United States Patent [19]
`Brugger et al.
`
`11111 ~111111111111111111m111m1111111~ 11
`US005693008A
`5,693,008
`[11] Patent Number:
`Dec. 2, 1997
`[45] Date of Patent:
`
`[54] DIALYSIS BLOOD TUBING SET
`
`FOREIGN PATENT DOCUMENTS
`
`[75]
`
`Inventors: James M. Brugger. Boulder; Keith J.
`Manica; William G. Palsulich. both of
`Lakewood. all of Colo.
`
`[73] Assignee: COBE Laboratories, Inc •• Lakewood.
`Colo.
`
`[21] Appl. No.: 480,856
`Jun. 7, 1995
`
`[22] Filed:
`Int. Cl.6
`.................................................... A61M 37/00
`[51]
`[52] U.S. Cl •.................................. 604/4; 604/86; 128/672
`[58] Field of Search .................................. 604130. 83, 86.
`604/118, 122. 125. 128. 141, 4. 5. 6, 64.
`65. 280. 283, 905; 13n15. 716; 128/668.
`672
`
`[56]
`
`References Cited
`
`5/1985 European Pat. Off ..
`0 142 866
`0 341 488 11/1989 European Pat. Off ..
`2176595 12/1986 United Kingdom.
`90/12606 11/1990 WIPO .
`
`OTHER PUBLICATIONS
`
`The Extracorporeal Circuit, by Hans-Dietrich Polaschegg.
`Seminars in Dialysis, Sep.-Oct.. 1995. vol. 8. No. 5, pp.
`299-304.
`Slow Nocturnal Home Hemodialysis. by Dr. Pierratos.
`Michaelene Ouwendyk. Robert Francoeur, Lynda Wallace,
`William Sit. Dr. Stephen Vas, and Dr. Robert Udall. Dialysis
`and Transplantation Oct.. 1995. vol. 24. No. 10. pp. 557, 558
`and 576.
`
`Primary &aminer-John G. Weiss
`Assistant Examiner-Ki Yong 0
`Attorne~ Agent, or Finn-Bruce R. Winsor; Edna
`O'Connor
`
`U.S. PATENT DOCUMENTS
`
`[57]
`
`ABSTRACT
`
`3,713,341
`3,908,653
`4,303,068
`4,666,598
`4,758,228
`4,798,580
`4,819,653
`5,041,215
`5,116,308
`5,203,340
`5,242,406
`5,322,516
`5,346,477
`5,348,539
`5,394,732
`5,399,166
`
`lll973 Madsen et al ...•....•..•....•.........•. 73/406
`9/1975 Kettering .................................... 60415
`12/1981 Zelman ....................................... 60415
`5/1987 Heath et al ..
`7/1988 Williams ................................. 604/118
`111989 DeMeo et al .•...........•...•.•...•..... 604/30
`4/1989 Marks .
`8/1991 Chamberlain, Jr. et al. .
`5/1992 Hagiwara .................................... 60415
`4/1993 Gustafson et al ....................... 1281675
`9/1993 Gross et al ....•.....•...••.•••......... 604/141
`6/1994 Brugger.
`911994 Edwards et al ....•.....••..••.•....... 604/141
`9/1994 Herskowitz ............................. 604/141
`3/1995 Johnson et al ..
`3/1995 Laing ...................................... 604/141
`
`A combination pressure pod and access site apparatus is
`suitable for use in a medical tubing set. The combination
`pressure pod and access site comprises a pressure sensing
`chamber and a measured fluid chamber separated by a
`pressure transmissive diaphragm. An access site having a
`needle or needle-less septum is in fluid communication with
`the measured fluid chamber and permits and withdrawing
`fluids from, the measured fluid chamber through the access
`site. One or more of the combination pressure sites and
`access sites may be provided in a simplified blood tubing set
`for an extracorporeal blood treatment apparatus. such as a
`hemodialysis apparatus.
