(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2009/0124979 A1
`Raymond et al.
`(43) Pub. Date:
`May 14, 2009
`
`US 20090 124979A1
`
`(54)
`
`(75)
`
`(73)
`
`(21)
`(22)
`
`(60)
`
`INSERTON DEVICES FOR INFUSION
`DEVICES
`Inventors:
`
`Randy Stephen Raymond, Eagle
`Mountain, UT (US); Joseph K.
`Walker, Pleasant Grove, UT (US);
`Dan Lopez, Vernal, UT (US); Dee
`E. Warren, Draper, UT (US)
`Correspondence Address:
`KNOBBE MARTENS OLSON & BEAR LLP
`2040 MAINSTREET, FOURTEENTH FLOOR
`IRVINE, CA 92.614 (US)
`Assignee:
`ICU Medical, Inc, San Clemente,
`CA (US)
`12/208,313
`Sep. 10, 2008
`Related U.S. Application Data
`Provisional application No. 60/973,134, filed on Sep.
`17, 2007, provisional application No. 61/042,232,
`filed on Apr. 3, 2008.
`
`Appl. No.:
`Filed:
`
`Publication Classification
`
`(51) Int. Cl.
`A6M 5/32
`
`(2006.01)
`
`(52) U.S. Cl. ........................................................ 6O4/195
`
`ABSTRACT
`(57)
`An insertion device for inserting an infusion device at least
`partially into skin for Subcutaneous infusion can comprise a
`sleeve having a lower Surface that is configured to engage the
`skin, a shuttle or carriage to carry the infusion device between
`a retracted position and an advanced position; at least a first
`biasing member to urge the shuttle or carriage toward the
`advanced position, and an actuator to cause the first biasing
`member to urge the carriage from the retracted position to the
`advanced position. In some embodiments, the insertion
`device can further comprise a hub and at least a second
`biasing member to urge the hub away from the shuttle or
`carriage. In some embodiments, the insertion device can fur
`ther comprise a needle attached to the hub. Methods for
`inserting an infusion device and various other features that
`can be comprised by an insertion device are also disclosed.
`
`//52
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`5. N
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`N 4. 2a. 3. N 2. Z2
`S.
`S s N
`N
`3. 2. % 2
`
`46
`
`2
`
`RCZ. Q) N B
`2 2 R N N 5 N sN B
`
`
`
`
`
`
`
`AN
`N N
`
`
`
`
`
`
`
`Page 1 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 1 of 30
`
`US 2009/O124979 A1
`
`
`
`Page 2 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 2 of 30
`
`US 2009/O124979 A1
`
`f/2/2 N
`
`A76, 2
`
`Page 3 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 3 of 30
`
`US 2009/O124979 A1
`
`
`
`A76,
`
`f
`
`Page 4 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 4 of 30
`
`US 2009/O124979 A1
`
`to
`
`
`
`--
`
`/42
`
`A76, 4
`
`Page 5 of 41
`
`

`

`
`
`Page 6 of 41
`
`Page 6 of 41
`
`

`

`Patent Application Publication
`
`May 14, 2009 Sheet 6 of 30
`
`US 2009/O124979 A1
`
`
`
`A76, 6
`
`Page 7 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 7 of 30
`
`US 2009/O124979 A1
`
`
`
`A/2 2.
`
`Page 8 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 8 of 30
`
`US 2009/O124979 A1
`
`//O-
`
`
`
`-/62
`
`W92
`
`755
`
`f/2 - - -
`
`A76, 7
`
`Page 9 of 41
`
`

`

`Page 10 of 41
`
`

`

`Patent Application Publication
`
`May 14, 2009 Sheet 10 of 30
`
`US 2009/0124979 A1
`
`267(7
`
`2/74
`
`1 ZZ
`
`?SN sn 2072
`
`§ N sº
`
`
`
`
`
`Page 11 of 41
`
`

