EP1198262A1 - Catheter with check valve - Google Patents

Catheter with check valve

Info

Publication number
EP1198262A1
EP1198262A1 EP00952210A EP00952210A EP1198262A1 EP 1198262 A1 EP1198262 A1 EP 1198262A1 EP 00952210 A EP00952210 A EP 00952210A EP 00952210 A EP00952210 A EP 00952210A EP 1198262 A1 EP1198262 A1 EP 1198262A1
Authority
EP
European Patent Office
Prior art keywords
catheter
check valve
valve
patient
combination
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP00952210A
Other languages
German (de)
French (fr)
Other versions
EP1198262A4 (en
Inventor
Thomas L. Spinks
Kevin H. Pike
Michael Kassel
Mark Godfrey
Scott Wells
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vadus Inc
Original Assignee
Vadus Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vadus Inc filed Critical Vadus Inc
Publication of EP1198262A1 publication Critical patent/EP1198262A1/en
Publication of EP1198262A4 publication Critical patent/EP1198262A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0693Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof including means for seal penetration

Definitions

  • This invention relates to peripherally inserted central and/or midline catheters
  • the check valve prevents hazardous blood spills when a
  • peripherally inserted central catheter line has reached the vascular areas near the heart.
  • Intravenous catheters for the infusion of fluids into the veins of a patient are
  • One type is the "through-the-needle" catheter
  • the needle is not withdrawn from the patient upon
  • the second type of catheters is the "over-the-needle" type.
  • the insertion needle is withdrawn
  • HCW healthcare workers
  • PICC catheter
  • peripheral venous system and the time required to place a typical PICC line, which can
  • the catheter upwardly through the vascular system, the catheter must be formed from a soft
  • catheters to extend from two to thirty inches or more through the vascular system of a patient.
  • the insertion of the PICC line must also occur without causing trauma to the
  • Y-connector including a hemostatic valve for enabling the introduction of an elongated
  • a member e.g., a balloon catheter, into the body of a living being while precluding blood
  • the Y-connector includes a housing having an interior in
  • valve element e.g., a disc-like member, has a small diameter opening therein.
  • valve element e.g., a duck-bill valve elements
  • valve element includes a normally closed, but
  • the plunger mechanism includes a tubular member having
  • the tubular member is arranged to be moved into and out of the aperture in the
  • the tubular member has a central passageway arranged to enable
  • the elongated member to be readily extended therethrough for location at a desired
  • the one valve element is arranged for engaging
  • valve member to preclude blood from flowing through the interface between the valve
  • a catheter check valve assembly has a valve housing with a wall defining a
  • a duckbill valve and an end cap supporting a catheter are positioned
  • a separator has a major portion positioned in said
  • the separator is axially moveable from a retraced position where the probe is
  • a needle may be extended through the catheter check valve
  • the apparatus comprises a
  • tubular member having a distal end portion and a proximal end portion.
  • end portion is in the form of a hollow housing for a hemostatic valve assembly
  • the reservoir is formed of a foam
  • valve element is a disk ⁇
  • polydimethylsiloxane located distally of the reservoir and has a openable passageway
  • the reservoir applies the lubricating fluid-
  • hollow housing is arranged to produce peripheral pressure on the valve element to
  • valve body is configured as a valve flap (20)
  • valve flap is mounted in the connection piece via an elastic
  • valve assembly having a proximal end, a distal end for
  • an elastic valve member having at least one slit and a slide
  • the device has a valve
  • valve opener extending through the valve member, and with the stem having a
  • An attachment structure has a proximal end
  • a needle is insertable through the outer
  • An inner cannula is attached to an inner cannula
  • the attachment structure can comprise two, hubs, one
  • a valve structure is associated
  • valve structure opens
  • the assembly allows the removal of the inner cannula and the insertion of a
  • cannula can also be provided if the material of the outer cannula is such that it will swell
  • angiographic catheter includes a housing having a first end adapted to form a luer lock
  • elastomeric slit seal is supported across the central bore to selectively seal the proximal
  • the slit seal is adapted to permit a guidewire to be passed
  • the second end of the housing is
  • a female luer lock connection fitting for receiving the conical tip of a syringe, stopcock, or the like, and forming a pressure-tight connection therebetween.
  • C.R. Bard also sells a PICC line having a valve type structure in the distal end of
  • PICC line is known as a Groshong valve.
  • the present invention provides a catheter and check valve system or combination
  • check valve prevents fluids from flowing out of the patient, which is particularly
