(12) United States Patent
`Safabash et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,207,974 B2
`*Apr. 24, 2007
`
`USOO7207974B2
`
`(54) INSERTION DEVICE FOR AN INSERTION
`SET AND METHOD OF USING THE SAME
`(75) Inventors: Jason H. Safabash, Los Angeles, CA
`(US); Susan M. McConnell, Woodland
`Hills, CA (US); Randy W. Adair,
`Valencia, CA (US); Jeffery V.
`Funderburk, Fremont, CA (US); April
`A. Marano, Manhattan, CA (US);
`Jeffrey F. Field, Camarillo, CA (US)
`(73) Assignee: Medtronic MiniMed, Inc., Northridge,
`CA (US)
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 700 days.
`This patent is Subject to a terminal dis-
`claimer.
`(21) Appl. No.: 10/370,831
`(22) Filed:
`Feb. 21, 2003
`
`(65)
`
`Prior Publication Data
`US 2003/O 130619 A1
`Jul. 10, 2003
`US 2006/OO69351 A9
`Mar. 30, 2006
`
`Related U.S. Application Data
`(63) Continuation of application No. 09/839,052, filed on
`Apr. 20, 2001, now Pat. No. 6,607 509 whi ch is a
`continuation-in-part of application No. 0925,356
`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. which is a continuati on-in-part of appli-
`cation No. 087795.968, filedon Feb.5.1997, now Pat
`No. 5.851.97.
`• al- s
`s
`•
`al- sy- a-- us u. --
`•
`(51) Int. Cl.
`A6M 5/20
`
`(2006.01)
`
`
`
`(52) U.S. Cl. ....................................... 604/136; 604/137
`(58) Field of Classification Search ................ 604/513,
`604/93.01, 16401, 136, 137, 157
`See application file for complete search history.
`References Cited
`U.S. PATENT DOCUMENTS
`M
`4,685,903. A
`
`8, 1987 Cable et al. ................ 604,154
`
`(56)
`
`Continued
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`WO
`
`02081012
`
`10, 2002
`
`OTHER PUBLICATIONS
`European Search Report, Dated Jul. 20, 2000, 3 pages.
`(Continued)
`Primary Examiner Kevin C. Sirmons
`Assistant Examiner Catherine Witczak
`
`(57)
`
`ABSTRACT
`
`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, including: a device housing and a carrier body 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 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. A driver urges the carrier body with a controlled
`force and speed 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 is removable from the insertion set while main
`taining installation of the insertion set to the patient.
`
`58 Claims, 25 Drawing Sheets
`
`ea
`
`2 d
`
`2
`
`Page 1 of 40
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`

`

`US 7,207,974 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`7, 1988 Konopka et al. ........... 604f167
`4,755,173 A
`6, 1992 Lucas ..........
`604f135
`5, 122,119 A
`9, 1992 Sullivan et al.
`... 606/182
`5,147,375 A
`1/1993 Bartholomew et al. ..... 604/283
`5,176,662 A
`5,257,980 A 1 1/1993 Van Antwerp et al. ..... 604/282
`5,390,671 A
`2/1995 Lord et al. .................. 128,635
`5,568,806 A 10/1996 Cheney, II et al. ......... 128/635
`5,584.813 A 12/1996 Livingston et al. ......... 604,177
`5,586,553 A 12, 1996 Halili et al. ................ 128,635
`
`1/1997 Waisman .................... 606, 182
`5,591, 188 A
`7/1998 Mastrototaro et al.
`... 604/51
`5,779,665 A
`5,851,197 A 12/1998 Marano et al. ............. 604f135
`6,293.925 B1* 9/2001 Safabash et al. ............ 604f136
`6,997,907 B2 * 2/2006 Safabash et al. ............ 604f157
`
`
`
`Einst
`
`OTHER PUBLICATIONS
`Search Report for International Application No.
