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Publication numberUS3399677 A
Publication typeGrant
Publication dateSep 3, 1968
Filing dateJul 1, 1966
Priority dateJul 1, 1966
Publication numberUS 3399677 A, US 3399677A, US-A-3399677, US3399677 A, US3399677A
InventorsJoseph C Gould, Myron C Monck, John H Lynch
Original AssigneeGoodrich Co B F
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Catheter and valve therefor
US 3399677 A
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Description  (OCR text may contain errors)

Se t. 3, 1968 J. c. GOULD ET AL 3,399,677

CATHETER AND VALVE THEREFOR Filed July 1. 1966 INVENTORS JOSEPH C. GOULD MYRON C. MONCK JOHN H. LYNCH 3,399,677 CATHETER AND VALVE THEREFOR Joseph C. Gould, Riverton, and Myron C. Monck, Pennsauken, N.J., and John H. Lynch, Norristown, Pa., as-

signors to The B. F. Goodrich Company, New York,

N.Y., a corporation of New York Filed July 1, 1966, Ser. No. 562,357 10 Claims. (Cl. 128349) This invention relates to inflatable bag catheters and pertains more particularly to an inflatable bag catheter provided with an improved catheter valve in the proximal end of the laterally offset inflation arm of the catheter.

Inflatable bag catheters are extensively used in hospitals and by physicians to drain internal body cavities of patients. One of the most frequently used catheters of this kind commonly is referred to as a Foley type inflatable bag catheter and consists of a thin-walled flexible hollow drainage tube provided with one or more lateral openings in its distal end to allow fluid contained in an internal organ into which the catheter is inserted to be drained into the hollow tube and be expelled at the proximal end of the tube which generally is flared to facilitate the insertion of a connector tube, an inflation sleeve (frequently referred to as the retention bag) positioned adjacent to the distal end of the drainage tube that is capable of being inflated into a bulbous shape for retaining the catheter in position within the body cavity after the catheter has been inserted in the patient, a thinwalled inflation tube that connects with the inflatable retention bag and extends to the proximal end of the catheter and terminates exteriorly of the drainage tube at the proximal end of the catheter as a laterally offset inflation arm, and a valve or plug positioned within the mouth of the inflation arm to maintain the mouth of the inflation arm normally sealed while the catheter is in use.

In using the catheter, it is customery to insert the distal end of the catheter into the organ to be drained and thereafter to inflate the inflatable retention bag of the catheter by introducing a required amount of inflating fluid (sterile water normally being used) into the inflation arm, either through use of a hypodermic syringe inserted through the plug in the mouth of the inflation arm (when a plug is used) or by means of a syringe provided with a syringe tip capable of opening the valve in the mouth of the inflation arm (when a valve is employed). When it is desired to remove the catheter from the body of the patient, the inflating fluid which had been introduced into the inflation tube is withdrawn by once more introducing the hypodermic syringe or valveopening syringe into the inflation arm and by withdrawing inflating fluid until the retention bag is deflated sufficiently to allow the catheter to be withdrawn from the patient without undue discomfort.

The use of a hypodermic syringe to inflate the retention bag of a catheter often results in the technician attending to the inflation being jabbed by the hypodermic needle when the needle inadvertently is caused to puncture the side wall of the inflation arm. Consequently, catheters fitted with a valve in the mouth of the inflation arm that can be opened merely by inserting a valveopening syringe into the valve is preferred by many technicians. Various valve constructions for use in such catheters have been proposed and have met with varying degrees of success. On such proposal is described in US. Patent No. 3,131,694.

The present invention concerns an inflatable bag catheter of the general type commonly referred to as a Foley type inflatable bag catheter and is provided with an improved poppet valve construction in the proximal nited States Patent 9 f 3,399,677 Patented Sept. 3, 1968 end of the inflation arm. While the valve construction described in US. Patent No. 3,131,694 functions quite satisfactorily when the technician attending to the inflation of the catheter is careful when initially inserting the valve-opening syringe into the valve so as not to cause the sealing element to rotate while in contact with the valve seat for the sealing element, if the technician is careless and twists the syringe as it is introduced into the valve, the sealing element of the valve is rotated while in contact with the valve seat which frequently causes damage to the sealing element because of the cutting action of the relatively sharp edges of the seat and results in a poor seal upon subsequent use of the valve. The construction of the valve of the present invention is such that rotation of the sealing element against the seat of the valve does not occur even if the technician is negligent and twists the valve-opening syringe as it is being initially introduced into the valve. The valve construction of the present invention also permits a physical locking of the valve-opening syringe with the valve when a Luer locking type syringe is employed so that the technician is relieved of the requirement of holding both the inflation arm of the catheter and the syringe tightly together during the inflation or deflation of the retention bag.

