An occlusive device is disclosed for surgical implant to occlude the lumen of an internal organ. The device includes a cuff having a backing collar and two isolated cuff chambers. The fluid pressure of one chamber is regulated by a pump/valve reservoir unit. The other chamber is unregulated in pressure but its fluid volume is adjusted by removing or adding fluid to a septum/reservoir by means of a hypodermic needle. Pressure changes are transmitted between the two cuff chambers via faying surfaces which are sufficiently large in contact area and thin as to transmit pressure generally without attenuation. By adjusting the fluid volume of the septum, the operating pressure of the device may be adjusted to accommodate tubular organs of different diameter sizes as well as to compensate for changes in the organ following implant without reoperation

Tenney, J. B., Jr.

English

NASA Technical Reports Server

States Patent E191 
Tenney, Jr. 
[54] 
[75] Inventor: John B. Tenney, Jr., Williamson, 
[73] Assignee: The United States of America as 
PROSTHETIC OCCLUSIVE DEVICE FOR AN 
INTERNAL PASSAGEWAY 
N.Y. 
represented by the Administrator of 
the National Aeronautics and Space 
Administration, Washington, D.C. 
[21] Appl. No.: 371,352 
[22] Filed: Apr. 23, 1982 
[52] 
[58]  
[561 References Cited 
[51] Int. Cl.3 .............................................. A61B 19/00 
US. c1. .................................... 128/1 R 128/346; 
128DIG. 25 
Field of Search ............... 128/1 R, DIG. 25, 325, 
128/344,346,686,24 R, 327, DIG. 20; 604/101 
U.S. PATENT DOCUMENTS 
3,580,248 SA971 Larson ........................ 128/DIG. 20 
4,019,499 4/1977 Fitzgerald ................. 
4,222,377 9/1980 Burton ................................ 128/1 R 
4,256,093 3/1981 Helms et al. ................ 128/DIG. 25 
Primary Examiner-Lee S. Cohen 
Assistant Examiner-Christine A. Fukushima 
Attorney, Agent, or Firm-Joseph H. Beumer; John R. 
Manning; Leon D. Wofford, Jr. 
1571 ABSTRACT 
An occlusive device is disclosed for surgical implant to 
occlude the lumen of an internal organ. The device 
includes a cuff A having a backing collar (10) and two 
isolated cuff chambers B and C. The fluid pressure of 
chamber B is regulated by a pump/valve reservoir unit 
E. Chamber C is unregulated in pressure but its fluid 
volume is adjusted by removing or adding fluid to a 
septum/reservoir D by means of a hypodermic needle. 
Pressure changes are transmitted between the two cuff 
chambers via faying surfaces (12) and (14) which are 
sufficiently large in contact area and thin as to transmit 
pressure generally without attenuation. By adjusting the 
fluid volume of septum D, the operating pressure of the 
device may be adjusted to accommodate tubular organs 
of different diameter sizes as well as to compensate for 
changes in the organ following implant without re- 
operation. 
6 Claims, 10 Drawing Figures 
https://ntrs.nasa.gov/search.jsp?R=19840003676 2020-03-22T07:57:51+00:00Z
U.S. Patent oct. 11, 1983 Sheet 1 of 2 4,408,597 
U.S. Patent oct. 11, 1983 Sheet 2 of 2 4,408,597 
1 
4,408,597 
2 
ouslv imdanted seDtum in which fluid can be added - -  
PROSTHETIC OCCLUSIVE DEVICE FOR AN 
INTERNAL PASSAGEWAY 
subcutaneously by means of a hypodermic needle. 
SUMMARY OF THE INVENTION 
ORIGIN OF THE INVENTION 
The invention described herein was made in perfor- 
mance of work under a NASA Contract, and is subject 
to the provisions of Section 305 of the National Aero- 
nautics and Space Act of 1968, Public Law 85-568 (72 
Stat. 435.002 U.S.C. 2457). 
5 The above objectives are accomplished according to 
the present invention by means Of an inflatable Cuff 
having an outer collar which may be fitted around a 
tubular organ and which includes two separate isolated 
pressurization chambers. These chambers are designed 
lo so that in a static configuration they are in contact over 
a faying surface having an area which is roughly equiv- 
alent to the diameter of the cuff collar. In this configura- BACKGROUND O F  THE INVENTION - 
The invention relates to a prosthetic occlusive device tion, the individual chambers are expanded but un- 
for occluding an internal passageway of the human 15 stressed. The cuff collar is reinforced to make it more 
body, for example, for closing the urinary canal in con- resistant to deformation than the inner faying surfaces 
trolling the bladder function where a person has lost of the chambers. When fluid is added to either chamber, 
bladder control. Implantable devices have been used the internal pressure is increased and by making the 
before for controlling bladder functions and for occlud- walls of the chambers sufficiently thin, pressure is trans- 
ing other internal passageways i n  the human body such 20 mitted across the faying surfaces with minimal attenua- 
as shown in U.S. Pat. NOS. 2,455,289; 3,750,194; and tion. In other words, a pressure increase in one chamber 
3,863,622; which utilize an inflatable or pressurized cuff would increase the pressure in the other chamber to 
which is pressurized by means of a fluid actuator. U.S. approximately the same level. 
