(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2007/0135774 A1
`Turner et al.
`(43) Pub. Date:
`Jun. 14, 2007
`
`US 20070135774A1
`
`(54) FLUID DELIVERY DEVICES, SYSTEMS AND
`METHODS
`
`(22) Filed:
`
`Nov. 3, 2006
`Related U.S. Application Data
`
`(75) Inventors: Brandon Turner, Austin, TX (US);
`John Burns, Austin, TX (US); Dan
`Benzon, Austin, TX (US); Adam
`Burnight, Austin, TX (US); Brian
`Highley, Keller, TX (US); Jason
`Adams, Frisco, TX (US); Kraig
`Kooiman, Flower Mound, TX (US);
`Clint Taylor, Addison, TX (US)
`
`Correspondence Address:
`FULBRIGHT & UAWORSK LLP.
`6OO CONGRESS AVE.
`SUTE 24 OO
`AUSTIN, TX 78701 (US)
`(73) Assignee: Patton Medical Devices, LP
`(21) Appl. No.:
`11/592,719
`
`(60) Provisional application No. 60/733,311, filed on Nov.
`3, 2005.
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6IR 9/02
`(52) U.S. Cl. .............................................................. 604/288
`
`(57)
`
`ABSTRACT
`
`Fluid delivery devices, systems and methods. The fluid
`delivery devices may be used to delivery fluid (e.g., insulin)
`to a user. The devices may have one or more inlets, and may
`be configured for use with an injection device, such as a
`Syringe, and/or with a pump.
`
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`US 2007/0135774 A1
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`Jun. 14, 2007
`
`FLUID DELIVERY DEVICES, SYSTEMS AND
`METHODS
`
`CROSS-REFERENCE(S) TO RELATED
`APPLICATION(S)
`0001. This application claims priority to U.S. Provisional
`Patent Application Ser. No. 60/733,311 filed Nov. 3, 2005.
`This provisional application is expressly incorporated by
`reference.
`
`BACKGROUND OF THE INVENTION
`0002) 1. Field of the Invention
`0003. The invention relates generally to devices that can
`be inserted in and attached to a living being for the purpose
`of facilitating the introduction of a fluid. Such as medicine,
`into the living being. The invention also relates to systems
`that include one or more Such devices, and to methods of
`delivering fluid into a living being.
`0004 2. Description of Related Art
`0005 Examples of devices that can be used to deliver
`fluids to a living being include: U.S. Pat. Nos. 4.755,173;
`4,966,588; 5,968,011; 6,017,328; 6,056,718; 6,074,371;
`6,685,674; 6,736,797; U.S. Patent Application Pub. Nos.
`2002/0072720, 2004/0006316; 2005/0101910; 2005/
`01.07743; and abandoned Ser. No. 09/110,360 (incorporated
`by reference in U.S. Pat. No. 6,074,371).
`
`SUMMARY OF THE INVENTION
`0006. Some embodiments of the present fluid delivery
`devices, systems and methods may be used to deliver fluid
`Such as insulin to users such as people with diabetes. Some
`embodiments of the present fluid delivery devices may be
`configured to be worn for an extended period of time (e.g.,
`multiple days) and allow a user to inject a fluid (Such as a
`physician-prescribed drug) into the user's body without the
`need to repeatedly puncture the user's skin with a needle.
`The present fluid delivery devices, systems and methods
`include many different features that distinguish them from
`prior devices, and certain of those features are different in
`many ways from the features of prior devices. Different
`embodiments of the present fluid delivery devices, systems
`and methods include one or more of these features, which
`are interchangeable between embodiments to the extent that
`they are not inconsistent with the other features of a given
`embodiment.