  • the check valve also prevents the introduction of air, fluids or other
  • the catheter and check valve combination include a catheter
  • valve housing having an internal cavity in fluid communication with
  • a check valve is disposed within the internal cavity of
  • the check valve is movable between a first position sealing the
  • valve housing has an end wall defining an opening
  • the check valve is normally biased against the end wall to seal the opening.
  • valve is movable to the second position away from the end wall, which opens the
  • the proximal end of the catheter includes a connector for
  • a suitable attachment such as a drug introduction device, an IV
  • the attachment includes a projection adapted for
  • the catheter comprises a PICC line.
  • the PICC line may be
  • valve housing or the valve housing may have a fitting for being secured
  • the catheter comprises an introducer catheter having
  • valve housing and check valve seal the
  • introducer catheter but permit fluid communication through the introducer catheter
  • the introducer catheter includes a connector and a cap is fitted
  • a guide wire extends through the introducer catheter and has one
  • cap and guide wire are removable from the introducer catheter with the guide wire being
  • the check valve is made of a resilient material that
  • the introducer catheter further includes a needle extending
  • the sharp end or tip of the needle is inserted
  • a needle into the patient. After insertion, a needle can be removed from the introducer
  • guide wire may have one end secured to the needle and the other end secured to a cap on
  • Fig. 1 is a schematic side view shown in partial cross-section of the catheter and
  • Fig. 2 is a schematic side view shown in partial cross-section of the catheter and
  • Fig. 3 is a schematic side view shown in cross-section of the check valve
  • Fig. 4 is a schematic side view shown in cross-section of the check valve
  • Fig. 5 is a schematic side view shown in partial cross-section of an embodiment
  • Fig. 6 is a schematic side view shown in partial cross-section of an embodiment
  • Fig. 7 is a schematic side view shown in partial cross-section of an embodiment
  • Fig. 8 is a schematic side view shown in partial cross-section of an embodiment
  • the numeral 10 designates a PICC line having a first
  • the proximal end 12 includes a valve housing 13
  • the connector 14 takes the form of a
  • PICC line 10 is shown for purposes of representation, and that the check value of the present
  • the attachment 17 is also
  • the valve housing 13 defines an internal cavity 18 in fluid communication with
  • the check valve 18 can thus be used to control fluid flow
  • a check valve 19 is positioned within the internal cavity 18 for sealing or
  • the check valve 19 is designed to seal an
  • valve 19 is biased against internal wall 21 and seals the opening 20, as shown in Fig. 1.
  • the check valve 19 seals the valve housing 11 to prevent, for example,
  • the connector 16 on attachment 17 includes a projection 22 that is inserted through the second end 12 and into the internal cavity 18 to displace the check valve 19 away from
  • the check valve 19 may take the
  • check valve in accordance with the present disclosure, the check valve
  • valve seat 24 that includes a number of fluid passageways (not shown) that
  • the PICC line 10 and the valve housing 13 may be any type of the PICC line 10 and the valve housing 13.
  • housing 13 includes a fitting 25 and lock member 26 that are inserted into the PICC line
  • PICC line 10 can be introduced into the patient's body in a variety of well known mechanisms, and then the valve housing 13 can be used to cap the open end of the PICC
  • valve housing 13 and check valve 18 thus seal the PICC line 10, while still
  • an introducer catheter 27 includes a valve housing 28 and a check valve
  • the check valve 29 is disposed in an internal cavity 30 within valve housing 28 and
  • a tube portion 27a formed of soft, pliable and biocompatible material and is
  • attachment 17 (Fig. 2) to the introducer of catheter 27, the attachment 17 can be
  • the guide wire 31 has an end 31a
  • the cap 32 can be connected to connector 30 with the shown male and female luer connectors 30a and 32a or other suitable connecting mechanisms.
  • the cap 32 can be
  • the introducer catheter 27 is used in any manner.
  • the introducer catheter 27 is used in any manner.
  • the needle 33 has a sharp end or tip 33a that projects outwardly beyond the
  • the sharp tip or end 33a of the needle 33 is first
  • the needle 33 into the body of the patient.
  • the needle 33 is attached by guide wire 31 to
  • the check valve 29 is made of a
  • check valve 29 automatically reseals
  • the cap 32 can be removed with the guide
  • check valve 39 seals the end of the catheter. Thereafter, the introducer catheter 27
  • the introducer catheter 27 may also be connected to a needle guard assembly
  • the needle guard assembly may take the form of the needle guard assembly disclosed in U.S. Patent No. 5,954,698, which is hereby incorporated by
  • the catheter and check valve combination of the present invention provides a
  • the check valve eliminates the