The invention will be more fully understood from the following description of two embodiments of this invention and by referring to the accompanying drawing in which:

FIG. 1 is an elevation view, partly broken away and in section, of an inflatable bag catheter embodying a valve construction of the present invention and showing a valve-opening syringe, partly broken away and in section, positioned for insertion into the valve of the catheter;

FIG. 2 is an elevation view in section of a valve embodying the present invention;

FIG. 3 is a bottom plan view of the valve housing employed in the valve shown in FIG. 2 before the retention lugs are depressed inwardly;

FIG. 4 is a perspective view of the poppet employed in the valve shown in FIG. 2;

FIG. 5 is an elevation view in section of a second embodiment of a valve embodying the present invention; and

FIG. 6 is a perspective view of the poppet employed in the valve shown in FIG. 5.

Referring to FIG. 1 of the drawing, the inflatable bag catheter 10 is comprised of an elongated flexible thinwalled hollow drainage tube 11 flared at its proximal end 12 to facilitate the insertion of a connector tube and rounded at its distal end 13 into a rounded closed tip 14. The distal end 13 of the catheter 10 is provided with one or more lateral openings 15 connecting into the interior of drainage tube 11 to permit fluid in the body cavity being drained to enter the drainage tube 11, travel the length of drainage tube 11 and be expelled through the opening in the proximal end of the drainage tube 11. Adjacent the distal end 13 of the catheter 10 a thin-walled elastic sleeve 16 is adhered along its marginal zones 17, 17 to the exterior surface of drainage tube 11 to form a fluid-tight seal. The central zone 18 of the sleeve 16 is unattached to the drainage tube 11 so that the central zone 18 can be expanded by inflating fluid into a bulbous contour in order to prevent the catheter from becoming inadvertently withdrawn from the patient. A flexible inflation tube 19 is disposed within drainage tube 11 and opens at its distal end into the space formed between the central zone 18 of the sleeve 16 and the adjacent exterior surface of the drainage tube 11. The inflation tube 19 emerges through the Wall of drainage tube 11 in the region adjacent the proximal end 12 of drainage tube 11 and terminates in an inflation arm laterally offset from the proximal end of the drainage tube 11. Valve 21 is provided in the mouth of the inflation arm 20 to maintain the mouth of the inflation arm 20 sealed except when the valve is forced into an open position by the insertion of the tip of the valve-opening syringe 22 into the valve as explained in detailed hereinafter.

One embodiment of a valve 21 constructed in accordance with this invention is shown in FIG. 2 and is identified by the designation 21a. Referring to FIG. 2, valve 21a is comprised of a hollow rigid generally cylindrical shaped valve body 23 which includes an outwardly extending flange 24 at its proximal end. The hollow interior of valve body 23 is comprised of an axial upper bore 25 and an axial lower bore 26 of larger cross-sectional area, the flat shoulder 27 formed at the juncture of the two bores forming a seat against which poppet 28 seats and forms a fluid-tight seal when the valve is in a closed condition. The body 23 may be made of metal, preferably a corrosion-resistant metal such as stainless steel or aluminum, or a rigid plastic material such as nylon. The poppet 28 of valve 21a comprises an upper stem 29 which is generally cylindrical in shape but has a sloping upper face 30 and which when the valve is in a closed condition is slidably housed within the upper bore 25 of valve body 23. The cross-sectional area of upper stem 29 is less than the cross-sectional area of the bore 25 to allow inflating fluid to flow between the stem 29 and the valve body 23. The distal end of stem 29 attaches to a cylindrical-shaped poppet head 31 slidably housed within bore 26 of valve body 23. The upper face 32 of poppet head 31 seats against the flat shoulder 27 of the valve body 23 to provide the desired fluid-tight seal when the valve is in a closed condition. The cross-sectional area of poppet head 31 is less than the cross-sectional area of the bore 26 to allow inflating fluid to flow between the head 31 and the valve body 23 when the valve is in an open condition but is greater than the cross-sectional area of bore 25. A depending stem 33 of the poppet 28 projects into the hollow core of coil spring 34 housed within bore 26 which spring 34 maintains the head 31 of poppet 28 normally seated against the shoulder 27 of valve body 23. The poppet 28 may be constructed as a single unit or may be comprised of several components secured together to form the composite structure. In order to insure the desired fluid seal, the upper face 32 of the poppet 31 desirably is formed of a resilient material such as soft rubber. If desired the entire poppet 28 may be formed of resilient rubber composition, in which case the poppet 28 can be molded conveniently as a unitary structure. The poppet 28 and spring member 34 are retained within bore 26 by lugs 35, 35 formed by depressing inwardly tabs defined by slits 36, 36 provided in the wall of the valve body 23 at its distal end, or, in the alternative, by crimping slightly the edge of the valve body 23 at its distal end.

