CA2208258A1 - Catheter fitting securement device - Google Patents
Catheter fitting securement deviceInfo
- Publication number
- CA2208258A1 CA2208258A1 CA002208258A CA2208258A CA2208258A1 CA 2208258 A1 CA2208258 A1 CA 2208258A1 CA 002208258 A CA002208258 A CA 002208258A CA 2208258 A CA2208258 A CA 2208258A CA 2208258 A1 CA2208258 A1 CA 2208258A1
- Authority
- CA
- Canada
- Prior art keywords
- channel
- retainer
- anchoring system
- catheter
- slot
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 239000012530 fluid Substances 0.000 claims description 25
- 239000000853 adhesive Substances 0.000 claims description 13
- 230000001070 adhesive effect Effects 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 5
- 210000003813 thumb Anatomy 0.000 claims description 4
- 230000007704 transition Effects 0.000 claims description 2
- 238000004873 anchoring Methods 0.000 claims 20
- 210000003811 finger Anatomy 0.000 claims 5
- 230000014759 maintenance of location Effects 0.000 claims 2
- 230000036541 health Effects 0.000 description 26
- SRVJKTDHMYAMHA-WUXMJOGZSA-N thioacetazone Chemical compound CC(=O)NC1=CC=C(\C=N\NC(N)=S)C=C1 SRVJKTDHMYAMHA-WUXMJOGZSA-N 0.000 description 18
- 239000006260 foam Substances 0.000 description 7
- 239000010410 layer Substances 0.000 description 7
- 239000000463 material Substances 0.000 description 5
- 235000004257 Cordia myxa Nutrition 0.000 description 2
- 244000157795 Cordia myxa Species 0.000 description 2
- 241000282320 Panthera leo Species 0.000 description 2
- 102000012152 Securin Human genes 0.000 description 2
- 108010061477 Securin Proteins 0.000 description 2
- 239000012790 adhesive layer Substances 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- BFKJFAAPBSQJPD-UHFFFAOYSA-N tetrafluoroethene Chemical group FC(F)=C(F)F BFKJFAAPBSQJPD-UHFFFAOYSA-N 0.000 description 2
- DHKHKXVYLBGOIT-UHFFFAOYSA-N 1,1-Diethoxyethane Chemical compound CCOC(C)OCC DHKHKXVYLBGOIT-UHFFFAOYSA-N 0.000 description 1
- 241001136792 Alle Species 0.000 description 1
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 229920001651 Cyanoacrylate Polymers 0.000 description 1
- 229920004943 Delrin® Polymers 0.000 description 1
- MWCLLHOVUTZFKS-UHFFFAOYSA-N Methyl cyanoacrylate Chemical compound COC(=O)C(=C)C#N MWCLLHOVUTZFKS-UHFFFAOYSA-N 0.000 description 1
- YFONKFDEZLYQDH-OPQQBVKSSA-N N-[(1R,2S)-2,6-dimethyindan-1-yl]-6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine Chemical compound C[C@@H](F)C1=NC(N)=NC(N[C@H]2C3=CC(C)=CC=C3C[C@@H]2C)=N1 YFONKFDEZLYQDH-OPQQBVKSSA-N 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229920000297 Rayon Polymers 0.000 description 1
- 241000270295 Serpentes Species 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 239000011354 acetal resin Substances 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- VKYKSIONXSXAKP-UHFFFAOYSA-N hexamethylenetetramine Chemical compound C1N(C2)CN3CN1CN2C3 VKYKSIONXSXAKP-UHFFFAOYSA-N 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 229920006324 polyoxymethylene Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 239000002964 rayon Substances 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/024—Holding devices, e.g. on the body having a clip or clamp system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/26—Cannula supporters
Abstract
A securement device (10) provides attachment of a catheter fitting to the skin of a patient, while allowing convenient disengagement of the catheter fitting from the securement device.
Description
CA 022082~8 1997-06-19 ~1 .
CATHETER FITTING SECUr'-~FNT DEVICE
Ba~.l,u,b.,,ld of the Invention Field of the Invention The present invention relates in ~eneral to a l,alll~ alion device. In pa~ ,ulal, the present invention relates to an anchorinq system for a catheter fittina.
Des~. i"; ~ of Related Art Medical ~l~allll.!~.L of patients commonly involves the use of pel~.ulail ~ously inserted calh~,lel~ to direct fluids directly into the bloodstream, a specific or~an or an internal location of the patient, or to monitor vital 1O functions of the patient. For instance, epidural catheters are commonly used to direct anesthesia into an epidural space to a~ a specific location of the patient.
In practice, fluid (e.p., an~ r~-~) typically flows throuah a fluid supply tubin~ into an indwellin~ catheter.
The catheter and fluid tubin~ are commonly ~ .aLl~ attached by a conventional co~ ~n; I~-- or catheter fittin~. One such co~ t~,. is soid commercially under the mark Snap-Lock~ by Arrow International, Inc., of Readin~, 1 5 F~
A health care provider, such as, for example, a nurse or doctor (for ease of description, as used herein the term "health care provider" will refer to health care providers ~enerally and will not be restrictive in meanin~), uses adhesive or sur~ical tape to secure the catheter fitting to the skin of the patient. The application of adhesi~re tape also helps inhibit movement between the components of the catheter fittin~ which possibly could loosen and allow 20 the catheter to disconnect from the fittinp.
Health care providers also commonly form a safety loop in the tubin~ so that any tension applied to the tubin~ does not directly pass to the catheter, but rather is absorbed by the slack of the safety loop. The health care provider typically loosely tapes the loop to the skin of the patient.
This entire tapin~ procedure takes several minutes of the valuable time of the health care provider.
25 ~u. ~h~".,o.~, health care providers commonly remove their ~loves when tapin~ because most people find such tapinq procedures difficult and cumbersome when wearin~ ~loves.
The catheterization process often requires frequent disconnection between the catheter and the fluid supply tube. The catheter tubinp is penerally replaced every few hours in order to maintain the sterility of the fluid and the free-flow of the fluid throu~h the tubin~. A health care provider thus must frequently chan~e the tubing a,nd 30 retape the connection.
A preat deal of valuable time is thus used in applyin9 si~nificant amounts of sur~ical tape to the catheter fittin~. The frequent application and removal of sur~ica! tape also commonly results in the eALc,idliJu of the skin of the patient in the area of the insertion.
Summarv of the Invention The s~.. ,u.~ "t device of the present invention provides a retainer for securin~ a catheter fittin~, such as that sold under the SNAP-LOCKn~ trademark by Arrow l"l"."dl lrll, Inc- The Se.,U~ ..2UI device is easily anchored CA 022082~8 1997-06-19 WO 97/15342 PCTfUS96/17067 ., -2- .
to the patient's skin. Once secured, a health care provider can easily insert and remove the catheter fittin~ from - the retainer. The retainer also ensures the that components of the catheter fittin~ remain ti~htly c0"l)6~l~d to prevent ac ~ r-l,-l rl;. n~ t of the catheter from the fittin~.
In acc.,.dan..e with one aspect of the present invention, an anchorin~ system ~ asabl~ secures a catheter 5 fittinp to a patient. The a,.cl,Gri"d system c..,.,u.;~r,s a retainer includin~ a first channel which is co.,~iuulcd to receive a first tubular portion of the catheter fitting. A second channel of the retainer is also co,,liuu~ll to receive a second tubular portion of the catheter fittin~. The first and second channels ~enerally extend alon~ a common axis. At least one lateral slot is i~ uGiQd between the first and second channels. The slot extends in a direction which is penerally perpendicular to the common axis. A bottom of the slot has an arcuate shape which ~enerally 10 matches a shape of a collar portion of the catheter fittina.
Another aspect of the invention involves an anchorin~ system for securin~ a medical article to the skin of a patient. The medical article includes an e' a~. ' tubular body and a radially extendin~ member which projects from the tubular body. The anch~ri,,u system cu,,,,u,i..~s a retainer includin~ first and second channel portions which extend about an axis, each channel portion ~enerally havin~ a tl~ .dled circular cross-sectional shape sized to 15 surround at least a portion of the medical article throu~h an arc of ~reater than 180~ about the axis. At least one lateral slot extends ~enerally ,~".elldiLular to the lon~itudinal axis between the first and second channel portions.
The slot has a thickness substantially equal to the thickness of the radially extendin~ member of the medical article.
The first and second channels have a combined lon~itudinal len~th SUII;L;~ to prevent lateral ...~ nl of the medical article with the radially ~ "di"~ member positioned within the lateral slot. A flexible anchor pad has an 20 adhesive bottom surface and a top surface on which the retainer is mounted. The retainer is po~ "ed on the top surface in a manner exposin~ openin~s to the channel portions.
