PTO/SB/05 (08-08)
`Approved for use through 06/30/2010. 0MB 0651-0032
`U.S. Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless it displays a valid 0MB control number
`I CEQ-002
`Attorney Docket No.
`I Peter Gravesen
`First Inventor
`CANNULA INSERTION DEVICE AND RELATED
`METHODS
`Express Mail Label No. I
`
`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`(ONLY FOR NEW NONPROV/S/ONAL APPL/CA T/ONS UNDER
`37 CFR 1.53(B))
`
`Title
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`See 37 CFR 1 .27.
`
`1. D Fee Transmittal Form (e.g., PTO/SB/17)
`2. Q Applicant claims small entity status.
`3. 0 Specification
`4. 0 Drawing(s) (35 U.S.C. 113)
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`[Total Pages
`Both the claims and abstract must start on a new page
`(For information on the preferred arrangement. see MPEP 608.01(a))
`15
`- - -
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`[Total Sheets
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`33
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`I
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`I
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`I
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`ACCOMPANYING APPLICATION PARTS
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`9. D Assignment Papers (cover sheet & document(s))
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`Name of Assignee
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`(when there is an assignee)
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`Attorney
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`I
`10. D 37 CFR 3.73(b) Statement □ Powerof
`11 . D English Translation Document (if applicable)
`12. 0 Information Disclosure Statement (PTO/SB/08 or PT0-1449)
`0 Copies of citations attached
`13. D Preliminary Amendment
`14. D Return Receipt Postcard (MPEP 503)
`15. D Certified Copy of Priority Document(s)
`16. D Nonpublication Request under 35 U.S.C.122 (b)(2)(B)(i).
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`(if foreign priority is claimed)
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`Applicant must attach form PTO/SB/35 or equivalent.
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`17. Oooe, I
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`5. Oath or Declaration
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`b. DA copy from a prior application (37 CFR 1.63(d))
`(for continuation/divisional with Box 18 completed)
`i □ DELETION OF INVENTOR(S)
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`Signed statement attached deleting inventor(s) name in the
`prior application. see 37 CFR 1.63(d)(2) and 1.33(b).
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`6. 0 Application Data Sheet. See 37 CFR 1.76
`7 _ D CD-ROM or CD-R in duplicate, large table or
`D Landscape Table on CD
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`Computer Program (Appendix)
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`8. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. - c. are required)
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`b.
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`Specification Sequence Listing on:
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`a. D Computer Readable Form (CRF)
`i. D CD-ROM or CD-R (2 copies); or
`ii. D Paper
`c. D Statements verifying identity of above copies
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`18. If a CONTI NU ING APPLICATION, check approptiate box, and supply the requisite infotmation below and in the first sentence of the
`specification fa/lowing the title, or in an Application Data Sheet under 37 CFR 1. 76:
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`D Continuation D Divisional D Continuation-in-part (GIP)
`
`of prior application No.:
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`Art Unit:
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`Prior application information: Examiner
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`0 The address associated with Customer Number: I
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`051414
`
`I OR D Correspondence address below
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`19. CORRESPONDENCE ADDRESS
`
`I State I
`I Telephone I
`/Andrew L. Jagenow/
`Andrew L. Jagenow
`
`I Email Address
`
`Date
`
`Registration No.
`/Attornev/Aaentl
`
`I Zip Code I
`
`October 14, 2008
`51,842
`
`Name
`
`Address
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`City
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`Country
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`Signature
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`Name
`(Print/Tvoe)
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`LIBC/3395642.1
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`Page 1 of 56
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`PATENT
`Attorney Docket No. CEQ-002
`
`Cannula Insertion Device and Related Methods
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`CROSS-REFERENCE TO RELATED APPLICATION
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`[0001] This application claims priority to and the benefit of German Patent Application
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`Serial No. 10 2007 049 446.9, filed October 16, 2007, the disclosure of which is hereby
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`incorporated by reference herein in its entirety.
