US3461869A - Permanent skin exit device - Google Patents

Description

Aug. 19, 1969 T. s. H'ARGEST I PERMANEN'I SKIN EXIT DEVICE Filed April 5, 1966 INVENTOR cw'y Tho as .51 d- United States Patent US. Cl. 128-214 6 Claims ABSTRACT OF THE DISCLOSURE A body with fluid passage means has a fabric-like coat to stimulate tissue growth for anchoring the lower body portion in the tissue with its entrance and exit ports disposed for fluid transfer with cannulae outside and within the tissue. A removable shunt can be telescopically received in the fluid passage means when the body is not connected for fluid transfer.

This invention relates to a new and useful improvement in surgical devices and more particularly to a permanent cannulae exit button.

In various surgical procedures, it has become commonplace where indicated to pass parenteral fluids or blood into a body vessel or duct or alternatively, to withdraw fluids or blood from such vessels or ducts. With the advent of procedures such as peritoneal dialysis, lymph dialysis and hemodialysis, it has become apparent that entry and exit to body vessels by means of cannulae through the tissue to the body cavity can be performed in a permanent manner. Such is the case with persons who must repeatedly undergo treatment wherein infusion of fluids or shunting between veins and arteries is necessary in order to maintain life as aid in recovery. As in the case with chronic extracorporeal hemodialysis; collection, dialysis and reinfusion of the lymph of a patient with marked renal failure, permanent cannulation is necessary. Here lymph is continuously collected from the thoracic duct by suitable cannula into bags or glass bottles. After being dialysized, the lymph collection is reinfused via indwelling venous cannulae inserted in the external jugular vein. At the exit point of the cannula through the tissue, it has been the practice to enter through a stab wound. Infection at this site is common despite the use of Silastic cannula. As with thoracic duct cannulae, it is frequently desired to provide a suitable shunt between a vein and artery, also on a permanent basis. The applications for the A-V shunt are well known in the art. In the case of the A-V shunts, separate cannulae are provided through the tissue into the respective vessels. Here again, two separate stab wounds are required in order to exit the cannulae from the body.

In all of the above procedures, one or more cannulae are positioned in a permanent manner. In the past, it has been necessary to change the site of entry when the tissue surrounding the exit or entry site would become inflamed or infected either by contamination or natural resistance between the tissue and the cannula. While it is normally the practice to provide such cannulae through the stab wound for short term dialysis or shunt, in the case of long term use there has been no means other than by repeated stab wounds to prevent the deleterious elfects of such long term cannulation.

Aside from the problem of tissue damage, it has been diflicult in the past to suitably anchor the cannula in place at the exit point. Because of the materials used and the configuration of cannulae, movement of the patient could bring about inadvertent displacement of the tube. It has frequently occurred that such tubing would be pulled out of or sucked into the body accidentally. Such a con- "ice tingency necessitated further surgical procedures. In the past, the rubber tubes or cannulae were secured to the body by sutures or even safety pins. In the case of sutures, long term cannulation proved impractical. In the case of the pin, the metal would rest directly uponthe wound causing the ill eifects referred to herein. In each one of these instances, it is necessary to provide a dressing around the tube at the body opening. This dressing requires frequent changing, each changing presenting the possibility of displacement of the cannula or contamination of the wound.

Another harmful effect occurring in the past has been a leakage at the exit point. In the case of the stab wound entering, there has been no way of effectively closing the tissue about the cannula to prevent such leakage.

The patent to HDoubler, No. 3,176,690, shows a catheter having integral flanges secured to the outer wall of the catheter and projecting radially outwardly therefrom. Thread is used to secure the flanges to the patient. The aperture formed in the HDoubler catheter is to assist in passing suture material through the structure when attaching a tube to a patient.

The problem of maintaining a non-anatomical conduit between the external environment and the internal body has been plagued with the incident of infection, trauma, irritation and contamination. This problem has been especially pronounced when a device of a substance foreign to an organism has been maintained in situ as the conduit across the body wall. In addition, the problem is corelated with the degree of occlusion or intimacy between the conduit device and the traversed tissue. Any spacing which occurs between the conduit and the opening in the body wall is a potential passageway for bacterial invasion and subsequent infection.

Surgically constructed anatomical openings, such as stab wounds, to the inner recesses of the body have been tolerated; however, conduits traversing the body wall, such as arterial-venous shunts, have demonstrated high incidence of trauma and infection. This problem is especially evident at the boundary between the conduit device and aperture through the body wall.

It is, therefore, an object of the present invention to provide a means for permanent access to the inner body through body wall tissue.

Another object of this invention is to provide a means of obviating infection or contamination in the body wall where a conduit has been passed through the tissue and skin defining the body wall.

Another object of this invention is to provide a permanent exit device through the body wall for a permanent fluid passageuay betmeen an internal body conduit and external reservoir.

Still another object of this invention is to provide a sealed and fixed cannula adaptor and receptacle through the tissue to eliminate the possibility of infection at the exit.

Another object of this invention is to provide a permanent cannula exit device having a low angle of entry and exit for cannulae being introduced into the human body.

