US3452366A - Percutaneous conduit and connector - Google Patents

Description

`Iwuly 1, 1969 w. M, DOWNEY 3,452,366

PERCUTANEOUS CONDUTT AND CONNECTOR Filed June 2l, 1966 woLcoTT M. DOwNEY INVENTOR.

ATTORNEYS United States Patent O 3,452,366 PERCUTANEOUS CONDUII AND CONNECTOR Wolcott M. Downey, Belmont, Mass., assignor to Avco Corporation, Cincinnati, Ohio, a corporation of Delaware Filed .lune 21, 1966, Ser. No. 559,219 Int. Cl. A61f 1/00; A61b 17/04; A61m 25/00 U.S. Cl. 3-1 1 Claim ABSTRACT OF THE DISCLOSURE A percutaneous conduit and connector for permitting the application of pressure and electrical connections through the skin. The connector has a generally dog-leg configuration defined by a hollow tube having electrical conductors embedded in its Walls. Metallic coupling means connected to one end of the tube provides a scalable connection to a source of pressure and electrical apparatus. A tissue permeable skirt connected to the tube is provided for anchoring the connector to the skin.

mma- This invention relates to percutaneous connectors and more particularly to percutaneous connectors for permitting the applicatiton of pressure and electrical connections through the skin of a living body as may be required for example in auxiliary ventricle and artificial heart pump systems.

The advent of open heart surgery has presented to the medical profession the opportunity of repairing damaged or diseased hearts of individuals and Where appropriate, using circulatory assist systems in individuals who without such correction and/or assistance face premature death. Many devices are involved in this type of surgery. For example, one circulatory assist system may comprise an auxiliary ventricle connected across the arch of the aorta and driven by uid pressure in response to electronic signals (QRS wave) provided by the heart itself. By operating the auxiliary ventricle in proper phase, the systolic pressure in the left heart can 4be reduced and the systemic circulation can be maintained with a substantially reduced work load on the heart muscle. In addition, the operation of the auxiliary ventricle has the effect of shifting the phase of the normal systolic pressure so that this pressure -appears in the aorta at a time when the left ventricle is relaxed. Assuming competence of the normal aortic valve, one then has an increased perfusion pressure available to the coronary arteries. It is believed that such an increase in coronary perfusion, together with a reduction in the elfort required from the heart, should be effective in la number of cases of cardiac insufiiciency.

As may be seen from the above, one important component of circulatory assist systems is a percutaneous connector for permitting the application of fluid pressure to the auxiliary ventricle and electrical connection of the electronic signals provided lby the heart itself to suitable electronic apparatus exterior of the body.

Although the present invention was designed for use with circulatory assist systems as described above, it is to be understood that it is applicable to any application which requires the provision of pulsatile pressure and electrical connections within a living body.

It is therefore a feature of the present invention to provide a percutaneous connector.

Another feature of the present invention is reliability and long life for a percutaneous connector.

Another feature of the present invention is to provide a percutaneous connector for permitting the applicatiton of pressure and electrical connections to the interior of a living body.

A still further feature ofthe present invention is the pro- CII vision of a percutaneous connector for permitting the application of pressure and electrical connections to the interior of a living Ibody which is not only reliable but of minimum size and weight and which can be quickly and simply connected to apparatus external of the body.

A still further feature of the present invention is a percutaneous connector for permitting the application of pressure and electrical connections to the interior of a living body which cannot be easily damaged in use and which cannot be improperly connected to support equipment.

According to the present invention, the foregoing and other objects are obtained by providing a ilexible electrically nonconductive hollow tube having a first end portion adapted to be disposed interior of a living body and a second end portion adapted to be disposed exterior of the body; a plurality of electrical conductors helically emybedded in spaced relationship in the wall of the tube and extending from the extreme end of the second end portion to the rst end portion; metallic coupling means attached to the second end portion of the tube and sealably coupling the tube to a source of pressure and coupling the electrical conductors to electrical apparatus; and electrical connector means carried by and electrically insulated from the coupling means for providing electrical connection with at least some of the electrical conductors embedded in the wall of the tube.

The novel features that are considered characteristic of the invention are set forth in the appended claims; the invention itself, however, both as to its organization and method of operation, together with additional objects and advantages thereof, will :best be understood from the following description of a specific embodiment, when read in conjunction with the accompanying drawings, in which:

FIGURE 1 is a vertical sectional view of a connector in accordance with the invention;

FIGURE 2 is an end view of the metallic coupler shown in FIGURE 1; and

FIGURE 3 is a perspective view partly in cross section of the coupler and an end member adapted to be connected thereto.

