Apparatus and methods for delivering compounds into vertebrae for vertebroplasty

• US 7,112,205 B2
• Filed: 06/17/2003
• Issued: 09/26/2006
• Est. Priority Date: 06/17/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Carrison, Harold F.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US10/463,757
• Publication Number:
  US 20040260303A1
• Time in Patent Office: 1,197 Days
• Field of Search: 606/93, 606/94, 606/95, 606/92, 606/213, 606/214, 606/215, 604/82, 604/28, 604/131, 604/187, 600/432
• US Class Current: 606/92
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• 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 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61M 2005/3152 including gearings to multiply or attenuate the piston displacing force
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31586 performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle

Abstract

An apparatus for delivering bone cement into a vertebra includes a cannula and a syringe pivotally coupled to the cannula. Preferably, the syringe is pivotally coupled to the cannula by a pivot fitting that may be detachable from one or both of the cannula and the syringe. The syringe includes a piston slidable in a barrel for advancing the bone cement through an outlet communicating with the cannula. A shaft and cable arrangement or a fluid-driven system may be used to advance the piston within the syringe. The cannula is inserted into a vertebra, and is connected to the syringe. The syringe is pivoted to a desired position, and bone cement is delivered from the syringe through the cannula and into the vertebra.

Claims

1. An apparatus for delivering bone cement into a vertebra, comprising:

a cannula comprising a proximal end, a distal end having a size and shape for insertion into a vertebra, and a lumen extending between the proximal end and an opening in the distal end; and

a delivery device comprising a barrel and a piston, the barrel defining a cavity for receiving a flowable compound therein, the barrel having a distal end comprising an outlet communicating with the cavity, the distal end of the barrel being pivotally connected to the proximal end of the cannula via only one pivot joint such that the outlet communicates with the lumen of the cannula, the piston being slidable within the cavity of the barrel for delivering the flowable compound therein through the outlet.

2. The apparatus of claim 1, further comprising a flowable compound in the cavity.

3. The apparatus of claim 2, wherein the flowable compound comprises bone cement.

4. The apparatus of claim 1, wherein the barrel comprises a threaded opening, and wherein a shaft coupled to the piston extends through the threaded opening, the shaft comprising a thread pattern thereon for mating with the threaded opening such that rotation of the shaft advances or retracts the piston axially within the cavity.

5. The apparatus of claim 1, wherein the distal end of the barrel is pivotally coupled to the proximal end of the cannula by a pivot fitting.

6. The apparatus of claim 5, wherein the pivot fitting is detachable from the proximal end of the cannula.

7. The apparatus of claim 5, wherein the pivot fitting is detachable from the distal end of the barrel.

8. The apparatus of claim 1, wherein the pivot fitting comprises a tubular member pivotable relative to a hollow housing, wherein one of the tubular member and the housing is connected to the distal end of the barrel and the other of the tubular member and the housing is connected to the proximal end of the cannula, thereby providing a flow path between the outlet and the lumen.

9. An apparatus for delivering bone cement into a vertebra, comprising:

a cannula comprising a proximal end, a distal end having a size and shape for insertion into a vertebra, and a lumen extending between the proximal end and an opening in the distal end;

a delivery device comprising a barrel defining a cavity for receiving a flowable compound therein, a distal end comprising an outlet communicating with the cavity, a piston slidable within the cavity of the barrel for delivering the flowable compound therein through the outlet, and a shaft coupled to the piston and having a thread pattern thereon for mating with the threaded opening such that rotation of the shaft advances the piston axially within the cavity, the distal end being pivotally connected to the proximal end of the cannula such that the outlet communicates with the lumen of the cannula;

a cable coupled to the shaft; and

an actuator coupled to the cable, wherein rotation of the actuator causes rotation of the shaft to advance the piston within the cavity.

10. The apparatus of claim 9, wherein the cable comprises an outer sleeve and an inner member extending through the outer sleeve from the actuator to the shaft.

11. The apparatus of claim 9, wherein the shaft and the distal end of the cable comprise cooperating gears for translating rotation of the cable to rotation of the shaft.

12. An apparatus for delivering bone cement into a vertebra, comprising:

a cannula comprising a proximal end, a distal end having a size and shape for insertion into a vertebra, and a lumen extending between the proximal end and an opening in the distal end;

a delivery device comprising a barrel defining a cavity for receiving a flowable compound therein, a distal end comprising an outlet communicating with the cavity, and a piston slidable within the cavity of the barrel for delivering the flowable compound therein through the outlet, wherein the piston divides the cavity into a distal region for receiving a flowable compound therein and a proximal region, the distal end being pivotally connected to the proximal end of the cannula such that the outlet communicates with the lumen of the cannula;

a source of fluid communicating with the proximal region of the cavity via tubing for delivering fluid into the proximal region to advance the piston distally within the barrel.

