Language selection

Search

Patent 2033195 Summary

Third-party information liability

Some of the information on this Web page has been provided by external sources. The Government of Canada is not responsible for the accuracy, reliability or currency of the information supplied by external sources. Users wishing to rely upon this information should consult directly with the source of the information. Content provided by external sources is not subject to official languages, privacy and accessibility requirements.

Claims and Abstract availability

Any discrepancies in the text and image of the Claims and Abstract are due to differing posting times. Text of the Claims and Abstract are posted:

  • At the time the application is open to public inspection;
  • At the time of issue of the patent (grant).
(12) Patent: (11) CA 2033195
(54) English Title: AORTIC GRAFT AND METHOD FOR REPAIRING ANEURYSM
(54) French Title: GREFFE DE L'AORTE ET METHODE POUR REPARER LES ANEVRISMES
Status: Deemed expired
Bibliographic Data
(52) Canadian Patent Classification (CPC):
  • 3/121
(51) International Patent Classification (IPC):
  • A61F 2/82 (2013.01)
  • A61F 2/07 (2013.01)
  • A61F 2/958 (2013.01)
(72) Inventors :
  • TROUT, HUGH H., III (United States of America)
(73) Owners :
  • TROUT, HUGH H., III (United States of America)
(71) Applicants :
(74) Agent: SWABEY OGILVY RENAULT
(74) Associate agent:
(45) Issued: 1994-11-15
(86) PCT Filing Date: 1990-06-15
(87) Open to Public Inspection: 1990-12-20
Examination requested: 1991-08-23
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US1990/003322
(87) International Publication Number: WO1990/015582
(85) National Entry: 1991-01-18

(30) Application Priority Data:
Application No. Country/Territory Date
367,716 United States of America 1989-06-19

Abstracts

English Abstract






An aortic graft and system (10) and method for implanting the aortic
graft are provided. The aortic graft (18) comprises a substantially cylindrical
graft material with attachment means (22) which comprise a plurality of post
(24) and hook (25) assemblies which are implanted with a double catheter
system (35) to penetrate the aorta wall (11) above and below the aneurysm
(12) to provide firm attachment of the aortic graft (18) and, thereby, exclude
the aneurysm (12) from the circulatory system.


Claims

Note: Claims are shown in the official language in which they were submitted.


-17-



I claim:



1. An aortic graft for performing an aortic anastomosis on a section of
aorta, comprising,



aortic graft means, having cephalic and caudal ends, and having an axis,



a plurality of attachment means attached to said cephalic and caudal ends of
said aortic graft means for securing said aortic graft means to the aorta,



said attachment means having



base means, oriented in substantially parallel relation to said axis of said
aortic graft means, and attached to said aortic graft means,



post means, attached to said base member and extending substantially
radially away from said aortic graft means, and




hook means oriented in substantially parallel relation to said axis,
attached to the distal end of said post means for penetrating the aorta
and securing said graft means to the aorta.



2. The aortic graft of claim 1, wherein said aortic graft means is subtantially
cylindrical in shape.



3. The aortic graft of claim 1, wherein said aortic graft means comprises a
resilient flexible material.


-18-
4. The aortic graft of claim 1, wherein said aortic graft means comprises a
material inert to bodily fluids.



5. The aortic graft of claim 1, wherein said hook means further comprises
barbed hooks.



6. The aortic graft of claim 1, wherein said aortic graft means further
comprises retainer ring means for maintaining said first and second ends of said aortic
graft in mated relation with abutting portions of the aorta.



7. An aortic graft for performing an aortic anastomosis on a section of
aorta, comprising,



substantially cylindrical aortic graft means, having first and second ends



a plurality of attachment means attached to said first and second ends of
said aortic graft means for securing said aortic graft means to the aorta,



said attachement means having




a base member attached to said aortic graft means at first or second ends
thereof, oriented in substantially parallel relation to the longitudinal axis
of said aortic graft means,



post means, attached to said base members and extending radially from
said aortic graft means,


-19-

hook means attached to the distal end of said post means for penetrating
the aorta and securing said graft means to the aorta,



said hook means further comprising a barbed hook.



8. The aortic graft of claim 7, wherein said aortic graft means comprises a
resilient flexible material.



9. The aortic graft of claim 7, wherein said aortic graft means comprises a
material inert to bodily fluids.



10. The aortic graft of claim 7, wherein said aortic graft means further
comprises retainer ring means for maintaining said first and second ends in mated
relation with adjoining portions of the aorta.



