(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2008/0319414 A1
`(43) Pub. Date:
`Dec. 25, 2008
`Yodfat et al.
`
`US 20080319414A1
`
`(54) INSERTION DEVICE
`
`(75) Inventors:
`
`Ofer Yodfat, Maccabim-Reut (IL);
`Avraham Neta, Misgav (IL); Illai
`Gescheit, Tel-Aviv (IL)
`
`Correspondence Address:
`MINTZ, LEVIN COHN FERRIS GLOVSKY &
`POPEO
`ATTN PATENT INTAKE CUSTOMER NO.
`35437
`ONE FINANCIAL CENTER
`BOSTON, MA 02111 (US)
`
`(73) Assignee:
`
`MEDINGO, LTD., Yoqneam (IL)
`
`(21) Appl. No.:
`
`12/215.255
`
`(22) Filed:
`
`Jun. 24, 2008
`
`Related U.S. Application Data
`(60) Provisional application No. 60/937,155, filed on Jun.
`25, 2007, provisional application No. 60/937,214,
`
`filed on Jun. 25, 2007, provisional application No.
`60/937,163, filed on Jun. 25, 2007.
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6M 5/20
`(2006.01)
`A6M 5/32
`(2006.01)
`A6IB 5/145
`(52) U.S. Cl. ......... 604/506; 604/192: 604/180; 604/157:
`6OO/365
`
`ABSTRACT
`(57)
`An insertion apparatus and a method for use with a device for
`delivery of a therapeutic fluid into a body of a patient and/or
`for sensing of a bodily analyte are disclosed. The apparatus
`includes a housing adapted for loading therein at least one
`cannula cartridge unit having a protective member. The pro
`tective member accommodates at least one penetrating car
`tridge having a subcutaneously insertable element and a pen
`etrating member. The apparatus includes a displacement
`mechanism capable of protracting the penetrating cartridge
`towards the body of the patient, where protraction of the
`penetrating cartridge results in insertion of the Subcutane
`ously insertable element into the body of the patient.
`
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`INSERTON DEVICE
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`0001. The present application claims priority to U.S. Pro
`visional Patent Application No. 60/937.214, entitled “Inser
`tion Device for Inserting a Cannula into a Body’. U.S. Pro
`visional Patent Application No. 60/937,155, entitled
`“Protector for Cannula and Penetrating Member Insertable in
`the Body of a Patient’, and U.S. Provisional Patent Applica
`tion No. 60/937,163, entitled “Devices and Methods for Pain
`Reduction', all filed on Jun. 25, 2007, the disclosures of
`which are incorporated herein by reference in their entireties.
`
`FIELD OF THE INVENTION
`0002 The present invention generally relates to medical
`devices, and particularly to devices that administer medica
`tion into the body of a patient and/or sense analyte levels in a
`bodily fluid. More particularly, some embodiments of the
`present invention are directed to an insertion device and a
`method for manual or automatic insertion of a cannula into a
`human body for delivering a drug using a skin adherable
`patch unit and/or for continuous sensing of a bodily analyte.
`
`BACKGROUND OF THE INVENTION
`0003 Continuous subcutaneous delivery of medication or
`monitoring of a body analyte is often accomplished using a
`cannula inserted into a human body that remains in place for
`several days. Diabetes patients may use such cannula, which
`is positioned in a Subcutaneous compartment for continuous
`delivery of insulin by pumps or for monitoring interstitial
`glucose levels by sensors. A combination of a tube connecting
`the insulin pump to the cannula and a detachable connector is
`often referred to as an infusion set. Such infusion sets and
`modes of their insertion are disclosed, for example, in U.S.
`Pat. Nos. 4,755,173, 5,176,662 and 5,257,980. Subcutaneous
`cannula insertion modes for continuous glucose monitoring
`are discussed, for example, in U.S. Pat. Nos. 5,390,671,
`5.568.806 and 5,586,553. Usually, trans-cutaneous (“hypo
`dermic”) cannula insertion can be carried out with a sharp
`metal penetrating member to be withdrawn after skin pierc
`ing. This procedure can be carried out manually by the user/
`patient. The insertion is usually painful and requires consid
`erable skill. Some patients are reluctant or hesitant to pierce
`their own skin, and thus, encounter difficulties in proper can
`nula insertion. Such difficulties can be attributed to insuffi
`cient manual dexterity or, alternatively, to anxiety associated
`with anticipated discomfort as the needle pierces the skin.
