U.S. patent number RE41,448 [Application Number 10/219,998] was granted by the patent office on 2010-07-20 for squitieri hemodialysis and vascular access systems.
This patent grant is currently assigned to Hemosphere, Inc.. Invention is credited to Rafael P. Squitieri.
United States Patent |
RE41,448 |
Squitieri |
July 20, 2010 |
**Please see images for:
( Certificate of Correction ) ** |
Squitieri hemodialysis and vascular access systems
Abstract
A hemodialysis and vascular access system comprises a
subcutaneous composite PTFE silastic arteriovenous fistula having
an indwelling silastic venous end which is inserted percutaneously
into a vein and a PTFE arterial end which is anastomosed to an
artery. Access to a blood stream within the system is gained by
direct puncture of needle(s) into a needle receiving site having a
tubular passage within a metal or plastic frame and a silicone
upper surface through which needle(s) are inserted. In an alternate
embodiment of the invention, percutaneous access to a blood stream
may be gained by placing needles directly into the system (i.e.
into the PTFE arterial end). The invention also proposes an
additional embodiment having an arterialized indwelling venous
catheter where blood flows from an artery through a tube and a port
into an arterial reservoir and is returned to a vein via a port and
a venous outlet tube distinct and distant from the area where the
blood from the artery enters the arterial reservoir. The site where
blood is returned to the vein is not directly fixed to the venous
wall but is free floating within the vein. This system provides a
hemodialysis and venous access graft which has superior longevity
and performance, is easier to implant and is much more user
friendly.
Inventors: |
Squitieri; Rafael P. (Wilton,
CT) |
Assignee: |
Hemosphere, Inc. (Eden Prairie,
MN)
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Family
ID: |
26713805 |
Appl.
No.: |
10/219,998 |
Filed: |
August 15, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60037094 |
Feb 3, 1997 |
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Reissue of: |
08835316 |
Apr 7, 1997 |
06102884 |
Aug 15, 2000 |
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Current U.S.
Class: |
604/8; 604/4.01;
604/6.01; 604/5.01 |
Current CPC
Class: |
A61M
1/3655 (20130101); A61M 1/3653 (20130101); A61M
39/0208 (20130101); A61M 2039/0211 (20130101); A61M
2005/1581 (20130101); A61M 2039/0258 (20130101) |
Current International
Class: |
A61M
37/00 (20060101) |
Field of
Search: |
;604/4.01,5.01,6.168,523,175,27,264-266,533,288.01-288.03,284,508
;623/1.1,1.36,1.43,1.49,11.1,902-903 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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4418910 |
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Jul 1995 |
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DE |
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44 18 910 |
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Dec 1995 |
|
DE |
|
295 15 546 |
|
Mar 1997 |
|
DE |
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57-14358 |
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Jan 1982 |
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JP |
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58-168333 |
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Nov 1983 |
|
JP |
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04-507050 |
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Dec 1992 |
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JP |
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05-212107 |
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Aug 1993 |
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JP |
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06-105798 |
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Apr 1994 |
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JP |
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09-84871 |
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Mar 1997 |
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JP |
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WO 84/03036 |
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Aug 1984 |
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WO |
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WO 95/19200 |
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Jul 1995 |
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WO |
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WO 96/24399 |
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Aug 1996 |
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WO |
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Other References
Alan S. Coulson, M.D., Jagjit Singh, M.D., Joseph C. Moya,
"Modification of Venous End of Dialysis Grafts: An Attempt to
Reduce Neointimal Hyperplasia," Dialysis& Transplantation, vol.
29, No. 1, Jan. 2000, pp. 10 to 18. cited by other .
A.S. Coulson, M.D., Ph.D, Judy Quarnstrom, I.V.N., J. Moshimia,
M.D., "A Combination of the Elephant Trunk Anastomosis Techinique
and Vascular Clips for Dialysis Grafts," Surgical Rounds, Nov.
1999, pp. 596 to 608. cited by other .
International Search Report for PCT Application No. PCT/US98/01939
dated May 5, 1998 in 3 pages. cited by other .
Search Report for EP Application No. 05006233.0 dated Jun. 8, 2005
in 2 pages. cited by other .
The Office Action dated Dec. 17, 2008 issued in Co-Pending Appl.
No. 11/417,658 in 11 pages. cited by other .
The Amendment dated Mar. 17, 2009 filed in Co-Pending Appl. No.
11/417,658 in 2 pages. cited by other .
Interview Summary dated Mar. 11, 2009 for Co-Pending Appl. No.
11/417,658 in 4 pages. cited by other.
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Primary Examiner: Deak; Leslie R
Attorney, Agent or Firm: Knobbe, Martens, Olson & Bear,
LLP
Parent Case Text
.Iadd.This is a reissue application of U.S. Pat. No. 6,102,884,
which issued on Aug. 15, 2000, and which claims benefit under 35
U.S.C. Section 119(e) to U.S. Provisional Patent Application Ser.
