PCT
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`WO 99/20334
`
`(11) International Publication Number:
`
`(51) International Patent Classification 6 :
`A61M 25/02
`
`Al
`
`(43) International Publication Date:
`
`29 April 1999 (29.04.99)
`
`(21) International Application Number: (cid:9)
`
`PCT/US98/21962
`
`(22) International Filing Date: (cid:9)
`
`16 October 1998 (16.10.98)
`
`(30) Priority Data:
`60/062,323
`09/049,825
`
`17 October 1997 (17.10.97) (cid:9)
`27 March 1998 (27.03.98) (cid:9)
`
`US
`US
`
`(71) Applicant: VENETEC INTERNATIONAL, INC. [US/US];
`Suite 260, 27405 Puerta Real, Mission Viejo, CA 92691
`(US).
`
`(72) Inventor: BIERMAN, Steven, F.; 143 Eighth Street, Del Mar,
`CA 92014 (US).
`
`(74) Agent: ALTMAN, Daniel, E.; Knobbe, Martens, Olson and
`Bear, LLP, 16th floor, 620 Newport Center Drive, Newport
`Beach, CA 92660 (US).
`
`(81) Designated States: AL, AM, AT, AU, AZ, BA, BB, BG, BR,
`BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GE,
`GH, GM, HR, HU, ID, IL, IS, JP, KE, KG, KP, KR, KZ,
`LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW,
`MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ,
`TM, TR, TT, UA, UG, UZ, VN, YU, ZW, ARIPO patent
`(GH, GM, KE, LS, MW, SD, SZ, UG, ZW), Eurasian patent
`(AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European patent
`(AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT,
`LU, MC, NL, PT, SE), OAPI patent (BF, BJ, CF, CG, CI,
`CM, GA, GN, GW, ML, MR, NE, SN, TD, TG).
`
`Published
`With international search report.
`Before the expiration of the time limit for amending the
`claims and to be republished in the event of the receipt of
`amendments.
`
`(54) Title: ANCHORING SYSTEM FOR A MEDICAL ARTICLE
`
`(57) Abstract
`
`An anchoring system secures a catheter to the body of a patient and arrests axial movement of the catheter without meaningfully
`impairing fluid flow through the catheter. The anchoring system includes an anchor pad that adheres to the patient's skin and supports a
`retainer. The retainer releasably receives a portion of the catheter and includes one or more retention mechanisms. The retention mechanisms
`inhibit axial movement of the catheter relative to the retainer when the catheter is secured therein. In one mode, the retention mechanism
`is positioned within a channel of the retainer and includes at least first and second members that project from opposite sides of the channel.
`The members are arranged to cooperate with one another when the cover is closed so as to capture a structural portion of the catheter
`between the first and second members without substantially occluding an inner lumen of the catheter.
