WO2007109505A2

WO2007109505A2 - Tube securement device

Info

Publication number: WO2007109505A2
Application number: PCT/US2007/064065
Authority: WO
Inventors: Roger W. Heegaard; John K. Lampe; Kelly Mcgurran; Thomas A. Diehl; Steven Johnson
Original assignee: Medtreo, Llc
Priority date: 2006-03-17
Filing date: 2007-03-15
Publication date: 2007-09-27
Also published as: WO2007109505A3

Abstract

A device for securing medical tubing comprising a base, a tab, a means for attaching the base to the skin of a mammal, and a means for releasably securing the tab to the base. The tab is pivotably attached to the base for pivoting about a laterally extending pivot axis as between a first position transversely projecting upward from the upper major surface of the base and a second position overlaying the upper major surface of the base. The means for releasably securing the tab to the base secures the tab to the base in the second position.

Description

TUBE SECUREMENT DEVICE

[0001] This application claims the benefit of United States Provisional Application No. 60/783,277, filed March 17, 2006.

BACKGROUND OF THE INVENTION

[0002] Patients commonly need to have drainage tubes attached to their bodies to remove fluids such as after a surgical procedure. Many times the drainage tube must be held in place over an extended period of time.

[0003] Various devices have been developed for securing drainage tubes to the body, typically the arm. One such device is United States Patent No. 5,685,859 to Kornerup. This device includes a plaster and a support element for bending the tubing from a perpendicular position to a substantially horizontal position relative to the skin surface. While effective for facilitating a smooth transition through a 90° bend, the device is bulky, expensive and does not provide any "play" in the tubing for absorbing minor jerks and tugs on the tubing without pulling upon the length of tubing between the device and a puncture site.

[0004] The purpose of the present invention is to overcome these and other shortcomings or limitations in the prior art.

SUMMARY OF THE INVENTION

[0005] A first aspect of the invention is a device for securing medical tubing comprising a base, a tab, a means for attaching the base to the skin of a mammal, and a means for releasably securing the tab to the base. The base has an upper major surface and a lower major surface. The tab is pivotably attached to the base for pivoting about a laterally extending pivot axis as between a first position transversely projecting upward from the upper major surface of the base and a second position overlaying the upper major surface of the base. The means for releasably securing the tab to the base secures the tab to the base in the second position.

[0006] A second aspect of the invention is a method of securing medical tubing in percutaneous fluid communication with a mammal. A first embodiment of the second aspect of the invention comprises the steps of (i) locating a mammal in fluid communication with medical tubing at a percutaneous puncture site wherein the tubing initially extends from the puncture site along a primary axis, (ii) obtaining a device for securing medical tubing having (A) a base, (B) a tab pivotably attached to the base for pivoting about a laterally extending pivot axis as between a first position transversely projecting upward from the upper major surface of the base and a second position overlaying the upper major surface of the base, (C) a means for attaching the base to the skin of a mammal, (D) a means from releasably securing the tab to the base in the second position, and (E) a means for securing medical tubing to the tab, wherein the attachment means is configured and arranged such that medical tubing secured to the tab will extend in a predominantly radial fashion from the pivot axis and pivot about the pivot axis in conjunction with pivoting of the tab, (iii) attaching the base to the skin of the located mammal proximate the percutaneous puncture site with the pivot axis positioned substantially perpendicular to the primary axis, (iv) securing the medical tubing to the tab such that the length of medical tubing secured to the tab extends in a predominantly radial fashion from the pivot axis and pivots about the pivot axis in conjunction with the tab, and (v) releasably pivoting the tab away from the puncture site and securing the tab to the base in the second position.

[0007] A second embodiment of the second aspect of the invention comprises the steps of (i) attaching a tube securement device to the skin of a mammal, (ii) securing a length of medical tubing to the device wherein (A) the medical tubing extends from a percutaneous puncture site on the mammal along a primary axis, and (B) the device is configured and arranged to permit pivoting of the length of tubing secured to the device about a pivot axis positioned substantially perpendicular to the primary axis as between a first position which is substantially perpendicular to the skin of the mammal attached to the device, and a second position which is substantially parallel to the skin of the mammal attached to the device, and (iii) releasably securing the length of tubing secured to the device in the second position. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a front view of one embodiment of the invention in collapsed form.

[0009] Figure 2 is a back view of the invention shown in FIG. 1 in collapsed form.

[0010] Figure 3 is a cross-sectional side view of the invention shown in FIG. 1 taken along line 3-3.