`
`* cited by examiner
`
`Page 2 of 40
`
`

`

`U.S. Patent
`U.S. Patent
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`Apr. 24, 2007
`Apr.24, 2007
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`US 7,207,974 B2
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`Apr. 24, 2007
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`US 7,207,974 B2
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`Apr. 24, 2007
`Apr.24, 2007
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`Sheet 3 of 25
`Sheet 3 of 25
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`US 7,207,974 B2
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`Apr. 24, 2007
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`Sheet 8 of 25
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`US 7,207,974 B2
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`U.S. Patent
`U.S. Patent
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`Apr. 24, 2007
`Apr.24, 2007
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`US 7,207,974 B2
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`Sheet 9 Of 25
`Sheet 9 of 25
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`U.S. Patent
`U.S. Patent
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`Apr. 24, 2007
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`US 7,207,974 B2
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`Page 12 of 40
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`Apr. 24, 2007
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`Apr. 24, 2007
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`Apr. 24, 2007
`Apr.24, 2007
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`US 7.207,974 B2
`US 7,207,974 B2
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`Apr. 24, 2007
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`U.S. Patent
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`US 7,207,974 B2
`US 7,207,974 B2
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`U.S. Patent
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`Apr. 24, 2007
`Apr.24, 2007
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`

`1.
`INSERTON DEVICE FOR AN INSERTON
`SET AND METHOD OF USING THE SAME
`
`US 7,207,974 B2
`
`RELATED APPLICATIONS
`
`This is a continuation of application Ser. No. 09/839,052
`filed on Apr. 20, 2001, now U.S. Pat. No. 6,607,509, which
`is a continuation-in-part of application Ser. No. 09/215,356
`filed Dec. 18, 1998, now U.S. Pat. No. 6,293.925, which is
`a continuation-in-pan of application Ser. No. 09/002,303
`filed Dec. 31, 1997 now U.S. Pat. No. 6,093,172, which is
`a continuation-in-part of application Ser. No. 08/795,968
`filed Feb. 5, 1997 now U.S. Pat. No. 5,851,197.
`
`FIELD OF THE INVENTION
`
`10
`
`15
`
`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 inser
`tion 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
`
`25
`
`30
`
`35
`
`40
`
`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 transcutane
`ous 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
`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
`ing specified patient parameters, such as blood glucose level.
`In certain medical treatment regimens, it may be neces
`sary 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 pro
`grammable 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
`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.
`55
`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 administration of the
`medication. Such difficulties can be attributable to insuffi
`cient manual dexterity or skill to achieve proper needle
`placement or, alternately to, anxiety associated with antici
`pated discomfort as the needle pierces the skin. This prob
`lem can be especially significant with medications 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
`
`45
`
`50
`
`60
`
`65
`
`2
`angle relative to the patient’s skin, and/or needle placement
`with an incorrect force and speed of insertion.
`The present invention relates to an automatic injector,
`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
`comfort.
`
`SUMMARY OF THE DISCLOSURE
`
`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.
`According to an embodiment of the invention, an injector
`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.
`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 transcu
`taneous 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.
`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
`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.
`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 advanced
`position, whereat the injector can be separated with minimal
`separation force from the insertion set.
`
`Page 28 of 40
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`US 7,207,974 B2
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`3
`In an alternative preferred form, the safety lock mecha
`nism comprises a plunger head having a cylindrical shape
`defining a forwardly open cavity for receiving and Support
`ing 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.
`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 coaxially 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 member release for trans
`cutaneously placing the medical insertion needle. After the
`needle is placed on the patient, the injector can be disas
`sembled 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.
`In other embodiments of the present invention, an inser
`tion 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
`ough the skin of the patient to install the insertion set to the
`patient. The receiving structure of the carrier body is remov
`able from the insertion set while maintaining the installation
`of the insertion set to the patient.
`In particular embodiments, the predetermined angle rela
`tive 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 translucta
`neous 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 embodiments, the at least one piercing
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`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-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.
`In yet other embodiments the insertion device, the device
`housing has a forward end defining a generally planarangled
`insertion contact Surface for placement against the skin of a
`patient with the device housing in a predetermined orienta
`tion relative to the patient’s skin that mirrors the predeter
`mined 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
`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
`ing the carrier body against rotation relative to the device
`housing.
`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.
