Navigated malleable surgical instrument

• US 9,226,800 B2
• Filed: 04/29/2011
• Issued: 01/05/2016
• Est. Priority Date: 04/30/2010
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Burg, Bruce M., Smetzer, Ross, Bzostek, Andrew, Hartmann, Steven L., Jacobsen, Brad, Nadeau, Matthew J.
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): HOFFA, ANGELA MARIE
• Application Number:
  US13/097,243
• Publication Number:
  US 20110270081A1
• Time in Patent Office: 1,712 Days
• Field of Search: 600/424
• US Class Current: 1/1
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/397 electromagnetic other than visible, e.g. microwave
• CPC Class Codes: A61B 2090/3975 active
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver

Abstract

A surgical instrument can include a body, a tracking device, and a handle. The body can include proximal and distal ends, and a flow passage extending therebetween. The body can be formed from a malleable material such that it can be bent between the proximal and distal ends from a first configuration to a second bent configuration and maintain the bent configuration. The tracking device can be positioned adjacent the distal end for tracking a distal tip of the instrument. The handle can be coupled to the proximal end of the body and can include an internal flow passage in fluid communication with the body flow passage. The tracking device can include a pair of lead wires wound around the body to the handle, where the wound wires can conform to the bent configuration of the body such that they do not strain or break during bending of the body.

Claims

1. A surgical instrument, comprising:

a body having a proximal end and a distal end, wherein the body is tubular-shaped and has a first internal flow channel extending between the proximal end and the distal end;

a sleeve distal to the body and having a proximal end and a distal end, wherein the proximal end of the sleeve is adjacent to and not in contact with the distal end of the body;

a tracking assembly adapted to cooperate with a navigation system to track a distal tip of the instrument, wherein the tracking assembly comprises a printed circuit board and a plurality of coils including a first coil, wherein each of the plurality of coils is wrapped around a respective one of a plurality of cores, and wherein the first coil is mounted on the sleeve;

a handle coupled to the proximal end of the body, wherein the handle comprises a second internal flow channel in fluid communication with the first internal flow channel;

a first pair of lead wires wound around the body from the tracking assembly to the handle;

a set of wires connecting the printed circuit board to the first coil, wherein the printed circuit board connects the first pair of lead wires to the set of wires; and

an insert received in the sleeve and the distal end of the body, wherein the insert is straight and tubular-shaped, wherein the insert is under at least a portion of the printed circuit board and prevents bending or flexing in a region of the printed circuit board, and

wherein the insert provides rigid support for the sleeve and the distal end of the body, maintains alignment of the sleeve relative to the distal end of the body, and prevents bending of the sleeve and the distal end of the body.

2. The surgical instrument of claim 1, wherein the first pair of lead wires is helically wound around the body from the tracking assembly to the handle.

3. The surgical instrument of claim 2, wherein the first pair of lead wires are helically wound around the body with consecutive revolutions of the first pair of lead wires being axially spaced apart by 15-45 mm.

4. The surgical instrument of claim 3, further comprising a shrink fit layer covering the body, the tracking assembly, and the sleeve.

5. The surgical instrument of claim 3, wherein the first pair of lead wires are twisted together and helically wound around the body at an angle of 5-45 degrees relative to a longitudinal axis of the body.

6. The surgical instrument of claim 2, wherein the first pair of lead wires comprises a lubricous coating.

7. The surgical instrument of claim 1, wherein:

the sleeve includes a depression;

the depression has a longitudinal axis positioned at an acute angle relative to a longitudinal axis of the body; and

the depression is configured to receive the first coil.

8. The surgical instrument of claim 7, wherein the acute angle is 55 degrees.

9. The surgical instrument of claim 1, wherein:

the sleeve includes a plurality of depressions equally spaced circumferentially around an outer surface of the sleeve;

each of the plurality of depressions has a longitudinal axis positioned at a respective acute angle relative to a longitudinal axis of the body;

the plurality of coils comprises the first coil, a second coil, and a third coil; and

each of the plurality of coils is disposed in a respective one of the plurality of depressions.

10. The surgical instrument of claim 9, wherein:

the sleeve further includes a plurality of planar sections spaced circumferentially around the outer surface of the sleeve; and

each of the plurality of depressions is formed in a corresponding one of the plurality of planar sections.

