`(12) Patent Application Publication (10) Pub. No.: US 2007/0093754 A1
`Mogensen et al.
`(43) Pub. Date:
`Apr. 26, 2007
`
`US 200700.93754A1
`
`(54) INVISIBLE NEEDLE
`
`(76) Inventors: Lasse W. Mogensen, Soborg (DK);
`Orla Mathiasen, Soro (DK)
`
`Correspondence Address:
`BRINKSHOFER GILSON & LONE
`P.O. BOX 10395
`CHICAGO, IL 60610 (US)
`
`(21) Appl. No.:
`
`11/519,137
`
`(22) Filed:
`
`Sep. 11, 2006
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/716,222, filed on Sep.
`12, 2005.
`Foreign Application Priority Data
`
`(30)
`
`Sep. 12, 2005 (EP).............................. EP 05 197 774.8
`
`
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6M 5/78
`(2006.01)
`A6M 5/00
`(2006.01)
`A6M 25/00
`(52) U.S. Cl. .............. 604/164.01: 604/181; 604/164.12:
`604/264
`
`ABSTRACT
`(57)
`The invention relates to an inserter for an infusion set for
`intermittent or continuous administration of a therapeutical
`Substance, such as e.g. insulin. The inserter comprises a
`needle hub comprising an insertion needle and two spring
`units assuring automatic insertion and automatic retraction
`of the insertion needle.
`The inserter comprises a housing (1), a carrier body (2)
`carrying an infusion part (8), a needle hub (3), a first moving
`unit (4) bringing the carrier body (2) to a forward position
`and a second moving unit (5) bringing the carrier body (2)
`to a retracted position. The inserter is characterized in that it
`has means for activation which should be activated at least
`once in order to bring the carrier body (2) from a retracted
`to a forward position, and back from the forward to the
`retracted position.
`
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`US 2007/0093754 A1
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`Apr. 26, 2007
`
`NVISIBLE NEEDLE
`0001) This application claims the benefit of U.S. Provi
`sional Application Ser. No. 60/716,222, filed Sep. 12, 2005,
`and EP Patent Application No. 05 197774.8, filed Sep. 12,
`2005, which are incorporated herein in their entirety.
`
`TECHNICAL FIELD
`0002 The invention relates to an inserter for an infusion
`set for intermittent or continuous administration of a thera
`peutical Substance, Such as e.g. insulin. The inserter com
`prises a needle hub comprising an insertion needle and two
`spring units assuring automatic insertion and automatic
`retraction of the insertion needle.
`
`BACKGROUND OF THE INVENTION
`0003) The document U.S. Pat. No. 6,387,078 pertains to
`an automatic injection apparatus which injects a single,
`pre-measured dose of stored medicine intramuscularly or
`transdermally, and the injection apparatus automatically
`retracts the hypodermic needle into the device after the
`injection is completed. The user presses the distal end i.e. the
`needle end, of the device onto the desired injection site and
`presses the actuation button. This releases the plunger
`Syringe-combination from its temporary engagement with
`the housing. The plunger-syringe-combination together with
`the spring-to-plunger-coupling are then forced away from
`the proximal end, i.e. the actuation end, of the housing by an
`energized driver spring. The driver spring propels the
`plunger-syringe-combination forward through the bore of
`the housing until the hypodermic needle exits the housing,
`and enters the recipient's tissue, and the Syringe barrel
`touches the interior distal end of the housing. During this
`movement, a return spring positioned between the Syringe
`assembly and the fixed, distal end of the housing becomes
`compressed and energized. When the liquid of the automatic
`injection apparatus is discharged by the plunger being
`pushed forward through the interior of the syringe barrel, the
`spring-to-plunger-coupling comes into contact with a split
`ter which disengages the driver spring from the plunger.
`Without the influence of the driver spring upon the plunger
`Syringe-combination, the energized return spring forces the
`plunger-syringe-combination to retreat rearward towards the
`proximal end of the device until the hypodermic needle is
`fully retracted into the housing.