`
`20 Claims, 4 Drawing Sheets
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`FIG. I
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`24
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`57 28
`26
`52 ~
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`22
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`20
`)
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`22
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`36
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`84
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`38
`40
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`U.S. Patent
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`Dec. 2, 1997
`
`Sheet 2 of 4
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`5,693,008
`
`FIG. 2
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`30
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`22"'
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`68
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`76
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`78
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`96
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`54
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`1
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`U.S. Patent
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`Dec. 2, 1997
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`Sheet 3 of 4
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`5,693,008
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`(.!) -
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`•
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`0
`C\l
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`U.S. Patent
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`Dec. 2, 1997
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`Sheet 4 of 4
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`5,693,008
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`FIG. 4
`164
`190
`186
`188
`162
`166
`
`FIG. 6
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`7
`l_
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`7
`_J
`
`FIG. 5
`194
`
`FIG. 7
`
`180
`214
`
`154
`'--;.,.
`
`212 '
`
`FIG. 8
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`FIG. 9
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`60
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`F I G. 10
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`F I G. 11
`84-.....
`192
`82
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`164
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`1
`DIALYSIS BLOOD TUBING SET
`
`FIELD OF THE INVENTION
`The present invention relates to blood tubing sets for use 5
`in dialysis procedw-es.
`
`BACKGROUND OF THE INVENTION
`
`Tremendous advances have been made in the treatment of
`end stage renal disease. Through dialysis with artificial 10
`kidneys it is possible to keep patients alive, and to permit
`them to lead relatively normal lives. even after loss of
`kidney function. One form of dialysis is hemodialysis.
`where the patient's blood is removed from the patient's
`body. anticoagulated, circulated by an extracorporeal tubing 15
`circuit through an artificial kidney. or dialyzer, to remove
`toxic substances, such as urea and creatinine, as well as
`excess fluid. and returned to the patient. Hemodialysis is
`typically performed on a patient about every three days.
`The extracorporeal tubing circuit typically consists of 20
`cannulae for drawing blood from and returning blood to a
`patient. the dialyzer and a blood tubing set The blood tubing
`set typically comprises a plurality of sections of medical
`tubing. bubble traps or drip chambers (collectively "bubble
`traps" herein), pressure monitoring sites. air bubble detec- 25
`tion sites. access sites connectors. clamps, peristaltic pump
`headers and accessories of various sorts. Pressure monitor(cid:173)
`ing sites are typically disposable pressure pods which trans(cid:173)
`mit the pressure of blood. or another fluid, to a pressure
`sensor while simultaneously isolating the blood or other 30
`fluid from the pressure sensor. Access sites are typically
`disposable septa and associated housing for sampling the
`patient's blood or adding medication. Access sites may
`require two hands to operate, one to hold the site steady.
`another to operate a sampling or injection syringe. This may 35
`increase the risk of needle sticks to the hand holding the
`access site.
`Because hemodialysis must be performed frequently. it is
`important to keep the cost of each treatment as low as
`possible. Further, it is desirable to minimize the amount of 40
`blood outside a patient's body in the extracorporeal circuit.
`thereby minimizing the stress on the patient as well as
`minimizing the potential for trauma to the blood. Bubble
`traps typically retain a relatively large volume of blood
`during normal operation. Blood trauma also can occur at an 45
`air-blood interface such as are found in typical bubble traps
`and drip chambers. It would further be advantageous to
`eliminate or reduce the need to add anticoagulant to the
`blood, further reducing the physical stress on the patient.
`It is against this background that the blood tubing set of
`the present invention developed.
`
`50
`
`55
`
`SUMMARY OF THE INVENTION
`One significant aspect of the present invention is a com(cid:173)
`bined pressure sensing pod and needle access site ("pod/
`site" herein) which reduces treatment cost by reducing the
`cost of the blood tubing set. The pod/site combines. in a
`single device, the functions of transmitting pressure from
`blood or other fluid to a pressure sensor without the blood 60
`contacting the pressure sensor and providing a site for
`injecting fluids into or withdrawing fluids from the blood or
`other fluid. The cost of the blood tubing set is reduced in
`accordance with this aspect of the invention by reducing the
`manufacturing cost of the pressure pods and needle access 65
`sites by combining them in a single part and further by
`reducing tubing set assembly cost by reducing the number of
`
`2
`parts. In accordance with this aspect of the invention, a
`needle access site is provided on a front or top face of a
`pressure pod. thus combining two functions into a single
`device and achieving the additional result that the needle
`access site may be used to remove air from the pod/site.