`This problem can be especially significant when an insulin
`pump is used, since misplacement of the cannula can cause
`kinking, incorrect insertion angle or incorrect cannula inser
`tion depth leading eventually to cannula obstruction. As a
`result, delivery of insulin could be hampered thereby causing
`a life-threatening situation.
`0004. In an attempt to cope with this problem, automatic
`infusion set insertion devices (“inserters') were developed to
`assure correct placement of a cannula into the Subcutaneous
`layer at a correctangle while minimizing pain and hazardous
`obstructions associated with cannula insertion. U.S. Pat. Nos.
`6,093,172 and 6,830,562 disclose inserters having a spring
`loaded plunger for an automatic Subcutaneous placement of
`an infusion set. These automatic inserters can be used with
`'pager like' pumps having long tubing and a cannula alto
`
`gether constituting an “infusion set'. However, these devices
`cannot be used for insertion of a cannula used with skin
`adherable pumps that do not employ long tubing. Such device
`is discussed in U.S. Pat. No. 6,699.218 to Flaherty et al. In
`Flaherty's skin adherable device, the cannula is rigidly con
`nected to the pump's housing. After adhesion to user's skin,
`the cannula is fired, thereby emerging from the device's hous
`ing and piercing the skin. Consecutively, the penetrating
`member is retracted back into the pump's housing. This
`device is relatively bulky, heavy and indiscreet because the
`spring-loaded mechanism is deployed within the device's
`housing during the entire period of usage. In addition, the
`cannula has only a single length size and penetrates the skin
`only at a certain angle; the patient cannot adjust these param
`eters based on various insertion sites and other clinical
`requirements.
`0005 Continuous glucose monitors are disclosed in U.S.
`Pat. Nos. 5,390,671 and 6,143,164, assigned to MiniMed and
`E. Heller & Company, respectively. These devices monitor
`glucose levels in the Subcutaneous compartment using a sen
`Sor, which is inserted manually or automatically in a fashion
`similar to the insertion of a cannula, as disclosed in U.S. Pat.
`No. 7,110,803, assigned to DexCom.
`0006 Thus, it would be desirable to provide improved
`systems and methods for inserting a cannula and/or sensor
`into the body of a patient.
`
`SUMMARY OF THE INVENTION
`0007. In some embodiments, the present invention relates
`to a device and a method for automatic insertion of a sensor,
`which can be suitable for continuous analyte (e.g., glucose)
`monitoring and which can be adhered to a patient's skin. The
`present invention also relates to an automatic insertion of a
`cannula (e.g., a single cannula or multiple cannulae) that can
`be used for delivery of medication (e.g., insulin) and can be
`used for continuous monitoring of body analyte (e.g., glu
`cose). In some embodiments, the present invention relates to
`an automatic insertion of two cannulae coupled to a single
`patch, wherein one cannula is used for delivery of medication
`and the other for continuous monitoring of a bodily analyte.
`For example, a patch could include one cannula for drug
`delivery and one sensor for sensing analytes. The present
`invention further allows insertion of a cannula at any desired
`depth, i.e., the user can choose the desired cannula length
`size. Further, the cannula can be inserted at any desired angle.
`0008. In some embodiments, the cannula insertion device
`can fit comfortably in the user's hand. The cannula insertion
`device can include minimal number of parts, which is easy to
`assemble, and which is inexpensive. In some embodiments,
`the cannula insertion device can be either reusable or dispos
`able.
`0009. In some embodiments, the present invention relates
`to an inserter device for a precise placement of a cannula
`within a body of a user. The device can be used for automatic
`insertion of a cannula that is employed together with, for
`example, a fluid dispensing device (which is also referred to
`hereinas a fluid delivery pump). The pump can be configured
`as a remote-controlled skin adherable patch (also, referred to
`hereinas a dispensing patch unit) allowing programmed fluid
`delivery. The pump also can include means for continuous
`analyte level monitoring. In some embodiments, the dis
`pensed fluidis insulin and the monitored analyte is glucose. In
`Some embodiments, the dispensing device includes the fol
`lowing three units:
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`Dec. 25, 2008
`
`0010) 1. A dispensing patch unit having:
`0011 a. A reusable part containing a driving mecha
`nism, a printed circuit board (PCB), and electronics.