`
`CORPAK Ex 1011, Page 1
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`
`AL
`AM
`AT
`AU
`AZ
`BA
`BB
`BE
`BF
`BG
`BJ
`BR
`BY
`CA
`CF
`CG
`CH
`CI
`CM
`CN
`CU
`CZ
`DE
`DK
`EE
`
`Albania
`Armenia
`Austria
`Australia
`Azerbaijan
`Bosnia and Herzegovina
`Barbados
`Belgium
`Burkina Faso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`COte d'Ivoire
`Cameroon
`China
`Cuba
`Czech Republic
`Germany
`Denmark
`Estonia
`
`ES
`FI
`FR
`GA
`GB
`GE
`GH
`GN
`GR
`HU
`IE
`IL
`IS
`IT
`JP
`KE
`KG
`KP
`
`KR
`KZ
`LC
`LI
`LK
`LR
`
`Spain
`Finland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungary
`Ireland
`Israel
`Iceland
`Italy
`Japan
`Kenya
`Kyrgyzstan
`Democratic People's
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
`
`LS
`LT
`LU
`LV
`MC
`MD
`MG
`MK
`
`ML
`MN
`MR
`MW
`MX
`NE
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SD
`SE
`SG
`
`Lesotho
`Lithuania
`Luxembourg
`Latvia
`Monaco
`Republic of Moldova
`Madagascar
`The former Yugoslav
`Republic of Macedonia
`Mali
`Mongolia
`Mauritania
`Malawi
`Mexico
`Niger
`Netherlands
`Norway
`New Zealand
`Poland
`Portugal
`Romania
`Russian Federation
`Sudan
`Sweden
`Singapore
`
`SI
`SK
`SN
`SZ
`TD
`TG
`TJ
`TM
`TR
`TT
`UA
`UG
`US
`UZ
`VN
`YU
`ZW
`
`Slovenia
`Slovakia
`Senegal
`Swaziland
`Chad
`Togo
`Tajikistan
`Turkmenistan
`Turkey
`Trinidad and Tobago
`Ukraine
`Uganda
`United States of America
`Uzbekistan
`Viet Nam
`Yugoslavia
`Zimbabwe
`
`CORPAK Ex 1011, Page 2
`
`

`

`WO 99/20334 (cid:9)
`
`PCT/US98/21962
`
`-1-
`
`ANCHORING SYSTEM FOR A MEDICAL ARTICLE
`
`Background of the Invention
`
`Field on the Invention
`
`The present invention relates to an anchoring system for securing a medical article to a patient to inhibit
`
`5 (cid:9)
`
`movement or migration of the medical article relative to the patient.
`
`Description of Related Art
`
`Hospitalized patients often have limited mobility due either to their condition or to doctor's orders. Such
`
`patients must lie in bed and not move about their hospital room, even to urinate. As such, a Foley catheter is often
`
`used with the bed-confined patient to drain urine from the patient's bladder. Use of a Foley catheter thus eliminates
`
`10 (cid:9)
`
`toilet trips as well as reduces bedpan use.
`
`A Foley catheter typically includes two coaxial lumens: a drainage lumen and an inflation lumen. The
`
`inflation lumen communicates with an inflation balloon located at the tip of the catheter (i.e., the catheter proximal
`
`end). The proximal end of the drainage lumen includes one or more influent openings to receive urine from the
`
`bladder. The lumens usually diverge in a Y-type pattern at the distal end of the catheter to form an effluent port
`
`15 (cid:9)
`
`and an inflation port.
`
`In use, a healthcare provider inserts the Foley catheter through the urinary tract of the patient to locate
`
`the tip of the catheter within the patient's bladder. Although the catheter usually includes a siliconized outer coating
`
`as provided by the manufacturer, healthcare providers often apply further lubricant, such as, for example, water-based
`
`jelly. The provider then inflates the balloon by attaching the inflation port to a source of pressurized working fluid
`
`20 (cid:9)
`
`(e.g., saline solution). Once inflated, a valve, which is located at the inflation port, inhibits the flow of fluid from
`
`the inflation lumen and the balloon to keep the balloon inflated. The inflated balloon prevents the catheter from
`
`unintentionally dislodging from the bladder. The healthcare provider then connects the distal end of the drainage
`
`lumen (i.e., its effluent port) to a drainage tube leading to a collection container.
`
`The healthcare provider usually secures the distal end of the Foley catheter to the patient using tape. That
`
`25 (cid:9)
`
`is, the healthcare provider commonly places long pieces of tape across the distal end of the catheter in a crisscross
`
`pattern to secure the catheter distal end to the inner thigh of the patient. This securement inhibits disconnection
`
`between the catheter and the drainage tube, as well as prevents the catheter or drainage tube from snagging on the
`
`bed rail or other object.
