U.S. patent number 3,878,565 [Application Number 05/382,631] was granted by the patent office on 1975-04-22 for vascular prosthesis with external pile surface.
This patent grant is currently assigned to Providence Hospital. Invention is credited to Lester R. Sauvage.
United States Patent |
3,878,565 |
Sauvage |
April 22, 1975 |
Vascular prosthesis with external pile surface
Abstract
A tubular textile synthetic cardio-vascular prosthesis
manufactured from polyester or other synthetic fibers and provided
externally with a thin resilient mat surface defined by a
multiplicity of fiber loops capable of enhancing the ability of the
graft to retain clotted blood and improve the rate of growth of
tissue within its confines while permitting free passage of
unclotted blood therethrough.
Inventors: |
Sauvage; Lester R. (Seattle,
WA) |
Assignee: |
Providence Hospital (Seattle,
WA)
|
Family
ID: |
26864453 |
Appl.
No.: |
05/382,631 |
Filed: |
July 25, 1973 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
168786 |
Jul 14, 1971 |
|
|
|
|
Current U.S.
Class: |
623/1.5;
623/1.28; 66/169R; 66/194; 66/169A |
Current CPC
Class: |
A61F
2/06 (20130101); D04B 1/02 (20130101); D10B
2509/06 (20130101) |
Current International
Class: |
A61F
2/06 (20060101); A61f 001/24 (); D04b 001/02 ();
D04b 009/12 () |
Field of
Search: |
;66/169,170,191,194,9R,9B ;28/72P ;26/2R ;139/387R ;3/1,DIG.1
;128/334R,334 ;138/121,123-125 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Knitting Spare Parts for Human Bodies, Textile Industries,
December, 1959. .
Prosthetic Reconstruction of the Trachea, Surgery, March, 1969,
Vol. 65, No. 3, pp. 462-469. .
Aritfical Skin, Vol. XII, Trans. Amer. Soc. Artif. Int. Organs,
1966, pp. 340-343..
|
Primary Examiner: Chi; James Kee
Attorney, Agent or Firm: Martine, Jr.; C. E.
Parent Case Text
This application is a continuation of copending application Ser.
No. 168,786 filed July 14, 1971 by Lester R. Sauvage, now
abandoned.
Claims
What I claim is:
1. A tubular knitted textile synthetic vascular graft comprising a
tubular body provided with a multiplicity of knitted fibrous loops
projecting outwardly from the outer surface of said body and
presenting a pile mat of filamentary material receptive to tissue
ingrowth on said outer surface, said loops being effective to
improve the rate of growth of tissue within said graft.
2. The synthetic graft of claim 1 in which said knitted tube is
formed from one continuous thread and the loops of said resilient
mat are formed from a second continuous thread.
3. The synthetic graft of claim 1 in which said knitted tube has
been axially compacted to define a multiplicity of circumferential
corrugations, along its length.
4. A tubular knitted textile synthetic vascular graft comprising a
seamless tubular body provided with a multiplicity of knitted
fibrous loops projecting outwardly from the outer surface of said
body and presenting a relatively open pile mat of filamentary
material receptive to tissue ingrowth on said outer surface, said
tubular body controlling the passage of tissue elements
therethrough.
Description
This invention relates generally to new and useful improvements in
synthetic vascular prostheses or grafts and particularly seeks to
provide a velour graft having its outer surface especially formed
to retain clotted blood while permitting free passage of unclotted
blood.
One type of synthetic graft that is being used for this purpose is
formed as a continuous tube knitted from a polyester or other
synthetic thread or yarn and axially compacted to define a
multiplicity of transverse corrugations, as shown in Jeckel U.S.
Pat. No. 3,337,673. These corrugations greatly increase the surface
area per unit length of the graft and the ridges and hollows of its
inner surface tend to hold any clotted blood within the confines of
the length of the graft until the clots become dissolved while
permitting the free passage of unclotted blood therethrough.
Although this type of synthetic graft has been quite successful, it
is believed that it would function more efficiently if more
positive means could be found to hold clotted blood within the
confines of the length thereof, thereby further reducing the
possibility of blood clots entering the blood stream before they
can be dissolved.
The literature in this field shows that braided, woven or knitted
cardiovascular prostheses should, in general, be at least partially
permeable and should be so textured as to promote healing with
minimum danger of thrombus formation. Velour-type fabrics have been
experimentally bonded to luminal surfaces of impermeable prostheses
to anchor autologous layers of fibrin in a position to form
pseudointimas, covering the plastic and interfacing with the blood
(SURGERY, Jan. 1969, Vol. 65, pp. 70-77). Such fabrics, with the
pile loops on the inside, have also been used alone, with some
success but with the disadvantage that the healing and
endothelialization on the inner surface reduce the size of the
lumen and thus require use, initially, of over-size grafts to
achieve a desired final result.
According to the present invention, a tubular prosthesis is knitted
with pile loops on the inside, as is customary with available
knitting machines, and is then turned inside out. Finishing
operations preferably include axial compression on a mandrel, as
suggested in Tapp U.S. Pat. No. 2,836,181, but to only a slight
extent (e.g. 30 percent or less), producing loose random
corrugations without flattening the pile, followed by setting in
any customary manner to give some dimensional stability. In small
sizes, for some applications, the crimping or corrugating step may
be omitted.