[0011] Figure 4A is a perspective view of the invention shown in FIG. 1 from the upper front right corner, with the base pivoted into an expanded position.

[0012] Figure 4B is a perspective view of the invention shown in FIG. 4A with the flap pivoted into an open position.

[0013] Figure 4C is a perspective view of the invention shown in FIG. 4B with the base attached to the arm of a human proximate a percutaneous puncture site with tubing extending from the puncture site through a lower notch in the flap and positioned along the alignment crotch defined by the flap.

[0014] Figure 4D is a perspective view of the invention shown in FIG. 4C with the release liner removed from the flap and the flap closed over the length of tubing positioned within the alignment crotch.

[0015] Figure 4E is a perspective view of the invention shown in FIG. 4D with the tab pivoted into a second position overlaying the upper major surface of the base and secured to the base.

[0016] Figure 5 is a cross-sectional side view of the invention shown in FIG. 4E taken along line 5-5.

[0017] Figure 6 is a front view of a second embodiment of the invention in collapsed form. [0018] Figure 7 is a cross-sectional side view of the invention shown in FIG. 6 taken along line 7-7.

[0019] Figure 8 A is a perspective view of a second embodiment of the invention from the upper front right corner, with the base pivoted into an expanded position.

[0020] Figure 8B is a perspective view of the invention shown in FIG. 6 A with the flap pivoted into an open position.

[0021] Figure 8C is a perspective view of the invention shown in FIG. 6B with the base attached to the arm of a human proximate a percutaneous puncture site with tubing extending from the puncture site through a lower notch in the flap to an upper notch in the tab.

[0022] Figure 8D is a perspective view of the invention shown in FIG. 6C with the release liner removed from the flap and the flap closed over the length of tubing positioned between the flap and the tab.

[0023] Figure 8E is a perspective view of the invention shown in FIG. 6D with the tab pivoted into a second position overlaying the upper major surface of the base and secured to the base.

[0024] Figure 9 is a cross-sectional side view of the invention shown in FIG. 8E taken along line 9-9.

[0025] Figure 10 is a side view of a third embodiment of the invention with the front and rear parts of the device spaced apart to facilitate viewing of the invention.

[0026] Figure 1 IA is a top view of the invention shown in FIG. 10 with the base of each section attached to the arm of a human on either side of a percutaneous puncture site and tubing extending from the puncture site passing between the tabs on each part.

[0027] Figure 1 IB is a top view of the invention shown in FIG. 1 IA with the tabs brought into adhesive contact with one another so as to sandwich the length of tubing between the tabs. DETAILED DESCRIPTION OF THE INVENTION

Nomenclature

100 First Embodiment of Device

110 Base

110a First Portion of Base

110b Second Portion of Base

Ilia First Major Surface of First Portion of Base

111b First Major Surface of Second Portion of Base

112a Second Major Surface of First Portion of Base

112b Second Major Surface of Second Portion of Base

119 Notch in First Portion of Base

120 Adhesive Layers 120a and 120b

120a Adhesive Layer on Second Major Surface of First Portion of Base

120b Adhesive Layer on Second Major Surface of Second Portion of Base

125a Release Liner Over Adhesive Layer on Second Major Surface of First Portion of Base

125b Release Liner Over Adhesive Layer on Second Major Surface of Second Portion of

Base

130 Tab

13Oh Height of Tab

131 First Major Surface of Tab

132 Second Major Surface of Tab 135 Living Hinge on Tab

140 Adhesive Layer on Second Major Surface of Tab

145 Release Liner Over Adhesive Layer on Second Major Surface of Tab

150 Flap

151 Outward Facing Major Surface of Flap

152 Inward Facing Major Surface of Flap

155 Living Hinge on Flap

156 Corner

156a First End of Corner

156b Second End of Corner

157 Lower Notch at First End of Corner 158 Upper Notch at Second End of Corner

160 Adhesive Layer on Inward Facing Major Surface of Flap

165 Release Liner Between Adhesive Layer and Tab

171 First Support Member

172 Second Support Member

200 Second Embodiment of Device

240 Hook and Loop Tape

241 First Portion of Hook and Loop Tape on Second Major Surface of Tab

242 Second Portion of Hook and Loop Tape on First Major Surface of Second Portion of Base

259 Slit in Flap

300 Third Embodiment of Device

300a First Half of Device

300b Second Half of Device

330a Tab on First Half of Device

330b Tab on Second Half of Device

331a First Major Surface of Tab on First Half of Device

331b First Major Surface of Tab on Second Half of Device

332a Second Major Surface of Tab on First Half of Device

332b Second Major Surface of Tab on Second Half of Device

335a Living Hinge on First Half of Device

335b Living Hinge on Second Half of Device

A First Layer of Material

Aupper Upper Portion of First Layer of Material

A_Lower Lower Portion of First Layer of Material

B Second Layer of Material

Bupper Upper Portion of Second Layer of Material

BLower Lower Portion of Second Layer of Material

P_A Primary Axis

Pi First Pivot Axis

P₂ Second Pivot Axis

H Mammal or Human

T Medical Tubing

N Puncture Site Definitions

[0028] As utilized herein, including the claims, the term "radial" means radiating orthogonally from a central axis.

