throbber
(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2009/0099521 A1
`Gravesen et al.
`(43) Pub. Date:
`Apr. 16, 2009
`
`US 20090099.521A1
`
`(54) CANNULA INSERTION DEVICE AND
`RELATED METHODS
`
`(76) Inventors:
`
`Peter Gravesen, Nordborg (DK);
`Heiko Arndts, Flensborg (DE)
`
`Add
`d
`C
`orrespondence
`CSS
`GOODWIN PROCTER LLP
`PATENT ADMINISTRATOR
`53 STATE STREET, EXCHANGE PLACE
`BOSTON, MA 02109-2881 (US)
`
`(21) Appl. No.:
`
`12/250,760
`
`(22) Filed:
`
`Oct. 14, 2008
`
`Foreign Application Priority Data
`(30)
`Oct. 16, 2007 (DE) ...................... 10 2007 O49 446.9
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6M 5/20
`(52) U.S. Cl. ........................................................ 604/136
`(57)
`ABSTRACT
`A cannula insertion device includes a housing defining an
`opening for receiving therethrough a cannula and further
`defining a channel, and a cannula forming a lumen, the can
`nula adapted for sliding movement within the housing from a
`retracted position to an extended position. When the cannula
`is in the retracted position, the lumen is located remotely from
`the channel and the channel is in fluidic communication with
`the opening. When the cannula is in the extended position, the
`lumen is in fluidic communication with the channel.
`
`16
`
`27a
`
`N
`
`XXXXXXKC XXXXX
`XXXXXX XXXXXX & S&
`
`
`
`
`
`
`
`
`
`Page 1 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 1 of 15
`
`US 2009/0099.521 A1
`
`8 & &
`%
`8 KO :
`LG3x
`
`N --&
`
`
`
`c
`N
`CN
`
`CO
`
`
`
`s
`
`s
`
`
`
`
`
`
`
`
`
`
`
`so
`
`
`
`
`
`%ta 3 %
`is 2N. ZŽZ
`
`8 X S C
`
`SS& AMY
`& CK X s
`
`X
`
`Ox
`
`H
`
`% R N
`
`& X &
`
`/
`
`N. cn r
`do od On
`re
`N > N so 92 &
`
`ld Ud
`CN
`
`CYo
`
`Page 2 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 2 of 15
`
`US 2009/0099.521 A1
`
`
`
`29
`
`FIG. 4
`
`Page 3 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 3 of 15
`
`US 2009/0099.521 A1
`
`
`
`26
`
`36
`37
`22
`
`
`
`
`
`16
`
`N
`2
`a
`
`2
`
`E
`
`18
`
`3.
`2.
`XXXXX XXXXX
`S&S&
`8
`
`
`
`FIG. 5
`
`Page 4 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 4 of 15
`
`US 2009/0099.521 A1
`
`7] ],
`
`Z0),
`
`(H
`
`-
`
`-SS
`
`N &
`N SN 12
`(Lu
`2- Stz
`N
`
`NYNY Y
`
`Nil
`
`
`
`
`
`
`
`
`
`90||
`
`XXXXXXXXXXXXXXX
`
`NSS
`
`N
`
`Page 5 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 5 of 15
`
`US 2009/0099.521 A1
`
`S 108
`
`109
`
`119
`
`114
`
`FIG. 8
`
`Page 6 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 6 of 15
`
`US 2009/0099.521 A1
`
`
`
`
`
`
`
`? CXXXXXX
`XXXXXX
`CXXXXXX
`
`×××××××××××××××
`CXOXOXOXOXOXOXOXOXOXOXOXOXOXO
`
`GOZ
`
`| ZZÇOZ
`
`Page 7 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 7 of 15
`
`US 2009/0099.521 A1
`
`r O
`CN
`
`
`
`s
`C
`
`2
`
`S.
