Medical line securement device for use with neonates

• US 6,551,285 B1
• Filed: 06/08/2000
• Issued: 04/22/2003
• Est. Priority Date: 06/08/2000
• Status: Expired due to Term

• Current Assignee: Venetec International Incorporated (Becton, Dickinson & Co)
• Original Assignee: Venetec International Incorporated (Becton, Dickinson & Co)
• Inventors: Bierman, Steven F.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/589,862
• Time in Patent Office: 1,048 Days
• Field of Search: 128/DIG.15, 604/174, 604/179, 604/180, 24/31, 243/04, 243/06, 24D/IG.11, 248/205.2, 248/205.3, 224/901, 224/901.2
• US Class Current: 604/180
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/026 where the straps are releasably secured, e.g. by hook and loop-type fastening devices
• CPC Class Codes: A61M 2240/00 Specially adapted for neonatal use
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: Y10S 128/15 Hook and loop type fastener

Abstract

A medical line securement device allows for inspection, repositioning, replacement and servicing of a medical line without removing an adhesive patch attached to the neonate'"'"'s skin, thereby saving the thin and fragile skin of the neonate. The securement device provides a releasable attachment between the adhesive anchor patch, which is attached to the neonate, and a coupler of the securement device, which is attached to the medical line. The patch has a base, a fastening element, and an adhesive layer that attaches to the skin of a medical patient. The coupler attaches to the medical line. By this configuration, the patch and coupler cooperate to retain and releasably secure a medical line to the patient. The device is particularly adapted for use in connection with neonates and provides a small securement surface to fit onto the small body locations of a neonate. The securement device consequently can be used to couple different types of catheters or tubes at different locations on the neonates body.

Claims

1. A securement device for securing a medical line to the skin of a patient, comprising:

a patch including at least one fastener element on a first side of the patch and an adhesive on at least a portion of an opposite second side of the patch to secure the patch to the skin of the patient; and

a coupler having a patch attachment section and a medical line attachment section connected together and both including a front side and an opposite back side, at least two fastener elements, each being cooperative with the fastener element on the patch to releasably secure the coupler to the patch, one being positioned on the front side of the patch attachment section and the other being position on the back side of the patch attachment section, and an adhesive on the front side of the medical line attachment section.

2. A securement device as in claim 1, wherein the fastener elements on the coupler are non-abrasive.

3. A securement device as in claim 2, wherein the fastener elements on the coupler each comprise a plurality of loops, and the fastener element on the patch comprises a plurality of hooks.

4. A securement device as in claim 1, wherein the coupler includes a flexible neck that connects together the patch attachment section and the medical line attachment section.

5. A securement device as in claim 4, wherein the neck comprises a flexible layer of substantially inelastic material.

6. A securement device as in claim 1, wherein the patch is moisture-vapor permeable.

7. A securement device as in claim 6, wherein the patch includes a plurality of perforations and the adhesive is moisture-vapor permeable.

8. A securement device as in claim 1, wherein the adhesive on the patch is hypoallergenic.

9. A securement device as in claim 1, wherein the patch is flexible to conform to a surface profile of the patient'"'"'s skin.

10. A securement device as in claim 1, wherein the fastener element is sized to cover only a portion of the first side of the patch.

11. A securement device as in claim 10, wherein the patch is configured and sized so that the portion of the patch not covered by the fastener element can be trimmed into a shape appropriate for securing the patch to the skin of the patient.

12. A securement device for securing a medical line to the skin of a patient, comprising:

a patch including at least one fastener element on a first side of the patch and an adhesive on at least a portion of an opposite second side of the patch to secure the patch to the skin of the patient; and

a coupler having a patch attachment section, a medical line attachment section connected together by a narrow flexible neck, the patch attachment section including at least one fastener element that is cooperative with the fastener element on the patch to releasably secure the coupler to the patch, and an adhesive on the medical line attachment section.

13. A securement device as in claim 12, wherein the flexible neck has a transverse width that is about one third the transverse width of the patch attachment section.

14. A securement device as in claim 13, wherein the neck comprises a flexible layer of substantially inelastic material.

15. A securement device as in claim 14, wherein the substantially inelastic material has modulus of elasticity of less than about 150,000 psi.

16. A securement device as in claim 14, wherein the flexible layer of material has a tensile strength of at least about 25 lbs./inch.

17. A securement device as in claim 14, wherein the flexible layer of material has a shear strength in a direction perpendicular to an axis of the neck of at least about 0.8 psi.

18. A securement device as in claim 12, wherein the fastener element on the coupler are non-abrasive.

19. A securement device as in claim 18, wherein the fastener element on the coupler comprises a plurality of loops, and the fastener element on the patch comprises a plurality of hooks.

20. A securement device as in claim 19, wherein the patch attachment section includes a front side and an opposite back side, and each of said front and back sides includes a plurality of soft loops that are capable of cooperating with the hooks on the patch.

