CA2677644A1 - Device, system and method for delivering a curable material into bone - Google Patents

Device, system and method for delivering a curable material into bone Download PDF

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Publication number
CA2677644A1
CA2677644A1 CA002677644A CA2677644A CA2677644A1 CA 2677644 A1 CA2677644 A1 CA 2677644A1 CA 002677644 A CA002677644 A CA 002677644A CA 2677644 A CA2677644 A CA 2677644A CA 2677644 A1 CA2677644 A1 CA 2677644A1
Authority
CA
Canada
Prior art keywords
cannula
delivery
curable material
deflectable segment
delivery cannula
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002677644A
Other languages
French (fr)
Other versions
CA2677644C (en
Inventor
John A. Krueger
Evan D. Linderman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CareFusion 2200 Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2677644A1 publication Critical patent/CA2677644A1/en
Application granted granted Critical
Publication of CA2677644C publication Critical patent/CA2677644C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8819—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8811—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer tip, i.e. the part inserted into or onto the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
    • A61B2017/00455—Orientation indicators, e.g. recess on the handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth

Abstract

A curable material delivery cannula device (25) is disclosed. The device includes a cannula and a hub. The cannula includes an open proximal end, a deflectable segment (88) forming a pre-set curve, a lumen, and side orifice (s) (84) adjacent, and proximally spaced from, the distal end and fluidly connected to the lumen. When inserted within a guide cannula, the deflectable segment straightens. When distally extended from the guide cannula, the deflectable segment reverts to the curved shape. The distal end has a blunt tip for non-traumatic interface with bodily material. During use, curable material, such as bone cement, is delivered from the side orifice (s) in a radial direction relative to the lumen.

Claims (30)