Referring now to FIGURE 1, a percutaneous connector generally designated by the numeral 10 in accordance with the invention is shown comprising a ilexible electrically nonconductive tube 11 having a dog-leg like configuration, a plurality of electrical conductors 12, 13 and 14 helically embedded in the wall of the tube, and a metallic coupler 15 more fully described hereinafter sealably attached to the lefthand end of the tube 11 as shown in FIGURE 1 for sealably coupling the tube 11 to a source of pressure (not shown) and coupling the electrical conductors 12-14 to electrical apparatus (also not shown).

Directing attention now to the tube 11, as shown in FIGURE l, it is comprised of a iirst end portion 16 adapted to be disposed interior of a living body, a second end portion 17 adapted to be disposed exterior of the body and a middle portion 18 typically normal to the rst end portion 16 and interconnecting Iboth end portions 16-17. While the angle between the middle portion 18 and the skin in the nal instance will be determined by anatomy and/or medical requirements, this angle should not be a small one. The tube 11 should have a smooth outer surface and be formed of a llexible material which is acceptable to the `body, such as Medical Silastic 372 supplied by Dow Corning Corporation, Midland, Mich. A skirt 23 in the form of mesh consisting of a material also acceptable to the body, such as RM-54. Mersilene mesh supplied by Ethicone Incorporated, Somerville, NJ., is bonded to the middle portion 18 of the tube adjacent the first end portion to permit the percutaneous connector to be internally attached to the body as by suturing and subsequent tissue growth through and around the skirt. A suitable tube may be fabricated in the following manner: A melt-out core having a stainless steel transition piece mounted on one end is bent to the desired configuration. Thereafter, a sheet of uncured Silastic approximately .040 inch thick is wrapped around the core and the enlarged end of the transition piece, all air bubbles are removed and the Silastic then cured as by heating it in boiling water for approximately one-half hour. Thereafter, the electrical conductors are continuously helically wound in spaced relationship one with another on the cured Silastic beginning at the inner portion 16 of the tube and terminating adjacent the transition piece 24. Suitable electrical conductors lmay comprise Helicable Research Electrodes supplied by General Electric Company, X-ray Department, Milwaukee, Wis. The portion of each electrical conductor disposed within the wall of the tube prior to being embedded, preferably is a straight bare wire as the wall of the tube in addition to functioning as a pressure conduit also provides the necessary electrical insulation for these conductors.

As shown by way of example, in FIGURE 1 two electrodes 12-13 and one ground wire 14, all of which may have a diameter of approximately .015 inch, are provided. After the electrical conductors have been wound on and attached at their ends in any suitable manner to the Silastic, a second layer of Silastic is is pressed over and between the wires, all air bubbles removed and the Silastic cured in the manner noted hereinabove. Thereafter, a third layer of Silastic is similarly provided to complete fabrication of the tube. After fabrication of the tube or alternately at the time the third layer of Silastic is cured, the mesh skirt 23 may be bonded to the tube in conventional manner. At this point, the melt-out core is no longer required and may be removed in conventional manner as by heating the tube to the required temperature.

Inasmuch as presently available Silastic does not bond well to metal, it is recommended that the tube be tied on the transition piece as at 25 with Daeron thread to provide increased mechanical strength and to insure the maintenance of a good seal at this point. Upon completion of the tube, the electrical conductors comprising electrodes or the like are connected as by soldering and/or swaging to respectively hollow electrical connectors 26 and 27 carried by the metallic coupler 15 and the ground wire soldered to the coupler itself as at 28. At this time, the transition piece 24 is disposed in and bonded to the passage 33 of the metallic coupler 15. Additionally, for purposes of providing strength and bend relief, the extreme outer portion of the tube adjacent the metallic coupler may have embedded therein mesh material 34 comprised of Daeron or the like. The enlarged end of the transition piece and the reinforcement at this point cooperate to provide bend relief and also prevent the tube 11 from being pinched and thereby prevent the free flow of a suitable gas or fluid in the tube. By Way of example, the tube may have an internal diameter of approximately 3/16 inch, a wall thickness of approximately 1/10 inch, the outer portion may be approximately 31/2 inches long, the middle poriton approximately 2% inches long and the inner portion at least approximately lnch long, its exact length depending on the medical application. For example, if the percutaneous connector 1s to permit the application of pulsatile pressure to pumps such as an auxiliary ventricle or the like, the inner portion 16 may be of sufficient length to permit direct connection to the pump.