[0029] As utilized herein, including the claims, the phrase "predominantly radial fashion" means radiating from a central axis at an angle of greater than 45°.

[0030] As utilized herein, including the claims, the phrases "substantially orthogonal" and "substantially perpendicular" mean positioned relative to one another at an angle of between 85° to 90°.

As utilized herein, including the claims, the phrase "essentially orthogonal" and "substantially perpendicular" mean positioned relative to one another at an angle of between 89° to 90°.

[0031] As utilized herein, including the claims, the phrase "substantially parallel" means never intersecting or intersecting at an angle of less than 10°.

Construction and Use of Specific Embodiments

[0032] The invention is a device 100, 200, 300 for securing an article to a surface. The device 100, 200, 300 is particularly suited for use in securing medical tubing T, such as IV tubing, a drainage tube or a catheter, to the body of a mammal H.

First Embodiment

[0033] Referring to FIGs 1-5, a first embodiment of the device 100 includes a base 110, a tab 130 and a flap 150.

[0034] The base 110 includes a first portion 110a and a second portion 110b separately and independently pivotable about a midsection (unnumbered) of the device 100. Each base portion 110a and 110b has a first major surface Ilia and 111b respectively (also referenced as outer major surfaces Ilia and 111b when the device 100 is in a collapsed form as seen in FIGs 1-3 and as upper major surfaces Ilia and 111b when the base portions 110a and 110b are pivoted about the first pivot axis Pi into the expanded positions as seen in FIGs 4A-E and 5), and a second major surface 112a and 112b respectively (also referenced as inner major surfaces 112a and 112b when the device 100 is in a collapsed form as seen in FIGs 1-3 and as lower major surfaces 112a and 112b when the base portions 110a and 110b are pivoted about the first pivot axis Pi into the expanded positions as seen in FIGs 4A-E and 5).

[0035] The first and second portions 110a and 110b of the base 110 can be constructed from the same or different materials, with the material comprising a single type of material or a combination of different laminated materials such as are commonly employed for the backing of adhesives bandages. Such materials include specifically, but not exclusively, polyurethane films, polyolefm films, polyvinylchloride films, ethylene vinyl acetate films, woven and nonwoven fabrics, and various types of foams.

[0036] A layer of adhesive 120a and 120b (collectively 120) and associated release liners 125a and 125b respectively, are provided on the second major surfaces 112a and 112b of the base portions 110a and 110b respectively. The adhesive layers 120 are used to secure the device 100 to the skin of a mammal H, such as a human. Suitable adhesives are well known in the art, with pressure sensitive adhesives typically selected for such use. Other means for securing the device 100 to the skin of a mammal H may be used, including specifically but not exclusively a wrap-around base 110 provided with contact adhesive or a mechanical fastening mechanism such as hook and loop tape, clips, clasps, pins, D-ring, etc. for fastening the base 110 to itself once wrapped around the mammal H. Exemplary mechanical fastening mechanisms are shown in United States Patents Nos. 4,470,410, 4,569,348, 4,799,923 and 5,664,581.

[0037] A laterally centered and longitudinally extending notch 119 is preferably provided in the first portion 110a of the base 110 for permitting the first portion 110a of the base 110 to substantially surround a puncture site N and permit the tab 130 to be positioned proximate a puncture site N without covering or otherwise occluding the puncture site N.

[0038] The tab 130 is pivotably attached to the base 110 at the midsection (unnumbered) of the device 100 for pivoting about a laterally extending first pivot axis Pi as between a first position transversely projecting upward from the upper major surfaces Ilia and 111b of the base 110 as shown in FIGs 4A-D, and a second position overlaying the upper major surface 111b of the second portion 110b of the base 110, as shown in FIGs 4E and 5. The tab 130 has a first major surface 131 (also referenced as an upper major surface 131 when the device 100 is in a collapsed form as seen in FIGs 1-3 or the tab 130 is pivoted about the first pivot axis Pi into the second position as seen in FIGs 4E and 5, and referenced as a forward facing major surface 131 when the tab 130 is in the first position as seen in FIGs 4A-D), and a second major surface 132 (also referenced as a lower major surface 132 when the device 100 is in a collapsed form as seen in FIGs 1-3 or the tab 130 is pivoted about the first pivot axis Pi into the second position as seen in FIGs 4E and 5, and referenced as a rearward facing major surface 132 when the tab 130 is in the first position as seen in FIGs 4A-D).