11. An aortic graft for performing an aortic anastomosis on a section of
aorta, comprising,



substantially cylindrical aortic graft, having first and second ends




a plurality of attachment means attached to said first and second ends of
said aortic graft means for securing said aortic graft means to the aorta,



said attachment means having
a base member abutting the interior surface of aortic graft means at said
first or second end of said aortic
graft means, said base member oriented


-20-

in substantially parallel relation to the longitudinal axis of said aortic
graft means,

post means, attached to said base members and extending through said
first or second end of said aortic graft means radially from said aortic
graft means,

a hook attached to the distal ends of said post means for penetrating the
aorta and securing said graft means to the aorta,

said hook means further comprising a barbed hook, and

retainer ring means for maintaining said first and second ends in mated relation with
adjoining portions of the aorta.

12. The aortic graft of claim 11, wherein said aortic graft means comprises
a resilient flexible material.

13. The aortic graft of claim 11, wherein said retainer ring means comprises
a series of short segments which ratchet past one another to resiliently maintain the
diameter of said retainer ring against compression.

14. A process for repairing an aortic aneurysm through the use of a balloon
catheter and aortic graft comprising the steps of,

Inserting a contrast filled balloon catheter into the aneurysm to a cephalic
point, just above the aneurysm abutting unaffected arterial tissue;

-21-




Measuring to diameter and position of the aorta at the cephalic point,
just above the aneurysm;



Withdrawing the contrast filled balloon catheter system from said cephalic
point;



Repositioning the contrast filled balloon catheter in the affected artery
to a caudal point, below the aneurysm abutting unaffected arterial tissue;



Reinflating the contrast filled balloon;



Measuring to diameter and position of the aorta at said distal point, just
below the aneurysm;



Removing the contrast filled balloon catheter;




Measuring the distance between said cephalic and caudal points through
radiographic techniques;



Inserting along with a double balloon balloon catheter a graft having first
and second ends substantially 1-10 mm larger than the size of the aorta
at said cephalic and cuadal points;



Inflating the cephalic balloon from the distal end of the cephalic balloon
to force hooks at the distal position of the proximal end of said graft into
mated relation with said cephalic aorta;


-22-




Continuing to blow up said cephalic balloon from said distal end of said
cephalic balloon until said cephalic balloon is fully inflated and said
proximal hooks are forced into mated relation with said artery at said
cephalic point;



Maintaining inflation of said cephalic balloon while inflating caudal
balloon;



Inflating said caudal balloon from the proximal end of said caudal
balloon to force hooks at said proximal position of said caudal end of
said graft into mated relation with said aorta at said caudal point;



Continuing to inflate said caudal balloon from said proximal end of said
caudal balloon until said caudal balloon is fully inflated and said caudal
hooks are forced into mated relation with said artery at said caudal point;



Removing the double balloon catheter system;




Inserting into said graft one or more retainers and a third balloon
catheter system;



Implanting retainers at said cephalic and caudal positions inside aortic
said graft;



Removing all catheters and wires;

-23-
Repairing all arterial incisions; and

Closing incision used to access femoral or iliac artery.

Description

Note: Descriptions are shown in the official language in which they were submitted.


- 2~331g5
WO 90~1~582 -1- . ' PCI/IIS90/033Z2

AORTIC GRAE-r AND MErHOD EOR REPAIRING ANFrll7y~

The invention is an aortic graft, and a device and method of using th~t device
for repair and treatment of arterial aortic aneurysms. An aneurysm is a ballooning of
the wall of an artery resulting from the weakening of the artery due to disease or other
conditions. Left untreated, the aneurysm will frequently rupture resulting in loss of blood
through the rupture.
Aortic aneurysrns are the most common form of arterial aneurysm and are li~e

threatening. The aorta is the main artery which supplies blood to the circulatory systern.

The aorta arises from the left ventricle of the heart, passing upward and bending over
behind the heart and passing down through the thorax and abdomen. The abdominal
aorta supplies two side vessels to the kidneys, the renal arteries. Below the level of the
renal arteries, the abdominal aorta continues to about the level of the fourth lumbar
vertebrae where it divides into the iliac arteries. The iliac arteries, in turn, supply blood
to the lower e~l,e~ ies and perineal region.
It is common for an aortic aneurysm to occur in that portion of the abdomina}
aorta between the renal arteries and the iliac arteries. This portion of the abdominal
aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. An aortic

- aneurysm larger than about 4 cm. in diameter in this section of the aorta is ominous.

Left untreated, the aneurysm may rupture, resulting in rapid and usually fatal
hemorrhaging.
Aneurysms in the abdominal aorta are associated with a particularly high
mortality rate. Accordinglyl current medical standards call for urgent operative repair of

abdominal aortic aneurysms. Abdominal surgery itself is a major procedure resulting in

substantial stress to the body. Although the mortality rate for an aortic aneurysm is
extrernely high, there is also considerable mortality and morbidity associated with surgical
intervention to repair an aortic aneurysm. This intervention involves going through the
abdominal wall to the location of the aneurysm to bypass or replace the diseased section