`
`Taped connections, however, often collect contaminates and dirt. Normal protocol therefore requires periodic
`
`30 (cid:9)
`
`(e.g., daily) tape changes in order to inhibit bacteria and germ growth at the securement site. Frequent tape changes
`
`though lead to another problem: excoriation of the patient's skin. In addition, valuable time is spent applying and
`
`reapplying the tape to secure the catheter. And healthcare providers often remove their gloves when taping because
`
`most find the taping procedure difficult and cumbersome when wearing gloves. Not only does this further lengthen
`
`the procedure, but it also subjects the healthcare provider to possible infection.
`
`35 (cid:9)
`
`A number of catheter securement devices have been developed to obviate the need for frequent application
`
`of tape. U.S. Patent Nos. 5,304,146 and 5,342,317 disclose several examples of such devices. Although these
`
`CORPAK Ex 1011, Page 3
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`WO 99/20334 (cid:9)
`
`PCT/US98/21962
`
`-2-
`
`devices hold the catheter to the patient, they fail to arrest longitudinal movement of the catheter. These devices
`
`rely upon friction between the catheter and a band wrapped over the catheter to prevent axial movement. Such
`
`contact between the catheter and the securement device, however, often fails to arrest axial movement of the
`
`catheter, especially when used with a lubricated catheter (e.g., a Foley catheter).
`
`5 (cid:9)
`
`Other securement devices have attempted to improve the securement of Foley catheters. One such
`
`securement device is disclosed in U.S. Patent No. 4,397,647. The approach taught by this patent, however, at least
`
`partially occludes the catheter and prevents the free flow of urine through the catheter. Improper drainage of the
`
`bladder consequently may occur, leading to patient discomfort and possible medical complications (e.g., infection).
`
`A need therefore exists for a simply-structured anchoring system that secures a catheter to a patient,
`
`10 (cid:9)
`
`without occluding or otherwise restricting fluid flow through the catheter.
`
`Summary of the Invention
`
`One aspect of the present invention thus involves an anchoring system for securing a medical article to the
`
`body of a patient. The system comprises an anchor pad having an upper surface and a lower surface. The lower
`
`surface has an adhesive layer which adheres to the body of a patient. A retainer is mounted onto the upper surface
`
`15 (cid:9)
`
`of the anchor pad and receives a portion of the medical article. The retainer is formed by a base and a cover. The
`
`base has a first side and a second, opposite side. The base also includes a groove having a curvilinear cross-
`
`sectional shape. The cover is formed in a similar manner as the base. The first side of the cover attaches to the
`
`first side of the base and the second side of the cover is moveable between a closed position, in which the second
`
`side of the cover lies generally above the second side of the base, and an open position, in which the second side
`
`20 (cid:9)
`
`of the cover is spaced apart from the second side of the base so as to expose the groove in the base. When the
`
`cover is closed, the grooves in the base and cover define a channel having a curvilinear cross-sectional shape. The
`
`cross-sectional area of the channel varies over the length of the channel. Also, a latching mechanism, which is
`
`operable between the base and the cover, releasably secures the second side of the cover to the second side of the
`
`base.
`
`25 (cid:9)
`
`Another aspect of the present invention involves an anchoring system including an anchor pad with an upper
`
`surface and a lower surface. At least a portion of the lower surface is formed with an adhesive layer for
`
`attachment to the patient's skin. A retainer is permanently affixed to the upper surface of the anchor pad and
`
`comprises a base and a cover. The base has a first groove to receive at least a portion of an elongated medical
`
`article. The cover is pivotally coupled to the base and moveable between an open position and a closed position.
`
`30 (cid:9)
`
`In the open position, the groove is exposed, and in the closed position, the groove is covered. The cover also
`
`includes a second groove that cooperates with the first groove when the cover is in the closed position to define
`
`a channel. The channel is configured to support the portion of the medical article received by the retainer on at least
`
`diametrically opposed sides thereof along the entire length of the received portion of the medical article. At least
`
`one retention member projects into the channel and is arranged to engage a portion of the medical article to inhibit
`
`35 (cid:9)
`
`longitudinal movement of the medical article through the channel. Interengaging structure also cooperates between
`
`the base and cover to releasably secure the cover to the base.