21. A securement device as in claim 12, wherein the patch is moisture-vapor permeable.

22. A securement device as in claim 21, wherein the patch includes a plurality of perforations and the adhesive is moisture-vapor permeable.

23. A securement device as in claim 12, wherein the adhesive on the patch is hypoallergenic.

24. A securement device as in claim 12, wherein the patch is flexible to conform to a surface profile of the patient'"'"'s skin.

25. A securement device as in claim 12, wherein the fastener element is sized to cover only a portion of the first side of the patch.

26. A securement device as in claim 25, wherein the patch is configured and sized so that the portion of the patch not covered by the fastener element can be trimmed into a shape appropriate for the region of the patient to which it is applied.

27. A securement device for securing a medical line to the skin of a patient, comprising:

a patch including a first side and an opposite second side, and an adhesive on at least a portion of the second side of the patch to secure the patch to the skin of the patient;

a coupler having a patch attachment section and a medical line attachment section being connected together and both including a front side and an opposite back side, and an adhesive on the front side of the medical line attachment section; and

means for releasably attaching the patch attachment section to the patch regardless of the orientation of the front side of the medical line attachment section relative to the patch.

28. A securement device as in claim 27 additionally comprising means for flexibly connecting the patch attachment section to the medical line attachment section.

29. A securement device as in claim 27, wherein the coupler includes a flexible neck that connects the patch attachment section to the medical line attachment section.

30. A securement device as in claim 29, wherein the patch attachment section and the medical line attachment section each include a base, and a unitary layer of flexible, substantially inelastic material forms the neck and the bases of the patch and medical line attachment sections.

31. A securement device as in claim 27, wherein the patch is flexible.

32. A securement device as in claim 27, wherein the medical line attachment section of the coupler is flexible.

33. A securement device as in claim 27, wherein the patch includes means of permitting moisture-vapor to permeate through the second and first sides of the patch.

34. A securement device as in claim 27, wherein the fastener element is sized to cover only a portion of the first side of the patch.

35. A securement device as in claim 34, wherein the patch is configured and sized so that the portion of the patch not covered by the fastener element can be trimmed into a shape appropriate for the region of the patient to which it is applied.

36. A securement device for securing a medical line to the skin of a patient, comprising:

a patch including at least one fastener element on a first side of the patch and an adhesive on at least a portion of an opposite second side of the patch to secure the patch to the skin of the patient; and

a coupler having a patch attachment section and a medical line attachment section connected together and both including a front side and an opposite back side, at least one fastener element being disposed on the front side of the patch attachment section and being cooperative with the fastener element on the patch to releasably secure the coupler to the patch, and at least two adhesive portions, one being disposed on the front side of the medical line attachment section and the other being disposed on the back side of the medical line attachment section.

37. A securement device as in claim 36, wherein the coupler includes another fastener element disposed on the back side of the patch attachment section.

38. A securement device as in claim 36, wherein the fastener element on the coupler comprises a plurality of loops, and the fastener element on the patch comprises a plurality of hooks.

39. A securement device as in claim 36, wherein the coupler includes a flexible neck that connects together the patch attachment section and the medical line attachment section.

40. A securement device as in claim 39, wherein the neck comprises a flexible layer of substantially inelastic material.

41. A securement device as in claim 36, wherein the patch is moisture-vapor permeable.

42. A securement device as in claim 36, wherein the fastener element is sized to cover only a portion of the first side of the patch.

43. A securement device as in claim 42, wherein the patch is configured and sized so that the portion of the patch not covered by the fastener element can be trimmed into a shape appropriate for the region of the patient to which it is applied.

44. A kit having a plurality of parts for securing a medical line to the skin of a neonate, comprising:

a securement device including,

a patch including at least one fastener element on a first side of the patch and an adhesive on at least a portion of an opposite second side of the patch to secure the patch to the skin of the patient, and

a coupler having a patch attachment section and a medical line attachment section connected together and both including a front side and an opposite back side, at least two fastener elements, each being cooperative with the fastener element on the patch to releasably secure the coupler to the patch, one being positioned on the front side of the patch attachment section and the other being position on the back side of the patch attachment section, and an adhesive on the front side of the medical line attachment section; and

at least one tape strip.

45. A kit as in claim 44 additionally comprising a second patch, one of the patches including a hypoallergenic adhesive.

46. A kit as in claim 44 additionally comprising an additional patch, one of the patches including a fastener element that is sized to cover only a portion of the first side of the patch.

47. A kit as in claim 44 additionally comprising an additional patch that is configured and sized so it can be trimmed into a shape appropriate for the region of the patient to which it is applied by a healthcare practitioner.

48. A kit as in claim 44 additionally comprising a second tape strip, and one of the tape strips having a hypoallergenic adhesive layer.