Stabilization of a catheter or cannula

• US 20090306602A1
• Filed: 05/29/2009
• Published: 12/10/2009
• Est. Priority Date: 06/04/2008
• Status: Active Grant

• Current Assignee: David G. Elwell, Kim A. Sena
• Original Assignee: David G. Elwell, Kim A. Sena
• Inventors: Elwell, David G., Sena, Kim A.
• Granted Patent: US 8,157,770 B2
• Time in Patent Office: Days
• US Class Current: 604/180
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: Y10S 128/06 Intravenous injection support
• CPC Class Codes: Y10S 128/26 Cannula supporters

Abstract

A stabilizing device (and method of use) for insertion and maintenance of a catheter or cannula maintains a sterile insertion site and is simple and easy to construct and use, yet optimally maintains the catheter or cannula in place. A first stabilizing element includes a pair of bilateral wings and a catheter or cannula receiving element generally between the wings. A proximal stabilizing element—desirably two distinct and spaced pieces of tape—is operatively connected to the wings and has a sterile adhesive for affixing the wings to a patient to provide stability during needle removal and substantially for the duration that the catheter or cannula is inserted into a patient. A lateral stabilizing element—desirably two pieces of tape—is distinct and spaced from the proximal stabilizing element, to provide primarily lateral and medial stability to a catheter or cannula in a patient. A release sheet may cover the tape adhesive, or the tape may have a pattern of adhesive and non-adhesive sections cooperating with each other. Butterfly catheter, or angiocatheter, embodiments are particularly desirable.

Claims

1. A stabilizing device for insertion and maintenance of a catheter or cannula, comprising:

a first stabilizing element including a pair of bilateral wings and a catheter or cannula receiving element generally between said bilateral wings;

a proximal stabilizing element operatively connected to at least one of said bilateral wings and including a sterile adhesive for affixing at least one of said bilateral wings to a patient to provide stability of the catheter or cannula during needle removal and substantially for the duration that the catheter or cannula is inserted into a patient; and

a lateral stabilizing element distinct and spaced from said proximal stabilizing element, said lateral stabilizing element including a sterile adhesive for affixing at least one of said bilateral wings to a patient to provide primarily lateral and medial stability to a catheter or cannula in a patient.

2. A device as recited in claim 1 wherein said proximal stabilizing element comprises at least first and second distinct and spaced tape strips with pressure sensitive sterile adhesive on portions thereof proximally overlapping said bilateral wings, one operatively connected to each of said bilateral wings.

3. A device as recited in claim 2 wherein said lateral stabilizing element comprises at least third and fourth distinct and spaced tape strips with pressure sensitive sterile adhesive on portions thereof laterally overlapping said bilateral wings, one operatively connected to each of said bilateral wings.

4. A device as recited in claim 1 wherein said lateral stabilizing element comprises at least third and fourth distinct and spaced tape strips with pressure sensitive sterile adhesive, one operatively connected to each of said bilateral wings.

5. A device as recited in claim 3 further comprising a separate release sheet covering overlapping adhesive on each of said tape strips to maintain sterility, and an adhesive free portion at an edge of each of said tape strips to facilitate removal thereof after affixation to a patient'"'"'s skin.

6. A device as recited in claim 3 wherein at least one of said tape strips has a bottom surface with a pattern of pressure sensitive adhesive and release sections, and is folded over on itself so that said adhesive and release sections operatively engage each other to maintain sterility until unfolded to be affixed to a patient'"'"'s skin.

7. A device as recited in claim 1 in combination with an angiocatheter or butterfly catheter.

8. A device as recited in claim 3 further comprising at least fifth and sixth distinct and spaced distal tape strips, one operatively connected to each of said bilateral wings and having a portion thereof with pressure sensitive sterile adhesive distally overlapping a wing.

9. A device as recited in claim 3 wherein said proximal and lateral stabilizing elements consist essentially of said first through fourth tape strips.

10. A device as recited in claim 1 wherein said receiving element comprises a substantially tubular hub or base, and a catheter extending proximally from said hub or base;

and in combination with a catheter insertion device having a needle extending through said hub or base and catheter

11. A device as recited in claim 2 wherein said tape strips have non-adhesive portions thereof facilitating removal of said tape strips from a patient'"'"'s skin when desired.

12. A method of stabilizing a catheter or cannula in a patient using a first stabilizing element having bilateral wings extending from a catheter or cannula supporting element, and at least one each of distinct and spaced proximal and lateral stabilizing elements having sterile pressure sensitive adhesive associated therewith, comprising:

a) inserting a catheter or cannula associated with the supporting element into the patient'"'"'s body adjacent the at least one proximal stabilizing element;

then

b) applying the sterile adhesive from the at least one proximal stabilizing element to a patient'"'"'s skin adjacent an area of insertion of a catheter or cannula to stabilize against catheter or cannula inadvertent withdrawal or adverse repositioning; and

then

c) applying the sterile adhesive from the at least one lateral stabilizing element to the patient'"'"'s skin to provide primarily lateral and medial stability to the catheter or cannula.

13. A method as recited in claim 12 wherein b) is practiced using a removable insertion device with a needle, and further comprising d) removing the removable insertion device after b) or after c).

14. A method as recited in claim 12 further comprising e) lifting the receiving element and removing any blood flash or IV fluid from the patient'"'"'s skin between b) and c).

15. A method as recited in claim 12 wherein the supporting element supports an angiocatheter and wherein the at least one proximal stabilizing element comprises first and second distinct and spaced proximal tape strips each having a portion with sterile pressure sensitive adhesive overlapping a bilateral wing, and wherein the at least one lateral stabilizing element comprises third and fourth distinct and spaced lateral tape strips each having a portion with sterile pressure sensitive adhesive overlapping a bilateral wing;

and wherein

b) is practiced to separately bring the sterile adhesive of each of the first and second tape strips into contact with a patient'"'"'s skin;

c) is practiced to separately bring the sterile adhesive of each of the third and fourth tape strips into contact with a patient'"'"'s skin; and

a)-c) are practiced to insert an angiocatheter into, and maintain within, a patient.

16. A stabilizing device for insertion and maintenance of a catheter or cannula, comprising:

a stabilizing element including a pair of bilateral wings and a catheter or cannula supporting element generally between said bilateral wings; and

at least first and second spaced and distinct tape strips, operatively connected to at least one bilateral wing, for stabilizing said receiving element, said tape strips each having a bottom surface with a pattern of pressure sensitive adhesive and release sections, and being folded over on itself so that the adhesive and release sections operatively engage each other to maintain sterility, and after unfolding the adhesive sections affix the tape strips to a patient'"'"'s skin.

17. A stabilizing device as recited in claim 16 wherein said at least first and second tape strips comprise a pair of spaced and distinct proximal tape strips, one operatively connected to each bilateral wing, and a pair of spaced and distinct lateral tape strips, one operatively connected to each bilateral wing.

18. A butterfly catheter having a base and highly flexible wings with superior and inferior surfaces, comprising:

at least two spaced, distinct, pieces of adhesive tape, with sterile adhesive; and

at least one piece of adhesive tape operatively connected to said superior surface of each of said flexible wings and each including a portion with sterile pressure sensitive adhesive overlapping a highly flexible wing so that the sterile adhesive on said overlapping portion may be affixed to a patient'"'"'s skin.

19. A butterfly catheter as recited in claim 18 wherein said at least two spaced, distinct, pieces of adhesive tape consist essentially of only two proximal pieces.

20. A butterfly catheter as recited in claim 18 wherein said at least two spaced, distinct, pieces of adhesive tape comprise two proximal pieces, and two lateral pieces.