`
`CORPAK Ex 1011, Page 4
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`WO 99/20334 (cid:9)
`
`PCT/US98/21962
`
`-3-
`
`In accordance with an additional aspect of the present invention, the anchoring system comprises an anchor
`
`pad with upper and lower surfaces. At least a portion of the lower surface is formed by an adhesive layer. A
`
`retainer is affixed to the upper surface of the anchor pad and comprises a base and a cover. The base has a first
`
`groove to receive at least a portion of the elongated medical article. The cover is pivotally coupled to the base and
`
`5 (cid:9)
`
`is moveable between an open position and a closed position. The cover also includes a second groove that
`
`cooperates with the first groove when the cover is in the closed position to define a channel. The channel is
`
`configured to accept a portion of the medical article received by the base. The base and cover include interengaging
`
`structure which releasably secures together the base and the cover in the closed position. At least one retention
`
`mechanism is positioned within the channel and includes at least first and second members that are arranged to
`
`10 (cid:9)
`
`cooperate with one another when the cover is closed to hold a structural portion of the medical article between the
`
`first and second members without substantially occluding the inner lumen of the medical article.
`
`Further aspects, features and advantages of the present invention will become apparent from the detailed
`
`description of the preferred embodiment that follows.
`
`Brief Description of the Drawings
`
`15 (cid:9)
`
`The above mentioned and other features of the invention will now be described with reference to the
`
`drawings of a preferred embodiment of the present anchoring system. The illustrated embodiment of the anchoring
`
`system is intended to illustrate, but not to limit the invention. The drawings contain the following figures:
`
`Figure 1 is a perspective view of an anchoring system in accordance with a preferred embodiment of the
`
`present invention and illustrates the anchoring system from a proximal end;
`
`20 (cid:9)
`
`Figure 2 is a perspective view of the anchoring system of Figure 1 from a distal end;
`
`Figure 3 is a bottom view of the anchoring system of Figure 1;
`
`Figure 4 is an elongated perspective view of a retainer of the anchoring system of Figure 2 with a cover
`
`of the retainer in an open position;
`
`Figure 5a is a perspective view of the retainer illustrated in Figure 2 with the cover in a closed position;
`
`25 (cid:9)
`
`Figure 5b is an elevational view of a distal end of the retainer of Figure 5a;
`
`Figure 6 is a top plan view of the retainer of Figure 4 with the cover in a fully open position;
`
`Figure 7 is a cross-sectional view of the retainer of Figure 5a, taken along the line 7.7;
`
`Figure 8 is a cross-sectional view of a latch receptacle of the retainer illustrated in Figure 6, taken along
`
`the line 8-8;
`
`30 (cid:9)
`
`Figure 9 is a cross-sectional view of the retainer of Figure 5a, taken along the line 9-9;
`
`Figure 10 is a partial side elevational view of the retainer of Figure 6 as viewed in the direction of line 10-
`
`10, and illustrates the cover and an associated latch mechanism of the retainer;
`
`Figure 11 is a perspective view of the anchoring system of Figure 1, and illustrates the cover in an open
`
`position and a catheter aligned above the anchoring system for insertion therein;
`
`35 (cid:9)
`
`Figure 12 is a perspective view of the anchoring system of Figure 1, and illustrates the cover in a partially
`
`closed position with a channel formed by the cover and base of the anchoring system receiving the catheter; and
`
`CORPAK Ex 1011, Page 5
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`WO 99/20334 (cid:9)
`
`PCT/US98/21962
`
`-4-
`
`Figure 13 is a perspective view of the anchoring system of Figure 1, and illustrates the cover in a closed
`
`position with the catheter secured within the channel of the anchoring system.