~UBSTITUSE ~iHEET i ,,~.,

wo go/15582 2 0 3 3 1 9 5 -2- PCr/US90/03322

of the aorta at the aneurysm. A prosthetic device, typically a synthetic tube, is used for
this purpose. This graft serves to exclude the aneurysm from the circulatory system, thus
relieving pressure and stress on the weakened section of the aorta at the aneurysm.
Repair of an aortic aneurysm by surgical means is a major operative procedure.
In addition, substantial morbidity accompanies the procedure, resulting in a protracted
recovery period. Finally, the procedure entails a substantial risk of mortality. While
surgical intervention is nonetheless called for in the case of an aortic aneurysm in spite
of these risks, certain patients may not be able to tolerate the stress of intraabdominal
surgery. It is desirable to reduce the mortality and morbidity associated with
intraabdominal surgical intervention.
In recent years, methods have been developed to attempt to treat an aortic
aneurysm v~rithout the attendant risks of intraabdominal surgical intervention. Among
them are inventions disclosed and claimed in Kornberg, U.S. Patent No. 4,562,596(January 7, 1986) for Aortic Graft, Device and Method for Performing an Intraluminal
Abdominal Aortic Aneurysm Repair; and ~ ~7arus, U.S. Patent No. 4,787,899 (November
29, 1988) for Intr~hlmin~l Graft Device, System and Method.
Kornberg discloses an aortic graft comprising a flexible tubular material havinga plurality of struts to lend the graft stability and resiliency. The struts have angled
hooks with barbs at their upper ends which are securely attached to the inside of the
aorta above the aneurysm. Kornberg's graft is inserted using a tubular device also
disclosed in his patent.
Kornberg, however, anchors only the proximal end of the graft in the aorta.
Kornberg claims that the downward flow of blood holds the distal graft securely in place
so that no mechanical attachment is necessary distally. Kornberg, U.S. Patent No.
4,562,596, Col. 6, lines 24-27. The blood pressure in the abdominal aorta, however, is

typically in the magnitude of 130 mm of mercury. In spite of the direction of flow of
blood through the graft, proximal to distal, substantial back pressures within the aneurysm

SU~ I ~ I ~ITE SHEET

~3, ~ .. 2~3319~
wO 90/15~82 _3_ r Pcr/usso/o3322


will result unless the distal end is also mechanically attached. Without distal attachmentr
the device of Kornberg will not effectively exclude the weakened arterial wall at the site
of the aneurysm from the forces and stress associated with the blood pressure.
T ~7arus discloses a grafting system that employs a plurality of staples mounted
in the proximal end of the graft. Lazarus's staples are forced thr.ough the aorta wall by
means of a balloon catheter. As does Kornberg, however, Lazarus discloses staples
mounted only in the proximal end of the graft. There is no tearhing or suggestion in
Lazarus, U.S. Patent No. 4,787,899 as to the desirability or means for mechanically
~tt~ching the graft to the distal aorta below the level of the aneurysm.
Lazarus, U.S. Patent No. 4,787,899 also discloses various means for repairing the
aorta. Among them are surgical techniques, the use of nitinol coil, and various graft
systems that are implaced by the use of a balloon catheter system.
Hence, although in recent years certain techniques have been developed that
avoid or reduce the stress, morbidity, and risk of mortality associated with surgical
intervention to repair aortic aneurysms, the systems that have been developed do not
effectively treat the aneurysm and exclude the affected section of aorta from the pressures
and stresses associated with the circulation. None of the devices disclosed in the prior
art provide a reliable and quick means to bypass an aneurysmal artery.

It is therefore an object of the invention to provide a method to repair an aortic

aneurysm with a much lower risk of morbidity and mortality than that associated with
intraabdominal surgical repair of the aneurysm.
A further object of the invention is to provide a means for repairing an aortic
aneurysm in patients who cannot tolerate major abdominal surgery.
A further object of the invention is to reduce the risk of morbidity and mortality
associated with extensive surgical procedures.
Another object of the invention is to provide a means to quickly stabilize
patients suffering from an aortic aneurysm as an emergency procedure.



SUW~ E SHEET

WO 90/1~582 2 0 3 3 1 9 ~ - PCr/US90/03322

Yet a further object of the invention is to provide a means for treatment of
abdominal aortic aneurysm without major surgical intervention.
A further object of the invention is to provide a device for repair of abdominal
aortic aneurysms while reducing the morbidity and mortality associated with surgical
procedures for repair of abdominal aortic aneurysms.
An additional object of the invention is to provide a procedure and system for
repairing abdominal aortic aneurysms at greatly reduced cost in terms of medical
resources relative to intraabdominal surgical repair of the aneurysm.

Yet, an a(ltlition~l object of the invention is to provide a procedure and system

for repairing abdominal aortic aneurysms at greatly reduced cost to the patient in terms
of medical expenses, rehabilitation, morbidity, and recovery time.