The provision of the transition piece 24 is particularly advantageous as it greatly facilitates and simplifies the attachment of the tube and its electrical conductors to the coupler. Further, in the unlikely event of wear or damage to coupler 15, it may be easily removed by breaking the bond between it and the transition piece (and the connectors if they too are bonded in place) and attaching a new coupler to tube 11.

Attention is now directed to the metallic coupler 15. The metallic coupler is preferably fabricated from stainless steel such as 303 or 316 stainless steel. The metallic coupler attached to tube 11 as shown in FIGURE 1 is provided with a cylindrical outer surface 41 and axial passage 33 open at both ends to provide communication through the coupler with the interior of tube 11. It is Significant to note that passage 33 is eccentrically located with respect to the longitudinal axis of the coupler whereby the radial dimensions of the coupler defining the passage 33 (as best shown in FIGURE 2) is greater at one portion 42 than any other portion. Where the percutaneous connector is intended to permit connection to only two electrodes disposed interior of the body, two electrical connectors 26-27 comprising hollow metal tubes of the type used in low-noise type banana plug electrical connectors are disposed in the aforementioned thickest portion 42 of the coupler and electrically insulated therefrom as by sleeves 43-44 of electrically nonconductive material bonded to respectively both the tube connector and the coupler. The electrical connectors 26-27 are preferably located on opposite sides of a plane passing through the longitudinal axis of both the coupler 15 and passage 33. Oppositely disposed axial aligning grooves 45-46 and radial locking grooves 47 are provided and arranged in conventional manner in the outer surface 41 of the coupler. One aligning groove is located nearer to the electrical connectors than the other groove to permit the provision of the locking grooves which of course extend circumferentially in the same direction.

The transition piece 24 which is sealably carried in passage 33 will now be described. To facilitate attachment of the coupler 15 to the tube 11, the transition piece 24 is provided with a shoulder 51, to provide space between the transition piece and the coupler to apply an epoxy bonding material or the like 52 for bonding the transition piece to the coupler.

Attention is particularly directed to the extreme end 0f the transition piece disposed wihin the coupler which is provided with a frusto-conical surface 53 which tapers inwardly and away from the transition piece and joins with a flat end surface 54 normal to the inner surface of the transition piece 24. An annular gasket 55 having a generally triangular shaped cross section and composed of a suitable compressible material is disposed in the groove dened by the frusto-conical surface 53 and the portion of the wall of passage 33 adjacent thereto. The exposed end of the gasket 55 extends slighlty past and at an angle of approximately 45 to end surface 54. It is important that not only gasket 55 provide a pressure seal but that the extreme ends and transition piece 24 and the hollow sliding member 56 (see FIGURE 3) mate one with another to prevent turbulence, whistling and/or extrusion of the gasket past the inner edge of end surface 54.

To facilitate coupling of the percutaneous connector to a source of pressure, a knurled grip ring 57 may be fxedly attached as by screws to the portion of the coupler adjacent the tube. The coupler preferably is sealably connectible to a pressure conduit and further electrical conductors via a cable that can be easily and quickly attached to the coupler in such a manner that the connection cannot be made incorrectly or result in damage to any component. For this purpose and referring now to FIGURE 3, the cable may be provided with a stainless steel end member generally designated by the numeral 61 having a passage 62 and two banana type electrical connectors 64 arranged and adapted to register with respective passage 33 and the electrical connectors 26-27 in the coupler 15. Thus, as shown in FIGURE 3, the end member 61 is provided with an eccentrically located passage 62 coaxial with passage 33 in coupler 15. The end member is counterbored to provide a sleeve portion 65 which slidably fits over coupler 15 and which will not bottom on coupler 15 when the coupler and end member 61 are in operative engagement. Electrical conectors 64 preferably extend past shoulder 66 but terminate within sleeve portion 65. As is the case with the female connectors 26-27, the male electrical connectors 64 are bonded to but electrically insulated from the end member 61 by electrically nonconductive epoxy resin and the like. Sleeve portion 65 is provided with oppositely disposed and inwardly extending lugs 68 arranged and adapted to register with and t into aligning grooves 45-46. A locking sleeve 69 surrounds sleeve 65 and is also provided with oppositely disposed lugs 72 which respectively extend inwardly and through slots 74 in sleeve 65. Slots 74 and lugs 72 maintain locking sleeve 69 in position and permit limited rotation thereof.