`Further in accordance with this aspect of the invention. a
`needle guard and flow diverter is provided to protect the
`diaphragm of the pressure pod from accidental needle punc(cid:173)
`tures and to prevent blood flowing in the pod/site from
`flowing directly through the pod/site. The flow diverter
`forces the pod/site to trap air, which may subsequently be
`removed with a needle through the access site. Further, the
`pod/site is typically held securely. obviating the need to hold
`the pod/site during sampling from or injecting into the
`pod/site.
`Another significant aspect of the present invention is a
`simplified blood tubing set incorporating the pod/sites to
`achieve still fw-ther significant benefits. In accordance with
`this aspect of the invention a blood tubing set is provided
`which facilitates the detection of, and protection of the
`patient against. the well known problems of air bubbles.
`without the use of the typical bubble traps. In accordance
`with this aspect of the invention, a pod/site is provided at a
`location in the blood tubing set normally occupied by an
`arterial bubble trap. This arterial pod/site is further provided
`with a saline line connection to permit the addition of saline
`solution to the blood tubing set, as for priming. Further in
`accordance with this aspect of the invention a pod/site is
`provided at a location typically occupied by a venous bubble
`trap. This venous pod/site is provided with a filter to prevent
`particulate matter from entering a patient and with a con(cid:173)
`nection to permit adding medication to the blood returning
`to the patient.
`Cost is reduced by eliminating the two bubble traps and
`by reducing assembly cost by reducing the number of parts
`in the blood tubing set. Further, the extracorporeal blood
`volume is greatly reduced by eliminating the bubble traps,
`thereby reducing blood trauma potential. Blood trauma
`potential is further reduced by the elimination of the air(cid:173)
`blood interfaces of the bubble traps. The reduction in
`extracoiporeal blood volume, and therefore the amount of
`time that blood is circulated outside the patient's body. may
`reduce or eliminate the need fot anticoagulant.
`Fw-ther significant aspects of the present invention will be
`apparent to one skilled in the art from the drawings. detailed
`description of the preferred embodiment and the claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a schematic diagram of a hemodialysis apparatus
`having a blood tubing set in accordance with the present
`invention.
`FIG. 2 is a pictorial representation of the blood tubing set
`of FIG. 1.
`FIG. 3 is a partially cut away perspective view of a
`pod/site of the present invention mounted to a pod/site
`holder.
`FIG. 4 is a top perspective view of a portion of the
`pod/site shown in FIG. 3.
`FIG. 5 is a bottom perspective view of a portion of the
`pod/site shown in FIG. 4.
`FIG. CJ is a plan view of the portion of the pod/site shown
`in F1G. 4.
`FIG. 7 is a sectional side view of the portion of the
`pod/site shown in F1G. fi viewed from line 7-7.
`FIG. 8 is a bottom view of the portion of the pod/site
`shown in FIG. 4.
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`FIG. 9 is a top perspective of an alternative embodiment
`of the portion of the pod/site shown in FIG. 4.
`FIG. 10 is a top perspective view of a further alternative
`embodiment of the pod/site shown in FIG. 4.
`FIG. 11 is a side sectional view of the portion of the
`pod/site shown in FIG. 10. viewed from line 11-11.
`DEfAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`FIG. 1 illusttates a hemodialysis apparatus 20 incorpo(cid:173)
`rating the blood tubing set 22 of the present invention.
`Blood, typically referred to as arterial blood, is withdrawn
`from a patient 24 through an arterial cannula and cannula
`line 26 into an arterial segment 28 of the blood tubing set 22.