`
`s
`
`s
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Ka/
`
`O KO
`
`: : : X d
`
`C C
`
`Page 8 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 8 of 15
`
`US 2009/0099.521 A1
`
`817
`
`08Z
`
`Z
`
`?A||22. – XHX
`
`
`
`Page 9 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 9 of 15
`
`US 2009/0099.521 A1
`
`
`
`FIG. 15A
`
`Page 10 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 10 of 15
`
`US 2009/0099.521 A1
`
`
`
`342
`
`16117
`
`340
`
`FIG. 15B
`
`Page 11 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 11 of 15
`
`US 2009/0099.521 A1
`
`
`
`
`
`FIG 16
`
`Page 12 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 12 of 15
`
`US 2009/0099.521 A1
`
`308
`
`336 316
`
`N
`
`
`
`304
`
`KXXXX X
`402
`
`FIG. 17
`
`Page 13 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 13 of 15
`
`US 2009/0099.521 A1
`
`310
`
`
`
`
`
`
`
`N
`
`
`
`N
`
`FIG. 18
`
`Page 14 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 14 of 15
`
`US 2009/0099.521 A1
`
`
`
`FIG. 19
`
`Page 15 of 25
`
`

`

`Patent Application Publication
`
`Apr. 16, 2009 Sheet 15 of 15
`
`US 2009/0099.521 A1
`
`
`
`
`
`
`
`
`
`Page 16 of 25
`
`

`

`US 2009/0099.521 A1
`
`Apr. 16, 2009
`
`CANNULAINSERTON DEVICE AND
`RELATED METHODS
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`0001. This application claims priority to and the benefit of
`German Patent Application Serial No. 10 2007 049 446.9,
`filed Oct. 16, 2007, the disclosure of which is hereby incor
`porated by reference herein in its entirety.
`
`FIELD OF THE INVENTION
`0002 This invention relates generally to systems and
`methods for inserting a cannula into a patient and, more
`specifically, to a device that automatically inserts a cannula,
`as well as connects the cannula lumen to a channel within an
`infusion device.
`
`BACKGROUND
`0003. In many cases, it is necessary to insert a catheter or
`cannula into the body, or a body part of a patient. By means
`of the so-inserted cannula, it is then possible to infuse medici
`nally-required fluid or material. Another reason for the
`employment of a cannula may be to aid in insertion of a
`micro-dialysis probe into the body.
`0004 To insert a cannula into a patient, a rigid needle is
`placed within the lumen of the cannula, and the needle and
`cannula combination is forced into the skin of a patient. Once
`the cannula combination is fully inserted, the needle is
`retracted, leaving the cannula in place. When performed
`manually, the penetration of the catheter-carrying needle into
`the body, however, may be considered uncomfortable for a
`patient, or may cause Some other anxiety. Also, the Subse
`quent manual withdrawal of the needle is often regarded by
`Some patients as painful.
`0005. Automatic cannula insertion devices have been
`developed to address these issues. Typically, a cannula is
`included in a stand-alone device called an insertion or injec
`tion set. In addition to the cannula and needle, the insertion set
`often includes a housing to which the cannula is attached
`during use. The housing may have an adhesive pad for adher
`ing the housing to the skin of the patient during use, as well as
`an internal void or chamber that is penetrated by an inlet and
`a septum. The needle passes through the septum, Void, and
`into the lumen of the cannula. After insertion, the needle is
`withdrawn from the septum, which seals the void. Thereafter,
`a tube is connected to the inlet, thereby placing the lumen (via
`the Void) in fluidic communication with an infusion device,
`intravenous (IV) drip bag, or other medical equipment. The
`above-described insertion sets may be acceptable for some
`patients, but the attached tube and medical device can be
`obtrusive, which may be undesirable in some cases. It would
`be desirable then, to incorporate the functionality of an inser
`tion set into an infusion device to minimize the attendant
`tubing and complications involved in connecting the insertion
`set to the infusion device.
`
`SUMMARY OF THE INVENTION
`0006. The invention relates to an insertion device for a
`cannula, wherein the cannula is carried on a needle, as well as
`a cannula configuration that allows for automatic alignment
`ofan inlet on the cannula with a channel in an infusion device,
`without having to separately connect a tube thereto. In com
`
`bination with a drive apparatus, the needle can be displaced
`from a retracted position into an extended position, thus form
`ing a fluidic connection.
`0007. During an insertion procedure described herein, a
`cannula is used in conjunction with a needle. The needle is
`used to penetrate the body. Subsequently, the needle is with
`drawn from the body, allowing the cannula to remain in its
`inserted position. Consequently, one advantage of the inven
`tion is to increase the comfort of a patient during the insertion
`and withdrawal of a catheter or cannula. This benefit may be
`achieved with a device for the insertion of a cannula of the
`type described herein, wherein the needle, after reaching its
`extended State, can be withdrawn quickly and automatically
`by a retraction apparatus.