[0039] The tab 130 is attached to the base 110 by a living hinge 135 for permitting pivoting of the tab 130 about the first pivot axis Pi.

[0040] The tab 130 preferably has a height 13Oh of about 2 to 8 cm. A height 13Oh of less than about 2 cm tends to provide an inadequate strength of attachment to medical tubing T and an insufficient length of "play" in the medical tubing T when the medical tubing T is tugged. Conversely, a height 13Oh of greater than about 8 cm increases the cost and bulkiness of the device 100 without providing a corresponding advantage.

[0041] The tab 130 can be constructed from the same types of materials as used for the base 110. Such materials include specifically, but not exclusively, polyurethane films, polyolefm films, polyvinylchloride films, ethylene vinyl acetate films, woven and nonwoven fabrics, and various types of foam. As shown in FIG 3, the first and second portions 110a and 110b of the base 110, and tab 130 can be quickly, easily and conveniently formed from two layers of material A and B, with a lower portion ALower of the first layer A forming the first portion 110a of the base 110, a lower portion

of the second layer B forming the second portion HOb of the base 110, and the upper portions A_Upp_er and B_Upper of the layers A and B laminated together to form the tab 130.

[0042] An adhesive layer 140 and associated release liner 145 are provided on the second major surface 132 of the tab 130 for use in securing the tab 130 to the second portion HOb of the base 110 when the tab 130 is pivoted about the first axis Pi and into the second position as seen in FIGs 4E and 5. Alternatively, the adhesive layer 140 and associated release liner 145 can be provided on the first major surface 111b of the second portion 110b of the base 110. Suitable adhesives are well known in the art and include pressure-sensitive adhesives and contact adhesives. Other means for securing the tab 130 to the second portion 110b of the base 110 may be used, including specifically but not exclusively mechanical fastening mechanism such as hook and loop tape, clips, clasps, snaps, a button and button-hole combination, pins, etc. The fastening means preferably permits repeated nondestructive release and refastening of the tab 130 to the second portion 110b of the base 110, with a preference for a repositionable pressure sensitive adhesive.

[0043] The flap 150 is pivotably attached to the tab 130 for pivoting about a second pivot axis P₂ as between a first position overlaying a portion of the first major surface 131 of the tab 130, as shown in FIGs 1-3, 4A, 4D, 4E and 5, and a second position projecting away from the tab 130, as shown in FIGs 4B and 4C.

[0044] The second pivot axis P₂ extends in a predominantly radial fashion relative to the first pivot axis Pi, with the second pivot axis P₂ preferably extending substantially orthogonal and most preferably essentially orthogonal to the first pivot axis Pi.

[0045] The flap 150 defines a first major surface 151 (also referenced as an outward facing major surface 151 when the flap 150 is in overlapping engagement with the tab 130 as seen in FIGs 1, 3, 4A, 4D, 4E and 5), and a second major surface 152 (also referenced as an inward facing major surface 152 when the flap 150 is in overlapping engagement with the tab 130 as seen in FIGs 1, 3, 4A, 4D, 4E and 5).

[0046] The flap 150 is attached to the tab 130 by a living hinge 155 for permitting pivoting of the flap 150 about the second pivot axis P₂. The flap 150 cooperates with the tab 130 to define a predominantly radially extending corner 156 extending from a first end 156a nearest the base 110 to a second end 156b furthest from the base 110. The corner 156 is effective as an alignment guide for placing medical tubing T into a preferred position on the tab 130.

[0047] A lower notch 157 is preferably cut into the flap 150 proximate the first end 156a of the corner 156 for accommodate passage of medical tubing T between the tab 130 and the flap 150 and into the corner 156a. Similarly, an upper notch 158 is preferably cut into the tab 130 proximate the second end 156b of the corner 156 for accommodate passage of medical tubing T out from between the tab 130 and the flap 150.

[0048] Structural support members 171 and 172 may be provided on either side of the tab 130 proximate the first pivot axis Pi for purposes of enhancing the structural rigidity of the tab 130. Such enhanced rigidity may be necessary to ensure that the tab 130 is capable of supporting medical tubing T above the base 110 when the tab 130 projects upward from the base 110 in the first position.