`The arterial segment 28 includes a pump header tubing
`section 3t which is acted on by a rotor of a peristaltic pump
`32 to move the blood through the hemodialysis apparatus 20.
`The blood then passes into a dialyzer 34 which is divided
`into a blood chamber 36 and a dialysate chamber 38 by a
`semi-permeable membrane 40. Substances such as urea and
`creatanine. as well as excess fluid. are transferred from the
`blood in the blood chamber 36 across the semi-permeable
`membrane 40, to dialysate flowing in the dialysate chamber
`38 in a well known manner. The dialysate chamber 38 of the
`dialyzer 34 is connected to a source of fresh dialysate (not
`shown) and a disposal line for spent dialysate (not shown).
`Blood exits the blood chamber 36 of the dialyzer 34 into a
`venous segment 42 of the blood tubing set 22 and from there
`returns to the patient 24 through a venous cannula and
`cannula line 44.
`The hemodialysis apparatus 20 is provided with a bubble
`detector 46 of a type which can detect the presence of
`bubbles in the fluid flowing in the tubing through the walls
`of the tubing of the tubing set 22. Such a bubble detector is
`disclosed in U.S. Pat. No. 5.394,732 to Johnson et al., which 35
`is assigned to the assignee of the present invention, the entire
`disclosure of which is incoiporated herein by reference. The
`bubble detector 46 may provide a signal to an automatic
`venous clamp 48 to cause the automatic venous clamp 48 to
`close, interrupting the flow of blood to the patient 24 in the 40
`event the bubble detector 46 detects air bubbles which are
`potentially harmful to the patient 24.
`The blood tubing set 22 will be described in more detail
`by reference to FIG. 2. The arterial segment 28 will be
`descnbed sequentially from the point where the arterial 45
`cannula and cannula line 26 connects to the arterial segment
`28 of blood tubing set 22, to the point where the arterial
`segment 28 connects to the dialyzer 34. The venous segment
`42 will then be described sequentially from the point where
`the venous segment 42 connects to the dialyzer 34, to the 50
`point where the venous segment 42 connects to the venous
`cannula and cannula line 44.
`The arterial segment 28 of the blood tubing set 22 is a
`continuous flow communication path comprising an arterial
`capped connector 50, adapted to be connected to a priming 55
`waste handling system, such as that described in U.S. Pat.
`No. 5.041.215 to Chamberlain et al., which is assigned to the
`assignee of the present invention, the entire disclosure of
`which is incorporated herein by reference. The arterial
`capped priming connector 50 is then connected to an arterial 60
`rotating collar luer connector 52 which connects to the
`arterial cannula and cannula line 26. A first tubing section 54
`connects the arterial rotating collar luer connector 52 to an
`inlet 56 of an arterial pod/site 58. A manually activated
`arterial pinch clamp 57 is inteiposed on the first tubing 65
`section 54 at a location near the arterial rotating collar luer
`connector 52.
`
`4
`The arterial pod/site 58 has a principal outlet 60 and a
`secondary outlet 62. A second tubing section 64 connects the
`secondary outlet 62 of the arterial pod/site 58 to a luer lock
`connector 66 which is, in turn, connected to a saline capped
`5 priming connector 68. The saline capped priming connector
`68 is similar to the arterial capped priming connector 50 and
`facilitates introduction of saline solution and other fluids
`into the tubing set.
`The pump header tubing section 3t, which has a diameter
`to and length coordinated to interfit with the peristaltic pump
`32 (FIG. 1), extends from the principal outlet 60 of the
`arterial pod/site 58 to a ferrule 72, which may be a reducing
`ferrule.
`A third tubing segment 74 then extends from the ferrule
`15 72 to an arterial dialyzer connector 76. which is adapted to
`connect the arterial segment 28 of the tubing set 22 to the
`dialyzer 34. The arterial dialyzer connector 76 may be a
`luer-lock connector or the like.