The perimeter of flange 24 of valve body 23 may be considered to be a square with rounded corners as shown clearly in FIG. 3. The radius of the rounded corners of the flange 24 is such that the largest diametric measurement of flange 24 is sli htly less than the internal diameter of the external wall 37 of the tip 38 of the valveopening syringe 22 so that the external wall 37 of tip 38 of syringe 22 can be slipped over the flange 24. If the tip 38 of the syringe 22 is of the Luer locking type which is provided with a spiral ridge 39 on the internal surface of the external wall 37 of the tip 38, the syringe 22 can be mated with the valve 21a (and thus the catheter) in a locking relationship which relieves the technician from holding both the inflation arm 20 and the syringe 22 during the inflation of the catheter retention bag or during its deflation. The configuration of the perimeter of flange 24 need not be the configuration shown, of course, but may have other configurations such as a circular configuration and still be capable of being mated in a locking relationship with a Luer locking type syringe tip.

In utilizing the catheter 10, the distal end of the catheter is inserted into the body cavity of the patient to a sufficient depth that the retention bag 16 is confined within the body cavity. The inflation of the retention bag 16 is then undertaken by inserting the hollow discharge tube 40 of the syringe tip 38 into the bore 25 of valve 21a (and twisting the syringe 22 to cause the flange 24 of valve 21a to engage with ridge 39 of syringe tip 38 and unite therewith in a locking relationship if a Luer locking type tip is used) to a depth sufficient that tube 40 engages the sloped upper face 30 of poppet 28 and displaces the poppet 28 downwardly toward the distal end of the valve thereby unseating the head 31 of the poppet 28. so that the upper face 32 of head 31 no longer is in contact with the shoulder 27 of the valve body 23. With the valve 21a in this unseated position the valve 21a permits inflating fluid expelled from the syringe 22 to flow within the space between the stem 29 of poppet 28 and valve body 23, into and through the space between the upper face 32 of the head 31 of poppet 28 and the shoulder 27 of valve body 23, into and through the space between the side faces of head 31 of the poppet 28 and the valve body 23, into and through inflation arm 20 and inflation tube 19 and finally into the space between the central portion 18 of retention bag 16 and the exterior surface of drainage tube 11 which flow of inflating fluid causes the retention bag 16 to expand to the desired bulbous shape thereby preventing the catheter from being unintentionally withdrawn from the body cavity. When the desired degree of inflation has been accomplished, the syringe 22 is disengaged from valve 2101. It will be understood that as poppet 28 is moved downwardly by the discharge tube 40 of the syringe tip 38 upon inserting the syringe tip 38 into the valve 21a the downward motion of the poppet 28 causes spring 34 of the valve to be corn-pressed. When the syringe tip 38 is withdrawn from the valve 21a, the compressed spring 34 causes the poppet 28 to move upward until the upper face 32 of the poppet head 31 again seats against shoulder 27 of the valve body 23 and prevents the inflating fluid introduced into the inflation arm of the catheter from escaping. Even when the valve is in a closed condition, the spring 34 desirably is under at least slight compression to hold poppet 28 snugly against the shoulder 27 of the valve body 23. When it is desired to withdraw the catheter from the patient, the syringe tip 38 again is introduced into the valve 21a in order to cause the poppet 28 to be moved downwardly and open the valve 21a. The syringe 22 then is utilized to withdraw inflating fluid from the catheter until the retention bag 16 is deflated sufficiently to allow the catheter to be withdrawn from the patient without undue discomfort.

It has been found that when the upper face 30 of the poppet 28 is a sloping surface (with respect to the longitudinal axis of the valve) the twisting of the syringe 22 upon being inserted into the valve 21a does not have a tendency to rotate the poppet 28. Instead, poppet 28 always is displaced axially. As a consequence, there is no danger of cutting or otherwise damaging the sealing face 32 of the poppet 28 as might occur if the poppet 28 is rotated within the valve body 23 while the sealing face 32 still is in contact with the shoulder 27 of the valve body 23 by twisting the syringe 22 as the syringe tip 38 is introduced into the valve 21a.