`0007 Some embodiments of the present fluid delivery
`devices include, broadly, a body, a cannula, a needle guide,
`and a septum. The body may be made from one or more
`pieces, such as two pieces. The body may include one or
`more fluid delivery passageways. One or more of the fluid
`delivery passageways may be oriented at a non-parallel
`angle to the normal direction of installation of the device. In
`some embodiments that include two or more fluid delivery
`passageways, one the of the passageways may extend into
`and be angled with respect to another. In some multi-fluid
`delivery passageway embodiments, the devices also may
`include a passageway closing structure that at least partially
`blocks one of the passageways in a first position and another
`of the passageways in a second position. The passageway or
`passageways that are not blocked in a given position may
`remain at least partially unobstructed and, more preferably,
`
`Substantially unobstructed. In some embodiments, the pas
`sageway closing structure may be actuated or shifted
`between positions by an injection device, such as an injec
`tion needle. In some multi-fluid delivery passageway
`embodiments, some or all of the fluid delivery passageways
`may be defined in part by a fitting adapted to be releasably
`coupled to an infusion pump connector fitting. Thus, in Such
`embodiments, the device may allow for fluid delivery from
`a pump and fluid delivery from another structure. Such as a
`Syringe.
`0008. The cannula and the body of the devices may be
`integrally formed, such that the cannula comprises a tube
`like structure that extends outwardly from the body (e.g.,
`from the bottom surface of the body). The devices also may
`include an insertion device that is coupled to the body and
`that may be used to aid in insertion of the device, and a
`needle guard that is coupled to the body and that may be
`used to protect users from inadvertent needle Sticks. In some
`embodiments of the present fluid delivery devices, a rigid
`cannula may be used instead of a needle guide and a soft
`cannula.
`0009. Some embodiments of the present systems (which
`may be characterized as fluid delivery systems) include one
`or more of the present fluid delivery devices that have been
`sterilized and enclosed in a package, with or without instruc
`tions for use contained within the package.
`0010 Some embodiments of the present methods (which
`may be characterized as fluid delivery methods) include
`installing one of the present fluid delivery devices to a user,
`and delivering fluid through the device and into the user.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0011. The following drawings illustrate by way of
`example and not limitation. Identical reference numbers do
`not necessarily indicate an identical structure. Rather, the
`same reference number may be used to indicate a similar
`feature or a feature with similar functionality, as may
`non-identical reference numbers. Every feature of each
`embodiment is not always labeled in every figure in which
`that embodiment appears, in order to keep the figures clear.
`The figures are drawn to scale, meaning the sizes of the
`depicted elements are accurate relative to each other for at
`least one set of embodiments of the present fluid delivery
`devices.
`0012 FIG. 1 is a perspective view of one embodiment of
`the present fluid delivery devices.
`0013 FIGS. 2A and 2B are exploded views of the fluid
`delivery device show in FIG. 1. The views are taken from
`different perspectives.
`0014 FIG. 3 is a cross-sectional view of the fluid delivery
`device shown in FIG. 1, taken along a plane that intersects
`the middle of both rotation-restricting recesses of the base
`element of the body.
`0015 FIG. 4 is a cross-sectional view of the fluid delivery
`device shown in FIG. 1, taken along a plane that intersects
`the middle of both rotation-restricting recesses of the base
`element of the body, showing the device installed to a user.
`Most of the background lines shown in FIG. 3 have been
`eliminated from this figure (and from the remaining figures)
`in an effort to make the figure easier to review.
`
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`0016 FIG. 5A is a cross-sectional view of the fluid
`delivery device shown in FIG. 1, taken along a plane that is
`perpendicular to the plane along which the FIG. 3 and FIG.
`4 cross sections were taken, showing the device installed to
`a user and the insertion device removed.
`0017 FIG. 5B is an enlarged detail view of a portion of
`the FIG. 5A view, showing aspects of one of the present
`Septa.
`0018 FIG. 5C is a cross-sectional view of an embodi
`ment of the FIG. 1 fluid delivery device that includes a
`septum having a retention flange.
`0019 FIG. 5D is a cross-sectional view of another
`embodiment of the FIG. 1 fluid delivery device that includes
`a septum having a retention flange and a retention collar
`extending perpendicularly from the retention flange.