SU~ 111 ~ITE SHEEl

~ ` 2033195
wo 90/15582 Pcr/usso/o3322
--5--


SUIVIMARY OF TI~E INVENl`ION
As illustrated in the accompanying drawings and disclosed in the accompanying
claims, the invention is an aortic graft for perforrning an aortic anastomosis on a section
of aorta, comprising, aortic graft means, having cephalic and caudal ends, and having an
axis, a plurality of ~tt~rhment means attached to said cephalic and caudal ends of said
aortic graft means for securing said aortic graft means to the aorta, said attachment
means having base means, oriented in subst~nti~lly parallel relation to said axis of said
aortic graft means, and attached to said aortic graft means, post means, attached to said
base member and eYten(ling substantially radially away from said aortic graft means, and
hool~ means oriented in substantially parallel relation to said axis, attached to the distal
end of said post means for penetrating the aorta and securing said graft means to the
aorta.
As set forth in the specification, the aortic graft of the invention is employed in
15 a process for ~Yclllrling from the circulation and, thus, rendering safe, an aortic aneurysm
through the use of a balloon catheter and aortic graft comprising the steps of, inserting
a contrast filled balloon catheter into the aneurysm to a proximal point just above the
aneurysm abutting unaffected arterial tissue; measuring the diameter of the aorta at the

proximal point just above the aneurysm; removing the contrast filled balloon catheter

from the proximal point and placing it in the affected artery at a distal point just below
the aneurysm abutting unaffècted arterial tissue; measuring the diameter of the vessel at
said distal point, just below the aneurysm; removing the contrast filled balloan catheter;
measuring the distance between said proximal and distal points through radiographic
25 techniques; inserting along with a double balloon catheter a graft having first and second
ends subst~nti~lly 1-4 mm larger than the size of the aorta at said proximal and distal
points; blowing up the cephalic balloon from the distal end of the cephalic balloon to
force hooks at the distal position of the cephalic end of said graft into mated relation


SUt~ 111 ~ITE SHEET


203319~
wo 90~ 82 -6- PCr/USso/03322


with said cephalic aorta; continuing to blow up said cephalic balloon from said distal end
of said cephalic balloon until said cephalic balloon is fully inflated and said proximal
hooks are forced into mated relation with said artery at said proximal end of the cephalic
aorta; m~int~ining inflation of said cephalic balloon while inflating cuadal balloon;
blowing up said cuadal balloon from the proximal end of said cuadal balloon to force
hooks at said proximal position of said cuadal end of said graft into mated relation with
said aorta at said cuadal point; co~ illg to blow up said cuadal balloon from said
proximal end of said cuadal balloon until said cuadal balloon is fully inflated and said

distal hooks are forced into mated relation with said artery at said distal end of the

caudal aorta; removing the double balloon catheter system; and inserting into said graft
a first expandable ring retainer.




2j



SU~SmUTE SHEET

2a33l9.5 .
wo 90/lS582 ~ ` ` ' ` PCr/US90/03322
--7--


BRIEF DESCRIPTION OF THE DRAVVINGS
The characteristics and features of the present invention will be better
understood through the following detailed description and accompanying drawings which
are incorporated herein by reference:
Fig. 1 is an enlarged coronal view of the aortic graft of the present invention
shown with a double balloon catheter system that is used to implant it.
Fig. 2 is an enlarged view of an at~chment means of a preferred embodiment

of the present invention.

Fig. 3 is a coronal view of a balloon catheter being inserted into the cephalic
end of the affected artery above the aneurysm in order to measure the diameter of the
vessel.
Fig. 4 is a coronal view of a contrast filled balloon catheter being inserted into
15 the caudal end of the abdominal artery below the aneurysm to measure the diameter of
the vessel.
Fig. 5 is a coronal view of the aortic graft and double balloon catheter system
of the present invention inserted into the abdominal artery so that the cephalic and
caudal ends of the aortic graft are aligned with the cephalic and caudal portions of the

aorta above and below the aneurysm, respectively.

Fig. 6 is a coronal view of the cephalic abdominal aorta above the aneurysm
with the aortic graft and double balloon catheter system inserted, showing the penetration
of the aorta wall of the attachment means as the cephalic balloon is inflated.
Fig. 7 is a coronal view of the aortic graft and cephalic balloon of Fig. 6 shown

at a subsequent stage during inflation of the cephalic balloon as attachment means have

penetrated the aorta wall.



SUt~ l l l LI~E SHET

wo go/15582 2 0 3 3 1 9 5 -8- PCr/US90/03322

Fig. 8 is a coronal view of the caudal abdominal aorta below the aneurysm with
the aortic graft and double balloon catheter system inserted, showing the penetration of
the aorta wall of the ~tt~chment means as the caudal balloon is inflated.
Fig. 9 is a coronal view of the aortic graft and cephalic balloon of Fig. 8 shown
at a subsequent stage during inflation of the caudal balloon as attachment means have
penetrated the aorta wall.
Fig. 10 is a coronal view of the aortic graft of the present invention after
~tt~chment means of cephalic and caudal ends have been implanted in the aorta wall and

the double balloon catheter system has been withdrawn, excluding the aneurysm.

