NEEDLE INSERTION SYSTEM AND METHOD FOR INSERTING A MOVABLE NEEDLE INTO A VERTEBRATE SUBJECT

• US 20160008556A1
• Filed: 07/10/2014
• Published: 01/14/2016
• Est. Priority Date: 07/10/2014
• Status: Abandoned Application

• Current Assignee: Elwha LLC (Intellectual Ventures LLC)
• Original Assignee: Elwha LLC (Intellectual Ventures LLC)
• Inventors: Baym, Michael H., Eckhoff, Philip A., Hyde, Roderick A., Kare, Jordin T., McKnight, Gary L., Pan, Tony S., Wood, Lowell L. Jr.
• Application Number:
  US14/328,444
• Publication Number:
  US 20160008556A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A needle insertion system is disclosed that includes a moveable hollow needle having a distal tip configured to be transdermally inserted into a vertebrate subject at an insertion-target region; at least one sensor operable to detect skin structure at a position in proximity to the distal tip of the moveable needle in the insertion-target region; and control circuitry operably coupled to the at least one sensor and configured to receive information therefrom indicating the skin structure at the insertion-target region in proximity to the distal tip, and the control circuitry configured to output moveable needle targeting instructions to control movement of the moveable needle into the skin in response to one or more signals from the at least one sensor detecting the skin structure in proximity to the distal tip. A method for inserting a movable needle of a needle insertion system into a vertebrate subject is disclosed.

Claims

1. A needle insertion system comprising:

a moveable hollow needle having a distal tip configured to be transdermally inserted into a vertebrate subject at an insertion-target region;

at least one sensor operable to detect skin structure at a position in proximity to the distal tip of the moveable needle in the insertion-target region; and

control circuitry operably coupled to the at least one sensor and configured to receive information therefrom indicating the skin structure at the insertion-target region in proximity to the distal tip, and the control circuitry configured to output moveable needle targeting instructions to control movement of the moveable needle into the skin in response to one or more signals from the at least one sensor detecting the skin structure in proximity to the distal tip.

2. The system of claim 1, wherein the at least one sensor is operable to detect the skin thickness of the vertebrate subject utilizing ultrasound longitudinal waves or ultrasound shear waves.

3. The system of claim 1, wherein the at least one sensor is operable to detect the skin thickness of the vertebrate subject utilizing optical coherence tomography.

4. The system of claim 1, wherein the at least one sensor is operable to detect skin conductivity.

5. The system of claim 1, wherein the skin structure includes skin subsurface structure.

6. The system of claim 5, wherein the skin subsurface structure includes at least one of size, location, or thickness of dermis, epidermis, hypodermis, papillary region of the dermis, reticular region of the dermis, boundaries between the epidermis and the dermis, boundaries between the dermis and the hypodermis, and boundaries between the reticular and papillary regions.

7. The system of claim 5, wherein the control circuitry is operable to control insertion depth of the distal tip of the needle relative to the skin subsurface structure.

8. The system of claim 7, wherein the control circuitry is operable to control insertion depth of the distal tip of the needle to a specified depth within dermis.

9. The system of claim 8, wherein the specified depth is within a papillary region of the dermis.

10. The system of claim 8, wherein the specified depth is within a reticular region of the dermis.

11. The system of claim 8, wherein the specified depth is proximate to a boundary between a papillary region and a reticular region of the dermis.

12. The system of claim 7, wherein the control circuitry is operable to control insertion depth of the needle to stop prior to entering hypodermis.

13. The system of claim 7, wherein the control circuitry is operable to control insertion depth of the needle such that a fluid delivery opening at the distal tip of the needle is at a specified depth within dermis.

14. The system of claim 1, wherein the control circuitry operably coupled to the at least one sensor is configured to receive location information therefrom about the insertion-target region.

15. The system of claim 1, further comprising at least one second sensor operable to detect an insertion depth of the movable needle, and to provide one or more signals related to the insertion depth to the control circuitry.

