Device for medical procedure localization and/or insertion

• US 10,595,898 B2
• Filed: 01/21/2016
• Issued: 03/24/2020
• Est. Priority Date: 01/22/2015
• Status: Active Grant

• Current Assignee: Innovital LLC
• Original Assignee: Innovital LLC
• Inventors: Krimsky, William Sanford, Kothera, Curt Steven, Shah, Amit Navin, Hiemenz, Gregory John
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US15/545,797
• Publication Number:
  US 20180008305A1
• Time in Patent Office: 1,524 Days
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

A device (100) for medical procedure localization and/or insertion that can be dimensionally adjusted for different patient sizes and properly aligned and stabilized using anatomical landmarks. The device (100) for medical procedure localization and/or insertion provides an adjustable template that indexes the site of interest at the intersection of a first axis or plane and a second axis or plane. An embodiment is disclosed in which a first axis is the axillary line through the patient'"'"'s axilla (armpit) and iliac crest (pelvis), and a second axis is the patient'"'"'s ideal horizontal nipple line. The intersection of the first and second axes is the 4th or 5th intercostal space, into which a needle and/or chest tube may be placed for decompression.

Claims

1. A device for assisting, preparing for, or training for a medical procedure, said procedure entailing localization, incision, or insertion at a procedure site on a human patient, said device comprising:

a locator base extending from a first end to a second end, said locator base having a shape at said first end configured to index contact with a first thoracic anatomical landmark defined by a sub-epidermal structure, and said locator base having a shape at said second end configured for visual or physical alignment with a second anatomical landmark that is caudad to said first thoracic anatomical landmark, said locator base thereby indexing a first reference point at said first thoracic anatomical landmark and a second reference point at said second caudad anatomical landmark, and a first axis extending between said first reference point and said second reference point;

a first movable member slidably attached to said locator base for movement along said first axis until alignment with a third anatomical landmark, said first movable member thereby indexing a third reference point at said third anatomical landmark, said third reference point being along a second axis that intersects said first axis; and

a guide for indicating said procedure site at an intersection of said first axis and second axis.

2. The device of claim 1, further comprising one or more flanges.

3. The device of claim 2, wherein said one or more flanges are movable to a plurality of positions.

4. The device of claim 2, wherein said one or more flanges are pivotally attached to said first movable member.

5. The device of claim 2, wherein said one or more flanges comprise an adhesive coating.

6. The device of claim 2, wherein said one or more flanges comprise two opposing flanges to anchor and/or stabilize said device.

7. The device of claim 1, further comprising visual instructional indicia including any one or more from among the group consisting of wording, labeling, numbering, arrows, hash marks, geometrical shapes, illustrations, text instructions and indices.

8. The device of claim 1, wherein said first movable member is linearly translatable along said locator base.

9. The device of claim 8, wherein said first movable member comprises an aperture, and said locator base comprises a slot, and the aperture of said first movable member is translatable along the slot of said locator base for indexing said intersection.

10. The device of claim 1, further comprising a locking mechanism for locking said first movable member in a position.

11. The device of claim 1, wherein said guide further comprises an instrument securer for constraining an instrument in at least one degree-of-freedom for said medical procedure at said site.

12. The device of claim 1, wherein said medical procedure comprises any one from among a group consisting of chest decompression, chest drainage, cricothyrotomy, tracheostomy, tracheotomy, lumbar puncture, intraosseous vascular access, thoracentesis, or arthrocentesis.

13. The device of claim 1, wherein said device enables conversion of a temporary decompression, drainage or access instrument to another decompression, drainage or access instrument.

14. The device of claim 1, further comprising at least one instrument securer.

15. The device of claim 14, wherein said instrument securer indexes an axis or plane of said procedure.

16. The device of claim 1, wherein said locator base is configured with a hinge.

17. The device of claim 1, further comprising a second movable member movably attached to said first movable member for defining a third axis or plane to assist said medical procedure.

18. The device of claim 17, wherein said third axis or plane indicates insertion depth for a medical instrument when performing said medical procedure.