Fig. 11 is a top view of a retainer ring of the present invention.
Fig. 12 is an oblique view of an alternative form of the retainer ring of the
present invention.
Fig. 13 is a coronal view of the cephalic end of aortic graft of the present

invention showing installation of retainer ring in cephalic end with a balloon catheter.

Fig. 14 is a coronal view of the caudal end of aortic graft of the present
invention showing installation of retainer ring in caudal end with a balloon catheter.
Fig 15 is a coronal view of the aortic graft of the present invention showing the
graft implanted in the aorta excluding the aortic aneurysm.

The aortic graft, and system and method of implanting an aortic graft of the

present invention will now be described in further detail with reference to the drawings.
The drawings and the detailed description of a preferred embodiment of the invention
which follows are illustrative and explanatory only and in no way limit the scope of the
invention as set forth in the appended claims.




S~SmUTE StlEEIr

203319S
wo go/l~582 -9- PCri-lS90/03322


DESCRIPrION OF A PREFERRED EMBODIMENT
Fig. 1 illustrates aortic graft means 10 for repairing an abdominal aortic
aneurysm 12. As illustrated in Fig. 3, the aortic aneurysm 12 is located in the abdominal
aorta 11 between the renal arteries 15 and the iliac arteries 16.
It will be apparent to those skilled in the art that the aortic graft 10 of the
present invention can also be used in other locations without departing from the scope
or spirit of the appended claims. For example, the graft could be used on any type of
fluid conducting vessel such as sections of arteries located in other parts of the body or
other types of vessels.
As embodied herein, aortic graft means 10 of the present invention comprises
an aortic graft 18 having cephalic 19 and caudal 20 ends and a body 21. The aortic graft
18 of the present invention is preferably fabricated from a flexible, yet resilient, material
such as polytetrafluoroethylene (Teflon) or other material having similar flexible and

resilient properties. Other substance such as natural or synthetic polymeric substances
(such as polyester fabric, Dacron, Mylar, Rayon, cellulose acetate, cellulose butynate) may
also be used. A critical consideration is that the substance of which the aortic graft 18
is made be biologically inert and be compatible with the tissues into which the aortic
graft is to be implanted. Many materials of this type are well known in the art.

In a preferred embodiment of the present invention aortic graft 18 has a
plurality of att~chment means 22 and a double balloon catheter system 35. The graft can
be prepared and packaged under sterile conditions and assembled in a kit comprising first
catheter system for measuring the diameter of the aorta, aortic graft 18, with att~chment
means 22, a second catherer system which is a double balloon catheter system 35, and

a third balloon catheter system 48 with retainer rings 4i. It is contemplated that the
aortic graft 18, double balloon catheter system 35, and third catheter system 48 of the
present invention be manufactured in various sizes so that the system of the presen~




SUts;~ JTE SHEET

wo so/lssg2 2 0 3 3 1 9 5 -lo- PCr/US90/03322

invention is adaptable to the size and configuration of the aortic aneurysm of the
individual patient.
As embodied herein and shown in Fig. 2, attachment means 22 of the present
invention comprises base means 23, post means 24, and hook means 25. Hook means
25, in turn, further comprises tip 26 to f~ilit~te penetration of aorta 11 by hook 25 and
barb 27 to resiliently hold ~tt~hment means in implanted position relative to aorta 11.
In a preferred embodiment of the present invention, aortic graft 18, is provided with a
plurality of att~rhment means 22, mounted in the cephalic 19 and caudal 20 ends of
aortic graft 18.
In a preferred embodiment of the present invention, base means 23, is
constructed of a biologically compatible material such as metal or plastic. Base 23 can
be a small flat strip of metal that is oriented in substantially parallel relation to the axis
of aortic graft 18. Base 23 is attached to the cephalic 19 and caudal 20 ends of aortic
graft 18. This atta~hment can be accomplished by a variety of means including, but not
limited to, gluing, welding, riveting, or simply positioning base 23 so that the distal
surface of base 23 abuts the proximal surface of the lumen of aortic graft 18 and is held
in place by force exerted on post 24.
Post means 24 is a post that is preferably oriented in substantially perpendicular

relation to base 23. In a preferred embodiment of the present invention, post 24 is

mounted on the distal surface of base 23 so that post 24 extends radially outward from
the axis of aortic graft 18 when base 23 is in mounted relation to aortic graft 18. Base
23 may be secured to aortic graft 18 through a variety of means including gluing, riveting,
welding, or other means that are biologically compatible and will provide a secure

attachment of post 24 to base 23. Base 23 can also be secured to aortic graft 18 by
mounting base 23 in the lumen of aortic graft 18 so that the distal surface of base 23
abuts the proximal surface of the lumen of aortic graft 18 so that post 24 penetrates and