`

`Page 12 of 41
`
`

`

`
`
`L1G. L2
`
`Page 13 of 41
`
`

`

`
`
`LLG, LS
`
`Page 14 of 41
`
`Page 14 of 41
`
`

`

`Patent Application Publication
`
`May 14, 2009 Sheet 14 of 30
`
`US 2009/O124979 A1
`
`<C)
`
`NONOSOK SŒ
`
`S`S`N
`=='S
`NONONOSTNOSTNOSTI
`
`<?FE7 CSONNOSZZZZ
`
`SUz
`
`S
`
`IXZZZZZZZZ
`
`SOSIS
`SQ
`
`ZZ
`
`ZZZZZZZ
`ZZZZ
`\S\SYS$
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 15 of 41
`
`

`

`Patent Application Publication
`
`May 14, 2009 Sheet 15 of 30
`
`US 2009/O124979 A1
`
`
`
`4
`
`A76,
`
`V2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 16 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 16 of 30
`
`US 2009/O124979 A1
`
`7367
`
`|
`
`SÈSÈ }
`
`
`
`A76 /6
`
`Page 17 of 41
`
`

`

`Patent Application Publication
`
`May 14, 2009 Sheet 17 of 30
`
`US 2009/O124979 A1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`N
`
`{{S |
`Š?zzzzò
`SSXN,
`
`S
`VI
`
`A76, M7
`
`92
`
`(22
`
`Page 18 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 18 of 30
`
`US 2009/O124979 A1
`
`
`
`Page 19 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 19 of 30
`
`US 2009/O124979 A1
`
`
`
`AG, 7.9
`
`Page 20 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 20 of 30
`
`US 2009/O124979 A1
`
`
`
`AV6 2/7
`
`Page 21 of 41
`
`

`

`Patent Application
`Publication
`
`May 14, 2009 Sheet 21 of 30
`
`US 2009/0124979 A1
`
`
`
`A76. 2/
`
`Page 22 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 22 of 30
`
`US 2009/O124979 A1
`
`
`
`A76, 2
`
`Page 23 of 41
`
`

`

`4, 2009 Sheet 23 of 30
`
`US 2009/0124979 Al
`
`
`
`LTG. 2S
`
`Page 24 of 41
`
`Page 24 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 24 of 30
`
`US 2009/O124979 A1
`
`777/7
`
`o
`
`f/23
`
`to
`
`A76, 27
`
`Page 25 of 41
`
`

`

`/
`
`SE
`N\N=__SyoS——=<>NSSOOS\
`
`L1G. 22
`
`Page 26 of 41
`
`
`
`

`

`Patent Application Publication May 14, 2009 Sheet 26 of 30
`
`US 2009/O124979 A1
`
`res
`
`
`
`A76 2/5
`
`Page 27 of 41
`
`

`

`:.cen;
`
`NN
`
`N
`
`
`
`
`
`=
`
`L1G. 27
`
`Page 28 of 41
`
`Page 28 of 41
`
`
`
`

`

`Application Publication
`
`May 14, 2009 Sheet 28 of 30
`
`US 2009/0124979 A1
`
`
`
`ZZZ
`M
`24,
`
`/ 2 %
`2
`
`Page 29 of 41
`
`

`

`Patent Application Publication May 14, 2009 Sheet 29 of 30
`
`US 2009/0124979 A1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`7227
`
`722
`
`7/72
`
`A76, 29
`
`Page 30 of 41
`
`

`

`Patent Application Publication
`
`May 14, 2009 Sheet 30 of 30
`
`US 2009/0124979 A1
`
`
`
`
`
`
`
`
`
`
`
`?<<<<<<<Ø?
`
`A76, f/7
`
`Page 31 of 41
`
`

