INTERGRATED CEMENT DELIVERY SYSTEM FOR BONE AUGMENTATION PROCEDURES AND METHODS

• US 20090093818A1
• Filed: 10/07/2008
• Published: 04/09/2009
• Est. Priority Date: 04/07/2006
• Status: Active Grant

• Current Assignee: Gamal Baroud
• Original Assignee: Société de commercialisation des produits de la recherche appliquée SOCPRA-Sciences et Génie S.E.C.
• Inventors: Baroud, Gamal
• Granted Patent: US 8,409,211 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• 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 17/8822 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 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/8844 Means for determining the viscosity of bone cement
• CPC Class Codes: A61B 2090/032 pressure limiting, e.g. hydrostatic
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• 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: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/467 for measuring fluid pressure
• CPC Class Codes: A61F 2002/4685 by means of vacuum
• CPC Class Codes: A61F 2002/469 : electrical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/32 : Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3286 : Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/329 : characterised by features of the needle shaft
• CPC Class Codes: A61M 5/347 : rotatable, e.g. bayonet or screw A61M5/344 takes precedence
• CPC Class Codes: A61M 5/484 : Regulating injection pressure
• CPC Class Codes: A61M 5/488 : Limiting injection pressure

Abstract

A cement delivery system for vertebroplasty including a rigid cannula having a tubular inner wall defining a central conduit to deliver bone cement and a tubular outer wall extending around the inner wall and spaced apart therefrom to define a peripheral conduit for aspirating bone fluids. Aspirating means communicate with a proximal outlet port of the peripheral conduit to create a pressure gradient between the central conduit and the peripheral conduit to provide a hydraulic force guiding the displacement of bone fluid and the flow of cement. Also, a bone cement delivery system including a rigid cannula having a tubular inner wall defining a central conduit, a tubular outer wall extending around the inner wall and spaced apart therefrom to define a peripheral conduit, and a tubular middle wall extending between the inner and peripheral walls and spaced apart therefrom to define a middle conduit around the central conduit.

Claims

1. A bone cement delivery system for vertebroplasty comprising a rigid cannula having:

a tubular inner wall defining and surrounding a central conduit to deliver bone cement into a vertebra under pressure, the inner wall defining a distal outlet port of the central conduit at a distal end of the cannula;

a tubular outer wall extending around the inner wall and spaced apart therefrom to define a peripheral conduit around the central conduit for aspirating bone fluids, the outer wall defining a distal inlet port of the peripheral conduit at the distal end of the cannula;

the outer wall having an outer diameter not exceeding acceptable parameters for vertebroplasty;

a proximal end of the cannula including a proximal inlet port in communication with the central conduit and a proximal outlet port in communication with the peripheral conduit; and

aspirating means communicating with the proximal outlet port of the peripheral conduit to create a pressure gradient between the central conduit and the peripheral conduit to provide a hydraulic force guiding the displacement of bone fluid and the flow of cement.

4. The bone cement delivery system according to claim 1, further including a pressure sensor connected to the proximal outlet port such as to sense an internal pressure at the distal inlet through the peripheral conduit.

5. The bone cement delivery system according to claim 1, further including a rotatable screw delivery mechanism extending within the central conduit along a length thereof.

6. The bone cement delivery system according to claim 5, wherein the rotatable screw delivery mechanism includes an inner conduit defined therewithin and along a length thereof, the inner conduit being concentric with the central conduit.

7. The bone cement delivery system according to claim 6, further including a pressure sensor connected to a proximal outlet of the inner conduit such as to sense an internal pressure at the distal end of the cannula through the inner conduit.

8. The bone cement delivery system according to claim 1, wherein the tubular inner wall defines a rotatable screw delivery mechanism extending within the peripheral conduit along a length thereof, such that the central conduit is defined inside the screw delivery mechanism.

9. The bone cement delivery system as defined in claim 1, wherein the pressure gradient is created by a vacuum pump communicating with the outlet port of the peripheral conduit.

10. The bone cement delivery system as defined in claim 9, wherein the vacuum applied is in the range of 10 to 100 KPa.

11. The bone delivery cement system as defined in claim 1, wherein the outlet port of the central conduit and the inlet port of the peripheral conduit are spaced apart linearly.

12. The bone cement delivery system according to claim 1, wherein the peripheral wall includes fenestrations defined therein in communication with the peripheral conduit.

13. The bone cement delivery system as defined in claim 1, further including an elastic and permeable membrane covering the distal outlet of the central conduit for delivery of injected fluid therethrough.

14. The bone cement delivery system according to claim 13, wherein the cannula is used to deliver bone cement, and the membrane has a permeability of approximately 10% that of osteoporotic cancellous bone.

15. The bone cement delivery system according to claim 13, wherein the size and elasticity of the membrane is such as to define an expanded diameter of at most 5 mm.

