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.

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.

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.