U.S. patent number 3,717,199 [Application Number 05/186,641] was granted by the patent office on 1973-02-20 for organ enclosure mantle.
This patent grant is currently assigned to Extracorporeal Medical Specialties, Inc.. Invention is credited to Stanley G. Dienst.
United States Patent |
3,717,199 |
Dienst |
February 20, 1973 |
ORGAN ENCLOSURE MANTLE
Abstract
An organ enclosure mantle comprises a flexible sac with a
pocket-like membrane disposed therein and secured thereto along its
top wall to form a closed chamber between the sac and membrane. The
membrane includes an opening to permit an organ to be inserted
therein. The membrane is made of a material which is expandable and
heat exchangeable so that upon supplying a refrigerant to the
chamber the membrane is caused to move into intimate contact with
the organ and to maintain the organ at a cold temperature.
Inventors: |
Dienst; Stanley G. (Birmingham,
MI) |
Assignee: |
Extracorporeal Medical Specialties,
Inc. (N/A)
|
Family
ID: |
22685731 |
Appl.
No.: |
05/186,641 |
Filed: |
October 5, 1971 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
91247 |
Nov 20, 1970 |
|
|
|
|
Current U.S.
Class: |
435/284.1;
607/105; 165/DIG.47; 165/46 |
Current CPC
Class: |
F28F
23/00 (20130101); A61F 7/10 (20130101); Y10S
165/047 (20130101); A61F 2007/101 (20130101) |
Current International
Class: |
F28F
23/00 (20060101); F28f 007/00 () |
Field of
Search: |
;195/1-7 ;165/46
;62/306,513 ;128/400,401 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Myhre; Charles J.
Assistant Examiner: Streule, Jr.; Theophil W.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of my copending
application Ser. No. 91,247, filed Nov. 20, 1970 now abandoned.
Claims
What is claimed is:
1. An organ enclosure mantle comprising a flexible sac having an
opening in its top wall, a flexible pocket-like membrane disposed
within said sac, said sac being secured to said membrane at said
opening in its top wall to create a closed chamber between said sac
and said membrane, said membrane having an opening in its top wall
to permit an organ to be inserted therein, said membrane being made
of an expandable and heat exchangeable material, and refrigerant
supplying means communicating with said chamber for moving said
membrane into intimate contact with the organ and for maintaining
the organ at a cold temperature.
2. A mantle as set forth in claim 1 including refrigerant discharge
means communicating with said chamber whereby refrigerant may be
circulated therein.
3. A mantle as set forth in claim 2 including spacer means in said
chamber for preventing complete surface to surface contact of said
sac and said membrane.
4. A mantle as set forth in claim 3 including means for adjusting
the size of said opening in said top wall of said membrane to
accommodate different size organs.
5. A mantle as set forth in claim 4 wherein said adjusting means
includes at least one V-shaped clip.
6. A mantle as set forth in claim 4 wherein said sac is generally
kidney shaped.
7. A mantle as set forth in claim 6 wherein said sac and said
membrane include side walls peripherally connected together and
bottom walls connected together at spaced locations thereof.
8. A mantle as set forth in claim 7 wherein said chamber is divided
by said side walls into an inlet side and an outlet side, said
supplying means being on said inlet side of said chamber, said
discharge means being on said outlet side of said chamber, and said
spacer means being in said outlet side of said chamber.
9. A mantle as set forth in claim 8 wherein said discharge means
includes a discharge tube projecting into said outlet side of said
chamber, and a plurality of drain holes in said discharge tube.
10. A mantle as set forth in claim 8 wherein said membrane is made
of thin silicone rubber material, said sac being made of thicker
silicone rubber material, and said spacer means being strips of
silicone rubber material secured to said membrane.
11. A mantle as set forth in claim 10 wherein said means for
adjusting the size of said opening is a plurality of silicone
rubber snap fasteners on the common top wall of said sac and said
membrane, and said top wall being concave.