In ac.,o,da...,e with an additional aspect of the present invention, an anchorin~ system involves a retainer havin~ a lon~itudinal channel confi~ured to receive in a snap-fit manner a tubular body of a catheter fittin~. The retainer additionally comprises at least one lateral slot sked to receive and to capture a radially ~ lld;,l~ member of the fittin~ with the fittin~ pcl ' within the lonaitudinal channel of the retainer. In this manner, the retainer prevents the adaptor from slidinp in a lon~itudinal direction. A flexible anchor pad includes an adhesive bottom surface which is adapted to attach to a patient's skin. The anchor pad supports the retainer.
Brief DE~I,I;IJ~;"a of the Drawin~s These and other features of the invention will now be described with ~el~e.l~e to the drawin~s of a preferred embodiment which is intended to illustrate and not to limit the invention, and in which:
Fipure 1 is a top p~ t~ti-~ view of a catheter fittin~ 5.,~,Ul~ llt device c 'iu~.~J in accol.l~"~e with a preferred embodiment of the present invention, shown securinp an exemplary catheter fittina;
Fi~ure 2 is an exploded top p~ ,UL.~ti.~ view of the se~ -,l device and catheter fittin~ illustrated in Fi~ure 1;
Fi~ure 3 is a plan view of the securement device and catheter fittin~ shown in Fi~ure 1;
WO 97/15342 . PCT/US96/17067 Fi~ure 4 is a cross-sectionai view of a retainer of the sELule",~"l device shown in Fi~ure 3 taken aion~
- line 44 with a portion of the catheter fittinp pG~;t;~u~d within a channel of the retainer;
Fi~ure 5 is a cross-sectional view of the retainer of Fi~ure 3 taken alon~ line 5-5 with a portion of the catheter fittin~ pc ~jt; .nPd within an aperture of the retainer;
Fi~ure 6 is a cross-sectional view of a tube clip of the securel"enl device of Fi~ure 3 taken alon~ line 6-6 of Fi~ure 3; and Fi~ure 7 is a cross-sectional view of an S-Clip of the securement device of Fi3ure 3 taken alon~ line 7-7 of Fi~ure 3.
Detailed DescriDtion of a Preferred Embodiment Fi~ure 1 illustrates a sccul~llldnL device 10 C~ ;UUILd in accG~ddllce with a preferred e ~l~ od; "~"I of the present invention. Althou~h the seLu,~ nl device 10 is iliustrated in iJrl ,tion with a pdlliLulal catheter fittin~
12, those skilled in the art will readily apl"eL;ale that the present 5eCU~ t device 10 can be adapted for use with other types of fittin~s, c ~ and adaptors which are used with catheters, fluid supply and draina~e tubes, electrical wires and cables, and the iike.
The seLlJlelWl~t device 10 securely anchors the catheter fittin~ 12 to the patient without the use of sur~ical tape. For most catheterization, the sec-",,..,~"l device 10 is attached to the patient only once. Althou~h a fluid supply tubin~ 14, which is cGr",~- Ied to the fittin3 12, may be replaced often for epidural al1l ' lions, the ~u~,u~n~ of the seLuJelll~lll device 10 remain attached to the patient. Thus, sur~ical tape need not be applied and removed from the patient's skin on multiple ~sr The illustrated catheter fittin~ 12 iS available commercially under the lldde",à,k SNAP-LOCKn' from Arrow hl~elllaliolldl of Readin~, Pennsylvania. However, before describin~ the present se~.u~ dlll device 10 in detail, the e~ làly catheter fittin~ 12 will first be ~enerally described to assist the reader in u"d~,~ld"din~ the illustrated sec.~,~",~"l device 10.
With r~ nce to Fi3ure 2, the catheter fittin~ 12 securely connects the tube 14, such as a fluid supply tube, to microbore tubing or catheter 16 le.a., 18 to 24 ~au~e). The catheter 16 is l~leds~bll~ conn~leil to the fittina 12 by threadin~ a proximal end of the catheter 16 throu~h a central channel Inot shown) within the fittin~
12. As used herein, plU~illldl and "distal" are used in reference to the proximity of the fluid supply tube 14. The central channel passes throu~h a collet Inot shown) of the fittin~ 12. An outer rina member 18 is slid over the collet section to secure and seal the microbore tubin~ 16 within the central channel. The rin~ 18 is slid toward a collar 20 on the fittin3 body until a collar 22 on the rin~ 18 contacts the body collar 20. As seen in Fi~ure 2, the collars 20, 22 ~enerally have identical elliptical shapes and sizes, and rest flush a~ainst each other with the rin~ 18 Culll~ 5;~illj~ the collet. Friction between the collet and the rin~ member 18 tends to maintain the rin~ member 18 in this position.
The catheter fittin~ 12 ~enerally presents a cylindrical shape on the distal side of the abuttin~ collars 20, 22. A tubular portion 24 of the ring member 18 principally defines this cylindrical shape.
:
CA 022082~8 1997-06-l9 WO 97/15342 PCT/US96/17~67 ~ -4-The catheter fittin~ 12 also includes a threaded lure-lock co,l,-~clur 26. The CO~ r~lO( 26 cooperates ~ith a coll~,pond; .~ con~erl~" 28 on the end of the fluid supply tube 14. As ulldelalùud from Fi~ure 2, a ~ap typically exists between the en~a~ed cunnecluls 26, 28 and the proximal side of the fittin~ collar 20. The exposed portion 30 of the fittin~ has a tubular shape of a diameter smaller than the diameter of the tubular portion 24 of the ring 5 member 18.
The individual cc ,~, n~ la of the seLu,e,-,enl device lO will now be described in detail. To assist in the description of the crmronent~ of the SêCIll elllelll device, a coordinate system has been provided. Fi~ure 2 illustrates a lon~itudinal axis, a l~a~.S~.ae axis and a lateral axis in relation to the catheter fittin~ seLulu...~.)l device 10. The lon~itudinal axis extends in a direction ~enerally parallel to an axis of the catheter fittin~ 12. The lateral axis lies perpendicular to the lon~itudinal axis ~enerally within the plane of the base of the seL~ ",è"l device lO. The transverse axis extends transverse to the lon~itudinal and lateral axes. Additionally, as used herein, "the lon~itudinal direction" refers to a direction s~b~ldnlially parallel to the lon~itudinal axis. "The lateral direction" and "the sl.~.ae direction" are in reference to the lateral axis and llall~.sè axis"e~"e~.t;.~:y.
With ,efe,er,~.e to Fi~ure 2, the Sel,ulelllel~l device 10 principally includes a flexible anchor pad 32 having an adhesive bottom side which attaches to the skin of a patient when used. The anchor pad 32 can be attached at any number of locations on a patient's body, such as, for example, on the anterior or pûsterior sides of the patient's torso.
The pad 32 supports a retainer 34. The retainer 34 is confi~ured to receive and secure in place the catheter fittin~ 12 which interconnects the microbore tubin~ 16 with the fluid supply tubin~ 14, as described above.
For this purpose, the retainer 34 includes a lar~e central channel 36 il,le,~ù~r,d between a pair of opposin~
I~Jr~;m ': ~1 walls 38. The central channel 36 is sized to receive the tubular portion 24 of the fittin~ rin~ member 18. The central channel 36 extends alonp an axis which is ~enerally collinear to the lon~itudinal axis of the retainer 34.
As best seen in Fi~ures 2 and 4, the central channel 36 has a ~enerally circular cross socliùl,al shape which is Iru.l.,dl~d at an upper end to form a ~enerally C-shaped channel havin~ an upper opening 40. The central channel 36 has a diameter sized to receive the ~enerally tubular portion 24 of the tube fittin~ rin~ 18. In a preferred embodiment, the diameter of the central channel 36 ~enerally matches that of the tubular portion 18 or is sli~htly lar~er.
In cross-section, as seen in Fi~ure 4, the central channel 36 extends throu~h an arc which is ~reater than 180O about the channel axis such that the lateral width of the openin~ 40 is less than the diameter of the central channel 36. In an exemplary embodiment, the central channel 36 extends throu~h an arc of about 2000 about the channel axis.
The lon~itudinal walls 38 are ;,~b~lalllidlly identical. The len9th of each wall 38, Illeas~leJ in the lon~itudinal direction, is ~JIeleldLly coe ~ with the len~th of the tubular portion 24 of the fittin~ rin~ 18.
The walls 38 desitably have a minimum thickness at the top of the channel 36 to allow flexure of the top portions of lon~itudinal walls 38 away from each other. The retainer 34 further is formed of ri~id but flexible CA 022082~8 1997-06-19 ~ -5-material to permit this P~ .,l;a,l of the lateral walls 38 when insertin~ and removin~ the tubular portion 24 of the - catheter fittin~ 18 from the channel 36. Althou~h the retainer 34 can be formed of any of a wide variety of materials, the retainer 34 desirably is formed of p~'~Gdlb~ 1~ or a like polymer, as d;, ~Issed below.