[0049] The support members 171 and 172 can be constructed as separate and independent members and attached to the device 100 by suitable means such as an adhesive, or they can be formed as an integral component of the layers A and B used to form the tab 130.

[0050] The support members 171 and 172 can be constructed from the same types of materials as used for the base 110 and tab 130. Such materials include specifically, but not exclusively, polyurethane films, polyolefin films, polyvinylchloride films, ethylene vinyl acetate films, woven and nonwoven fabrics, and various types of foam. Other types of materials may also be used such as bands, strips and sheets of plastic, paperboard, cardboard, cardstock, wood, metal and other materials capable of providing the desired structural rigidity.

[0051] Other mechanisms may be employed for enhancing the structural rigidity of the tab 130 including incorporation of a structurally rigid layer (not shown) into the tab 130 (e.g., an internal cardboard or metal layer), shaping or forming the tab 130 with radially extending ribs or ridges (not shown), etc.

[0052] An adhesive layer 160 and associated release liner 165 are provided on the inward facing second major surface 152 of the flap 150 for use in securing the flap 150 to the tab 130 with a length of medical tubing T sandwiched therebetween as depicted in FIGs 4D, 4E and 5. Alternatively, the adhesive layer 160 may be provided on the first major surface 131 of the tab 130 over the area immediately underneath the flap 150. [0053] Suitable adhesives are well known in the art and include pressure-sensitive adhesives and contact adhesives. Other means for securing the flap 150 to the tab 130 so as to secure a length of medical tubing T therebetween may also be used, including specifically but not exclusively hook and loop tape.

[0054] The medical tubing T may be attached to the tab 130 by fastening systems other than by sandwiching the medical tubing T between the tab 130 and flap 150 as described above. Such alternative fastening systems including specifically, but not exclusively, mechanical fastening systems shown and described in United States Patents Nos. 4,569,348 (short strap of hook and loop tape wrapped around the tubing), 6,224,571 (fitting on tubing cooperatively engaging a base clip), and 6,572,588 (length of tubing compressed within a clam-shell retainer), etc.

[0055] The device 100 can be used to secure medical tubing T, extending from a puncture site N along a primary axis P_A, to the skin of a mammal H by (i) removing the device 100 from its packaging (not shown), (ii) separating the first portion 110a and the second portion 110b of the base 110 by pivoting them in opposite directions about the first pivot axis Pi so as to expose the release liners 125a and 125b, (iii) removing the release liners 125a and 125b from the first portion 110a and the second portion 110b of the base 110 respectively, so as to expose the adhesive layers 120a and 120b, (iv) placing the exposed adhesive layers 120a and 120b into adhesive contact with the skin of a mammal H so as to place a currently existing or future planned puncture site N on the mammal H within the notch 119 in the first portion 110a of the base 110 with the first pivot axis Pi preferably positioned substantially perpendicular to the primary axis P_A, (V) pivoting the flap 150 about the second pivot axis P₂ so as to reveal the corner defined by the intersection of the tab 130 and the flap 150, (vi) removing the release liner 165 from the flap 150 to expose the adhesive layer 160 on the flap 150, (vii) positioning a length of medical tubing T through the lower notch 157 in the flap 150 and along the corner 156, (viii) pivoting the flap 150 about the second pivot axis P₂ back into overlapping relationship with the tab 130 so as to adhesively attach the flap 150 to the tab 130 and sandwich a length of the medical tubing T therebetween, (ix) removing the release liner 145 from the second major surface 132 of the tab 130 to expose adhesive layer 140, (x) pivoting the tab 130 about the first pivot axis Pi towards the second portion of the base 110b until the exposed adhesive 140 on the second major surface 132 of the tab 130 adhesively contacts the upper major surface 111b of the second portion 110b of the base 110.

[0056] When the strength of attachment between the tab 130 and the second portion 110b of the base 110 is less than the strength of attachment between the base 110 and the skin of the mammal H to which the device 100 is secured, then a "tug" on the medical tubing T other than a tug directly at the puncture site N will result in (i) a non-injurious lifting of the skin underlying the device 100 without an alteration in the configuration of the device 100 when the tug force is less that the strength of attachment between the tab 130 and the second portion 110b of the base 110, and (ii) a non-injurious lifting of the skin underlying the device, 100, and a non-injurious detachment of the tab 130 from the second portion 110b of the base 110, with accompanying pivoting of the tab 130 and associated length of medical tubing T about the first pivot axis Pi into the first position (i.e., projecting transversely upward from the base 110) when the tug force is greater than the strength of attachment between the tab 130 and the second portion 110b of the base 110 but less than the strength of attachment between the base 110 and the skin of the mammal H to which the device 100 is secured. Of course, as with any other securement devices, a tug force in excess of the strength of attachment between the base 110 and the skin of the mammal H to which the device 100 is secured will result in a detachment of the device 100 from the mammal H along with a awkward and often injurious removal of a sharp (not shown) from the puncture site N.

