(19) United States
`(12) Patent Application Publication
`Bobroff et al.
`
`(10) Pub. No.: US 2002/0022855 Al
`Feb. 21, 2002
`(43) Pub. Date:
`
`1111111111111111 IIIIII IIIII 11111 1111111111 11111 111111111111111 11111111111111
`US 20020022855Al
`
`(54)
`
`INSERTION DEVICE FOR AN INSERTION
`SET AND METHOD OF USING THE SAME
`
`(76)
`
`Inventors: Randa M. Bobroff, Oak Park, CA
`(US); Lawrence Kiliszewski, Lancaster,
`CA (US); Hans Lickliter, Santa Clarita,
`CA (US); Frederick C. Houghton,
`Moorpark, CA (US); Jason H.
`Safabash, Aliso Viejo, CA (US); Susan
`M. McConnell, Woodland Hills, CA
`(US); April A. Marano, Manhattan
`Beach, CA (US)
`
`Correspondence Address:
`MEDTRONIC MINIMED INC.
`18000 DEVONSHIRE STREET
`NORTHRIDGE, CA 91325-1219 (US)
`
`(21)
`
`Appl. No.:
`
`09/839,052
`
`(22)
`
`Filed:
`
`Apr. 20, 2001
`
`Related U.S. Application Data
`
`(63)
`
`Continuation-in-part of application No. 09/215,356,
`filed on Dec. 18, 1998, now Pat. No. 6,293,925,
`which is a continuation-in-part of application No.
`09/002,303, filed on Dec. 31, 1997, now Pat. No.
`6,093,172.
`
`Publication Classification
`
`Int. Cl.7 ..................................................... A61B 17/34
`(51)
`(52) U.S. Cl. .............................................................. 606/185
`
`(57)
`
`ABSTRACT
`
`An insertion device and insertion set. The insertion device
`for inserting at least a portion of at least one piercing
`member of an insertion set through the skin of a patient
`includes a device housing, a carrier body and a driver. The
`carrier body is slidably received within the device housing
`for movement between an advanced position and a retracted
`position. The carrier body also includes a receiving structure
`to support the insertion set in a position with the at least one
`piercing member oriented for insertion through the skin of
`the patient at a predetermined or variable angle relative to
`the skin of the patient upon movement of the carrier body
`from the retracted position to the advanced position. The
`driver is operatively coupled between the device housing
`and the carrier body to urge the carrier body from the
`retracted position toward the advanced position to place at
`least a portion of the at least one piercing member of the
`insertion set thorough the skin of the patient to install the
`insertion set to the patient. The receiving structure of the
`carrier body is removable from the insertion set while
`maintaining the installation of the insertion set to the patient.
`
`Page 1 of 52
`
`

`

`Patent Application Publication Feb. 21, 2002 Sheet 1 of 33
`
`US 2002/0022855 Al
`
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`Page 2 of 52
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`

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`Patent Application Publication Feb. 21, 2002 Sheet 2 of 33
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`Page 3 of 52
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`

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`Patent Application Publication Feb. 21, 2002 Sheet 3 of 33
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`Page 4 of 52
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`

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`Patent Application Publication Feb. 21, 2002 Sheet 4 of 33
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`Page 5 of 52
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`Page 6 of 52
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`Patent Application Publication Feb. 21, 2002 Sheet 6 of 33
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`Page 7 of 52
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`Patent Application Publication Feb. 21, 2002 Sheet 7 of 33
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`Page 8 of 52
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`Patent Application Publication Feb. 21, 2002 Sheet 8 of 33
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`Page 9 of 52
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`Patent Application Publication Feb. 21, 2002 Sheet 9 of 33
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`Patent Application Publication Feb. 21, 2002 Sheet 10 of 33
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`Page 12 of 52
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`Patent Application Publication Feb. 21, 2002 Sheet 12 of 33
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`Page 13 of 52
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`Patent Application Publication Feb. 21, 2002 Sheet 13 of 33
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`Patent Application Publication Feb. 21, 2002 Sheet 14 of 33
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`Page 15 of 52
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`Patent Application Publication Feb. 21, 2002 Sheet 15 of 33
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`Feb. 21, 2002 Sheet 32 of 33
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`Patent Application Publication Feb. 21, 2002 Sheet 33 of 33
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`Page 34 of 52
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`

`

`US 2002/0022855 Al
`
`Feb.21,2002
`
`1
`
`INSERTION DEVICE FOR AN INSERTION SET
`AND METHOD OF USING THE SAME
`
`RELATED APPLICATIONS
`
`[0001] This application is a continuation-in-part of U.S.