`0008. One embodiment of the invention allows the needle
`to not only quickly penetrate the body tissue (i.e., blood
`vessel, organ, or other body part) of a patient, but due to aid
`from the retraction apparatus, the needle is quickly with
`drawn from the body tissue and simultaneously, the inserted
`cannula remains within the body tissue. In this way, since the
`needle is relatively quickly withdrawn from the body tissue, a
`much more comfortable sensation is experienced than that
`associated with a slower insertion and withdrawal. Further,
`any sensation is transient. The retraction apparatus is acti
`vated, in any case, when the needle is already within the
`patient's tissue, that is to say, when the needle is in its
`extended position. Thereby, it is possible for the operator to
`insert the needle and its associated cannula to a sufficient
`depth to reach a desired position within the body tissue.
`0009. In one embodiment, the driving element or needle
`plunger is Subject to the force of a spring. The spring can be
`prestressed and restrained by an arresting apparatus from
`which it is released to carry out its driving function. The
`spring acts upon a drive mechanism, which includes at least
`one first part (e.g., a plunger), which is in driving contact with
`a free end of the spring and the drive mechanism includes one
`separate second part (e.g., a Support structure), indirectly
`activated by the spring. Thus, the second part is made slid
`ingly displaceable in a first direction by means of the motion
`of the first part and, conversely, separates itself therefrom
`upon a movement of the first part in an opposite direction.
`Such an arrangement reduces the weight, which contributes
`to momentum during the retraction of the needle. Simulta
`neously, the needle, upon its movement from the retracted
`position into the extended position, stabilizes the cannula
`Sufficiently when so projected, so that that the insertion pro
`cedure can be reliably carried out.
`0010. In certain embodiments, the needle, which is seated
`in the second part, is releasably held. Accordingly, the needle
`can disengage itself from the second part at the outset of a
`retracting motion and can be withdrawn without obstruction.
`In this way, the needle is not permanently affixed to the drive
`mechanism, an advantage which can be usefully employed to
`even move the needle more quickly, i.e., through more rapid
`increments of retractive motion.
`0011. At the time that the needle is disconnected from the
`second part, nothing more than the weight of the needle need
`be placed in motion, an advantage which allows undimin
`ished acceleration. Since the movement of a needle within the
`body tissue can be uncomfortable, it is helpful if the displace
`ment of the needle can be accelerated so that it can be
`removed from the tissue in a minimal amount of time.
`0012. In one embodiment, the activation of the needle is
`Subjected to force by a separate retraction spring (compres
`
`Page 17 of 25
`
`

`

`US 2009/0099.521 A1
`
`Apr. 16, 2009
`
`sion type) dedicated thereto, which acts in a direction from
`the second part toward the first part. It is possible, then, that
`this retraction spring serving the needle can be employed to
`force the now-released needle away from the second part in a
`direction that withdraws it from the penetrated body tissue.
`The second part can include at least one holding element that
`retains the needle therein, and permits the needle to be sub
`sequently retracted from an extended position. The concept of
`“retraction' or “withdrawal, as used herein, is used to
`describe removal of the needle from the lumen of the cannula
`after full insertion or extension of the cannula. The method of
`construction of the holding element, that is, as to whether its
`retaining characteristic is due to mechanical, magnetic, or
`other induced forces, is of secondary importance for the pur
`pose of this description. During the interim within which the
`needle has not yet reached its extended position, the holding
`element acts to affix the needle within the second part. As
`Soon as the second part has reached its final and extended
`position, the retention of the needle is no longer necessary.
`Accordingly, at this time, the holding element releases the
`needle, so that it departs from the second part and extricates
`itself therefrom.
`0013. In one embodiment, the holding element is located
`in the exposed surface of an end of the second part, from
`which the needle projects. From this end surface of the second
`part, when in extended position, the tip of the needle comes
`into contact with another surface. This so designated “other
`surface' can well be a surface of the patient's tissue, wherein
`the cannula is in the process of being inserted. Otherwise, the
`contacted Surface can even be a lining of a device housing. In
`any case, by means of an impact of the second part against a
`target Surface, the holding element is released, i.e., the reten
`tion of the needle therein is ended.