13. The apparatus of claim 12, wherein the source of fluid comprises a syringe or pump.

14. The apparatus of claim 12, further comprising flexible tubing connecting the source of fluid to the delivery device such that fluid from the source of fluid may flow through the tubing into the proximal region.

15. The apparatus of claim 14, wherein the tubing is removably connected to at least one of the source of fluid and the delivery device.

16. The apparatus of claim 14, wherein the tubing is permanently connected to at least one of the source of fluid and the delivery device.

17. A method for delivering bone cement into a vertebra of a patient, the method comprising:

inserting a distal end of a cannula into the vertebra;

connecting a proximal end of the cannula to a delivery device comprising bone cement therein using a pivot fitting, the delivery device comprising a cable coupled to a piston within the delivery device;

pivoting the delivery device relative to the cannula to a desired position;

rotating the cable, thereby causing the piston to advance within the delivery device to deliver the bone cement from the delivery device through the cannula and into the vertebra; and

removing the cannula from the vertebra.

18. The method of claim 17, further comprising imaging the vertebra with an imaging device, and wherein the cable comprises an actuator disposed outside a field of the imaging device, the actuator being activated to rotate the cable.

19. A method for delivering a flowable compound into a hard tissue structure of a patient, the method comprising:

inserting a distal end of a cannula into the tissue structure to be treated;

pivotally connecting a proximal end of the cannula to a barrel via only one pivot joint, the barrel containing a flowable compound therein;

pivoting the barrel relative to the cannula to a desired position;

delivering the compound from the barrel through the cannula and into the tissue structure; and

removing the cannula from the tissue structure.

20. The method of claim 19, wherein the cannula is inserted percutaneously through cutaneous tissue overlying the tissue structure before being inserted into the tissue structure.

21. The method of claim 19, wherein the cannula is inserted into the tissue structure before the proximal end of the cannula is connected to the delivery device.

22. The method of claim 19, wherein the compound comprises at least one of bone cement and biomaterial.

23. The method of claim 19, wherein the hard tissue structure comprises a vertebra.

24. The method of claim 19, wherein the cannula comprises a sharpened distal tip that penetrates through cortical bone of the vertebra into cancellous bone of the vertebra as the cannula is inserted into the vertebra.

25. The method of claim 19, wherein the delivery device is pivoted until the delivery device rests on the patient'"'"'s skin.

26. The method of claim 19, further comprising distally displacing a piston within the barrel to deliver the compound.

27. A method for delivering a flowable compound into a hard tissue structure of a patient, the method comprising:

inserting a distal end of a cannula into the tissue structure to be treated;

pivotally connecting a proximal end of the cannula to a delivery device comprising a flowable compound therein;

pivoting the delivery device relative to the cannula to a desired position;

delivering the compound from the delivery device through the cannula and into the tissue structure by rotating a cable coupled to a piston slidably disposed within the delivery device to advance the piston within the delivery device; and

removing the cannula from the tissue structure.

28. The method of claim 27, further comprising imaging the tissue structure being treated with an imaging device, and wherein the cable comprises an actuator disposed outside a field of the imaging device.

29. The method of claim 28, wherein the delivery device is at least partially exposed within the field of the imaging device.

30. The method of claim 27, wherein the cable is coupled to a shaft extending from the piston, and wherein the cable is rotated to rotate the shaft, thereby advancing the piston within the barrel.

31. The method of claim 30, wherein the cable and the shaft are rotatably coupled to one another by cooperating gears.

32. The method of claim 27, wherein another end of the cable is coupled to a motor, and wherein the motor is activated to rotate the cable and advance the piston within the barrel.

33. A method for delivering a flowable compound into a hard tissue structure of a patient, the method comprising:

inserting a distal end of a cannula into the tissue structure to be treated;

pivotally connecting a proximal end of the cannula to a delivery device comprising a flowable compound therein, wherein a piston is slidable within the delivery device, thereby defining a proximal chamber within the delivery device;

pivoting the delivery device relative to the cannula to a desired position;

delivering the compound from the delivery device through the cannula and into the tissue structure by delivering a fluid into the proximal chamber to advance the piston within the delivery device; and

removing the cannula from the tissue structure.

34. The method of claim 33, further comprising imaging the tissue structure being treated with an imaging device, and wherein the tubular member is coupled to at least one of a syringe and pump disposed outside a field of the imaging device for delivering the fluid into the proximal chamber.

35. The method of claim 33, further comprising connecting a source of fluid to the delivery device, the fluid being delivered into the proximal chamber from the source of fluid.

36. The method of claim 35, wherein the source of fluid is connected to the delivery device by flexible tubing.