`
`Detailed Description of a Preferred Embodiment
`
`The present embodiment of the medical article anchoring system is disclosed in the context of an exemplary
`
`5 (cid:9)
`
`Foley type catheter. The principles of the present invention, however, are not limited to Foley catheters. Instead,
`
`it will be understood by one of skill in this art, in light of the present disclosure, that the anchoring system and
`
`retainer disclosed herein also can be successfully utilized in connection with other types of medical articles, including
`
`other types of catheters, fluid drainage and delivery tubes and electrical wires. For example, but without limitation,
`
`the retainer disclosed herein can also be configured to receive and secure central venous catheters, peripherally
`
`10 (cid:9)
`
`inserted central catheters, hemodialysis catheters, surgical drainage tubes, feeding tubes, chest tubes, nasogastric
`
`tubes, scopes, as well as electrical wires or cables connected to external or implanted electronic devices or sensors.
`
`One skilled in the art may also find additional applications for the devices and systems disclosed herein. Thus, the
`
`illustration and description of the anchoring system in connection with a Foley catheter is merely exemplary of one
`
`possible application of the anchoring system.
`
`15 (cid:9)
`
`The anchoring system described herein is especially adapted to arrest axial movement of the catheter with
`
`a slippery coating, as well as hold the catheter against the patient. For this purpose, the anchoring system 10
`
`utilizes one or more retention mechanisms. The anchoring system accomplishes this though without meaningfully
`
`impairing (i.e., substantially occluding) the fluid flow through the catheter to a degree that would create
`
`complications. As described below, such retention mechanisms involve, among others, the shape of the channel that
`
`20 (cid:9)
`
`retains a section of the catheter, retaining structure either aligned with or positioned within the channel, a
`
`securement barb(s) or friction ridge(s) that bites into the catheter body without substantially occluding the catheter
`
`drainage lumen, andlor cooperating members that come together to clamp onto or pin a portion of the catheter (e.g.,
`
`a webbing formed between the branches at the Foley catheter `kite).
`
`The anchoring system also desirably releasably engages the catheter. This allows the catheter to be
`
`25 (cid:9)
`
`disconnected from the anchoring system, and from the patient, for any of a variety of known purposes. For
`
`instance, the healthcare provider may want to remove the catheter from the anchoring system to ease disconnection
`
`of the catheter from the drainage tube or to clean the patient. The disengagement of the catheter from the
`
`anchoring system, however, can be accomplished without removing the anchoring system from the patient.
`
`Before describing the present anchoring system in detail, a brief description of a Foley catheter is provided
`
`30 (cid:9)
`
`to assist the reader's understanding of the exemplary embodiment that follows. As best understood from Figure 6,
`
`the catheter 8 includes a proximal tip with an inflatable balloon (not shown) and a distal end 110. The distal end
`
`110 includes a Y-site 112 formed by an inflation branch 114 and a drainage branch 116. The drainage branch 116
`
`and the inflation branch 114 merge together at the Y-site 112. The lumens of these branches assume either a
`
`coaxial or side-by-side arrangement on the proximal side of the Y-site 112 to form a main catheter body 118. On
`
`35 (cid:9)
`
`the distal side of the Y-site 112, a webbing 120 extends between the two branches 114, 116 at a point next to
`
`the Y-site 112.
`
`CORPAK Ex 1011, Page 6
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`WO 99/20334 (cid:9)
`
`PCT/US98/21962
`
`-5-
`
`With reference now to Figures 1 to 3, the anchoring system 10 includes an anchor pad 12 and a retainer
`
`20. The anchor pad 12 secures the retainer 20 to a patient's skin. The anchor pad 12 has a lower adhesive
`
`surface 16 which adheres to the skin of a patient and a roughened upper surface 14 which supports a retainer 20.
`
`The retainer 20 is configured to accept and retain a section of a Foley catheter 8 within the anchoring system 10.
`
`5 (cid:9)
`
`In the illustrated embodiment, the retainer comprises a base 22 and a cover 24. The cover 24 is detachably secured
`
`to the base 22 and moveable between open and closed positions.
