US 3111125 A
Description (OCR text may contain errors)
Nov. 19, 1963 R. R. scHULTE DRAINAGE DEVICE Filed Nov. 6, 1961 United States Patent O 3,111,125 DRAFLNAGE DEJECE Rudolf R. Schutte, 16 Wade Court, Santa Barbara, Calif.
Filed Nov. n, 1962i, Ser. No. 156,272 18 Claims. (Ci. 12S-350) This invention relates to a diaphragm-type pump, and to conduit means which can be associated therewith to form shunt connections with various parts of the human body to relieve one of said parts of undesirable accumulations of uids.
`in the medical iield, there is a standing requirement for small and reliable diaphragm pumps which can be installed in body cavities, and be used for ilushing purposes. As a single example, the ailment known as hydrocephalus involves the complication that fluids which ought to drain away accumulate within the skull where they exert excruciating pressure and sku'll-deforming forces. Draining these iluids by means such as the device shown in United States Patent No. 2,969,066- issued lanuary 24, 1961, relieves the symptoms and frees the individual from the terrible consequences of the iluid accumulation by draining away the i'luid. However, conventional methods of treatment of hydrocephalus by drainage have often utilized components which tended to become obstructed by particulate matter entering the drainage system, or by the backward diffusion of blood into the system.
The difficulties inherent in conventional drainage devices can be cured by providing a flushing pump which is capable of overcoming both the tendencies -to clog and to diiiuse backwardly. Conventional diaphragm pumps are not suitable for this type of pump, because it has been found that sometimes when the diaphragm is pressed down, it will adhere to the wall of the pump cavity and will not spring back. Then the pump itself clogs the drain, and adds to the malfunction which it is provided to obviate. Furthermore, since the pump is not external to the body, but rather is installed under the skin, in order to repair or manipulate it to reopen the same, it is necessary to undergo extensive and careful surgical procedures which ought to be avoided. Furthermore, conventional diaphragm pumps ordinarily utilize ytwo check valves, thereby increasing the complexity of the device.
This invention has as its objective the provision of a diaphragm-type pump which requires only one check valve, which check valve is the one provided on the drain pump anyway, and the sole moving part of which, a diaphragm, is so disposed, arranged and designed that it cannot possibly freeze in any position at all, including the position corresponding to adhesion with the pump cavity wall.
A further object of this invention is to provide a pump together with a cheek tube, which in combination provides means for draining and positively discharging, in unidirectional iiow, accumulated undesired fluids from body cavities.
A diaphragm pump according to this invention includes a body which has a wall defining an internal cavity. A diaphragm extends across this cavity and divides it into a iirst and second chamber. An inlet port extends through the wall and opens into the first chamber, while an outlet port extends through the wall and opens into the second chamber. There is an imperforate area on the diaphragm which is so disposed and arranged as `to be contactible with the inlet port to close it in one of the diaphragm positions and to move away from it to leave the inlet port open in another of the diaphragm positions.
The diaphragm is provided with an open passage therethrough `which is disposed outside the imperforate area and which places the two chambers in constant fluid ICC communication. The wall of the body has a flexible portion in at least one part of the wall which bounds the second chamber so that force can be exerted in the second chamber for moving the imperforate area of the diaphragm to close the inlet port and to pump iiuid out or" both chambers by the force exerted. Fluid from the first chamber passes through the passage in the diaphragm to get into the second chamber, and thence tiows through the outlet por-t.
According to a preferred but optional feature of the invention, a crown surrounds the inlet port inside the first chamber and extends into it in order to prevent the imperforate areas making contact with the wall immediately adjacent to the inlet port where it might occasionally occur that a reverse pressure, combined with surface adhesion properties, could tend to hold the diaphragm firmly and permanently against the wall, thereby requiring the removal and replacement of the pump.
According to another preferred but optional feature of the invention, a check tube is connected to the outlet port of the diaphragm pump to provide for a uid conduit system for accomplishing the objectives of the invention.
IWhile the device of the invention may be made of any one of a number of conventional materials, it is preferably made of silicon rubber. Such a material provides the necessary transparency and flexibility of the structure, while being a material which is essentially inert to the body iiuids.
