INTEGRATED CEMENT DELIVERY SYSTEM FOR BONE AUGMENTATION PROCEDURES AND METHODS

• US 20130190680A1
• Filed: 03/08/2013
• Published: 07/25/2013
• 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 9,204,913 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• 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 bone cement delivery system for vertebroplasty with a cannula having a rigid metal tubular inner wall surrounding a central conduit with a distal outlet port, a rigid metal tubular outer wall extending around the inner wall to define a peripheral conduit with a distal inlet port in the form of fenestrations defined in the tubular outer wall, unobstructed and directly exposed to an environment of the delivery system, a proximal inlet port in communication with the central conduit and a proximal outlet port in communication with the peripheral conduit. A vacuum pump communicating with the proximal outlet port of the peripheral conduit applies a pressure in the range of 10 to 100 KPa to create a pressure gradient between the central conduit and the peripheral conduit to produce a difference in flow rate between the conduits guiding the displacement of bone fluid and the flow of cement.

Claims

1. A bone cement delivery system for vertebroplasty comprising:

a cannula having;

a rigid metal 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 rigid metal 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 having an outer diameter not exceeding acceptable parameters for vertebroplasty, the outer wall defining a distal inlet port in the form of fenestrations defined in the tubular outer wall in communication with the peripheral conduit at the distal end of the cannula wherein the outlet port of the central conduit and the inlet port of the peripheral conduit are spaced apart linearly, the fenestrations being unobstructed and directly exposed to an environment of the delivery system;

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

a vacuum pump communicating with the proximal outlet port of the peripheral conduit and applying a pressure in the range of 10 to 100 KPa to create a pressure gradient between the central conduit and the peripheral conduit to produce a difference in flow rate between the conduits guiding the displacement of bone fluid and the flow of cement.

2. The bone cement delivery system according to claim 1, further comprising a rigid metal 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.

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 is shaped as 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 according to claim 1, further including an elastic and permeable membrane covering the distal outlet of the central conduit for delivery of injected fluid therethrough.

10. The bone cement delivery system according to claim 9, wherein the cannula is used to deliver bone cement, and the membrane has a permeability corresponding to approximately 10% of a permeability of osteoporotic cancellous bone.

11. The bone cement delivery system according to claim 9, wherein the size and elasticity of the membrane is such as to define an expanded diameter of at most 5 mm.

12. A method of injecting bone cement within a bone in a vertebroplasty procedure, comprising:

inserting a cannula in the bone through a surgical site;

injecting the bone cement through a first conduit of the cannula;

aspirating fluid from the bone through a second conduit of the cannula simultaneously with the bone cement injection;

wherein the step of injecting the bone cement is performed at a first flow rate and the step of aspirating fluid from the bone is performed at a second flow rate, the second flow rate being slightly higher than the first flow rate such that the injected cement takes the place of the aspirated fluid.

13. The method according to claim 12, further comprising measuring an internal pressure of the vertebra through said surgical site simultaneously with the bone cement injection.

14. The method according to claim 12, further comprising measuring an 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.