SYSTEM FOR USE IN TREATMENT OF VERTEBRAL FRACTURES

• US 20130231654A1
• Filed: 03/29/2013
• Published: 09/05/2013
• Est. Priority Date: 04/29/2010
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: GERMAIN, Aaron
• Granted Patent: US 9,526,507 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1617 with mobile or detachable parts
• CPC Class Codes: A61B 17/1631 Special drive shafts, e.g. flexible shafts A61B17/1642, A61B17/164 take precedence
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1644 using fluid other than turbine drive fluid
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00309 : Cut-outs or slits
• CPC Class Codes: A61B 2018/00196 : reciprocating lengthwise
• CPC Class Codes: A61B 2018/00339 : Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/00565 : Bone
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00589 : Coagulation
• CPC Class Codes: A61B 2018/00642 : with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1497 : Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration

Abstract

Methods and devices that displace bone or other hard tissue to create a cavity in the tissue. Where such methods and devices rely on a driving mechanism for providing moving of the device to form a profile that improves displacement of the tissue. These methods and devices also allow for creating a path or cavity in bone for insertion of bone cement or other filler to treat a fracture or other condition in the bone. The features relating to the methods and devices described herein can be applied in any region of bone or hard tissue where the tissue or bone is displaced to define a bore or cavity instead of being extracted from the body such as during a drilling or ablation procedure.

Claims

1. A medical device for treating hard tissue, comprising:

a handle having a shaft with a tip affixed thereto;

the handle having an actuating portion and being configured to receive and transfer an impact force applied thereto;

a shaft having an articulating portion moveable upon actuation of the actuation portion between a straight configuration and a curved configuration where the straight configuration and curved configuration are limited to a single plane, the shaft being configured to transfer the impact force to the tip; and

the tip being configured to penetrate hard tissue upon the application of the impact force, the tip further comprising an offset distal point being offset towards a direction of curvature of the curved configuration, wherein the offset distal point drives the tip and articulating portion towards the direction of curvature upon the application of the impact force when advancing through hard tissue.

2. The medical device of claim 1, further comprising an actuation portion on the handle, the actuation portion being configured to deform the working end into an articulated configuration.

3. The medical device of claim 1, where the tip comprises a first electrode and where a second electrode is located proximal to the articulating portion.

4. The medical device of claim 1, further comprising at least a first temperature sensing element on the shaft.

5. The medical device of claim 4, further comprising at least a second temperature sensing element proximally spaced along the shaft from the first temperature sensing element.

6. The medical device of claim 1, where the handle is configured to receive an impact force to causes the working end to penetrate bone.

7. The medical device of claim 1, further comprising a lumen extending through the shaft and working end.

8. The medical device of claim 1, where the shaft further comprises a first sleeve located concentrically within a second sleeve, the shaft having a distal portion comprising a working end capable of moving between a linear configuration and an articulated configuration and where each sleeve comprises a series of slots or notches to limit deflection of the articulating portion where the respective series of slots or notches are radially offset in adjacent sleeves.

9. The medical device of claim 1, where the distal tip comprises a sharp tip adapted to penetrate bone and having sufficient column strength such that application of an impact force on the handle causes the distal portion of the shaft and the distal tip to mechanically displace the bone.

10. The medical device of claim 8, further comprising a force-limiting assembly coupled between the actuating portion and the first sleeve such that upon reaching a threshold force, the actuating portion disengages the first sleeve.

11. The medical device of claim 1, wherein the force-limiting mechanism is adapted to limit force applied to tissue when moving the articulating portion from the straight configuration toward the curved configuration.

12. The medical device of claim 8, further comprising at least one spring element extending through the shaft, where the spring element is affixed to the shaft and causes the working end to assume the linear configuration in a relaxed state.

13. The medical device of claim 1, further comprising a source of a bone cement material that is fluidly coupled to a lumen in the shaft, where the bone cement material can pass through the lumen to exit at the working end.

14. The medical device of claim 1, further comprising a series of slots or notches on the shaft have a uniform width.

15. The medical device of claim 1, where the shaft comprises a non-circular cross-sectional shape.