The invention may be more readily understood by referring to the accompanying drawings in which:
FIGURE l is a pictorial representation of a small child, illustrating the placement of the apparatus according to the invention;
FIGURE 2 is an exploded perspective view of a diaphragm pump of the present invention;
`FIGURE 3 is a sectional View of the device of FIG. 2 as disposed in use;
FEGURE 4 is a sectional view of the diaphragm pump of this invention in use and being flushed by an attendant; and
FIGURE 5 is a partial sectional view of the check tube termination of the apparatus illustrating the disposition of the outlet slits.
Referring now to FIG. 1, there is shown a small child lil having a head and a heart, between which is disposed a ventrculo-atrial shunt apparatus 11. The ventrculoatrial shunt apparatus .11 includes an inlet tube 12 shown in dotted lines, extending from a pump 13I into the cranial cavity of the head, and an outlet tube 14 (sometimes herein called a check tube) extending between the valve 13 and the atrium portion of the heart, through the childs jugular vein 15. rhe pump 13 is held in place in a small burr hole (not shown) in the skull of the child by means of a tlap of skin sho-wn as sewn in place by stitches.
In FIG. 2 the pump 13 is seen to consist of an upper member 16 and a lower member 17, within which is disposed a perforate diaphragm 1S having apertures 19' extending therethrough. A tube or conduit forms an outlet port Zd and fits between a irst recess 21 in the lower member and a second recess 21 in the upper member. The lower member 17 has an inlet conduit 22 extending thereinto about the opening of which is formed a shoulder 23.
The central portions of the lower surface of uppermember 16 and of the upper surface of lower member 17 form a wall defining a cavity therein. The diaphragm divides the cavity into a iirst and a second chamber. The first chamber is formed between the diaphragm and that portion of the wall formed by lower member 17. The second chamber is formed between the diaphragm and that portion of the wal'l formed by upper member 16.
animas At least a portion of one of these walls is exible, and in the embodiment illustrated, a portion of the wall bounding the second chamber is more ilexible than that bounding the iirst chamber. Inlet port 24 (sometimes called inlet conduit opening) opens into the rst chamber at a central location. Apertures 19 (sometimes herein called passages) are laterally placed relative to the inlet port so that they do not overlay it. This leaves a central imperforate diaphragm area which can move down to close the inlet port.
Referring now to FIG. 3, there is shown the pump 1.3 in place in the human body. The upper and lower members 16 and 17 may be held together by Iany conventional adhesive means so as to fonm the capsular enclosure therebetween. The pump has been inserted in a burr hole, indicated generally at Sil, which has been cut through the skull bone 31 of the child. A flap of skin 32 overlies the apparatus.
As shown, the members 16 and 17 are curved in configuration so as to form a hollow enclosure within which the diaphragm `1S is disposed. It will be noted that the diaphragm 18 is held in position by -means of an inner projecting ring 35 formed in the lower member 17. O-f course, if desired, the ring 35 can be formed in the upper member 16. The pump 13 has an outer peripheral ilange portion 36 formed by both the upper and lower members 16 and 17, which assists in holding the device in position by providing la portion through which ligatures may be threaded and sewn into the surrounding ilesh.
The burr hole 36 is filled with body fluid 3,8, which is not the uid of interest in the treatment of hydrocephalus.
VThe cerebral spinal Ifluid (not shown) is drained from the cranial cavity, enters the inlet tube 12 (see FIG. 1), and passes through the inlet conduit -22 into the portion of the pump 13 beneath the diaphragm 18 as shown by the arrows. Due to the slight pressure dilferential existing between the cranial cavity and heart, the fluid then passes through the apertures I19 in the perforate diaphragm 18 and into the upper portion of the enclosure. The Huid may then pass through the outlet port 2t) and into the check tube .1 through a connector 39, to which the conduit iil and check tube '15 are tied by ligatures 40, for example. The conduit 22 is similarly connected to the tube 12.
