Medical line securement device

• US 6,224,571 B1
• Filed: 11/14/1997
• Issued: 05/01/2001
• Est. Priority Date: 11/14/1997
• 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:
  US08/970,223
• Time in Patent Office: 1,264 Days
• Field of Search: 604/174, 604/177, 604/179, 604/180, 604/283, 128/DIG. 26
• US Class Current: 604/174
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/0246 fixed on the skin having a cover for covering the holding means
• CPC Class Codes: A61M 2025/0253 where the catheter is attached by straps, bands or the like secured by adhesives
• 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 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

A securement device includes a simply-structured retention mechanism that permits a portion of a catheter hub or a similar medical article to be easily anchored to a patient, without the use of tape or needles and suturing. A unitary retainer desirably includes a base defining a locator mechanism. The locator mechanism interacts with a fitting of the medical device so as to position the medical device relative to the retainer. The locator mechanism also desirably guides the medical device fitting into contact with an adhesive member mounted on an outer surface of the retainer. In one form, the locator mechanism includes one or more posts that engage mating holes defined in the medical device fitting. In other forms, the locator mechanism includes a cradle defining an arcuate channel to receive a convex surface of the medical device, or a recess shaped to matingly receive the fitting. The retainer is attached to a flexible anchor pad that includes an adhesive bottom surface, which can be attached to the patient'"'"'s skin. In use, a health care provider positions the medical device fitting on the retainer in a position established and guided by the locator mechanism, and attaches the fitting to the retainer via the adhesive member.

Claims

1. A securement device for securing a fitting on a medical line having an elongated body to a body of a patient, the fitting including at least one laterally extending surface that projects beyond the body of the medical line to at least one side of the medical line, the securement device comprising:

a mounting surface at least partially covered by an adhesive layer for attaching the securement device to the patient'"'"'s body;

a receiving area oriented so as to face away from the patient'"'"'s body, the receiving area including a longitudinally extending section along which the elongated body of the medical line lies when secured by the securement device;

an adhesive member extending laterally beyond at least one side of the longitudinally extending section and having a lateral dimension which is at least generally equal to a lateral dimension of the laterally extending surface of the fitting, the adhesive member covering at least a portion of the receiving area and positioned to contact at least a portion of the fitting secured by the securement device; and

a locator mechanism configured to interact with the fitting so as to orient the portion of the laterally extending surface of the fitting on the receiving area and above at least a portion of the adhesive member.

2. A securement device as in claim 1, wherein the adhesive member is sized so as to be completely covered by the secured medical line fitting portion.

3. A securement device as in claim 2, wherein the shape of the member generally matches the shape of the portion of the medical line fitting to be secured.

4. A securement device as in claim 2, wherein the adhesive member is generally planar, the receiving surface is arranged to receive the medical line fitting in a manner generally aligning an axis of the medical line fitting with a longitudinal axis of the securement device, and a length of the adhesive member, as measured parallel to the longitudinal axis, is greater than a width of the adhesive member, as measured perpendicular to the longitudinal axis and generally parallel to the adhesive member.

5. A securement device as in claim 4, wherein the adhesive member has generally a cruciform shape.

6. A securement device as in claim 1 additionally comprising a flexible anchor pad, the mounting surface being defined on one side of the flexible anchor pad and the receiving area being accessible from an opposite side of the flexible anchor pad.

7. A securement device as in claim 6, wherein the anchor pad comprises a flexible foam layer, and the adhesive layer covers at least a portion of one side of the foam layer.

8. A securement device as in claim 6, wherein the locator mechanism comprises a recess formed in the anchor pad.

9. A securement device as in claim 8, wherein said recess extends through the anchor pad and the adhesive layer is formed at least in part over at least a portion of a substrate, the substrate being positioned over one side of the recess.

10. A securement device as in claim 9, wherein said adhesive member being located within said recess.

11. A securement device as in claim 8, wherein at least a portion of the recess is configured to correspond to the secured portion of the medical line in shape and size.

12. A securement device as in claim 6 additionally comprising a retainer attached to an upper side of the anchor pad, the retainer including the locator mechanism with the receiving area being defined on a side of the retainer facing away from the anchor pad.

13. A securement device as in claim 12, wherein the locator mechanism includes a recess formed in the retainer.

14. A securement device as in claim 13, wherein said recess extends through the retainer and the adhesive member is located between the anchor pad and the retainer with a portion of the member being exposed within the recess.

15. A securement device as in claim 13, wherein at least a portion of the recess is configured to correspond to the secured portion of the medical line in shape and size.