[0057] The securement device 100 provides several advantages including specifically, but not exclusive (i) economical production and packaging via a web converting operation using a single press run, (ii) simplicity of application and use, (iii) superior protection against crimping or kinking of medical tubing T, in both the longitudinal and transverse directions, and (iv) the ability to secure medical tubing T to a mammal H without covering or occluding the puncture site N.

Second Embodiment

[0058] A second embodiment of the device 200 is shown in FIGs 6-9, wherein elements common to the first and second embodiments are identified by common reference number. The second embodiment of the device 200 differs from the first embodiment 100 as to (i) the specific means for releasably securing the tab 130 to the second portion 110b of the base 110, and (ii) the configuration, arrangement and attachment of the flap 150.

[0059] As shown in FIGs 7 an 9, the adhesive layer 140 and associated release liner 145 provided on the second major surface 132 of the tab 130 in the first embodiment of the device 100, has been replaced with hook and loop tape 240 on the second embodiment of the device 200. A first portion 241 of the hook and loop tape 240 is secured to the second major surface 132 of the tab 130 and a second portion 242 secured to the first major surface 111b of the second portion 110b of the base 110. The hook and loop tape portions 241 and 242 are positioned on the second portion 110b of the base 110 and the tab 130 so that they will engage one another when the tab 130 is pivoted about the first pivot axis Pi into the second position overlapping the second portion 110b of the base 110 as seen in FIGs 8E and 9. As with the first embodiment of the device 100, other means for securing the tab 130 to the second portion 110b of the base 110 may be used.

[0060] The flap 150 on the second embodiment of the device 200 is sized, configured and arranged to be essentially coextensive with the tab 130 and pivot about a second pivot axis P₂ extending substantially parallel to the first pivot axis Pi.

[0061] As shown in FIGs 6 and 8A-E, a laterally centered lower notch 157 can be cut into the flap 150 proximate the base 110 and a slit 259 cut through the flap 150 from the lower notch 157 to the periphery (unnumbered) of the flap 150 for accommodating passage of medical tubing T into the lower notch 157. In similar fashion, an upper notch 158 may be cut into the tab 130 proximate the top (unnumbered) of the tab 130 as a guide for positioning medical tubing T along the tab 130 from the lower notch 157 to the top (unnumbered) of the tab 130, and also for accommodating passage of the medical tubing T out from between the flap 150 and tab 130.

Third Embodiment

[0062] A third embodiment of the device 300 is shown in FIGs 10 and 1 IA-B, wherein elements common to the first and third embodiments are identified by the same reference number. The third embodiment of the device 300 differs from the first embodiment of the device 100 in that (i) the device 300 has no flap, and (ii) the device 300 is provided and used as two separate and independent pieces (i.e., a first half 300a and a second half 300b).

[0063] The first half 300a of the third embodiment of the device 300 includes a first layer of material A with a lower portion ALower forming the first portion 110a of the base 110 and an upper portion Au_pper forming a cover tab 330a. The cover tab 330a is pivotable relative to the first portion 110a of the base 110 about a first pivot axis Pi on the first half 300a of the device 300 along a living hinge 335a. A layer of adhesive is provided on the second major surface 112a of the first layer of material A, providing both a layer of adhesive 120a on the second major surface 112a of the first portion 110a of the base 110, and a layer of adhesive 160 on the second major surface 332a of the cover tab 330a. The layer of adhesive 120a on the second portion 110a of the base 110 is covered with a release liner 125a and the layer of adhesive 160 on the cover tab 330a covered with a release liner 165. The release liners 125a and 165 are separate and independent tabs capable of separate and independent removal from the first layer of material A. A first support member 171 may be provided on the first major surface 331a of the cover tab 330a proximate the first pivot point Pi.

