Method and apparatus for enhancing penetration of a member for the intradermal sampling or administration of a substance

• US 6,537,242 B1
• Filed: 06/06/2000
• Issued: 03/25/2003
• Est. Priority Date: 06/06/2000
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Palmer, Phyllis J.
• Primary Examiner(s): Denion, Thomas
• Assistant Examiner(s): TRIEU, THAI BA
• Application Number:
  US09/588,767
• Time in Patent Office: 1,022 Days
• Field of Search: 604/22, 604/191, 604/181, 604/183, 604/200, 604/207, 604/272, 606/181, 606/184-186, 606/172, 606/189, 600/309, 600/583, 422/57
• US Class Current: 604/22
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A device for monitoring, sampling or delivering a substance to the skin of a patient includes a medical device and a stretching device for stretching the skin to enhance the contact by the medical device. The medical device generally includes at least a skin penetrating member, such as a cannula. The cannula can be a single needle or an array of microneedles. The method for monitoring, sampling or delivering a substance positions the device on the skin and presses downwardly on the device causing the stretching device to stretch the skin in a target area of the skin penetrating member to enable uniform penetration of the skin. The uniform penetration provides for a more uniform monitoring, sampling or delivery of the substance to the patient.

Claims

1. A device for stretching the surface of the skin of a patient, said device comprising:

a medical device for contacting the skin of a patient; and

a skin stretching device coupled to said medical device for stretching skin of a patient away from said medical device when a downward pressure is applied on said medical device toward the skin of a patient, said stretching device having length sufficient to contact said skin of a patient prior to said medical device contacting said skin.

2. The device of claim 1, wherein said medical device is a monitoring, sampling or delivery device.

3. The device of claim 1, wherein said skin stretching device comprises a shield coupled to said medical device, said shield having a first end coupled to said medical device and a second end positioned radially outward from said medical device, wherein said shield extends at an incline with respect to said medical device.

4. The device of claim 3, wherein said shield encircles said medical device and has a substantially frustoconical shape.

5. The device of claim 4, wherein said shield is made of a flexible material, and said second end of said shield is movable from a first position to a second position spaced radially outward from said first position.

6. The device of claim 4, wherein said shield is spaced axially and radially from said medical device when in a first position and is movable to a second position where said second end is spaced radially outward from said first position.

7. The device of claim 3, wherein said shield has a length to extend beyond said medical device whereby said second end of said shield contacts the skin of a patient before said medical device contacts the skin.

8. The device of claim 7, wherein said second end of said shield is movable radially outward from said medical device by a pressure on said shield against the skin of a patient.

9. The device of claim 3, wherein said second end of said shield includes a friction enhancing member for enhancing friction between said shield and the skin of a patient.

10. The device of claim 9, wherein said friction enhancing member is an adhesive on said shield.

11. The device of claim 9, wherein said friction enhancing member is a ridge on said second end.

12. The device of claim 1, wherein said medical device includes at least one solid or hollow skin penetrating member.

13. The device of claim 1, wherein said medical device includes an array of microneedles for penetrating the skin of a patient.

14. The device of claim 13, wherein said microneedles include a hollow passage extending axially through said microneedles.

15. The device of claim 14, wherein said delivery device includes at least one skin penetrating member and a cavity for directing a substance to said at least one skin penetrating member.

16. The device of claim 12, wherein said at least one skin penetrating member has a coating of a dried or lyophilized drug.

17. The device of claim 1, wherein said stretching device comprises at least two arms for contacting the skin of a patient and stretching the skin in at least one dimension, wherein said arms have a first end coupled to said medical device and a second end spaced from said medical device, said arms being movable from a first position where said second end is spaced axially and radially from said medical device to a second position where said second end is spaced radially from said medical device and is coplanar with said medical device.

18. The device of claim 17, wherein said arms are made of a flexible material and bendable from said first position to said second position.

19. The device of claim 17, wherein said arms extend from opposite sides of said medical device for stretching skin in one dimension.

20. The device of claim 17, wherein said stretching device comprises four arms substantially uniformly spaced around said medical device.

21. A device for withdrawing, delivering or monitoring a substance through the skin of a patient, said device comprising:

a housing supporting at least one skin penetrating member for delivering a substance intradermnally to a patient; and

a stretching device coupled to said housing for stretching the skin of a patient in at least one dimension, said stretching device having at least one member with a first end coupled to said device and a second end spaced axially from said housing and said at least one skin penetrating member, wherein said at least one member has a length greater than said at least one skin penetrating member and is positioned to contact and stretch the skin of a patient in said at least one dimension prior to the contact and penetration of said skin by said skin penetrating member.

22. The device of claim 21, wherein said stretching device comprises a substantially frustoconical shaped shield having a first end coupled to said housing and a second end extending axially and radially from said housing, said second end being spaced axially from said housing.

23. The device of claim 22, wherein said shield is made of a flexible material and said second end of said shield is movable from a first position to a second position spaced radially outward from said first position.

24. The device of claim 22, wherein said second end of said shield includes a friction-enhancing member.

25. The device of claim 22, wherein said friction enhancing member is an adhesive.

26. The device of claim 22, wherein said friction enhancing member is a rib.

27. The device of claim 21, wherein said stretching device comprises at least two flexible arms, each of said arms having a first end coupled to said housing and a second end diverging away from said housing, said arms having a length wherein said second end is spaced axially and radially from said cannula and said second end of said arm is movable from a first position in a plane spaced from said cannula to a second position coplanar with said cannula.

28. The device of claim 27, wherein said stretching device comprises two of said arms, each of said arms being spaced on opposite sides of said housing.

29. The device of claim 27, wherein said stretching device comprises four of said arms, each of said arms being substantially uniformly spaced apart around said housing.

30. A method of subjecting the skin of a patient to a medical device, said method comprising the steps of

providing a medical device having a skin stretching device, and

positioning said medical device with said stretching device on the skin of a patient and applying a sufficient force on said device toward said skin where said stretching device stretches the skin away from said medical device prior to said medical device contacting said skin.

31. The method of claim 30, wherein said medical device is a delivery device having at least one skin penetrating member, and said method further comprises delivering a substance to a patient.

32. The method of claim 30, wherein said medical device is a monitoring device and said method further comprises monitoring the level of a substance in a patient.

33. The method of claim 30, wherein said medical device is a sampling device and said method further comprises withdrawing a sample from a patient.

34. The method of claim 30, wherein said stretching device comprises at least one member with a first end coupled to said medical device and a second end spaced axially from said medical device and having a length to extend beyond said medical device, said method comprising applying a force to push said at least one member and said skin away from said medical device.

35. The method of claim 30, wherein said stretching device comprises a flexible substantially frustoconical shaped shield having a first end coupled to said medical device and a second end extending axially and radially from said medical device, and said method comprises applying sufficient pressure to cause said second end to expand radially outwardly from said medical device to stretch said skin.

36. The method of claim 30, wherein said stretching device comprises at least two flexible arms, each of said arms having a first end coupled to said medical device and a second end diverging away from said medical device, said arms having a length wherein said second end is spaced axially and radially from said medical device and said second end of said arm is movable from a first position in a plane spaced from said medical device to a second position in a plane with said medical device, and said method comprises applying sufficient pressure to said device to cause said arms to flair radially outward from said medical device to stretch said skin.

37. The method of claim 36, wherein said stretching device comprises at least four arms spaced around said medical device, said method comprising applying a force onto said medical device to force said arms outwardly from said medical device.