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`FIELD OF THE INVENTION
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`[0002] This invention relates generally to systems and methods for inserting a cannula
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`into a patient and, more specifically, to a device that automatically inserts a cannula, as well as
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`connects the cannula lumen to a channel within an infusion device.
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`BACKGROUND
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`[0003]
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`In many cases, it is necessary to insert a catheter or cannula into the body, or a
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`body part of, a patient. By means of the so-inserted cannula, it is then possible to infuse
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`medicinally-required fluid or material. Another reason for the employment of a cannula may be
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`to aid in insertion of a micro-dialysis probe into the body.
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`[0004] To insert a cannula into a patient, a rigid needle is placed within the lumen of
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`the cannula, and the needle and cannula combination is forced into the skin of a patient. Once
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`the cannula combination is fully inserted, the needle is retracted, leaving the cannula in place.
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`When performed manually, the penetration of the catheter-carrying needle into the body,
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`however, may be considered uncomfortable for a patient, or may cause some other anxiety.
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`Also, the subsequent manual withdrawal of the needle is often regarded by some patients as
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`painful.
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`[0005] Automatic cannula insertion devices have been developed to address these
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`issues. Typically, a cannula is included in a stand-alone device called an insertion or injection
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`set. In addition to the cannula and needle, the insertion set often includes a housing to which the
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`cannula is attached during use. The housing may have an adhesive pad for adhering the housing
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`to the skin of the patient during use, as well as an internal void or chamber that is penetrated by
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`an inlet and a septum. The needle passes through the septum, void, and into the lumen of the
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`cannula. After insertion, the needle is withdrawn from the septum, which seals the void.
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`Thereafter, a tube is connected to the inlet, thereby placing the lumen (via the void) in fluidic
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`communication with an infusion device, intravenous (IV) drip bag, or other medical equipment.
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`The above-described insertion sets may be acceptable for some patients, but the attached tube
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`and medical device can be obtrusive, which may be undesirable in some cases. It would be
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`desirable then, to incorporate the functionality of an insertion set into an infusion device to
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`minimize the attendant tubing and complications involved in connecting the insertion set to the
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`infusion device.
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`SUMMARY OF THE INVENTION
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`[0006] The invention relates to an insertion device for a cannula, wherein the cannula
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`is carried on a needle, as well as a cannula configuration that allows for automatic alignment of
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`an inlet on the cannula with a channel in an infusion device, without having to separately
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`connect a tube thereto. In combination with a drive apparatus, the needle can be displaced from
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`a retracted position into an extended position, thus forming a fluidic connection.
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`[0007] During an insertion procedure described herein, a cannula is used in
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`conjunction with a needle. The needle is used to penetrate the body. Subsequently, the needle is
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`withdrawn from the body, allowing the cannula to remain in its inserted position. Consequently,
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`one advantage of the invention is to increase the comfort of a patient during the insertion and
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`withdrawal of a catheter or cannula. This benefit may be achieved with a device for the insertion
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`of a cannula of the type described herein, wherein the needle, after reaching its extended state,
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`can be withdrawn quickly and automatically by a retraction apparatus.
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`[0008] One embodiment of the invention allows the needle to not only quickly
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`penetrate the body tissue (i.e., blood vessel, organ, or other body part) of a patient, but due to aid
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`from the retraction apparatus, the needle is quickly withdrawn from the body tissue and
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`simultaneously, the inserted cannula remains within the body tissue. In this way, since the
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`needle is relatively quickly withdrawn from the body tissue, a much more comfortable sensation
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`is experienced than that associated with a slower insertion and withdrawal. Further, any
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`sensation is transient. The retraction apparatus is activated, in any case, when the needle is
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`already within the patient's tissue, that is to say, when the needle is in its extended position.
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`Thereby, it is possible for the operator to insert the needle and its associated cannula to a
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`sufficient depth to reach a desired position within the body tissue.