The valve 21b shown in FIG. 5 is similar to valve 21a except that the sealing face 41 of poppet 42 of valve 21b is beveled and the shoulder 43 of valve body 44 is beveled with a slant that is complementary to that of the sealing face 41 of poppet 42. The valve 21b also differs from valve 21a in that a cylindrical-shaped opencell resilient sponge member 45 replaces the spring 34 of valve 21a. The poppet 42 of valve 21b (like poppet 28 of valve 21a) is comprised of an upper stem 46 that is generally cylindrical in shape and which is slidably housed in the upper bore 47 of valve body 44 and which is attached at its distal end to a generally cylindrical poppet head 48 that is slidably housed in the lower bore 49 of valve body 44. As is clearly shown in FIG. 6, the poppet stem 46 is provided with a sloping upper face 50 for the reason previously mentioned when discussing valve 21a. The cross-sectional area of poppet stem 46 is smaller than the cross-sectional area of bore 47 of valve body 44 so that inflating fluid can flow between the poppet stem 46 and the wall of the valve body 44 which forms bore 47. Likewise, the cross-sectional area of poppet head 48 is smaller than the cross-sectional area of bore 49 of valve body 44 so that inflation fluid can flow between the poppet head 48 and the wall of the valve body 44 which forms bore 49. The resilient open-cell sponge spring member confined within bore 49 may be made of any resilient open-cell material such as open-cell rubber sponge. It is desirable that an open-cell sponge material be used so that the interconnecting cells of the sponge will allow inflating fluid to flow therethrough during the inflation and deflation of the retention bag of the catheter. If a closed-cell material is used it then would be necessary to provide channels in the spring member 45 which would allow inflating fluid to flow through the member 45. The entire poppet 42 may be made of a resilient material such as soft rubber. If the poppet 42 is not formed entirely of a resilient material, preferably at least the sealing face 41 of the poppet is made of a resilient material such as soft rubber to insure a fluid-tight seal being obtained when face 41 of the poppet engages the beveled shoulder 43 of the valve body 44 when the valve 211) is in a closed condition. The poppet 42 and sponge spring member 45 are retained within bore 49 of the valve body 44 by lugs 51, 51 formed in the manner described above in connection with valve 21a.

In utilizing a catheter provided with valve 21b, the discharge tube 40 of the syringe tip 38 is introduced into the valve 21b in the manner described in connection with valve 21a. The discharge tube 40 bears against the sloping upper face of poppet 42 as the syringe tip 38 is introduced into the valve and causes the poppet 42 to be moved axially downwardly a distance sufficient to break the sealing relationship between the beveled surface 43 of the valve body 44 and the beveled sealing face 41 of the poppet 42 and thereby cause the valve to be in an open condition. lnflating fluid then can be introduced by the syringe 22, the inflating fluid flowing between the stem 46 of the poppet and the wall of valve body 44, into and through the space between the poppet head 48 and the wall of the valve body 44, into and through the sponge spring member 45, into and through the inflation arm 20 and inflation tube 19, and into the space between the retention bag 16 and the adjacent exterior surface of the drainage tube 11 to cause the retention bag to enlarge into the desired bulbous shape. When the desired inflation is obtained, the syringe 22 is withdrawn from the valve 21b. It will be understood that when the poppet 42 is displaced downwardly, the resilient sponge spring member 45 is compressed somewhat. When the syringe 22 is disengaged from the valve 21b, the resiliency of the compressed sponge spring member 45 causes the poppet 42 to move upwardly and return the valve to the closed position. The retention bag 16 is deflated by once again inserting the syringe tip 38 into the valve 21b until the valve is in the open position and withdrawing inflating fluid until the retention bag of the catheter is deflated suflicient to allow the catheter to be removed from the patient without undue discomfort.

While two embodiments of the invention have been described, it will be understood that the scope of the invention is not intended to be limited to these specific embodiments.

We claim:

1. An inflatable bag catheter comprising a flexible drainage tube closed at its distal tip and open at its proximal discharge end, said drainage tube at its distal end having an opening in the side wall of the drainage tube to allow fluid which is to be removed from the body cavity into which the catheter is inserted to enter said drainage tube through said opening and travel the length of said drainage tube and be discharged at the proximal discharge end of the tube, said drainage tube having an inflatable element on the distal end thereof inwardly of said opening in the distal end of said drainage tube, a flexible inflating tube having an outside diameter materially smaller than the internal diameter of said drainage tube, said inflating tube being housed within said drainage tube and opening at its one end into said inflatable element and at its other end passing through the wall of the drainage tube in the proximal end thereof and terminating as a flexible inflation arm laterally off-set from the proximal end of said drainage tube, said inflating tube providing a passage for introducing inflating fluid into said inflatable element and for withdrawing inflating fluid from said inflatable element, and a valve inserted in the proximal open end of said inflation arm for maintaining the proximal end of the inflation arm normally closed, said valve comprising a hollow rigid generally cylindricalshaped valve body which includes an outwardly extending flange at its proximal end intended for engaging in locking relationship a locking type syringe tip, the hollow interior of said valve body being comprised of an axial upper bore and an axial lower bore, said lower bore being of larger cross-sectional area than the cross-sectional area of said upper bore, a poppet housed within said valve body, said poppet being comprised of (1) an upper stem which has a sloping upper face and (2) a poppet head attached to the distal end of said upper stem, said upper stem being slidably housed within said upper bore of said valve body when said valve is in a closed condition and having a cross-sectional area which is less than the cross-sectional area of said upper bore of said valve body to allow inflating fluid to flow between the upper stem and the interior wall of the valve body when the valve is in an open condition, said poppet head being slidably housed Within the lower bore of said valve body and having a cross-sectional area less than the crosssectional area of the lower bore of said valve body to allow inflating fluid to flow between the side walls of the poppet head and the side walls of the lower bore of said valve body when the valve is in an open condition, compressible means housed within the distal end of the lower bore of said valve body for urging the upper face of said poppet head in sealing relationship with the shoulder formed at the juncture of the upper bore with the lower bore of the valve body, and means for retaining said poppet and said compressible means within the hollow interior of said valve body.

2. The inflatable bag catheter of claim 1 in which the said upper face of the poppet head is formed of a resilient rubber composition.

3. The inflatable bag catheter of claim 1 in which the said upper face of the poppet head is beveled and the shoulder formed at the juncture of the upper bore with the lower bore of the valve body is beveled with a slant that is complementary to the bevel of the said upper face of the poppet head.

4. The inflatable bag catheter of claim 1 in which the compressible means housed within the lower bore of the valve body is comprised of a coil spring which is under slight compression when the valve is in a closed condition.

5. The inflatable bag catheter of claim 4 in which the poppet is provided with a depending stem that projects in the hollow core of the said coil spring housed within the lower bore of the valve body.

6. A valve comprising a hollow rigid generally cylindrical-shaped valve body which includes an outwardly extending flange at its proximal end intended for engaging in locking relationship a locking type syringe tip, the hollow interior of said valve body being comprised of an axial upper bore and an axial lower bore, said lower bore being of larger cross-sectional area than the cross-sectional area of said upper bore, a poppet housed within said valve body, said poppet being comprised of (1) an upper stem which has a sloping upper face and (2) a poppet head attached to the distal end of the said upper stern, said upper stem being slidably housed within said upper bore of said valve body when said valve is in a closed condition and having a cross-sectional area which is less than the cross-sectional area of said upper bore of said valve body to allow inflating fluid to flow between the upper stem and the interior wall of the valve body when the valve is in an open condition, said poppet head being slidably housed within the lower bore of said valve body and having a cross-sectional area less than the cross-sectional area of the lower bore of said valve body to allow inflating fluid to flow between the side walls of the poppet head and the side walls of the lower bore of said valve body when the valve is in an open condition, compressible means housed within the lower bore of said valve body for urging the upper face of said poppet head in sealing relationship with the shoulder formed at the juncture of the upper bore with the lower bore of the valve body, and means for retaining said poppet and said compressible means within the hollow interior of said valve body.

7. The valve of claim 6 in which the said upper face of the poppet head is formed of a resilient rubber composition.

8. The valve of claim 6 in which the compressible means housed within the lower bore of the valve body is comprised of a coil spring which is under slight axial compression when the valve is in a closed condition.

9. The valve of claim 8 in which the poppet is provided with a depending stern that projects into the hollow core of the said coil spring housed within the lower bore of the valve body.

10. The valve of claim 6 in which the compressible means housed within the lower bore of the valve body is comprised of an open-cell resilient cellular material which is under slight axial compression when the valve is in a closed condition.

References Cited UNITED STATES PATENTS 1,789,964 1/1931 Buehrer 25l-339 X 3,087,492 4/1963 Garth l28350 3,131,694 5/1964 Garth 128349 3,192,949 7/1965 De See 137--540 3,352,531 11/1967 Kilmarx 251-1496 3,356,093 12/1967 Monahon 128-349 DALTON, L. TRULUCK, Primary Examiner.

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Classifications
U.S. Classification604/99.2, 137/223, 137/903, 604/920, 141/354, 251/149.6, 251/339
International ClassificationA61F2/958
Cooperative ClassificationY10S137/903, A61M25/1018
European ClassificationA61M25/10E