`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
`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
`mined angle relative to the skin of the patient to install the
`insertion set to the patient. The set housing of the insertion
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`5
`set is removable from the receiving structure of the carrier
`body while maintaining the installation of the insertion set to
`the patient.
`In particular embodiments of the insertion set, the prede
`termined 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 transluctaneous 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
`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
`needles. Also, in some embodiments, the insertion set can be
`both an infusion set and a sensor set combined into an
`integral unit.
`Other features and advantages of the invention will
`become apparent from the following detailed description,
`taken in conjunction with the accompanying drawings which
`illustrate, by way of example, various features of embodi
`ments of the invention.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`A detailed description of embodiments of the invention
`will be made with reference to the accompanying drawings,
`wherein like numerals designate corresponding parts in the
`several figures.
`FIG. 1 is a perspective view illustrating use of an auto
`matic injector embodying the novel features of the inven
`tion;
`FIG. 2 is an enlarged front elevation view of the injector
`shown in FIG. 1;
`FIG. 3 is a front or nose end view of the injector, taken
`generally on the line 3—3 of FIG. 2;
`FIG. 4 is an enlarged exploded perspective view illustrat
`ing assembly of the injector with a Subcutaneous insertion
`Set;
`FIG. 5 is a further enlarged longitudinal sectional view
`taken generally on the line 5–5 of FIG. 4;
`FIG. 6 is a transverse sectional view taken generally on
`the line 6–6 of FIG. 5:
`FIG. 7 is an enlarged longitudinal sectional view taken
`generally on the line 7 7 of FIG. 2:
`FIG. 8 is an enlarged and exploded fragmented perspec
`tive view illustrating a trigger assembly for use in the
`injector,
`FIG. 9 is a longitudinal sectional view similar to FIG. 5,
`and showing the injector with insertion set received therein
`for transcutaneous placement through the skin of a patient;
`FIG. 10 is a transverse sectional view taken generally on
`the line 10 10 of FIG. 9;
`FIG. 11 is a longitudinal sectional view taken generally on
`the line 11–11 of FIG. 9;
`FIG. 12 is a rear end elevation view taken generally on the
`line 12–12 of FIG. 11, and depicting the trigger assembly
`in a locked position;
`FIG. 13 is an enlarged fragmented longitudinal view
`similar to a portion of FIG. 11, but depicting actuation of the
`trigger assembly for releasing the spring-loaded plunger,
`FIG. 14 is a rear end elevation view taken generally on the
`line 14—14 of FIG. 13, similar to FIG. 12, but showing the
`trigger assembly in an unlocked position;
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`FIG. 15 is a fragmented longitudinal sectional view
`depicting the spring-loaded plunger in a fully advanced
`position with the infusion set placed on the patient’s skin;
`FIG. 16 is an exploded perspective view illustrating
`separation of the insertion needle from the cannula of the
`Subcutaneous insertion set;
`FIG. 17 is a perspective view depicting an alternative
`preferred form of the invention;
`FIG. 18 is a front elevation view of the injector shown in
`FIG. 17:
`FIG. 19 is a front or nose end view of the injector, taken
`generally on the line 19–19 of FIG. 18;
`FIG. 20 is an enlarged side elevation view of the injector,
`taken generally on the line 20–20 of FIG. 19:
`FIG. 21 is a further enlarged longitudinal sectional view
`taken generally on the line 21—21 of FIG. 17:
`FIG. 22 is an enlarged exploded perspective view illus
`trating construction details of a plunger and trigger member
`for use in the injector of FIG. 17:
`FIG. 23 is an enlarged longitudinal sectional view similar
`to FIG. 21, and depicting the injector with the trigger
`member in a cocked position;
`FIG. 24 is a fragmented perspective view showing the
`upper end of the injector depicted in FIG. 23, with the trigger
`member in the cocked position;
`FIG. 25 is an enlarged and fragmented longitudinal sec
`tional view illustrating actuation of the trigger member;
`FIG. 26 is an enlarged and fragmented longitudinal sec
`tional view showing the plunger in a fully advanced position
`with the infusion set placed on the patient’s skin;
`FIG. 27 is an enlarged fragmented longitudinal sectional
`view taken generally on the line 27 27 of FIG. 22, and
`depicting a portion of the plunger,
`FIG. 28 is a front or nose end elevational view of the
`plunger, taken generally on the line 28 28 of FIG. 27; and
`FIG. 29 is an enlarged fragmented longitudinal sectional
`view illustrating release of the injector from an infusion set
`placed on the patient’s skin;
`FIG.30 is an exploded prospective view generally similar
`to FIG. 17, but depicting a further alternative preferred form
`of the invention, and showing assembly of an insertion set
`with the illustrative injector;
`FIG.31 is a perspective view similar to FIG. 32, depicting
`further assembly of the insertion set with the injector;
`FIG. 32 is an enlarged fragmented vertical sectional view
`taken generally on the line 32—32 of FIG. 31;
`FIG.33 is a perspective view showing use of the injector
`of FIGS. 30–32 for transcutaneous placement of the inser
`tion set; and
`FIG. 34 is an exploded perspective view similar to FIG.