SU~STITUlE SttEEt

203319S
wo 90/15582 -11- PCI/~lS90/03322


extends through aortic graft 18. Force exerted on the distal end of post 24 then holds
base 23 and post 24 in place.
In a preferred embodiment of the present invention, hook means 25 is a hook
that is mounted on the distal end of post 24. Hook 25 is oriented substantially parallel
relation to base 23 and, thus, the axis of aortic graft 18 when it is implanted in aorta 11.
In a preferred embodiment of the present invention, the limb of hook 25 on which tip
26 is located is longer as measured from post 23 than the end of hook 25 distal from tip
26. Further, hook 25 may have one or more barbs 27 for holding attachment means 22
and aortic graft 18 firmly in place relative to aorta 14 at the cephalic 12 and caudal 13
portions of the abdominal aorta above and below aneurysm 11 respectively.
Aortic graft means 10 is implanted in abdorninal aorta 11 through the use of a
double balloon catheter system 35. The double balloon catheter system 35 of the present
invention, is oriented so that when the balloons are inflated, tip 26 of hook 25 engages

the wall of aorta 11 in substantially non-parallel relation in order to facilitate hook 25
15 penetrates abdominal aorta 11 to secure aortic graft 18 of the present invention to aorta

11.
It will be apparent to those skilled in the art that various modifications and
variations can be made in the construction and implantation of attachment means 22 of
the present invention without departing from the scope or spirit of the claimed invention.
For example, the relative lengths of the limbs of hook 25 on each side of post 24 could
be modified. Post 24 in turn could assume various configurations, provided the distal end
of post 24 extends radially from aortic graft 18 to penetrate through aorta 11. Hook 25
could also assume various configurations and orientations, provided it is oriented in a
manner so that it does not pose a hazard to nearby organs or systems when aortic graft
18 as implanted in aorta 11. Further, att~hment means 22 could be oriented so that it
does not rotate in order to penetrate aorta 11 but, rather, simply erodes through aorta
11. Hence, it is intended that the present invention cover the modifications and
SUBSTITUTE SHEEr


` 2033195 -12-
wo go/15582 PCl /US90/03322

variations of the invention, provided they come within the scope of the appended claims
and their equivalents.
The operation and att~hment of aortic graft means 10 can perhaps best be
illustrated by the operation of the double balloon catheter system 35. Impiantation of
the aortic graft means of the present invention involves several steps. First, an incision
is made in the femoral artery 17 or iliac artery 16 to provide a means of access to
aneurysm 12. In a preferred embodiment of the present invention, as shown in Fig. 3,
a first balloon catheter assembly 28 is employed to measure certain critical features of
aorta 11. First balloon catheter 28, as embodied herein, comprises a guide wire 29, a
balloon 30, a supply tube 31, a first balloon catheter sheath 32, and contrast material 33.
Guide wire 29 is inserted through the incision in femoral artery 17 or iliac artery 16 with
first catheter assembly 28. Balloon 30 is filled with a radioopaque contrast material 33
to allow vicu~li7~tion of balloon 30 by radiographic means. Catheter assembly 28 is
threaded through the opening of femoral artery 17 or iliac artery 16 until balloon 30 of
first catheter 28 has been inserted into aneurysm 12 in the abdominal aorta 11. Using
a radiographic system 34, balloon 30 is aligned with the cephalic portion 13 of the
abdominal aorta 11 above aneurysm 12. Balloon 30 is then inflated until it engages the
interior surface of the cephalic portion 13 of abdomin~l aorta 11 immediately above
aneurysm 12. Radiographic system 34 is then employed to measure the diameter of the
abdominal aorta 11 at its cephalic portion 13, above the aneurysm. This measurement
is then recorded.
As shown in Fig. 4, first catheter assembly 28 is then withdrawn until balloon
30 is aligned with the caudal portion 14 of abdominal aorta 11 below aneurysm 12.
Balloon 30 is reinflated until it abuts the interior wall of abdominal aorta 11 at the
caudal portion 14 of the abdominal aorta 11 below aneurysm 12. Radiographic system
34 is again employed to measure the diameter of abdominal aorta 11 at the caudalportion of abdominal aorta below aneurysm 12. This measurement is also recorded.
SUBS~ITUTE SHER