`
`To assist in the description of these components of the anchoring system 10, the following coordinate terms
`
`are used. A "longitudinal axis" is generally parallel to the section of the catheter 8 retained by the anchoring system
`
`10. A "lateral axis" is normal to the longitudinal axis and is generally parallel to the plane of the anchor pad 12.
`
`10 (cid:9)
`
`A "transverse axis" extends normal to both the longitudinal and lateral axes. In addition, as used herein, "the
`
`longitudinal direction" refers to a direction substantially parallel to the longitudinal axis; "the lateral direction" refers
`
`to a direction substantially parallel to the lateral axis; and "the transverse direction" refers to a direction substantially
`
`parallel to the transverse axis. Also, the terms "proximal" and "distal", which are used to describe the present
`
`anchoring system 10, are used consistently with the description of the exemplary application. Thus, proximal and
`
`15 (cid:9)
`
`distal are used in reference to the center of the patient's body. A detailed description of the anchoring system 10,
`
`and its associated method of use, now follows.
`
`Figures 1 to 3 illustrate an anchor pad 12 which desirably comprises a laminate structure with an upper
`
`foam layer (e.g., closed-cell polyethylene foam), and a lower adhesive layer. The lower adhesive layer constitutes
`
`the lower surface 16 of the anchor pad 12. The lower surface 16 desirably is a medical-grade adhesive and can
`
`20 (cid:9)
`
`be either diaphoretic or nondiaphoretic, depending upon the particular application. Such foam with an adhesive layer
`
`is available commercially from New Dimensions in Medicine of Columbus, Ohio. Although not illustrated, it will be
`
`understood that the anchor pad 12 can include suture holes in addition to the adhesive layer to further secure the
`
`anchor pad 12 to the patient's skin.
`
`A surface of the upper foam layer constitutes an upper surface 14 of the anchor pad 12. The upper
`
`25 (cid:9)
`
`surface 14 desirably is roughened by corona-treating the foam with a low electric charge. The roughened or porous
`
`upper surface 14 improves the quality of the adhesive joint (which is described below) between the base 22 and the
`
`anchor pad 12. In the alternative, the flexible anchor pad 12 can comprise a medical-grade adhesive lower layer,
`
`an inner foam layer and an upper paper or other woven or nonwoven cloth layer.
`
`A removable paper or plastic release liner 18 desirably covers the adhesive lower surface 16 before use.
`
`30 (cid:9)
`
`The liner 18 preferably resists tearing and desirably is divided into a plurality of pieces to ease attachment of the
`
`pad to a patient's skin. In the illustrated embodiment, the liner 18 is split along a center line 19 of the flexible
`
`anchor pad 12 in order to expose only half of the adhesive lower surface 16 at one time.
`
`The liner 18 length, as measured in the lateral direction, extends beyond the center line 19 of the anchor
`
`pad 12 and is folded over, or back onto the liner 18. This folded over portion defines a pull tab 17 to facilitate
`
`35 (cid:9)
`
`removal of the liner 18 from the adhesive lower surface 16. A medical attendant uses the pull tab 17 by grasping
`
`and pulling on it so that the liner 18 is separated from the lower surface 16. The pull tab 17 overcomes any
`
`CORPAK Ex 1011, Page 7
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`WO 99/20334 (cid:9)
`
`PCT/US98/21962
`
`-6-
`
`requirement that the medical attendant pick at a corner edge or other segment of the liner 18 in order to separate
`
`the liner 18 from the adhesive layer. The pull tab 17 of course can be designed in a variety of configurations. For
`
`example, the pull tab 17 can need not be located along a center line 19 of the anchor pad 12; rather, the pull tab
`
`17 may be located along any line of the anchor pad 12 in order to ease the application of the anchor pad 12 onto
`
`5 (cid:9)
`
`the patient's skin at a specific site. For example, an area of a patient's skin with an abrupt bend, such as at a
`
`joint, may require that the pull tab 17 be aligned toward one of the lateral ends of the anchor pad 12 rather than
`
`along the center line 19.
