STABILIZATION SYSTEM AND ASPIRATION DEVICE WITH PROTECTED CUTTING EDGE

• US 20120179187A1
• Filed: 01/09/2012
• Published: 07/12/2012
• Est. Priority Date: 01/07/2011
• Status: Active Grant

• Current Assignee: Preceptis Medical, Inc.
• Original Assignee: Preceptis Medical, Inc.
• Inventors: Loushin, Michael K. H., Leland, Keith J.
• Granted Patent: US 8,574,240 B2
• Time in Patent Office: Days
• US Class Current: 606/185
• CPC Class Codes: A61B 1/00149 using articulated arms
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2010/0054 Ear liquid
• CPC Class Codes: A61B 2017/00738 part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61M 1/7411 by changing the size of a vent in combination with changing the cross-section of the line A61M1/7413
• CPC Class Codes: A61M 1/76 Handpieces specially for suction-irrigation A61M1/774, aspiration tips A61M1/84

Abstract

A device performs a myringotomy and includes a main body, a hollow positioning member, a cutting edge for piercing a tympanic membrane, a protective sheath and an actuator. The main body is oriented along an axis and has a proximal end, a distal end and an outer surface. The main body includes an attachment hub for receiving components that provide suction. The hollow positioning member extends at least partially along the axis, is coupled to the main body and includes a distal end. The actuator is located on the main body and is configured to move the protective sheath from a first position that surrounds the cutting edge to a second position that exposes the cutting edge and from the second position back to the first position.

Claims

1. A device for performing a myringotomy, the device comprising:

a main body oriented along a central axis having a proximal end, a distal end and an outer surface, the main body including an attachment hub for receiving components that provide suction;

a hollow positioning member coupled to the main body and including a distal end, the positioning member extending at least partially along the central axis;

a cutting edge for piercing a tympanic membrane of a body;

a protective sheath; and

an actuator located on the main body, the actuator configured to move the protective sheath from a first position that surrounds the cutting edge to a second position that exposes the cutting edge and from the second position back to the first position.

2. The device of claim 1, wherein the cutting edge is located on the distal end of the positioning member.

3. The device of claim 2, further comprising a visual indicator for indicating a maximum depth of penetration of the cutting edge when the cutting edge is exposed.

4. The device of claim 3, wherein the visual indicator comprises a flange coupled to and extending outwardly from a distal end of the protective sheath.

5. The device of claim 3, wherein the visual indicator comprises a flange coupled to and extending outwardly from the positioning member at a location proximal to and a spaced distance from the cutting edge.

6. The device of claim 1, wherein the main body further comprises a removable chamber for collecting fluids draining through the myringotomy using the components that provide suction.

7. The device of claim 1, wherein the actuator is a slider-type component that protrudes from the outer surface of the cylindrical main body and is moveable along an axis that is parallel with the central axis.

8. The device of claim 2, further comprising a removable nosepiece coupled to the distal end of the cylindrical main body, the removable nosepiece configured to retain a proximal end of the positioning member.

9. A method of performing a myringotomy comprising:

obtaining a device including a main body, a hollow positioning member, a cutting edge and a protective sheath, wherein the positioning member, the cutting edge and the protective sheath are located distal to the main body;

manually inserting at least portions of the positioning member, the cutting edge and the protective sheath into an ear canal of a patient using an outer surface of the main body as a handle, wherein the positioning member, the protective sheath and the cutting edge are advanced together such that the cutting edge and the protective sheath are located a spaced distance from the tympanic membrane and wherein the protective sheath covers the cutting edge;

actuating the protective sheath while the positioning member and the cutting edge remain in place such that the protective sheath slides relative to and along the positioning member to expose the cutting edge;

manually advancing the positioning member, the cutting edge and the actuated protective sheath using the handle such that the cutting edge pierces the tympanic membrane;

manually retracting the positioning member, the cutting edge and the actuated protective sheath such that the cutting edge is again located the spaced distance from the tympanic membrane;

actuating the protective sheath while the positioning member and the cutting edge remain in place such that the protective sheath slides relative to and along the positioning member to again cover the cutting edge; and

manually extracting the positioning member, the cutting edge and the protective sheath from the ear canal using the handle.

10. The method of claim 9, wherein the cutting edge is located on the distal end of the positioning member.

11. The method of claim 9, further comprising applying suction after the cutting edge is retracted from the tympanic membrane to aspirate fluid being drained through the myringotomy.

12. The method of claim 11, further comprising collecting the aspirated fluid in a removable chamber that is removably coupled to the main body of the device.

13. The method of claim 9, wherein obtaining a device comprises:

obtaining the main body that extends along an axis and has a proximal end, a distal end and an outer surface; and

selectively obtaining a removable assembly removably coupled to the distal end of the cylindrical main body, the removable assembly including a nosepiece that is removably coupled to the distal end of the main body, the hollow positioning member, the cutting edge and the protective sheath;

wherein the removable assembly is selectively obtained from a plurality of differently sized removable assemblies based on anatomy specific to a patient for whom the myringotomy is to be performed on.

14. The method of claim 10, further comprising using a visual indicator located on one of the positioning member or the protective sheath for indicating a maximum depth of penetration of the cutting edge when the cutting edge is exposed.

15. The device of claim 9, further comprising means for deploying a tympanostomy tube in the myringotomy after the cutting edge pierces the tympanic membrane.

19. The device of claim 15, further comprising a visual indicator for indicating a maximum depth of penetration of the cutting edge when the cutting edge is exposed, wherein the visual indicator comprises a flange coupled to and extending outwardly from a distal end of the protective sheath.

20. The device of claim 15, further comprising a visual indicator for indicating a maximum depth of penetration of the cutting edge when the cutting edge is exposed, wherein the visual indicator comprises a flange coupled to and extending outwardly from the positioning member at a location proximal to and a spaced distance from the cutting edge.

16. A device for performing a myringotomy, the device comprising:

a main body extending along a central axis having a proximal end, a distal end and an outer surface that provides a handle, the main body including an attachment hub for receiving components that provide suction;

a rotatable assembly coupled to the distal end of the main body, the rotatable assembly comprising;

a nosepiece rotatably coupled to the cylindrical main body and extending along the central axis;

a hollow positioning member fixed to the nosepiece, the positioning member extending at least partially along the axis and partially along an axis orthogonal to the central axis;

a cutting edge being capable of piercing a tympanic membrane of a body; and

a protective sheath slidable along the positioning member between a first position and a second position, wherein in the first position the protective sheath covers the cutting edge and in the second position the protective sheath exposes the cutting edge;

wherein the rotatable nosepiece is adjustable such that the hollow positioning member can be oriented in more than one direction relative to the central axis.

17. The device of claim 16, wherein the cutting edge is located on a distal end of the positioning member.

18. The device of claim 16, further comprising a cutting component removably coupled to a distal end of the positioning member and including the cutting edge.