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`[0009]
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`In one embodiment, the driving element or needle plunger is subject to the force
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`of a spring. The spring can be prestressed and restrained by an arresting apparatus from which it
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`is released to carry out its driving function. The spring acts upon a drive mechanism, which
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`includes at least one first part (e.g., a plunger), which is in driving contact with a free end of the
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`spring and the drive mechanism includes one separate second part (e.g., a support structure),
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`indirectly activated by the spring. Thus, the second part is made slidingly displaceable in a first
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`direction by means of the motion of the first part and, conversely, separates itself therefrom upon
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`a movement of the first part in an opposite direction. Such an arrangement reduces the weight,
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`which contributes to momentum during the retraction of the needle. Simultaneously, the needle,
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`upon its movement from the retracted position into the extended position, stabilizes the cannula
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`sufficiently when so projected, so that that the insertion procedure can be reliably carried out.
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`[0010]
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`In certain embodiments, the needle, which is seated in the second part, is
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`releasably held. Accordingly, the needle can disengage itself from the second part at the outset
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`of a retracting motion and can be withdrawn without obstruction. In this way, the needle is not
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`permanently affixed to the drive mechanism, an advantage which can be usefully employed to
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`even move the needle more quickly, i.e., through more rapid increments of retractive motion.
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`[0011] At the time that the needle is disconnected from the second part, nothing more
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`than the weight of the needle need be placed in motion, an advantage which allows undiminished
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`acceleration. Since the movement of a needle within the body tissue can be uncomfortable, it is
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`helpful if the displacement of the needle can be accelerated so that it can be removed from the
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`tissue in a minimal amount of time.
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`[0012]
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`In one embodiment, the activation of the needle is subjected to force by a
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`separate retraction spring ( compression type) dedicated thereto, which acts in a direction from
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`the second part toward the first part. It is possible, then, that this retraction spring serving the
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`needle can be employed to force the now-released needle away from the second part in a
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`direction that withdraws it from the penetrated body tissue. The second part can include at least
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`one holding element that retains the needle therein, and permits the needle to be subsequently
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`retracted from an extended position. The concept of "retraction" or "withdrawal," as used
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`herein, is used to describe removal of the needle from the lumen of the cannula after full
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`insertion or extension of the cannula. The method of construction of the holding element, that is,
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`as to whether its retaining characteristic is due to mechanical, magnetic, or other induced forces,
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`is of secondary importance for the purpose of this description. During the interim within which
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`the needle has not yet reached its extended position, the holding element acts to affix the needle
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`within the second part. As soon as the second part has reached its final and extended position,
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`the retention of the needle is no longer necessary. Accordingly, at this time, the holding element
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`releases the needle, so that it departs from the second part and extricates itself therefrom.
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`[0013]
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`In one embodiment, the holding element is located in the exposed surface of an
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`end of the second part, from which the needle projects. From this end surface of the second part,
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`when in extended position, the tip of the needle comes into contact with another surface. This so
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`designated "other surface" can well be a surface of the patient's tissue, wherein the cannula is in
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`the process of being inserted. Otherwise, the contacted surface can even be a lining of a device
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`housing. In any case, by means of an impact of the second part against a target surface, the
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`holding element is released, i.e., the retention of the needle therein is ended.
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`[0014]
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`In one embodiment, the first part possesses an activation element, which, at the
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`completion of needle extension, acts upon the needle holding element. In this case, the first part
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`is employed to relieve the holding element of the second part from its retaining function. By
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`means of the mechanical structure of the holding element the needle is released when the
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`position of the holding element changes. If the principle of construction of the holding element
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`is electromagnetic in character, then the activation means may open a switch, which will
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`interrupt a supply of current to the magnetic system. In such a case, the magnet becomes
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`deprived of its power. Additionally, it is contemplated to displace a working magnet thereby
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`terminating its holding ability. Additional methods for this removal of holding power are
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`contemplated.
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`[0015]
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`In an embodiment of the invention, the activation means of the first part and
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`also the holding element possess complementary, coacting, inclined surfaces. Motion of the
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`activation means toward the holding element, which is carried out in a direction parallel to the
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`needle, can be diverted to a motion not parallel, but rather angular therefrom. In this alteration,
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`the angular direction could even be at a right angle.