Another object of this invention is to provide a permanent cannula exit device maintained in position upon the human bod through tissue by means of tissue growth upon only a portion of the device.

These and other objects of the invention will become apparent from the detailed description of the drawings herein;

FIG. 1 is a perspective illustration, partly in phantom, showing the permanent exit button of the present invention in position within a fragment of body wall and further showing two pairs of cannulae terminating in fluid communication within the device;

FIG. 2 is a plan view of the exit device of FIG. 1 and shows a closed loop shunt in phantom within the device;

FIG. 3 is a longitudinal elevational view taken on lines 3-3 of FIG. 2;

FIG. 4 is a front end view of the device of FIG. 3 taken on lines 4-4 of FIG. 3;

FIG. 5 is a sectional illustration taken on lines 5-5 of FIG. 4;

FIG. 6 is a perspective illustration similar to FIG. 1 illustrating a modification of the exit device of the present invention having a single passageway therethrough;

FIG. 7 is an elevational view of a further modification of the device of the present invention;

FIG. 8 is an end view of a modification of the device of the present invention of FIG. 7 showing apertures formed in the device for anchoring purposes;

FIG. 9 is a top plan view of the device of FIG. 7 taken on lines 99 of FIG. 7;

FIG. 10 is a bottom plan view of the device of FIG. 7 taken on lines 1010 of FIG. 7; and

FIG. 11 is a sectional illustration taken on lines 1111 of FIG. 7.

Referring now to the drawings, in FIG. 1 there is shown a permanent skin exit button 10 provided through a fragment of body wall tissue 12. A pair of cannulae 14 are shown having one end 16 terminating within the button 10. The cannulae 14 enter the button 10 through a pair of longitudinally extending cylindrical passageways 18 which extend through the button 10. The button 10 includes a body 13 having an upper portion and lower portion 17. The passageways 18 have their entry point above the surface of the body tissue 12 through the upper portion 15 and their exit beneath the body tissue 12 through the lower portion 17. It is therefore apparent that the button provides a passageway to the subcutaneous tissue by means of passageway 18. A second pair of cannulae 20 are illustrated beneath the surface of tissue 12. The cannulae 20 have their ends 22 likewise terminating within passageway 18 of the button 10. The end portions 16 and 22 abut to prevent turbulence within the button at the point that the end portions 16 and 22 of the cannulae 14 and 20 meet. The cannulae 20 are connected with subcutaneous body vessels at a point not shown. The cannulae 20 are normally permanently implanted within the body tissue. The button 10 thus provides fluid communication between the internal cannulae 20 and externally disposed cannulae 14. Approximately half of the button 10 (the upper portion 15) appears above the surface of the tissue 12, and half (the lower portion) below the surface of tissue 12. A peripheral groove 24 which is disposed in a plane is provided in the body 13 to facilitate the sealing of the tissue and skin about the outer wall of the button 10 and further to anchor the button in position through the body wall. Accordingly, when the button is anchored for use groove 24 will be disposed at or adjacent the outer surface of the tissue. The button 10 may be formed of a silicone rubber material. It will be understood, however, that any material which is compatible with the body tissue and adapted to formation of a like device may be used. The lower portion 17 of the button 10 is provided with Teflon felt 19 to promote growth of tissue about the lower portion 17 of the button 10. Although it is felt that Teflon will provide the necessary surface about which tissue may be grown, other suitable fabric-like plastics may also be used without departing from the spirit or scope of the present invention. The groove 24 also aids in the growth of tissue about button 10. To provide access to internal cannulae 20 which will minimize strain on body vessels (not shown) each passageway 18 is disposed at an oblique angle to the plane of groove 24, the inclination of the passageway being such that a cannula 14, when mounted in untensioned condition, will form a small acute angle with the external surface on the tissue when button 10 is anchored in such tissue.

When it is desired to provide fluid communication between the internally placed cannulae 20 and a bath, receptacle or other fluid or blood treatment means, cannulae 14 are telescopically passed into the entry ports of the passageways 18 in an abutting relationship with the end portions 22 of the cannulae 20. In this manner, fluid is provided in a continuous path through the body wall and into an external cleansing or treatment container or vessel (not shown). A radially outward extending peripheral flange 30 is provided upon the lower wall portion of the button 10. This flange 30 also promotes anchoring or fixing of the button in position prior to and after tissue growth within the groove 24.

When it is desired to simply shunt between the passageways 18 of the button 10, a closed loop shunt 32 (FIG. 2) is positioned across the passageways 18 of the button 10. In this manner, the passageways are sealed against the entry of bacteria or other contamination which might enter the body by means of the permanent skin exit button 10. Therefore, when the skin exit button of the present invention is not providing communication to the subcutaneous tissue, it may be effectively closed by shunt 32.

In FIG. 3, the button 10 is of a generally rectangular configuration. The passageway 18 diagonally passes through the body portion 13 of the button 10 so that as the button 10 is in position upon the arm (or portion of the body wall), the outer surface of the arm would parallel the diagonally extending peripheral groove. In this manner, the passageway 18 opens external to the skin and tissue and exits internal the tissue. The Teflon felt material is provided upon the lower portion of the button 10 by means of a suitable bonding agent such as silicone rubber glue. It will be understood that various means may be utilized to adhere the Teflon felt to the silicone rubber button 10.