[0064] The second half 300b of the third embodiment of the device 300 includes a second layer of material B with a lower portion

forming the second portion 110b of the base 110 and an upper portion B_Upper forming a backing tab 330b. The backing tab 330b is pivotable relative to the second portion 110b of the base 110 about a first pivot axis Pi on the second half 300b of the device 300 along a living hinge 335b. A layer of adhesive 120b is provided on the second major surface 112b of the second portion 110b of the base 110. The layer of adhesive 120b is covered with a release liner 125b. A second support member 172 may be provided on the first major surface 331b of the backing tab 330b proximate the first pivot point Pi.

[0065] The third embodiment of the device 300 is used to secure medical tubing T to the skin of a mammal H by (i) removing the device halves 300a and 300b from their packaging (not shown), and (ii) selecting one of the halves 300a or 300b for initial application. Assuming for the balance of this discussion that the first half 300a is selected, use then involves (iii) removing the release liner 125a from the first portion 110a of the base 110 on the first half 300a of the device 300 to expose the adhesive layer 120a, (iv) placing the exposed adhesive layer 120a into adhesive contact with the skin of a mammal H so as to place the living hinge 335a on the first half 300a of the device 300 adjacent a puncture site N on the mammal H, (v) removing the release liner 125b from the second portion 110b of the base 110 on the second half 300b of the device 300 to expose the adhesive layer 120b, (vi) placing the exposed adhesive layer 120b into adhesive contact with the skin of the mammal H so as to register the tabs 330a and 330b with the second major surfaces 332a and 332b of the tabs 330a and 330b facing one another, and medical tubing T extending from the puncture site N sandwiched between the tabs 330a and 330b, (vii) removing the release liner 165 from the cover tab 330a to expose the adhesive layer 160 on the cover tab 160, (viii) positioning a length of the medical tubing T extending from the puncture site N into engagement with the adhesive 160 on the cover tab 330a, and (ix) bringing the cover tab 330a and backing tab 330b into overlapping adhesive engagement around the length of the medical tubing T.

[0066] If desired, one or both of the tabs 330a and 330b on the third embodiment of the device 300 could be provided with a laterally centered lower notch 157 and slit 259 as described in connection with the second embodiment of the device 200 for accommodating passage of medical tubing T between the tabs 330a and 330b when the puncture site N is not located between the tabs 330a and 330b. An advantage provided by such a modification of the third embodiment of the device 300 is that it allows the device 300 to be deployed over a puncture site N, as described above in connection with the third embodiment of the device 300 and shown in FIGs 1 IA and 1 IB, or deployed proximate but not over a puncture site N, as described above in connection with the second embodiment of the device 300 and shown in FIGs 8C-E. For some applications, and based on the practice of some caregivers, it is preferred to cover the puncture site N with the securement device 300 while other applications and other caregivers prefer to leave the puncture site N open or exposed.

Modifications

[0067] The present invention should not be considered limited to the particular examples described above, but rather should be understood to cover all aspects of the invention as fairly set out in the claims arising from this application. For example, while suitable sizes, materials and arrangement of the elements have been disclosed in the above discussion, it should be appreciated that these are provided by way of example and not of limitation as to the size, material and arrangement of the elements. Various modifications, as well as numerous structures within the scope of the invention, will be readily apparent to those of skill in the art upon review of the present specifications. The claims which arise from this application are intended to cover such modifications and structures.

[0068] While the device 100, 200 and 300 has been described herein in connection with the securement of medical tubing T to the skin of a mammal H, the securement device 100, 200 and 300 may be useful for other purposes, including specifically, but not exclusively, securement of catheters and other articles to the skin of a mammal H, securement of electrodes (e.g., EMG or EKG electgrodes) to the skin of a mammal H, or any other use where economical securement of a device might be usable and beneficial.

Claims

We claim:

1. A device for securing medical tubing, comprising:

(a) a base having an upper major surface and a lower major surface,

(b) a means for attaching the base to the skin of a mammal,

(c) a tab pivotably attached to the base for pivoting about a laterally extending pivot axis as between a first position transversely projecting upward from the upper major surface of the base and a second position overlaying the upper major surface of the base,

(d) a means for releasably securing the tab to the base in the second position,

(e) a means for securing medical tubing to the tab, wherein the attachment means is configured and arranged such that medical tubing secured to the tab will extend in a predominantly radial fashion from the pivot axis and pivot about the pivot axis in conjunction with pivoting of the tab.

2. The device of claim 1 wherein the base is configured and arranged with a first portion extending longitudinally forward from the pivot axis, a second portion extending longitudinally rearward from the pivot axis, and a laterally centered opening in the first portion for permitting attachment of the device around a puncture site without occluding the puncture site.