As best seen in Fi~ure 3, the walls 38 desirably ~ive the retainer 34 a width in the luuui~ direction which is less than the common maximum width of the fittin~ collars 20, 22. The distal ends of the 1 walls 38 taper in thickness to reduce the width of the retainer 34 at this end.
At the distal end of the retainer 34, a fin~er platform 42 extends from each wall 38. The ~Idl~Ollll;~ 42 have a sufficient size to allow the tips of the health care provider's index fin~er and thumb to press a~ainst the pldl~ulllla 42. In this manner, the health care provider can press the retainer 34 a~ainst the patient when removin~
the catheter fittin~ 12 from the retainer 34, as described below.
As best seen in Fi~ure 2, at least one lateral slot 44 extends throu~h the retainer 34 in a direction that is ~eneraOy p~l,uG~ to the axis of the retainer 34. The slot 44 is sized to receive the collars 20, 22 of the catheter fittin~ 12 and includes an arcuate bottom surface 46. The bottom surface 46 is shaped to match the section of the elliptical shaped collars 20, 22 that sit a5ainst the bottom surface 46 with the catheter fittin~ 12 posi~ d within the retainer 34.
The slot 44 extends throu~h the walls 38 of the retainer 34 such that the ends of the elliptical collars 20, 22 of the catheter fittin~ 12 are exposed on either side of the retainer 34. That is, the width of the retainer 34 at the location of the slot 44 is less than the major diameter of the elliptical shaped collars 20, 22 of the catheter fittin3 12.
The thickness of the slot 44, as measured in the lon~itudinal direction, ~enerally matches the thickness of the abuttin~ collars 20, 22, measured in the same direction. In this matter, the slot 44 captures a portion of the ends of the collars 20, 22 to prevent lon~itudinal movement of the catheter fittin~ 12 within the retainer 34.
As best seen in Figure 2, the slot 44 has a hei~ht, which is ulda~ul~d in the tldn~ e direction, between an upper ed~e of the lon~itudinal wall 38 and the bottom 46 of the slot 44. The bottom 44 extends below the central channel 36 in order to receive the portion of the catheter fittin~ collars 20,22 that extend below the tubular portion 24 of the rin~ member 18.
With reference to Fi~ures 2 and 3, the retainer 34 includes a slender front wall 48 positioned on the proximal side of the slot 44. The thickness of the wall 48 as measured in the lon~itudinal direction desirably is less than the ~ap formed between the catheter fitting collar 20 and the lure-lock co~ ,e~ r 28 when en~a~e with the fittin~ 12.
As best seen in Fi~ures 2 and 5, the front wall 48 defines a second channei or aperture 50 which receives ths proximal tubular portion 30 of the fittin~ 12. (In order to dif~.LulidlQ between the proximal and distal channels of the retainer, the followiri~ d - will refer to the channel in the front wall 48 as an aperture; this is done without limiting the i... ~n{inn J The aperture 50 ~enerally has a circular shape which is llullcdl~d at an upper end so as to define an upper openin~ 52 to the aperture 50. The center of the circular shape of the aperture 50 ~enerally lies on the axis of retainer 34.
CA 022082~8 1997-06-19 The aperture SO has a diameter sized to receive the proximal tubular portion 30 of the fittin~ 12. In a - preferred embodiment, the diameter of the aperture 50 ~enerally matches that of the proximal tubular portion 30 or is sli~htly lar~er.
The aperture 50 desirably extends throu~h an arc which is ~reater than 180~ about the retainer axis such 5 that the lateral width of the openin3 52 is less than the diameter of the aperture 50. In an e.,~l"~,ld,~ e~l,oJi.",~
the aperture 50 extends throu~h an arc of about 200~ about the retainer axis.
As seen in Fi~ure 5, the upper ed~es 54 of the front wall 48 ~loxill,dl~ to the aperture openinp 52 are rounded and slope toward the openina 52. This cor,~ c.aliun helps 9uide the tubular portion 30 of the catheter fittinp 12 into the aperture 50. It also helps deflect the upper ends of the front wall 48 in the lateral direction to 10 allow the health care provider to push the tubular portion 30 into the aperture 50, as dE~LI;lJdd below.
The circular portion of the aperture 50, however, ;1lt~l~6~.lS with each sloped upper ed~e 54 at a ~enerally sharp anple. The resultin~ distinct l.an~ition point 56 inhibits uni"tP~ retraction of the fittin~ tubular portion 30 from the aperture 50.
The retainer 34 may be constructed in any of a variety of ways which wili be well known to one of skill 15 in the art. For instance, the retainer 34 may be inte~rally molded such as by injection molding or by Ih~llllOpla~ly.
The retainer 34 l~bf~ bly comprise a durably, flexible material, and more pl~feldbl) comprise a ~enerally inert, non-toxic material. In a preferred embodiment, the retainer 34 is molded of plastic, such as, for example, pGlyl~a'Lundld~ pc'~ 1ullloride, pol~-l",ul' pclyu,~ll,dne, tetrafluoroethylene (e.~., TEFLON~), 20 polytt l-dRuo, JE~hylene (a.k.a., PTEF), acetal resin (e.~., DELRIN~), ch't olli~luo.~ ~thylene (e.~., KEL-F~), nylon or like polymers.
With Id~ nce to Fi~ure 2, the retainer 34 desirably is secured to the anchor pad 32 by means of c~dnod~ ldl~, or other bondin~ material. The flexible anchor pad 32 comprises a laminate structure formed by an upper paper or other woven or nur . ~.~n cloth layer, an inner cellulose foam layer, and a bottom adhesive layer.
25 Altellld~ ly, the flexible anchor pad 32 may comprise an adhesive bottom layer and an upper cellulose foam layer.
An upper surface of the foam layer is lo.,~h~lldd by corona treatin~ the foam with a low electric charpe, as known in the art. The ~~n:,Jh. --~ ~ or porous upper surface of the anchor pad 32 improves cyanoacrylate (other types of adhesive or bondinp ,llal~l;als) adhesion when attachinp the retainer to the anchor pad 32.
A r~:lllù113~lt paper or plastic backin~ 58 desirably covers the bottom adhesive surface before use. .The 30 backinp 58 p~ dbl~ resists tearing and is divided into a plurality of pieces to ease all -~hn~ t of the pad 32 to the patient's skin. The backin~ 58 desirably is split alon~ a center line of the flexible anchor pad 32 in order to expose only half of the adhesive bottom surface at one time. The backin~ also advanld~oo.Jsl~ extends beyond at least one edpe of the anchor pad to ease removal of the backina from the adhesive layer.
In an e..~",~Jlary embodiment, the laminate structure of the anchor pad 32 is ~ dbl~ formed by rollinp 35 a paper tape, such as a micro-porous rayon tape, available commercially as MICRO-PORE tape from 3M (Item No.
1530), over a medical ~rade polyvinyl chloride foam tape, such as that available c0.l....3.L;dlly from 3M (Item No.
CA 022082~8 1997-06-19 WO 97/15342 ~ PCT/US96/17067 9777L). The foam tape ~u,efe,ut'~ includes the bottom liner or backin~ 58. The anchor pad 32 is then stamped - out of the l~ d sheet of foam and paper. The backin~ formin~ the release taps, however, is not severed such that the tabs remain attached. The backin~ 58 is then cut into two pieces alon~ the center line of the pad between the tabs.
In the illustrated embodiment, as best seen in Fi~ure 3, the anchor pad 32 includes a pair of lateral win~
sections 60 which extend from a narrowed center section 62 of the anchor pad 32. The retainer 34 is attached to the center section 62. As a result, the lateral ends 60 of the anchor pad have more contact area to provide preater stability and adhesion to the patient's skin.
The anchor pad 32 also may include indicia (not shown~ which indicates the proper ~ri~nlaliu" of the anchor pad 32 in reference to the call,~te~iL~d site. Such indicia can include, for example, arrows, words, icons, or other ~raphics.
As seen in Fipure 2, the pad 32 may also support a tube clip 64 for retainin~ a portion of fluid tubin~ 14.
The clip 64, shown in Fipures 3 and 6, secures the fluid supply tube 14 to form a safety loop, as is known in the art. The tube clip 64 has a plate-like base 66 adhered to or ~ dde~ in the anchor pad 32. The tube clip 64 may be located on the pad 32 on either side of the retainer 34.
The clip 64, as best seen in Fiaure 6, defines a channel 68 havin~ a ~enerally circular cross sectional con~i~u,dlion t,u"-,aled to form an upper orifice. The diameter of the channel 68 is desirably sli~htly less than that of the fluid supply tube 14 so as to ensure a secure illl~lconil~ tiv-~ The channel 68 receives a portion of the fluid supply tube 14 throu~h the orifice upon application of ~entle pressure or by pullincJ the tubin~ 14 across and through the orifice of the tube clip 64, as explained below. The clip 64 su.,,,u.. ds a sufficient portion of the tubin~ 14 with the tubinp 14 po~i~inned within the channel 68 to secure and stabilize the held section of tubin~ 14.