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`[0016] The needle is supported by the said retraction spring to lie against the first part.
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`This constructive support can be used with or without a holding element. The retraction spring
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`assures that the needle can be secured by means of one or more projections on the second part.
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`This securement would hold the needle in place during the movement of the drive mechanism.
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`When the needle and catheter begin to penetrate into the body tissue, the needle itself is
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`subjected to a reaction force, which, without an element for holding, finally causes the needle to
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`act contrary to the force of the retraction spring. Nevertheless, by means of an appropriate
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`dimensioning of the retraction spring, arrangement can be made such that the needle-catheter
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`combination penetrates sufficiently far into the subject body tissue.
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`[0017] The first part may possess a second holding means to which the needle becomes
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`secured during a withdrawal from the extended position. This holding means retains the needle
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`firmly within the first part, so that the needle retracts by means of the reversing motion of the
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`first part of the drive mechanism.
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`[0018]
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`In this arrangement, a second holding means consists of a cavity in the first
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`part. The needle, or if necessary, a thickened section of the needle, is then simply retainingly
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`inserted into the first part and subsequently held there by a force of friction. The necessary
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`frictional forces can be increased by an appropriate surfacing of the interior of the cavity and/or
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`increasing the size of the active exterior of the needle.
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`[0019] The first part and the second part are located in a housing. This housing
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`possesses in the area remote from the drive spring, an end face that blocks the travel of the
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`second part. If the second part makes contact with the end face of the housing, or places itself
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`very close thereto, it will be held in position by the above described holding means. This
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`prevents the second part from following the first part as it withdraws.
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`[0020] A storage means for medicaments or a communicating fluidic connection for
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`the cannula is located in the second part. In one embodiment, the second part is secured to the
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`cannula, so that after the withdrawal of the needle, the cannula remains in its extended position
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`in the tissue of the patient. The medicament can then be infused through the cannula into the
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`body. An input or outtake branching can also be joined to the cannula line. By means of the
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`input or outtake device, a medicament can be applied or blood or the like can be withdrawn from
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`the body.
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`[0021] The drive mechanism functions with the aid of an inclined surface on which is
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`formed a path for movement of the needle, since the inclined surface moves in a direction
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`transverse (or angular) to that of the needle. This path, which accommodates the perpendicular
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`travel of the needle, ends in a step like termination. With such a termination as described, the
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`functional movement of the needle is thus decoupled from its penetrative direction. The needle
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`is forced by the inclined surface and accordingly slides along this inclined surface, being
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`augmented by the intervention of the drive mechanism. Because of the inclined surface, the
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`needle is subjected to an angular resultant force, which causes the needle to move. Upon an
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`activation of the drive mechanism, an additional force may be applied to alter the direction of
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`motion of the needle.
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`[0022] The above "step" is formed by a recess in the inclined surface. The needle, or
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`an integral element thereof, drops into the recess once it has reached its final, extended position.
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`This recess also blocks any additional movement of the inclined surface. The inclined surface
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`possesses a helical configuration and moves in a rotatable body. This rotatable body comprises,
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`for example, a cylindrical shape, and can form a part of the drive mechanism. When this body is
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`rotated, then an effective area of the inclined surface forms a slidingly spiral path for the needle
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`alone or for both the needle and the drive mechanism together. As the needle moves from its
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`withdrawn position into its extended position it may move with the drive mechanism. In this
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`way, a relatively long length of the sliding path on the helical inclined surface is achieved with
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`minimum space and an excessive dimensioning of the insertion mechanism is thereby avoided.