Abstract

A catheter (10, 29) and check valve (19) combination is disclosed. In an embodiment, the catheter (10) comprises a PICC line having a first end for introduction into a body and a second end having a valve housing (11). The valve housing (11) includes an end wall (21) defining an opening, and a check valve (19) is disposed within the housing (11) and normally biased against the end wall (21) to seal the opening. The check valve (19) prevents blood loss from the patient when the catheter (10) is introduced into the body of a patient, which is particularly important for lines that connect with the vascular system of the body near the heart. In an embodiment, the catheter comprises an introducer catheter (29) and the check valve (19) prevents blood loss when the introducer catheter is inserted into the patient, as well as preventing the introduction of air or other fluid into the patient through the introducer catheter (29). In other embodiments, the introducer catheter (29) may include a guide wire (31) and/or a needle (33) that are retractable through a check valve (19) disposed in the valve housing (11).

Description

Catheter With Check Valve
This application claims the benefit of U.S. Provisional Application No.
60/146,045, filed 27 July 1999.
Field of the Invention
This invention relates to peripherally inserted central and/or midline catheters
lines and, more specifically, to a catheter device fitted with a simple, very reliable and
effective check valves. The check valve prevents hazardous blood spills when a
peripherally inserted central catheter line has reached the vascular areas near the heart.
Background of the Invention
Intravenous catheters for the infusion of fluids into the veins of a patient are
typically one of two general types. One type is the "through-the-needle" catheter
wherein the catheter is threaded through the needle and into the vein of a patient. In the
through-the-needle type catheter, the needle is not withdrawn from the patient upon
placement of the catheter. The second type of catheters is the "over-the-needle" type.
Upon insertion of the introducer catheter into a patient, the insertion needle is withdrawn
leaving the catheter in the body.
Traditionally, PICC lines are open-ended, requiring hurried and potentially
dangerous manipulations by healthcare workers (HCW) to contain and/or minimize
blood spills during their insertion and use. There is no protection from life threatening
loss of blood other than the HCW technique during insertion and some devices on the
market offer no protection from patient "bleed out" (life threatening loss of blood). Short peripheral catheters are distinguishable from peripherally inserted central
catheter ("PICC") lines in that PICC lines are inserted into the vascular system of the
patient whereas short peripheral catheters are inserted into a vein of the patient. Not
surprisingly, these different applications require different catheter structures and
correspondingly different restrictions to the use of a needle guard on the introducer
catheter.
Current PICC lines suffer any of several disadvantages due to the pressure of the
peripheral venous system and the time required to place a typical PICC line, which can
result in a significant blood spill. Contact with human blood can result in exposure to
blood-borne pathogens. The effort to contain the blood flow prior to connection to or
changing out an IV bag or other device is difficult and can result in damage to the
catheter or the insertion site. Significant blood loss can also occur should the arterial
line become accidentally disconnected, and entrapment of air is a problem if the line is
left open for a prolonged period of time. The loss of blood can be life threatening for
the patient. Finally, the cost associated with the clean-up and disposal of soiled
materials can be significant.
In the use of a PICC line, a flexible catheter is introduced into the vascular
system of a patient and subsequently manipulated to move the catheter through the
vascular system of a patient to a desired location. Because the catheter must be moved
upwardly through the vascular system, the catheter must be formed from a soft,
biocompatible, pliable, and flexible material which is capable of winding through and
extending through substantial lengths of the vascular system. It is not unusual for such
catheters to extend from two to thirty inches or more through the vascular system of a patient. The insertion of the PICC line must also occur without causing trauma to the
vascular system.
In an effort to overcome these problems, several devices have been disclosed in
the prior art that attempt to provide some means of checking the above-mentioned blood
spills and associated problems.
One such prior art system is disclosed in U.S. Patent No. 5,195,980 to Catlin. A
Y-connector including a hemostatic valve for enabling the introduction of an elongated
member, e.g., a balloon catheter, into the body of a living being while precluding blood
from flowing out of the valve. The Y-connector includes a housing having an interior in
which a pair of resilient valve elements and a plunger mechanism are located. One
valve element, e.g., a disc-like member, has a small diameter opening therein. The other
valve element, e.g., a duck-bill valve elements, includes a normally closed, but