,` 203319~
wo 90/15582 -13- PCr/~lS90/03322


Using the data collected by the radiographic system, the distance between the cephalic
portion 12 of abdominal aorta 13 and the caudal portion 14 of abdominal aorta 11,
above and below aneurysm 12, respectively, as well as the diameter of the cephalic and
caudal regions 13 and 14 of aorta 11, are then determined. Using this information, aortic
graft means 10 of applo~-iate size for the patient is selected.
As embodied herein aortic graft 18 is preferably 2 to 10 rnm longer than the
distance between the cephalic 13 and caudal 14 portions of abdominal aorta 11 as
deterrnined by the radiographic system 34. Aortic graft means 10 of the present

invention comprises aortic graft 18, att~chment means 22, and double balloon catheter
system 35. Double balloon catheter system 35 also comprises radioopaque markers 42.
Radioopaque markers 42 are provided on the proximal 37 and distal 38 ends of cephalic
balloon 36 as well as on the proximal 40 and distal 41 ends of caudal balloon 39, of
double balloon catheter 35. As shown in Fig. S, using radioopaque markers 42, and
radiographic system 34, aortic graft 10 is inserted through the opening in femoral artery
17 or iliac artery 16 until cephalic balloon 36 is aligned with cephalic portion 13 of


abdominal aorta 11 and caudal balloon 39 is aligned with caudal portion 14 of abdominal
aorta 11.
Cephalic balloon 36 is then inflated. As shown in Fig. 6, inflation of cephalic

balloon 36 begins at the distal end 38 of cephalic balloon 36. As distal end 38 of
cephalic balloon 36 is inflated, abutting att:~chment means 22 rotate so that the distal
ends of base 23 are moved radially outward from the axis of aortic graft 18 while the
proximal ends of base 23 remain proximate to axis of aortic graft 18. This rotation
orient tips 26 of hooks 25 in substantially non-parallel relation to abdominal aorta 11.
As cephalic balloon 36 is inflated further, tip 26 engages abdominal aorta 11. Tntlatinn
of cephalic balloon 36 forces tip 26 to penetrate abdominal aorta wall 11 so that hook
25 extends through abdominal aorta wall 11. Barb 27 passes through the penetration so


SUBS~ITUTE SHEET

wo9O/1~582 20~3I9~ -14- PCI/US90/03322

that tip 26 and barb 27 of hook 25 penetrate abdominal aorta wall 11 and lie on the
outer wall surface of abdominal aorta 11.
As shown in Fig. 7, inflation of cephalic balloon 36 continues in this manner,
forcing att~hmPnt means 22 through abdominal aorta wall 11 until cephalic balloon 36
is fully inflated. When cephalic balloon 36 is fully infl~te~, attachment means 22 on
cephalic portion 19 of aortic graft 18 will penetrate abdominal aorta wall 11 at cephalic
region 13, firrnly and permanently anchoring aortic graft 18 to abdominal aorta 11.
Cephalic balloon 36 is fully inflated and att~çhment means 22 and cephalic portion 19

of aortic graft 18 are anchored in proximal portion 13 of vessel wall 11, cephalic balloon

is left fully distended. The distention of cephalic balloon 36 effectively closes off the
flow of blood through abdominal aorta 11 during the remainder of the procedure.
Inflation of cephalic balloon 36 firmly holds the cephalic portion 19 of aortic graft 18 in
place while the caudal portion 20 of aortic graft 18 is being implanted in the caudal
portion 14 of abdominal aorta 11.
As shown in Fig. 8, caudal portion 20 of aortic graft 18 is implanted in caudal
portion 14 of abdominal aorta 11 by infl~ting caudal balloon 39 of double balloon system
35 beginning at the proximal end 40 of caudal balloon 39. As proximal end 40 of caudal
balloon 39 is inflated, ~ttachment means 22 in caudal portion 20 of aortic graft 18 rotate

as described above with respect to cephalic end 19 so that ~tt~hment means 22 of
caudal portion of aortic graft 18 are firmly and perm~nently mounted in caudal portion
14 of abdominal aorta 11, as shown in Fig. 9.
As shown in Fig. 10, once cephalic balloon 36 and caudal balloon 39 are fully
distended, aortic graft 18 is seated both proximally and distally in abdominal aorta 11.
At that point, cephalic 19 and caudal 20 portions of aortic graft 18 effectively exclude
further blood from the proximal or distal aorta from reaching aneurysm 11. iBody 21 of
aortic graft 18 functions as abdominal aorta wall 11 of aneurysm 12. As shown in Fig.
10, once aortic graft 18 is fully seated in cephalic 13 and caudal 14 portions of abdominal


SUBSTITUTE SHEEr

203319~
W O 90/15582 - PC~r/US90/03322
-15-
aorta 11, double balloon catheter system 35 is removed. Aortic graft 18 then assumes
the full pressure and stress of the circulatory flow through abdominal aorta 11 effectively
excluding aneurysm 12 and, thereby, substantially relieving aneurysm 12 of the stresses
on it.
In a preferred embodiment of the present invention, aortic graft means 10
further comprises retainer means 45. Retainer means 45 can be a resilient ring of
material which functions to hold aortic graft 18 firmly in place in abdominal aorta 11.
As embodied herein, retainer 45 comprises body 46, locking means 47. In a preferred
embodiment of the invention, as shown in Fig. 11, retainer 45 can be a split ring which

is configured so that the two ends of the split ring cooperate to form a smooth ring.
It will be apparent to those skilled in the art that various modifications and
variations can be made in the construction and implantation of att~hment means 22 of
the present invention without departing from the scope or spirit of the claimed invention.
For example, retiner 45 can be a resilient mesh web as shown in Fig. 12. Body 46 of
the web preferably comprises legs which are mounted in relation to each other so that
the web can collapse to allow for for insertion and to lock in place once it has been
implanted and expanded. Hence, it is intended that the present invention cover the
modifications and variations of the invention, provided they come within the scope of the
appended claims and their equivalents.

