloride, and latex rubber and the stylet comprises a material selected from a group consisting of stainless steel, Nitinol, and stiff nylon.

13. A balloon catheter as recited in claim 1, wherein a distal end of the stylet comprises a blunt tip.

14. A balloon catheter comprising:

a catheter extending between opposite proximal and distal ends, the catheter comprising an inner surface defining a lumen, the distal end comprising an opening that is in communication with the lumen, the proximal end comprising a valve, the valve including a membrane constructed from a resealable material;

a balloon comprising a distal end that is coupled to the distal end of the catheter such that a distal end surface of the balloon is flush with a distal end surface of the catheter; and

a stylet extending through the membrane such that the stylet is removably disposed in the lumen to provide strength to the catheter, the stylet having a length that prevents a distal tip of the stylet from being positioned distal to the distal end surface of the balloon,

wherein the catheter comprises a port that is continuous with the lumen such that a material can be moved through the port and into an interior volume of the balloon to inflate the balloon,

wherein the stylet has a maximum diameter that is less than that of the lumen and the opening such that a material in the lumen may be passed around the stylet and exit the lumen through the opening.

15. A method comprising:

inserting a cannula into a patient;

inserting a catheter through the cannula such that a balloon is positioned within the patient, a distal end of the balloon being coupled to a distal end of the catheter such that a distal end surface of the balloon is flush with a distal end surface of the catheter, the catheter comprising an inner surface defining a lumen, the distal end of the catheter comprising an opening that is in communication with the lumen, the catheter further comprising a port that is continuous with the lumen, wherein a proximal end of the catheter comprises a valve, the valve including a membrane;

inserting a stylet through the membrane such that the stylet is removably disposed in the lumen to provide strength to the catheter, the stylet has a maximum diameter that is less than that of the lumen and the opening, the stylet having a length that prevents a distal tip of the stylet from being positioned distal to the distal end surface of the balloon;

moving a material through the lumen and around the stylet such that the material exits the lumen through the opening and moves into the boney structure; and

withdrawing the catheter from the patient.

16. A method as recited in claim 15, wherein the stylet extends through the membrane and into the lumen.

17. A method as recited in claim 15, further comprising inflating the balloon and deflating the balloon.

18. A method as recited in claim 15, wherein the stylet extends through the membrane and into the lumen while the material moves through the lumen and the opening and into the boney structure.

19. A method as recited in claim 15, wherein the membrane reseals itself once the stylet is inserted through the membrane.

20. A method as recited in claim 15, further comprising removing the stylet from the catheter after the balloon is positioned in the boney structure.