No. 60/037,094, filed Feb. 3, 1997.
Notice: More than one reissue application has been filed for the
reissue of U.S. Pat. No. 6,102,884. The reissue applications are
U.S. application Ser. No. 10/219,998(the present application) and
U.S. application Ser. No. 11/417,658, which is a continuation
reissue of U.S. Pat. No. 6,102,884..Iaddend.
Claims
What is claimed, is:
1. A Squitieri hemodialysis and vascular access system to shunt
blood between a vein and an artery the system comprising: (a) a
first tube having a first end adapted to be connected to the artery
and a second end; (b) a second tube having a first end adapted to
be connected to the vein and including a plurality of apertures
extending therethrough and having a second end; and (c) a needle
access port having a frame including a conduit extending
therethrough, said frame having an inlet connected to the second
end of the first tube and an outlet connected to the second end of
the second tube to provide a flow path for blood and a silicone
member protruding from the frame to provide access for needles into
the flow path, wherein the needle access port includes: an outer
frame member having an upper surface including an aperture
extending therethrough and downwardly extending walls about its
periphery having inlet and outlet apertures, wherein the upper
surface includes a lower portion having a plurality of teeth; a
silicone member mounted within the frame having a surface engaged
by the frame teeth and an upwardly protruding portion extending
through the frame aperture; and a second frame member having a
transverse conduit extending between the inlet and outlet
apertures, an upper surface having a plurality of teeth engaging
the silicone member to effect a seal and wherein the second frame
member is positioned within the walls of the first frame
member.
2. The Squitieri hemodialysis and vascular access system of claim
1, wherein: the first tube corresponds to PTFE tubing; the second
tube corresponds to silicone tubing; and the protruding silicone
member has an oval configuration.
3. The Squitieri hemodialysis and vascular access system of claim
1, wherein the first tube includes rings mounted thereabout to
provide additional strength.
4. The Squitieri hemodialysis and vascular access system of claim 1
further comprising: a second needle access port having an inlet and
an outlet and .[.silastic.]. .Iadd.silicone .Iaddend.tubing
coupling the inlet of the second needle access port to the outlet
of the other needle access port and wherein the outlet of the
second access port is coupled to the second end of the second
tube.
5. The Squitieri hemodialysis and vascular access system of claim 1
wherein: the first tube is provided as PTFE tubing which is adapted
for attachment to the artery at one end and coupled to the access
port at the other end; and the second tube is provided as silicone
tubing which is coupled to the needle access port at one end and is
capable of being floated within the vein at the other end.
6. The Squitieri hemodialysis and vascular access system of claim
1, wherein: the first tube is inserted within an outer silicone
tubing at the inlet to the needle access port.
7. The Squitieri hemodialysis and vascular access system of claim
1, further including: an adjustable band mounted about the first
tube at the inlet to the needle access port to regulate blood
flow.
8. The Squitieri hemodialysis and vascular access system of claim
4, wherein: a second needle access port is mounted to the needle
access port, said ports having a single frame and a conduit
extending longitudinally therethrough to the outlet tubing.
9. A Squitieri hemodialysis and vascular access system to shunt
blood between a vein and an artery, the system including: (a) a
first tube having a first end adapted to be connected to the
artery; (b) a second tube having a first end adapted to be
connected to the vein and including a plurality of apertures
extending therethrough and having a second end; (c) a needle access
port having a frame including a conduit extending therethrough,
said frame having an inlet connected to the second end of the first
tube and an outlet connected to the second end of the second tube
to provide a flow path for blood and a silicone member protruding
from the frame to provide access for needles into the flow path;
and a quick coupler for joining the first tube to the needle access
port comprising a port member projecting outwardly from the frame
inlet and having a circumferential slot extending thereabout, a
cooperating member having an outer portion extending concentrically
with the first tube and a portion extending outwardly therefrom and
an outwardly sloped portion extending over the projecting port
member and having an inner circumferential projection which engages
the circumferential slot, and wherein the first tube extends over
the port member to be engaged by the projecting portion of the
cooperating member within the slot and a removable coupling which
snaps over the cooperating member forcing it into a sealed
engagement with the port member.
10. A Squitieri hemodialysis and vascular access system to shunt
blood between a vein and an artery, the system including: (a) a
first tube having a first end adapted to be connected to the
artery; (b) a second tube having a first end adapted to be
connected to the vein and including a plurality of apertures
extending therethrough and having a second end; and (c) a needle
access port having a frame including a conduit extending
therethrough, said frame having an inlet connected to the second
end of the first tube and an outlet connected to the second end of
the second tube to provide a flow path for blood and a silicone
member protruding from the frame to provide access for needles into
the flow path, wherein the needle access port comprises: a first
member having a base, walls extending upwardly therefrom to form an
enclosed area, and outwardly extending couplings on opposite walls
thereof at the inlet and outlet of said port; a second member
having a top including an upper aperture, downwardly extending side
walls engaging the walls of the first member and having a conduit
extending from the inlet to the outlet and a silicone member
projecting form the upper aperture to provide needle access; and a
tube mounted over each coupling and a coupler which fits over each
tube to seal the tubes to the couplings.