`

`US 2009/O124979 A1
`
`May 14, 2009
`
`INSERTON DEVICES FOR INFUSION
`DEVICES
`
`RELATED APPLICATIONS
`0001. This application claims the benefit under 35 U.S.C.
`S 119(e) of U.S. Provisional Application No. 60/973,134,
`filed Sep. 17, 2007, titled INSERTION DEVICE FOR AN
`INFUSION SET, and U.S. Provisional Application No.
`61/042,232, filed Apr. 3, 2008, titled INSERTION DEVICE
`FOR AN INFUSION SET. The entire contents of each of
`these applications are hereby incorporated by reference
`herein and made a part of this specification.
`
`BACKGROUND
`
`0002 1. Field
`0003. The present disclosure relates to devices that facili
`tate insertion of infusion devices, such as infusion sets, into a
`Subject, and more particularly devices for inserting infusion
`devices at least partially into a person's skin.
`0004 2. Description of the Related Art
`0005 Subcutaneous injection is a standard method for the
`delivery of medication into a patient’s body. To facilitate
`frequent or continuous Subcutaneous injection of medication,
`Subcutaneous injection ports are often used. Such injection
`ports include a component that extends through the skin and
`may remain in place for several days. Currently, a major
`application of Such injection ports is to provide continuous
`delivery of medication, such as insulin, from portable pumps
`carried with the patient.
`0006. Subcutaneous injection ports generally require a
`sharp, rigid needle to pierce the person's skin when initially
`attached to the person. In many cases the needle is withdrawn
`and a soft plastic cannula remains inside the body for an
`extended period. In other cases, the rigid needle can be hollow
`and remain in the patient to deliver medication.
`0007 Subcutaneous injection ports are
`inserted into the skin using an insertion device.
`
`Sometimes
`
`SUMMARY OF THE DISCLOSURE
`
`0008 Prior insertion devices do not adequately address
`the needs of users. Some users may suffer from conditions,
`Such as diabetic neuropathy. It can be advantageous for an
`insertion device for an infusion device to be easily grasped
`and operated by diabetics suffering from diabetic neuropathy.
`Diabetic neuropathy can cause numbness, loss offeeling and
`muscle weakness in the hands and fingers making fine motor
`control difficult. At times, a user may need to insert an infu
`sion device at a location on the user's body which may com
`plicate insertion, e.g., on a user's side or back. In some
`instances, an adult may need to assist a child in placing an
`infusion device on the child's body. In these instances and
`others, it can be beneficial for an insertion device for an
`infusion device to require a minimum number of operational
`steps while providing safe operation and disposal. Such an
`insertion device may advantageously minimize the possibil
`ity of accidental needle Sticks and/or premature activation of
`the insertion device. Accordingly, it can be advantageous for
`an insertion device to insert an infusion device, such as an
`infusion set, quickly, safely, and conveniently.
`0009. Thus, in accordance with at least one of the embodi
`ments disclosed herein, a device for inserting an infusion
`device through skin for Subcutaneous infusion comprises a
`
`sleeve, a shuttle, at least a first biasing member, a hub, a
`needle, at least a second biasing member, and an actuator.
`0010. The sleeve can have an upper surface and a lower
`surface. The lower surface of the sleeve can be configured to
`engage skin.
`0011. The shuttle can comprise a receptacle for accommo
`dating an infusion device, at least a first movement-restrain
`ing arm, and a least a first hub-retaining arm. The shuttle can
`be movable between a retracted position and an advanced
`position. The first movement-restraining arm can engage the
`upper surface of the sleeve when the shuttle is in the retracted
`position to inhibit movement of the shuttle toward the
`advanced position. The first biasing member can be opera
`tively connected to the shuttle to urge the shuttle toward the
`advanced position.
`0012. The hub can have an upper side and a lower side. The
`hub can be movable between a first position and a second
`position with respect to the shuttle. The first hub-retaining
`arm of the shuttle can inhibit movement of the hub away from
`the shuttle when the hub is in the first position.
`0013 The needle can have an upper end and a lower end.
`The upper end can be fixedly attached to the lower side of the
`hub. The lower end can be configured to pierce skin. The
`lower end of the needle can extend below the lower surface of
`the sleeve when the shuttle is in the advanced position and the
`hub is in the first position. The lower end of the needle can be
`positioned above the lower surface of the sleeve when the hub
`is in the second position. The second biasing member can be
`operatively connected to the hub to urge the hub upwardly
`from the shuttle away from the lower surface of the sleeve.
`0014. The actuator can be movably attached to the sleeve
`Such that, when the first movement-restraining arm is
`engaged with the upper Surface, advancement of the actuator
`toward the sleeve permits disengagement the first movement
`restraining arm of the shuttle from the upper surface of the
`sleeve. Disengagement of the first movement-restraining arm
`of the shuttle from the upper surface of the sleeve can allow
`the first biasing member to move the shuttle from the retracted
`position to the advanced position. Movement of the shuttle
`from the retracted position to the advanced position can allow
`the first hub-retaining arm of the shuttle to release the hub
`such that the second biasing member moves the hub from the
`first position to the second position.
`0015. In accordance with at least one of the embodiments
`disclosed herein, an inserter for placing an infusion device at
`least partially into skin can comprise a sleeve, a carriage, at
`least at first biasing member, a hub, a needle, at least a second
`biasing member, and an actuator.
`0016. The sleeve can have a bottom surface. The bottom
`Surface can be configured to engage skin.
`0017. The carriage can carry the infusion device. The car
`riage can be positioned at least partially within the sleeve. The
`carriage can be movable between a retracted position and an
`advanced position. The lowest portion of the infusion device
`can be spaced upwardly from the bottom surface of the sleeve
`when the carriage is in the retracted position. The bottom
`portion of the infusion device can extend below the lower
`surface of the sleeve when the carriage is in the advanced
`position. The first biasing member can be operatively con
`nected to the carriage to urge the carriage toward the
`advanced position
`0018. The hub can be movable between a first position and
`a second position with respect to the carriage. The needle can
`have an upper end and a lower end. The upper end can be
`
`Page 32 of 41
`
`