`0012 b. A disposable part containing a reservoir, a
`delivery tube and an outlet port with a connecting lumen.
`0013 2. A cradle unit for connecting and reconnecting the
`dispensing patch unit to the body. The cradle has a tubular
`passage, referred to as “well, for allowing cannula penetra
`tion of the skin. The cradle also has an adhesive layer for
`attachment to the body.
`0014 3. A cannula cartridge unit, which can be a dispos
`able item. The cannula cartridge unit includes a cannula, a
`penetrating member, and a protector. The cannula is also
`provided with a hub disposed within the cannula cartridge
`unit and which contains a rubber septum that can be repeat
`edly pierced by a connecting lumen provided in the dispos
`able part of the dispensing patch unit.
`0015. A method for setting up the above system can
`include the following steps:
`0016 1. fill the reservoir with therapeutic fluid;
`0017 2. assemble the dispensing patch unit from two parts
`(i.e., a disposable part and a reusable part):
`0018. 3. adhere the cradle unit to the skin of the user (in
`Some embodiments, this step can be performed after connect
`ing the inserter to the cradle unit);
`0019 4. insert cannula, where this step includes:
`0020 a. load the cannula cartridge unit into the inserter
`(in Some embodiments, this step can be performed after
`connecting the inserter to the cradle unit);
`0021 b. connect the inserter to the cradle unit:
`0022 c. advance the cannula, either automatically or
`manually, through the cradle unit towards the body,
`thereby piercing the skin and disposing the cannula in
`the Subcutaneous compartment; and,
`0023 d. withdraw the penetrating member, either auto
`matically or manually, from the body into the protector,
`while the cannula remains in the cradle unit;
`0024 5. connect the dispensing patch unit to the cradle
`unit, such that a connecting lumen emerges from the dispos
`able parts outlet port and pierces the cannula hub's rubber
`septum to maintain fluid communication between the reser
`voir, the delivery tube, the cannula and the subcutaneous
`tissue;
`0025 6. using a remote control unit, program fluid deliv
`ery.
`0026. In some embodiments, the cannula delivering the
`fluid (e.g., insulin) also includes a sensor for monitoring a
`bodily analyte (e.g., glucose). Fluid delivery can be adjusted
`based on sensor inputs (in a semi- or fully-closed-loop sys
`tem). In some embodiments, the dispensing patch unit can
`include both the cannula for fluid delivery and a sensor for
`analyte sensing, which can both be inserted into the body.
`0027. In some embodiments, the present invention relates
`to an automatic insertion of the cannula for delivery of medi
`cation to a patient using the fluid delivery skin adherable
`patch pump.
`0028. In some embodiments, the present invention relates
`to an automatic insertion of a sensor Suitable for continuous
`analyte monitoring and that can be adhered to the skin of the
`patient.
`0029. In some embodiments, the present invention relates
`to an automatic insertion of a single cannula that can be used
`for delivery of medication (e.g., insulin) and for continuously
`monitoring of body analyte (e.g., glucose).
`
`0030. In some embodiments, the present invention relates
`to an automatic insertion of two cannulae coupled to one
`patch, where one cannula is used for delivery of medication
`and the other for continuously monitoring a body analyte. In
`Some embodiments, the patch contains one cannula for drug
`delivery and one sensor for sensing and monitoring analytes.
`0031. In some embodiments, the present invention relates
`to manual and/or automatic insertion of a cannula that can
`pass through a “well assembly' and be inserted into a subcu
`taneous compartment. In some embodiments, the cannulacan
`pass through a “cradle unit' and be inserted into the subcu
`taneous compartment. The cannula can be inserted at any
`desired depth, i.e., the user can choose the desired cannula
`length size and/or any desired angle.
`0032. In some embodiments, the cannula can be inserted
`and the penetrating member can be retracted manually. In
`Some embodiments, insertion of the cannula and retraction of
`the penetrating member are automatic. In some embodi
`ments, insertion of the cannula is automatic and retraction of
`the penetrating member is manual.