`0004 As this automatic injection apparatus is directed
`toward injections of a pre-measured dose of stored liquid
`medicine where the plunger during injection pushes the
`liquid dose of stored medicine out of the apparatus, the
`Solution will not be applicable for use when inserting an
`injection device as the handling and injection of a liquid
`under Sterile conditions necessitates a complicated injection
`apparatus which need to interact with the liquid.
`0005 WO 2005/046780 (FIG.97-102) describes a device
`used for automatic insertion of a cannula of an infusion
`device into the skin of a patient, and afterwards automatic
`retraction of the insertion needle. The insertion device has
`the form of an oblong cylinder (lengths4x diameter) which
`is open in one end (1984) and provided with means for
`activation at the other end (1952). When the infusion set has
`been loaded onto the needle (1968) the lock member (1962)
`is moved in direction of the end provided with means for
`activation by the patient using projections (1974) which
`
`projections are accessible through a slot (1976) of the
`housing until barbs (1956) of the lock member (1962)
`engage an outer Surface of the housing (page 26, I. 24-27).
`Then the open end (1984) is placed against the skin of the
`patient and the means for activation (1952) is activated.
`When activated shoulders (1954) on the means for activation
`engage, the barbs (1956) are pushed toward each other in
`order to disengage the barbs from the housing. When the
`barbs are clear of the housing the lock member, the needle
`hub, the retainer body and the associated infusion device are
`moved by a first spring in direction of the open end (1984).
`The inserter device moves the infusion device towards the
`skin of the patient thereby inserting the needle and the
`cannula of the infusion device. As the cannula is fully
`inserted, barbs (1964) of the needle hub (1965) engage
`ramped surfaces (1972) of the sleeve (1982), causing the
`barbs (1964) to be forced toward one another. When the
`barbs (1964) have been forced sufficiently inwardly to clear
`ends (1988) of the main body (1980), the second spring
`(1966) then moves the needle hub (1965) in the direction of
`the activation means (1952). Thus the needle is removed
`from the infusion device leaving the infusion device in place
`on the skin while the retainer body remains in a position
`adjacent the open end of the sleeve so that once the insertion
`device is removed from the skin of the patient, the retainer
`body protects the patient from further contact with the
`needle.
`0006. This insertion device is rather complex and the
`length of the device is defined by the individual units
`forming the functional parts of the device as these units have
`to be placed more or less end to end. A feature illustrating
`the complexity of the unit is the fact that the two springs
`respectively biases the housing from the lock member and
`the retainer body from the needle hub while a main body is
`placed between the two spring systems to transfer the force
`from the first spring to the second spring.
`0007 According to the present invention the two spring
`units work directly together, as the first spring unit directly
`affects the movement of the carrier body while the second
`spring system is directly affected by the movement of the
`carrier body. That the spring units directly affect or is
`directly affected by the carrier body means that the spring
`units are connected to the carrier body directly or through a
`part which transfers the power either unchanged or under
`controlled modifications.
`
`DESCRIPTION OF INVENTION
`0008. The object of the invention is to provide a simple,
`non-expensive inserter for an infusion device which inserter
`would be easy and safe for the user to handle during use and
`safe to dispose of after use.
`0009. The invention concerns an inserter for an infusion
`set comprising a housing, a carrier body carrying an infusion
`part, a needle hub, a first moving unit bringing the carrier
`body to a forward position and a second moving unit
`bringing the carrier body to a retracted position, where the
`inserter has means for activation which should be activated
`at least once in order to bring the carrier body from a
`retracted to a forward position, and back from the forward
`to the retracted position.
`0010. In a preferred embodiment the inserter has means
`for activation which has to be activated only once in order
`
`Page 7 of 10
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`US 2007/0093754 A1
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`Apr. 26, 2007
`
`both to bring the carrier body from a retracted to a forward
`position, and back from the forward to the retracted position.
`0011
`Preferably the first moving unit and the second
`moving unit are placed at least partly parallel to each other,
`where “parallel' is understood as not being “serially”.
`“Serially’ means that one moving unit is placed in extension
`of the other as described e.g. in WO 2005/046780. When the
`moving units are placed at least partly parallel they could be
`placed beside each other i.e. they extend over the same
`length or partly over the same length, or one unit could be
`placed inside the other if e.g. one of the units is of a kind
`presenting a hollow centre Such as a helical spring.