Pat. No. 4,019,499 discloses an implant device for uri- The tubular organ is fitted between the faying sur- 
nary incontinence in which the fluid volume and pres- 25 faces and opened and closed by pressurization thereof 
sure may be adjusted after implant. However, devices accordingly. One of the chambers is connected to a 
of these types do not effectively mmnmodate tubular pressurizing pump/valve for regulating and actuating 
organs Of Varying diameters nor effectively permit read- the device and the other chamber is unregulated but 
justment Of operating pressures due to changing condi- connected to a septum which is implanted with the 
tions after implant. 30 device. By adjusting the fluid volume and pressure in 
In the cuff type devices, fluid cannot be readily added the unregulated chamber, the single size cuff device 
intra-operatively due to the inherent characteristics of chambers, the single size cuff device may be adapted to 
the designs of the prior art devices and fluid cannot be occlude organs of varying diameters and sizes. This 
added postoperatively without re-operation. Accord- eliminates or minimizes having a wide range of cuff 
growthy atrophy Or scarring by Of adding Or changes in diameter as occurs through scarring, growth 
removing fluid after implantation. and aging without requiring cuff replacement and re- 
Furthermore, it has been found that the prior art 
devices have not been entirely satisfactory in control of 
the pressures required to effectively occlude the organ. 40 BRIEF DESCRIPTION OF THE DRAWINGS 
The pressurization actually transmitted to cuff and The construction designed to carry out the invention 
Organ may exceed Or be less than that required to OC- will be hereinafter described, together with other fea- 
clude the organ due to changed conditions. Excess tures thereof. pressures to the organ often results in tissue damage to 45 readily understood from 
a reading of the following specification and by refer- the organ. Accordingly, an important object of the present in- ence to the accompanying drawings forming a part vention is to provide an occlusive device for occluding thereof, wherein an example of the invention is shown a tubular organ in which operating pressure adjustments 
may be made in an implanted device to compensate for 5o and wherein: 
1 is a partially cut-away view illustrating an changing patient conditions such as growth, atrophy, 
device surgically implanted for occluding a and scarring without separating. 
Yet another important object of the present invention 
is to provide an occlusive device for occluding tubular FIG. 2 is a perspective view illustrating an occlusive 
ferent diameters. 
Still another important object of the present inven- 
tion is to provide an occlusive cuff device for occluding 
an organ in which fluid may be added to or removed 
from the device after implantation for adjusting operat- 60 
ing pressures. 
Yet another important object of the present invention 
is to provide an occlusive device for surgical implanta- 
tion for occluding a tubular organ wherein the fluid 
volume required to effect closure may be sent within a 65 the present invention fitted about a small urethra, and 
limited range by utilizing a two-chamber inflatable cuff 
wherein one chamber is attached to a pressurizing 
valve, and the other chamber is attached to a subcutane- 
in&', no adjustment can be made to the device for 35 sizes. This also permits adjustment for when the organ 
ne invention will be 
organs which will readily accommodate organs of dif- 55 system for occluding a t d d a r  organ constructed ac- 
cording to the invention, 
FIG. 3 is an enlarged view illustrating an occlusive 
device constructed according to the present invention 
as fitted about the colon with the device in a static state, 
FIG. 3.4 is a perspective view illustrating the device 
of FIG. 3 in a pressurized state for occluding the lumen 
of the colon, 
FIGS. 4A-4C are a series of schematic views illus- 
trating an occluding device constructed according to 
FIGS. Sa-5c are a series of schematic views illustrat- 
ing an occlusive device of FIGS. 4a-4c adapted to a 
large urethra. 
4.408,597 
3 
DESCRIPTION O F  A PREFERRED 
EMBODIMENT 
The invention is directed to an occlusive device 
which includes an inflatable cuff means A which can be 
opened or closed after surgical implantation for pur- 
poses of occluding the lumen of a tubular organ such as 
the colon, ileum, urethra, ureters, etc. While the device 
may be applied to any tubular organ, the invention is 
shown as applied to an urethra for purposes of illustra- 
tion. 
To be successful, a hydraulically actuated occlusive 
cuff must act within a range of pressures which are 
determined by the body. At the high end, the cuff pres- 
sure must be high enough to occlude the lumen of the 
organ without shutting off blood supply and causing 
tissue damage. When this pressure is known, a suitable 
regulator valve, such as shown in U.S. Pat. No. 