12. A mantle as set forth in claim 11 wherein discharge means is a
discharge tube terminating at the side wall of said outlet side of
said chamber and communicating with said chamber, said supplying
means being a supply tube at the side wall of said inlet side of
said chamber and communicating with said chamber, and said supply
tube having a flow capacity no greater than the flow capacity of
said discharge tube.
13. A mantle as set forth in claim 1 wherein said sac and said
membrane are integrally secured together at said top wall in a
seamless manner.
14. A mantle as set forth in claim 1 wherein said refrigerant
supplying means includes a pump and tubing means connecting said
pump to said chamber, and said tubing means being a pair of tubes
joined together between said pump and said chamber and separated at
said pump and said chamber.
15. A mantle as set forth in claim 1 wherein said sac and said
membrane are adhesively bonded together at said top wall.
16. A mantle as set forth in claim 1 wherein reinforcing means are
provided for said chamber.
17. A mantle as set forth in claim 16 wherein said reinforcing
means comprises dacron cloth strips imbedded in the wall of said
sac to provide flexibility without distensibility.
Description
BACKGROUND OF INVENTION
This invention relates to an organ enclosure mantle and more
particularly to such a mantle which is intended to be used in
kidney transplant procedures.
The procedure of transplanting a kidney involves the surgical
removal of a nondiseased kidney from a donor and the anastomosis of
its artery and vein to major vessels in a recipient. This procedure
necessarily requires the interruption of blood supply to the kidney
for a period varying from 30 to 60 minutes. The most reliable and
universally accepted method of preserving the potential function of
a kidney during this period is cooling. Generally in such cooling
procedures the kidney is immersed in a saline ice slush while cold
electrolyte solution is perfused through the artery. This rapidly
brings the core temperature of the kidney to 0.degree. to
4.degree.C. The kidney then may safely be left at this temperature
for an hour or is often practiced even up to 6 hours. When removed
from the ice bath, the kidney naturally starts warming. The outer
cortical area of the kidney, which has the highest oxygen demand
and is the most vulnerable to damage, is the exact portion which is
warming most rapidly.
In experimental animals in a controlled laboratory situation where
cooling is carried out immediately after interruption of the blood
supply and the vessels are reanastomosed in 20 minutes, urine
output is immediate. The functions of glomerular filtration and
tubular reabsorption are acutely reduced, but return to 80 to 90
percent of normal values within three weeks and eventually to
greater than normal values (for one kidney).
In the clinical situation, however, the kidney has often been
underperfused because of prolonged shock or even cessation of
circulation in the donor. The vascular anastomosis takes longer,
averaging 35 to 40 minutes. These liabilities in clinical
transplantation are reflected in creatinine clearances (kidney
function test) which often start at 20 to 30 percent of normal and
rise over a period of months to 40 to 60 percent of normal, as well
as blood urea levels, which remain abnormally high. These "average
results" in the cadaver transplant indicate that the kidney has
lost over 50 percent of its potential function. Often this is
attributed to "rejection." However, the difference between the well
preserved kidney and the one damaged by warm ischemia is often
apparent before any rejection has occurred.
There is therefore a need for a mantle which effectively preserves
the kidney and other organs by continuous cooling during
anastomosis as required for successful transplants.
SUMMARY OF INVENTION
An object of this invention is to provide an organ enclosure mantle
which effectively preserves an organ during transplanting
procedures.
A further object of this invention is to provide such a mantle
which is particularly useful in kidney transplant procedures.
In accordance with this invention an organ enclosure mantle
comprises a flexible sac with a pocket-like membrane disposed
therein and secured thereto along its top wall to form a closed
chamber between the sac and membrane. The membrane includes an
opening to permit an organ to be inserted therein. The membrane is
made of a material which is expandable and heat exchangeable so
that upon supplying a refrigerant to the chamber the membrane is
caused to move into intimate contact with the organ and to maintain
the organ at a cold temperature.