`

`US 2009/O124979 A1
`
`May 14, 2009
`
`fixedly attached to the lower side of the hub. The lower end
`can be configured to pierce skin. The needle can extend below
`the carriage when the hub is in the first position. The lower
`end of the needle can extend no lower than the carriage when
`the hub is in the second position. The second biasing member
`can be operatively connected to the hub to urge the hub
`upwardly from the carriage away from the lower surface of
`the sleeve.
`0019. The actuator can be operatively connected to the
`sleeve to cause the first biasing member to move the carriage
`from the retracted position to the advanced position. Move
`ment of the carriage from the retracted position toward the
`advanced position permits the hub to move from the first
`position to the second position.
`0020. In accordance with at least one of the embodiments
`disclosed herein, an inserter for placing an infusion device at
`least partially into skin can comprise a housing, I carriage, at
`least at first biasing member, and an actuator.
`0021. The housing can have a bottom surface. The bottom
`Surface can be configured to engage skin.
`0022. The carriage can be configured to carry an infusion
`device. The carriage can be positioned at least partially within
`the housing. The carriage can be movable between a retracted
`position and an advanced position. The lowest portion of the
`infusion device can be spaced upwardly from the bottom
`Surface of the housing when the carriage is in the retracted
`position. The bottom portion of the infusion device can
`extend below the lower surface of the housing when the
`carriage is in the advanced position. The carriage can com
`prise at least one movable member for engaging the infusion
`device to inhibit release of the infusion device from the car
`riage before the carriage moves from the retracted position
`toward the advanced position. The first biasing member can
`be operatively connected to the carriage to urge the carriage
`toward the advanced position.
`0023 The actuator can be operatively connected to the
`housing to cause the first biasing member to move the car
`riage from the retracted position to the advanced position.
`Movement of the carriage from the retracted position toward
`the advanced position can cause the hub to move from the first
`position to the second position.
`0024. These and other embodiments of the present inven
`tion will become readily apparent to those skilled in the art
`from the following detailed description of the preferred
`embodiments having reference to the attached figures, the
`invention not being limited to any particular preferred
`embodiment(s) disclosed.
`0025 Neither this summary nor the following detailed
`description purports to define the invention. The invention is
`defined by the claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`0026 Specific embodiments will now be described with
`reference to the drawings, which are intended to illustrate and
`not limit the various features of the invention.
`0027 FIG. 1 is an exploded perspective view of an inser
`tion device and an insertion set according to one embodiment.
`0028 FIG. 2 is an assembled perspective view of the inser
`tion device of FIG. 1.
`0029 FIG. 3 illustrates a protective cap removed from an
`actuator of the insertion device of FIG.1.
`0030 FIG. 4 is a side view of the actuator of the insertion
`device of FIG. 1.
`
`0031 FIG. 5 is a lower perspective view of the actuator of
`FIG.S.
`0032 FIG. 6 is an upper perspective view of the sleeve of
`the insertion device of FIG. 1.
`0033 FIG. 7 is a lower perspective view of the sleeve of
`FIG. 6.
`0034 FIG. 8 is a lower perspective view of a needle and
`needle hub of the insertion device of FIG. 1.
`0035 FIG.9 is an upperperspective view of a shuttle of the
`insertion device of FIG. 1.
`0036 FIG. 10 is a cross-sectional view of the shuttle of
`FIG.9, taken along line 10-10 shown in FIG.9.
`0037 FIG. 11 is a cross-sectional view of the shuttle of
`FIGS. 9 and 10, taken along line 11-11 shown in FIG.9.
`0038 FIG. 12 is an upper perspective view of a protective
`cap for use with an insertion device.
`0039 FIG. 13 is an upper perspective view of the protec
`tive cap of FIG. 12, showing a portion of an infusion device
`accommodated therein.
`0040 FIG. 14 is a cross-sectional view of the insertion
`device of FIG. 1 before actuation, taken along line 14-14
`shown in FIG. 3.
`0041
`FIG. 15 is another cross-sectional view of the inser
`tion device in FIG. 1 before actuation, taken along line 15-15
`shown in FIG. 14.
`0042 FIG. 16 is a cross-sectional view, similar to FIG. 15,
`of the insertion device of FIG. 1 after actuation.
`0043 FIG. 17 is another cross-sectional view, similar to
`FIG. 14, of the insertion device of FIG. 1 after actuation.
`0044 FIG. 18 is an exploded perspective view of an inser
`tion device and an insertion set according to one embodiment.
`004.5
`FIG. 19 is an assembled perspective view of the
`insertion device of FIG. 18.
`0046 FIG. 20 is a perspective view of an actuator of the
`insertion device of FIG. 18.
`0047 FIG. 21 is a lowerperspective view of the actuator of
`FIG. 20.
`0048 FIG. 22 is an upper perspective view of a sleeve of
`the insertion device of FIG. 18.
`0049 FIG. 23 is a lower perspective view of the sleeve of
`FIG 22.
`0050 FIG.24 is an upperperspective view of a needle hub
`of the insertion device of FIG. 18.
`0051 FIG.25 is an upperperspective view of the shuttle of
`the insertion device of FIG. 18.
`0052 FIG. 26 is a lower perspective view of the shuttle of
`FIG. 25.
`0053 FIG. 27 is a cross-sectional view of the shuttle of
`FIGS. 25 and 26, taken along line 27-27 shown in FIG. 25.
`0054 FIG. 28 is another cross-sectional view of the shuttle
`of FIGS. 25 and 26, taken along the line 28-28, shown in FIG.
`25.
`0055 FIG. 29 is a cross-sectional view, similar to FIG. 27,
`of the insertion device of FIG. 18 before actuation.
`0056 FIG. 30 is a cross-sectional view, similar to FIGS.
`27 and 29, of the insertion device of FIG. 18 after actuation.
`
`DETAILED DESCRIPTION OF SPECIFIC
`EMBODIMENTS
`0057 FIG. 1 illustrates an embodiment of an insertion
`device 100 for an infusion device 102, such as infusion set.
`Further details regarding some exemplifying infusion
`devices, including infusion sets, are provided in United States
`Patent Application Publication Nos. 2005/0107743 and 2007/
`
`Page 33 of 41
`
`

