US 3310051 A
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arch 21, 1967 R. R. SCHULTE 3,31%051 SURGICAL RESERVOIR FOR IMPLANTATION BENEATH THE SKIN Filed Dec. 10, 1963 SCALP-// rfmaw United States Patent 3,310,051 SURGICAL RESERVGIR FOR Iii PLANTATION BENEATH THE SKIN Rudolf R. Schulte, 3328 Calle Fresno, Santa Barbara, Calif. 93185 Filed Dec. 10, 1963, Ser. No. 329,443 2 Claims. (Cl. 128-216) This invention relates to a surgical implant which provides a reservoir located conveniently to the skin of a person which may be utilized to introduce, withdraw, or mix fluids in regions located farther inside the body.
There are numerous instances Where repetitive samplings of body fluids need to be made, or in which repetitive introductions or medication must be made to interior regions. An example i the repetitive sampling of cerebro-spinal fluid, and vthe introduction of medication thereto, such as in the treatment of cryptococcal meningitis or tubercular meningitis. Medication for these diseases is often only marginally effective if given intravenously, because in order to supply the concentration needed at the situs of the ailment, the total dosage in the body would have to be too high. In fact, these diseases have been unmanageable with intravenous injections principally for this reason. However, if the medications are injected at the situs of the ailment, the local concentration can be made high enough to be effective, and the diseases may be controlled, even though the total dosage in the body is relatively low.
A concurrent problem associated with the foregoing is that concentration levels need to be maintained at the situs over a protracted period of time. To make repeated injections by means of repetitive punctures is obviously undesirable, and in many regions of the body soon becomes impossible. One reason is that fibrosis develops around t-he multiple needle tracks and renders access increasingly diflicult, particularly in the brain. Furthermore, repeated punctures of the brain are inherently undesirable. While the examples given in this specification relate to treatment of regions within the skull, clearly the same criteria apply to ailments in other regions of the body.
It is an object of this invention to provide a device which, once installed, gives continuous access to internal regions of the body without requiring additional needle penetrations into these regions. Instead, a tubular portion of the device remains in the body and extends to the affected area where it serves as a continuously-available conduit placed there but once. Thereafter, a syringe or other device need only be placed in fluid communication with this conduit to inject, Withdraw or mix fluids in the interior region.
Still another object of the invention is to provide a mixing or flushing reservoir into which fluids may readily be injected or from which they may readily be withdrawn. An optional object is to provide such a reservoir which may also serve to provide surge-generatiug means of flush and mix fluids in it and in the region under treatment.
A device according to this invention comprises a tube having a central passage, the tube being adapted to be inserted in to the body so that its passage communicates with a selected region therein. A capsule is adapted to be connected to this tube and to be placed beneath the skin of the body. This capsule comprises an enclosure which has an internal periphery and a first and second wall, these walls facing each other inside the capsule. The wall next to the skin is tolerant to, and self-sealing after, needle puncture. One of the walls has a passage therethrough in fluid communication with the passage through the tube.
According to a preferred but optional feature of the invention, one of the walls is flexible and palpable through the skin by force exerted by the hand. The material of the flexible wall is flexible enough to be moved toward the other wall and thereby reduce the volume of the capsule and also sufficiently springy to return to its normal unstressed condition, thereby providing for pumping means to create bi-directional flow in the passages for mixing purposes.
The above and other features of this invention will be fully understood from the following detailed description and the accompanying drawings in which:
FIG. 1 is a cross-section of a portion of a skull, showing the device of the invention, partly in cutaway crosssection and in its normal, unstressed condition;
FIG. 2 is a top view of the invention, partly in cutaway cross-section;
FIG. 3 is a bottom view of the device taken at line 33 of FIG. 1; and
FIG. 4 is a fragmentary cross-section of a portion of FIG. 1, showing the device in another of its conditions.
FIG. 1 illustrates a skull 10, showing the scalp 11 and the bone 12 of the skull surrounding the brain 13. The drawing of the anotomical portions is simplified because these form no portion of the present invention. It will be noted that the device is installed within a burr hole 14 having an internal wall 15 in the bone of the skull, and is held beneath the skin of the scalp by means of a sutured slit 16.
The reservoir elements 20 comprising the invention includes a tube 21 having a central passage 22 and a closed end 23. Perforations 24 through the wall provide for fluid communication between the passage and the outside of the tube. The tube is connected to a capsule 25 by means of a connector 26, which connector is attached to a passage extension 27 which has a passage 28 that enters the capsule itself through one wall thereof. The capsule has a boss 29 which fits within burr hole 14 and provides for lateral restraint of the device. The capsule outward of the boss rests on the skull so as to give longitudinal restraint.