11. The surgical instrument of claim 9, wherein:

the tracking assembly comprises a plurality of pairs of lead wires extending between the handle and the printed circuit board;

the printed circuit board is mounted on the distal end of the body;

the first coil corresponds to the first pair of lead wires;

the second coil corresponds to a second pair of lead wires;

the third coil corresponds to a third pair of lead wires;

the plurality of pairs of lead wires comprise the first pair of lead wires, the second pair of lead wires, and the third pair of lead wires; and

each of the plurality of pairs of lead wires is helically wound around the body and adjacent to each other from the tracking assembly to the handle with consecutive revolutions of the plurality of pairs of lead wires being axially spaced apart by approximately 15-45 mm.

12. The surgical instrument of claim 11, further comprising a shrink layer covering the sleeve, the insert, the circuit board, and the body, wherein the plurality of pairs of lead wires are moveably captured between the shrink layer and the body.

13. The surgical instrument of claim 1, wherein:

the first coil is cylindrically-shaped and has a plurality of windings; and

the plurality of windings have an outer diameter of less than 0.5 mm and an axial length of 1.5-2.0 mm.

14. The surgical instrument of claim 1, wherein:

the first coil has a plurality of windings wound to form at least a partially concave outer surface between opposed ends of the coil; and

the concave outer surface is configured to nest around a cylindrical surface of the sleeve.

15. The surgical instrument of claim 1, wherein:

the tracking assembly includes a second coil adjacent to the distal end of the body; and

the first coil and the second coil are orientated perpendicular to a longitudinal axis of the body.

16. The surgical instrument of claim 1, wherein:

the tracking assembly includes a second coil; and

the first coil and the second coil are individually wrapped around the body adjacent a distal tip of the sleeve and at an acute angle relative to a longitudinal axis of the body.

17. The surgical instrument of claim 16, wherein:

the tracking assembly includes a third coil; and

the first coil, the second coil, and the third coil are individually wrapped around the body and overlap one another.

18. The surgical instrument of claim 1, wherein:

the first coil is an axial coil; and

the tracking assembly includes two oval-shaped coils adjacent a distal tip of the sleeve.

19. The surgical instrument of claim 1, wherein:

the body is formed from a malleable metallic material such that the body can be bent without kinking from a first configuration to a second configuration;

the body is configured to maintain the second configuration until being manually bent from the second configuration to a third configuration; and

the pair of lead wires is configured to conform to the body during bending of the body.

20. The surgical instrument of claim 1, wherein:

the body comprises (i) a first inner diameter, and (ii) a second inner diameter at the distal end of the body;

the first inner diameter is smaller than the second inner diameter;

the sleeve comprises a third inner diameter, wherein the third inner diameter matches the second inner diameter; and

the insert comprises an outer diameter; and

the outer diameter is substantially equal to the second inner diameter and the third inner diameter.

21. The surgical instrument of claim 1, wherein:

the printed circuit board is on the distal end of the body and comprises connectors;

the first pair of lead wires is connected to the connectors; and

the set of wires extend from the connectors to the first coil and over a gap between the sleeve and the distal end of the body.

22. The surgical instrument of claim 1, further comprising a plurality of pairs of lead wires, wherein:

the tracking assembly comprises a plurality of coils;

the plurality of coils comprise the first coil and a second coil;

the plurality of pairs of lead wires helically wrap around the body from the handle to the distal end of the body; and

each of the pairs of lead wires is connected to a respective one of the plurality of coils.

23. The surgical instrument of claim 1, wherein the tracking assembly comprises:

a plurality of connectors mounted on the distal end of the body; and

the set of wires extending between the plurality of connectors and the first coil.

24. A surgical instrument, comprising:

a body having a proximal end and a distal end, wherein the body is tubular shaped and has a first internal flow channel extending between the proximal end and the distal end;

an insert having a proximal end, wherein the insert is straight and tubular-shaped, and wherein the proximal end of the insert is configured to be received in the distal end of the body;

a sleeve configured to slide over the insert;

a tracking assembly comprising a plurality of connectors, a first set of wires, and a plurality of coils, wherein the plurality of connectors are mounted on the distal end of the body, wherein the first set of wires extends from the plurality of connectors to the plurality of coils, wherein the plurality of coils are mounted on the sleeve, wherein each of the plurality of coils is wrapped around a respective one of a plurality of cores, and wherein the tracking assembly is adapted to cooperate with a navigation system to track a distal tip of the instrument;

a handle coupled to the proximal end of the body and including a second internal flow channel in fluid communication with the first internal flow channel;

a second set of wires helically wound around the body from the handle to the distal end of the body and at an acute angle relative to a longitudinal axis of the body,

wherein the plurality of connectors connect the first set of wires to the second set of wires, and

wherein the insert is under at least a portion of plurality of connectors and prevents bending or flexing in a region of the plurality of the connectors; and

an outer layer covering the body, the sleeve, the insert and the tracking assembly.