`

`US 2009/O124979 A1
`
`May 14, 2009
`
`0185441, both of which are hereby incorporated by reference
`herein in their entireties. There are many different types of
`infusion devices, such as infusion sets, that may be inserted
`using insertion devices, and the foregoing publications are
`provided merely to illustrate some infusion devices that can
`be used with or adapted to be used with the insertion devices
`described herein.
`0058 Referring to FIG. 1, the insertion device 100 can
`comprise an actuator 104, a sleeve 106, an insertion spring
`108, a needle hub 110, a needle 112, a retraction spring 114,
`a shuttle or carriage 116, a protective cap 118, and a cover
`120. The infusion device 102 can be an infusion set, and can
`comprise a base 122 and a tubing set 124. The base 122 can
`comprise a soft cannula 264 and an adhesive sheet 266. The
`tubing set can comprise an infusion cap 240, a length of
`tubing 250, and a connector 254 (see FIG. 13). In some
`embodiments, the infusion device 102 can be packaged
`within the insertion device 100.
`0059 FIG. 2 illustrates the insertion device 100 in an
`assembled state with the protective cap 118 engaged with the
`actuator 104. The protective cap 118 can be removed from the
`actuator 104, as shown in FIG. 3, in preparation for insertion
`of the base 122. In some embodiments, the insertion device
`100 may omit the cap 118.
`0060 Referring to FIG.4, the actuator 104 can include one
`or more gripping Surfaces 126, one or more pushing Surfaces
`130, one or more arms 134 having feet 136, and a coupling
`region 140. In some embodiments, the actuator 104 can be
`made of a rigid plastic, such as ABS (acrylonitrile butadiene
`styrene), polycarbonate, polyethylene, or PET (polyethylene
`terephthalate).
`0061 The gripping surface 126 can extend entirely or
`partially around the circumference of the actuator 104 or may
`alternatively be located on opposite sides of the actuator 104
`or otherwise spaced on the actuator 104. The gripping Surface
`126 preferably has a dimension, Such as an external diameter,
`that is Sufficiently large to facilitate easy grasping by diabet
`ics who have lost dexterity and strength due to diabetic neu
`ropathy. In embodiments having multiple gripping Surfaces
`126, the gripping Surfaces can be spaced apart by a distance
`for facilitate easy grasping. The gripping Surface(s) 126 can
`also have sufficient Surface area and be positioned to allow a
`user to hold the actuator 104 at the gripping surface(s) 126
`using the middle section of a user's fingers and/or palm.
`0062. In some embodiments, the gripping surface 126 can
`include a plurality of ridges or other surface elements 128.
`Surface elements 128 can increase friction or interface
`between a user's fingers and the actuator 104 to improve the
`user's ability to securely hold the actuator 104. For example,
`the surface elements 128 can comprise one or more of textur
`ing, dimples, bumps, grooves, or other Surface shapes. The
`surface elements 128 can be integrally formed with one or
`more other portions of the actuator 104, or may be separately
`formed and attached by mechanical coupling. Such as by
`interference fit, or by any known bonding technique. Such as
`adhesives.
`0063. The pushing surfaces 130, 132 of the actuator 104
`can comprise one or more upper pushing Surfaces 130 and/or
`one or more lower pushing Surfaces 132 that can be sized and
`positioned to be contacted by a user's fingers and/or palm. For
`example, the upper pushing Surface 130 can be configured to
`be contacted primarily by a user's palm, while lower pushing
`surfaces 132 can be configured to be contacted primarily by a
`user's fingers. In the embodiment of the actuator 104 that is