`0033. In some embodiments, a cannula insertion device
`allows precise alignment of the cannula relative to the “well
`assembly'. Highly accurate alignment is desirable for the
`following reasons: 1) it avoids tearing of the well's lower
`gasket, thus, maintaining intact sealing; 2) it permits skin
`penetration at any desired angle; 3) it provides sealing of the
`upper opening with the rubber cap; and 4) it allows precise
`placement of the cannula within the well and maintenance of
`flow communication. In some embodiments, the cannula
`insertion device maintains precise alignment of the cannula
`relative to the “cradle unit' and maintains connection of the
`cannula to the cradle after insertion. In some embodiments,
`the cannula insertion device can be connected to the cradle
`unit before adhesion and used as a means for attaching the
`cradle unit to the patient's body. In some embodiments, the
`cannula insertion device can be automatically detached from
`the cradle unit after the cannula has been inserted, for
`example, to avoid unintentional detachment of the cradle
`from the skin.
`0034. In some embodiments, the cannula insertion device
`is spring-loaded. The spring can be loaded by the patient and
`released upon patient's discretion. The inserter can be con
`figured to prevent unintentional or premature firing. In some
`embodiments, the cannula insertion device is Suitable for use
`in conjunction with a cannula protector. The cannula protec
`tor can be easily manipulated by the user and may be receiv
`able within the inserter and positioned in a single spatial
`direction. In some embodiments, the cannula insertion device
`fits comfortably in the user's hand. In some embodiments, the
`cannula insertion device has relatively few parts, which are
`easy to assemble and are inexpensive. The cannula insertion
`device can be reusable. In other embodiments, the cannula
`insertion device can be disposable.
`0035. In some embodiments, the present invention relates
`to an automatic insertion of the cannula and/or the sensor used
`in association with the skin adherable infusion pump having
`analyte sensing and drug dispensing capabilities and in which
`the fluid dispensing can be adjusted according to analyte
`sensing (in semi- or fully-closed loop mode). In some
`embodiments, the inserter can be preloaded with the cannula
`cartridge unit and the cradle unit. Upon spring loading, the
`user attaches the cradle unit to the skin and pushes a release
`button. A spring loaded flywheel forcibly pushes the cannula
`and the penetrating member through the well into the body.
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`Dec. 25, 2008
`
`Consecutively, the penetrating member is automatically
`retracted into the protector while the cannula hub remains
`connected to the well. Finally, the inserter is detached from
`the cradle unit and the protector (with penetrating member
`inside) is unloaded from the inserter and is disposed of. In
`some embodiments, the inserter can be preloaded with at least
`one (or more than one) cannula cartridge unit.
`0036. In some embodiments, the present invention
`includes a disposable inserter preloaded with the cannula
`cartridge unit and after cannula insertion, the used protector
`(with the penetrating member inside) remains within the
`inserter's housing, which is then can be discarded.
`0037. In some embodiments, the present invention pro
`vides an inserter that allows for passing of the cannula
`through the well assembly and its penetration through the
`skin. After insertion, the cannula remains in the body, the
`cannula hub is secured to the well and the penetrating member
`can be retracted. In some embodiments, the inserter enables
`alignment of the cannula with the cradle unit. In some
`embodiments, the inserter enables alignment of the cannula
`with the outlet port in the dispensing patch unit's housing and
`the passage of the well assembly. In some embodiments, the
`inserter includes a drum member Suitable for retaining one or
`more cannula cartridge units. In some embodiments, the
`inserter contains safety means for preventing inadvertent or
`premature insertion. The safety means may be an integral part
`of the inserter or it may be an additional component which is
`detachable from the inserter before operation. In some
`embodiments, safety means are provided for disposing of the
`sharp penetrating member after manual retraction of penetrat
`ing member from the body.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0038. For a better understanding of the present invention,
`including the various objects and advantages thereof, refer
`ence is made to the following description, which is to be taken
`in conjunction with the accompanying illustrative drawings.
`0039 FIGS. 1a-c show exemplary single-part dispensing
`unit, two-part dispensing unit and remote control unit,
`according to some embodiments of the present invention.