`patent application Ser. No. 09/215,356, filed Dec. 18, 1998,
`which is a continuation-in-part of U.S. patent application
`Ser. No. 09/002,303, filed Dec. 31, 1997, both or which are
`herein specifically incorporated by reference.
`
`FIELD OF THE INVENTION
`
`[0002] This invention relates generally to an insertion
`device for automatic placement of an insertion set through
`the skin of a patient, and in particular embodiments to a
`compact and easily operated insertion device for placement
`of an insertion needle of a subcutaneous insertion set or the
`like through the skin of a patient with a controlled force and
`insertion speed by the patient.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Medical needles are widely used in the course of
`patient care and treatment, particularly with respect to the
`delivery of selected medications to a patient. In one common
`form, hollow hypodermic needles are employed for trans(cid:173)
`cutaneous delivery of a selected medication from a syringe
`or the like. In another common form, insertion needles are
`employed for transcutaneous placement of a soft and rela(cid:173)
`tively flexible tubular cannula, followed by insertion needle
`removal and subsequent infusion of medical fluid to the
`patient through the cannula. More recently, insertion needles
`have also been used for transcutaneously placing other
`medical devices such as a subcutaneous sensor for monitor(cid:173)
`ing specified patient parameters, such as blood glucose level.
`
`[0004]
`In certain medical treatment regimens, it may be
`necessary or desirable for the patient to transcutaneously
`place the medical needle. For example, diabetic patients
`frequently self-administer insulin injections or periodically
`place a subcutaneous insertion with a cannula for subsequent
`programmable delivery of insulin by means of a medication
`infusion pump of the general type described in U.S. Pat. No.
`4,685,903. Such subcutaneous insertion sets are disclosed,
`for example, in U.S. Pat. Nos. 4,755,173; 5,176,662; and
`5,257,980 which are incorporated by reference herein. Dia(cid:173)
`betic patients may also use a subcutaneous insertion set to
`periodically place a transcutaneous glucose sensor wherein
`such sensor insertion sets are disclosed, for example, In U.S.
`Pat. Nos. 5,390,674; 5,568,806; 5,586,553, which are also
`incorporated by reference herein.
`
`[0005] Some patients are reluctant or hesitant to pierce
`their own skin with a medical needle, and thus encounter
`difficulties in correct needle placement for proper adminis(cid:173)
`tration of the medication. Such difficulties can be attribut(cid:173)
`able to insufficient manual dexterity or skill to achieve
`proper needle placement or, alternately to, anxiety associ(cid:173)
`ated with anticipated discomfort as the needle pierces the
`skin. This problem can be especially significant with medi(cid:173)
`cations delivered via a subcutaneous flexible insertion set,
`since incorrect placement can cause kinking of the cannula
`and resultant obstruction of medication flow to the patient.
`Cannula kinking can be due to insertion set placement at an
`incorrect angle relative to the patient's skin, and/or needle
`placement with an incorrect force and speed of insertion.
`
`[0006] The present invention relates to an automatic injec(cid:173)
`tor, particularly for use with a subcutaneous insertion set, for
`quickly and easily placing an insertion needle through the
`skin of a patient at the correct insertion angle, and with a
`speed and force of insertion which minimizes patient dis(cid:173)
`comfort.
`
`SUMMARY OF THE DISCLOSURE
`
`[0007]
`It is an object of an embodiment of the present
`invention to provide an improved insertion device and
`insertion set, which obviates for practical purposes, the
`above mentioned limitations.
`
`[0008] According to an embodiment of the invention, an
`mJector is provided for quick and easy transcutaneous
`placement of a medical needle through the skin of a patient,
`particularly such as an insertion of a subcutaneous insertion
`set. The injector is designed to place the needle through the
`skin at a selected insertion angle and with a controlled force
`and speed of insertion, to ensure proper needle placement
`with minimal patient discomfort. The injector is particularly
`designed to meet these objectives, while safeguarding
`against undesired projection of the medical needle through
`free space, in the event that the injector is actuated in spaced
`relation to the patient's skin.
`
`[0009] The injector comprises a spring-loaded plunger
`having a head for receiving and supporting an insertion set
`in a position with an insertion projecting outwardly for
`transcutaneous placement through the skin of a patient. The
`plunger is designed for retraction and retention within a
`barrel to a cocked position with a drive spring compressed
`in a manner applying a predetermined spring force to the
`plunger head. A front or nose end of the injector barrel is
`designed for pressed placement against the skin of a patient,
`at a selected needle insertion site, and in an orientation with
`the needle disposed at a correct or desired insertion angle. A
`trigger member is operable to release the plunger and
`thereby permit the drive spring to carry the insertion set
`toward the patient's skin with a controlled force and speed,
`resulting in proper transcutaneous placement of the insertion
`needle with minimal patient discomfort.