`0014. In one embodiment, the first part possesses an acti
`Vation element, which, at the completion of needle extension,
`acts upon the needle holding element. In this case, the first
`part is employed to relieve the holding element of the second
`part from its retaining function. By means of the mechanical
`structure of the holding element the needle is released when
`the position of the holding element changes. If the principle of
`construction of the holding element is electromagnetic in
`character, then the activation means may open a Switch,
`which will interrupt a Supply of current to the magnetic sys
`tem. In Such a case, the magnet becomes deprived of its
`power. Additionally, it is contemplated to displace a working
`magnet thereby terminating its holding ability. Additional
`methods for this removal of holding power are contemplated.
`0.015. In an embodiment of the invention, the activation
`means of the first part and also the holding element possess
`complementary, coacting, inclined surfaces. Motion of the
`activation means toward the holding element, which is carried
`out in a direction parallel to the needle, can be diverted to a
`motion not parallel, but rather angular therefrom. In this
`alteration, the angular direction could even be at a right angle.
`0016. The needle is supported by the said retraction spring
`to lie against the first part. This constructive Support can be
`used with or without a holding element. The retraction spring
`assures that the needle can be secured by means of one or
`more projections on the second part. This securement would
`hold the needle in place during the movement of the drive
`mechanism. When the needle and catheter begin to penetrate
`into the body tissue, the needle itself is subjected to a reaction
`force, which, without an element for holding, finally causes
`the needle to act contrary to the force of the retraction spring.
`
`Nevertheless, by means of an appropriate dimensioning of the
`retraction spring, arrangement can be made such that the
`needle-catheter combination penetrates sufficiently far into
`the subject body tissue.
`0017. The first part may possess a second holding means
`to which the needle becomes secured during a withdrawal
`from the extended position. This holding means retains the
`needle firmly within the first part, so that the needle retracts by
`means of the reversing motion of the first part of the drive
`mechanism.
`0018. In this arrangement, a second holding means con
`sists of a cavity in the first part. The needle, or if necessary, a
`thickened section of the needle, is then simply retainingly
`inserted into the first part and subsequently held there by a
`force of friction. The necessary frictional forces can be
`increased by an appropriate Surfacing of the interior of the
`cavity and/or increasing the size of the active exterior of the
`needle.
`0019. The first part and the second part are located in a
`housing. This housing possesses in the area remote from the
`drive spring, an end face that blocks the travel of the second
`part. If the second part makes contact with the end face of the
`housing, or places itself very close thereto, it will be held in
`position by the above described holding means. This prevents
`the second part from following the first part as it withdraws.
`0020. A storage means for medicaments or a communi
`cating fluidic connection for the cannula is located in the
`second part. In one embodiment, the second part is secured to
`the cannula, so that after the withdrawal of the needle, the
`cannula remains in its extended position in the tissue of the
`patient. The medicament can then be infused through the
`cannula into the body. An input or outtake branching can also
`be joined to the cannula line. By means of the input or outtake
`device, a medicament can be applied or blood or the like can
`be withdrawn from the body.
`0021. The drive mechanism functions with the aid of an
`inclined surface on which is formed a path for movement of
`the needle, since the inclined surface moves in a direction
`transverse (or angular) to that of the needle. This path, which
`accommodates the perpendicular travel of the needle, ends in
`a steplike termination. With such a termination as described,
`the functional movement of the needle is thus decoupled from
`its penetrative direction. The needle is forced by the inclined
`Surface and accordingly slides along this inclined surface,
`being augmented by the intervention of the drive mechanism.
`Because of the inclined surface, the needle is subjected to an
`angular resultant force, which causes the needle to move.
`Upon an activation of the drive mechanism, an additional
`force may be applied to alter the direction of motion of the
`needle.
`0022. The above “step” is formed by a recess in the
`inclined Surface. The needle, or an integral element thereof,
`drops into the recess once it has reached its final, extended
`position. This recess also blocks any additional movement of
`the inclined Surface. The inclined Surface possesses a helical
`configuration and moves in a rotatable body. This rotatable
`body comprises, for example, a cylindrical shape, and can
`forma part of the drive mechanism. When this body is rotated,
`then an effective area of the inclined surface forms a slidingly
`spiral path for the needle alone or for both the needle and the
`drive mechanism together. As the needle moves from its with
`drawn position into its extended position it may move with the
`drive mechanism. In this way, a relatively long length of the
`sliding path on the helical inclined surface is achieved with
`
`Page 18 of 25
`
`

`

`US 2009/0099.521 A1
`
`Apr. 16, 2009
`
`minimum space and an excessive dimensioning of the inser
`tion mechanism is thereby avoided.