`
`illustrated in FIG.4, the upper pushing surface 130 is gener
`ally convexly domed and the lower pushing surface 132 is
`generally concave.
`0064. With continued reference to FIG.4, the actuator can
`comprise one or more arms 134 which can have feet 136. The
`feet 136 may be located at or near a terminal end of arms 134.
`The feet can include a cam surface 138 and may face out
`wardly, as illustrated in FIG.4, inwardly or circumferentially
`or in other directions. In some embodiments, the actuator 104
`may omit the arms, feet, and cam Surfaces. In some embodi
`ments, the actuator 104 can comprise other features.
`0065. The coupling region 140 may facilitate secure
`attachment of the actuator 104 with the protective cap 118
`(see FIGS. 1 and 2). The coupling region 140 can comprise a
`groove 142 which can securely engage a complementary
`structure of the protective cap 118, while also allowing easy
`removal of the protective cap 118 from the actuator 104. In
`Some embodiments, the coupling region 140 can additionally
`or alternatively comprise a ridge which can securely engage a
`complementary structure of the protective cap 118, while also
`allowing easy removal of the protective cap 118 from the
`actuator 104.
`0.066
`Referring to FIG. 5, the actuator 104 can comprise a
`number of features in an interior of the actuator 104. For
`example, the actuator 104 can comprise one or more displace
`ment members 144, one or more guideposts 148, and a travel
`limiting member 152. Some or all of the displacement mem
`bers 144, the guideposts 148, and the travel-limiting member
`152 can extend downwardly from the underside of the actua
`tor 104. The displacement member 144 can include an
`engagement Surface 146. One or more of the guideposts 148
`may include a stop surface 150. The travel-limiting member
`152 may be cylindrical, or may have other configurations,
`Such as square, triangular, frustoconical, or actuate.
`0067 Referring to FIG. 6, the sleeve 106 can comprise an
`upper surface 154. The upper surface 154 can include one or
`more apertures 156 that are sized and positioned to cooperate
`with the guideposts 148 of the actuator 104. Alternatively, the
`apertures 156 can be formed in a surface of the sleeve other
`than the upper surface 154. In some embodiments, the aper
`tures 156 can comprise recesses formed in the sleeve 106,
`such as in the upper surface 154, in a side surface, or both.
`0068. The sleeve 106 can comprise one or more external
`guide rails 158 and/or one or more internal guide rails 160.
`The external guide rails 158 are preferably sized and config
`ured to cooperate with one or more interior surfaces of the
`actuator 104, such as interior surface 260 (see FIG. 5). For
`example, the external guide rails 158 can slidingly engage the
`interior surface 260 of the actuator 104 to cause the actuator
`104 and the sleeve 106 to move along a generally straight path
`with respect to one another. The external guide rails 158 can
`additionally or alternatively cooperate with one or more inte
`rior surfaces of the actuator 104 to allow the cap 104 and the
`sleeve 106 to rotate with respect to each other. The external
`guide rails 158 may extend generally linearly (e.g., Straight),
`as shown in FIG. 6, though the external guide rails 158 may
`also have other configurations.
`0069. The internal guide rails 160 can be sized and con
`figured to cooperate with appropriate structures of the shuttle
`116, discussed below. The internal guide rails 160 can extend
`longitudinally, as shown on FIG. 6, or may have other con
`figurations. In some embodiments, the internal guide rails
`160 are arranged in pairs to define a channel therebetween.
`
`Page 34 of 41
`
`