`0020 FIG. 5E is an enlarged detail view of a portion of
`the FIG. 5A view, showing aspects of one of the present fluid
`delivery devices.
`0021 FIG.5F is an enlarged detail view showing aspects
`of another embodiment of the present fluid delivery devices,
`and more specifically another of the present septa.
`0022 FIG.5G shows the boundary illustrated in FIG. 5E
`in perspective.
`0023 FIGS. 5H-5J show enlarged detail views of cross
`sections of a portion of different embodiments of the present
`fluid delivery devices.
`0024 FIG. 6 is a cross-sectional view of the fluid delivery
`device shown in FIG. 1, taken along the same plane as FIG.
`5A, showing an injection needle inserted into the device.
`0025 FIGS. 7A and 7B are perspective views of the FIG.
`1 fluid delivery device, showing the result of trying to
`decouple the insertion device and needle guard from the
`body using equal and opposite forces: the needle guard
`uncouples first.
`0026 FIG. 8 is a cross-sectional view of an embodiment
`of the present fluid delivery devices that includes a body
`cavity that is in fluid communication with the exterior of the
`device through at least one opening in a sidewall of the
`device.
`0027 FIG. 9 is a perspective exploded view of another
`embodiment of the present fluid delivery devices.
`0028 FIG. 10 is a cross-sectional view of the fluid
`delivery device shown in FIG. 9, taken along a plane that
`does not intersect either rotation-restricting recess of the
`base element of the body, showing the device installed to a
`user and the insertion device removed.
`0029 FIG. 11 is a perspective view showing the position
`of different perimeters of one of the present fluid delivery
`devices, the different perimeters being positioned in differ
`ent planes that intersect the device.
`0030 FIG. 12 is a cross-sectional view of a fluid delivery
`device having a cannula integral with the body.
`0031 FIGS. 13A and 13B are exploded views of an
`embodiment of a fluid delivery device that is assembled
`from at least two body pieces, or elements, of Substantially
`equal height. The views are taken from different perspec
`tives.
`
`0032 FIG. 14 is a perspective view of the assembled
`version of the fluid delivery device shown in FIGS. 13A and
`13B.
`0033 FIG. 15 is a cross-sectional view of the FIGS. 13A
`and 13B embodiment, taken along line 15-15 shown in FIG.
`16.
`0034 FIGS. 16 and 17 are cross-sectional views, respec
`tively, of the two different elements that comprise the body
`of the FIGS. 13A and 13B fluid delivery device, taken along
`the plane at which the front surfaces of each element meet.
`0035 FIG. 18 shows an embodiment of a fluid delivery
`device similar to the one depicted in FIGS. 13A and 13B, but
`having a rigid cannula with a sharp end.
`0.036
`FIG. 19 is an exploded perspective view of an
`embodiment of the present fluid delivery devices that
`includes a body made from a majority (Volumetrically) of
`septum material.
`0037 FIG. 20 is an exploded view of the FIG. 19 fluid
`delivery device, shown from the bottom perspective looking
`toward the top.
`0038 FIG. 21 is a perspective view of the assembled
`version of the fluid delivery device shown in FIG. 19.
`0.039
`FIG. 22 is a cross-sectional view of the FIG. 19
`fluid delivery device, taken along a plane that intersects two
`of the four cap element attachment protrusions of the base
`element of the depicted embodiment.
`0040 FIG. 23 is a cross-sectional view of a version of the
`FIG. 19 fluid delivery device that includes a septum exten
`sion that is positioned within the needle guide and cannula
`passagewayS.
`0041
`FIG. 24 is a cross-sectional view of a version of the
`FIG. 19 fluid delivery device that includes a rigid cannula
`having a sharp end.
`0042 FIG. 25 is a perspective view of an embodiment of
`the present fluid delivery devices that includes a fluid
`delivery passageway having at least a portion that is oriented
`at an angle that is not parallel with the normal direction of
`insertion of the device.
