Device and method for introducing flowable material into a body cavity

• US 20080021463A1
• Filed: 01/29/2007
• Published: 01/24/2008
• Est. Priority Date: 07/21/2006
• Status: Active Grant

• Current Assignee: Bassem Georgy
• Original Assignee: Bassem Georgy
• Inventors: Georgy, Bassem
• Granted Patent: US 8,986,312 B2
• Time in Patent Office: Days
• US Class Current: 606/61
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

The present invention relates to medically useful devices and methods for introducing flowable compositions into mammalian body cavities. More specifically, the devices and methods of the present invention are useful for introducing restorative compositions into intraosseous cavities. Such devices and methods are particularly useful in percutaneous vertebroplasty or kyphoplasty procedures for the controlled introduction of bone cement into a vertebral cavity.

Claims

1. A device for delivering a flowable composition into a body cavity comprising:

an outer cannula comprising an outer cannula wall, an open outer cannula proximal end, an open outer cannula distal end having a size and shape suitable for insertion into a body cavity, an outer cannula lumen extending between the outer cannula proximal end and the outer cannula distal end;

wherein the outer cannula wall comprises a first outer cannula side-port situated near the outer cannula distal end such that the outer cannula lumen is in fluid communication with the body cavity; and

an inner cannula insertable into and removable from the outer cannula as well as slidable and rotatable within the outer cannula;

wherein the inner cannula comprises an inner cannula wall, an open inner cannula proximal end, a closed inner cannula distal end and an inner cannula lumen; and

wherein the inner cannula wall comprises two or more inner cannula side-ports disposed along the inner cannula longitudinal axis near the inner cannula distal end and disposed around the circumference of the inner cannula such that the inner cannula can be rotatably positioned relative to the outer cannula to align a least one of said inner cannula side-ports with said first outer cannula side-port such that a flowable material can be discharged from within the inner cannula lumen into the body cavity.

2. The device of claim 1 wherein the outer cannula wall further comprises a second outer cannula side-port situated near the outer cannula proximal end.

3. The device of claim 2 wherein the first outer cannula side-port and the second outer cannula side-port are diametrically opposed.

4. The device of claim 1 wherein the inner cannula side-ports are rectangular or ovate.

5. The device of claim 4 wherein the rectangular or ovate inner cannula side-ports and are aligned such that the major axes are parallel to the longitudinal axis of the inner cannula.

6. The device of claim 1 wherein the inner cannula side-ports are circular.

7. The device of claim 1 wherein the inner cannula side-ports overlap with respect to the circumference of the inner cannula from 0 to about 50% of the circumferential dimension of said inner cannula side ports, and wherein the inner cannula side-ports overlap with respect to the longitudinal axis of the inner cannula from 0 to about 50% of the longitudinal dimension of said inner cannula side ports.

8. The device of claim 1 wherein at least one of the inner cannula and outer cannula is fabricated from stainless steel.

9. The device of claim 1 wherein both the proximal end of the outer cannula and the proximal end of the inner cannula each comprise a gripping means.

10. The device of claim 1 wherein the proximal end of the inner cannula further comprises an attachment means with which a flowable material dispensing means may be secured.

11. The device of claim 1 wherein the outer cannula diameter in the immediate area of the proximal side-port is greater than the overall diameter of the outer cannula.

12. The device of claim 1 wherein the first outer cannula side-port extends to the tip of the open outer cannula distal end such that the open outer cannula distal end and the first outer cannula side-port define a single opening.

13. The device of claim 1 wherein the first outer cannula side-port does not extend to the tip of the open outer cannula distal end.

14. A system for performing a vertebroplasty procedure comprising:

at least one device of claim 1;

a trocar or similar surgical tool insertable into and removable from the outer cannula;

an osteotome or similar surgical tool insertable into and removable from the outer cannula;

an injecting means for introducing a flowable composition into the inner cannula through the open proximal end.

15. The system of claim 14 further comprising a visualization or diagnostic probe insertable into and removable from the outer cannula.

16. The system of claim 14 further comprising a flowable composition.

17. The system of claim 16 wherein the flowable compositions is bone cement.

18. A method for dispensing a flowable composition into a body cavity comprising the steps of:

i. providing the device of claim 1;

ii. percutaneously deploying the outer cannula into the body cavity;

iii. inserting the inner cannula into the outer cannula;

iv. positioning the inner cannula within the outer cannula such that one of the two or more inner cannula side-ports is aligned with the first outer cannula side-port;

v. introducing a flowable composition into the inner cannula lumen;

vi. dispensing the flowable composition into the body cavity through said first inner cannula side-port;

vii. repeating steps iv, v and vi for each unused inner cannula side-port; and

vii. removing both the outer and inner cannulae from the body cavity.

19. The method of claim 18 wherein the body cavity is an intraosseous cavity.

20. The method of claim 19 wherein the intraosseous cavity is a cavity in a vertebra of the spine.

21. The method of claim 20 applied to a unilateral vertebroplasty or kyphoplasty procedure.

22. The method of claim 20 applied to a bilateral vertebroplasty or kyphoplasty procedure.