`0023. In one aspect, the invention relates to a cannula
`insertion device including a housing defining an opening for
`receiving therethrough a cannula and further defining a chan
`nel, and a cannula forming a lumen, the cannula adapted for
`sliding movement within the housing from a retracted posi
`tion to an extended position, wherein when the cannula is in
`the retracted position, the lumen is located remotely from the
`channel and the channel is in fluidic communication with the
`opening, and when the cannula is in the extended position, the
`lumen is in fluidic communication with the channel. In an
`embodiment of the above aspect, the cannula insertion device
`further includes a base connected to the cannula, the base
`defining an internal chamber in fluidic communication with
`the lumen. In another embodiment, the base further defines a
`chamber extension in fluidic communication with the internal
`chamber. In yet another embodiment, when the cannula is in
`the extended position, the chamber extension is aligned with
`the channel. In still another embodiment, a wall of the base
`defines the chamber extension.
`0024. In another embodiment of the above aspect, the base
`includes a resilient sheath, the sheath defining a port Substan
`tially aligned with the chamber extension. In another embodi
`ment, when the cannula is in the extended position, the port is
`aligned with the channel. In yet another embodiment, when
`the cannula is in the extended position, the sheath seals the
`opening. In still another embodiment, the cannula insertion
`device further includes a plunger for driving the cannula from
`the retracted position to the extended position. In another
`embodiment, the cannula insertion device further includes a
`needle disposed in the lumen when the cannula is in the
`retracted position. In another embodiment, the needle is
`adapted to be automatically withdrawn from the lumen when
`the cannula is in the extended position. In another embodi
`ment, the needle is adapted to be automatically disconnected
`from the plunger when the cannula is in the extended position.
`0025. In another aspect, the invention relates to a method
`of inserting a cannula, the method including the steps of
`providing a housing defining an opening for receiving there
`through a cannula and further defining a channel, providing a
`cannula forming a lumen, the cannula adapted for sliding
`movement within the housing from a retracted position to an
`extended position, and extending the cannula from the
`retracted position, in which the lumen is located remotely
`from the channel and the channel is in fluidic communication
`with the opening, to the extended position, in which the lumen
`is in fluidic communication with the channel. In an embodi
`ment of the above aspect, the method further includes the step
`of piercing a skin of a patient with a needle and the cannula as
`the cannula moves from the retracted position to the extended
`position. In another embodiment, the method further includes
`the step of withdrawing the needle from the lumen automati
`cally when the cannula is in the extended position. In yet
`another embodiment, a plunger extends the cannula from the
`retracted position to the extended position, the plunger in
`contact with the needle. In still another embodiment, the
`method includes the step of disconnecting the needle from the
`plunger when the cannula is in the extended position. In
`another embodiment, the method includes the step of sealing
`the opening with the cannula when the cannula is in the
`extended position.