25. The surgical instrument of claim 24, wherein:

each of the plurality of coils includes a longitudinal axis orientated at an acute angle relative to the longitudinal axis of the body; and

the plurality of coils are rigidly supported by the insert.

26. The surgical instrument of claim 24, wherein the plurality of coils are orientated at (i) acute angles relative to the longitudinal axis of the body, and (ii) acute angles relative to each other.

27. The surgical instrument of claim 26, wherein each of the plurality of coils is positioned equidistant from each other around a circumference of the sleeve.

28. The surgical instrument of claim 24, wherein each of the plurality of coils includes a longitudinal axis orientated perpendicular to the longitudinal axis of the body.

29. The surgical instrument of claim 24, further comprising (i) a first plurality of sets of wires connecting the plurality of connectors to the plurality of coils, and (ii) a second plurality of sets of wires extending from the handle to the plurality of connectors, wherein:

the first plurality of sets of wires comprise the first set of wires;

the second plurality of sets of wires comprise the second set of wires;

the tracking assembly comprises a printed circuit board;

the printed circuit board comprises the plurality of connectors;

each of the plurality of coils corresponds to one of the first plurality of sets of wires and one of the second plurality of sets of wires; and

the second plurality of sets of wires are helically wound adjacent to each other and around the body at an acute angle relative to the longitudinal axis of the body.

30. The surgical instrument of claim 29, the proximal end of the insert extends into the body and through a center opening of the printed circuit board.

31. The surgical instrument of claim 24, wherein a distal tip of the sleeve is chamfered or rounded.

32. The surgical instrument of claim 24, wherein the outer layer comprises a polymeric material and is shrink fit over the body, the sleeve, the insert and the tracking assembly.

33. The surgical instrument of claim 24, wherein the second set of wires are moveably captured between the outer layer and the body.

34. A surgical instrument, comprising:

a body having a proximal end and a distal end, wherein the body is tubular-shaped and has an inner diameter defining (i) a first internal flow channel between the proximal end and the distal end, and (ii) an annular recess formed in the distal end;

an insert having a proximal end and a distal tip, wherein the proximal end of the insert is configured to be received in the annular recess of the distal end of the body;

a sleeve configured to be received over only a portion of the insert and extend from the distal end of the insert towards the proximal end of the insert;

a tracking assembly coupled to the sleeve and the body, wherein the tracking assembly is adapted to cooperate with a navigation system to track the distal tip of the insert, wherein the tracking assembly includes a printed circuit board and at least two electromagnetic coils, wherein the at least two electromagnetic coils are disposed in respective depressions in an outer surface of the sleeve, wherein each of the at least two electromagnetic coils is positioned at an acute angle relative to a longitudinal axis of the body and wrapped around a respective one of a plurality of cores, and wherein the at least two electromagnetic coils and at least a portion of the printed circuit board are supported by the insert;

a handle coupled to the proximal end of the body and including a second internal flow channel in fluid communication with the first internal flow channel,

wherein the tracking assembly includes a pair of lead wires for each of the at least two electromagnetic coils, wherein the pairs of lead wires are helically wound around the body adjacent to each other and at an acute angle relative to the longitudinal axis of the body

a plurality of wires connecting the at least two electromagnetic coils to the printed circuit board,

wherein the printed circuit board connects the pairs of lead wires to the plurality of wires, and

wherein the insert is under at least a portion of the printed circuit board and prevents bending or flexing in a region of the printed circuit board; and

a heat shrink layer covering the body, the sleeve, the insert and the tracking assembly,

wherein the pairs of lead wires are moveably captured between the body and the heat shrink layer.

35. The surgical instrument of claim 34, wherein:

each of the pairs of lead wires is separate from the other pairs of lead wires;

each of the pairs of lead wires comprises a first wire and a second wire; and

the second wire of each of the pairs of lead is twisted with the corresponding one of the first wires.