openable, aperture therein. The plunger mechanism includes a tubular member having
an outer diameter, which is smaller than the diameter of the opening in the one valve
element. The tubular member is arranged to be moved into and out of the aperture in the
other valve element. The tubular member has a central passageway arranged to enable
the elongated member to be readily extended therethrough for location at a desired
position within the body of the being. The one valve element is arranged for engaging
the periphery of the elongated member after the elongated member has been extended
through the passageway and after the tubular member is moved out of the opening in the
valve member to preclude blood from flowing through the interface between the valve
member and the elongated member. Another prior art system is disclosed in U.S. Patent No. 5,405,323 to Rogers et
al. A catheter check valve assembly has a valve housing with a wall defining a
generally cylindrical chamber and a transverse wall having an aperture lying on the axis
of such chamber. A duckbill valve and an end cap supporting a catheter are positioned
on one side of the transverse wall. A separator has a major portion positioned in said
cylindrical chamber and an elongated cylindrical probe extending from said major
portion. The separator is axially moveable from a retraced position where the probe is
out of contact with the duckbill valve to a forward position extending through and
opening the duckbill valve. A needle may be extended through the catheter check valve
assembly when the separator is in the forward position.
Thomas et al., U.S. Patent No. 5,409,463, discloses an apparatus for introducing
a catheter percutaneously into the body of a living being. The apparatus comprises a
tubular member having a distal end portion and a proximal end portion. The proximal
end portion is in the form of a hollow housing for a hemostatic valve assembly
comprising a lubricant reservoir and a valve element. The reservoir is formed of a foam
material impregnated with a lubricant liquid, e.g., silicone. The valve element is a disk¬
like member formed of resilient material, e.g., silicone impregnated with
polydimethylsiloxane, located distally of the reservoir and has a openable passageway
extending through it for the catheter to pass. The reservoir applies the lubricating fluid-
in a controlled manner onto the catheter as it is passed through it, to thereby facilitate
the passage of the catheter through the openable passageway in the valve element. The
hollow housing is arranged to produce peripheral pressure on the valve element to
facilitate its closure. Schmidt, et al., U.S. Patent No. 5,613,663, discloses that in a valve device in a
connection piece, it is provided that the valve body is configured as a valve flap (20)
with a closed surface, which valve flap is mounted in the connection piece via an elastic
radial tongue (21) and rests against an annular supporting surface (26) in the closed
position, and that the sliding member pivots the valve flap (20) in opening direction
about the radial tongue (21) by pressure against its closed surface.
Wendell, U.S. Patent No. 5,062,836, discloses a placement device for catheter
and guide wire comprising, a valve assembly having a proximal end, a distal end for
connection to the catheter, an elastic valve member having at least one slit and a slide
member begin slidably received in the valve assembly and being movable between a
first position spaced from the valve member with the valve member being closed, and a
second position engaged against the valve member with the valve member being open,
with the slide member having a bore extending therethrough. The device has a valve
opener having an elongated stem on an end of the opener with an outer diameter
sufficiently small to be received in the bore of the slide member, with the stem having
sufficient length to extend through the slide member and open the valve member with
the valve opener extending through the valve member, and with the stem having a
channel with an inner diameter sufficiently large to receive the guide wire.
Another prior art system is disclosed in U.S. Patent No. 5,156,596 Balbierz, et
al. A catheter assembly is provided. An attachment structure has a proximal end
portion of an outer cannula attached to it. A needle is insertable through the outer
cannula and the attachment structure. An inner cannula is attached to an inner cannula
attachment region of the attachment structure. The inner cannula is insertable axially through the attachment structure. The attachment structure can comprise two, hubs, one
for the outer cannula and the other for the inner cannula, the two hubs being attachable
to one another to form the overall attachment structure. A valve structure is associated
with the attachment structure, suitably with the outer cannula hub. The valve structure
normally closes communication between an access passage in the attachment structure,
e.g., in the outer cannula hub, and the outer cannula lumen. The valve structure opens
sufficiently for the inner cannula to pass through it and to open communication between
the access passage and the outer cannula lumen when the inner cannula is inserted
through another passage in the attachment structure and through the outer cannula