As shown in Fig. 10, after double balloon catheter 35 is removed from
abdominal aorta 11, guide wire 29 is left in place. As shown in Fig. 13, retainer 45 is
inserted into abdominal aorta 11 through the use of third catheter system 48. Retainer
45 has radioopaque markers 42 on its proximal and distal surfaces. As retainer 45 and
third catheter assembly 48 are inserted into abdominal aorta 11, radiographic system 34
tracks the location of retainer 45 relative to cephalic portion 13 and 19 of the abdominal
aorta 14 and aortic graft 18, respectively. Once retainer 45 has been aligneà with
cephahc portion 12 and 19 of abdominal aorta 14 and aortic graft 18, respectively,

SUE~STITUTE SltEET

9 S -16- Pcr/US90/03322

cephalic balloon 49 is inflate(l As cephalic balloon 49 is distended, locking means 47
engage, fixing retainer 45 in the aorta 11 the open position. Once balloon 30 has been
fully inflated so that retainer 45 is fully expanded, retainer 45 distends aortic graft 18 and
aorta 11, forcing aortic graft 18 and attachment means 22 against cephalic portion 13 of
abdominal aorta 11.
As shown in Fig. 14, caudal balloon 50 is then inflated, locking retainer 45 in
the caudal portion of aortic graft 20 and aorta 14. Third catheter system 48 is then
removed, along with guide wire 29. The incision in femoral artery 17 or iliac artery 16,
through which the procedure was performed, is then closed and sutured. Circulation to
the lower limbs is restored with aortic graft 18 excluding aneurysm 12 from circulation.

It will be apparent to those skilled in the art that various modifications and
variations of the invention can be made without departing from the scope or spirit of the
appended claims. In particular, aortic graft means 10 can be used with or without
15 retainer 45. Retainer 45 could assume a variety of configurations, shapes and sizes while

performing the function of securing aortic graft means l0 and abdominal aorta 14.
~tt~hment means 22 could also assume a variety of configurations in accordance with
the scope and spirit of the appended claims. Moreover, the direction in which each of
the balloons of the double balloon catheter system 35 is inflated is not critical, provided
~tt~rhment means 22 is oriented relative to the direction of inflation of cephalic 36 and
caudal 39 balloons to facilitate penetration of aorta 11. Hence, it is intended that the
present invention cover the modifications and variations of the invention, provided they
come within the scope of the appended claims or their equivalents.




SUBSTITUTE SHEEr

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date 1994-11-15
(86) PCT Filing Date 1990-06-15
(87) PCT Publication Date 1990-12-20
(85) National Entry 1991-01-18
Examination Requested 1991-08-23
(45) Issued 1994-11-15
Deemed Expired 1995-12-17

Abandonment History

There is no abandonment history.

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $0.00 1991-01-18
Maintenance Fee - Application - New Act 2 1992-06-15 $50.00 1992-06-10
Maintenance Fee - Application - New Act 3 1993-06-15 $50.00 1993-05-20
Maintenance Fee - Application - New Act 4 1994-06-15 $50.00 1994-06-15
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
TROUT, HUGH H., III
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

To view selected files, please enter reCAPTCHA code :



To view images, click a link in the Document Description column. To download the documents, select one or more checkboxes in the first column and then click the "Download Selected in PDF format (Zip Archive)" or the "Download Selected as Single PDF" button.

List of published and non-published patent-specific documents on the CPD .

If you have any difficulty accessing content, you can call the Client Service Centre at 1-866-997-1936 or send them an e-mail at CIPO Client Service Centre.


Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Claims 1994-11-15 7 158
Cover Page 1994-11-15 1 17
Abstract 1994-11-15 1 43
Description 1994-11-15 16 691
Drawings 1994-11-15 13 193
National Entry Request 1991-01-18 3 123
International Preliminary Examination Report 1991-01-18 2 83
Prosecution Correspondence 1991-01-18 3 144
Prosecution Correspondence 1991-08-23 2 45
Office Letter 1991-09-26 1 24
PCT Correspondence 1994-09-02 1 47
Fees 1994-06-15 1 67
Fees 1993-05-20 1 39
Fees 1992-06-10 1 50