3. The device of claim 2 wherein the opening is a notch.

4. The device of claim 1 wherein the means for attaching the base to the skin of a mammal is a pressure sensitive adhesive on the lower major surface of the base, and the device further includes a release liner over the adhesive.

5. The device of claim 1 wherein the tab is attached to the base by a living hinge.

6. The device of claim 1 wherein the tab has a height of about 2 to 8 cm.

7. The device of claim 2 wherein the means from releasably securing the tab to the base releasably secures the tab to the second portion of the base.

8. The device of claim 1 wherein the means from releasably securing the tab to the base is a pressure sensitive adhesive, and the device further includes a release liner over the adhesive.

9. The device of claim 1 wherein the means from releasably securing the tab to the base is hook and loop tape.

10. The device of claim 1 further comprising a flap pivotably attached to the tab for pivoting about a predominantly radially extending second pivot axis as between a first position overlaying the tab and a second position projecting away from the tab.

11. The device of claim 10 wherein the flap defines a predominantly radially extending alignment crotch in conjunction with the tab for guiding the placement of medical tubing into properly positioned engagement with the tab.

12. The device of claim 1 wherein the means from securing medical tubing to the tab is a pressure sensitive adhesive, and the device further includes a release liner over the adhesive.

13. The device of claim 10 wherein the means from securing medical tubing to the tab is a pressure sensitive adhesive, and the device further includes a release liner over the adhesive.

14. The device of claim 11 wherein (i) the alignment crotch has a first end nearest the base and second end furthest from the base, (i) a lower notch is cut into the flap proximate the first end of the alignment crotch for accommodate passage of medical tubing into the alignment crotch, and (ii) an upper notch is cut into the tab proximate the second end of the alignment crotch for accommodate passage of medical tubing out from the alignment crotch.

15. The device of claim 1 further comprising a support member on the tab for enhancing structural rigidity of the tab.

16. A method of securing medical tubing in percutaneous fluid communication with a mammal, comprising:

(a) locating a mammal in fluid communication with medical tubing at a percutaneous puncture site wherein the tubing initially extends from the puncture site along a primary axis,

(b) obtaining a device for securing medical tubing, comprising:

(i) a base having an upper major surface and a lower major surface, (ii) a means for attaching the base to the skin of a mammal, (iii) a tab pivotably attached to the base for pivoting about a laterally extending pivot axis as between a first position transversely projecting upward from the upper major surface of the base, and a second position overlaying the upper major surface of the base, (iv) a means from releasably securing the tab to the base in the second position, (v) a means for securing medical tubing to the tab, wherein the attachment means is configured and arranged such that medical tubing secured to the tab will extend in a predominantly radial fashion from the pivot axis and pivot about the pivot axis in conjunction with pivoting of the tab,

(c) attaching the base to the skin of the located mammal proximate the percutaneous puncture site with the pivot axis positioned substantially perpendicular to the primary axis,

(d) securing the medical tubing to the tab such that the length of medical tubing secured to the tab extends in a predominantly radial fashion from the pivot axis and pivots about the pivot axis in conjunction with the tab, and (e) releasably pivoting the tab away from the puncture site and securing the tab to the base in the second position.

17. The method of claim 16 wherein the mammal is a human.

18. The method of claim 16 wherein (i) the base is configured and arranged with a first portion extending longitudinally forward from the pivot axis, a second portion extending longitudinally rearward from the pivot axis, and a laterally centered opening in the first portion, and (ii) the base is attached to the skin of the located mammal with the puncture site positioned within the opening in the first portion of the base.

19. The method of claim 16 wherein (i) the device further comprises a flap pivotably attached to the tab for pivoting about a predominantly radially extending second pivot axis as between a first position overlaying the tab and a second position projecting away from the tab, (ii) the flap defines a predominantly radially extending alignment crotch in conjunction with the tab for guiding the placement of medical tubing into properly positioned engagement with the tab, and (iii) the medical tubing is secured to the tab along the alignment crotch.

20. A method of securing medical tubing in percutaneous fluid communication with a mammal, comprising:

(a) attaching a tube securement device to the skin of a mammal,

(b) securing a length of medical tubing to the device wherein (i) the medical tubing extends from a percutaneous puncture site on the mammal along a primary axis, and (ii) the device is configured and arranged to permit pivoting of the length of tubing secured to the device about a pivot axis positioned substantially perpendicular to the primary axis as between a first position which is substantially perpendicular to the skin of the mammal attached to the device, and a second position which is substantially parallel to the skin of the mammal attached to the device, and

(c) releasably securing the length of tubing secured to the device in the first position.