The upper ed~e of the channel 68 can include tapered ends at the proximal and distal ends of the clip 64.
Each tapered end forms a smooth transition between the side edae of the channel 68 and the upper ed~e, and tapers in lateral width from the side edpe toward the center of the tube clip 64. The tapered ends help ~uide the fluid supply tube 14 into the channel 68 when a health care provider pulls the tube 14 across the clip 64. Thus, the health care provider does not have to pinch the tube 14 to insert it into the clip 64. Also, the health care provider's ~loves do not ~et stuck in the clip 64 when insertin~ the tube 14, as is typically the case where the health care provider is required to pinch the tube to insert it into the clip 64.
The sc~,u.~",~..l device 10 also can include an S-clip 70 to retain microbore tubina 16. As best seen in Fipures 2, 3 and 7, the S-clip includes a plurality of retainers 72. Each retainer 72 has a flared head 74 , r~ l~d by a cylindrical stem 76. The retainers 72 extend upwardly from a base plate 78 and are pc-,i'ior~d from one another by a distance sli~htly ~reater than the diameter of the microbore tubin~ 16. The retainers 72 are also FQ: i such that the spherical heads 74 of the retainers 72 are spaced from one another by a distance sliphtly less than the diameter of the microbore tubing 16. As best seen in Fi~ure 1, the retainer heads 74 prevent the microbore tubin~ 16 from disenpaging from the S-clip 70 in the t-ars- ~~e direction once the ~ IOGGI~ tubinp 16 is snaked between the retainers 72.
CA 022082~8 1997-06-19 WO 97/15342 PcTlus96ll7o67 An adhesive attaches the base plate 78 of the S-clip 70 to anchor pad 32- Alle",dli.~:~, the base plate -78 can be attached to the pad 32 by other means known to those of skill in the art (e-~., embeddin~ or otherwise weavin~ the plate into the base pad).
In use, a health care provider couples the catheter fittin~ 12 to the proximal end of the catheter 16 throuph 5 known means and connects a fluid supply tube 14 to the proximal end of the catheter fittin~ 12. The fluid supply tube 14 communicates with the catheter 16 throu~h the fittin3 12 in order to introduce fluids (e.p., an~ll,dsia) to the body canal or cavity in which the catheter distal end indwells.
To secure the catheter fittin~ 12 to the patient, the health care provider removes the paper backin~ 58 which initially covers the adhesive bottom surface of the anchor pad 32, and attaches the pad 32 to the patient's 10 skin at a desired location. For epidural application, the pad 32 c ~ 't is attached to the side of the patient's ~b~lomen, to the patient's chest, or to the back of the patient. The health care proYider places the bottom layer of the pad 32 a~ainst the patient's skin to adhere the anchor pad 32 to the patient. The indicia on the pad 32 ~ f~lably point in the direction of the indwellina catheter. Li~ht pressure over the upper layer of the pad 32 assures ~ood adhesion between the pad 32 and the patient's skin. The pad 32, due to its flexibility, conforms to the 15 contours of the topical surface to which the pad adheres.
The health care provider o,i~"ldl~s the catheter fittin~ 12 above the retainer 34 with the collars 20, 22 of the fittin~ 12 pG~;ti~ e(l over the lateral slot 44 in the retainer 34. The health care provider then snaps the fittinp 12 into the retainer 34. In doin~ so, the tubular portion 24 of the fittin~ rin~ 18 is pressed between the 1~ IDit"~ walls 38 of the retainer 34 while the proximal tubular portion 30 of the fittin~ 12 is pressed into the 20 openin~ 52 of the front wall aperture 50.
As u~ lion~ d above, the openin~ 40 of the channel 36 has a smaller width l..a~.~uled in the lateral direction than the diameter of the tubular portion 24 of the fittin~ rin~ 18. Likewise, the openin~ 52 of the front aperture 50 has a smaller width measured in the lateral direction than the diameter of the proximal tubular portion 30 of the fittin~ body 1Z. The longitudinal walls 38 and the lateral side of the front wall 48 thus deflect Oul~.àldly in the 25lateral direction when the fittinp 12 is pressed into the retainer 34. The rounded upper ed~es 54 about the front wall openin~ 52 ease the insertion of the proximal tubular portion 30 of the fittin~ 12 into the front aperture 50.
Once the tubular portions 24, 30 of the fittin~ 12 rest within the cu.--, din~ channel 36 and aperture 50, the lateral walls 38 and the lateral side of the front wall 48 sprin~ back to snap the fittin~ 12 into the retainer 34.
The walls 38 of the retainer 34 thus prevent unintentional transverse and lateral movement of the fittin~ 12.
30In this position, the collars 20, 22 of the catheter fittin~ 12 rest in the lateral slot 44. The walls 38, 48 surroundinp the slot 44 capture the frttin~ collars 20, 22 and prevent the lon~itudinal movement of the fittin3 12.
As ulld~l ~d from Fi~ure 1, the health care provider may also form a safety loop in the fluid supply tubin~
16, as known in the art, and secure the safety loop to the patient by insertin9 a portion of the tubin~ 14 into the tube clip 64. The safety loop absorbs any tension applied to the fluid supply tube 14 to prevent the fittin~ 12 35andlor the catheter 16 from bein~ pulled.
CA 022082~8 1997-06-19 WO 97/1~;342 PCT/US96/17067 .9.
The health care provider, ll~s~ lly snakes the microbore tubin~ 16 throu~h the S-clip 70, as seen in Fi~ures 1 and 7, by first pressin~ the tube between the retainers 72. Li~ht pressure forces the tubing 14 between the retainers 72. The S-clip 70 secures the microbore tube 16 in place and isolates the tube 16 from tension placed on the fittin~ 12 andlor the fluid supply tube 14.
To remove the catheter fittin~ 12 from the retainer 34, the health care provider places lliS or her index fin~er on one side of the retainer 34 and his or her thumb on the other. The fin~ers desirably are placed on the p6l~o,~ 42 of the retainer 34 in order to hold the retainer 34 a~ainst the patient. With the other hand, the health care provider prips the end of the fittin~ collars 20, 22, which extend beyond the side of the retainer 34, with his or her index fin~er and thumb, and then rotates one end of the collars 20, 22 out of the retainer 34. The opposite side of the slot 44 acts as a fulcrum to allow the health care provider to apply levera~e to pull the fittin~ tubular portions 24, 30 from the co"~,u ~ D channel 36 and aperture 50 of the retainer 34. This cam like action forces the fittin~ 12 from retainer 34 with minimal effort. However, without performin~ this specific process, it is difficult to remove the fitting 12 from the retainer 34.
Althou~h this invention has been described in terms of a certain preferred ~ bGdil~ent, other embodiments apparent to those of ordinary skill in the art are also within the scope of this invention. Accordin~ly, the scope of the invention is intended to be defined only by the claims which follow.
CATHETER FITTING SECUr'-~FNT DEVICE
Ba~.l,u,b.,,ld of the Invention Field of the Invention The present invention relates in ~eneral to a l,alll~ alion device. In pa~ ,ulal, the present invention relates to an anchorinq system for a catheter fittina.
Des~. i"; ~ of Related Art Medical ~l~allll.!~.L of patients commonly involves the use of pel~.ulail ~ously inserted calh~,lel~ to direct fluids directly into the bloodstream, a specific or~an or an internal location of the patient, or to monitor vital 1O functions of the patient. For instance, epidural catheters are commonly used to direct anesthesia into an epidural space to a~ a specific location of the patient.
In practice, fluid (e.p., an~ r~-~) typically flows throuah a fluid supply tubin~ into an indwellin~ catheter.
The catheter and fluid tubin~ are commonly ~ .aLl~ attached by a conventional co~ ~n; I~-- or catheter fittin~. One such co~ t~,. is soid commercially under the mark Snap-Lock~ by Arrow International, Inc., of Readin~, 1 5 F~
A health care provider, such as, for example, a nurse or doctor (for ease of description, as used herein the term "health care provider" will refer to health care providers ~enerally and will not be restrictive in meanin~), uses adhesive or sur~ical tape to secure the catheter fitting to the skin of the patient. The application of adhesi~re tape also helps inhibit movement between the components of the catheter fittin~ which possibly could loosen and allow 20 the catheter to disconnect from the fittinp.
Health care providers also commonly form a safety loop in the tubin~ so that any tension applied to the tubin~ does not directly pass to the catheter, but rather is absorbed by the slack of the safety loop. The health care provider typically loosely tapes the loop to the skin of the patient.
This entire tapin~ procedure takes several minutes of the valuable time of the health care provider.