1. A method of injecting curable material to a delivery site within a bone structure, the method comprising:
providing a delivery cannula defining:
an open, proximal end, a deflectable segment opposite the proximal end having a distal end, a lumen extending from the proximal end, wherein the deflectable segment has a shape memory characteristic and naturally assumes a curved shape in longitudinal extension;
locating a distal tip of a guide cannula within the bone structure;
inserting the delivery cannula within the guide cannula, characterized by the deflectable segment deflecting to a substantially straightened shape within the guide cannula;
distally advancing the delivery cannula such that the distal end and at least a portion of the deflectable segment projects distal the distal tip, characterized by the portion of the deflectable segment distal the distal tip naturally reverting to the curved shape;
manipulating the delivery cannula such that at least a portion of the deflectable segment creates one or more voids in soft body tissue within the bone structure; and delivering the curable material to the delivery site wherein the curable material is delivered to the one or more voids in the soft body tissue created by the deflectable segment.
2. The method of claim 1 wherein manipulating the delivery cannula comprises retracting at least a portion of the delivery cannula from the delivery site relative to the guide cannula and distally advancing the delivery cannula relative to the guide in a reciprocating manner such that at least a portion of the deflectable segment creates voids in soft body tissue within the bone structure.
3. The method of claim 1 wherein manipulating the delivery cannula comprises rotating the delivery cannula such that at least a portion of the deflectable segment creates voids in the soft body tissue within the bone structure.
4. The method of claim 1 wherein the deflectable segment of the delivery cannula terminates in a closed end and the delivery cannula further comprises a side orifice fluidly connected to the lumen.
5. The method of claim 1 further comprising the step of preloading the delivery cannula with curable material prior to inserting the delivery cannula into the guide cannula.
6. A method of injecting curable material within a bone structure, the method comprising:
providing a delivery cannula defining:
an open, proximal end, a deflectable segment opposite the proximal end having a distal end, a lumen extending from the proximal end, wherein the deflectable segment has a shape memory characteristic and naturally assumes a curved shape in longitudinal extension;
locating a distal tip of a guide cannula within the bone structure;
inserting the delivery cannula within the guide cannula, characterized by the deflectable segment deflecting to a substantially straightened shape within the guide cannula;
distally advancing the delivery cannula such that the distal end and at least a portion of the deflectable segment projects distal the distal tip, characterized by the portion of the deflectable segment distal the distal tip naturally reverting to the curved shape;
positioning the distal end distally adjacent a first region within the delivery site;
delivering the curable material to the first region within the delivery site;
positioning the distal end distally adjacent a second region within the delivery site; and delivering the curable material to the second region within the delivery site.
7. The method of claim 6 wherein a region between the first region and second region is substantially free of curable material.
8. The method of claim 6 wherein the deflectable segment of the delivery cannula terminates in a closed end and the delivery cannula further comprises a side orifice fluidly connected to the lumen.
9. The method of claim 6 further comprising the step of preloading the delivery cannula with curable material prior to inserting the delivery cannula into the guide cannula.
10. The method of claim 6 wherein the bone structure is a vertebral body.
11. The method of claim 6 wherein the bone structure is a sacrum.
12. A cannula device for delivering a curable material, such as bone cement, into bone as part of a curable material delivery system, the device comprising:
a delivery cannula preloaded with bone cement defining:
an open, proximal end, a deflectable segment opposite the proximal end and terminating in a closed distal end;
a lumen extending from the proximal end, at least one side orifice formed adjacent to, and proximally spaced from, the distal end and fluidly connected to the lumen, wherein the deflectable segment forms a curved shape in longitudinal extension and has a shape memory characteristic such that the deflectable segment is configured to assume a longitudinally, substantially straightened form when subjected to a force and naturally revert to the curved shape upon removal of the force.
13. The device of claim 12, wherein the cannula device further comprises a removable cap to cover the open, proximal end.
14. The device of claim 12, wherein the closed end is substantially flat.
15. The device of claim 12, wherein the closed end is substantially sharp.
16. The device of claim 13, wherein the closed end is substantially trocar shaped.
17. The device of claim 12 further comprising a rotatable connector to rotatably connect the delivery cannula with a source of curable material.
18. The device of claim 12, wherein the cannula device further comprises a probe operable to be inserted into the lumen.
19. The device of claim 18, wherein the probe is of a smaller diameter than the lumen to allow material to flow around the probe when inserted into the lumen.
20. A cannula device for delivering a curable material, such as bone cement, into bone as part of a curable material delivery system, the device comprising:
a delivery cannula defining:
an open, proximal end, a deflectable segment opposite the proximal end and terminating in a distal end;, a lumen extending from the proximal end, wherein the deflectable segment defines a plurality of curved shapes in longitudinal extension and has shape memory characteristic such that the deflectable segment is configured to assume a longitudinally, substantially straightened form when subjected to a force and naturally revert to the curved shapes upon removal of the force.
21. The device of claim 20, wherein the distal end forms an open end.
22. The device of claim 20, wherein the distal end forms a closed end and comprises at least one side orifice formed adjacent to, and proximally spaced from, the distal end and fluidly connected to the lumen,.
23. An intraosseous, curable material delivery system for delivering a curable material such as bone cement to a delivery site within bone, the system comprising:
a delivery cannula defining:
an open, proximal end, a deflectable segment opposite the proximal end and terminating in a distal end, a lumen extending from the proximal end, wherein the deflectable segment has a shape memory characteristic and assumes a curved shape in longitudinal extension; and a guide cannula defining an inner diameter greater than an outside diameter of the delivery cannula and having an open distal tip;
wherein the deflectable segment is configured to be deflectable to a substantially straightened shape such that the delivery cannula is slidable within the guide cannula, and to naturally revert to the curved shape when extended distal the distal tip for delivery of a curable material within implantation site via the distal end; and wherein the delivery cannula is smoothly slidable within the guide cannula.
24. The system of claim 23, wherein the guide cannula has a substantially smoothed inner diameter surface.
25. The system of claim 24, wherein the substantially smoothed inner diameter surface has an RMS value of about 0 to about 16.
26. The system of claim 25, wherein the substantially smoothed inner diameter surface is coated by a layer of Teflon.
27. The system of claim 23, wherein the delivery cannula has a substantially smoothed outer diameter surface.
28. The system of claim 24, wherein the substantially smoothed outer diameter surface has an RMS value of about 0 to about 16.
29. The system of claim 23, wherein the substantially smoothed outer diameter surface is coated by a layer of Teflon.
30. A curable material structure for stabilizing a vertebral body comprising:

a first curable material deposit proximal to an endplate of a vertebral body for providing support to a first endplate of the vertebral body;

a second curable material deposit proximal to an endplate of a vertebral body for providing support to a second endplate of the vertebral body; and a column of curable material between the first curable material deposit and the second curable material deposit for providing support to the vertebral body.
CA2677644A 2007-02-08 2008-02-08 Device, system and method for delivering a curable material into bone Expired - Fee Related CA2677644C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/704,139 2007-02-08
US11/704,139 US7799035B2 (en) 2005-11-18 2007-02-08 Device, system and method for delivering a curable material into bone
PCT/US2008/001747 WO2008097659A2 (en) 2007-02-08 2008-02-08 Device, system and method for delivering a curable material into bone

Publications (2)

Publication Number Publication Date
CA2677644A1 true CA2677644A1 (en) 2008-08-14
CA2677644C CA2677644C (en) 2012-09-18

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CA2677644A Expired - Fee Related CA2677644C (en) 2007-02-08 2008-02-08 Device, system and method for delivering a curable material into bone

Country Status (11)

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US (3) US7799035B2 (en)
EP (1) EP2117455A2 (en)
JP (1) JP2010517683A (en)
CN (2) CN102166131A (en)
AU (1) AU2008214200B2 (en)
BR (1) BRPI0807229A2 (en)
CA (1) CA2677644C (en)
NZ (1) NZ579020A (en)
RU (1) RU2009130398A (en)
WO (1) WO2008097659A2 (en)
ZA (1) ZA200905547B (en)

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