lumen. The assembly allows the removal of the inner cannula and the insertion of a
replacement inner cannula, if desired, without removing the outer cannula from the
blood vessel. Use of a relatively small diameter needle for a desired diameter outer
cannula can also be provided if the material of the outer cannula is such that it will swell
in place.
Palestrant, U.S. Patent No. 5,336,192, discloses a self-sealing valve device for an
angiographic catheter includes a housing having a first end adapted to form a luer lock
connection with the proximal end of the angiographic catheter. A central bore extends
between the first end of the housing and an opposing second end, and a deformable
elastomeric slit seal is supported across the central bore to selectively seal the proximal
end of the catheter. The slit seal is adapted to permit a guidewire to be passed
therethrough and advanced into the catheter while sealingly engaging the walls of the
guidewire to prevent blood loss through the catheter. The second end of the housing is
provided with a female luer lock connection fitting for receiving the conical tip of a syringe, stopcock, or the like, and forming a pressure-tight connection therebetween.
The insertion of the conical tip of the syringe into the second end of the housing
automatically deforms the slit seal for allowing fluid to pass freely therethrough, while
again sealing the proximal end of the catheter when the conical tip of the syringe is
removed.
Wolbring, U.S. Patent No. 5,456,675, discloses a main cannula arrangement (10)
with a metal cannula (12) and a connecting piece (14), featuring a valve (46), which is
closed in the disconnected state and open in the connected state.
C.R. Bard also sells a PICC line having a valve type structure in the distal end of
the PICC line which is inserted into the patient. This valve at the distal end or tip of the
PICC line is known as a Groshong valve.
However, these prior art devices all suffer from one or more disadvantages due
to complex design. These include undesirable delicacy in handling and use,
undependable operation over time, component wear, difficulty in flushing completely,
and difficult, expensive manufacture. The prior art also does not provide a PICC line
that provides a positive shut off to the flow of blood out of the body or fluid and/or air
into the body.
Summary of the Invention
The present invention provides a catheter and check valve system or combination
that advantageously seals the catheter after insertion into the body of a patient. The
check valve prevents fluids from flowing out of the patient, which is particularly
advantageous when the catheter extends into the vascular system near the heart where
there is increased blood pressure. Without the check valve, this increased blood pressure could cause blood to flow back through the catheter and result in heavy blood
loss to the patient. The check valve also prevents the introduction of air, fluids or other
contaminants through the catheter into the patient.
In an embodiment, the catheter and check valve combination include a catheter
having a distal end for insertion into a body and a proximal end. The combination
further includes a valve housing having an internal cavity in fluid communication with
the proximal end of the catheter. A check valve is disposed within the internal cavity of
the valve housing. The check valve is movable between a first position sealing the
proximal end of the catheter to a second position permitting the flow of liquid through
the proximal end of the catheter.
In an embodiment, the valve housing has an end wall defining an opening and
the check valve is normally biased against the end wall to seal the opening. The check
valve is movable to the second position away from the end wall, which opens the
opening in the end wall so that liquid can flow through the valve housing to the catheter.
In an embodiment, the proximal end of the catheter includes a connector for
securing the catheter to a suitable attachment, such as a drug introduction device, an IV
system, or other like systems. The attachment includes a projection adapted for
insertion into the proximal end of the catheter in order to move the check valve from the
first position to the second position, which permits the flow of liquid through the
proximal end of the catheter.
In an embodiment, the catheter comprises a PICC line. The PICC line may be
integral with the valve housing or the valve housing may have a fitting for being secured
to the PICC line. In an alternate embodiment, the catheter comprises an introducer catheter having
a tube portion for insertion into the body. The valve housing and check valve seal the
introducer catheter, but permit fluid communication through the introducer catheter
when an attachment is secured to the introducer catheter.
In an embodiment, the introducer catheter includes a connector and a cap is fitted
over the connector. A guide wire extends through the introducer catheter and has one
end secured to the cap and the other end extending through the tube portion of the
catheter to guide placement of the introducer catheter within the body of a patient. The
cap and guide wire are removable from the introducer catheter with the guide wire being
retractable through the check valve. The check valve is made of a resilient material that