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`[0023]
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`In one aspect, the invention relates to a cannula insertion device including a
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`housing defining an opening for receiving therethrough a cannula and further defining a channel,
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`and a cannula forming a lumen, the cannula adapted for sliding movement within the housing
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`from a retracted position to an extended position, wherein when the cannula is in the retracted
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`position, the lumen is located remotely from the channel and the channel is in fluidic
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`communication with the opening, and when the cannula is in the extended position, the lumen is
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`in fluidic communication with the channel. In an embodiment of the above aspect, the cannula
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`insertion device further includes a base connected to the cannula, the base defining an internal
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`chamber in fluidic communication with the lumen. In another embodiment, the base further
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`defines a chamber extension in fluidic communication with the internal chamber. In yet another
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`embodiment, when the cannula is in the extended position, the chamber extension is aligned with
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`the channel. In still another embodiment, a wall of the base defines the chamber extension.
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`[0024]
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`In another embodiment of the above aspect, the base includes a resilient sheath,
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`the sheath defining a port substantially aligned with the chamber extension. In another
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`embodiment, when the cannula is in the extended position, the port is aligned with the channel.
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`In yet another embodiment, when the cannula is in the extended position, the sheath seals the
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`opemng. In still another embodiment, the cannula insertion device further includes a plunger for
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`driving the cannula from the retracted position to the extended position. In another embodiment,
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`the cannula insertion device further includes a needle disposed in the lumen when the cannula is
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`in the retracted position. In another embodiment, the needle is adapted to be automatically
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`withdrawn from the lumen when the cannula is in the extended position. In another
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`embodiment, the needle is adapted to be automatically disconnected from the plunger when the
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`cannula is in the extended position.
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`[0025]
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`In another aspect, the invention relates to a method of inserting a cannula, the
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`method including the steps of providing a housing defining an opening for receiving
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`therethrough a cannula and further defining a channel, providing a cannula forming a lumen, the
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`cannula adapted for sliding movement within the housing from a retracted position to an
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`extended position, and extending the cannula from the retracted position, in which the lumen is
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`located remotely from the channel and the channel is in fluidic communication with the opening,
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`to the extended position, in which the lumen is in fluidic communication with the channel. In an
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`embodiment of the above aspect, the method further includes the step of piercing a skin of a
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`patient with a needle and the cannula as the cannula moves from the retracted position to the
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`extended position. In another embodiment, the method further includes the step of withdrawing
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`the needle from the lumen automatically when the cannula is in the extended position. In yet
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`another embodiment, a plunger extends the cannula from the retracted position to the extended
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`position, the plunger in contact with the needle. In still another embodiment, the method
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`includes the step of disconnecting the needle from the plunger when the cannula is in the
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`extended position. In another embodiment, the method includes the step of sealing the opening
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`with the cannula when the cannula is in the extended position.
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`BRIEF DESCRIPTION OF THE FIGURES
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`[0026] Other features and advantages of the present invention, as well as the invention
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`itself, can be more fully understood from the following description of the various embodiments,
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`when read together with the accompanying drawings, in which:
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`FIG. 1 is a schematic sectional side view of an insertion device in a retracted
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`position in accordance with one embodiment of the invention;
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`FIG. 2 is a schematic sectional side view of the insertion device of FIG. 1 in an
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`intermediate position;
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`FIG. 3 is a schematic sectional side view of the insertion device of FIG. 1 in a
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`second intermediate position;
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`FIG. 4 is a schematic perspective view of a portion of an insertion device in
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`accordance with another embodiment of the invention;
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`FIG. 5 is a schematic sectional side view of an insertion device in accordance
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`with another embodiment of the invention;
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`FIG. 6 is a schematic side view of an insertion device in a retracted position in
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`accordance with another embodiment of the invention;
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`FIG. 7 is a schematic side view of the insertion device of FIG. 6 in a withdrawn
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`position;
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`FIG. 8 is a schematic perspective view of an insertion ramp in accordance with
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`one embodiment of the invention;
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`FIG. 9 is a schematic side view of an insertion device in a retracted position in
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`accordance with another embodiment of the invention;
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`FIG. 10 is a schematic side view of the insertion device of FIG. 9 in an extended
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`position;
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`FIG. 11 is a schematic side view of the insertion device of FIG. 9 in a withdrawn
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`position;
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`FIG. 12 is a schematic top sectional view of the insertion device of FIG. 9;
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`FIG. 13 is a schematic top sectional view of the insertion device of FIG. 11;
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`FIG. 14 is a schematic diagram of an exemplary infusion device microcircuit;
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`FIG. ISA is a schematic perspective view of an automatically-aligning cannula in
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`accordance with one embodiment of the present invention;
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`FIG. ISB is a schematic top view of the cannula of FIG. ISA;
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`FIG. 16 is a schematic side sectional view of the cannula of FIG. ISA in a
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`retracted position from an associated housing;
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`FIG. 17 is a schematic side sectional view of the cannula of FIG. ISA in an
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`extended position;
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`FIG. 18 is a schematic side sectional view of the cannula of FIG. ISA in the
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`retracted position;
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`FIG. 19 is another schematic side sectional view of the cannula of FIG. ISA in the
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`extended position; and
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`FIGS. 20A-20C are schematic side sectional views depicting a method of
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`inserting an automatically-aligning cannula in accordance with one embodiment
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`of the invention.