In FIG. 4, the device of FIG. 3 is shown while being hushed. Flushing is accomplished by pressure, as by a linger 41, upon the upper portion of the enclosure 13. Since ythe pump 13 is filled with lluid, this pressure forces the diaphragm 1-8 against the raised shoulder 23 (sometimes called a crown) surrounding the inlet conduit 22 so as to close the inlet conduit opening 24. This increased pressure is applied therefore only to the fluid already within the enclosure Iand in the outlet tube. This fluid is then forced through the outlet tube and out of the openings therein so as to clean out any particulate material or blood which may be in the outlet tube causing blockage.
In FIG. 5 the termination `and slit valve of the check tube 1'4 lare shown. It lwill be seen that the termination consists of a solid tapered portion yl5 and the slit valve of a plurality of slits 46 (three being shown in FIG. 5). These slits are preferably about one-sixteenth inch in length, and four of them are formed in the tubing in the preferred embodiment by cutting the slits in the tubing `without removing any material therefrom. The use of such a multiple slit valve in the outlet tube permits cerebral spinal fluid to llow `freely when the pressure in the tube exceeds six to ten centimeters of water, while remaining closed at a lower pressure. This structure also reduces t-he tendency of blood to diifuse into the outlet end and cause its obstruction. The operation of the outlet slit valve structure is readily checked by filling the outlet tube with sterile physiological saline solution, while holding the tube in vertical position. In a period of from thirty to sixty seconds, the height of iiuid in the l outlet tube should diminish to six to ten centimeters from the top of the slit valve.
The tubing itself is conventional tubing of preferably one-sixteenth inch in diameter and one-sixtyafourth inch wall thickness. The capsular enclosure is comparatively small so as to iit in a burr hole of sixteen to eighteen millimeters diameter, the iiange extending out over the edges of the hole so as to overlie the surrounding skull. The enclosure may have a Wall thickness, for example, of one-thirty-second of an inch. The diaphragm at its central portion is preferably from three to ve thousandths of an inch in thickness in order to provide the requisite flexibility. The silicon rubber is comparatively flexible so as to permit 'facile ilushing of the device, as has been previously described.
The surgical technique for utilization of the apparatus will now be described. Two incisions are required; a small scalp flap in the posterior temporal region and a diagonal incision crossing the anterior edge of the sternomastoid muscle lat the angle of the jaw. The posterior temporal burr hole is located in a manner Ithat allows the tube to curve gently without kinking as it emerges from the lateral `ventricle and passes subcautaneously into the neck.
A standard trephine opening, sixteen to eighteen millimeters in diameter, is made. The dura is incised in a cruci-ate manner. A ventricular cannula is passed into the lateral ventricle and immediately withdrawn so that only a minimal amount of cerebrospinal fluid escapes. The ventricular component of the shunt is then immediately inserted into the cannula tract and directed into the lateral ventricle. At least five centimeters to eight centimeters of the tube should lie within the lateral ventricle. A small amount of cerebrospinal fluid is permitted to escape from the tube. This maneuver assures the operator that the fluid is clear and colorless, and that the tube is unobstructed by brain fragments. This tube is then occlvuded with a small bulldog clamp, applied just beyond the point of emergence ffrom the dura. Every effort should be made to prevent the loss of centricular lluid so that when the ends of the shunt are joined it will be set in operation by a satisfactory pressure. The dura is closed tightly 4around the tube with non-absorbable sutures.
The incision in the neck is made at the point overlying the entrance of the common facial vein into the internal jugular vein. This vein enters the jugular vein on its mesial aspect at the level of the hyoid bone. Even in young infants this vessel is sufciently large to permit passage of the cardiac end of the shunt. The common facial vein is preferred, but when its use is not practical, a similar vein or even the internal jugular vein may be used. 'After dissecting the vein free of the surrounding tissue, two 3 0 silk ligatures are placed beneath it. At this point, the cardiac segment of the shunt is prepared for insertion. The distance from the suprasternal notch up to the point at which the tube will enter the jugular vein is added to the pre-operative measurement from the suprasternal notch to the fifth and sixth dorsal vertebral interspace. This distance is marked on the tube by tying a ligature around it, care being taken not to occlude the lumen of the tube. The tube is then filled With physiological saline leaving the syringe attached to it. The common yfacial vein is then stretched between the two ligatures and incised with the iris scissors. While the slit is held open with fine mouse-tooth forceps held by the surgeon and his assistant, the tapered end of the tube containing the valve is passed into the lumen and directed down the internal jugular vein into the right atrium. The tip of the tube should be located in the right atrium `at the level of the fifth or sixth dorsal 'vertebral bodies. The ligature on the common `facial vein proximal to the jugular vein is relaxed as the tube passes this point. Since this tube completely iills the lumen of the vessel, there is no danger of air embolism. Two
milliliters of contrast medium (Renografin, Hypaque) are then injected into the tube, and an X-ray is made. Adjustments in the position of the valve in the right atrium can now be made, depending on the indication of the X-ray film. When properly located, the ligature surrounding the common facial Vein containing the shunt is tied snugly but not so tightly as to occlude the tube. The other ligature on the common facial vein is tied tightly and the vessel is divided. The contrast medium is then flushed from the tube with physiological saline.