reseals itself after retraction of the guide wire through the check valve.
In an embodiment, the introducer catheter further includes a needle extending
through the tube portion and having a sharp end that projects outwardly from the tube
portion of the introducer catheter. In use, the sharp end or tip of the needle is inserted
into the body of a patient and the tube portion of the introducer catheter follows the
needle into the patient. After insertion, a needle can be removed from the introducer
catheter by withdrawing it with an attached guide wire through the check valve. The
guide wire may have one end secured to the needle and the other end secured to a cap on
the introducer catheter. When the needle is retracted to the check valve, the check valve
automatically reseals itself due to the resilient nature of the check valve that is made of a
material such as rubber.
Brief Description of the Drawings Fig. 1 is a schematic side view shown in partial cross-section of the catheter and
check valve combination of the present invention.
Fig. 2 is a schematic side view shown in partial cross-section of the catheter and
check valve combination of the present invention.
Fig. 3 is a schematic side view shown in cross-section of the check valve
disposed within the valve housing of the combination of the present invention.
Fig. 4 is a schematic side view shown in cross-section of the check valve
disposed within the valve housing of the combination of the present invention.
Fig. 5 is a schematic side view shown in partial cross-section of an embodiment
of a catheter and check valve combination of the present invention.
Fig. 6 is a schematic side view shown in partial cross-section of an embodiment
of a catheter and check valve combination of the present invention.
Fig. 7 is a schematic side view shown in partial cross-section of an embodiment
of a catheter and check valve combination of the present invention.
Fig. 8 is a schematic side view shown in partial cross-section of an embodiment
of a catheter and check valve combination of the present invention.
Detailed Description of the Preferred Embodiments
Referring to Figs. 1 and 2, the numeral 10 designates a PICC line having a first
end 11 and a second proximal end 12. The proximal end 12 includes a valve housing 13
and a fitting or connector 14 so that various attachments can be connected to the PICC
line 10. In the embodiment show is the drawings, the connector 14 takes the form of a
male luer 15 for connection to a female luer 16 on an attachment 17. However, other
suitable connectors or fittings may be used. It will also be understood that PICC line 10 is shown for purposes of representation, and that the check value of the present
invention could be used with other similar catheter devices. The attachment 17 is also
shown as a generic attachment, which will be understood to represent any one of a
number of various attachments that are commonly connected to PICC lines or other
similar catheters.
The valve housing 13 defines an internal cavity 18 in fluid communication with
the proximal end 12 of PICC line 10. In particular, fluids that are introduced into or
withdrawn from the proximal end 12 of PICC line 10 flow through the internal cavity 18
to or from the PICC line 10. The check valve 18 can thus be used to control fluid flow
to or from the PICC line 10
A check valve 19 is positioned within the internal cavity 18 for sealing or
opening the PICC line 10. In particular, the check valve 19 is designed to seal an
opening 20 in an internal wall 21 of value housing 11. In the normal position, the check
valve 19 is biased against internal wall 21 and seals the opening 20, as shown in Fig. 1.
In this position, the check valve 19 seals the valve housing 11 to prevent, for example,
blood from flowing out of the PICC line 10 and to prevent air or fluids from entering the
PICC line 10. This check valve 19 and PICC line combination 10 is particularly
advantageous when the line is connected to the vascular system near the heart where the
blood is highly pressurized and the blood could otherwise flow back through the PICC
line 10 and cause significant blood loss to the patient.
In order to secure an attachment 17 to PICC line 10 and open the check valve 19,
the connector 16 on attachment 17 includes a projection 22 that is inserted through the second end 12 and into the internal cavity 18 to displace the check valve 19 away from
the internal wall 21. When the check valve 19 is displaced, fluid can flow through the
internal cavity 18 and into or from the PICC line 10. The check valve 19 may take the
form of a variety of different check valves. In preferred embodiments, the check valve
19 would take the form of one of the check valves disclosed in U.S. Patent Nos.
5,954,698 or 5,967,490, which are commonly owned by the assignee of this application,
Vadus, Inc., and which references are hereby incorporated by reference.
To illustrate the operation of the check valve 19, a representative embodiment is
illustrated in Figs. 3 and 4. As shown in Figs. 3 and 4, the check valve 19 normally
seals against wall 21, and projection 22 is used to push check valve 19 inward to unseal
opening 20. The passageway 23 at the other end of the valve housing 13 is always open