19. The device of claim 1, wherein said first thoracic anatomical landmark consists of said patient'"'"'s axilla.

20. The device of claim 1, wherein said first thoracic anatomical landmark consists of said patient'"'"'s clavicle.

21. The device of claim 1, wherein said second anatomical landmark that is caudad to said first thoracic anatomical landmark consists of said patient'"'"'s iliac crest.

22. The device of claim 1, wherein said third anatomical landmark consists of said patient'"'"'s nipple.

23. The device of claim 1, wherein said second anatomical landmark that is caudad to said first thoracic anatomical landmark consists of said patient'"'"'s sternum.

24. The device of claim 1, wherein said first axis corresponds to said patient'"'"'s mid-clavicular line.

25. The device of claim 1, wherein said first axis corresponds to said patient'"'"'s axillary line.

26. The device of claim 1, wherein said second axis corresponds to said patient'"'"'s nipple line.

27. A device for assisting percutaneous procedures on a human patient, comprising:

a base extending from a first end to a second end, said base having a first shape at said first end configured to index contact with a first thoracic anatomical landmark, said base having a second shape at said second end configured for visual or physical alignment with a second anatomical landmark that is caudad to said first thoracic anatomical landmark, said base thereby indexing a first reference point at said first thoracic anatomical landmark and a second reference point at said second caudad anatomical landmark, said first and second reference points being along and a first axis extending between said first reference point and said second reference point;

at least one adjustable component attached to said base for linear sliding movement along said first axis until alignment with a third anatomical landmark along a second axis that intersects said first axis; and

a guide that assists percutaneous access at a procedure site at an intersection of said first axis and second axis.

28. A device for assisting, preparing for, or training for a medical procedure, said procedure entailing localization, incision, or insertion at a procedure site on a human patient, said device comprising:

a locator base extending from a first end to a second end,

said locator base having a first shape at said first end configured to index contact with a thoracic anatomical landmark and thereby indexing a first point,

said locator base having a second shape at said second end configured for visual or physical indexing of an anatomical landmark that is caudad to said thoracic anatomical landmark and thereby indexing a second point,

said first and second points being along a first axis extending between said first point and said second point; and

a guide comprising an aperture through said locator base centered at an intersection of said first axis and a second axis that is offset from one of said thoracic anatomical landmark and caudad anatomical landmark and generally perpendicular to said first axis for indicating said procedure site.

29. The device of claim 28, wherein said thoracic anatomical landmark consists of said patient'"'"'s axilla.

30. The device of claim 28, wherein said thoracic anatomical landmark consists of said patient'"'"'s clavicle.

31. The device of claim 28, wherein said anatomical landmark that is caudad to said thoracic anatomical landmark consists of said patient'"'"'s iliac crest.

32. The device of claim 28, wherein said anatomical landmark that is caudad to said thoracic anatomical landmark consists of a point on said patient'"'"'s mid-clavicular line.

33. The device of claim 28, wherein said anatomical landmark that is caudad to said thoracic anatomical landmark consists of said patient'"'"'s sternum.

34. The device of claim 28, wherein said first axis corresponds to said patient'"'"'s mid-clavicular line.

35. The device of claim 28, wherein said first axis corresponds to said patient'"'"'s axillary line.

36. A device for assisting, preparing for or training for a medical procedure, said procedure entailing localization, incision, or insertion at a procedure site on a human patient, said device comprising:

a locator base extending from a first end to a second end, said locator base having a first shape at said first end configured to index contact with a first thoracic anatomical landmark to thereby index a first point, said locator base having a second shape at said second end configured for visual or physical alignment with a second anatomical landmark that is caudad to said first thoracic anatomical landmark, said locator base thereby indexing a first reference point at said first thoracic anatomical landmark and a second reference point at said second caudad anatomical landmark, said first and second reference points being along a first axis extending between said first thoracic reference point and said second caudad reference point;

a first movable member movably attached to said locator base for linear translation along said first axis; and

a guide on said movable member for indicating said procedure site relative to said first axis, relative to at least one different anatomical landmark.