`
`[0010] The plunger head includes a safety lock mechanism
`to retain the insertion set against projection from the injector
`barrel. In one preferred form, the safety lock mechanism
`comprises at least one and preferably a pair of safety lock
`arms for engaging and retaining the insertion set when the
`plunger is retracted from a fully advanced position. Each
`safety lock arm includes a cam lobe for engaging an appro(cid:173)
`priately shaped recess on the insertion set to prevent release
`thereof from the plunger head, unless and until the plunger
`head is returned to the fully advanced position. In such fully
`advanced position, the shape of the cam lobe permits quick
`and easy separation of the injector from the insertion set with
`a minimal separation force.
`
`[0011]
`In operation, the safety lock arms thus prevent
`projection of the insertion set from the injector, in the event
`that the trigger member is actuated with the nose end of the
`barrel spaced from the skin of a patient. In that event, the
`plunger head is advanced with the controlled force and
`speed to the fully advanced position, but the insertion set is
`not thrown from the injector as a projectile. Instead, the
`insertion set travels rapidly with the plunger head to the fully
`
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`advanced position, whereat the injector can be separated
`with minimal separation force from the insertion set.
`
`[0012]
`In an alternative preferred form, the safety lock
`mechanism comprises a plunger head having a cylindrical
`shape defining a forwardly open cavity for receiving and
`supporting an insertion set with the insertion needle and
`cannula projecting outwardly. In this embodiment, the
`plunger head includes a radially inwardly projecting rim at
`a forward or nose end thereof, wherein the rim defines an
`oval-shaped opening. The size of the rim opening permits
`relatively free reception of a hub on the insertion set, with
`the infusion set oriented at an angle relative to a central axis
`of the plunger head and barrel. The insertion set is then
`reoriented to align the insertion needle coaxially with the
`central axis of the barrel and plunger head, so that the rim
`is received into a recess on the insertion set and functions to
`retain the infusion set against undesired release from the
`injector during spring-driven placement of the needle. After
`needle placement, the injector is released from the insertion
`set with minimal separation force by orienting the injector
`angularly relative to the insertion set to permit free slide out
`passage of the hub through the oval rim opening.
`
`[0013]
`In a further alternative form of the invention, the
`plunger head is shaped to define a laterally open undercut
`slot sized for relatively free slide-fit reception of the needle
`hub of the insertion set. In this version, the insertion set is
`assembled quickly and easily with the plunger head of the
`injector by laterally sliding the hub into the laterally open
`slot, thereby orienting the medical needle generally coaxi(cid:173)
`ally relative to the central axis of the injector barrel and
`plunger head. In this position, the plunger head can be
`retracted and locked, followed by appropriate trigger mem(cid:173)
`ber release for transcutaneously placing the medical inser(cid:173)
`tion needle. After the needle is placed on the patient, the
`injector can be disassembled from the insertion set by
`laterally sliding the injector relative to the needle hub.
`Alternatively, the injector can be withdrawn or retracted
`from the patient's skin to slidably separate the needle from
`the insertion set which remains in place on the patient's skin.
`
`[0014]
`In other embodiments of the present invention, an
`insertion device for inserting at least a portion of at least one
`piercing member of an insertion set through the skin of a
`patient includes a device housing, a carrier body and a
`driver. The carrier body is slidably received within the
`device housing for movement between an advanced position
`and a retracted position. The carrier body also includes a
`receiving structure to support the insertion set in a position
`with the at least one piercing member oriented for insertion
`through the skin of the patient at a predetermined angle
`relative to the skin of the patient upon movement of the
`carrier body from the retracted position to the advanced
`position. The driver is operatively coupled between the
`device housing and the carrier body to urge the carrier body
`with a controlled force and speed from the retracted position
`toward the advanced position to place at least a portion of
`the at least one piercing member of the insertion set thor(cid:173)
`ough the skin of the patient to install the insertion set to the
`patient. The receiving structure of the carrier body is remov(cid:173)
`able from the insertion set while maintaining the installation
`of the insertion set to the patient.