11. The Squitieri hemodialysis and vascular access system of claim
1, wherein: the second tube is capable of being floated within a
vein at the one end and the plurality of apertures in the second
tube are distant from the site where the second tube is inserted
into the vein, said second tube not being fixed to the vein
wall.
.[.12. A hemodialysis and vascular access system comprising: an
arterialized indwelling venous catheter having a graft section
provided from a material which is biocompatible with an artery, has
a nonthrombogenic characteristic, which is adapted for long term
attachment to an artery and which includes a region for repeated
needle access and a catheter section, with a first end of said
graft section adapted to be coupled to an artery and a portion of
the catheter section adapted to be inserted within a vein at an
insertion site, said catheter section portion having at least one
opening in an end thereof with at least one of the at least one
openings in the catheter section portion adapted to be within the
vein itself and wherein the at least one opening is distant from
the insertion site such that blood flows from the artery through
the catheter and is returned to the vein through the at least one
opening while providing laminar blood flow between the artery and
the vein..].
.[.13. The hemodialysis and vascular access system of claim 12,
further comprising: at least one needle having a first end coupled
to a hemodialysis device and having a second end adapted for
insertion directly into said graft section of the catheter to shunt
the blood flow through the dialysis device..].
.[.14. The hemodialysis and vascular access system of claim 13
wherein said graft section is provided from a first tube and said
catheter section is provided from a second tube comprising multiple
layers and a first end of said first tube is coupled to a first end
of said second tube..].
.[.15. The hemodialysis and vascular access system of claim 14
wherein said first and second tubes are adapted for percutaneously
placement..].
.[.16. The hemodialysis and vascular access system of claim 14
wherein the end of said second tube which is coupled to the first
tube includes an enlarged portion in which the first end of said
first tube is disposed..].
.Iadd.17. A hemodialysis and vascular access system, comprising: an
arterialized indwelling venous catheter having a graft section
provided from a material which is biocompatible with an artery, has
a nonthrombogenic characteristic, which is adapted for long term
attachment to an artery and which includes a region of repeated
needle access and a catheter section, with a first end of said
first graft section adapted to be coupled to an artery and a
portion of the catheter section adapted to be inserted within a
vein at an insertion site, said catheter section portion having an
outside diameter which is less than an inner diameter of the vein
and having at least one opening in an end thereof with at least one
of the at least one openings in the catheter section portion
adapted to be within the vein itself and wherein the at least one
opening is distant from the insertion site such that, in operation,
blood flows from the artery through the catheter and is returned to
the vein through the at least one opening while providing laminar
blood flow between the artery and the vein and blood also flows
through the vein uninterrupted around at least an outer portion of
said catheter; and at least one needle having a first end coupled
to a hemodialysis device and having a second end adapted for
insertion directly into the arterialized indwelling venous catheter
to shunt the blood flow through the dialysis device..Iaddend.
.Iadd.18. The hemodialysis and vascular access system of claim 17
wherein the graft section of said arterialized indwelling venous
catheter is provided from a first tube and said catheter section is
provided from a second tube comprising multiple layers and a first
end of said first tube is coupled to a first end of said second
tube..Iaddend.
.Iadd.19. The hemodialysis and vascular access system of claim 18
wherein said first and second tubes are adapted for percutaneous
placement..Iaddend.
.Iadd.20. The hemodialysis and vascular access system of claim 18
wherein the end of said second tube which is coupled to the first
tube includes an enlarged portion in which the first end of said
first tube is disposed..Iaddend.
.Iadd.21. A hemodialysis and vascular access system as in claim 17,
wherein the graft section comprises PTFE..Iaddend.
.Iadd.22. A hemodialysis and vascular access system as in claim 17,
wherein the graft section comprises polyethylene
terephthalate..Iaddend.
.Iadd.23. A hemodialysis and vascular access system as in claim 17,
wherein the graft section has a diameter of approximately 7
mm..Iaddend.
.Iadd.24. A hemodialysis and vascular access system as in claim 17,
wherein the first end of the graft section has a diameter of about
4 mm..Iaddend.
.Iadd.25. A hemodialysis and vascular access system as in claim 17,
wherein the catheter section comprises silicone..Iaddend.
.Iadd.26. A hemodialysis and vascular access system as in claim 17,
wherein a downstream end of the catheter section is provided with a
bevel..Iaddend.
.Iadd.27. A hemodialysis and vascular access system as in claim 17,
additionally comprising an access segment for receiving a needle to
allow access to blood flowing through the catheter..Iaddend.
.Iadd.28. A hemodialysis and vascular access system as in claim 27,
wherein the access segment comprises a self sealing
material..Iaddend.
.Iadd.29. A hemodialysis and vascular access system as in claim 28,
wherein the self sealing material comprises silicone..Iaddend.