due to a valve seat 24 that includes a number of fluid passageways (not shown) that
connect passageway 23 to valve cavity 18. While one particular embodiment has been
shown in Figs. 3 and 4, it will be understood that a wide variety of check valves 19
could be incorporated into the PICC line and check valve combination of the present
invention, including the various check valves disclosed in U.S. Patent Nos. 5,967,490
and 5,954,698, which are hereby incorporated by reference.
Referring to Figure 5, the PICC line 10 and the valve housing 13 may be
separate components that are secured together. As shown in that embodiment, the valve
housing 13 includes a fitting 25 and lock member 26 that are inserted into the PICC line
10 to secure it to the valve housing 13. This embodiment is advantageous because the
PICC line 10 can be introduced into the patient's body in a variety of well known mechanisms, and then the valve housing 13 can be used to cap the open end of the PICC
line 10. The valve housing 13 and check valve 18 thus seal the PICC line 10, while still
permitting various attachments to be easily connected to the PICC line 10.
Referring to Figs. 6 and 7, an alternate embodiment of the present invention is
shown in which an introducer catheter 27 includes a valve housing 28 and a check valve
29. The check valve 29 is disposed in an internal cavity 30 within valve housing 28 and
works in substantially the same way as check valve 19. The introducer catheter 27
includes a tube portion 27a formed of soft, pliable and biocompatible material and is
adapted for insertion into the body of a patient. When the introducer catheter 27 is
inserted into the body of a patient, the check valve 29 and valve housing 28 prevent the
escape of blood from the patient and also prevents the introduction of fluid or air into
the patient through the introducer catheter 27. When it is desired to connect an
attachment 17 (Fig. 2) to the introducer of catheter 27, the attachment 17 can be
connected to the connector 30 on the introducer catheter in the same fashion as it would
be connected to the PICC line 10 in the embodiment in Figs. 1 and 2, wherein the
projection 22 on the attachment 17 engages the check valve 29 in order to permit fluid
flow through the valve housing 28.
In some instances, it is desirable to have a guide wire 31 that passes through an
introducer catheter, PICC line or other similar catheter device in order to guide
placement of the line within the body of a patient. In the embodiment shown in Figs. 6
and 7, such a guide wire 31 extends through the tube portion 27a of the introducer
catheter 27 and also through the valve housing 28. The guide wire 31 has an end 31a
connected to a cap 32. The cap 32 can be connected to connector 30 with the shown male and female luer connectors 30a and 32a or other suitable connecting mechanisms.
After the introducer catheter 27 is inserted into the patient, the cap 32 can be
disconnected from the introducer catheter 27 and the guide wire 31 can be retracted from
the introducer catheter 27 by pulling on the cap 32 as shown in Fig. 7.
In embodiment shown in Fig. 8, the introducer catheter 27 is used in
combination with a needle 33 that is disposed in a tube portion 27a of the introducer
catheter 27. The needle 33 has a sharp end or tip 33a that projects outwardly beyond the
end of the tube portion 27a. In use, the sharp tip or end 33a of the needle 33 is first
inserted into the body, and then the tube portion 27a of introducer catheter 27 follows
the needle 33 into the body of the patient. The needle 33 is attached by guide wire 31 to
the cap 32, which has been previously described. The check valve 29 is made of a
resilient resealable material such as rubber, thus the needle 33 and guide wire 31 can
easily be passed through check valve 29, and then check valve 29 automatically reseals
the opening due the resiliency of the material. Thus, after introduction of the introducer
catheter 27 with the needle 33 into a patient, the cap 32 can be removed with the guide
wire 31 and needle 33 being retracted through check valve 29 in a bloodless fashion so
that check valve 39 seals the end of the catheter. Thereafter, the introducer catheter 27
remains in the patient and is sealed against blood loss or introduction of fluids or air into
the patient until it is desired to attach a suitable attachment device to the introducer
catheter 27.
The introducer catheter 27 may also be connected to a needle guard assembly
(not shown). The needle guard assembly may take the form of the needle guard assembly disclosed in U.S. Patent No. 5,954,698, which is hereby incorporated by
reference.
The catheter and check valve combination of the present invention provides a
rugged, dependable system for preventing blood loss and for preventing the introduction
of fluid or air into the catheter. Among other advantages, the check valve eliminates the
various slits, multiple elements, and other complex configurations disclosed in the PICC
prior art.
While this invention has been described with specific embodiments, many
alternatives, modifications and variations will be apparent to those skilled in the art in
light of the foregoing description. Accordingly, it is intended to include all such
alternatives, modifications and variations set forth within the spirit and scope of the
description.