Sliding member 56 is provided with substantially the same radial dimensions as transition piece 24 and is slidably carried in passage 62 of the end member 61. Annular lip 75 and spring 76 function `to permit the sliding member 56 to move rearwardly when the coupler and end member are brought into operative engagement. Sliding member 56 is preferably of suicient length to extend past the end of sleeve 65 to further facilitate alignment of the end member 61 with coupler 15. As will be shown from inspection of FIGURE 3, the extension of sliding member 56 past the end of the end member 61 not only facilitates alignment of coupler and end member 61, but prevents damage to the exposed portions of electrical connectors 64. Spring 76 is conveniently held in position by a split ring 77 and bend relief member 78 attached as by screws to the rear surface of end member 61. In addition to holding the split ring 77 in place, the -bend relief member 78 protects the electrical conductors 81-82 disposed therein and holds them in a position which provides clearance for attachment of a pressure conduit (not shown) to the extreme rear end portion of a sliding member 56.

Coupler 15 and end member 61 are simply and quickly brought into operative engagement without danger of damage by rst aligning lugs 68 and 72, inserting the slidable member 56 into passage 33, forcing the coupler 15 and end member 61 together until the locking lugs 72 are aligned with locking grooves 47 and rotating the locking sleeve 69 to lock the coupler 15 and end member 61 together in conventional manner. It will now be seen that the provision of an eccentrically located passage in coupler 15 which receives member 56 is particularly advantageous as it results in the requirement that the coupler and an end member be properly orientated before they can be joined, thereby making it virtually i-mpossible to damage the coupler and, incidentally, end member 61.

While there is shown and described herein certain specific structure embodying the invention, it will be manifest to those skilled in the art that various modications and rearrangements of the parts may be made without departing from the spirit and scope of the underlying inventive concept yand that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claim.

I claim:

1. In apparatus for providing pulsatile pressure and electrical communication within a living body, a percutaneous connector comprising:

(a) a flexible electrically nonconductive and medically inert hollow tube having a first end portion 6 adapted to be disposed interior of the body, a second end portion adapted to be disposed exterior of the body, and a middle portion adapted to be disposed at right angles to the skin through which it passes;

(b) a plurality of electrical conductors helically ernibedded in spaced relationship within the wall of said tube and extending from the extreme end of said second portion along said middle portion to said first portion;

(c) cylindrical metallic coupling means for sealably coupling said tube to a source of pressure and coupling said conductors to electrical apparatus, said coupling means having an eccentrically located axial passage open at both ends and in communication with the interior of said tube;

(d) a transition piece bonded to the extreme end of said second end portion and extending part way into and iixedly attached to said eccentrically located axial passage, the extreme end of said transition piece in said passage being provided with a substantially frusto-conical surface which tapers inwardly and away from said transition piece and a substantially flat surface connecting said frusto-conical surface and the inner surface of said transition piece, said flat surface being substantially normal to said inner surface of said transition piece and said frusto-conical surface forming `a triangular shaped groove with the portion of said passage adjacent thereto;

(/e) compressible sealing means disposed in said groove and extending a short distance past said flat surface;

(f) a skirt of tissue permeable, medically inert -material connected to said middle portion adjacent said first end portion; and

(g) electrical connector means disposed within and electrically insulated from said coupling means for providing electrical connection with respectively at least some of said conductors, said electrical connector means being disposed in the thickest portion of said coupling means defining said passage.

References Cited UNITED STATES PATENTS 872,001 11/1907 Massie 285-174 1,333,342 3/1920 Robertson et al. 285-377 XR 2,602,608 7/ 1952 Darling 339-15 2,865,978 12/1958 Modrey 339-16 2,949,910 8/1960 Brown et al 12S-2.05 3,082,394 3/1963 Hahn et al. 339-16 3,085,219 4/1963 Bass 339-15 3,196,375 7/1965 Jones 128-2.05 XR 3,244,174 4/1966 Wesbey et al 12S-418 3,272,204 9/1966 Artandi et al 12S-334 3,333,045 7/1967 Fisher et al 128-419' XR 3,359,974 12/1967 Khalil 12S-*2.05

RICHARD A. GAUDET, Primary Examiner. KYLE L. HOWELL, Assistant Examiner.

U.S. Cl. X.R. 128-1, 260, 334, 348

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