.Iadd.30. A hemodialysis and vascular access system as in claim 28,
wherein the access segment is removably connected to the access
system..Iaddend.
.Iadd.31. A hemodialysis and vascular access system as in claim 27,
further comprising a support structure in the access
segment..Iaddend.
.Iadd.32. A hemodialysis and vascular access system as in claim 31,
wherein the support structure comprises a frame..Iaddend.
.Iadd.33. A hemodialysis and vascular access system as in claim 31,
wherein the support structure comprises ridges..Iaddend.
.Iadd.34. A hemodialysis and vascular access system as in claim 33,
wherein the ridges comprise teeth..Iaddend.
.Iadd.35. A hemodialysis and vascular access system as in claim 17,
wherein at least a portion of the indwelling venous catheter
comprises multiple layers..Iaddend.
.Iadd.36. A hemodialysis and vascular access system as in claim 35,
wherein the multiple layers comprise a first PTFE layer and a
second silicone layer..Iaddend.
.Iadd.37. A hemodialysis and vascular access system as in claim 36,
wherein the first PTFE layer is an inner PTFE layer and the second
silicone layer is an outer silicone layer..Iaddend.
.Iadd.38. A hemodialysis and vascular access system as in claim 37,
wherein the multiple layers further comprises a PTFE coating on the
outer silicone layer..Iaddend.
.Iadd.39. A hemodialysis and vascular access system as in claim 17,
wherein said graft section and said catheter section comprise a
material selected from the group consisting of PTFE, silicone, or
flexible plastic..Iaddend.
.Iadd.40. A hemodialysis and vascular access system as in claim 17,
comprising first and second needle access sites..Iaddend.
.Iadd.41. A hemodialysis and vascular access system as in claim 17,
wherein the catheter section comprises a long, flexible plastic
tube..Iaddend.
.Iadd.42. A hemodialysis and vascular access system as in claim 17,
wherein the region for repeated needle access comprises needle
receiving sites(s) and comprises an internal chamber that is
tubular in shape..Iaddend.
.Iadd.43. A hemodialysis and vascular access system as in claim 17,
wherein the region for repeated needle access comprises a
self-sealing material..Iaddend.
.Iadd.44. A hemodialysis and vascular access system as in claim 17,
wherein the catheter section comprises a silicone
section..Iaddend.
.Iadd.45. A hemodialysis and vascular access system as in claim 44,
wherein the silicone section is lined with PTFE..Iaddend.
.Iadd.46. A hemodialysis and vascular access system as in claim 17,
wherein the region of repeated needle access comprises multiple
layers..Iaddend.
.Iadd.47. A hemodialysis and vascular access system as in claim 46,
wherein the multiple layers comprise PTFE on the inside and
silicone on the outside..Iaddend.
.Iadd.48. A hemodialysis and vascular access system as in claim 46,
wherein the multiple layers comprise PTFE on the inside and
silicone disposed outside of the PTFE..Iaddend.
.Iadd.49. A hemodialysis and vascular access system as in claim 17,
wherein the material providing the graft section comprises a
thrombus resistant coating..Iaddend.
.Iadd.50. A hemodialysis and vascular access system as in claim 49,
wherein the thrombus resistant coating comprises
heparin..Iaddend.
.Iadd.51. A hemodialysis and vascular access system as in claim 17,
wherein a nonthrombenic characteristic is provided by continuous
flow of blood through at least the graft section..Iaddend.
Description
BACKGROUND OF THE INVENTION
Currently, HD (hemodialysis) and vascular access for chemotherapy
and plasmapheresis is achieved in one of several ways. Applicant's
invention involves a new method and instrumentation for HD and
vascular access designed to eliminate the problems of the prior
methods and create a new, more durable, easier to use, vascular
access system.
One prior art method involves a primary arteriovenous fistula. In
this method, a native artery is sewn to a native vein creating a
high flow system of blood in a vein which over time can be accessed
with two hemodialysis needles attached to a dialysis machine. The
problem with this method is that few patients are candidates
secondary to anatomy and in others the veins or shunt fail to
enlarge and mature properly even if the primary fistula remains
patent. These arteriovenous fistulas also become aneursymbol over
time requiring revision.
Another method involves a subcutaneous prosthetic conduit (PTFE) in
the shape of a tube which is sewn at either end to openings made in
an artery and vein. This method causes recurrent stenosis at the
venous outflow leading to thrombosis (i.e., graft closure)
secondary to intimal hyperplasia at venous anastomosis. Thrombosis
also occurs at needle puncture sites along the PTFE.
Another method involves a "tunneled" percutaneous dual lumen
catheter which is inserted into a central vein. This causes
recurrent thrombosis secondary to stasis of blood in the lumen
(i.e., not a continuous flow system like an A-V fistula) and build
up of fibrinous debris at the venous end. Further, the access end
of the catheter protrudes through the skin making it cosmetically
unappealing, cumbersome to live with, as well as more likely to
become infected.
