( 12 ) United States Patent
`Miller et al .
`
`US 10,806,491 B2
`( 10 ) Patent No .:
`( 45 ) Date of Patent :
`Oct. 20 , 2020
`
`US010806491B2
`
`( * ) Notice :
`
`( 54 ) VASCULAR ACCESS KITS AND METHODS
`( 71 ) Applicant : TELEFLEX LIFE SCIENCES
`LIMITED , Valletta ( MT )
`( 72 ) Inventors : Larry J. Miller , Spring Branch , TX
`( US ) ; David S. Bolleter , San Antonio ,
`TX ( US ) ; Robert W. Titkemeyer , San
`Antonio , TX ( US ) ; Charles M.
`Schwimmer , Los Gatos , CA ( US )
`( 73 ) Assignee : Teleflex Life Sciences Limited , Valletta
`( MT )
`Subject to any disclaimer , the term of this
`patent is extended or adjusted under 35
`U.S.C. 154 ( b ) by 0 days .
`( 21 ) Appl . No .: 15 / 854,406
`( 22 )
`Dec. 26 , 2017
`Filed :
`( 65 )
`Prior Publication Data
`May 17 , 2018
`US 2018/0132894 A1
`Related U.S. Application Data
`( 60 ) Division of application No. 14 / 791,654 , filed on Jul .
`6 , 2015 , now Pat . No. 9,872,703 , which is a
`( Continued )
`
`( 51 ) Int . Ci .
`A61B 1734
`A61B 50/31
`
`( 52 ) U.S. CI .
`CPC
`
`( 2006.01 )
`( 2016.01 )
`( Continued )
`A61B 1713472 ( 2013.01 ) ; A61B 50/20
`( 2016.02 ) ; A61B 50/31 ( 2016.02 ) ;
`( Continued )
`Field of Classification Search
`CPC
`A61B 17/34 ; A61B 17/3472 ; A61B 50/20 ;
`A61B 50/31
`See application file for complete search history .
`
`( 58 )
`
`( 56 )
`
`CA
`CA
`
`References Cited
`U.S. PATENT DOCUMENTS
`2,317,648 A
`2,419,045 A
`
`4/1943 Skiveland
`4/1947 Wittaker
`( Continued )
`FOREIGN PATENT DOCUMENTS
`
`2138842
`6/1996
`9/2000
`2366676 A1
`( Continued )
`
`OTHER PUBLICATIONS
`European Search Report issued in European Patent Application No.
`17198059.2 dated Jan. 29 , 2018 .
`( Continued )
`Primary Examiner — Christopher J Beccia
`( 74 ) Attorney , Agent , or Firm
`BakerHostetler
`
`( 57 )
`ABSTRACT
`Kits carrying various components and devices are provided
`for use in obtaining access to a patient's vascular system .
`Various methods and procedures may be used to treat both
`emergency and more routine conditions using the contents
`of such kits . For example , such kits may contain various
`types of intraosseous ( IO ) devices including , but not limited
`to , drivers , penetrator assemblies , IO needles and other
`related components . Intravenous ( IV ) devices such as
`syringes , needles , IV bags , tubing and other related compo
`nents for use in obtaining access to portions of a patient's
`vascular system may be included . Various types of connec
`tors for communicating fluids with and / or monitoring a
`patient's vascular system may be provided . Such kits may
`contain medications , drugs and fluids used to treat a wide
`variety of both acute and chronic diseases and conditions .
`
`20 Claims , 9 Drawing Sheets
`
`-64
`62 56
`
`206
`
`200
`
`58
`
`20a
`
`51
`
`56
`
`202
`204 30
`
`4100
`
`74
`
`26
`
`34a
`22
`
`36
`
`41
`
`24
`
`72
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 1
`
`

`

`US 10,806,491 B2
`Page 2
`
`Related U.S. Application Data
`continuation of application No. 11 / 380,340 , filed on
`Apr. 26 , 2006 , now Pat . No. 9,072,543 , which is a
`continuation - in - part of application No. 10 / 449,503 ,
`filed on May 30 , 2003 , now Pat . No. 7,670,328 .
`( 60 ) Provisional application No. 60 / 675,246 , filed on Apr.
`27 , 2005 , provisional application No. 60 / 384,756 ,
`filed on May 31 , 2002 .
`( 51 ) Int . Ci .
`( 2016.01 )
`A61B 50/20
`A61M 5/158
`( 2006.01 )
`( 52 ) U.S. CI .
`A61B 2017/3492 ( 2013.01 ) ; AIM 5/158
`CPC
`( 2013.01 ) ; A61M 2005/1581 ( 2013.01 ) ; A61M
`2005/1585 ( 2013.01 ) ; A61M 2210/02
`( 2013.01 )
`
`( 56 )
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`
`