4,256,093, can be employed to insure that the closing 
pressure is not exceeded when the cuff is pressurized 
and that the pressure level drops only as is needed to 
permit the fluid to again move through the previously 
occluded lumen. If the cuff is adjusted to the tubular 
organ intraoperatively, the desired pressure change can 
occur with only a small change of fluid volume. This 
permits the volume of fluid required in the valve reser- 
voir to be small. This is a desirable attribute since the 
fluid reservoir is also part of the implanted device and 
occupies space in the body. Ideally, the smallest sizes 
consistent with successful function are preferred for all 
elements of such systems. 
Referring now in more detail to the drawings, an 
occlusive cuff device A is illustrated for surgical im- 
plantation in the human body which includes a cuff 
collar means 10 and a first cuff pressure chamber B and 
a second, isolated cuff pressure chamber C. Cuff cham- 
ber B is regulated and pressurizable for effecting closure 
of the lumen of the organ. Cuff chamber C is unregu- 
lated during operation. Each pressure chamber includes 
a faying surface 12 and 14, between which surfaces the 
organ is fitted. A subcutaneous septum means D is con- 
nected in fluid communication with the chamber C so 
that the fluid volume of the septum and hence chamber 
C may be adjusted accordingly post or intraoperatively. 
The walls of the inflatable chambers B and C are thin 
and flexible and the thickness is determined by consider- 
ation of pressures, shape and materials. In general, the 
thin walls are sufficiently compliant to permit the con- 
formance of the cuff chamber with the geometry of the 
tubular organ which is being occluded. Faying surfaces 
12 and 14 of the chambers B and C, respectively, must 
be in contact over a substantial area which is preferably 
equivalent to the area defined by the diameter of the 
cuff collar 10 and its width. When both chambers B and 
C are filled with a suitable fluid, typically saline with an 
appropriate radioopaque tag material, and when both 
chambers are extended to their full unstressed limits at a 
low internal pressure, the volume change to either 
chamber should create a pressure change in that cham- 
ber which is transmitted with very little diminution to 
the opposite side. The large faying surfaces provide 
minimal attenuation of the pressure transmitted thereto 
from pressure chamber B to chamber C for effective 
occlusion. This eliminates cusps and other discontinuit- 
ies associated with other conventional cuff shapes. 
The two independent and isolated cuff chambers B 
and C may be connected to suitable valves, fluid reser- 
voirs, regulating reservoirs, septa or other system ele- 
5 
10 
15 
20 
25 
30 
35 
40 
45 
50 
55 
60 
65 
4 
ments. In a preferred embodiment, cuff chamber B is 
connected to a pressure regulator valve E which pre- 
vents internal pressure levels from exceeding desired 
operational levels, and chamber C is connected to a 
subcutaneous septum/reservoir D. A suitable valve for 
use as the pressure regulation value E is disclosed in 
U.S. Pat. No. 4,256,093. If excess fluid pressure is trans- 
mitted into the cuff chamber B the valve will crack and 
let fluid bleed back into the reservoir forming a part 
thereof. If internal pressure in the unregulated chamber 
C were inadvertently increased above design levels this 
increase would be transmitted to the faying surface and 
to the opposite cuff chamber B again causing the valve 
to crack and bleed back into the reservoir. 
The cuff collar 10 is preferably a deformation resis- 
tant backing the outer contour of which is reinforced to 
restrict outward radial deformation and to force fluid 
pressure to deform the thin wall cuff chambers in the 
direction of their faying surfaces in the organ which is 
being occluded. The cuff collar 10 includes split ends 16 
and 18 which accommodate placement of the cuff collar 
and cuff chambers about the organ. Latch means for 
securing the free ends of the cuff collar together is 
illustrated in the form of a latch eye 22 and a latching 
member 24 which may be inserted in the eye 22 and 
hooked therein. The cuff collar 10 and latching means 
are integral such as they present a smooth contour sur- 
face which is compatible with either encapsulation or 
ingrowth. The latching member 24 and eye 22 hold the 
ends of the cuff together and prevent separation when 
pressure is applied for occluding the tubular organ. All 
cuff materials including the illustrated latch are prefera- 
bly formed or molded from suitable biocompatible ma- 
terial such as a medical grade silicon. rubber. 
Valve/reservoir E is connected in fluid communica- 
tion to regulated chamber B by tubing 26. 
Septumheservoir means D is connected to the cuff 
chamber C by means of tubing 28 placing the two to- 
gether in fluid communication so that fluid volume of 
the cuff chamber C may be adjusted by adjusting the 
volume of fluid in the septum by means of a hypodermic 
needle. For this reason, septum means D is implanted 
subcutaneously for reliable needle access. The septum 
permits the introduction of fluid intra-operatively with- 
out the penetration or contamination of the previously 
sealed valve side. In this way, the static pressure of the 
cuff/chamber C,  that is with the tubular organ still 
open, can be raised to a desired level at which a small 
desired increase will effectively occlude the organ. The 
subcutaneous placement of the septum provides for 
postoperative adjustment of cuff pressure without sur- 
gery due to changes in the size of the organ which may 
be caused by changes in weight, age, scarring, disease, 
or a device malfunction. The septum is preferably pro- 
vided with a needle stop 30 to prevent the needle from 
penetrating the septum. 