FIGURE 4 shows the relative position of the openings of the passageways 18 above and beneath the body wall 12.

FIGURE 5 illustrates, in section, the positioning of the button within the tissue. The silicone rubber glue 36 holds the Teflon felt 19 in place upon the button 10.

In the event that it is desired to have a single passageway to an internal body cavity or vessel, a permanent skin exit button 40 having a single passageway 42 formed therethrough may be provided. The general configuration of the button 40 has a diagonally extending peripheral groove 44 formed within the entire outer wall of the button 40. The modification of the permanent skin exit button 50 of the present invention is shown in FIG. 7. This modification includes apertures 48 formed in outwardly extending flange 46, which flange is formed upon the lower wall portion of the button 50.

FIGURES -8, 9, 10 and 11 illustrate the button 50 in various ways to show the flange and apertures. The Teflon felt 19 is also indicated upon the lower portion of this modification. The apertures 48 are provided to allow tissue growth therethrough in order to permanently anchor the button 50 in place. It is apparent that tissue will grow over the lower portion of the button 50 and thus seal against contamination from without the body wall.

In operation, the permanent skin exit button 10 of the present invention is positioned through a suitable surgically provided opening in the body wall with its upper portion 15 having the access openings above the body wall and its lower portion 17 having the exit openings beneath the body wall. In this manner, the passageways 18 provide communication through the body wall 12. Prior to positioning the button 10 through the tissue 12, cannulae 20 are passed within the body and connected in fluid flow communication with inernal vessels, canals or other body fluid cavities. The connection between the cannulae 20 and the body member may be by any known means. After the button 10 has been positioned through the body wall, it will eventually be held in place therein by means of tissue growth close fitting around the periphcry of the button 10. After the button has become fixed in position, thereby providing a closed entry to the subcutaneous tissue, the recipient will be adapted for permanent cannulation by means of the exit button of the present invention. When cannulation is not required, a closed loop shunt 32 may be provided to maintain the passageways 18 free from passage of contamination therethrough. Due to the configuration and positioning of the button an extremely low angle of entry is provided for hook-up to external cannulae.

In another modification of this invention, a plurality of openings 48 formed upon a peripheral flange 46 of the button 40 promote tissue growth therethrough to aid in anchoring the button in place through the body wall.

I have provided therefore a new and improved means of maintaining a non-anatomical conduit between the external environment and the internal body reducing to a minimum the incident of infection, trauma, irritation and contamination.

It is apparent that modifications and variations of the invention hereinbefore set forth may be met without departing from the spirit and scope thereof.

I claim: 7

1. A permanent skin exit button adapted to provide a non-anatomical cannulae connector conduit through living body wall tissue and comprising: a unitary body having an outer Wall surface with a peripheral groove disposed about said body in a plane for facilitating sealing said body in living tissue, lower and upper portions on said body defined by said groove and adapted, respectively, for embedment internally within, and projection externally from, living body tissue, a fabric-like coating about said lower portion for promoting tissue growth to anchor said body in place through tissue, said body having a passageway extending therethrough at an oblique angle to the plane of said groove and entrance and exit ports, respectively arranged in said lower and upper portions at the ends of said passageway.

2. A permanent skin exit button according to claim 1 wherein said body has an annular flange extending radially therefrom on the internal side thereof, said flange having apertures formed therethrough to allow growth of tissue to further anchor said body portion in place.

3. A permanent skin exit button substantially in accordance with claim 1 whereby the body is formed of silicone rubber and the fluid passageway passes diagonally through the body wall tissue.

4. A permanent skin exit button adapted to provide a non-anatomical cannulae connector conduit through living cutaneous tissue and comprising: a body formed of a silicone rubber and having at least two fluid passageways extending therethrough, each passageway having internal and external portions with entrance and exit ports adapted to be disposed respectively externally above and internally below the tissue, said exit ports adapted for fluid communication with internal cannulae or internally positioned vessels, a peripheral groove provided in the outer wall of the body between the external and internal portions to facilitate the sealing of tissue and skin about the outer wall of the button, and a Teflon felt coating provided upon a portion of the button within the living body wall tissue to promote growth of the tissue around said body to anchor the button in place.

5. A permanent skin exit button substantially in accordance with claim 4 and wherein means are provided which seal said passageways free from passage of contamination when connection is not provided between said ports and the external cannulae and the internal cannulae.

6. A permanent skin exit button substantially in accordance with claim 5 wherein the sealing means comprises a U-shaped channel shunt device formed for telescopic reception within the entrance ports in the button.

Merrill et al., Amer. Soc. Art. Int. Organs, vol. 8, 1962, pp. 252-255.

Boen et al., Amer. Soc. Art. Int. Organs, vol. 8, 1962, pp. 256-261.

DALTON L. TRULUCK, Primary Examiner US. Cl. X.R. 3-1; l28-348

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