`BRIEF DESCRIPTION OF THE FIGURES
`0026. Other features and advantages of the present inven
`tion, as well as the invention itself, can be more fully under
`
`stood from the following description of the various embodi
`ments, when read together with the accompanying drawings,
`in which:
`0027 FIG. 1 is a schematic sectional side view of an
`insertion device in a retracted position in accordance with one
`embodiment of the invention;
`0028 FIG. 2 is a schematic sectional side view of the
`insertion device of FIG. 1 in an intermediate position;
`0029 FIG. 3 is a schematic sectional side view of the
`insertion device of FIG. 1 in a second intermediate position;
`0030 FIG. 4 is a schematic perspective view of a portion
`of an insertion device in accordance with another embodi
`ment of the invention;
`0031
`FIG. 5 is a schematic sectional side view of an
`insertion device in accordance with another embodiment of
`the invention;
`0032 FIG. 6 is a schematic side view of an insertion
`device in a retracted position in accordance with another
`embodiment of the invention;
`0033 FIG. 7 is a schematic side view of the insertion
`device of FIG. 6 in a withdrawn position:
`0034 FIG. 8 is a schematic perspective view of an inser
`tion ramp in accordance with one embodiment of the inven
`tion;
`0035 FIG. 9 is a schematic side view of an insertion
`device in a retracted position in accordance with another
`embodiment of the invention;
`0036 FIG. 10 is a schematic side view of the insertion
`device of FIG. 9 in an extended position;
`0037 FIG. 11 is a schematic side view of the insertion
`device of FIG. 9 in a withdrawn position:
`0038 FIG. 12 is a schematic top sectional view of the
`insertion device of FIG.9;
`0039 FIG. 13 is a schematic top sectional view of the
`insertion device of FIG. 11;
`0040 FIG. 14 is a schematic diagram of an exemplary
`infusion device microcircuit;
`0041
`FIG. 15A is a schematic perspective view of an
`automatically-aligning cannula in accordance with one
`embodiment of the present invention;
`0042 FIG. 15B is a schematic top view of the cannula of
`FIG.15A;
`0043 FIG. 16 is a schematic side sectional view of the
`cannula of FIG.15A in a retracted position from an associated
`housing:
`0044 FIG. 17 is a schematic side sectional view of the
`cannula of FIG. 15A in an extended position;
`004.5
`FIG. 18 is a schematic side sectional view of the
`cannula of FIG. 15A in the retracted position;
`0046 FIG. 19 is another schematic side sectional view of
`the cannula of FIG. 15A in the extended position; and
`0047 FIGS. 20A-20C are schematic side sectional views
`depicting a method of inserting an automatically-aligning
`cannula in accordance with one embodiment of the invention.
`
`DETAILED DESCRIPTION
`0048 FIG. 1 depicts an embodiment of an insertion device
`for a catheter 1 having a housing 2, within which a needle 3 is
`affixed by a needle holder 4. On the end remote from the
`needle holder 4, the needle3 carries a catheter or cannula 5. In
`this document, the terms “catheter and “cannula” are used
`interchangeably and without limitation to described any tube
`like implement to deliver fluids to anybody part of a patient.
`In the attached figures, for the sake of clarity, the representa
`
`Page 19 of 25
`
`

`

`US 2009/0099.521 A1
`
`Apr. 16, 2009
`
`tion of the catheter 5 is enlarged. In general, the diameter of
`the catheter 5 is only slightly larger than the outside diameter
`of the needle 3.
`0049. The needle 3, in a manner not shown, is so envel
`oped by a guide in the housing 2, that it can only move in a
`direction parallel to its longitudinal axis L. The design allows
`the needle 3 to be displaced into an extended position. In this
`extended position of the needle 3, depicted in FIG. 2, the
`catheter 5 is positioned at least partially outside the housing 2
`and thus penetrating into body tissue 6. Designated here as
`“body tissue' is to be understood, for example, the skin, vein,
`or organ of a patient.
`0050. In order to move the needle3 in conjunction with the
`catheter 5, a drive mechanism V is provided. Alternative drive
`mechanisms are also described in FIGS. 6-13. The drive
`mechanism V depicted in FIGS. 1-3 possesses a drive spring
`16 which powers the drive mechanismV. Described in greater
`detail, the drive spring 16 acts upon a first part or plunger 17,
`which is positioned against a second part or Support structure
`18. This support structure 18 can be loosely affixed to the first
`part or plunger 17 or, alternately, secured thereto by an addi
`tional spring (not shown), which would abut the housing 2. In
`another embodiment, a holding means can be installed to
`combine the first and second parts, respectively 17 and 18.
`This holding means may be any type of chemical, mechani
`cal, electromagnetic, or other fastener. In any case, the two
`parts 17 and 18 are made to move under the force of the drive
`spring 16 in the direction of the tissue 6 of a patient, as
`depicted by arrow 27a.
`0051. In the support structure 18, the needle 3 is retained,
`in particular by means of two needle holding elements 19.
`These holding elements 19 project outward from the patient
`proximal end face 20 of the support structure 18. The two
`holding elements 19 each include endwise, remote from the
`end face 20, a hook 21, which is shown in FIGS. 1 and 2 as
`located on the top of the needle holder 4. The needle holder 4
`Supports itself against the Support structure 18 by means of a
`retraction spring 22. However, this needle holder 4 can only
`be displaced in the direction of the plunger 17 to such extent
`that it is permitted by the needle holding elements 19.