`The venous segment 42 of the blood tubing set 22
`comprises a venous dialyzer connector 78. which may also
`be a luer-lock connector or the like which is connected by a
`fourth section of tubing 80 to an inlet 82 of a venous pod/site
`84. The venous pod/site 84 has a principal outlet 86 and a
`secondary outlet 88. The secondary outlet 88 of the venous
`25 pod/site 84 is connected by a fifth tubing section 90 to a luer
`connector '2 which is adapted to receive dispensing
`apparatus, such as a luer connected syringe (not shown). for
`medication to be administered to the patient 24 (FIG. 1) by
`injection in the patient's blood flowing in the venous seg(cid:173)
`ment 42.
`The venous pod/site has within it a tubular particulate
`filter 94, which prevents particulates entering the venous
`pod/site 84 through the inlet 82 from exiting the pod/site 84
`through the principal outlet 86. The principal outlet 86 of the
`venous pod/site 84 is connected by a sixth tubing section 96
`to a venous rotating collar luer connector ,8. lnteiposed on
`the sixth tubing segment 96 near the venous rotating collar
`luer connector 98 is a manually activated venous pinch
`clamp 100. The sixth tubing section 96 interfits with the air
`bubble detector 46 and automatic venous clamp 48 between
`the venous pod/site 84 and the venous pinch clamp 100. The
`rotating collar luer connector 98 is then terminated with a
`venous capped priming connector 102.
`The tubing set 22 of the present invention is assembled
`using conventional medical tubing connectors and connec(cid:173)
`tion techniques well known in the art.
`The general construction and function of pressure pods is
`described in U.S. Pat. No. 4,666,598 which is assigned to the
`assignee of the present invention, the entire disclosure of
`which is incorporated herein by reference. Access sites take
`many forms. Exemplary access sites are described in U.S.
`patent application Ser. No. 08/483,740, Internally Lubri(cid:173)
`cated Elastomers for Use in Biomedical Applications filed
`Jun. 7, 1995, assigned to the assignee of the present inven(cid:173)
`tion which is a continuation-in-part of U.S. patent applica(cid:173)
`tion Ser. No. 08/047,856. filed Apr. 15, 1993. the entire
`disclosure of which is incorporated herein by reference.
`Further examplary access sites are described in U.S. Pat. No.
`5322,516 which is assigned to the assignee of the present
`invention and which is incorporated herein by reference in
`its entirety.
`The combination pressure pod/access site 150 will be
`described by reference to FIG. 3. It will be appreciated by
`one skilled in the art that this description covers one specific
`pressure pod design and one specific access site design but
`the invention is not so limited. In particular, it is within the
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`scope of the present invention to combine many different
`pressure pod designs with many different access site designs
`in order to achieve the objects of the present invention.
`The pod/site 150 of the present invention comprises a pod
`base 152. a pod cap 154 and an elastomeric pressure 5
`transmission diaphragm such as a silicone diaphragm 156,
`sandwiched sealingly between the pod cap 154 and the pod
`base 152. The pod base 152 and pod cap 154 may be
`injection molded from any of a variety of plastic materials,
`such as polyethylene terephthalate glycol (PEfG). selected 10
`at least in part for their biocompatible properties. The pod
`cap 154 is preferably transparent.
`The pod base 152 further comprises a generally circular
`disk-like member with a central orifice 158 that mates
`removably and sealingly with a pressure sensing member
`160. A resilient elastomeric frustoconical seal 161 surrounds
`the pressure sensing member 160 and seals the orifice 158 to
`the pressure sensing member 160 at a lower radiused edge
`163 of the orifice 158. The pod cap 154 comprises a
`generally cylindrical chamber 162 having two co-linearly
`extending tubing connections 164, 166 in fluid communi(cid:173)
`cation with the interior 180 of chamber 162. The pod cap
`154 has a bottom portion 170 having a generally annularly
`extending peripheral L-shaped flange 172 which matches a
`annularly extending upwardly facing peripheral mating
`ledge 174 on the pod base 152. A downward facing. annu(cid:173)
`larly extending cap ridge 171 is located in the interior 180
`of the pod cap 154 inwardly of the flange 172. An upward
`facing annularly extending base ridge 173 matching the cap
`ridge 171 is located on the pod base 152. The pod base 152
`interfits with the bottom 170 of the pod cap 154 with the
`flange 172 of the pod cap 154 mating with the mating ledge
`174 of the base 152. The flange 172 and cap ridge 171 of the
`cap 154 and the base ridge 173 and an annular ledge 177
`inward of the mating ledge 174 of the base 152 cooperate to
`define an annular retention cavity 176 opening into an
`interior 180 of the chamber 162 of the cap 154.