25 ~u. ~h~".,o.~, health care providers commonly remove their ~loves when tapin~ because most people find such tapinq procedures difficult and cumbersome when wearin~ ~loves.
The catheterization process often requires frequent disconnection between the catheter and the fluid supply tube. The catheter tubinp is penerally replaced every few hours in order to maintain the sterility of the fluid and the free-flow of the fluid throu~h the tubin~. A health care provider thus must frequently chan~e the tubing a,nd 30 retape the connection.
A preat deal of valuable time is thus used in applyin9 si~nificant amounts of sur~ical tape to the catheter fittin~. The frequent application and removal of sur~ica! tape also commonly results in the eALc,idliJu of the skin of the patient in the area of the insertion.
Summarv of the Invention The s~.. ,u.~ "t device of the present invention provides a retainer for securin~ a catheter fittin~, such as that sold under the SNAP-LOCKn~ trademark by Arrow l"l"."dl lrll, Inc- The Se.,U~ ..2UI device is easily anchored CA 022082~8 1997-06-19 WO 97/15342 PCTfUS96/17067 ., -2- .
to the patient's skin. Once secured, a health care provider can easily insert and remove the catheter fittin~ from - the retainer. The retainer also ensures the that components of the catheter fittin~ remain ti~htly c0"l)6~l~d to prevent ac ~ r-l,-l rl;. n~ t of the catheter from the fittin~.
In acc.,.dan..e with one aspect of the present invention, an anchorin~ system ~ asabl~ secures a catheter 5 fittinp to a patient. The a,.cl,Gri"d system c..,.,u.;~r,s a retainer includin~ a first channel which is co.,~iuulcd to receive a first tubular portion of the catheter fitting. A second channel of the retainer is also co,,liuu~ll to receive a second tubular portion of the catheter fittin~. The first and second channels ~enerally extend alon~ a common axis. At least one lateral slot is i~ uGiQd between the first and second channels. The slot extends in a direction which is penerally perpendicular to the common axis. A bottom of the slot has an arcuate shape which ~enerally 10 matches a shape of a collar portion of the catheter fittina.
Another aspect of the invention involves an anchorin~ system for securin~ a medical article to the skin of a patient. The medical article includes an e' a~. ' tubular body and a radially extendin~ member which projects from the tubular body. The anch~ri,,u system cu,,,,u,i..~s a retainer includin~ first and second channel portions which extend about an axis, each channel portion ~enerally havin~ a tl~ .dled circular cross-sectional shape sized to 15 surround at least a portion of the medical article throu~h an arc of ~reater than 180~ about the axis. At least one lateral slot extends ~enerally ,~".elldiLular to the lon~itudinal axis between the first and second channel portions.
The slot has a thickness substantially equal to the thickness of the radially extendin~ member of the medical article.
The first and second channels have a combined lon~itudinal len~th SUII;L;~ to prevent lateral ...~ nl of the medical article with the radially ~ "di"~ member positioned within the lateral slot. A flexible anchor pad has an 20 adhesive bottom surface and a top surface on which the retainer is mounted. The retainer is po~ "ed on the top surface in a manner exposin~ openin~s to the channel portions.
In ac.,o,da...,e with an additional aspect of the present invention, an anchorin~ system involves a retainer havin~ a lon~itudinal channel confi~ured to receive in a snap-fit manner a tubular body of a catheter fittin~. The retainer additionally comprises at least one lateral slot sked to receive and to capture a radially ~ lld;,l~ member of the fittin~ with the fittin~ pcl ' within the lonaitudinal channel of the retainer. In this manner, the retainer prevents the adaptor from slidinp in a lon~itudinal direction. A flexible anchor pad includes an adhesive bottom surface which is adapted to attach to a patient's skin. The anchor pad supports the retainer.
Brief DE~I,I;IJ~;"a of the Drawin~s These and other features of the invention will now be described with ~el~e.l~e to the drawin~s of a preferred embodiment which is intended to illustrate and not to limit the invention, and in which:
Fipure 1 is a top p~ t~ti-~ view of a catheter fittin~ 5.,~,Ul~ llt device c 'iu~.~J in accol.l~"~e with a preferred embodiment of the present invention, shown securinp an exemplary catheter fittina;
Fi~ure 2 is an exploded top p~ ,UL.~ti.~ view of the se~ -,l device and catheter fittin~ illustrated in Fi~ure 1;
Fi~ure 3 is a plan view of the securement device and catheter fittin~ shown in Fi~ure 1;
WO 97/15342 . PCT/US96/17067 Fi~ure 4 is a cross-sectionai view of a retainer of the sELule",~"l device shown in Fi~ure 3 taken aion~
- line 44 with a portion of the catheter fittinp pG~;t;~u~d within a channel of the retainer;
Fi~ure 5 is a cross-sectional view of the retainer of Fi~ure 3 taken alon~ line 5-5 with a portion of the catheter fittin~ pc ~jt; .nPd within an aperture of the retainer;
Fi~ure 6 is a cross-sectional view of a tube clip of the securel"enl device of Fi~ure 3 taken alon~ line 6-6 of Fi~ure 3; and Fi~ure 7 is a cross-sectional view of an S-Clip of the securement device of Fi3ure 3 taken alon~ line 7-7 of Fi~ure 3.
Detailed DescriDtion of a Preferred Embodiment Fi~ure 1 illustrates a sccul~llldnL device 10 C~ ;UUILd in accG~ddllce with a preferred e ~l~ od; "~"I of the present invention. Althou~h the seLu,~ nl device 10 is iliustrated in iJrl ,tion with a pdlliLulal catheter fittin~
12, those skilled in the art will readily apl"eL;ale that the present 5eCU~ t device 10 can be adapted for use with other types of fittin~s, c ~ and adaptors which are used with catheters, fluid supply and draina~e tubes, electrical wires and cables, and the iike.
The seLlJlelWl~t device 10 securely anchors the catheter fittin~ 12 to the patient without the use of sur~ical tape. For most catheterization, the sec-",,..,~"l device 10 is attached to the patient only once. Althou~h a fluid supply tubin~ 14, which is cGr",~- Ied to the fittin3 12, may be replaced often for epidural al1l ' lions, the ~u~,u~n~ of the seLuJelll~lll device 10 remain attached to the patient. Thus, sur~ical tape need not be applied and removed from the patient's skin on multiple ~sr The illustrated catheter fittin~ 12 iS available commercially under the lldde",à,k SNAP-LOCKn' from Arrow hl~elllaliolldl of Readin~, Pennsylvania. However, before describin~ the present se~.u~ dlll device 10 in detail, the e~ làly catheter fittin~ 12 will first be ~enerally described to assist the reader in u"d~,~ld"din~ the illustrated sec.~,~",~"l device 10.
With r~ nce to Fi3ure 2, the catheter fittin~ 12 securely connects the tube 14, such as a fluid supply tube, to microbore tubing or catheter 16 le.a., 18 to 24 ~au~e). The catheter 16 is l~leds~bll~ conn~leil to the fittina 12 by threadin~ a proximal end of the catheter 16 throu~h a central channel Inot shown) within the fittin~
12. As used herein, plU~illldl and "distal" are used in reference to the proximity of the fluid supply tube 14. The central channel passes throu~h a collet Inot shown) of the fittin~ 12. An outer rina member 18 is slid over the collet section to secure and seal the microbore tubin~ 16 within the central channel. The rin~ 18 is slid toward a collar 20 on the fittin3 body until a collar 22 on the rin~ 18 contacts the body collar 20. As seen in Fi~ure 2, the collars 20, 22 ~enerally have identical elliptical shapes and sizes, and rest flush a~ainst each other with the rin~ 18 Culll~ 5;~illj~ the collet. Friction between the collet and the rin~ member 18 tends to maintain the rin~ member 18 in this position.
The catheter fittin~ 12 ~enerally presents a cylindrical shape on the distal side of the abuttin~ collars 20, 22. A tubular portion 24 of the ring member 18 principally defines this cylindrical shape.
:
CA 022082~8 1997-06-l9 WO 97/15342 PCT/US96/17~67 ~ -4-The catheter fittin~ 12 also includes a threaded lure-lock co,l,-~clur 26. The CO~ r~lO( 26 cooperates ~ith a coll~,pond; .~ con~erl~" 28 on the end of the fluid supply tube 14. As ulldelalùud from Fi~ure 2, a ~ap typically exists between the en~a~ed cunnecluls 26, 28 and the proximal side of the fittin~ collar 20. The exposed portion 30 of the fittin~ has a tubular shape of a diameter smaller than the diameter of the tubular portion 24 of the ring 5 member 18.