`0040 FIGS. 2a-c show an exemplary dispensing unit
`directly adhered to the skin of a patient, according to some
`embodiments of the present invention.
`0041
`FIGS. 3a-c show an exemplary connection of the
`dispensing unit to a cradle unit, according to some embodi
`ments of the present invention.
`0042 FIGS. 4a–b schematically illustrate an exemplary
`cradle unit, according to some embodiments of the present
`invention.
`0043 FIG. 4c is a perspective view of the cradle unit,
`according to some embodiments of the present invention.
`0044 FIG. 5 schematically shows an exemplary inserter
`loaded with a cannula cartridge unit, according to some
`embodiments of the present invention.
`0045 FIGS. 6a-c show an exemplary inserter connected to
`the cradle unit (as illustrated in FIG. 6a), a well assembly (as
`illustrated in FIG. 6b), or an infusion set (as illustrated in FIG.
`6c), according to Some embodiments of the present invention.
`0046 FIGS. 7a-c show various exemplary ways of loading
`an exemplary cannula cartridge unit into the inserter, accord
`ing to Some embodiments of the present invention.
`0047 FIGS. 8a-b show exemplary inserters loaded with
`the cannula cartridge unit, according to Some embodiments of
`the present invention.
`
`0048 FIGS. 9a-b are perspective and cross-sectional
`views, respectively, of the cannula cartridge unit, according to
`Some embodiments of the present invention.
`0049 FIGS. 10a-i are cross-sectional views of the cannula
`cartridge unit during manual cannula insertion process,
`according to some embodiments of the present invention.
`0050 FIGS. 11a-e are cross-sectional views of the can
`nula cartridge unit during a semi-automatic cannula insertion
`process, according to some embodiments of the present
`invention.
`0051
`FIGS. 12a-c are cross-sectional views of the can
`nula cartridge unit during an automatic cannula insertion
`process, according to some embodiments of the present
`invention.
`0.052 FIGS. 13a-c show an exemplary pen-like inserter
`and loading of the cannula cartridge unit into the pen-like
`inserter, according to Some embodiments of the present
`invention.
`0053 FIGS. 14a-fare cross-sectional views of the pen
`like inserter during a cannula insertion process, according to
`Some embodiments of the present invention.
`0054 FIGS. 15a-b are side and perspective views of an
`exemplary mouse-like inserter, according to some embodi
`ments of the present invention.
`0055 FIG. 15c shows an exemplary cannula cartridge unit
`provided with a handle, according to some embodiments of
`the present invention.
`0056 FIG. 16 is an exploded view of the mouse-like
`inserter, according to Some embodiments of the present
`invention.
`0057 FIGS. 17a-b shows an exemplary connection of the
`mouse-like inserter to the cradle unit, according to some
`embodiments of the present invention.
`0.058
`FIG. 18 shows an exemplary loading of the flywheel
`torsion spring of the mouse-like inserter, according to some
`embodiments of the present invention.
`0059 FIGS. 19a-d show an exemplary loading of the can
`nula cartridge unit into the mouse-like inserter, according to
`Some embodiments of the present invention.
`0060 FIGS. 20a-b show the cradle unit being adhered to
`the user's skin, according to some embodiments of the present
`invention.
`0061
`FIGS. 21a-i show an exemplary cannula insertion
`process using the mouse-like inserter, according to some
`embodiments of the present invention.
`0062 FIG.22 shows an exemplary unloading of a protec
`tor from the mouse-like inserter, according to Some embodi
`ments of the present invention.
`0063 FIG. 23 shows an exemplary disconnection of the
`mouse-like inserter from the cradle unit, according to some
`embodiments of the present invention.
`0064 FIGS. 24a–b show an exemplary mouse-like inserter
`which allows the user to choose the desired cannula penetra
`tion angle, according to Some embodiments of the present
`invention.
`0065 FIGS. 25a-g show another exemplary inserter
`which allows the user to choose the desired cannula penetra
`tion angle, according to Some embodiments of the present
`invention.