FIGS. 3a and 3 illustrate application of the device to 
the lumen of urethra 32 with the cuff means A in a static 
state in FIG. 3 wherein the lumen is opened and a pres- 
surized state in FIG. 3a in which regulated chamber B 
is pressurized for occluding the lumen. 
The cuff chamber C and septum D may be utilized to 
adapt the occluding device to a range of organ diame- 
ters and sizes by adjusting the fluid volume in the unreg- 
ulated chamber C of cuff means A. This can best be seen 
in FIGS. 4a. b, c and Sa, b, c,. 
In FIGS. 4a-c adaptation of the occlusive cuff device 
is illustrated with a small urethra 33. In step a, cuff 
4,408,597 
5 6 
means A is illustrated with the cuff chamber C in its 
normally fluid filled condition surrounding the urethra 
and cuff chamber B unfilled with fluid. In step b, cuff 
chamber B is filled to a fluid volume and pressure at 
which the lumen of the urethra remains open and in 5 
which the device is essentially static. In step c, the de- 
vice is illustrated with the cuff chqmber B pressurized 
by means of the pump valve E such that the regulated 
pressure transmits a change in pressure through the 
faying surfaces 12 and 14 to the organ which is suffi- 
cient to effect closure of the lumen. 
In FIGS. 5a-c, the cuff is shown fitted around a 
but this time a smaller fluid volume would be needed in 15 
the cuff chamber C which could be adjusted by remov- 
ing fluid or adding less fluid to the septum D. With the 
volume and pressure of chamber C adjusted, the larger 
urethra remains open in step b with the same fluid vol- 
ume in chamber B. The cuff is still effective to effect 20 
closure of the lumen of the larger urethra by actuation 
of pump valve E. 
Thus, it can be seen that a highly advantageous con- 
struction can be had for an occlusive device according 2. The device of claim 1 wherein said collar is split 
to the invention which may be easily adapted to tubular 25 having free ends accommodating Placement thereof 
organs ofdifferent size diameters and in which the oper- over said organ and including latch means for securing 
ational condition of the device may be adjusted to com- 
1. An occlusive cuff device for surgical implantation 
in the human body for the purpose of opening and clos- 
ing an internal Passageway in a tubular organ and the 
like comprising: 
Cuff means including a first and second isolated Cuff 
said first cuff chamber being regulated and pressur- 
pressure chamber; 
izable for effectively occluding said passageway of 
said tubular organ; 
said second cuff chamber being unregulated during 
normal operation of said device; 
each said cuff chamber including a faying surface in 
which said passageway is receivably fitted; 
cuff chambers; and 
a fluid containing septum in fluid communica- 
tion with said second cuff chamber adapted for 
subcutaneous placement so that the fluid volume of 
said septum means and hence said second chamber 
may be adjusted accordingly by means penetrating 
the skin to accommodate use on organs of different 
diameter sizes and to compensate for changing 
organ conditions without re-operation. 
10 
larger urethra 34 wherein Same steps are a deformation resistant cuff collar encircling said two 
ends Of said together- 
pensate for changes in the condition of the tubular 3. The device of claim 1 including pump/valve 
organ as often occurs through aging, atrophy, or scar- connected to said first cuff chamber for selectively 
30 regulating and pressurizing said first cuff chamber for ring. The occlusive cuff device may be adjusted to the 
fluid to provide just the right pressure conditions such 
not exceed that required for Occluding the lumen as 35 are of sufficient dimension and contact with one another 
may lead to the suPPIY and as to cause the pressure changes to be transmitted across 
accompanying tissue. said faying surfaces from either cuff chamber without 
While a preferred embodiment of the invention has significant attenuation of said pressure. 
been described using specific teras, such description is 6. The device of claim 1 wherein said faying surfaces 
for illustrative purposes only, and it is to be understood 40 are in contact over an area generally equivalent to the 
that changes and variations may be made without de- area defined by the diameter of said cuff collar and its 
parting from the spirit Qr scope of the following claims. width. 
occluding said passageway. 
cuff chambers comprise thin wall flexible material. 
Organ intra-operatively by removing Or adding 
E do 
4. The device of claim 1 wherein said first and second 
that the pressures transmitted by the pump 5. The device of claim 1 wherein said faying surfaces 
Off Of the 
* * * * *  What is claimed is: 
45 
50 
55 
65 


Prosthetic occlusive device for an internal passageway

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