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`DETAILED DESCRIPTION
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`[0027] FIG. 1 depicts an embodiment of an insertion device for a catheter 1 having a
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`housing 2, within which a needle 3 is affixed by a needle holder 4. On the end remote from the
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`needle holder 4, the needle 3 carries a catheter or cannula 5. In this document, the terms
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`"catheter" and "cannula" are used interchangeably and without limitation to described any tube(cid:173)
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`like implement to deliver fluids to any body part of a patient. In the attached figures, for the
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`sake of clarity, the representation of the catheter 5 is enlarged. In general, the diameter of the
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`catheter 5 is only slightly larger than the outside diameter of the needle 3.
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`[0028] The needle 3, in a manner not shown, is so enveloped by a guide in the
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`housing 2, that it can only move in a direction parallel to its longitudinal axis L. The design
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`allows the needle 3 to be displaced into an extended position. In this extended position of the
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`needle 3, depicted in FIG. 2, the catheter 5 is positioned at least partially outside the housing 2
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`and thus penetrating into body tissue 6. Designated here as "body tissue" is to be understood, for
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`example, the skin, vein, or organ of a patient.
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`[0029]
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`In order to move the needle 3 in conjunction with the catheter 5, a drive
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`mechanism Vis provided. Alternative drive mechanisms are also described in FIGS. 6-13. The
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`drive mechanism V depicted in FIGS. 1-3 possesses a drive spring 16 which powers the drive
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`mechanism V. Described in greater detail, the drive spring 16 acts upon a first part or plunger
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`17, which is positioned against a second part or support structure 18. This support structure 18
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`can be loosely affixed to the first part or plunger 17 or, alternately, secured thereto by an
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`additional spring (not shown), which would abut the housing 2. In another embodiment, a
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`holding means can be installed to combine the first and second parts, respectively 17 and 18.
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`This holding means may be any type of chemical, mechanical, electromagnetic, or other fastener.
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`In any case, the two parts 17 and 18 are made to move under the force of the drive spring 16 in
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`the direction of the tissue 6 of a patient, as depicted by arrow 27a.
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`[0030]
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`In the support structure 18, the needle 3 is retained, in particular by means of
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`two needle holding elements 19. These holding elements 19 project outward from the patient
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`proximal end face 20 of the support structure 18. The two holding elements 19 each include
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`endwise, remote from the end face 20, a hook 21, which is shown in FIGS. 1 and 2 as located on
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`the top of the needle holder 4. The needle holder 4 supports itself against the support structure
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`18 by means of a retraction spring 22. However, this needle holder 4 can only be displaced in
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`the direction of the plunger 17 to such extent that it is permitted by the needle holding
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`elements 19.
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`[0031] Each of the hooks 21 on the needle holders 19 possesses on the end proximate
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`to the plunger 17 an inclined outer surface 23. The plunger 17 is equipped on the side proximate
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`to the support structure 18 with projections having inclined surfaces 24, which are
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`complementary to the above-mentioned surfaces 23. When the parts 17 and 18 are sufficiently
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`displaced by the force of the drive spring 16, the needle holding elements 19, projecting out of
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`the end face 20 of the support structure 18, make contact with a base wall 25 of the housing 2.