A further method involves the use of the Sorenson Catheter. This is
a percutaneous (not tunneled) dual lumen catheter, placed into the
central venous system, which is used to provide temporary access
for the purposes of hemodialysis. These catheters are prone to
kinking, clotting, infection, and poor flow rates.
A still further method of vascular access involves the
"Porta-a-cath". This system of venous access, which utilizes a
subcutaneous reservoir attached to a central venous catheter, is
used for long term intervenous access for chemotherapy etc. (It is
not intended for HD.) The ports are prone to clotting and must be
continually flushed since they are a stagnant system.
Applicant's invention involves a vascular access system, known as
the Squitieri Hemodialysis and Vascular Access System, which
creates a continuous blood flow and which is easily accessed and
resistant to clotting. These advantages provide ideal access for
long term HD, chemo or blood draws. An example, would be patients
who are on coumadin which require weekly blood draws. This new
system becomes less painful over time as the skin over the "needle
access" site become less sensitive. The veins are spared repeated
blood draws which results in vein thrombosis to such a degree that
some patients "have no veins left" making routine blood draws
impossible.
Among the more relevant prior art patents are U.S. Pat. Nos.
4,898,669; 4,822,341; 5,041,098; and, 4,790,826. None of the
foregoing patents disclose a system having the features of this
inventions
SUMMARY OF THE INVENTION
A hemodialysis and vascular access system comprises a PTFE end
which is sutured to an opening in an artery at one end and the
other end is placed into a vein using any technique which avoids
the need for an anastomosis between the silicone "venous" end of
the catheter and the vein wall. The system comprises any material,
synthetic or natural (i.e. vein) which can be sutured to the artery
(i.e. preferably PTFE) at one end while the other end is composed
of a material which is suitable for placement into a vein in such a
way that the openings in the "venous" end of the system are away
from the site where the graft enters the vein. The system may also
be constructed of multiple layers of materials i.e. PTFE on the
inside with silastic on the outside. The "Needle Receiving Site"
may also be covered with PTFE to encourage self sealing and tissue
ingrowth.
A preferred embodiment comprises a combination of PTFE conduit sewn
to an artery on one end of the system with the other end connected
to a silastic-plastic catheter which can be percutaneously inserted
into a vein via an introducer. The venous end may also be placed
via open cut down. The seal around the system where it enters the
vein may be "self sealing" when placed in percutaneous technique;
it may be achieved with a purse string when done by open technique
"cut down"; or, it may be sewn to the vein to create a seal with a
"cuff" while the system continues downstream within the venous
system to return the arterial blood away from the site of entry
into the vein. The entire system can be positioned subcutaneously
at the completion of insertion. This design is a significant
improvement over existing methods because it avoids the most
frequent complication of current HD access methods. By utilizing an
indwelling venous end, one avoids creating a sewn anastomosis on a
vein which is prone to stenosis secondary to neointimal
hyperplasia. By having continuous flow through the silastic end of
the catheter, thrombosis of these catheters can be avoided.
Dialysis is made more efficient by decreasing recirculation of
blood which accompanies the use of side by side dual lumen
catheters inserted into a central vein. This invention not only
benefits the patient but it also speeds dialysis thus saving time
and money.
To summarize, the Squitieri Access System comprises a tube composed
of PTFE and a silastic catheter. This tube is used to create an
arteriovenous fistulu. The PTFE end (arterial end) of the tube is
sewn to an artery while the silastic catheter end is placed into
the venous system by the Seldinger technique much like a standard
central line. The entire system is subcutaneous at the completion
of insertion. This system is a composite of the arterial end of a
"gortex graft" joined to the venous end of a "permacath". This
system enjoys strengths of each type of access and at the same time
avoids their weaknesses.
Accordingly, an object of this invention is to provide a new and
improved vascular access system.
Another object of this invention is to provide a new and improved
hemodialysis and vascular access system including an easily
replaceable needle receiving site which has superior longevity and
performance, is more easily implanted, more easily replaced, and is
"user friendly" i.e. easily and safely accessed by a nurse or
patient which is ideal for home hemodialysis.
A more specific object of this invention is to provide a new and
improved Squitieri hemodialysis and vascular access system
including a subcutaneous composite PTFE/Silastic arteriovenous
fistula.
A further object of this invention is to provide a new and improved
hemodialysis and vascular access system including a fistula
utilizing an indwelling silastic end which is inserted
percutaneously into the venous system and a PTFE arterial end which
is anastomosed to an artery and including a unique needle receiving
sites which are positioned anywhere between the ends and which have
superior longevity and performance.
A further object of this invention is to provide a system
constructed to preserve laminar flow within the system and at the
venous outflow end to reduce turbulence and shear force in the
vascular system to the degree possible.
A still further object of this invention is to provide a system
wherein the arterial end (PTFE) may also be placed by percutaneous
technique including one where blood entry holes are distant from
the site where blood enters the veins.