`The interior 180 of the chamber 162 receives and retains
`a portion of the fluid, typically blood. the pressure of which
`is to be measured by the pod/site 150. The diaphragm 156 is
`generally disc-like and may have a shape adapted to facili(cid:173)
`tate the transfer of pressures from the fluid in the interior 180
`of the chamber 162 to a pressure measuring space 182
`between the pod base 152 of the pod/site 150 and the
`diaphragm 156, and from there to the pressure sensing
`element 160. The diaphragm has a thickened peripheral
`portion 184which is retained in the retention cavity 176. The
`remainder of the disk-like diaphragm 156 cooperates with
`the cap ridge 171 and the base ridge 173 to form a fluidly
`sealed resilient pressure transmissive barrier between the
`interior 180 of the chamber 162 of the pod cap 154 and the
`pressure metering space 182 between the diaphragm 156 and
`the pod base 152. The pod base 152 and pod cap 154 are
`typically joined by ultrasonic welding.
`The cap further comprises an access extension 186, also
`in fluid communication with the interior 180. The access
`extension 186 is a generally tubular member extending from
`the top 188 of the cap 154. It should be understood that the
`terms top and bottom are used for reference only. The
`pod/site may be installed in several orientations, a common
`one being with the cap top 188 facing away from a dialysis
`machine 20 and the bottom 150 of the cap 154 towards the
`machine. The access extension 186 has an exterior periph(cid:173)
`eral ring 190. Extending downwardly from the access exten(cid:173)
`sion 186. and in fluid communication with the interior 180
`of the chamber 162 is a needle guard portion 192. The needle
`guard portion has a solid floor 194. The needle guard portion
`
`6
`192 further has a wall that has lateral windows 196 which
`are positioned so that fluid entering or leaving the access site
`150 through the tubing connections, 164. 166 cannot flow
`directly into the windows 196 of the needle guard portion
`192, but rather are diverted by the needle guard portion's
`192 extension into the interior 180 of the chamber 162 to
`flow around the needle guard portion. 92 when flowing from
`one inlet tube 164 to the other tube 166 or the reverse.
`Fluid may only flow into and out of the interior 180 of the
`chamber from and to an interior 198 of the needle guard
`portion 192 through the windows 196. The windows 196 are
`preferably too small for the smallest expected needles to
`pass through the windows. preferably no more than 0.020
`inches in at least one dimension, but large enough to pass air
`15 and blood freely.
`A septum plug 200 is inserted into the access extension
`186 into the interior 198 of the access extension 186. A
`shoulder 201 defines an orifice 203 in the interior 198 of the
`access extension 186 that is smaller than the diameter of the
`20 septum plug 200. The shoulder 201 in the interior 198 of the
`access extension 186 retains and sealingly mates with the
`septum plug 200. The septum plug 200 is held in place by
`a retention ring 202 which fits over the access extension 186
`and mates with the peripheral ring 190 of the access exten-
`25 sion 186 and has a lip 204 for retaining the septum plug 200
`in place in the access extension 186. The septum plug may
`be an injection molded cylinder of a silicone impregnated
`thermoplastic styrene-ethylene/bytylene-styrene block poly(cid:173)
`mer having a Shore A durometer hardness of 15 to 40, such
`30 as C-FLEX™ manufactured by Consolidated Polymer
`Technologies, Inc.