`

`US 2009/O124979 A1
`
`May 14, 2009
`
`0070. With continued reference to FIG. 6, the sleeve 106
`can also comprise a recess 168. The recess 168 can permitone
`or more portions of the infusion device 102 to extend there
`through (see FIGS. 14 and 17).
`0071
`Referring again to FIG. 6, the sleeve 106 can com
`prise one or more apertures 166 that can be used to facilitate
`molding internal features of the sleeve 106.
`0072 The sleeve 106 can also comprise a stop ledge 262,
`the purpose of which is described further below in connection
`with FIGS. 14-17.
`0073. The sleeve 106 can comprise one or more apertures
`162 that are configured to permit the arms 134 of the actuator
`104 (see FIG. 4) to extend therethrough. Theaperture 162 can
`have a width that allows the arm 134 to move within the
`aperture 162 as the actuator 104 is rotated with respect to
`sleeve 106 between a locked position and an unlocked posi
`tion. When such embodiments are in the locked position, the
`stop surfaces 150 of the actuator 104 can be positioned over
`the upper surface 154 of the sleeve 106 to prevent movement
`of the actuator 104 relative to the sleeve 106 toward the skin.
`When such embodiments are in the unlocked position, the
`stop surfaces 150 are aligned with the apertures 156 such that
`the guideposts, including the stop surfaces, are allowed to
`advance through the apertures 156. The sleeve 106 can also
`comprise indicia 164 to indicate whether the actuator 104 and
`sleeve 106 are in the unlocked or locked position.
`0074) Referring to FIG. 7, the sleeve 106 can comprise a
`recess 170 in which the one or more feet 136 of the actuator
`134 may move. The recess 170 can be bounded on one side by
`a shoulder 172 that is configured to engage the one or more
`feet 136 of the actuator 104. The shoulder 172 can comprise
`a protrusion 174 to prevent unintentional rotation of the
`actuator 104 with respect to sleeve 106 between the locked
`position and the unlocked position. The protrusion 174 can
`also provide tactile feedback to a user when the actuator 104
`is moved with respect to the sleeve 106 between the locked
`position and the unlocked position.
`0075. The sleeve 106 can also comprise a lower surface
`176. The lower surface 176 can be configured to provide
`stable contact with a person's skin during placement of the
`base 122 of the infusion device 102 into the person's skin. The
`lower surface 176 can be continuous, as illustrated in FIG. 7,
`or segmented.
`0076. In some embodiments, the sleeve 106 can comprise
`a recess 178 (see, e.g., FIGS. 15 and 16) to receive all or a
`portion of the insertion spring 108 therein.
`0077. With continued reference to FIG. 7, in some
`embodiments, the sleeve 106 can comprise a cam surface 180.
`The cam surface 180 can be cylindrical, as illustrated in FIG.
`7, or have other configurations. For example, the cam Surface
`180 can have a generally circular cross-section, as illustrated
`in FIG. 7, or can have other cross-sectional shapes such as
`polygonal. The cam Surface 180 can form a closed loop as
`shown in FIG. 7, or may not form a closed loop, but instead
`comprise one or more longitudinal cam Surfaces.