The individual cc ,~, n~ la of the seLu,e,-,enl device lO will now be described in detail. To assist in the description of the crmronent~ of the SêCIll elllelll device, a coordinate system has been provided. Fi~ure 2 illustrates a lon~itudinal axis, a l~a~.S~.ae axis and a lateral axis in relation to the catheter fittin~ seLulu...~.)l device 10. The lon~itudinal axis extends in a direction ~enerally parallel to an axis of the catheter fittin~ 12. The lateral axis lies perpendicular to the lon~itudinal axis ~enerally within the plane of the base of the seL~ ",è"l device lO. The transverse axis extends transverse to the lon~itudinal and lateral axes. Additionally, as used herein, "the lon~itudinal direction" refers to a direction s~b~ldnlially parallel to the lon~itudinal axis. "The lateral direction" and "the sl.~.ae direction" are in reference to the lateral axis and llall~.sè axis"e~"e~.t;.~:y.
With ,efe,er,~.e to Fi~ure 2, the Sel,ulelllel~l device 10 principally includes a flexible anchor pad 32 having an adhesive bottom side which attaches to the skin of a patient when used. The anchor pad 32 can be attached at any number of locations on a patient's body, such as, for example, on the anterior or pûsterior sides of the patient's torso.
The pad 32 supports a retainer 34. The retainer 34 is confi~ured to receive and secure in place the catheter fittin~ 12 which interconnects the microbore tubin~ 16 with the fluid supply tubin~ 14, as described above.
For this purpose, the retainer 34 includes a lar~e central channel 36 il,le,~ù~r,d between a pair of opposin~
I~Jr~;m ': ~1 walls 38. The central channel 36 is sized to receive the tubular portion 24 of the fittin~ rin~ member 18. The central channel 36 extends alonp an axis which is ~enerally collinear to the lon~itudinal axis of the retainer 34.
As best seen in Fi~ures 2 and 4, the central channel 36 has a ~enerally circular cross socliùl,al shape which is Iru.l.,dl~d at an upper end to form a ~enerally C-shaped channel havin~ an upper opening 40. The central channel 36 has a diameter sized to receive the ~enerally tubular portion 24 of the tube fittin~ rin~ 18. In a preferred embodiment, the diameter of the central channel 36 ~enerally matches that of the tubular portion 18 or is sli~htly lar~er.
In cross-section, as seen in Fi~ure 4, the central channel 36 extends throu~h an arc which is ~reater than 180O about the channel axis such that the lateral width of the openin~ 40 is less than the diameter of the central channel 36. In an exemplary embodiment, the central channel 36 extends throu~h an arc of about 2000 about the channel axis.
The lon~itudinal walls 38 are ;,~b~lalllidlly identical. The len9th of each wall 38, Illeas~leJ in the lon~itudinal direction, is ~JIeleldLly coe ~ with the len~th of the tubular portion 24 of the fittin~ rin~ 18.
The walls 38 desitably have a minimum thickness at the top of the channel 36 to allow flexure of the top portions of lon~itudinal walls 38 away from each other. The retainer 34 further is formed of ri~id but flexible CA 022082~8 1997-06-19 ~ -5-material to permit this P~ .,l;a,l of the lateral walls 38 when insertin~ and removin~ the tubular portion 24 of the - catheter fittin~ 18 from the channel 36. Althou~h the retainer 34 can be formed of any of a wide variety of materials, the retainer 34 desirably is formed of p~'~Gdlb~ 1~ or a like polymer, as d;, ~Issed below.
As best seen in Fi~ure 3, the walls 38 desirably ~ive the retainer 34 a width in the luuui~ direction which is less than the common maximum width of the fittin~ collars 20, 22. The distal ends of the 1 walls 38 taper in thickness to reduce the width of the retainer 34 at this end.
At the distal end of the retainer 34, a fin~er platform 42 extends from each wall 38. The ~Idl~Ollll;~ 42 have a sufficient size to allow the tips of the health care provider's index fin~er and thumb to press a~ainst the pldl~ulllla 42. In this manner, the health care provider can press the retainer 34 a~ainst the patient when removin~
the catheter fittin~ 12 from the retainer 34, as described below.
As best seen in Fi~ure 2, at least one lateral slot 44 extends throu~h the retainer 34 in a direction that is ~eneraOy p~l,uG~ to the axis of the retainer 34. The slot 44 is sized to receive the collars 20, 22 of the catheter fittin~ 12 and includes an arcuate bottom surface 46. The bottom surface 46 is shaped to match the section of the elliptical shaped collars 20, 22 that sit a5ainst the bottom surface 46 with the catheter fittin~ 12 posi~ d within the retainer 34.
The slot 44 extends throu~h the walls 38 of the retainer 34 such that the ends of the elliptical collars 20, 22 of the catheter fittin~ 12 are exposed on either side of the retainer 34. That is, the width of the retainer 34 at the location of the slot 44 is less than the major diameter of the elliptical shaped collars 20, 22 of the catheter fittin3 12.
The thickness of the slot 44, as measured in the lon~itudinal direction, ~enerally matches the thickness of the abuttin~ collars 20, 22, measured in the same direction. In this matter, the slot 44 captures a portion of the ends of the collars 20, 22 to prevent lon~itudinal movement of the catheter fittin~ 12 within the retainer 34.
As best seen in Figure 2, the slot 44 has a hei~ht, which is ulda~ul~d in the tldn~ e direction, between an upper ed~e of the lon~itudinal wall 38 and the bottom 46 of the slot 44. The bottom 44 extends below the central channel 36 in order to receive the portion of the catheter fittin~ collars 20,22 that extend below the tubular portion 24 of the rin~ member 18.
With reference to Fi~ures 2 and 3, the retainer 34 includes a slender front wall 48 positioned on the proximal side of the slot 44. The thickness of the wall 48 as measured in the lon~itudinal direction desirably is less than the ~ap formed between the catheter fitting collar 20 and the lure-lock co~ ,e~ r 28 when en~a~e with the fittin~ 12.
As best seen in Fi~ures 2 and 5, the front wall 48 defines a second channei or aperture 50 which receives ths proximal tubular portion 30 of the fittin~ 12. (In order to dif~.LulidlQ between the proximal and distal channels of the retainer, the followiri~ d - will refer to the channel in the front wall 48 as an aperture; this is done without limiting the i... ~n{inn J The aperture 50 ~enerally has a circular shape which is llullcdl~d at an upper end so as to define an upper openin~ 52 to the aperture 50. The center of the circular shape of the aperture 50 ~enerally lies on the axis of retainer 34.
CA 022082~8 1997-06-19 The aperture SO has a diameter sized to receive the proximal tubular portion 30 of the fittin~ 12. In a - preferred embodiment, the diameter of the aperture 50 ~enerally matches that of the proximal tubular portion 30 or is sli~htly lar~er.
The aperture 50 desirably extends throu~h an arc which is ~reater than 180~ about the retainer axis such 5 that the lateral width of the openin3 52 is less than the diameter of the aperture 50. In an e.,~l"~,ld,~ e~l,oJi.",~
the aperture 50 extends throu~h an arc of about 200~ about the retainer axis.
As seen in Fi~ure 5, the upper ed~es 54 of the front wall 48 ~loxill,dl~ to the aperture openinp 52 are rounded and slope toward the openina 52. This cor,~ c.aliun helps 9uide the tubular portion 30 of the catheter fittinp 12 into the aperture 50. It also helps deflect the upper ends of the front wall 48 in the lateral direction to 10 allow the health care provider to push the tubular portion 30 into the aperture 50, as dE~LI;lJdd below.
The circular portion of the aperture 50, however, ;1lt~l~6~.lS with each sloped upper ed~e 54 at a ~enerally sharp anple. The resultin~ distinct l.an~ition point 56 inhibits uni"tP~ retraction of the fittin~ tubular portion 30 from the aperture 50.
The retainer 34 may be constructed in any of a variety of ways which wili be well known to one of skill 15 in the art. For instance, the retainer 34 may be inte~rally molded such as by injection molding or by Ih~llllOpla~ly.
The retainer 34 l~bf~ bly comprise a durably, flexible material, and more pl~feldbl) comprise a ~enerally inert, non-toxic material. In a preferred embodiment, the retainer 34 is molded of plastic, such as, for example, pGlyl~a'Lundld~ pc'~ 1ullloride, pol~-l",ul' pclyu,~ll,dne, tetrafluoroethylene (e.~., TEFLON~), 20 polytt l-dRuo, JE~hylene (a.k.a., PTEF), acetal resin (e.~., DELRIN~), ch't olli~luo.~ ~thylene (e.~., KEL-F~), nylon or like polymers.
With Id~ nce to Fi~ure 2, the retainer 34 desirably is secured to the anchor pad 32 by means of c~dnod~ ldl~, or other bondin~ material. The flexible anchor pad 32 comprises a laminate structure formed by an upper paper or other woven or nur . ~.~n cloth layer, an inner cellulose foam layer, and a bottom adhesive layer.