`
`[0015]
`the predetermined
`In particular embodiments,
`angle relative to the skin is about 90 degrees, between 90
`
`degrees and 10 degrees, or is after insertion between O and
`10 degrees. In additional embodiments, the insertion set is a
`transcutaneous insertion set, a subcutaneous insertion set, an
`infusion set, sensor set or the like. In still other embodi(cid:173)
`ments, the insertion set rests mainly on the surface of the
`skin after insertion or the insertion set is implanted in the
`skin of the patient. In preferred embodiments, the at least
`one piercing member is a needle. In alternative embodi(cid:173)
`ments, the at least one piercing member is a plurality of
`needles, and can also be a plurality of micro-needles. Also,
`in some embodiments, the insertion set insertion set can be
`both an infusion set and a sensor set combined into an
`integral unit.
`[0016]
`In yet other embodiments the insertion device, the
`device housing has a forward end defining a generally planar
`angled insertion contact surface for placement against the
`skin of a patient with the device housing in a predetermined
`orientation relative to the patient's skin that mirrors the
`predetermined angle relative to the skin of the patient. Other
`embodiments include a trigger mechanism that actuates the
`driver. For instance, the trigger mechanism includes at least
`one trigger for fingertip depression to actuate the driver for
`movement of the carrier body from the retracted position to
`the advanced position. In addition, the driver can include at
`least one spring for spring-loaded movement of the carrier
`body from the retracted position to the advanced position.
`Further, the driver can include a force changing mechanism
`that permits alteration of the controlled force and speed of
`the carrier body moving from the retracted position to the
`advanced position from one insertion cycle to another inser(cid:173)
`tion cycle. In still further embodiments, the device housing
`and the carrier body include a cooperatively engageable
`track mechanism for guiding movement of the carrier body
`between the advanced and retracted positions while retain(cid:173)
`ing the carrier body against rotation relative to the device
`housing.
`
`[0017]
`In additional embodiments of the insertion device,
`the at least one piercing member is provided with a piercing
`member hub as part of the insertion set. In addition, the
`receiving structure of the carrier body includes a recess
`formed therein for mated slide-fit reception of the piercing
`member hub of the insertion set. Further, the recess of the
`receiving structure can include a laterally open undercut
`recess. Alternatively, the receiving structure may include a
`safety retainer structure that retains the at least one piercing
`member on the receiving structure during movement from
`the retracted position to the advanced position. This safety
`retainer structure permits separation of the at least one
`piercing member from the carrier body when the carrier
`body is in the advanced position.
`
`[0018] Yet another embodiment of the present invention is
`directed to an insertion set for insertion through the skin of
`a patient by an insertion device. The insertion device has a
`slidable carrier body for movement between an advanced
`position and a retracted position. The carrier body of the
`insertion device including a receiving structure to support
`the insertion set in a position for insertion through the skin
`of the patient upon movement of the carrier body from the
`retracted position to the advanced position. The insertion
`device also having a driver operatively coupled to the carrier
`body that urges the carrier body with a controlled force and
`speed from the retracted position toward the advanced
`position for insertion of the insertion set thorough the skin
`
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`

`US 2002/0022855 Al
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`3
`
`of the patient. The insertion set includes at least one piercing
`member and a set housing. The at least one piercing member
`includes a portion of the at least one piercing member that
`is insertable through the skin of the patient. The set housing
`is coupled to the at least one piercing member. Also, the set
`housing is shaped to fit within the carrier body of the
`insertion device to orient the at least one piercing member
`for placement through the skin of the patient of at least a
`portion of the at least one piercing member at a predeter(cid:173)
`mined angle relative to the skin of the patient to install the
`insertion set to the patient. The set housing of the insertion
`set is removable from the receiving structure of the carrier
`body while maintaining the installation of the insertion set to
`the patient.
`
`[0019]
`In particular embodiments of the insertion set, the
`predetermined angle relative to the skin is about 90 degrees,
`between 90 degrees and 10 degrees, or is after insertion
`between 0 and 10 degrees. In additional embodiments, the
`insertion set is a transcutaneous insertion set, a subcutaneous
`insertion set, an infusion set, sensor set or the like. In still
`other embodiments, the insertion set rests mainly on the
`surface of the skin after insertion or the insertion set is
`implanted in the skin of the patient. In preferred embodi(cid:173)
`ments, the at least one piercing member is a needle. In
`alternative embodiments, the at least one piercing member is
`a plurality of needles, and can also be a plurality of micro(cid:173)
`needles. Also, in some embodiments, the insertion set can be
`both an infusion set and a sensor set combined into an
`integral unit.