`0012. In a preferred embodiment the first moving unit
`and the second moving unit are placed at least partly parallel
`to each other inside the housing.
`0013 The invention also comprises an inserter for an
`infusion set comprising a housing, a carrier body carrying an
`infusion part, a needle hub, a first spring unit and a second
`spring unit, where
`0014 the housing is provided with guiding means on
`the internal Surface for guiding the movement of the
`carrier body,
`0015 the needle hub comprises an insertion needle for
`p
`piercing of the skin,
`0016 the carrier body has a retracted and a forward
`position, and in the retracted position before insertion
`the carrier body and the needle hub are locked to each
`other,
`0017 the carrier body is provided with guiding means
`corresponding to the guiding means on the housing,
`0018 the first spring unit is biasing the housing and the
`carrier body and the second spring unit is biasing the
`carrier body and the needle hub.
`0019. In a preferred embodiment the first and the second
`spring unit are both connected to a distal Surface of the
`carrier body.
`0020. In another preferred embodiment the carrier body
`stays in a forward position after insertion of the needle.
`0021. In another preferred embodiment the infusion part
`is provided with an adhesive proximal Surface.
`0022. In another preferred embodiment the infusion part
`is provided with an adhesive distal surface.
`0023. In another preferred embodiment an adhesive pad
`is releasably fastened to a proximal part of the housing, and
`the adhesive pad can cover a proximal opening of the
`housing through which the infusion part will be conveyed.
`0024. In another preferred embodiment the first spring
`unit and the second spring unit respectively comprises one
`compression spring.
`0025. In another preferred embodiment the carrier body
`is provided with at least one inclined surface which surface
`is in contact with a rotating part of the needle hub, which
`rotating part can rotate in relation to the main part of the
`needle hub to which the insertion needle is fastened, and the
`housing is provided with a member preventing the rotating
`part of the needle hub from rotating when the carrier body
`is in a retracted position.
`
`0026. The invention also comprises a method for insert
`ing an infusion part where the infusion part is releasably
`fastened to a needle hub and the needle hub is releasably
`fastened to a carrier body which carrier body carries the
`infusion part from a retracted to a forward position, where
`0027 a biased spring unit activated by the user, moves
`the carrier body, the needle hub and the infusion part
`forward from a retracted position, until a proximal Surface of
`the infusion part contacts the patients skin or contacts a part
`connected to the patients skin;
`0028 at this forward position the needle hub is released
`from the carrier body and a biased spring unit moves the
`needle hub away from the carrier body resulting in the
`retraction of the needle hub; then the infusion part is released
`from the carrier body and the housing including the carrier
`body and the needle hub is removed from the patient.
`
`DESCRIPTION OF THE DRAWINGS
`0029. The invention is explained in greater detail below
`with reference to the accompanying drawings wherein a
`preferred embodiment of the invention is shown.
`0030 FIG. 1 is a side view of an embodiment of the
`inserter of the invention where the carrier body and the
`infusion device are in a retracted position;
`0031 FIG. 2 is a side view of the inserter with the carrier
`body and the infusion device in an advanced position where
`the needle hub is locked to the carrier body;
`0032 FIG. 3 is a side view of the inserter with the carrier
`body and the infusion device in an advanced position where
`the needle hub has been released from the carrier body;
`0033 FIG. 4 is a side view of the inserter with the carrier
`body and the infusion device in an advanced position where
`the needle hub is in a retracted position;
`0034 FIG. 5 is a side view of the inserter after the inserter
`has been removed from the patient leaving the infusion part
`on the patient’s skin.
`0035) In this document “distal describes a surface or a
`part turned away from or placed away from the patient when
`the inserter is positioned with the needle end toward the
`patient. “Proximal describes a surface or a part turned in
`direction of or placed close to the patient.
`0036) The embodiment of the inserter in FIG. 1 has a
`housing 1 with a length a little smaller than the diameter
`(lengths 1x diameter). The design of this inserter is mainly
`defined by the use and not by the constructional units inside
`the inserter. The constructional units of the device are few
`and Small, and the design of the inserter Such as size and
`shape, results from a wish of making the device easy to store
`and easy to handle for a user, even if the user has reduced
`dexterity of the hands.