`
`In the illustrated embodiment, the anchor pad 12 also desirably includes a pair of opposing concave sections
`
`13, 15 that narrows the center of the anchor pad 12 proximate to the base 22. As a result, the lateral sides of
`
`10 (cid:9)
`
`the anchor pad 12 have more contact area which provides greater stability and adhesion to a patient's skin.
`
`With reference now to Figures 4.10, the retainer 20 includes a rigid structure principally formed by the base
`
`22 and the cover 24. In the illustrated embodiment, the base 22 and cover 24 are integrally formed to comprise
`
`a unitary retainer 20. This can be accomplished in any of a variety of ways well known to those skilled in the art.
`
`For instance, the entire retainer 20 can be injection molded in order to reduce fabrication costs.
`
`15 (cid:9)
`
`Additionally, as will be apparent from the below description, several features of the retainer (e.g., a latch
`
`keeper and a hinge) desirably are flexible. Suitable ridged but flexible materials include, for example, but without
`
`limitation, plastics, polymers or composites such as polypropylene, polyethylene, polycarbonate, polyvinylchloride,
`
`acrylonitrile butadiene styrene, nylon, olefin, acrylic, polyester, as well as moldable silicon, thermoplastic urethane,
`
`thermoplastic elastomers, thermoset plastics and the like. The illustrated retainer 20 preferably is formed by injection
`
`20 (cid:9)
`
`molded using polyethylene or polypropylene material. However, other materials can be utilized, and the retainer 20
`
`can comprise a non-unitary base 22 and cover 24.
`
`With reference to Figure 4, a base 22 in the illustrated embodiment comprises an elongated body of a
`
`generally parallelepiped shape. The base 22, however, can be configured in a wide variety of shapes as well, such
`
`as circular, square, triangular or the like in order to suit a particular application. The longitudinal dimension of the
`
`25 (cid:9)
`
`base 22 though desirably is sufficiently long to provide stability to the catheter 8 along its length. That is, the
`
`longitudinal length of the retained catheter portion is sufficient to inhibit rocking of the catheter 8 relative to the
`
`retainer 20 (i.e., to prevent the retainer 20 from acting as a fulcrum for the catheter). Also, the lateral dimension
`
`of the base 22 desirably allows the healthcare provider to easily and naturally grip the base 22, as well as provides
`
`space on which to locate a hinge 40 and a portion of the latch mechanism 80.
`
`30 (cid:9)
`
`The base 22 includes first and second sides 26, 28. The first side 26 lies generally at one lateral end of
`
`the base 22, and the second side 28 lies at an opposite lateral end of the base 22.
`
`A groove 30 is formed on the base 22 between the first side 26 and the second side 28. In the illustrated
`
`embodiment, the groove 30 has generally a curvilinear cross-sectional shape. As best seen in Figure 6, the lower
`
`groove 30 is also varied in width (i.e., in the lateral direction) along its longitudinal length. That is, the side walls
`
`35 (cid:9)
`
`of the lower groove 30 diverge from each other in a generally linear manner from one longitudinal side of the retainer
`
`20 to the other longitudinal side of the retainer.
`
`CORPAK Ex 1011, Page 8
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`WO 99/20334 (cid:9)
`
`PCT/US98/21962
`
`-7-
`
`The base 22 of the retainer 20 is attached to the upper surface 14 of the anchor pad 12. The base 22
`
`desirably is secured to the upper surface 14 by a solvent bond adhesive, such as cyanoacrylate or other bonding
`
`material. (cid:9) One such adhesive is available commercially as Part No. 4693 from the Minnesota Mining and
`
`Manufacturing Company (3M).
`
`5 (cid:9)
`
`As also seen in Figure 4, the cover 24 has an elongate shape which desirably is coextensive with the planar
`
`size and shape of the base 22 (i.e., desirably has the same geometric shape and size as the base 22); however, the
`
`cover 24 need not be the same size or shape as the base 22. For instance, the cover 24 can be sized to extend
`
`beyond any of the lateral, traverse, or longitudinal edge of the base 22 or, alternatively, can be sized so as to not
`
`extend to the lateral, traverse, or longitudinal edge of the base 22. The cover can also include a skirt or flange that
`
`10 (cid:9)
`
`extends over andlor about the base 22 or any portion thereof.