`0.043
`FIG. 26 is a perspective view from the bottom of
`the FIG. 25 fluid delivery device.
`0044 FIG. 27 is a cross-sectional view of the FIG. 25
`fluid delivery device, taken along a plane that intersects the
`non-recessed portion of the bottom surface of the body.
`004.5
`FIG. 28 is an enlarged detail of the FIG. 27 view.
`0046 FIGS. 29 and 30 show different perspective views
`of a multi-inlet embodiment of one of the present fluid
`delivery devices that includes a passageway closing struc
`ture.
`0047 FIG. 31 is a cross-sectional view of the FIGS. 29
`and 30 fluid delivery device, taken in a plane that intersects
`the middles of both inlets, and shows the passageway
`closing structure in its biased position.
`0048 FIG. 32 is another cross-sectional view of the
`FIGS. 29 and 30 fluid delivery device, showing the passage
`way closing structure in another position.
`
`Page 53 of 67
`
`

`

`US 2007/0135774 A1
`
`Jun. 14, 2007
`
`0049 FIG.33 is an enlarged view of a detail from FIG.
`32.
`0050 FIG. 34 is an enlarged view of a detail from FIG.
`31, in which the passageway closing structure has returned
`to its normally-biased position after an injection needle has
`been removed.
`0051 FIGS. 35 and 36 are enlarged detail views similar
`to FIGS. 33 and 34, and depict another embodiment of the
`present passageway closing structures.
`0.052 FIG.37 is a perspective view of another multi-inlet
`embodiment of one of the present fluid devices that includes
`a passageway closing structure, showing the passageway
`closing structure in one position.
`0053 FIG. 38 is a perspective view of the FIG. 37 fluid
`delivery device, showing the passageway closing structure
`in another position.
`0054 FIG. 39 is a perspective view of the passageway
`closing structure of the FIG. 37 fluid delivery device.
`0055 FIG. 40 is another perspective view of the FIG. 37
`fluid delivery device, showing the passageway closing struc
`ture blocking flow into and through the centrally-oriented
`fluid delivery passageway.
`0056 FIG. 41 is a perspective cross-sectional view
`(minus the cross-hatching), taken along line 41-41 in FIG.
`40, showing how the opening in the passageway closing
`structure of the FIG. 37 fluid delivery device aligns with the
`laterally-oriented fluid delivery passageway.
`0057 FIG. 42 is another perspective view of the FIG. 37
`fluid delivery device, showing the passageway closing struc
`ture allowing flow into and through the centrally-oriented
`fluid delivery passageway.
`0.058
`FIG. 43 is a perspective cross-sectional view
`(minus the cross-hatching), taken along line 43-43 in FIG.
`42, showing how a portion of the passageway closing
`structure of the FIG. 37 fluid delivery device blocks flow
`through the laterally-oriented fluid delivery passageway and
`out of the body of the device.
`
`DESCRIPTION OF ILLUSTRATIVE
`EMBODIMENTS
`0059. The terms “comprise' (and any form of comprise,
`Such as "comprises' and "comprising”), “have (and any
`form of have, such as “has and “having”), “contain' (and
`any form of contain, Such as “contains' and “containing”),
`and “include” (and any form of include, such as “includes’
`and “including') are open-ended linking verbs. As a result,
`a device, a system or a method that “comprises.”has,
`'contains,” or “includes one or more recited elements or
`steps possesses those recited elements or steps, but is not
`limited to possessing only those elements or steps; it may
`possess elements or steps that are not recited. Likewise, an
`element of a device, System or method that “comprises,
`'has,'contains,” or “includes one or more recited fea
`tures possesses those features, but is not limited to possess
`ing only those features; it may possess features that are not
`recited. Furthermore, a structure that is configured in a
`certain way must be configured in at least that way, but also
`may be configured in a way or ways that are not specified.
