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

Info

Publication number
CA2568374A1
CA2568374A1 CA 2568374 CA2568374A CA2568374A1 CA 2568374 A1 CA2568374 A1 CA 2568374A1 CA 2568374 CA2568374 CA 2568374 CA 2568374 A CA2568374 A CA 2568374A CA 2568374 A1 CA2568374 A1 CA 2568374A1
Authority
CA
Grant status
Application
Patent type
Prior art keywords
cannula
delivery
end
distal
device
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
CA 2568374
Other languages
French (fr)
Other versions
CA2568374C (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
Allegiance Corporation
John A. Krueger
Evan D. Linderman
Cardinal Health Cmp 200, Inc
Carefusion 2200, Inc.
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

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8819Equipment 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8811Equipment 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3472Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/062Measuring instruments not otherwise provided for penetration depth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M2005/341Constructions for connecting the needle, e.g. to syringe nozzle or needle hub angularly adjustable or angled away from the axis of the injector

Abstract

A curable material delivery cannula device is disclosed. The device includes a cannula and a hub. The cannula includes an open proximal end, a deflectable segment forming a pre-set curve, a lumen, and side orifice(s) 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 (34)

1. 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 closed distal end having a blunt tip, 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;
and a hub forming a fluid port fluidly coupled to the proximal end.
2. The device of claim 1, wherein the delivery cannula has an outer diameter of less than 0.125 inch.
3. The device of claim 2, wherein the outer diameter is less than 0.09 inch.
4. The device of claim 3, wherein the delivery cannula has a wall thickness of less than 0.020 inch.
5. The device of claim 1, wherein the blunt tip is hemispherical.
6. The device of claim 1, wherein the curved shape defines a bend greater than 90 degrees.
7. The device of claim 1, wherein the curved shape is a J-shape.
8. The device of claim 7, wherein the curved shape defines a radius of curvature of less than approximately 1.5 inches.
9. The device of claim 1, wherein the delivery cannula is formed of a shape memory alloy.
10. The device of claim 1, wherein the delivery cannula forms a plurality of circumferentially spaced side orifices adjacent the distal end.
11. The device of claim 1, wherein the delivery cannula forms a plurality of longitudinally spaced side orifices.
12. The device of claim 1, wherein the at least one side orifice defines a non-circular perimeter.
13. The device of claim 1, wherein the delivery cannula defines an inside diameter, and further wherein the at least one side orifice has at least one orifice dimension that is greater than the inside diameter.
14. The device of claim 1, wherein the delivery cannula is sized for use in a vertebroplasty procedure.
15. The device of claim 1, further comprising a handle assembly including:
a handle forming an aperture sized to receive the hub; and a retainer selectively couplable to the handle for securing the hub within the aperture.
16. The device of claim 1, further comprising:
a handle coupled to a hub; and directional indicia on the handle indicating a spatial direction of the curved shape.
17. The device of claim 1, further comprising:
indicia provided on an exterior of the delivery cannula adjacent the proximal end indicating a predetermined length from the distal end.
18. The device of claim 1, further comprising:
a support body secured between the delivery cannula and the hub;
wherein the support body provides tensile strength to an interface between the hub and the delivery cannula.
19. 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 closed distal end having a blunt tip, 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 has a shape memory characteristic and assumes a curved shape in longitudinal extension;
a hub forming a fluid port fluidly coupled to the proximal end; 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 bone via the at least one side orifice.
20. The system of claim 19, wherein the delivery cannula has an outside diameter of less than 0.125 inch.
21. The system of claim 19, wherein the guide cannula and the delivery cannula are sized for use in a vertebroplasty procedure.
22. The system of claim 19, further comprising a handle assembly including:
a handle forming an aperture sized to receive the hub; and a retainer selectively coupled to the handle for securing the hub within the aperture.
23. The system of claim 16, further comprising:
a curable material source fluidly coupled to the hub and maintaining a volume of curable material.
24. The system of claim 23, wherein the curable material is bone cement.
25. The system of claim 19, wherein the blunt tip is a hemisphere and the at least one side port extends radially relative to a longitudinal axis of the delivery cannula.
26. The system of claim 19, further comprising:

indicia located along an exterior of the delivery cannula adjacent the proximal end, the indicia including a first depth marking;
wherein a linear distance between the first depth marking and the distal end has a known relationship with a length of the guide cannula such that the first depth marking provides a visual indication of a longitudinal position of the distal end relative to the distal tip upon insertion of the delivery cannula within the guide cannula.
27. A method of stabilizing a bone structure of a human patient, the method comprising:
providing a delivery cannula defining:
an open, proximal end, a deflectable segment opposite the proximal end and terminating in a closed distal end having a blunt tip, 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 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 desired delivery site within the bone structure;

injecting a curable material into the lumen;
delivering the curable material to the delivery site via the at least one side orifice otherwise proximally spaced from the distal end; and allowing the curable material to cure to stabilize the bone structure.
28. The method of claim 27, wherein positioning the distal end includes atraumatically contacting tissue at the site with the blunt tip.
29. The method of claim 27, wherein delivering the curable material includes dispensing the curable material from the delivery cannula in a radial direction relative to an axis defined by the lumen.
30. The method of claim 27, wherein positioning the distal end includes rotating the delivery cannula relative to the guide cannula to locate the at least one side orifice at a desired spatial position.
31. The method of claim 30, wherein rotating the delivery cannula includes providing a user with a visual indication of the spatial position of the curved shape of the delivery cannula via indicia associated with the proximal end of the delivery cannula.
32. The method of claim 27, further comprising:
retracting the delivery cannula from the guide cannula after delivering the curable material via the at least one side orifice; and injecting a second volume of curable material into the delivery site through the guide cannula.
33. The method of claim 27, wherein the method is performed as part of a vertebroplasty procedure.
34. The method of claim 27, wherein the curable material is bone cement.
CA 2568374 2005-11-18 2006-11-17 Device, system and method for delivering a curable material into bone Active CA2568374C (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US11282102 US7713273B2 (en) 2005-11-18 2005-11-18 Device, system and method for delivering a curable material into bone
US11/282,102 2005-11-18

Publications (2)

Publication Number Publication Date
CA2568374A1 true true CA2568374A1 (en) 2007-05-18
CA2568374C CA2568374C (en) 2012-05-15

Family

ID=37762223

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2568374 Active CA2568374C (en) 2005-11-18 2006-11-17 Device, system and method for delivering a curable material into bone

Country Status (6)

Country Link
US (1) US7713273B2 (en)
CA (1) CA2568374C (en)
DE (1) DE602006019192D1 (en)
DK (1) DK1787592T3 (en)
EP (1) EP1787592B1 (en)
ES (1) ES2357496T3 (en)

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EP1787592A2 (en) 2007-05-23 application
EP1787592A3 (en) 2008-10-01 application
DE602006019192D1 (en) 2011-02-10 grant
EP1787592B1 (en) 2010-12-29 grant
DK1787592T3 (en) 2011-04-18 grant
US20070118142A1 (en) 2007-05-24 application
ES2357496T3 (en) 2011-04-27 grant
CA2568374C (en) 2012-05-15 grant
US7713273B2 (en) 2010-05-11 grant

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