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`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 4
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`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 5
`
`

`

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`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 6
`
`

`

`U.S. Patent
`
`Oct. 20 , 2020
`
`9
`
`Sheet 1 of 9
`
`US 10,806,491 B2
`
`20
`
`24
`
`60
`
`42
`
`ME
`
`46
`
`40
`
`38
`
`22
`
`26
`
`29
`
`48
`
`44
`
`48
`
`34
`
`30
`
`38
`
`28
`36 FIG . IA
`
`46
`
`29
`
`20
`
`28
`
`23
`FIG . 1B
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 7
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`

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`U.S. Patent
`
`Oct. 20 , 2020
`
`9
`
`Sheet 2 of 9
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`US 10,806,491 B2
`
`AL
`
`46
`
`www .
`
`40
`
`
`
`44 ??? ?? 24
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`48
`
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`
`94
`58
`
`86
`
`80
`
`29
`
`20
`
`30
`
`31
`
`38
`
`96
`
`26
`
`34
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`
`FIG . 2A
`
`36
`
`136
`
`136
`
`50
`
`230
`
`G 230
`
`52
`FIG . 2B
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 8
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`

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`U.S. Patent
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`Oct. 20 , 2020
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`9
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`Sheet 3 of 9
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`US 10,806,491 B2
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`100
`
`100
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`108
`
`FIG . 3
`
`80
`
`82
`
`98
`
`106
`
`108
`92
`
`104
`
`91
`
`200
`
`202
`
`206
`
`216
`
`208
`
`204
`
`100
`
`206
`
`200
`
`-204
`
`80
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 9
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`

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`U.S. Patent
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`Oct. 20 , 2020
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`9
`
`Sheet 4 of 9
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`US 10,806,491 B2
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`41
`
`42
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`24
`
`54
`
`ht D
`
`62
`
`20a
`
`51
`
`56
`
`64
`56
`
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`
`206
`
`GLUTIR
`
`7
`
`202
`204
`30
`
`31
`
`58
`
`38
`
`74
`
`76
`
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`22
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`38
`
`80
`
`96
`
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`
`FIG . 6
`
`36
`
`142
`
`140
`
`120
`
`144
`120
`
`143
`
`EMERGENCY TO DRUGS
`
`130
`
`FIG . 7A
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 10
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`U.S. Patent
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`Oct. 20 , 2020
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`9
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`Sheet 5 of 9
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`US 10,806,491 B2
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`-127 ** -120
`
`132
`
`BLUE
`
`NARCAN
`
`-126
`
`BROWN
`AMIODARONE
`
`-125
`
`123
`
`GREEN
`ATROPINE
`
`RED
`
`EPINEPHRINE
`
`YELLOW
`DIAZEPAM
`EMERGENCY IO DAUGS
`FIG . 7B
`
`124
`
`130
`
`162
`172
`
`186
`
`-160
`180
`
`186
`
`SKN
`156
`
`164
`
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`
`152
`BONE
`
`154
`BONE
`MARROW
`
`184 188
`180
`
`182
`
`186
`
`FIG . 9
`
`-186
`
`-170 U - 17
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 11
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`U.S. Patent
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`Oct. 20 , 2020
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`9
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`Sheet 6 of 9
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`US 10,806,491 B2
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`170a
`
`174
`
`186a 180a
`182a
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`1862
`188
`1818
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`
`1723
`
`176
`
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`FIG . 10
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`178
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`180b
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`
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`161
`FIG . 11
`
`152
`
`178
`
`160
`186
`
`196
`
`190
`
`FIG . 12 154
`
`161
`LEG 164
`
`162
`
`-180
`186
`
`-152
`
`-170
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 12
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`

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`U.S. Patent
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`Oct. 20 , 2020
`
`9
`
`Sheet 7 of 9
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`US 10,806,491 B2
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`TO MONITOR
`
`186
`
`170
`
`196
`
`-162
`-160a
`186 154
`
`.
`
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`
`1700
`
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`
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`
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`
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`FIG . 13
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`198
`
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`
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`
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`
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`f
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`FIG . 15
`
`194
`
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`
`199
`180C
`
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`
`1150
`
`FIG . 16
`biegen
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 13
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`