16. The system of claim 15, where the control circuitry is operable to output movable needle targeting instructions to control movement of the moveable needle into the skin in response to the one or more signals related to the insertion depth.

17. The system of claim 15, wherein the at least one second sensor is operable to detect an insertion depth of the distal tip of the movable needle relative to at least one skin subsurface structure.

18. A method for inserting a movable hollow needle of a needle insertion system into a vertebrate subject, comprising:

locating an insertion-target region on the vertebrate subject with at least one sensor operable to detect skin structure at a position in proximity to the distal tip of the moveable needle in the insertion-target region;

outputting location information from the at least one sensor to control circuitry including the location of the insertion-target region and skin structure information in proximity to the distal tip; and

automatically moving the needle to a defined depth into skin at the insertion-target region of the vertebrate subject in response to needle-targeting instructions output from the control circuitry.

19. The method of claim 18, wherein automatically moving the needle to the defined depth into the skin in response to the needle-targeting instructions output from the control circuitry occurs without human intervention and after the needle is in operational range relative to the vertebrate subject.

20. The method of claim 18, wherein automatically moving the needle to the defined depth into the skin in response to the needle-targeting instructions output from the control circuitry includes automatically moving the needle to the defined depth into the skin with an actuator that receives the needle-targeting instructions.

21. The method of claim 18, wherein the skin structure includes skin subsurface structure.

22. The method of claim 21, wherein the skin subsurface structure includes at least one of size, location, or thickness of dermis, epidermis, hypodermis, papillary region of the dermis, reticular region of the dermis, boundaries between the epidermis and the dermis, boundaries between the dermis and the hypodermis, and boundaries between the reticular and papillary regions.

23. The method of claim 21, comprising controlling with the control circuitry insertion depth of the distal tip of the needle relative to the skin subsurface structure.

24. The method of claim 23, comprising controlling with the control circuitry insertion depth of the distal tip of the needle to a specified depth within dermis.

25. The method of claim 24, wherein the specified depth is within a papillary region of the dermis.

26. The method of claim 24, wherein the specified depth is within a reticular region of the dermis.

27. The method of claim 24, wherein the specified depth is proximate to a boundary between a papillary region and a reticular region of the dermis.

28. The method of claim 23, wherein the control circuitry is configured to control insertion depth of the needle to stop prior to entering hypodermis.

29. The method of claim 23, wherein the control circuitry is configured to control insertion depth of the needle such that a fluid delivery opening at the distal tip of the needle is at a specified depth within dermis.

30. The method of claim 18, comprising automatically moving the needle to the defined depth at one or more of an epidermal layer, dermal layer, and hypodermal layer of the skin.

31. The method of claim 18, comprising outputting location information from the at least one sensor to the control circuitry including the skin structure information of the size or thickness of dermis, epidermis, hypodermis, papillary region of the dermis, reticular region of the dermis, boundaries between the epidermis and the dermis, boundaries between the dermis and the hypodermis, and boundaries between the reticular region and the papillary region.

32. The method of claim 18, comprising locating the insertion-target region on the vertebrate subject with the at least one sensor operable to detect the skin thickness of the vertebrate subject utilizing ultrasound longitudinal waves or ultrasound shear waves.

33. The method of claim 18, comprising locating the insertion-target region on the vertebrate subject with the at least one sensor operable to detect the skin thickness of the vertebrate subject utilizing optical coherence tomography.

34. The method of claim 18, comprising locating the insertion-target region on the vertebrate subject with the at least one sensor operable to detect skin conductivity.

35. The method of claim 18, comprising outputting location information including an insertion depth of the movable needle from at least one second sensor to the control circuitry.

36. The method of claim 35, comprising outputting movable needle targeting instructions from the control circuitry to control movement of the moveable needle into the skin in response to the one or more signals from the least one second sensor related to the insertion depth.

37. The method of claim 35, comprising detecting with the least one second sensor an insertion depth of the distal tip of the movable needle relative to at least one skin subsurface structure.