`0052 Each of the hooks 21 on the needle holders 19 pos
`sesses on the end proximate to the plunger 17 an inclined
`outer surface 23. The plunger 17 is equipped on the side
`proximate to the Support structure 18 with projections having
`inclined Surfaces 24, which are complementary to the above
`mentioned surfaces 23. When the parts 17 and 18 are suffi
`ciently displaced by the force of the drive spring 16, the
`needle holding elements 19, projecting out of the end face 20
`of the support structure 18, make contact with a base wall 25
`of the housing 2. The holding elements 19 are detachably
`connected to the Support structure 18. Accordingly, as the
`holding elements 19 make contact with the base wall 25,
`spring 16 continues to drive support structure 18 toward the
`base wall 25, causing the holding elements 19 to detach from
`the support structure 18. The continued movement of the
`support structure 18 in the direction of the base wall 25 forces
`the needle holding elements 19 in the direction of the plunger
`17, until the complementary inclined surfaces 23, 24 contact
`one another. At this point, the holding elements 19 are dis
`placed outward and thus free the needle holder 4 from the
`support structure 18. With this arrangement, the needle 3.
`activated by the force of a retraction spring 22, is moved in the
`direction of the plunger 17. At this point of operation, the
`compressed retraction spring 22 initially displaces the needle
`
`3 with a relatively greater acceleration. Accordingly, the
`needle 3 is forced backward out of the body tissue 6.
`0053. The first part includes a recess 26, into which the
`needle holder 4 can retreat under the force of the retraction
`spring 22. This recess 26 is, in this case, simply shown as a
`cavity sized to match the needle holder 4. Other types of
`recesses are also contemplated. In function, the recess 26
`accepts the needle holder 4 with the thereto affixed needle 3
`and, at the same time, firmly secures the needle 3, so that, after
`the initial movement, the needle 3 can be retracted along with
`plunger 17 out of its extended position. The needle holder 4
`may be secured within the recess 26 by mechanical, chemical,
`magnetic, friction, or other means. At the same time, the
`needle 3 is relieved of the catheter 5, which remains in its
`embedded position in the patient's tissue 6. This displacement
`of parts is shown by the arrow 27b.
`0054 The support structure 18, in this state of the opera
`tion, remains in the position shown in FIG. 3. The support
`structure 18 may be equipped with lateral lugs 28, which may
`fit into clamps 29, when the support structure 18 is fully
`extend and the catheter inserted into the patient tissue 6.
`These lugs 28 and clamps 29 are depicted in FIG. 4. The
`clamps 29 firmly secure to the lugs 28, so that the support
`structure 18 lies fixedly on the base wall 25 of the housing 2.
`In an alternative to the depicted lugs and clamps, matching
`male and female ports may be located on the Support structure
`18 and base wall 25 to hold the support structure 18 in place
`against the base wall 25. Additionally, lugs be used in
`embodiments of the catheter insertion device that do not
`utilize a Support structure. For example, the automatically
`aligning cannula depicted in FIG. 14 utilizes lugs for align
`ment, secured directly to the catheter base. This embodiment
`is described in more detail below.
`0055 Additionally, means can be provided that exert a
`clamping force between the support structure 18 and the
`needle 3 or between the catheter 5 and the needle 3. In such a
`case, during a displacement of the Support structure 18, forces
`would be transferred to the needle 3, which would be suffi
`cient to firmly align the needle 3 in place during its penetra
`tion into the body tissue 6. When the catheter 5 and the needle
`3 attain their desired penetration, i.e., reach the extended
`position, then the clamping of the holding means is relaxed
`and the retaining friction attributable thereto against the
`needle 3 is removed, so that the needle 3 is free to be with
`drawn in the manner described above.
`0056. The support structure 18 may possess a stand-alone
`storage means for medicaments, whereby the medicaments
`can be delivered through the catheter 5. Alternatively, the
`cannula insertion device described herein may be integrated
`with a medication delivery device having its own storage
`means of medicament. In Such an embodiment, the Support
`structure 18 can be provided with an opening 31, by means of
`which an input of medicament Supply or the like can be
`effected. Such an opening would also permit the input or
`removal of materials, for instance of blood or sera. Such an
`embodiment is described in more detail w

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket