U.S. patent number 3,818,515 [Application Number 05/305,661] was granted by the patent office on 1974-06-25 for bifurcated tracheo-bronchial prostheses.
Invention is credited to William E. Neville.
United States Patent |
3,818,515 |
Neville |
June 25, 1974 |
BIFURCATED TRACHEO-BRONCHIAL PROSTHESES
Abstract
A prosthetic device for implantation into the tracheobronchial
tree in replacement of a damaged or diseased trachea and one or
both bronchi is disclosed. The device comprises a bifurcated tube
having a cuff or cuffs on either distal end of the arms which are
to be inserted into and anastomosed with the bronchi. A central or
trunk tube is connected to these lateral tubes and may also have a
cuff like arrangement distally positioned thereon. The central tube
is to be inserted into the trachea or what is remaining of the
endothoracic trachea. The bifurcated tube structure is comprised of
a molded polysiloxane-epoxide substrate having positioned
depression therein within which depressions a porous fabric like
mesh is partially recessed so as to completely circumvent the
exterior of the tube. These cuffs are of a polyester fabric and
form one or more circumferential sleeves about the tube. The
particular structural arrangement gives a smooth interior surface
to the implant, little tissue reactivity and excellent flex to the
device coupled with an outer surface which is conducive to
excellent fibroblastic ingrowth of the surrounding tissue as well
as permitting "blooding" of the connection between the natural body
tissue and the implant.
Inventors: |
Neville; William E. (Chatam,
NJ) |
Family
ID: |
23181770 |
Appl.
No.: |
05/305,661 |
Filed: |
November 13, 1972 |
Current U.S.
Class: |
623/9;
606/153 |
Current CPC
Class: |
A61F
2/04 (20130101); A61F 2002/046 (20130101) |
Current International
Class: |
A61F
2/04 (20060101); A61f 001/22 () |
Field of
Search: |
;3/1,DIG.1
;128/334R,334C,1R,348,351 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"Prosthetic Reconstruction of the Trachea" by W. F. Cheng et al.,
Surgery, Vol. 65, No. 3, March 1969, pp. 462-469. .
"Prosthetic Replacement of Esophageal Segments" by J. N. LaGuerre
et al., The Journal of Thoracic & Cardiovascular Surgery," Vol.
6, No. 5, November 1968, pp. 674-682. .
"Evaluation of Two Prostheses for Total Replacement of The Mitral
Valve" by F. S. Cross et al., The Journal of Thoracic &
Cardiovascular Surgery," Vol. 46, No. 6, December 1963, pp.
719-725..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
I claim:
1. A prosthetic device for implantation into humans in replacement
of a portion of the tracheo-bronchial tree which comprises:
a. a bifurcated tube having superimposed thereon at least one cuff
or sleeve of a fabric which circumvents the same,
b. said circumferential cuff member partially recessed in a
circumferential depression in the outer surface of the wall of the
tube located at the distal portion of the same,
c. said cuff member comprised of a seamless circular sleeve of
porous fabric having a hollow center portion thereof and adhesively
attached to the walls of the circumferential depression in the
outer surface of the tube.
2. A prosthetic device according to claim 1 wherein the tube has
superimposed thereon a circumferential cuff member on the distal
segment thereof.
3. A prosthetic device according to claim 1 wherein the tube is a
bifurcated tube having two arms extending therefrom, each arm
having a circumferential cuff member on the distal segment
thereof.
4. A prosthetic device according to claim 1 wherein the outside
diameter of the tube is smaller in a short segment of the tube
distal to the location of the cuff members thereon.
5. A prosthetic device according to claim 3 wherein the outside
diameter of the tube is smaller in a short segment of the tube
distal to the location of the cuff members thereon.
Description
BACKGROUND OF THE INVENTION
Although the ideal situation exists in the use of the individual
patients use of his own tissue when surgical repair or
reconstruction of the tracheo-bronchial tree is attempted this is
frequently not possible when there is a marked difference between
the divided ends of the passageway which has been cut to remove a
damaged or diseased portion thereof.
While anatomic studies on human cadavers indicate that as much as
about 6 centimeteres of endothoracic trachea can be surgically
excised and a successful end to end anastromosis of the cut ends
accomplished, this is not applicable in a clinical situation where
other factors intervene. The continued maintainence of a viable
lung implant is even more important when it is necessary to
surgically resect the distal trachea and both stem bronchii.