`
`0060 Thus, and by way of example, a fluid delivery
`device comprising a body having a first inlet, a first fluid
`delivery passageway extending from the first inlet, and a
`second fluid delivery passageway; a cannula having a por
`tion that is coaxial with a portion of one of the first and
`second fluid delivery passageways; and a passageway clos
`ing structure oriented in a first position that Substantially
`prevents fluid from flowing from the first inlet through the
`first fluid delivery passageway and out of the body, while
`allowing fluid to flow through the second fluid delivery
`passageway; the passageway closing structure being mov
`able to a second position that substantially prevents fluid
`from flowing through the second fluid delivery passageway
`while allowing fluid to flow through the first fluid delivery
`passageway, is a fluid delivery device that possesses the
`recited body, cannula, and passageway closing structure, but
`is not limited to possessing only the recited elements (thus,
`other non-recited elements are not excluded). For example,
`the fluid delivery device also may include one or more septa.
`0061
`Furthermore, the elements recited are not limited to
`possessing only the recited features. For example, the pas
`sageway closing structure may pivot about an axis that is
`centered within a portion of one of the fluid delivery
`passageways. As another example, an axis that is centered
`within or parallel to a portion of a passageway is one that is
`centered within or parallel to at least the portion, and may be
`centered within or parallel to the entire passageway. Simi
`larly, a structure (e.g., a needle guide) "having a portion
`positioned within a fluid delivery passageway has at least the
`portion positioned in the passageway, and may be positioned
`entirely within the passageway.
`0062. In any of the claims, the term “consisting of or
`“consisting essentially of may be substituted for any of the
`open-ended linking verbs recited above, in order to change
`the scope of a given claim from what it would otherwise be
`using the open-ended linking verb.
`0063. The terms “a” and “an are defined as one or more
`than one unless this disclosure explicitly requires otherwise.
`The terms “substantially' is defined as at least close to (and
`includes) a given value or state (preferably within 10% of
`more preferably within 1% of, and most preferably within
`0.1% of).
`0064. The present fluid delivery devices may be used to
`deliver fluid to a living being for any of a variety of reasons.
`For example, some embodiments of the present fluid deliv
`ery devices may be used to deliver insulin to the subcuta
`neous tissue of a person with diabetes. However, embodi
`ments of the present fluid delivery devices also may be used
`to deliver other fluids, such as saline, medication other than
`insulin, chemicals, enzymes, antigens, hormones, vitamins
`or the like, into Subcutaneous tissue or other types of tissue,
`Such as the epidermis, dermis, and different types of Sub
`dermal tissue such as muscle. The embodiments of the
`present fluid delivery devices shown in the figures are
`adapted for use with humans; however, those of ordinary
`skill in the art will, in light of this disclosure, understand that
`other embodiments may be adapted for use with animals.
`0065. The present fluid delivery devices may be charac
`terized as ports, fluid delivery ports, injection ports, injec
`tion aides, infusion ports or infusion devices. The present
`fluid delivery systems may be characterized as injection
`systems or infusion systems.
`
`Page 54 of 67
`
`

`

`US 2007/0135774 A1
`
`Jun. 14, 2007
`
`FIG. 1 is a perspective view of one embodiment of
`0.066
`the present fluid delivery devices. Fluid delivery device 100
`includes a multi-piece body 20, an insertion device 70 that
`is coupled to body 20 at a first location, and a needle guard
`80 that is coupled to body 20 at a second location. Device
`100 also includes a generically-depicted adhesive layer 30
`(which may include a protective backing sheet). Adhesive
`layer 30 may include a pad having two opposing, adhesive
`coated sides, one of which is attached to the relevant portion
`of the bottom surface of body 20 and the other of which will
`be attached to a user's body (e.g., once a backing sheet has
`been removed). Alternatively, one of the two opposing sides
`may be welded (e.g., ultrasonically welded) to the bottom
`surface of body 20 instead of being attached via an adhesive.