`
`The cover 24 though desirably has a sufficient size to cover the lower groove 30 in the base and to
`
`accommodate a portion of the latch mechanism 80 and the hinge 40 which operate between the base 22 and the
`
`cover 24, as described below. The cover 24 also desirably is of a dimension which provides for easy manipulation.
`
`For example, the cover's size easily accommodates the grasp of a medical attendant.
`
`15 (cid:9)
`
`The cover 24 includes a first side 32 which lies generally at one lateral end of the cover 24. The first
`
`side 32 of the cover therefore generally corresponds to the first side 26 of the base 22. The cover 24 also has
`
`a second side 34. The second side 34 lies generally toward a lateral end of the cover 24, opposite of the first end,
`
`and corresponds generally to the second side 28 of the base 22.
`
`An upper groove 36 is formed on an inner catheter of the cover 24 between the first and second sides 32,
`
`20 (cid:9)
`
`34 of the cover 24 and corresponds generally to the lower groove 30 formed in the base 22. The width of the
`
`upper groove 36 is also varied in the lateral direction along its longitudinal length. That is, the side walls of the
`
`upper groove 36 diverge from each other in a generally linear manner from one longitudinal end of the cover 24 to
`
`the other longitudinal end.
`
`The cover 24 is flexibly coupled to the base 22 by way of a flexible coupling or hinge 40. The coupling
`
`25 (cid:9)
`
`40 desirably comprises a flexible band 42 that can take any number of forms to mechanically connect the cover 24
`
`to the base 22 while permitting pivotal movement of the cover 24 relative to the base 22 so as to enable
`
`engagement or disengagement of these parts, as described below. In the illustrated embodiment, the band 42 is
`
`formed of flexible material, desirably of the same material from which the base 22 and cover 24 are comprised.
`
`Advantageously, the hinge 40 is integrally molded with the base 22 and the cover 24 to form a unitary member,
`
`30 (cid:9)
`
`as noted above. The hinge 40 is located at an outer edge of the base 22 and the cover 24; however, the hinge
`
`40 need not be laterally located at an extreme end of the base 22 or cover 24.
`
`As best understood from Figure 6, the width of the hinge 40, as measured in the longitudinal direction, is
`
`desirably less than that of either the base 22 or the cover 24 to allow some leeway or play when engaging or
`
`disengaging the cover 24 to the base 22. That is, this shape allows the hinge 40 to twist to some degree to
`
`35 (cid:9)
`
`compensate for some manufacturing tolerances; however, the hinge 40 can have at least as large of a longitudinal
`
`dimension as the base 22 and the cover 24.
`
`CORPAK Ex 1011, Page 9
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`WO 99/20334 (cid:9)
`
`PCTMS98/21962
`
`-8-
`
`The hinge 40 is desirably integrally formed along a common corresponding exterior surface of the cover 24
`
`and base 22. In the illustrated embodiment, as best understood from Figure 5b, the hinge 40 has generally a U-
`
`shape when the cover 24 is closed, and extends from both the base 22 and the cover 24 in the lateral direction to
`
`the side of the retainer 20. A gap 44, corresponding to a transverse height of the hinge 40, exists between the
`
`5 (cid:9)
`
`base 22 and cover 24. This gap 44, however, can be reduced or eliminated from the retainer for some applications
`
`by using a different hinge design.
`
`The hinge 40 enables the cover 24 to move between the open position and the closed positions. The open
`
`position, as illustrated in Figure 4, is characterized by exposing the grooves 30, 36 in the base 22 and the cover
`
`24 in the transverse direction and thereby spacing apart the base 22 and the cover 24.