`33, and showing use of the injector to separate a medical
`needle from the installed insertion set.
`FIG. 35 is a perspective view of an insertion device with
`one type of an insertion set in accordance with a second
`embodiment of the present invention.
`FIG. 36 is a bottom perspective view of the insertion
`device of FIG. 35.
`FIG. 37 is a side plan view of the insertion device and
`insertion set shown in FIG. 35.
`FIG. 38 is an exploded cross-sectional view of the inser
`tion device and the one type of insertion set as shown along
`the line 38 38 in FIG. 37.
`FIG. 39 is a top perspective view of one type of insertion
`set for use with the insertion device shown in FIG. 35.
`FIGS. 40a 40g illustrate the steps of inserting the one
`type of insertion set of FIG. 39 with the insertion device of
`FIG. 35.
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`7
`FIG. 41 is a perspective view of an insertion device with
`one type of an insertion set in accordance with a third
`embodiment of the present invention.
`FIG. 42 is an exploded perspective view of the insertion
`device shown in FIG. 41.
`FIG. 43 is an exploded side plan view of the insertion
`device and the one type of insertion set shown in FIG. 41.
`FIG. 44 is an enlarged side plan view of the one type of
`insertion set held in a carrier body of the insertion device
`shown in FIG. 41.
`FIG. 45 is a front perspective view of the insertion device
`and the one type of insertion set shown in FIG. 41.
`FIG. 46 is a cross-sectional view of the insertion device
`and the one type of insertion set as shown along the line
`46 46 in FIG. 45.
`FIG. 47 is a top schematic view of an insertion device in
`accordance with a fourth embodiment of the present inven
`tion.
`FIGS. 48a–48d are cross-sectional views of a force
`changing mechanism for use with embodiments of the
`present invention.
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`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`As shown in the drawings for purposes of illustration, the
`invention is embodied in an insertion device for insertion
`sets such as an infusion set, sensorset, medical device, or the
`like. Further embodiments of the insertion device may be
`used to insert other insertion sets or medical devices such as
`biodegradable implants, capsules, impregnated threads (with
`medications or the like). Other insertion sets may be directed
`to a threaded needle insertion set, such as that described in
`U.S. Pat. No. 5,584,813 issued Dec. 17, 1996 to Livingston
`et al. entitled “Subcutaneous Injection Set' and U.S. Pat. No.
`5,779,665 issued on Jul. 14, 1998 to Mastrototaro et al.
`entitled “Transdermal Introducer Assembly', which are
`herein incorporated by reference. In addition, the insertion
`sets may be coated with medications, or other agents, that
`inhibit infection and/or promote healing of the insertion site.
`Preferred embodiments of the insertion device and insertion
`sets are for transcutaneous placement of the insertion set in
`Subcutaneous tissue. However, in alternative embodiments,
`the insertion set may be inserted into other subdermal
`tissues. In addition, still further embodiments may be used
`to place the sets in other types tissue. Such as muscle, lymph,
`organ tissue or the like, and used in animal tissue. In
`preferred embodiments of the prese