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`The holding elements 19 are detachably connected to the support structure 18. Accordingly, as
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`the holding elements 19 make contact with the base wall 25, spring 16 continues to drive support
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`structure 18 toward the base wall 25, causing the holding elements 19 to detach from the support
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`structure 18. The continued movement of the support structure 18 in the direction of the base
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`wall 25 forces the needle holding elements 19 in the direction of the plunger 17, until the
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`complementary inclined surfaces 23, 24 contact one another. At this point, the holding elements
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`19 are displaced outward and thus free the needle holder 4 from the support structure 18. With
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`this arrangement, the needle 3, activated by the force of a retraction spring 22, is moved in the
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`direction of the plunger 17. At this point of operation, the compressed retraction spring 22
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`initially displaces the needle 3 with a relatively greater acceleration. Accordingly, the needle 3
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`is forced backward out of the body tissue 6.
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`[0032] The first part includes a recess 26, into which the needle holder 4 can retreat
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`under the force of the retraction spring 22. This recess 26 is, in this case, simply shown as a
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`cavity sized to match the needle holder 4. Other types ofrecesses are also contemplated. In
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`function, the recess 26 accepts the needle holder 4 with the thereto affixed needle 3 and, at the
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`same time, firmly secures the needle 3, so that, after the initial movement, the needle 3 can be
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`retracted along with plunger 17 out of its extended position. The needle holder 4 may be secured
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`within the recess 26 by mechanical, chemical, magnetic, friction, or other means. At the same
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`time, the needle 3 is relieved of the catheter 5, which remains in its embedded position in the
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`patient's tissue 6. This displacement of parts is shown by the arrow 27b.
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`[0033] The support structure 18, in this state of the operation, remains in the position
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`shown in FIG. 3. The support structure 18 may be equipped with lateral lugs 28, which may fit
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`into clamps 29, when the support structure 18 is fully extend and the catheter inserted into the
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`patient tissue 6. These lugs 28 and clamps 29 are depicted in FIG. 4. The clamps 29 firmly
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`secure to the lugs 28, so that the support structure 18 lies fixedly on the base wall 25 of the
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`housing 2. In an alternative to the depicted lugs and clamps, matching male and female ports
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`may be located on the support structure 18 and base wall 25 to hold the support structure 18 in
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`place against the base wall 25. Additionally, lugs be used in embodiments of the catheter
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`insertion device that do not utilize a support structure. For example, the automatically aligning
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`cannula depicted in FIG. 14 utilizes lugs for alignment, secured directly to the catheter base.
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`This embodiment is described in more detail below.
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`[0034] Additionally, means can be provided that exert a clamping force between the
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`support structure 18 and the needle 3 or between the catheter 5 and the needle 3. In such a case,
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`during a displacement of the support structure 18, forces would be transferred to the needle 3,
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`which would be sufficient to firmly align the needle 3 in place during its penetration into the
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`body tissue 6. When the catheter 5 and the needle 3 attain their desired penetration, i.e., reach
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`the extended position, then the clamping of the holding means is relaxed and the retaining
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`friction attributable thereto against the needle 3 is removed, so that the needle 3 is free to be
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`withdrawn in the manner described above.
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`[0035] The support structure 18 may possess a stand-alone storage means for
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`medicaments, whereby the medicaments can be delivered through the catheter 5. Alternatively,
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`the cannula insertion device described herein may be integrated with a medication delivery
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`device having its own storage means of medicament. In such an embodiment, the support
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`structure 18 can be provided with an opening 31, by means of which an input of medicament
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`supply or the like can be effected. Such an opening would also permit the input or removal of
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`materials, for instance of blood or sera. Such an embodiment is described in more detail with
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`regard to FIGS. 14-20C.
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`[0036] FIG. 5 shows an alternative embodiment of the needle retraction system
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`depic