16. A securement device as in claim 12, wherein the locator mechanism comprises a cradle with the receiving area being formed within the cradle.

17. A securement device as in claim 16, wherein the adhesive member is positioned within the cradle and covers at least a portion of the receiving area.

18. A securement device as in claim 17, wherein a foam layer is interposed between the adhesive member and the cradle.

19. A securement device as in claim 16, wherein the cradle comprises a contoured surface configured to mate with a complementary contoured surface defined by the secured portion of the medical line.

20. A securement device as in claim 16, wherein the cradle includes an arcuate channel.

21. A securement device as in claim 20, wherein at least a portion of the surface of the channel extends about a central axis of the channel by more than 180 degrees.

22. A securement device as in claim 20, wherein the channel has a tapering frusto-conical surface.

23. A securement device as in claim 21, wherein the cradle includes a flexible coupling interconnecting sides of the channel to permit movement of the sides relative to each other at least between an open position and a closed position.

24. A securement device as in claim 23, wherein the flexible coupling comprises an actuation mechanism which causes the channel sides to move from the open position to the closed position when a portion of the medical line presses against the flexible coupling within the channel.

25. A securement device as in claim 12, wherein the retainer comprises a base and a raised pedestal extending upwardly from the base, and the receiving area is defined on the raised pedestal.

26. A securement device as in claim 12, wherein the retainer includes a base and a pair of latches spaced apart from each other on the base, and the adhesive member is located between the latches.

27. A securement device as in claim 26, wherein each latch includes a tang, which projects toward the other latch, a generally upright support, which suspends the tang above the base, and an actuator, which is attached to the support at a point above the base, whereby moving the actuator toward the base causes the support to flex and moves the tang away from the other latch.

28. A securement device as in claim 27, wherein each support has an elongated shape, and the supports are arranged on the base generally parallel to each other so as to define a generally rectangular channel between the supports and the base.

29. A securement device as in claim 28, wherein the channel is sized to receive the secured portion of the medical line, and the latches are arranged on the base to engage a portion of the medical line to secure, at least in part, within the channel.

30. A securement device as in claim 26, wherein a release line covers the adhesive member.

31. A securement device as in claim 12, wherein the retainer is attached to the anchor pad by a solvent bond adhesive.

32. A securement device as in claim 31, wherein the solvent bond adhesive comprises cyanoacrylate.

33. A securement device as in claim 12 additionally further comprising a foam pad interposed between the retainer and the adhesive member, the adhesive member covering at least a portion of one side of the foam pad.

34. A securement device as in claim 1, wherein the receiving surface is at least coextensive with the adhesive layer.

35. A securement device for securing a fitting on a medical line having an elongated body to a body of a patient, comprising

a mounting surface at least partially covered by an adhesive layer for attaching the securement device to the patient'"'"'s body,

a receiving area oriented so as to face away from the patient'"'"'s body,

an adhesive member at least partially covering the receiving surface and positioned to contact at least a portion of the fitting secured by the securement device,

a locator mechanism comprising at least one post that is configured to interact with the fitting and to position the fitting on the receiving area relative to the adhesive member, and

a retainer attached to an upper side of the anchor pad including the locator mechanism with the receiving area being defined on a side of the retainer facing away from the anchor pad, and a flexible anchor pad, the mounting surface being defined on one side of the anchor pad and the receiving area being accessible from an opposite side of the anchor pad.

36. A securement device as in claim 35, wherein the locator mechanism comprises at least a pair of posts spaced apart from each other.

37. A securement device as in claim 36, wherein the adhesive member is positioned between the pair of posts.

38. A securement device as in claim 37, wherein the retainer includes an inclined surface positioned between the posts, and the adhesive member is located on the inclined surface.

39. A securement device for anchoring a fitting on a medical device having an elongated body to the body of a patient, the fitting including at least one laterally extending surface that projects beyond the body of the medical line to at least one side of the medical line, the securement device comprising:

a mounting surface at least partially covered by an adhesive layer for attaching the securement device to the patient'"'"'s body, a receiving area oriented so as to face away from the patient'"'"'s body, a longitudinally extending section of the receiving area, an adhesive member extending laterally beyond at least one side of the longitudinally extending section and having a lateral dimension which is at least generally equal to a lateral dimension of the laterally extending surface of the fitting, the adhesive member covering at least a portion of the receiving area, and guide means for locating the medical device relative to the adhering means in a position wherein a portion of the fitting attaches to and generally completely covers the adhering means.