The final step is the attachment of the ventricular and cardiac tube to the diaphragm pump. Care should be taken not to puncture the capsule while placing securing ligatures through the flange. These ligatures are used to fasten the flange to either the skull or pericranium. The operation of the fiushing device should be checked before closing the wounds.
The invention claimed is:
`1. A diaphragm pump for use in draining fiuid from one portion of a human body and transferring it to another portion of the body comprising a capsular enclosure, at least the upper portion of which is iiexible, an outlet conduit formed in the upper portion of the enclosure and opening thereinto, an inlet conduit formed in the lower portion of the enclosure and opening thereinto, a raised shoulder formed on the inner surface of the lower portion about the inlet opening, a iiexible diaphragm disposed within the enclosure, and means holding the diaphragm within the enclosure so as to separate the upper portion from the lower portion thereof, said diaphragm having an aperture extending therethrough, said aperture being disposed so as to be out of alignment with the inlet opening.
2. Fluid-conducting shunt apparatus comprising an inlet tube, an outlet tube, a capsular enclosure of fiexible material, a diaphragm disposed within the capsular enclosure and held therewithin, an outlet conduit extending through the enclosure and opening onto one side of the diaphragm, an inlet conduit extending through the enclosure and opening onto the other side of the diaphragm, a raised shoulder formed on the inner surface of the enclosure about the inlet conduit opening, said diaphragm having an aperture extending therethrough and disposed so as to be out of alignment with the inlet conduit opening, an imperforate region on said diaphragm in alignment with the inlet conduit opening adapted to close said opening in one position of the diaphragm, means connecting the outlet conduit to the outlet tube so as to form a fluid conduit therethrough, and means connecting `the inlet conduit to the inlet tube so as to form a iiuid conduit therethrough.
3. Apparatus according to claim 2 in which the outlet tube termination remote from the enclosure is a solid tapered end and has a plurality of longitudinally disposed outlet slits formed therein adjacent the solid end.
4. Apparatus according to claim 3 in which the enclosure and diaphragm are made of silicone rubber,
5. A diaphragm pump comprising: a body having a wall defining an internal cavity; a diaphragm extending across the cavity and dividing it into a rst and a second chamber; an iniet port through the wall opening into the first chamber; an outlet portion through the wall opening into the second chamber; an imperforate area on the diaphragm so disposed and arranged as to be contactable with the inlet port to close it in one diaphragm position, and to move away from it to leave the inlet port open in another diaphragm position, the diaphragm also having an open passage therethrough disposed outside the imperforate area and placing the two chambers in constant fluid communication; and a iiexible portion in at least part of the wall which bounds the second chamber, whereby force applied externally to the flexible portion moves the imperforate area to close the inlet port and applies pressure to expel fluid through lthe outlet port, fluid from the first chamber flowing into the second chamber through the passage, `and from the second chamber into the outlet port, release of the flexible wall portion enabling the diaphragm to move away from the inlet port, the diaphragm pump then permitting substantially unimpeded passage of Huid from inlet port to outlet port through the passage in the diaphragm.
6. A diaphragm pump according to claim 5 in which the wall of one of the chambers is less liexible than the wall of the other chamber.
7. A diaphragm pump according to claim 5 in which a crown surrounds the inlet port inside the first chamber and extends into the first chamber to prevent the imperforate areas making contact fwith the wall immediately adjacent to the inlet port.
