A pump/valve unit for controlling the inflation and deflation of a urethral collar in a prosthetic urinary sphincter device is described. A compressible bulb pump defining a reservoir was integrated with a valve unit for implantation. The valve unit includes a movable valve member operable by depression of a flexible portion of the valve unit housing for controlling fluid flow between the reservoir and collar; and a pressure sensing means which operates the valve member to relieve an excess pressure in the collar should too much pressure be applied by the patient

Helms, C. R.

Smyly, H. M.

English

NASA Technical Reports Server

11 11 4,256,093 
[45] Mar. 17, 8981 
[54] ~ ~ ~ $ ~ ~ E ~ ~  URINARY SPHINCTER 
[75] Inventors: 
[73] Assignee: 
[21] Appl. No.: 
[22] Filed: 
Curtis R. Helms; Harold M. Smyly, 
both of Huntsville, Ala. 
The United States of America as 
represented by the Administrator of 
the National Aeronautics and Space 
Administration, Washington, D.C. 
950,877 
Oct. 12, 1978 
[51] Tnt. Cl.3 ......................... A61B 19/00; A61F 1/00 
[52] U.S. CP. .................................... 128/1 R; 128/346; 
128/DIG. 25; 137/493 
137/493 
[58] Field of Search ............... 128/1 R, 346, DIG. 25; 
1561 Refeiences Cited 
U.S. PATENT DOCUMENTS 
2,455,859 12/1948 Foley ................................... 128/346 
2,533,924 12/1950 Foley ................................... 128/346 
3,854,469 12/1974 Giori et al. .......................... 128/1 R 
3,863,622 2/1975 Buuck .................................. 128/1 R 
4,061,882 12/1977 Johnson et al. ............... 128/349 BV 
4,167,952 9/1979 Reinicke .......................... 128/1 R X 
OTHER PUBLICATIONS 
Timm et a1.-IEEE Transact. Bio-Med. Engr., Oct. 
1970, p. 352. 
Primary Examiner-Dalton L. Truluck 
Attorney, Agent, or Firm-J. H. Beumer; J. R. Manning; 
L. D. Wofford, Jr. 
[571 ABSTRACT 
A pump/valve unit for controlling the inflation and 
deflation of a urethral collar in a prosthetic urinary 
sphincter device is disclosed including a compressible 
bulb pump defining a reservoir made integral with a 
valve unit for implant wherein the valve unit includes a 
movable valve member operable by depression of a 
flexible portion of the valve unit housing for controlling 
fluid flow between the reservoir and collar and a pres- 
sure sensing means which operates the valve member to 
relieve an excess pressure in the collar should too much 
pressure be applied by the patient. 
4 Claims, 4 Drawing Figures 
https://ntrs.nasa.gov/search.jsp?R=19810017124 2020-03-21T09:54:32+00:00Z
Mar. 17, 1981 4,256,O 
A 
1 
4,256,093 
I 
P R O S W m C  URINARY SPHINCTER 
ORIGIN O F  THE INVENTION 
The invention described herein was made by employ- 
ees of the United States Government and may be manu- 
factured and used by or for the Government for govern- 
mental purposes without the payment of any royalties 
thereon or therefor. 
BACKGROUND OF THE INVENTION 
The invention relates to a prosthetic urinary sphinc- 
ter device for controlling the bladder function in the 
situation where a person has lost bladder control. Im- 
plantable devices have been used before for controlling 
the bladder functions such as shown in U.S. Pat. No. 
3,863,622 which typically include an inflatable cuff 
surrounding the urethric tube, an inflating pump con- 
nected to the cuff for pressurizing the cuff, and a sepa- 
rate deflating pump for removing fluid from the cuff 
enabling relief of the bladder. A reservoir containing a 
suitable fluid solution such as a saline solution is con- 
nected to the inflating and deflating pumps and check 
valves are used to control the flow direction. However, 
this device is not used in extensive application due to 
the frequent failure of the device and the extensive 
surgery required for implanting the device, the failure 
rate being caused primarily by the pump structure and 
the existence of numerous check valves in the fluid 
lines. A similar device is shown in U.S. Pat. No. 
3,744,063 including separate inflating and deflation 
pumps wherein the pumps and valves are arranged so 
that the inflation and deflation are carried out in incre- 
mental steps whereby pressure is graduated and con- 
trolled. 
U.S. Pat. Nos. 3,903,894 and 3,854,469 disclose other 
implantable devices utilizing bulb reservoirs and flap 
and slit valves, respectively, which are simple requiring 
minimum surgery but which do not afford highly accu- 
rate pressure control and relief. 
U.S. Pat. Nos. 2,455,859 and 2,533,924 typlify a sec- 
ond type of artificial sphincter device for controlling 
urinary incontinence in which the device for control- 
ling inflation of the urethral cuff is not implanted, thus 
permitting a more conventional construction. 
Accordingly, an important object of the present in- 
vention is to provide a prosthetic sphincter device for 
controlling urinary incontinence which is reliable and 
does not require replacement following implant. 
Another important object is a simplified device 
whose implant requires a minimum amount of surgery. 
