PULMONARY NODULE ACCESS DEVICES AND METHODS OF USING THE SAME

• US 20130226026A1
• Filed: 02/26/2013
• Published: 08/29/2013
• Est. Priority Date: 02/28/2012
• Status: Abandoned Application

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: Dillard, David H., Hoffman, Peter, O'Connell, Desmond, Gonzalez, Xavier, Thralls, Christopher
• Application Number:
  US13/778,008
• Publication Number:
  US 20130226026A1
• Time in Patent Office: Days
• US Class Current: 600/562
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

In certain embodiments, a device is configured to be delivered to the site of a nodule in the lung or other body organ or lumen. The device can be configured to attach directly to the target nodule or to tissue adjacent the target nodule. The device can be configured to provide repeatable access to the site of the target nodule. In some embodiments, the device includes a guide wire that can extend proximal the device. The guide wire can be configured to engage with a catheter or other medical device to provided repeatable and dependable navigation to the site of the target nodule. In some embodiments, the device can include a channel portion through which medical devices and/or instruments can be navigated. In some embodiments, the device can be deployed in the wall of an airway or other body lumen to provide transluminal access to a nodule outside of the lumen.

Claims

1. A device for providing access to a nodule, lesion, or pathological area in a lung or other body organ or lumen, the device comprising:

a channel portion, the channel portion having a proximal end and a distal end, wherein the channel portion defines a lumen, the lumen extending from the proximal end of the channel portion to the distal end of the channel portion; and

at least one anchor member, the anchor member configured to inhibit rotational, proximal, and distal motion of the channel portion with respect to the nodule upon deployment of the device in a body lumen.

2. The device of claim 1, wherein the channel potion further comprises at least one radiopaque marker.

3. The device of claim 1, wherein the device further comprises a guide member.

4. The device of claim 3, wherein the guide member comprises a guide wire.

5. The device of claim 3, wherein the guide member comprises a guide tube.

6. The device of claim 3, wherein the guide member comprises at least one radiopaque marker.

7. The device of claim 1, wherein the channel portion further comprises one or more cut portion, the one or more cut portions configured to increase the flexibility of the channel portion.

8. The device of claim 7, wherein channel portion further comprises a heat shrink.

9. The device of claim 1, wherein the channel portion is further configured to deploy transluminally in the wall of an airway or other body lumen.

10. The device of claim 1, wherein the channel portion is further configured to transition between a compressed state within a working channel of a catheter or other delivery device and an expanded state upon deployment in an airway or other body lumen.

11. The device of claim 1, wherein the channel portion further comprises a port between the proximal end of the channel portion and the distal end of the channel portion.

12. The device of claim 1, wherein the at least one anchor member comprises a piercing portion configured to pierce tissue at or near the nodule, and wherein the at least one anchor member comprises a pad portion configured to limit a depth to which the piercing portion pierces the tissue.

13. The device of claim 1, wherein the channel portion comprises a first anchor coupled with the proximal end of the channel portion and extending proximally from the proximal end of the channel portion when the device is deployed.

14. The device of claim 1, wherein the channel portion comprises a first anchor coupled with the distal end of the channel portion and extending distally from the distal end of the channel portion when the device is deployed.

15. The device of claim 1, wherein the device further comprises a directional member coupled with the distal end of the channel member, the directional member configured to direct the distal end of the channel member toward a wall of an airway or other body lumen upon deployment of the device in an airway or other body lumen.

16. The device of claim 15, wherein the distal end of the channel member has an echogenically unique portion configured to identify the orientation of the directional member.

17. The device of claim 16, wherein the channel member can be rotated prior to deployment to rotationally align the echogenically unique portion with respect to the nodule.

18. The device of claim 15, wherein the channel member can be rotated prior to deployment to rotationally align the directional member with respect to the nodule.

19. The device of claim 15, wherein the anchor member engages the lumen wall upon deployment of the device, engagement of the anchor member with the lumen wall fixing the rotational alignment of the directional member with the nodule.

20. The device of claim 15, wherein the directional member comprises one or more projections.

21. A method of deploying and using a fiducial device for repeatable access to a nodule in a lung or other body organ, the method comprising:

locating a target nodule in the body;

compressing the fiducial device within the working channel of a catheter or other delivery device, the fiducial device comprising a fixation portion and a guide portion;

navigating the catheter or other delivery device to the site of the target nodule;

removing the fiducial device from the working channel of the catheter or other delivery device;

attaching the delivery device to tissue proximate the target nodule;

removing the catheter or other delivery device from the site of the target nodule;

engaging a second catheter or other delivery device with the guide portion of the fiducial device, the second catheter of other delivery device including a treatment or diagnosis instrument;

navigating the second catheter or other delivery device along the guide portion of the fiducial device to the site of the target nodule;

treating or collecting a sample from the target nodule; and

withdrawing the second catheter or other delivery device along the guide portion of the fiducial device.

22. A device for providing access to a nodule in a lung or other body organ or lumen, the device comprising:

a fixation portion having a proximal end and a distal end, the fixation portion comprising one or more anchor portions, the fixation portion configured to be attached to tissue in substantially constant proximity to the nodule; and

a guide portion having a proximal end and a distal end, the guide portion configured to removably engage with a medical instrument, the guide portion further configured to guide the navigation of the medical instrument to the fixation portion.

23. The device of claim 22, wherein the one or more anchor portions are configured to removably attach to tissue.

24. The device of claim 22, wherein the fixation portion is attached directly to the nodule.

25. The device of claim 22, wherein the fixation portion is attached proximal to the nodule.

26. The device of claim 22, wherein the guide portion comprises a guide wire.

27. The device of claim 22, wherein the guide portion comprises a guide channel.

28. The device of claim 22, wherein the guide portion further comprises one or more anchors on the proximal end of the guide portion.

29. The device of claim 22, wherein the fixation portion further comprises one or more radiopaque markers.

30. The device of claim 22, wherein the guide portion further comprises one or more radiopaque markers.

31. The device of claim 22, wherein the device is configured to transition between a compressed state within a working channel of a catheter or other delivery device and an expanded state within an airway or other body lumen.

32. The device of claim 22, wherein the fixation portion is configured to attach to an airway wall.