`The septum may be any of several types including a
`septum for a sharp needle. a septum for a blunt needle, or a
`pre-split septum for a blunt needle or cannula.
`The needle guard portion 192 is located so that the floor
`194 of the needle guard portion is above the diaphragm 156
`and so that a sharp or blunt needle or cannula (not shown)
`penetrating the septum plug 200 will be blocked by the floor
`40 194 and cannot damage the diaphragm 156.
`The pod site may be releasably mounted to a hemodialysis
`apparatus 20 by a pod/site mounting assembly 206 which
`comprises the pressure sensor 160 and a pod/site retention
`member 208 which may, for example, retain the pod/access
`45 site by a pair of clip arms 210 which interfit with, and hook
`around, the tubing connections 164, 166. The resilient
`frustoconical seal 161 of the pressure sensor 160 is com(cid:173)
`pressed when the pod/site 150 is installed, biasing the
`pod/site upward to retain it in the clip arms 210 of the
`50 pod/site retention member 208.
`The cap will be described in more detail with reference to
`FIGS. 4-8. The cap comprises the chamber 162 and the two
`tubing connections 164. 166 which extend along, and define
`a flow path about. an axis 212 and which are in fluid
`55 communication with the interior 180 of the chamber 162.
`The access extension 186 with its ring 190 extends vertically
`from the cap. The needle guard portion 192 extends into the
`flow path defined by the axis 2U from the access site
`extension 186. The needle guard portion 192 partially
`60 obstructs the flow path along the axis 212 so that fluid
`entering either tubing connection 164. 166 is prevented from
`flowing in a straight path through the interior 180 of the cap
`154 to the other tubing connection 164, 166 but is instead
`diverted to one side or the other. or below the floor 194, of
`65 the needle guard portion 192. The needle guard portion 192
`floor 194 is connected to the top 188 of the chamber 162 by
`a vertically extending wall 214. The vertically extending
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`walls 214 generally block the direct passage of fluid between
`the tubing connections 164, 166 and are contoured to
`smoothly direct impinging flow downward. lnteiposed in the
`wall 214, on an axis 216 peipendicular to the axis 212 of the
`tubing connectors 164, 166, are the two windows 196 which
`provide fluid communication between the interior 180 of the
`cap 154 and the interior 198 of the access extension 186. The
`tubing connections 56, 62, 82. 86, 88, 164, 166 may be the
`typical welded push fit sockets for typical medical flexible
`tubing as are well known in the art The tubing connections 10
`56, 62, 82, 86, 88, 164, 166 may be the typical welded push
`fit sockets for typical medical flexible tubing as are well
`known in the art
`FIG. 9 illustrates a cap 350 adapted for use on the
`simplified blood tubing set 22 of the present invention for 15
`use as the arterial pod/site SS. The arterial cap 350
`comprises, in addition to the co-linear tubing connections
`56, 60, a secondary tubing connection of smaller diameter
`62 offset from and parallel to, the axis 212 defined by the
`co-linear tubing connectors 60, 56. This offset secondary 20
`tubing connector 62 adjacent to one of the co-linear tubing
`connections 60 and is further in fluid communication with
`the interior 180 of the cap 350.
`FIGS. 10 and 11 illustrate another embodiment of the cap
`355 which may be adaptable for use on the venous pod/site 25
`84. In this embodiment the venous cap 355 comprises the
`secondary tubing connection 88 offset from the axis of the
`co-linear tubing connectors 82,86 and adjacent to, and
`parallel to one of the co-linear connectors 86.
`The tubular filter 94 is installed within the venous cap 30
`355. The tubular filter 94 has a flange 357 at its base and a
`porous tubular filtration portion 359. A shoulder in one of the
`tubing connectors 86 has a shoulder 361 that defines 8:11
`orifice 363 into the interior 180 of the chamber 164 that is
`smaller than the flange 357 and larger than the diameter of 35
`the filter portion 359. The filter 94 is installed by passing the
`filter portion 359 through the orifice until the flange 3S7 is
`sealingly engaged with the shoulder 361. The filter 94 is then
`retained by the end 365 of a medical tubing section 96
`secured in the tubing connector 86 against the flange 361, as 40
`has been well known for many years.