Still another important object of the present inven- 
tion is to provide a prosthetic sphincter device which 
has an improved pumphalve unit for controlling pres- 
surization of the urethral collar. 
Yet another important object is the provision of a 
prosthetic urinary sphincter device having automatic 
and highly accurate relief of an excess pressure exerted 
on the urethra due to over pressurization by the user 
avoiding tissue damage thereto. 
SUMMARY O F  THE INVENTION 
The invention provides a novel unitary press bulb 
pumphalve device which eliminates the use of two 
pumps. The device includes a press bulb which acts as a 
reservoir for containing the fluid and an integral valve 
unit for controlling the flow direction and manual relief 
for patient urination. The device further includes a 
relief feature for controlling the maximum pressure 
exerted by the urethral collar against the urethra. 
BRIEF DESCRIPTION OF THE DRAWING 
The construction designed to carry out the invention 
will be hereinafter described, together with other fea- 
tures thereof. 
The invention will be more readily understood from 
a reading of the following specification and by refer- 
10 ence to the accompanying drawing forming a part 
thereof, wherein an example of the invention is shown 
and wherein: 
FIG. 1 is an elevation illustrating the implant of a 
prosthetic sphincter device according to the invention; 
FIG. 2 is an elevation of a pump/valve unit con- 
structed according to the invention for inflating and 
deflating a urethral collar of a prosthetic sphincter de- 
vice; 
FIG. 3 is a top plan view of the device of FIG. 2; and 
FIG. 4 is an enlarged elevation in cutaway form illus- 
trating in detail a pump/valve unit constructed in accor- 
dance with the invention. 
DESCRIPTION O F  A PREFERRED 
5 
15 
2o 
25 EMBODIMENT 
The drawing illustrates a device, designated gener- 
ally as A, for pressurizing and relieving the collar B, of 
a urinary prosthetic sphincter device. The device in- 
3o cludes a compressible bulbous pump means C, having a 
press bulb 10 made from a soft synthetic material such 
as a silicon elastomer which provides a reservoir for a 
suitable fluid solution which is used as a pressurizing 
fluid, such as a saline solution and an integral valve unit 
35 D, having a housing 12 which encloses the components 
thereof. The housing 12 is illustrated as being cylindri- 
cal in shape consisting of a cap portion 13 and a base 
portion 14 received within a flange portion 13a of the 
cap which may be bonded or welded. The reservoir 
4o bulb material 10 is made integral with the housing 12 
preferably by bonding at loa and 10b by any suitable 
bonding agent which is biocompatible. The cap 13 in- 
cludes a bulb fitting 16 and boss 18 providing a fluid 
port for interfacing with the pressurization tubing 19 
45 connected to the urethral collar B. The pressurization 
tubing 19 may be made of any suitable tubing material 
such as expanded Teflon. 
Internally of the housing 12, the device D has as its 
components a main body portion 20 which may be of 
50 stainless steel and provides a member for retaining the 
shape of the device generally. The body 20 includes two 
upstanding leg portions 21 and 22 and a central upstand- 
ing stem portion 23 which serves as a valve stem. A 
fluid port 24 is provided in the upstanding leg portion 21 
A reciprocating valve member 25 is included within 
the housing and includes a depressible button member 
26 which serves as a valve actuator and a valve body 27 
attached to the button 26 by means of pin 2 6 ~ .  The 
60 housing 12 is made from a suitable resilient material 
such as silicone elastomer such that the center of cap 
portion 13 is depressible to manually operate valve 
actuator button 26 by squeezing the housing between 
the thumb and finger at arrows E when implanted. 
The valve body 27 includes a fluid port 270, a valve 
seat 276 defining a second fluid port, and a bore 27c 
connecting the two ports. A valve element is provided 
in the form of a ball poppet 28 maintained on the seat 
55 communicating with the fluid reservoir 10. 
65 
4,256,093 
3 4 
27b by a biasing spring 30. The bias of spring 30 may be that changes and variations may be made without de- 
adjusted by adding or subtracting shims 31 between parting from the spirit or scope of the following claims. 
button member 26 and the end of spring 30. The poppet What is claimed is: 
valve element thus has a first position off the seat per- 1. In a prosthetic sphincter device for controlling 
mitting flow through the valve member and a second 5 urinary incontinence of the type having an inflatable 
Position on the seat blocking flow therethrough. A flow urethral collar for surrounding the urethra and prevent- 
path exists between the reservoir 10 and collar B when ing flow in the urethral passage when inflated while 
valve element 28 is in its first position through port 24, permitting flow when deflated, a pump/valve unit for 
valve bore 27c, and port 16 of the valve unit. inflating and deflating said collar comprising: 