`0037. The inserter comprises a carrier body 2 with at least
`two locking members 2a protruding from a distal Surface of
`the carrier body. A needle hub 3 is placed between the two
`locking members 2a, and the needle hub is provided with
`members 3a protruding from a distal surface of the needle
`hub and corresponding to the locking means 2a of the carrier
`body 2. These protruding members 3a can rotate towards the
`center of the device along an axis through which they are
`also fastened to the main part of the needle hub 3. Further
`
`Page 8 of 10
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`Apr. 26, 2007
`
`the needle hub is provided with an insertion needle 6
`protruding from a proximal surface of the needle hub.
`Before insertion an infusion part 8 is fastened to the carrier
`body 2, the infusion part is provided with a cannula which
`is adjoined to the insertion needle in Such a way that
`insertion of the needle 6 will result in insertion of the
`cannula. An adhesive pad 7 with an adhesive proximal
`Surface covers the proximal opening of the housing 1. The
`adhesive surface of the pad 7 will normally be covered with
`a release liner in order to protect the adhesive surface.
`0038. During insertion the needle hub 3 is moved from a
`retracted position, to a forward position and back to a
`retracted position by a system of springs. The system in FIG.
`1-5 comprises two springs, a first spring 4 and a second
`spring 5. According to Hooke's law the force exerted by a
`spring depends on displacement of the spring X and of the
`spring constant k. F--k X. Each of the springs 4 and 5
`can be replaced by more than one spring, then the spring unit
`replacing e.g. the first spring 4 shown in FIG. 1-5, would
`exert the force:
`
`Fspring =
`
`. .k are the spring constants for the
`.
`where k, k .
`individual springs, and
`Fi-kx, where k=k1+k+...+k,
`0.039 The first spring 4 and the second spring 5 can
`comprise both compression and tension springs.
`0040. In the embodiment of FIG. 1-5, the housing 1 is
`provided with guiding means 1a and 1b. The guiding means
`1a and 1b comprises parallel walls, an inner wall 1a and an
`outer wall 1b, protruding from the distal inner surface of the
`housing 1. The locking members 2a of the carrier body 2 and
`the protruding members 3a of the needle hub 3 are placed
`between the parallel walls 1a and 1b. The locking members
`2a have one or more inclined surfaces which are in contact
`with a part of the protruding members 3a. When the carrier
`body 2 is pulled or pushed towards the patient’s skin, the
`locking members 2a will exert a force on and perpendicular
`to each inclined surface. This force has one component
`parallel to the walls 1a and 1b pointing in same direction as
`the movement, and another component perpendicular to the
`first component pointing toward the inner wall 1a. As long
`as the inner wall 1a is present, a force of same size but
`opposite direction as the second component will push back
`from the inner wall 1a keeping the protruding member 3a in
`a steady position between the walls 1a and 1b. When the
`inner wall la is not present the second component of the
`force exerted by the locking member will push the protrud
`ing members 3a towards the center of the device.
`0041 When the protruding members 3 have been
`released from interlocking with the locking members 2a, the
`needle hub is not influenced by a force in direction of the
`infusion part, and the force exerted by the second string 5
`will overcome the friction between the insertion needle and
`the cannula extending from the infusion part 8 and move the
`needle hub 3 away from the infusion part 8.
`0042. In FIG. 1 the carrier body 2 is placed and locked in
`a retraced position. The insertion needle 6 which is adjoined
`
`to the cannula is seen below the infusion part 8. Both the
`spring units 4 and 5 are biased, and the locking members 2a
`is interlocked with the protruding members 3a of the needle
`hub 3 due to support of the inner walls 1a.
`0043. When the user wants to insert the infusion device,
`the device is first placed on the insertion site on the patient.
`Then the inserter is activated by the user by unlocking the
`carrier body 2 from the housing 1.
`0044) It is not shown on this embodiment how unlocking
`of the carrier body 2 is done but one way is to provide the
`carrier body 2 with two members protruding into openings
`of the housing 1 opposite each other. Unlocking of the
`carrier body is then performed by the user pressing on the
`housing 1 at two opposite points placed on a line perpen
`dicular to the line formed by the two protruding members of
`the carrier body 2. Pressing on the two points on the
`perpendicular line will cause a deformation of the housing 1
`and increase the distance between the two corresponding
`openings in the housing 1, the protruding members of the
`carrier body will then be released from the housing 1.