25 Altellld~ ly, the flexible anchor pad 32 may comprise an adhesive bottom layer and an upper cellulose foam layer.
An upper surface of the foam layer is lo.,~h~lldd by corona treatin~ the foam with a low electric charpe, as known in the art. The ~~n:,Jh. --~ ~ or porous upper surface of the anchor pad 32 improves cyanoacrylate (other types of adhesive or bondinp ,llal~l;als) adhesion when attachinp the retainer to the anchor pad 32.
A r~:lllù113~lt paper or plastic backin~ 58 desirably covers the bottom adhesive surface before use. .The 30 backinp 58 p~ dbl~ resists tearing and is divided into a plurality of pieces to ease all -~hn~ t of the pad 32 to the patient's skin. The backin~ 58 desirably is split alon~ a center line of the flexible anchor pad 32 in order to expose only half of the adhesive bottom surface at one time. The backin~ also advanld~oo.Jsl~ extends beyond at least one edpe of the anchor pad to ease removal of the backina from the adhesive layer.
In an e..~",~Jlary embodiment, the laminate structure of the anchor pad 32 is ~ dbl~ formed by rollinp 35 a paper tape, such as a micro-porous rayon tape, available commercially as MICRO-PORE tape from 3M (Item No.
1530), over a medical ~rade polyvinyl chloride foam tape, such as that available c0.l....3.L;dlly from 3M (Item No.
CA 022082~8 1997-06-19 WO 97/15342 ~ PCT/US96/17067 9777L). The foam tape ~u,efe,ut'~ includes the bottom liner or backin~ 58. The anchor pad 32 is then stamped - out of the l~ d sheet of foam and paper. The backin~ formin~ the release taps, however, is not severed such that the tabs remain attached. The backin~ 58 is then cut into two pieces alon~ the center line of the pad between the tabs.
In the illustrated embodiment, as best seen in Fi~ure 3, the anchor pad 32 includes a pair of lateral win~
sections 60 which extend from a narrowed center section 62 of the anchor pad 32. The retainer 34 is attached to the center section 62. As a result, the lateral ends 60 of the anchor pad have more contact area to provide preater stability and adhesion to the patient's skin.
The anchor pad 32 also may include indicia (not shown~ which indicates the proper ~ri~nlaliu" of the anchor pad 32 in reference to the call,~te~iL~d site. Such indicia can include, for example, arrows, words, icons, or other ~raphics.
As seen in Fipure 2, the pad 32 may also support a tube clip 64 for retainin~ a portion of fluid tubin~ 14.
The clip 64, shown in Fipures 3 and 6, secures the fluid supply tube 14 to form a safety loop, as is known in the art. The tube clip 64 has a plate-like base 66 adhered to or ~ dde~ in the anchor pad 32. The tube clip 64 may be located on the pad 32 on either side of the retainer 34.
The clip 64, as best seen in Fiaure 6, defines a channel 68 havin~ a ~enerally circular cross sectional con~i~u,dlion t,u"-,aled to form an upper orifice. The diameter of the channel 68 is desirably sli~htly less than that of the fluid supply tube 14 so as to ensure a secure illl~lconil~ tiv-~ The channel 68 receives a portion of the fluid supply tube 14 throu~h the orifice upon application of ~entle pressure or by pullincJ the tubin~ 14 across and through the orifice of the tube clip 64, as explained below. The clip 64 su.,,,u.. ds a sufficient portion of the tubin~ 14 with the tubinp 14 po~i~inned within the channel 68 to secure and stabilize the held section of tubin~ 14.
The upper ed~e of the channel 68 can include tapered ends at the proximal and distal ends of the clip 64.
Each tapered end forms a smooth transition between the side edae of the channel 68 and the upper ed~e, and tapers in lateral width from the side edpe toward the center of the tube clip 64. The tapered ends help ~uide the fluid supply tube 14 into the channel 68 when a health care provider pulls the tube 14 across the clip 64. Thus, the health care provider does not have to pinch the tube 14 to insert it into the clip 64. Also, the health care provider's ~loves do not ~et stuck in the clip 64 when insertin~ the tube 14, as is typically the case where the health care provider is required to pinch the tube to insert it into the clip 64.
The sc~,u.~",~..l device 10 also can include an S-clip 70 to retain microbore tubina 16. As best seen in Fipures 2, 3 and 7, the S-clip includes a plurality of retainers 72. Each retainer 72 has a flared head 74 , r~ l~d by a cylindrical stem 76. The retainers 72 extend upwardly from a base plate 78 and are pc-,i'ior~d from one another by a distance sli~htly ~reater than the diameter of the microbore tubin~ 16. The retainers 72 are also FQ: i such that the spherical heads 74 of the retainers 72 are spaced from one another by a distance sliphtly less than the diameter of the microbore tubing 16. As best seen in Fi~ure 1, the retainer heads 74 prevent the microbore tubin~ 16 from disenpaging from the S-clip 70 in the t-ars- ~~e direction once the ~ IOGGI~ tubinp 16 is snaked between the retainers 72.
CA 022082~8 1997-06-19 WO 97/15342 PcTlus96ll7o67 An adhesive attaches the base plate 78 of the S-clip 70 to anchor pad 32- Alle",dli.~:~, the base plate -78 can be attached to the pad 32 by other means known to those of skill in the art (e-~., embeddin~ or otherwise weavin~ the plate into the base pad).
In use, a health care provider couples the catheter fittin~ 12 to the proximal end of the catheter 16 throuph 5 known means and connects a fluid supply tube 14 to the proximal end of the catheter fittin~ 12. The fluid supply tube 14 communicates with the catheter 16 throu~h the fittin3 12 in order to introduce fluids (e.p., an~ll,dsia) to the body canal or cavity in which the catheter distal end indwells.
To secure the catheter fittin~ 12 to the patient, the health care provider removes the paper backin~ 58 which initially covers the adhesive bottom surface of the anchor pad 32, and attaches the pad 32 to the patient's 10 skin at a desired location. For epidural application, the pad 32 c ~ 't is attached to the side of the patient's ~b~lomen, to the patient's chest, or to the back of the patient. The health care proYider places the bottom layer of the pad 32 a~ainst the patient's skin to adhere the anchor pad 32 to the patient. The indicia on the pad 32 ~ f~lably point in the direction of the indwellina catheter. Li~ht pressure over the upper layer of the pad 32 assures ~ood adhesion between the pad 32 and the patient's skin. The pad 32, due to its flexibility, conforms to the 15 contours of the topical surface to which the pad adheres.
The health care provider o,i~"ldl~s the catheter fittin~ 12 above the retainer 34 with the collars 20, 22 of the fittin~ 12 pG~;ti~ e(l over the lateral slot 44 in the retainer 34. The health care provider then snaps the fittinp 12 into the retainer 34. In doin~ so, the tubular portion 24 of the fittin~ rin~ 18 is pressed between the 1~ IDit"~ walls 38 of the retainer 34 while the proximal tubular portion 30 of the fittin~ 12 is pressed into the 20 openin~ 52 of the front wall aperture 50.
As u~ lion~ d above, the openin~ 40 of the channel 36 has a smaller width l..a~.~uled in the lateral direction than the diameter of the tubular portion 24 of the fittin~ rin~ 18. Likewise, the openin~ 52 of the front aperture 50 has a smaller width measured in the lateral direction than the diameter of the proximal tubular portion 30 of the fittin~ body 1Z. The longitudinal walls 38 and the lateral side of the front wall 48 thus deflect Oul~.àldly in the 25lateral direction when the fittinp 12 is pressed into the retainer 34. The rounded upper ed~es 54 about the front wall openin~ 52 ease the insertion of the proximal tubular portion 30 of the fittin~ 12 into the front aperture 50.
Once the tubular portions 24, 30 of the fittin~ 12 rest within the cu.--, din~ channel 36 and aperture 50, the lateral walls 38 and the lateral side of the front wall 48 sprin~ back to snap the fittin~ 12 into the retainer 34.
The walls 38 of the retainer 34 thus prevent unintentional transverse and lateral movement of the fittin~ 12.
30In this position, the collars 20, 22 of the catheter fittin~ 12 rest in the lateral slot 44. The walls 38, 48 surroundinp the slot 44 capture the frttin~ collars 20, 22 and prevent the lon~itudinal movement of the fittin3 12.
As ulld~l ~d from Fi~ure 1, the health care provider may also form a safety loop in the fluid supply tubin~
16, as known in the art, and secure the safety loop to the patient by insertin9 a portion of the tubin~ 14 into the tube clip 64. The safety loop absorbs any tension applied to the fluid supply tube 14 to prevent the fittin~ 12 35andlor the catheter 16 from bein~ pulled.
CA 022082~8 1997-06-19 WO 97/1~;342 PCT/US96/17067 .9.