a compressible bulbous pump means having an inte- 
with a cylindrical retainer body portion 33 of the main rior space defining a fluid reservoir; 
body 20 to limit the upward vertical movement of the a valve 
which includes: valve member 25. A flexible diaphragm 34 is attached at 
one end between the retainer body 33 and main body 20 a valve housing having a resilient depressible por- 
tion; and is partially carried by valve member 25 by attach- 15 
said valve housing having a first port communicat- ment at a diaphragm seat member 35 integral with mem- 
ing with said fluid reservoir and a second port ber 25. 
adapted for connection to said inflatable collar; The diaphragm 34 divides the interior of housing 12 
a fluid flow path in said valve housing between said into a first compartmented section 12u in fluid commu- 
first and second ports; nication with collar B and a second compartmented 20 
a valve member enclosed within said housing dis- section 126 in fluid communication with reservoir 10. 
posed in said fluid flow path having a valve actu- The outwardly extending flanges 32 include openings 
ator element operable by depression of said resil- 36 through which the pressure of the fluid in section 12u and hence collar B is transmitted for relieving the pres- ient portion of said valve housing; sure should it exceed a predetermined value. Action of 25 said valve member including a valve element hav- the excessive pressure against the diaphragm 34 causes ing a first position permitting fluid flowthrough the valve member 25 to move downwardly engaging said valve member and a second position block- the ball poppet against the plunger 23 to open the valve ing fluid flow therethrough; and and allow the excessive pressure to be relieved, the 
response to the compression of said pump means ber to raise back to its normal position abutting the 
allowing fluid to flow from said reservoir to said retaining member 33 allowing the ball poppet to seat 
once again. inflatable collar and in response to said operation 
A spring 37 biases the valve body 27 in its normal of said actuator element allowing fluid to flow 
position wherein flange 32 abutts the retaining member 35 from said collar to said reservoir. 
33 away from the base 20. The amount of bias of spring 2. The structure of claim 1 wherein said valve unit 
37 may be adjusted by adding or removing annular includes pressure sensing and relief means for sensing 
shims 38 received over stem 23. the pressure of said fluid in said inflatable collar and 
A Pair of outwardly extending flanges 32 cooperate 10 
integral with said bulbous pump 
action against the diaphragm will allow the valve mem- 30 said occupying said first position in 
The amount of pressure differential across the dia- Causing said Valve element to move to said first position 
phagm 34 required to unseat ball poppet 28 being a 40 in the event said fluid pressure in said Collar exceeds a 
function of the combination of spring bias force pro- Predetermined amount. 
vided by springs 31 and 37 whereby the amount of 3. The StIUCtUre Of Claim 1 wherein said Valve unit 
spring bias may be adjusted so as to relieve a desired, includes: 
predetermined excess of pressure in section 120 and base means having an upstanding stem, 
hence collar B. The amount of pressure being limited to 45 said valve member being carried for movement 
that value necessary to close off the urethral passage toward said base means affording engagement be- 
while avoiding deterioration of the tissue cells as can tween said stem and valve element, and 
result from poor blood circulation due to maintenance biasing means carried between said base means and 
of an excess pressure on the urethra. said valve member urging said valve member away 
from said base means. 
tion for an implantable pump/valve device can be had 4. The structure of claim 1 wherein said valve mem- 
according to the invention for controlling the inflation 
and deflation of a urethral collar in an artificial sphinc- a valve body having a fluid port, 
ter device which is simple and reliable, requiring a mini- a valve seat formed in said valve body remote from 
mum of implant area and surgery and which automati- 55 
cally and accurately relieves an excess of pressure a bore formed in said valve body connecting said first 
placed upon the urethra by over inflation of the collar 
by the user avoiding permanent damage to the tissue of said valve element carried in said bore seatable on 
the urethra. 
said valve actuator element carried by an end of said 
been described using specific terms, such description is 
Thus, it can be seen that an advantageous construc- 50 
ber includes: 
said fluid port defining a second fluid port; 
and second ports, 
said valve seat in said second position, and 
valve body opposite said valve seat. 
While a preferred embodiment of the invention has 60 
for illustrative purposes only, and it is to be understood * * * * *  
65 


Prosthetic urinary sphincter

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