8. A diaphragm pump according to claim 7 in which the pump in plan view is generally symmetrical around an axis, with the inlet port, imperforate area, and flexible wall portion centered on said axis, and with the outlet port at one side thereof.
9. A diaphragm pump according to claim 8 in lwhich a peripheral installation flange is attached to the body.
10. A diaplnagm pump comprising: a body having a wall defining an internal cavity; an internal flange extending peripherally around `the wall; a diaphragm retained by the internal flange and extending across the cavity to divide it into a first and a second chamber, a flexible, imperforate diaphragm area at a medial region of the diaphragm, and a heavier-sectioned reinforcing bead portion `surrounding said iiexible area and joining to the wall at the internal flange, said diaphragm also having an open passage therethrough which places the two chambers in constant fluid communication; an inlet p-ort through the wall opening into the first chamber; an outlet port opening through the wall into the second chamber, at least a part of the imperforate diaphragm area being so disposed and arranged as to be contactible with the inlet port to close it in one diaphragm position, and to move away from it to leave the inlet port open in another diaphragm position, the passage lying outside the imperforate diaphragm area; and a flexible portion in at least part of the wall which bounds the second chamber, whereby force applied externally to the flexible portion moves the imperforate area to close the inlet port and applies pressure to expel fluid through the outlet port, fluid owing from the first chamber into the second chamber through 'the passage, and from the second chamber into the outlet port, release of the flexible rwall portion enabling the diaphragm to move away from the inlet port, the diaphragm pump `then permitting substantially unimpeded passage of fluid from inlet port to outlet port through the passage in the diaphragm.
11. A diaphragm pump according to claim 10 in which the wall of one of the chambers is less flexible than the wall of the other chamber.
l2. A diaphragm pump according to claim 11 in which the less flexible wall is that of the first chamber.
13. A diaphragm pump according to claim 10 in which a crown surrrounds the inlet port inside the first chamber and extends into the first chamber to prevent the imperforate areas making contact with the wall immediately adjacent to the inlet port.
14. A diaphragm pump according to claim 13 in which the pump in plan View is generally symmetrical around an axis, with `the inlet port, imperforate area, and fiexible wall portion centered on said axis, and with the outlet port at one side thereof.
15. A diaphragm pump according to claim 14 in which a peripheral installation fiange is attached to the body.
16. In combination: a drain tube having openings to admit fluid thereto; a check tube having unidirectional liow check means for permitting flow only in a first direction; a diaphragm pump comprising: a body having a wall defining an internal cavity; a diaphragm extending across the cavity and dividing it into a first and second chamber; an inlet port through the wall opening into the irst chamber; an outlet port through the wall opening into the second chamber; an imperforate area on the diaphragm so disposed and arranged as to be contactible with the inlet port to close it in one diaphragm position, and to move away from it to leave the inlet port lopen in another diaphragm position, the diaphragm also having an open passage therethrough disposed outside the imperforate area and placing the two chambers in constant fluid communication; and a iiexible portion in at least part of `the wall which bounds the second chamber, whereby force applied externally to the flexible portion moves the imperforate area to close the inlet port and applies pressure to expel fluid through the outlet port, fluid flowing from the rst chamber into the second charmber through the passage, and from the second chamber into the outlet port, release of the flexible wall portion enabling the diaphragm to morve away from the inlet port, the diaphragm permitting substantially unimpeded passage of fluid from inlet port to outlet port through the passage; said drain tube being connected to the inlet port, and the check tube being connected to the outlet port with said iirst ow direction being away from the outlet port, whereby steady drainage from the drain tube through the pump and out the check tube is possible through the diaphragm passage, and pumped flow in the same direction is causable by exerting force on the llexible wall portion.
17. A combination according to claim 16 in which a crown surrounds the inlet port inside the first chamber and extends into the -rst chamber to prevent the imperforate areas making contact with the wall immediately adjacent to the inlet port.
18. A combination according to claim 16 in which the wall of the `first chamber is less iiexible than the wall of the second chamber.
References Cited in the le of this patent UNITED STATES PATENTS 2,758,609 Dickert et a1 Aug. 14, 1956 20 2,867,213 Thomas Jan. 6, 1959 2,969,066 Holter et al Ian. 24, 1961