BRIEF DESCRIPTION OF THE DRAWINGS
The above and other objects of this invention may be more clearly
seen when viewed in conjunction with the accompanying drawings
wherein:
FIG. 1 is a perspective view of the vascular access system
comprising the invention;
FIG. 2 is a cross-sectional view of the needle access site taken
along the line 2--2 of FIG. 1;
FIG. 3 is a cross-sectional view similar to FIG. 2 with a needle
inserted into the access site;
FIG. 4 is a cross-sectional view of the coupling between the PTFE
and the silicone venous end of the catheter;
FIG. 5 is a perspective view of an alternate embodiment of the
invention with one port having a tube sewn to a vein;
FIG. 6 is a perspective view of the embodiment in FIG. 5 with a
silastic tube floated down a vein;
FIG. 7 illustrates a ringed tube sewn to an artery and connected to
a first access site which is joined to a second site by silastic
tubing and includes an outflow through silastic tubing which is
floated into the venous system;
FIG. 8 is similar to FIG. 7 but shows PTFE sewn to an artery and
silastic tubing floated into a different portion of the venous
system;
FIG. 9 depicts ringed PTFE tubing sewn to the subclavian artery and
a dual access site coupled to the venous system at its other
end;
FIG. 10 shows a multi-layered variation at the venous end of the
system;
FIG. 11 discloses a quick coupler design utilized in conjunction
with the system;
FIG. 12 is a unique port design utilized in conjunction with the
system;
FIG. 13 shows holes where ports can be fixed in place while FIG.
13a and FIG. 13b show cross-sectional views which depict the
internal construction of the invention with FIG. 13b illustrating
multi-layered tubing; and,
FIG. 14 shows a variation of the system entry through vein wall
(i.e. not percutaneous or purse string) wherein a cuff, sewn to
vein as indwelling portion, is floated down stream.
DETAILED DESCRIPTION OF THE INVENTION
Referring to the drawings the Squitieri hemodialysis and vascular
system, as shown in FIG. 1, comprises a PTFE/dacron (or other
synthetic or natural material) tube 10 of several centimeters in
length which is attached at one end by means of a coupling 11 to a
needle access site 20. Adjustable band 18 regulates the blood flow
through the access site 20. The PTFE tube 10 is approximately 7 mm
in diameter and transitions downward to an open end portion 19
approximately 4 mm in diameter.
The access site 20 includes an in line aperture 16, see FIG. 2,
having a silicone tube 41 connected thereto at one end leading to a
long flexible plastic/silastic/silicone tube 12 with transverse
holes 13 along its free end. The number of holes 13 may vary within
predetermined limits to achieve optimum results. The end 36 may be
beveled for ease of insertion. This tubular arrangement functions
as a subcutaneous connection between the arterial and venous
systems. It may also be modified to allow part of the system to
exit through the skin 14 to provide access to the blood circulation
without placing needles 15 through the skin 14 into the fistula
(usually at the PTFE end).
Along the length of the catheter specially constructed access
segments 20 are located to receive specially designed needles 15
into the system to gain access to the blood stream which flows
through aperture 16. This method avoids perigraft bleeding which
leads to thrombosis either by compression of the graft by hematoma
or by manual pressure applied to the graft in an attempt to control
the bleeding.
The needle access areas 20 which are designed to receive needles 15
etc. to allow access to the system are in line conduits with
self-sealing material 17 such as silicone located beneath the skin
surface. The silicone member 25 comprises an oval configuration
exposed within the frame 26 for ease of puncture. The system may be
accessed immediately after insertion without having to wait for the
graft to incorporate into the tissues as is the case with the
current methods of subcutaneous fistulas. These access areas 20
will protect the graft since they are uniformly and easily utilized
requiring little training or experience. The "needle receiving"
sites 20 are designed in such a way to preserve laminar flow as far
as possible (i.e. not a reservoir arrangement). Needle receiver
sites 20 may be connected to a system via "quick couple" 45 for
easy exchangability, see FIG. 11.
FIGS. 2 and 3 disclose a needle access site 20 wherein a silicone
member 25 is mounted within a plastic or metal frame 26. A
protruding portion 27 of member 25 extends upwardly through the
aperture 31 while a flange portion 28 extends outwardly on both
sides of the portion 27 to be gripped by teeth 29 on the internal
surface of frame 26 and member 32. The member 26 includes a passage
16 for blood flow. The blood flow is accessed by inserting needles
15 through the silicone 25 which is preferably oval in shape. The
teeth 29 seal the arterial pressure. The internal chamber 16 of the
needle receiving site 20 is tubular in shape.
The free end 19 of the PTFE tube 10 is sewn to an opening in an
artery 30, see FIG. 7, while the plastic end 24 having been
inserted percutaneously lies in the venous system in such a way
that the openings 13 in the silastic tube 12 are downstream from
the site where the flexible plastic tube 24 enters the vein 40. The
venous end may be inserted via "cutdown". The purpose of the system
is to allow communication between an artery 30 and a vein 40 in
such a way that the system may be accessed by either puncturing the
PTFE segment or by entering the specialized "needle receiving" site
20. This allows blood to flow from the system to a hemodialysis
machine (not shown) and then return into the venous outflow portion
at a more distal (venous end) location allowing the blood 35 to
return from the HD machine (not shown) back into the patient.