Although a variety of prosthesis constructed over the recent years
have been utilized none has been completely satisfactory in one
respect or another. Tubes constructed of Marlex mesh have shown
promise until a cicatricial stenosis of the graft was reported by
Pearson and his associates along with the dangers of erosion
causing hemmorrhage from the aorta, which has dampened the
enthusiam for this approach.
The reasons that a successful lung implant has not been previously
made are acceptance of the implant by the surrounding tissue and
concurrent strength and flexibility in the implamt to render it
stable. In general the achievement or solution of one of these
problems was at the expense of the other. Hence it was necessary to
design and construct a tracheo-bronchial implant structure which
was both strong and non reactive to tissue.
OBJECTS OF THE INVENTION
It is a primary object of the present invention to present to the
art a new and unobvious improvement in the structural implant
field. The tracheo-bronchial implant device described has been
proven to be capable of ready insertion into the body and is
extremely durable without causing tissue reaction. It therefore
exhibits a compatible blending of the body tissue and the resinous
material of the implant when the two are sutured together.
It is a further object of the invention to describe a method for
replacement of damaged lung tissue and a replacement of a part of
the tracheo-bronchial tree.
BRIEF SUMMARY OF THE INVENTION
Accordingly an implant device in the form of a bifurcated tube of
polysiloxane-elastomer material enwrapped by a porous sleeve of
polyester resin in the form of one or more cuffs is the essential
nature of the invention sought to be patented.
The invention will be specifically described by reference to FIGS.
1 to 3 of the drawing.
FIG. 1 is a perspective view of the device in the form which
constitutes a bifurcated embodiment having sewing cuffs
thereon.
FIG. 2 is a perspective view of a variation in the embodiment of
FIG. 1 which variation discloses a reduction means at the terminal
portions.
FIG. 3 is a cross-sectional side view of a second embodiment of the
invention showing a single tube with the structure adapted for the
attachment of the sewing cuff.
The implant prostheses will be more particularly described by
reference to FIG. 1 of the drawing. This Figure comprises a plan
view of the device of the invention. The polyester sleeve or cuff 2
surrounds the inner polysiloxane resin core or base tube 1. This is
true even on the both arms of the device where the maximum amount
of anastomosis is desired. A locking groove 3 is shown for the
affixing of the cuff member on the base tube 1. An entrance
protrusion 5 is shown between the distal cuff 2 and the end of the
arm which extends into the lateral bronchus. The lateral arms 4 and
4' of the device fit into the bronchii. A central tracheal tube 6
is the portion of the device inserted into the endothorax. On each
lateral arm of the device a rounded edge or entrance recess 7 is
shown which makes it easier to insert the lateral arm into the
tissue of the bronchus. The sewing and anastomosis cuff has a
center blood space 8 which serves to moderate the borders of the
plastic to the tissue. The locking groove 3 for the cuff member 2
has the innermost surface thereof adhesively attached to the bottom
and walls of the polyester cuff member 2 by means of a non toxic
resinous adhesive which binds the polysiloxane base tube 1 to the
DACRON knitted sleeve or cuff 2. The entrance to the trachea is
shown at 10 and the entrance arm 11 goes into the bronchus. The
median line of the bifurcated tube is shown at 12 and depending on
the situation medically and surgically the length of either or both
arms of the bifurcated tube which extend laterally into the
bronchii can vary from that median line. As shown in FIG. 1 of the
drawing the fact that more than one cuff member is present at a
spaced distance along the lateral branches of the tube makes it
possible to surgically adjust the length of the tube to fit the
particular medical and surgical situation.
In FIGS. 2 and 3 of the drawing certain alternate forms of the
device of the invention is illustrated. In FIG. 2 for example is
shown a lateral arm 4 which has a reducing shoulder 14 and a
probing tip 13 thereon which makes it easier to insert the lateral
tip of the implant into the connecting tubular portion of the
bronchus. In FIG. 3 a single variant of the concept is shown which
embodiment would also employ the cuff and anastomotic sleeve 2 of
porous polyester fabric to tie together the implant and the natural
tissue.
Many other variations of my basic concept will fall within that
concept and are included therein. The scope of that concept must be
measured by the appended claims and not by the specific disclosure
set forth herein to illustrate the same.
* * * * *