The health care provider, ll~s~ lly snakes the microbore tubin~ 16 throu~h the S-clip 70, as seen in Fi~ures 1 and 7, by first pressin~ the tube between the retainers 72. Li~ht pressure forces the tubing 14 between the retainers 72. The S-clip 70 secures the microbore tube 16 in place and isolates the tube 16 from tension placed on the fittin~ 12 andlor the fluid supply tube 14.
To remove the catheter fittin~ 12 from the retainer 34, the health care provider places lliS or her index fin~er on one side of the retainer 34 and his or her thumb on the other. The fin~ers desirably are placed on the p6l~o,~ 42 of the retainer 34 in order to hold the retainer 34 a~ainst the patient. With the other hand, the health care provider prips the end of the fittin~ collars 20, 22, which extend beyond the side of the retainer 34, with his or her index fin~er and thumb, and then rotates one end of the collars 20, 22 out of the retainer 34. The opposite side of the slot 44 acts as a fulcrum to allow the health care provider to apply levera~e to pull the fittin~ tubular portions 24, 30 from the co"~,u ~ D channel 36 and aperture 50 of the retainer 34. This cam like action forces the fittin~ 12 from retainer 34 with minimal effort. However, without performin~ this specific process, it is difficult to remove the fitting 12 from the retainer 34.
Althou~h this invention has been described in terms of a certain preferred ~ bGdil~ent, other embodiments apparent to those of ordinary skill in the art are also within the scope of this invention. Accordin~ly, the scope of the invention is intended to be defined only by the claims which follow.
Claims (18)
1. An anchoring system for releasably securing a catheter fitting to a patient, said anchoring system comprising a retainer including a first channel configured to receive a first tubular portion of the catheter fitting, a second channel configured to receive a second tubular portion of the catheter fitting, said first and second channels extending along a common axis, and at least one lateral slot interposed between said first and second channels, said slot extending in a direction perpendicular to said common axis, a bottom of said slot having an arcuate shape which generally matches a shape of a collar portion of the catheter fitting.
2. The anchoring system of Claim 1, wherein said first channel is defined by a pair of opposing longitudinal walls, each wall having a finger platform extending laterally from each wall distal to said first channel.
3. The anchoring system of Claim 1, wherein at least one of said first and second channels has a generally truncated circular cross-sectional shapes section sized to surround at least a portion of the catheter fitting through an arc of greater than 180° about the common axis.
4. The anchoring system of Claim 4, wherein said first channel includes upper sections which slope toward the center of the channel and intersect with the truncated circularly-shaped section of the channel at distinct transition points along edges positioned toward the upper end of the channel on opposing sides of the channel.
5. The anchoring system of Claim 1, wherein the slot has a thickness, measured in a direction parallel to the common axis, that substantially matches the thickness of the collar portion of the catheter fitting.
6. The anchoring system of Claim 1, wherein lower side edges of the slot lie at an elevated level relative to the center of a midpoint of the slot between the side edges so as to act as a fulcrum when the collar portion of the catheter fitting is rotated within said lateral slot.
7. The anchoring system of Claim 1 additionally comprising a flexible anchor pad having an adhesive bottom surface and a top surface on which said retainer is mounted.
8. The anchoring system of Claim 7 additionally comprising a catheter retention device.
9. The anchoring system of Claim 8, wherein said catheter retention device is an S-clip including a plurality of upright retainers attached to a base having retainer heads distal to said base, said retainers spaced from one another by a distance slightly greater than the diameter of the tubular portion of the catheter, and said retainer heads spaced from one another by a distance slightly less than the diameter of the tubular portion of the catheter.
10. The anchoring system of Claim 1 additionally comprising a tube clip for securing a portion of a fluid supply tube.
11. An anchoring system for securing a medical article to the skin of a patient, said medical article including an elongated tubular body and a radially extending member which projects from the tubular body, said anchoring system comprising:
a retainer including first and second channel portions which extend about an axis, each channel portion generally having a truncated circular cross-sectional shape sized to surround at least a portion of the medical article through an arc of greater than 180° about said axis, and at least one lateral slot which extend generally perpendicular to said longitudinal axis between said first and second channel portions, said slot having a thickness substantially equal to the thickness of the radially extending member of said medical article, said first and second channels having a combined longitudinal length sufficient to prevent lateral movement of the medical article with the radially extending member positioned within said lateral slot; and a flexible anchor pad having an adhesive bottom surface and a top surface on which said retainer is mounted, said retainer being positioned on said top surface in a manner exposing openings to said channel portions.
a retainer including first and second channel portions which extend about an axis, each channel portion generally having a truncated circular cross-sectional shape sized to surround at least a portion of the medical article through an arc of greater than 180° about said axis, and at least one lateral slot which extend generally perpendicular to said longitudinal axis between said first and second channel portions, said slot having a thickness substantially equal to the thickness of the radially extending member of said medical article, said first and second channels having a combined longitudinal length sufficient to prevent lateral movement of the medical article with the radially extending member positioned within said lateral slot; and a flexible anchor pad having an adhesive bottom surface and a top surface on which said retainer is mounted, said retainer being positioned on said top surface in a manner exposing openings to said channel portions.
12. The anchoring system of Claim 11, wherein said lateral slot includes a curvilinear lower surface extending below said first and second channel portions to receive said radially extending member of said medical article.
13. The anchoring system of Claim 12, wherein a side of said lateral slot lies at an elevated level relative to a lowermost point of the slot to act as a fulcrum providing leverage when said radially extending member is rotated within said lateral slot.
14. The anchoring system of Claim 11, wherein said first channel portion is sized to receive a proximal tubular portion of the elongated tubular body of the medical article and the second channel portion is sized to receive a distal tubular portion of the elongated tubular body of the medical article.
15. The anchoring system of Claim 11, wherein said first channel portion is defined by a pair of opposing walls, each wall having a finger platform extending laterally from the wall distal to said channel.
16. The anchoring system of Claim 11, wherein said first channel has a longitudinal length greater than the longitudinal length of said second channel.
17. The anchoring system of Claim 11 additionally comprising a flexible anchor pad having an adhesive bottom surface and a top surface on which said retainer is mounted.
18. A method of removing an adaptor from a retainer of an anchoring system, wherein said retainer has a longitudinal channel for receiving a tubular body of an adaptor, said channel defined by a pair of opposing walls, each wall having a finger platform extending laterally from the wall distal to said channel, and a lateral slot having an arcuate bottom surface extending below said longitudinal channel for receiving a radially extending member of said adaptor with said adaptor positioned within said longitudinal channel of said retain, comprising the steps of:
placing fingertips on said finger platforms and holding said retainer against a patient's body;
gripping said radially extending member of said adaptor with a finger and thumb; and rotating said radially extending member of said adaptor such that a portion of said radially extending member contacts a side of said lateral slot which acts as a fulcrum providing leverage to pull said tubular body of an adaptor out of said longitudinal channel.
placing fingertips on said finger platforms and holding said retainer against a patient's body;
gripping said radially extending member of said adaptor with a finger and thumb; and rotating said radially extending member of said adaptor such that a portion of said radially extending member contacts a side of said lateral slot which acts as a fulcrum providing leverage to pull said tubular body of an adaptor out of said longitudinal channel.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US582695P | 1995-10-24 | 1995-10-24 | |
US60/005,826 | 1995-10-24 | ||
US08/601,527 | 1996-02-14 | ||
US08/601,527 US5810781A (en) | 1995-10-24 | 1996-02-14 | Catheter fitting securement device |
Publications (1)
Publication Number | Publication Date |
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CA2208258A1 true CA2208258A1 (en) | 1997-05-01 |
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ID=26674817
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CA002208258A Abandoned CA2208258A1 (en) | 1995-10-24 | 1996-10-24 | Catheter fitting securement device |
Country Status (5)
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US (1) | US5810781A (en) |
JP (1) | JP3834725B2 (en) |
AU (1) | AU7597096A (en) |
CA (1) | CA2208258A1 (en) |
WO (1) | WO1997015342A1 (en) |
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-
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- 1996-02-14 US US08/601,527 patent/US5810781A/en not_active Expired - Lifetime
- 1996-10-24 CA CA002208258A patent/CA2208258A1/en not_active Abandoned
- 1996-10-24 JP JP51678497A patent/JP3834725B2/en not_active Expired - Lifetime
- 1996-10-24 AU AU75970/96A patent/AU7597096A/en not_active Abandoned
- 1996-10-24 WO PCT/US1996/017067 patent/WO1997015342A1/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
AU7597096A (en) | 1997-05-15 |
JP3834725B2 (en) | 2006-10-18 |
US5810781A (en) | 1998-09-22 |
JPH10512178A (en) | 1998-11-24 |
WO1997015342A1 (en) | 1997-05-01 |
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Legal Events
Date | Code | Title | Description |
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FZDE | Discontinued |