2. A bone cement delivery system comprising a rigid cannula having:

a tubular inner wall defining and surrounding a central conduit for bone cement delivery, the inner wall defining a distal outlet of the central conduit at a distal end of the cannula;

a tubular outer wall extending around the inner wall and spaced apart therefrom to define a peripheral conduit around the central conduit, the outer wall defining a distal inlet of the peripheral conduit at the distal end of the cannula; and

a proximal end of the cannula including a proximal inlet port in communication with the central conduit and a proximal outlet port in communication with the peripheral conduit; and

further comprising a tubular middle wall extending between the inner and peripheral walls and spaced apart therefrom to define a middle conduit around the central conduit, the peripheral conduit being defined around the middle conduit.

3. The bone cement delivery system according to claim 2, further including a pressure sensor connected to the proximal end of the cannula such as to sense an internal pressure at the distal end of the cannula through the middle conduit.

16. A medical cannula comprising:

at least one tubular wall defining and surrounding an injection conduit, the wall defining a distal outlet of the injection conduit at a distal end of the cannula, and a proximal end of the cannula including a proximal inlet in communication with the injection conduit; and

an elastic and permeable membrane covering the distal outlet of the injection conduit for delivery of injected fluid therethrough.

17. The medical cannula according to claim 16, wherein the cannula is used to deliver bone cement, and the membrane has a permeability of approximately 10% that of osteoporotic cancellous bone.

18. The medical cannula according to claim 16, wherein the size and elasticity of the membrane is such as to define an expanded diameter of at most 5 mm.

19. A method of injecting bone cement within a vertebra, comprising:

injecting bone cement within the vertebra through a pedicle; and

at least one of aspirating bone fluid from the vertebra through said pedicle simultaneously with the bone cement injection and creating a pressure gradient between the injection and aspiration steps to provide a hydraulic force guiding the displacement of bone fluid and the flow of bone cement.

20. The method according to claim 19, wherein the method comprises aspirating the fluid from the vertebra through said pedicle simultaneously with the bone cement injection and measuring an internal pressure of the vertebra through said pedicle simultaneously with the bone cement injection.

21. The method according to claim 19, wherein the method comprises aspirating the fluid from the vertebra through said pedicle simultaneously with the bone cement injection, and wherein injecting the bone cement is performed at a first flow rate and aspirating fluid from the vertebra is performed at a second flow rate, the second flow rate being higher than the first flow rate such that the injected cement takes the place of the aspirated fluid.

22. The method according to claim 19 further including inserting a cannula in the vertebra through said pedicle, and wherein injecting the bone cement includes injecting the bone cement through a first conduit of the cannula, and the fluid is aspirated through at least a second conduit of the cannula.

23. The method according to claim 19 wherein the method comprises measuring the internal pressure of the vertebra, including at least one of measuring a cement infiltration pressure required to force the cement to penetrate a cavity of the vertebra and measuring an intravertebral bone marrow pressure.

24. A method of rinsing marrow within a vertebra, comprising inserting a cannula in the vertebra, injecting a liquid in the vertebra through a first conduit of the cannula, aspirating the marrow and bone fluid through a second conduit of the cannula and creating a pressure gradient between the first conduit and the second conduit.

25. A bone cement delivery device, comprising:

a syringe body for containing the bone cement;

a plunger snuggly and slidably received within the syringe body for pushing the bone cement out of the syringe body;

a driving system connected to the plunger and sliding the plunger within the syringe body; and

a control system controlling the driving system in a displacement-controlled and continuous manner over a given time period to produce a constant flow of bone cement out of the syringe body within the time period based on commands from a user.

26. The bone cement delivery device according to claim 25, wherein the control system produces several short and equal delivery time periods to provide a steady flow of bone cement with an interruption between consecutive ones of the time periods.

27. The bone cement delivery device as defined in claim 25, wherein the control system controls the driving system to advance the plunger in one of a stepped motion including a series of equally spaced apart steps of equal duration and a constant motion at a constant speed to produce a steady flow of bone cement out of the syringe body.

28. A control system for a bone cement delivery device, the control system comprising:

a delivery pressure sensor for measuring a cement delivery pressure and producing corresponding delivery pressure data;

a control panel for receiving commands from a user and producing corresponding command data;

a driving system for actuating the cement delivery device to deliver the bone cement;

a control module for receiving the command data and the delivery pressure data, and for sending a control signal actuating the driving system based on the command data and the delivery pressure data such as to deliver the bone cement in a steady flow; and

a display unit for receiving the pressure data from the control module and displaying delivery pressure information based on the delivery pressure data.

29. A bone cement delivery device comprising:

a body for containing the bone cement therein and for progressively injecting the bone cement therefrom for delivery into the bone;

at least one sensor for measuring a physical parameter of the bone cement within the body wherein the sensor is integral with the body;

the at least one parameter being indicative of curing of the bone cement; and

a display unit receiving data from the sensor and displaying at least one of the physical parameter and the curing progress of the bone cement.