Claims

We claim:
1. A catheter and check valve combination comprising:
a catheter having a distal end for insertion into a body and a proximal end;
a valve housing having an internal cavity in fluid communication with the
proximal end of the catheter; and
a check valve disposed in the internal cavity, the check valve being movable
between a first position sealing the proximal end of the catheter to a second position
permitting the flow of liquid through the proximal end of the catheter.
2. The combination of claim 1 wherein the valve housing has an end wall defining
an opening, and the check valve is normally biased against the end wall to seal the
opening.
3. The combination of claim 2 wherein the check valve is movable to a second
position away from the end wall and the opening of the valve housing so that the
opening is unsealed and liquid can flow through the valve housing to the catheter.
4. The combination of claim 1 in which the proximal end of the catheter includes a
connector.
5. The combination of claim 1 further including an attachment for connection to the
proximal end of the catheter, the attached including a projection adapted for an insertion
into the proximal end of the catheter in order to move the check valve from the first
position to the second position, which permits the flow of liquid through the proximal
end of the catheter.
6. The combination of claim 1 wherein the catheter comprises of PICC line.
7. The combination of claim 1 wherein the catheter comprises a PICC line, and the
valve housing is a separate piece have a fitting that is secured to the PICC line.
8. The combination of claim 1 in which the catheter comprises an introducer
catheter having a tube portion for insertion into the body of a patient.
9. The combination of claim 8 in which the introducer catheter has a connector, a
cap fitted over the connector and a guide wire connected to the cap and extending
through the valve housing, check valve, and tube portion of the introducer catheter, the
cap and guide wire being removable from the introducer catheter with the guide wire
being retracted through the check valve such that the check valve reseals itself after
retraction of the guide wire from the check valve.
10. The combination of claim 9 in which the introducer catheter further includes a
needle extending through the tube portion and having a sharp end that projects
outwardly from the tube portion of the introducer catheter, the needle being connected to
the guide wire and being retractable with the cap and guide wire from the introducer
catheter.
11. A method of placing a catheter in intravenous connection with a living being, the
method comprising the steps of:
providing a catheter having a first end for insertion into the body and a second
end having a valve housing, the valve housing including a check valve normally biased
against an opening in an end wall of the valve housing to seal the proximal end of the
catheter;
inserting the first end of the catheter into the body of a patient; providing an attachment having a connector adapted to connect to a connector on
the proximal end of the catheter, the attachment further including a projection shaped to
project into the opening in the end wall of the valve housing and push the check valve
away from the opening;
connecting the connector on the attachment to the connector on the catheter so
that the check valve is pushed away from the opening in the housing so that fluid
communication is established between the catheter and the attachment.
12. The method of claim 11 wherein the catheter comprises a PICC line.
13. The method of claim 11 wherein the catheter comprises an introducer catheter.
14. The method of claim 11 wherein the check valve is comprised of a resealable
material.
15. The method of claim 11 wherein, prior to insertion of the catheter into the
patient, the catheter further includes an end cap secured to a connector on the catheter
and connected to a guide wire, the guide wire extending through the valve housing,
check valve, and tube portion of the catheter.
16. The method of claim 15 further including the step of, prior to securing the
attachment to the catheter, removing the end cap and guide wire from the catheter.
17. The method of claim 11 wherein the catheter comprises an introducer catheter
and a needle is positioned within the tubular portion of the catheter and has a sharp end
projecting outward from the tube portion of the catheter.
18. The method of claim 17 wherein the step of inserting the catheter into the patient
includes first inserting the sharp end of the needle into the patient, and then having the
tube portion of the catheter follow the needle into the patient.
EP00952210A 1999-07-27 2000-07-26 Catheter with check valve Withdrawn EP1198262A4 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US14604599P 1999-07-27 1999-07-27
US146045P 1999-07-27
US62588000A 2000-07-26 2000-07-26
PCT/US2000/020369 WO2001007103A1 (en) 1999-07-27 2000-07-26 Catheter with check valve
US625880 2000-07-26

Publications (2)

Publication Number Publication Date
EP1198262A1 true EP1198262A1 (en) 2002-04-24
EP1198262A4 EP1198262A4 (en) 2003-02-12

Family

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Application Number Title Priority Date Filing Date
EP00952210A Withdrawn EP1198262A4 (en) 1999-07-27 2000-07-26 Catheter with check valve

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EP (1) EP1198262A4 (en)
WO (1) WO2001007103A1 (en)

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Also Published As

Publication number Publication date
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