FIG. 4 discloses, as an alternative, a "glued" connection between
PTFE tubing 60 and silicone tubing 61 wherein the PTFE 61 is
inserted into an enlarged portion of silicone 61 wherein the
longitudinally extending portion includes a raised section 63 which
locks a raised section 64 of PTFE 61 within the silicone 60.
In this invention, the materials used may vary as specified herein.
The system may be constructed of one or more specific materials.
The arteries and veins used may also vary. Material may also be
covered with thrombus resistant coatings (heparin, etc.) or
biologic tissue. The system may in specific cases be "ringed" for
support.
The same concept of using an arterialized venous access catheter
may be applied to the use of long term indwelling catheters used to
give chemotherapy etc., making the current ports obsolete as these
new access systems will have a decreased thrombosis and they will
no longer need to be flushed as continuous blood flow through the
system makes thrombus formation unlikely. This will definitely cut
down on costs since it will decrease nursing requirements in out
patient settings, etc.
In alternate embodiments shown in FIGS. 5 and 6, the system
comprises an arterial reservoir structure or port 50 with a needle
accessible top portion .[.51.]. preferably constructed of silicone.
The reservoir 50 is connected to an outlet tube 53 of PTFE
(gortex-ringed), which is sewn to an artery 30 at its other end.
The venous outlet tube 52 is constructed in a similar way but it is
either sewn to a vein 40 via gortex ringed portion .[.52.].
.Iadd.52a .Iaddend.or is placed percutaneously into the central
circulation via an indwelling venous (silicon) catheter 42 as shown
in FIG. 6. There is no continuous flow through this version of the
system since the ports are not connected. Flow is established when
the system is attached to an HD machine with a needle 15 in the
arterial port 51a to deliver blood to the HD machine and a second
needle 15 is placed in the venous port 51b to the vein 40 to
deliver blood to the patient. The ports 51a, 51b will remain
flushed with heparin when not in use to avoid clotting when
accessed through the skin 14 with needles 15. The ports 51a, 51b
will also provide high flow access to both the arterial and venous
systems. FIG. 6 shows two separate ports 51a and 51b with .[.one.].
.Iadd.the .Iaddend.tube 53 sewn to an artery 30 and the other tube
42 floated down a vein 40.
FIG. 7 illustrates in an anatomical drawing, a ringed gortex tubing
53 sewn to an artery 30 at 62 and coupled at its other end 63 to
the needle access site 20. The site 20, see FIGS. 1-3, is joined by
silastic tubing 64 to a second access site 20a which has an outlet
silastic tube 65. The outlet tube 65 includes a plurality of
perforations 66 at its outlet end which is positioned in the venous
system 67 through vein 40. Either site 20 or 20a can be used for
needle access.
FIG. 8 depicts an embodiment similar to that of FIG. 7 except that
the coupling between the artery 30 and the first needle access site
20 is PTFE tube 69. The entry to the venous system 67 is via vein
40 which has silastic tubing 65 floated therein. 69a depicts PTFE
joining parts 20 and 20a.
FIG. 9 illustrates a dual needle access site 80 which is coupled
via ringed PTFE 53 to the subclavian artery 30 and floated into the
venous system 67 via silastic tubing 65. The dual site 80 provides
additional access through 25a, 25b in approximately the same area
with tubing (not shown) extending through the dual site 80.
FIG. 10 depicts a variation of the invention at the venous end
wherein the outlet of the port 20 comprises PTFE tubing 91 located
within a silastic catheter 92. The design is appropriate if
thrombosis is a problem in the outlet silastic portion of the
shunt.
FIG. 11 discloses a quick coupler 45 joining the PTFE .[.tubing.].
.Iadd.outlet tube .Iaddend.53 to the port 46 in the needle access
site 20. A plastic or metal member 47 includes a portion 48 which
engages the cylindrical tubing 10, an intermediate portion 49
extending perpendicularly outward and an end portion 43 tapered
outwardly at an angle and including an inward projection 44. The
projecting portion 44 of the member 47 engages a slot 54 in the
port 46 firmly fixing the PTFE 10 therebetween. .[.45a.].
.Iadd.Portion 48 .Iaddend.is made of flexible material to allow a
gentle curve in tubing as it exits/enters .Iadd.the
.Iaddend.port.
FIG. 12 is an exploded view of a new port embodiment wherein the
port 71 comprises a frame 72 having an inlet 73 and an outlet 74.
The plastic or metal frame 75 includes a recessed reservoir 76 and
end walls 78a and 78b. An upper member 85 having a recess 86 and
downwardly projecting sides 87a and 87b fits within walls 77a and
77b. The member 45 rapidly couples the PTFE tubing 10 to site 71
with tubing 88 which fits over the inlet coupling 73 and the outlet
coupling 74 with recessed portions 75a and 75b which engage tubing
88a and 88b and have couplers 89a and 89b which slide over the
tubing 88a, 88b to engage the couplings 73 and 74.