`0045 When the inserter is activated the first string 4 tries
`to return to an unbiased position and doing this brings the
`carrier body 2 and the infusion part 8 to a forward position
`shown in FIG. 2.
`0046.
`In this forward position the insertion needle 6 and
`the adjoined cannula have penetrated the adhesive pad 7
`placed at the proximal end of the housing 1. The protruding
`members 3a of the needle hub 3 have in FIG. 2 been released
`from the Support of the inner walls 1a, and as soon as the
`release from the inner walls 1a has taken place the protrud
`ing members 3a of the needle hub will be forced towards the
`center of the inserter to the position shown in FIG. 3.
`0047 Immediately after the protruding members 3a of
`the needle hub are free of the inner walls 1a, the upward
`force from the spring unit 5 will bring the needle hub 3 to
`the position shown in FIG.4, where the needle hub 6 and the
`insertion needle 6 is fully covered by the housing 1.
`0.048. In FIG. 5 it is shown how the infusion part 8 has
`been secured to the adhesive pad 7, the pad 7 is secured to
`the patient, and then the inserter is removed and can be
`disposed of in a safe way together as the contaminated
`insertion needle 6 is placed behind the protective walls of the
`inserter housing 1.
`1. An inserter for an infusion set comprising a housing (1),
`a carrier body (2) carrying an infusion part (8), a needle hub
`(3), a first moving unit (4) bringing the carrier body (2) to
`a forward position and a second moving unit (5) bringing the
`carrier body (2) to a retracted position, characterized in that
`the first moving unit (4) and the second moving unit (5) are
`placed at least partly parallel to each other.
`2. The inserter of claim 1, wherein the first and the second
`moving unit (4, 5) both are connected to a distal surface of
`the carrier body (2).
`3. The inserter of claim 1, wherein the first moving unit
`(4) and the second moving unit (5) are placed inside the
`housing (1).
`4. The inserter of claim 1, wherein
`the housing (1) is provided with guiding means (1a, 1b)
`on the internal Surface for guiding the movement of the
`carrier body (2),
`
`Page 9 of 10
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`Apr. 26, 2007
`
`the needle hub (3) comprises an insertion needle (6) for
`piercing of the skin,
`the carrier body (2) has at least one retracted and at least
`one forward position, and in the retracted position
`before insertion, the carrier body (2) and the needle hub
`(3) are locked to each other,
`the carrier body (2) is provided with guiding means (2a)
`corresponding to the guiding means (1a, 1b) of the
`housing (1),
`the first moving unit (4) is biasing the housing (1) and the
`carrier body (2) and the second moving unit (5) is
`biasing the carrier body (2) and the needle hub (3).
`5. The inserter of claim 1, wherein the carrier body (2)
`stays in a forward position after insertion of the needle (6).
`6. The inserter of claim 1, wherein the infusion part (8) is
`provided with an adhesive proximal surface.
`7. The inserter of claim 1, wherein the infusion part (8) is
`provided with an adhesive distal surface.
`
`8. The inserter of claim 4, wherein an adhesive pad (7) is
`releasably fastened to a proximal part of the housing (1).
`9. The inserter of claim 8, wherein the adhesive pad (7)
`covers the proximal opening of the housing (1) through
`which the infusion part (8) is conveyed.
`10. The inserter of claim 8, wherein the first moving unit
`(4) and the second moving unit (5) each comprises a
`compression spring.
`11. The inserter of claim 4, wherein the carrier body (2)
`is provided with at least one inclined surface which surface
`is in contact with a rotating part (3.a) of the needle hub (3),
`which rotating part (3.a) can rotate in relation to a main part
`of the needle hub (3) to which the insertion needle is
`fastened, and the housing (1) is provided with a member (1a)
`preventing the rotating part (3.a) of the needle hub (3) from
`rotating when the carrier body (2) is in a retracted position.
`
`Page 10 of 10
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