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`U.S. Patent
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`Oct. 20 , 2020
`
`Sheet 8 of 9
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`US 10,806,491 B2
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`232
`
`ananana
`
`234
`
`236
`
`on G.
`
`280 281
`
`276 274
`
`273
`260 261
`
`271
`
`272
`
`270
`
`-252
`
`-258
`
`
`
`254 259
`
`250
`256
`
`206
`
`200
`
`FIG . 17
`
`I
`
`202
`
`208
`204 180c
`
`156
`
`752
`
`
`
`198 240
`
`154
`
`LEG
`
`240
`
`200a
`
`251
`
`258
`
`wry
`
`216a
`O
`CORO
`
`214
`
`212
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 14
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`

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`U.S. Patent
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`Oct. 20 , 2020
`
`9
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`Sheet 9 of 9
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`US 10,806,491 B2
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`232
`
`234
`
`250
`
`270
`
`290
`
`292
`
`236
`
`240
`
`230
`
`FIG . 18B
`
`200b
`
`216b
`
`-2146
`
`O 9 2046
`
`212b
`
`FIG . 19
`
`MacNeil Exhibit 2161
`Yita v. MacNeil IP, IPR2020-01139, Page 15
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`US 10,806,491 B2
`
`1
`VASCULAR ACCESS KITS AND METHODS
`
`2
`much lower where Army medics may only be about twenty
`nine ( 29 % ) percent successful in starting an IV line during
`emergency conditions in the field . These patients are probed
`RELATED APPLICATION
`repeatedly with sharp needles in an attempt to solve this
`This application is a divisional application of U.S. appli- 5 problem and may require an invasive procedure to finally
`establish an intravenous route .
`cation Ser . No. 14 / 791,654 , filed Jul . 6 , 2015 , which is a
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`In the case of patients with chronic disease or the elderly ,
`Apr. 26 , 2006 , now U.S. Pat . No. 9,072,543 , which claim the
`the availability of easily accessible veins may be depleted .
`benefit of U.S. Provisional Patent Application Serial No.
`Other patients may have no available IV sites due to
`60 / 675,246 , filed Apr. 27 , 2005 , and entitled “ Vascular
`anatomical scarcity of peripheral veins , obesity , extreme
`Access Kit , ” and which is a continuation - in - part application
`dehydration or previous IV drug use . For these patients ,
`of U.S. application Ser . No. 10 / 449,503 entitled “ Apparatus
`finding a suitable site for administering life saving drugs
`And Method To Provide Emergency Access To Bone Mar
`may become a difficult and frustrating task . It is generally
`row ” , filed May 30 , 2003 now U.S. Pat . No. 7,670,328 ,
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`which claims the benefit of U.S. Provisional Patent Appli
`15
`have died because access to the patient's vascular system
`cation Ser . No. 60 / 384,756 , filed May 31 , 2002. The entire
`with life saving IV therapy was delayed or simply not
`contents of each of the above - referenced disclosures are
`possible .
`specifically incorporated herein by reference without dis
`An accepted alternative route to give IV medications and
`claimer .
`20 fluids is through bone marrow by providing intraosseous
`( 10 ) access . Drugs and other fluids may enter a patient's
`CROSS - REFERENCE TO RELATED
`vascular system just as rapidly via the intraosseous route as
`APPLICATIONS
`when en intravenously . Bone and associated bone mar
`The present disclosure is related to U.S. patent application
`row may be considered a large non - collapsible vein . The IO
`Ser . No. 10 / 449,503 filed May 30 , 2003 ; U.S patent appli- 25 route has been used for alternative emergency access in
`cation Ser . No. 10 / 448,650 filed May 30 , 2003 ; U.S. patent
`pediatric patients , whose bones are soft enough to permit
`application Ser . No. 10 / 449,476 filed May 30 , 2003 ; and
`manual insertion of IO needles .
`U.S. patent application Ser . No. 10 / 987,051 filed Nov. 12 ,
`2004 .
`
`SUMMARY
`
`10
`
`30
`
`TECHNICAL FIELD
`The present disclosure relates to kits , apparatus contained
`in such kits and associated procedures to obtain access to a
`The present disclosure is related to apparatus and methods
`patient's vascular system . For some embodiments such kits
`to obtain vascular access and more particularly to a kit ,
`may include intravenous ( IV ) access devices and intraosse
`apparatus contained in the kit and associated methods which 35 ous ( 10 ) access devices . Such kits may be used in both
`may be used to provide access to bone , bone marrow and
`emergency situations or more routine procedures associated
`other portions of a patient's vascular system using the
`with treating chronic conditions . The present disclosure may
`apparatus .
`provide apparatus and methods to establish vascular access
`40 during treatment of a patient at a wide variety of locations
`BACKGROUND
`and facilities including , but not limited to , accident sites ,
`emergency rooms , battlefields , emergency medical services
`Every year , millions of patients are treated for life threat