`
`[0020]
`In other embodiments of the present invention, an
`insertion device for inserting at least a portion of at least one
`piercing member of an insertion set through the skin of a
`patient includes a device housing with an angled end, a
`carrier body and a driver. The device housing includes an
`angled end of the housing device to support a selectable
`insertion angle of the insertion device relative to the skin of
`the patient. The carrier body is slidably received within the
`device housing for movement between an advanced position
`and a retracted position. The carrier body also includes a
`receiving structure to support the insertion set in a position
`with at least one piercing member oriented for insertion
`through the skin of the patient at the selectable insertion
`angle relative to the skin of the patient upon movement of
`the carrier body from the retracted position to the advanced
`position. The driver is operatively coupled between the
`device housing and the carrier body to urge the carrier body
`from the retracted position toward the advanced position to
`place at least a portion of the at least one piercing member
`of the insertion set through the skin of the patient to install
`the insertion set to the patient. The receiving structure of the
`carrier body is removable from the insertion set while
`maintaining the installation of the insertion set to the patient.
`
`[0021]
`In particular embodiments, a portion of the angled
`end includes a multi-planar surface to facilitate the selection
`of selectable insertion angle. In additional embodiments, the
`angled end is a separate-rotatable member connected to the
`device housing by at least one pin to facilitate the movement
`of the device housing about the separate-rotatable member
`and support the selectable insertion angle of the insertion
`device. In other embodiments, the separate-rotatable mem(cid:173)
`ber of the device housing includes a contact surface to
`provide a substantially flat contact surface for the insertion
`device against the patient's skin.
`
`[0022]
`In additional embodiments, the piercing-member
`insertion angle is from 20 degrees to 45 degrees, or is
`between 0 and 20. In other embodiments, a portion of the
`angled end forms a curved opening with two arms surround(cid:173)
`ing the receiving structure, and the two arms extend beyond
`the receiving structure of the carrier body to support the
`device housing at the selectable insertion angle of the
`insertion device. In other embodiments, the receiving struc(cid:173)
`ture has a skin contacting surface with a multi-planar front
`end. The multi-planar front end of the receiving structure is
`shaped to be co-extensive with the angled end of the device
`housing when the carrier body is in the advanced position to
`facilitate insertion at the selectable insertion angle of the
`device housing relative to the patient's skin.
`
`[0023]
`In yet other embodiments, the receiving structure
`may include a locking mechanism to engage at least a
`portion of the insertion set. In addition, the locking mecha(cid:173)
`nism may include teeth which are coupled to the insertion set
`and secured in position by a spring member to facilitate
`locking and placement of the piercing member at the select(cid:173)
`able insertion angle of the device housing relative to the
`patient's skin.
`
`[0024]
`In yet still other embodiments, the selectable inser(cid:173)
`tion angle relative to the skin is about 90 degrees, between
`90 degrees and 10 degrees, or after insertion is greater than
`0 and less than or equal to 10 degrees. In additional
`embodiments, the insertion set is a transcutaneous insertion
`set, a subcutaneous insertion set, rests mainly on the surface
`of the skin after insertion, or is fully implanted in the skin
`of the patient. In preferred embodiments, the at least one
`piercing member is a needle. In alternative embodiments,
`the at least one piercing member is at least one needle or a
`micro-needle. In some embodiments, the insertion set is an
`infusion set or a sensor set. In other embodiments, the
`insertion device includes a trigger mechanism that actuates
`the driver.
`
`[0025] Another embodiment of the present invention is for
`an insertion device for inserting at least a portion of at least
`one piercing member of an insertion set through the skin of
`a patient includes a device housing, a carrier body, a locking
`mechanism and a driver. The device housing supports the
`insertion device relative to the skin of the patient. The carrier
`body is slidably received within the device housing for
`movement between an advanced position and a retracted
`position. The carrier body includes a receiving structure to
`support the insertion set in a position with at least one
`piercing member oriented for insertion through the skin of
`the patient upon movement of the carrier body from the
`retracted position to the advanced position. The locking
`mechanism is included to engage at least a portion of an
`insertion set and secure it to the receiving structure of the
`carrier body, and to substantially prevent the premature
`release of the carrier body before securing it in position
`against the patient's skin. The driver is operatively coupled
`between the device housing and the carrier body to urge the
`carrier body from the retracted position toward the advanced
`position to place at least a portion of the at least one piercing
`member of the insertion set through the skin of the patient
`to install the insertion set to the patient. Also, the receiving
`structure of the carrier body is removable from the insertion
`set while maintaining the installation of the insertion set to
`the patient. In particular embodiments, the locking mecha(cid:173)
`nism includes a lever arm coupled with teeth to se