`0.066
`FIGS. 26a-b show exemplary drum of the cannula
`cartridge units and an exemplary inserter provided with a
`
`Page 54 of 63
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`US 2008/0319414 A1
`
`Dec. 25, 2008
`
`drum member for retaining plurality of cannula cartridge
`units, according to some embodiments of the present inven
`tion.
`
`DETAILED DESCRIPTION OF THE INVENTION
`0067. A skin adherable insulin delivery device was dis
`closed in a co-owned/co-pending International Patent Appli
`cation No. PCT/IL07/000932, filed Jul. 24, 2007, claiming
`priority to U.S. Provisional Patent Application No. 60/833,
`110, filed Jul. 24, 2006, and U.S. Provisional Patent Applica
`tion No. 60/837,877, filed Aug. 14, 2006, and also disclosed
`in a co-owned/co-pending U.S. patent application Ser. No.
`12/004.837, and International Patent Application No. PCT/
`IL07001578, both filed Dec. 20, 2007 and both claiming
`priority to U.S. Provisional Patent Application No. 60/876,
`679, filed Dec. 22, 2006. The disclosures of the above appli
`cations are incorporated herein by reference in their entirety.
`The device contains a remote control unit and a skin adher
`able unit ("dispensing patch unit”). The dispensing patch unit
`is coupled to a unique cannula apparatus, which does not
`require an infusion set and long tubing. The cannula appara
`tus allows the patient to choose the desired depth and angle
`for cannula insertion. In some embodiments, the device is
`provided with a “well assembly” connected to an insulin
`delivery tube. The well assembly has an upper opening and a
`lower opening sealed by rubber gasket. The insertion appa
`ratus is provided also with a “penetrating cartridge' having a
`cannula, a penetrating member and a rubber cap. The pen
`etrating cartridge allows for the cannula to penetrate through
`the well assembly and then through the skin, while keeping
`the upper opening sealed and maintaining the delivery of
`insulin. In some embodiments, the device includes a “cradle
`unit'. The cradle unit is configured as a sheet with an adhesive
`layer that is attached to the skin before cannula insertion, and
`is used to allow connection and disconnection of the dispens
`ing patch unit to and from the body. The cannula is inserted
`through the cradle unit into the skin and remains secured at
`the cradle unit after insertion. The penetrating member, which
`is configured as a sharp needle, is then retracted and disposed
`of.
`0068. In a co-pending, co-owned International Patent
`Application No. PCT/IL08/
`, and U.S. Patent Applica
`tion No.
`, both filed on an even date herewith, entitled
`“A Protector Apparatus’, and claiming priority to U.S. Pro
`visional Patent Application No. 60/937,155, filed on Jun. 25,
`2007, a device and a method are disclosed for protecting the
`user from unintentional pricking by providing a protective
`cover that shields the penetrating cartridge, further referred to
`as a “protector. The disclosures of the above applications are
`incorporated herein by reference in their entireties. The pro
`tector is detachably connectable to the cradle unit and con
`secutively the cannula can be manually or automatically
`inserted. Upon insertion and piercing of the skin, the penetrat
`ing member is retracted into the protector and both items can
`be disposed of.
`0069 Continuous glucose monitors are disclosed in a co
`owned/co-pending International Patent Application No.
`PCT/IL07/001096, filed Sep. 5, 2007, claiming priority to
`U.S. Provisional Patent Applications No. 60/842,869, filed
`Sep. 6, 2006, and International Patent Application No. PCT/
`IL07/001177, filed Sep. 25, 2007, claiming priority to U.S.
`Provisional Patent Application No. 60/848,511, filed Sep. 29,
`2006. The disclosures of the above applications are incorpo
`rated herein by reference in their entireties.
`
`0070 The further description of the invention deals mostly
`with insertion of a cannula. It should be borne in mind how
`ever that this description may be equally used for insertion of
`a sensor for sensing bodily analyte or any other Subcutane
`ously insertable element.
`(0071
`FIG. 1a shows an example of the fluid delivery
`device in which the inserter of the present invention can be
`implemented. The delivery device includes a dispensing
`patch unit (10) and a remote control unit (40). In some
`embodiments, the dispensing patch unit (10) can include a
`single part (as shown in FIG. 1b) or two parts (as shown in
`FIG. 1c), i.e., a reusable part (100) and a disposable par