40. A securement device as in claim 39 additionally comprising a flexible foam pad on which said adhesive layer is disposed and which supports said adhering means and said guide means.

41. A method of securing a fitting on a medical device to the body of a patient comprising:

providing a securement device having a first adhesive member on one side of a securement device, a second adhesive member on an opposite side of the securement device, the securement device comprising a locator mechanism having at least one post adapted to engage the fitting so as to guide the fitting into a position relative to the first adhesive member,

engaging the fitting with the locator mechanism so as to position a portion of the fitting over the first adhesive member by inserting at least one post of the locator mechanism through a hole of a fitting of the medical device;

engaging the portion of the fitting with the first adhesive member thereby releasably securing the fitting to the securement device, and

placing the second adhesive member on the patient'"'"'s body to secure the securement device thereto.

42. A method as in claim 41, wherein engaging the fitting with the locator mechanism involves placing a portion of the fitting within a cradle of the locator mechanism.

43. A method of securing a fitting on a medical device to the body of a patient, the fitting including at least one laterally extending surface that projects to the side of the medical line, the method comprising the acts of:

providing a securement device having a first adhesive member on one side of a securement device and sized to make contact with at least a portion of the laterally extending surface of the fitting, a second adhesive member on an opposite side of the securement device, the securement device further comprising a locator mechanism adapted to engage the fitting so as to guide the fitting into a position relative to the first adhesive member;

engaging the fitting with the locator mechanism so as to position a portion of the fitting over the first adhesive member,

engaging the portion of the laterally extending surface of the fitting with the first adhesive member thereby releasably securing the fitting to the securement device; and

placing the second adhesive member on the patient'"'"'s body to secure the securement device thereto.

44. A method as in claim 43, wherein engaging the medical device fitting with the locator mechanism involves placing a mating portion of the medical device fitting within a recess of the securement device.

45. A method as in claim 43, wherein the provided securement device comprises a pair of cooperating latches with a channel defined between the latches, and engaging the medical device fitting with the locator mechanism involves placing a portion of the medical device fitting within a channel.

46. A method as in claim 45 additionally comprising latching the portion of the medical device to the securement device using the latches.

47. A method as in claim 43, wherein engaging the medical device fitting with the locator mechanism means placing the to-be-retained portion of the medical device fitting within a cradle of the locator mechanism, pressing the medical device fitting portion against a flexible coupling, and moving opposing sides of the cradle around the portion of the medical device fitting.

48. A method as in claim 47, wherein engaging the medical device fitting with the first adhesive member involves bringing the opposing sides of the cradle into contact with the medical device fitting with the first adhesive member covering at least portions of opposing sides.

49. A securement device for securing a fitting on a medical line having an elongated body to a body of a patient, the fitting including at least one laterally extending surface that projects beyond the body of the medical line to at least one side of the medical line, the securement device comprising:

a mounting surface and a locator mechanism, said mounting surface at least partially covered by an adhesive layer for attaching the securement device to the patient'"'"'s body, and said locator mechanism comprising a recess oriented so as to face away from the patient'"'"'s body, the recess having a lateral dimension which is at least generally equal to a lateral dimension of the laterally extending surface of the fitting, a receiving area located within the recess, a longitudinally extending section of the receiving area, and an adhesive member extending laterally beyond at least one side of the longitudinally extending section of the receiving area, the adhesive member having a lateral dimension which is at least generally equal to a lateral dimension of the laterally extending surface of the fitting, and said recess configured to interact with the fitting so as to orient the portion of the laterally extending surface of the fitting on the receiving area and above at least a portion of the adhesive member, and said adhesive member sized to make contact with at least a portion of the laterally extending surface of the fitting.

50. A securement device as in claim 49 additionally comprising a flexible anchor pad, the mounting surface being defined on one side of the flexible anchor pad.

51. A securement device as in claim 50, wherein the recess extends through the flexible anchor pad.

52. A securement device as in claim 50, wherein at least a portion of the recess is configured to correspond to the secured portion of the medical line in shape and size.

53. A securement device as in claim 50 additionally comprising a retainer attached to an upper side of the anchor pad, the retainer including the locator mechanism.

54. A securement device as in claim 53, wherein the recess extends through the retainer and the adhesive member is located between the anchor pad and the retainer with a portion of the adhesive member being exposed within the recess.

55. A securement device as in claim 53, wherein at least a portion of the recess is configured to correspond to the secured portion of the medical line in shape and size.