The capsule is a continuou enclosure and includes a circumferential periphery defined by circumferential edge 30. First and second interior walls 31, 32 are provided on opposite sides of the periphery. The first wall lies closer to the skull, and includes an interior crown 33 which surrounds the opening 34 of passage 28 into the interior of the capsule. The crown has a plurality of notches 35 formed therein.
Second wall 32 is generally domed and has a central section which is thicker than the edges. This wall is flexible and, as best shown in FIG. 4, is adapted to be palpated by finger pressure through the scalp to move it toward the first wall, thereby reducing the volume of the capsule. In order to prevent the first and second walls from adhering to each other and closing the passages, the crown is provided to hold them apart. However, the notches provide for fluid flow past the crown to the passage even when the second wall is pressed against the crown.
The entire structure is, of course, made of material which is compatible with the human tissue with which it comes in contact. A convenient substance is silicone rubber manufactured by Dow Corning Company, of Midland, Mich. The thickness of the second wall is selected such that it is springy enough to restore itself to its normal, unstressed condition shown in FIG. 1, and yet sufliciently flexible that it can be deflected to the configuration shown in FIG. 4. It is also tolerant to repetitive needle punctures (with a resonable number), because, as best shown in FIG. 1, material may be in- 3 jected from a hypodermic syringe 36 by puncturing the scalp and the second wall with the needle. When the needle is withdrawn, the material of the second wall will seal the opening made by the needle.
The use of the device should be evident from the foregoing. If it is desired either to withdraw fluid from region 37 within the brain or to introduce medication thereto, the tube will be forced into this region by means well known in the surgical arts. Once in place, this tube is connected to the capsule, and the capsule is placed in position as shown, and the scalp sutured over the capsule. The capsule is filled with fluid, which, after a time, will be identical with fluid in the region under study, particularly if the device is pumped for a while, either by depressing the second wall or by pumping with a syringe. The fluid may be withdrawn for sampling by a hypodermic syringe. Also, medication may be introduced to the region by a syringe as shown, mixing being attained either by depressing the second wall or by pumping with the syringe.
It will thereby be seen that this device provides a reservoir of fluid which in effect is an extension of a region under treatment or study. Only one puncture of the brain or other region is necessary because the tube remains in place for sensible periods of time to provide a continuously-available conduit to the region, and the dome i available for introduction and withdrawal of material even were the second wall to be too stifl to flex. On the other hand, should the device be made flexible enough for this purpose, then even better results may be attained as a result of the more complete bi-directional flow attainable thereby.
This invention is not to be limited by the embodiment shown in the drawings and described in the description which is given by way of example and not of limitation, but only in accordance with the scope of the appended claims.
1. A reservoir element for implantation in a human being comprising: a tube having a central passage and adapted to be inserted into the body so that its passage communicates with a selected region to be treated; and
a capsule of a size to be placed beneath the skin so as to rest between the skin and the bony structure of the body, said capsule comprising an envelope having an in ner cavity bounded by a first and a second wall, the first wall being adapted to lay on surface to surface contact with said bony structure, the second wall being domed and springily flexible so as to be deformable and movable toward the first wall so as to reduce the volume of the cavity as the result of external force thereon, and to return to its dome shape of its own accord when the force is removed, there being a passage through said first wall connected to the passage in the tube, and a crown formed inside the cavity around the entrance of the passage thereinto, said cr-own having notches thereon, whereby the walls are prevented from adhering to each other and also from shutting off flow through the passage when the capsule is compressed, the second wall being made of material which permits puncture by a needle and is self-sealing after the needle is withdrawn.
2. A reservoir element according to claim 1 in which a boss surrounds the capsule passage on the outside surface of the first wall, whereby to fit in a hole in the said bony structure and thereby to provide lateral positioning support for the capsule.
References Cited by the Examiner UNITED STATES PATENTS 513,238 1/1894 Lalonde 128-126 3,021,842 2/1962 Flood 128215 3,111,125 11/1963 Schulte 128350 3,144,866 8/1964 Ellis 128232 3,154,074 10/1964 Harrison l28232 FOREIGN PATENTS 790,220 2/ 1958 Great Britain.
OTHER REFERENCES Lancet, vol 2 (63), No. 7315, Nov. 9, 1963, pp. 983-84.
RICHARD A. GAUDET, Primary Examiner.
DALTON L, TRULUCK, Examiner.
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