`As opposed to using an adhesive layer, a portion (e.g., all)
`of the bottom surface of body 20 may be configured to
`adhere directly to a living being's skin, Such as by making
`the bottom surface material from a material that chemically
`reacts with and adheres to skin. Adhesive layer 30 is one
`example of an adhesive portion (of a fluid delivery device)
`that is configured to adhere directly to a living being's skin.
`The cannula of device 100 (see cannula 60 in FIG. 3) is
`example of a cannula having a portion extending from the
`adhesive portion.
`0067 FIGS. 2A and 2B are exploded perspective views
`of the components of one embodiment of fluid delivery
`device 100. As these figure show, body 20 may include a first
`element 22 (which may be characterized as a base element)
`and a second element 24 (which may be characterized as a
`top element or a cap element). Device 100 also may include
`a septum 40, a needle guide 50, and a cannula 60. Septum
`40 is one type of sealing mechanism.
`0068. Insertion device 70 comprising an insertion needle
`72 connected to an insertion device hub 74. As shown in
`FIG. 3, a portion 73 of insertion needle 72 is located above
`the bottom surface of body 20 and is exposed when insertion
`device 70 is fully inserted in body 20. One manner in which
`this exposure is accomplished is by providing insertion
`device hub 74 with an insertion needle access region 76 that
`allows access to portion 73 when insertion device 70 is fully
`inserted in body 20. In other embodiments, insertion needle
`72 could be configured such that portion 73 extends out
`wardly to a side of hub 74. Such that no access region is
`needed. Still other embodiments that allow access to a
`portion of insertion needle 73 are possible. In the embodi
`ment shown in the figures, the insertion needle access region
`comprises an opening that extends from one side of the hub
`to the other. In other embodiments involving an access
`region, the access region comprises a recess that extends
`from one side of the hub to (but not beyond) a portion of the
`insertion needle. The access region may be located any
`where along the hub, and need not be closer to the top of hub
`74 than the bottom of hub 74 (as is the depicted access
`region).
`0069 Body 20 and insertion device 70 may be configured
`such that insertion device 70 cannot rotate with respect to
`body 20 when fully inserted in body 20. One manner of
`achieving this configuration comprises providing hub 74
`with rotation-restricting protrusions 71, which extend in a
`downstream or downward direction from the main portion of
`insertion device hub 74, and by providing cap element 24 of
`body 20 with rotation-restricting recesses 77. When inser
`tion device 70 is fully inserted in body 20, as shown in FIG.
`
`3, at least a portion of each protrusion 71 extends into each
`recess 77 Such that the recess side walls interfere with the
`protrusions to prevent rotation of the insertion device rela
`tive to body 20. Although the embodiment shown includes
`two protrusions and two recesses, other embodiments may
`include fewer or greater numbers of each.
`0070 Body 20 includes a fluid delivery passageway 25,
`which extends from entrance opening 21 (which also may be
`characterized as inlet port 21, or inlet 21) in cap element 24
`through exit opening 23 in base element 22. Cap element 24
`includes a portion 26 that tapers inwardly, or in a down
`stream direction, and extends from entrance opening 21 to a
`straight-walled portion 27 (“straight' meaning that, in this
`embodiment, the portion has no bend and a constant diam
`eter), which extends to the bottom surface of cap element 24
`and terminates at cap element exit opening 28. The portion
`of cap element 24 that overlaps an outer portion of Septum
`40 may be characterized as a sealing mechanism-retaining
`shoulder, or a septum retaining shoulder. Base element 22
`includes a base element entrance opening 31 from which a
`straight-walled portion 32 extends. Straight-walled portion
`32 ends at tapered wall portion 33, which extends into
`another straight-walled portion 34. Straight-walled portion
`34 extends into a tapered portion 35 that ends at exit opening
`23. Fluid delivery passageway 25 is characterized by all of
`these portions and openings.
`0071
`FIG. 3 shows that cap element 24 is permanently
`attached to base element 22 at a location 29 that is closer to
`the outer perimeter 37 of body 20 than to the center of