`To accommodate the filter 92 the access extension 186
`may be of a length as necessary to bring the needle guard
`portion 192 above the filter 92.
`A presently preferred embodiment of the present inven(cid:173)
`tion has been described Many variations of the invention
`may be made which are within the spirit and scope of the
`invention as claimed in the following claims.
`The invention claimed is:
`1. A combination pressure pod and access site apparatus
`for use in a medical tubing set comprising:
`a pressure sensing chamber having a pressure measuring
`space;
`a measured fluid chamber for receiving fluid;
`a pressure transmissive diaphragm sealingly separating
`the pressure measuring space from the measured fluid
`chamber wherein the diaphragm prevents received fluid
`from flowing into the pressure measuring space;
`an access site in fluid communication with the measured 60
`fluid chamber; and
`a septum forming a portion of the access site that permits
`injecting fluids into, and withdrawing fluids from, the
`measured fluid chamber through the access site.
`2. An apparatus as defined in claim 1 further comprising: 65
`a needle guard configured and located to prevent damag(cid:173)
`ing the pressure transmissive diaphragm during use of
`
`8
`the septum while permitting fluid to be transferred from
`the measured fluid chamber to the access site and from
`the access site to the measured chamber.
`3. An apparatus as defined in claim 1 further comprising
`5 at least one tubing connection in fluid communication with
`the measured fluid chamber.
`4. An apparatus as defined in claim 3 wherein the at least
`one tubing connection comprises:
`two co-linear tubing connections each in fluid communi(cid:173)
`cation with the measured fluid chamber; further com(cid:173)
`prising:
`a flow diverter to prevent flow entering the measured fluid
`chamber from flowing in a straight line from one of the
`tubing connections to another one of the tubing con(cid:173)
`nections.
`5. An apparatus as defined in claim 4 further comprising
`a third tubing connection in fluid communication with the
`measured fluid chamber.
`6. An apparatus as defined in claim 4 further comprising:
`a needle guard configured and located to prevent damag(cid:173)
`ing the pressure transmissive diaphragm during use of
`the septum while permitting fluid to be transferred from
`the measured fluid chamber to the access site and from
`the access site to the measured chamber.
`7. An apparatus as defined in claim 3 further comprising
`a filter mutually fitting with the tubing connection.
`8. Blood tubing set apparatus for use with an extracor(cid:173)
`poreal blood treatment apparatus comprising:
`at least one combination pressure pod and access site for
`use in a medical tubing set comprising:
`a pressure sensing chamber having a pressure measur(cid:173)
`ing space;
`a measured fluid chamber for receiving fluid;
`a pressure transmissive diaphragm sealingly separating
`the pressure measuring space from the measured
`fluid chamber wherein the diaphragm prevents
`received fluid from fl.owing into the pressure mea(cid:173)
`suring space;
`an access site in fluid communication with the mea(cid:173)
`sured fluid chamber; and
`a septum forming a portion of the access site that
`permits injecting fluids into, and withdrawing fluids
`from, the measured fluid chamber through the access
`site.
`9. A blood tubing set apparatus as defined in claim 8
`wherein:
`the at least one combination pressure pod and access site
`further comprises:
`a needle guard configured and located to prevent dam-
`aging the pressure transmissive diaphragm during
`use of the septum while permitting fluid to be
`transferred from the measured fluid chamber to the
`access site and from the access site to the measured
`fluid chamber.
`10. A blood tubing set apparatus as defined in claim 9
`wherein:
`the at least one combination pressure pod and access site
`comprises:
`two co-linear tubing connections each in fluid commu(cid:173)
`nication with the measured fluid chamber;
`a flow diverter to prevent flow entering the measured
`fluid chamber from fl.owing in a straight line from
`one of the tubing connectio