`0078. In some embodiments, the sleeve 106 can be made
`of a rigid plastic, such as ABS, polycarbonate, polyethylene,
`or PET.
`0079 Referring to FIG. 8, the needle hub 110 can com
`prise an upper side 182 and a lower side 184. The lower side
`184 can comprise a needle-mounting aperture 186 and a
`recess 188. The recess 188 can be configured to receive all or
`a portion of the retraction spring 114 (see FIGS. 1 and 14-17).
`The needle hub can also include one or more engagement
`
`surfaces 190 and a follower surface 192. In some embodi
`ments, the needle hub 110 can be made of a rigid plastic, such
`as ABS, polycarbonate, polyethylene, or PET.
`0080. The needle 112 can be inserted into and fixed within
`the needle-mounting aperture 186 of the needle hub 110. The
`needle 112 can be fixed to the needle hub 110 by any suitable
`adhesive, such as a solvent adhesive. The needle 112 can
`include a beveled end 194. In some embodiments, the needle
`112 can be made of a suitable metal. Such as stainless steel.
`I0081
`Referring to FIGS. 9-11, the shuttle 116 can include
`recesses 202 that are configured to receive at least a portion of
`the insertion spring 108 (see FIGS. 14-17). The insertion
`spring 108 can engage the sleeve 106, and the insertion spring
`108 can bias the shuttle 116 from the sleeve 106. The guide
`posts 148 can extend through the apertures 156 in the sleeve
`106 (FIG. 6), and the insertion spring can engage the guide
`posts 148 to bias the actuator from the shuttle 116 (see FIGS.
`14-15).
`0082. The shuttle 116 can include one or more sleeve
`engaging arms 196, each having a sleeve-engaging foot 198.
`The sleeve-engaging arms 196 of the shuttle 116 can be
`biased so that the sleeve-engaging feet 198 rest upon the
`upper surface 154 of the sleeve 106 to maintaining the inser
`tion spring 108 in a compressed state (see FIG. 14).
`I0083. The sleeve-engaging feet 198 and upper surface 154
`are preferably configured to align with the displacement
`member 144 of the actuator 144 so that the engagement
`surface 146 of the displacement member 144 aligns with cam
`surfaces 200 of the sleeve-engaging feet 198. Thus, move
`ment of the displacement member 144 against the feet 198
`can cause the feet 198 to disengage from the upper surface
`154 of the sleeve 106. The cam Surfaces 200 of the sleeve
`engaging feet 198 can be beveled, as shown in FIGS. 9-10 and
`14, or alternatively the engagement Surface 146 can be bev
`eled.
`I0084. The shuttle 116 can be configured to accommodate
`the needle hub 110 and needle 112. For example, the shuttle
`116 can comprise one or more cam Surfaces 204 configured to
`cooperate with the follower surface 192 of the needle hub 110
`to orient the needle hub 110 while permitting sliding move
`ment of the needle hub 110 relative to the shuttle 116. The
`shuttle 116 can also comprise a needle aperture 206 to permit
`the needle 110 to extend therethrough.
`I0085. Referring to FIG. 11, the shuttle 116 can comprise
`one or more recesses 208 to receive at least a portion of the
`retraction spring 114. The retraction spring also can engage
`the needle hub 110, at the recess 188 for example, and the
`retraction spring 114 can bias the needle hu