FIG. 13 shows a typical dual port system showing holes 55 where
ports 20 can be fixed in place.
FIG. 14 discloses a cuff 56 which is made of PTFE and sewn to a
vein. No physiological/functional venues anastomosis is created as
blood is returned at the end of the system distant from the cuff.
The silastic end 12 may still be lined with PTFE.
The upper member 86 includes an oval silicone access site 90 with
an outer housing 91 which includes an aperture 92 surrounds the
silicone oval 90. This embodiment provides a quick assembly for a
needle access site 71.
The Squitieri Hemodialysis/Vascular Access System avoids creation
of a venous anastomosis, a revolutionary advancement, i.e. there is
no site for neointimal hyperplasia at a venous anastomosis which
accounts for the vast majority of PTFE arteriovenous graft failures
(60-80%). This is accomplished by returning the blood into a larger
vein via an indwelling venous catheter 42. The site of blood return
to the venous system is not fixed to the vein wall where neointimal
hyperplasia occurs with the standard PTFE bridge graft. This
feature represents a tremendous advantage over the present
grafts.
As a further advantage, the system is not stagnant and prone to
thrombosis, i.e. constant flow through the new system avoids the
problem of clotting inherent in indwelling dual lumen venous
catheters which remain stagnant when not in use. It also avoids
need to flush catheters with heplock thereby reducing nursing costs
to maintain the catheter.
The Squitieri system avoids externalization of components which are
prone to infection. Since dual lumen catheters exit the skin 14,
they frequently lead to sepsis requiring catheter removal despite
subcutaneous tunneling. This new access is entirely
subcutaneous.
Very importantly the system proposed herein, avoids problems with
the aspiration of blood from the venous system and "positional"
placement through continuous flow. A frequent problem with dual
lumen catheters is their inability to draw blood from the venous
system due to clot and fibrinous debris ball-valving at the tip of
a catheter. This new system receives blood directly from arterial
inflow which ensures high flow rates needed for shorter, more
efficient dialysis runs. It also avoids the frequent problem of the
catheter tip "sucking" on the vein wall inhibiting flow to the
dialysis machine and rendering the access ineffective.
The system avoids recirculation seen with dual lumen catheters
resulting in more efficient and more cost effective dialysis.
The system avoids the need for temporary access with incorporation
of "Needle Access Sites" 20. A-V fistulas and gortex grafts must
"mature" for several weeks before use. This creates a huge strain
on the patient as well as the doctor to achieve temporary access
while waiting to use the permanent access. Temporary access is very
prone to infection, malfunction and vein destruction. By placing
sites 20 designed to receive needles 15 along the new access, the
system may be used the day it is inserted.
The system avoids PTFE needle site damage with the incorporation of
"Needle Access Sites" 20. Needle access directly into PTFE is
presently uncontrolled and user dependent. Often, PTFE is lacerated
by access needles. While this system may be accessed via the PTFE
segment, the needle receiving sites are the preferred method. This
leads to excessive bleeding which requires excessive pressure to
halt the bleeding causing thrombosis of the graft. "Needle Access
Sites" 20 on the Squitieri access system allow safe, quick, and
easy entry into the system and avoid the complications inherent in
placing needles directly into PTFE. It also avoids perigraft
bleeding which will compress and thrombose the graft. By elminating
the long time needed to compress bleeding at the needle site, the
system shortens dialysis runs.
The Squitieri system permits an easier, faster insertion technique.
Only one anastomosis at the arterial end and a percutaneous
placement of the venous end is required. A modification allows the
system to be sutured to the vein wall while the system tubing is
floated down stream from this site where the system enters the vein
40. This saves operating room time at thousands of dollars per
hour. The technique is easier with faster replacement. It avoids
difficult and time consuming revision of venous anastomosis
required to repair venous outflow occluded by neointimal
hyperplasia. If the system malfunctions, the silastic catheter end
65 slips out easily and the arterial PTFE end 53 is
thrombectomized. New access sewn to the thrombectomized PTFE at the
arterial end and the silastic venous end is replaced percutaneously
via Seldinger technique or "open technique".
The end result of the above advantages translates into superior
patency rates and a decreased complication rate with this new
system. Patients are spared the repeated painful hospitalizations
for failed access as well as the emotional trauma associated with
this difficult condition. The physicians are spared the dilemma of
how to best treat these patients. This system will have a large
impact on the current practice of vascular access in areas such as
hemodialysis; plasmapheresis; chemotherapy; hyperalimentation; and
chronic blood draws.
While the invention has been explained by a detailed description of
certain specific embodiments, it is understood that various
modifications and substitutions can be made in any of them within
the scope of the appended claims which are intended also to include
equivalents of such embodiments.
* * * * *