Therefore, an object of this invention is to provide a synthetic
graft having a velour exterior surface formed to enhance the
retention of clotted blood and improve the rate of growth of tissue
within the confines of the length thereof.
Another object of this invention is to provide a synthetic graft of
the character stated which is formed as a continuous tube knitted
from two or more polyester or other inert threads or yarns and of
diverse forms.
Another object of this invention is to provide a synthetic graft of
the character stated in which the continuous tube thereof is
knitted from two or more yarns, one of which is inwardly displaced
to define a loop at each knitting point thereby forming a resilient
mat-like surface over the entire inside of said tube, the tube
being then turned inside out and loosely crimped or corrugated.
With these and other objects, the nature of which will be apparent,
the invention will be more fully understood by reference to the
drawing, the accompanying detailed description and the appended
claims.
FIG. 1A represents an elevation of a knitted velour tube for
synthetic graft constructed without transverse corrugations,
provided externally with a thin resilient mat surface defined by a
multiplicity of fiber loops;
FIG. 1B represents an end elevation of the knitted tube of FIG. 1A
having a resilient mat surface on the inside of the tube, before
being turned inside out;
FIG. 1C represents an end elevation of the knitted tube of FIG. 1A,
having the resilient mat surface on the outside of the tube;
FIG. 2A represents an elevation of a knitted velour tube for
synthetic graft constructed with random transverse corrugations,
provided externally with a thin resilient mat surface defined by a
multiplicity of fiber loops.
FIGS. 2B represents an end elevation of the knitted tube of FIG. 2A
having the resilient mat surface on the outside of the tube.
FIG. 3 represents an enlarged fragmentary diagram of the knitting
pattern.
The size of the loops forming mat surfaces is exaggerated in FIGS.
1B, 1C and 2B for purposes of illustration.
Referring to the drawing in detail, the invention as illustrated is
embodied in a synthetic graft formed from a continuously knit tube
6.
The entire inner surface of the tube 6 is covered by a thin
resilient mat, generally indicated at 7, defined by a multiplicity
of internally directed thread loops 8 that are formed by a loop
thread 9 (see FIG. 3) and concatenated with the jersey knit loops
10 formed from a body thread 11.
The tube 6 with its loop mat 7 is knitted on a jersey knit circular
knitting machine that has been modified to accept and properly
position the loop thread 9 so that a loop is formed in it for
enclosure by and concatenation with each new loop of the body
thread 11, all of the mat-forming loops 8 being on the inside of
the tube, as originally knitted.
To further explain, if for a given size artificial artery a 66
needle circular knitting machine is used then there would be 66
wales and each of the body thread loops 10 in each course would
contain a concatinated loop of the thread 9, each mat-forming loop
8 being formed by the operation in a suitable manner of jacks
alternating with the needles.
After the internally matted tube 6 has been knitted it is further
processed by being turned inside out (FIG. 1C) followed by
controlled axial compaction and heat treatment to form a
multiplicity of random transverse corrugations (FIGS. 2A and 2B)
the mat-covered surface being capable of enhancing the ability of
the graft to retain clotted blood and improve the rate of growth of
tissue where desired while permitting free passage of unclotted
blood therethrough.
In the normal operation of the circular knitting machine referred
to above the loops 8 are formed on the inside of the tube, as
stated, resulting in the tube shown in FIG. 1B. Important
advantages have been noted in the use of synthetic grafts having
the "velour" or mat surface on the outside (FIGS. 1C and 2B), and
such tubes can most conveniently be made merely by turning inside
out the tubes as produced on the machine.
It will of course be understood that the mat-forming loops 8 need
not be formed between each pair of the body loops 10, but may be
formed in any desired sequence so long as the mat 7 is well
defined. However, at the present time and with the presently used
types of polyester or other inert fiber threads, it appears
preferable to have a mat-forming loop with each body loop.
A presently preferred polyester for use as described above is
"Dacron;" "Teflon" also appears to be practical and desirable under
some circumstances.
By the use of the random crimp or corrugation (FIG. 2A) there is no
crushing of the loops which occurs if the spiral wound corrugation
of Jeckel U.S. Pat. No. 3,367,673 is resorted to. Loops on the
inside reduce the area of the lumen, as noted, whereas placing the
loops on the exterior leaves the interior of the tube smooth and
full size while healing takes place over the entire exterior
surface, not merely at the points of anastomosis, as commonly noted
in presently used grafts.
In actual use of these prostheses in man, no long-term observations
are available but short term observations are very significant. In
experimental use during the past year such grafts have been
implanted in more than 75 patients, some of whom required difficult
arterial repairs and the distal bed being often quite restricted.
At the outset it was found that ease of suturing was a great
advantage, and the external velour surface provided a high degree
of filamentousness which facilitated pre-clotting of the prosthesis
and minimized blood loss.
Observation for periods up to 6 months showed impressively the
apparent benign incorporation of the prosthesis into the
surrounding tissues, with which they blend in a manner contrasting
sharply with the fibrotic reaction around conventional grafts with
relatively smooth outer walls. In previously known grafts the
fibrous tissue ingrowing from the end of the artery, adjacent the
anastomosis, was not thrombogenic, whereas that growing in from the
perigraft sources was undesirably thrombogenic compacted fibrin. No
such thrombogenicity has been observed in the grafts disclosed
herein.
* * * * *