Spacers may be provided in the chamber to keep the walls of the sac
and the membrane apart. If desired means may be provided at the
common top wall of the sac and membrane to adjust the size of the
membrane opening to accommodate different size organs. The sac and
the membrane may be joined together at their side walls whereby the
chamber is divided into an inlet side and an outlet side with the
spacers being silicone rubber strips secured to the membrane in the
outlet side of the chamber. The refrigerant supply means may be an
inlet tube terminating at the side wall of the inlet side of the
chamber, while an outlet tube may be provided on the outlet side of
the chamber so as to permit the refrigerant to be circulated
throughout the chamber. The outlet tube may have at least as great
as or greater capacity than the inlet tube.
THE DRAWINGS
FIG. 1 is a side elevation view partly in section of an organ
mantle in accordance with this invention in its non-use
condition;
FIG. 2 is a side elevation view of the mantle shown in FIG. 1
during usage thereof;
FIG. 3 is a top plan view of the mantle shown in FIG. 2;
FIG. 4 is a side elevation view of the mantle shown in FIGS.
2-3;
FIG. 5 is a cross-sectional view taken through FIG. 2 along the
line 5--5;
FIG. 6 is a cross-sectional view similar to FIG. 5 showing an
alternative mantle;
FIG. 7 is an elevation view of a portion of a modified mantle
similar to FIG. 1;
FIG. 8 shows the general arrangement for usage of the inventive
mantle;
FIG. 9 is a side elevation view partly in section of a modified
mantle in accordance with this invention;
FIG. 10 is a top plan view of the mantle shown in FIG. 9;
FIG. 11 is a cross-sectional view taken through FIG. 9 along the
line 11--11;
FIG. 12 is an elevation view showing the mantle of FIGS. 9-11 in
operation; and
FIG. 13 is a cross-sectional view taken through FIG. 12 along the
line 13--13.
DETAILED DESCRIPTION
To minimize the warm ischemia, the kidney cooling jacket or mantle
10 has been developed to maintain the kidney at, for example,
4.degree.C during the surgical vascular anastomosis. As shown in
the drawings mantle 10 includes an outer sac 12 made of a flexible
material and having an opening in its top wall 14. Disposed within
sac 12 is a flexible pocket-like membrane 16 which is made of an
expandable and heat exchangeable material. For example membrane 16
may be made of a thin gauge silicone rubber material, while sac 12
may be made of a thicker silicone rubber. This material is
particularly suitable since it provokes no tissue reaction or
toxicity and can be either gas sterilized or steam autoclaved. Top
wall 14 is peripherally connected to membrane 16 as indicated by
the seam 18 (FIGS. 5-6) to form a closed chamber 20 between the sac
and membrane. Additionally, the side walls of the sac and membrane
are connected together as indicated by the seam 22 so as to divide
the chamber into inlet side 24 and an outlet side 26. The bottom
wall is maintained open with spaced connecting points such as the
single anchoring point 28 being provided between the sac and
membrane to permit flow communication between inlet side 24 and
outlet side 26.
An inlet tube 30 such as a silicone rubber tubing terminates at the
side wall of sac 12 and communicates with inlet side 24 of chamber
20 while outlet tubing 32 is provided generally opposite thereto
and also terminates at the side wall of sac 12 and communicates
with the outlet side 26 of chamber 20.
During operation mantle 10 is inserted over the donor kidney and
refrigerant is supplied to tubing 30 by any suitable means such as
pump 34 (FIG. 4) into inlet side 24 of chamber 20. Outlet tubing 32
may be clamped to prevent flow therethrough so that the flowing
refrigerant causes membrane 16 to move into intimate contact with
the kidney. As shown for example in FIGS. 2 and 4 membrane 16 also
bulges slightly outwardly so as to be in contact with the kidney
vessels such as the ureter 38, the renal artery 40 and the renal
vein 42. As shown in FIG. 7 the top wall 44 of mantle 10 is
recessed or concave to facilitate approach to these kidney vessels.
Once the membrane 16 is in intimate contact with kidney 36, the
clamp is removed from outlet tubing 32 and refrigerant is
circulated through mantle 10 with membrane 16 remaining in intimate
contact with kidney 36. Since membrane 16 is made of a heat
exchangeable material the temperature of kidney 36 is quickly
brought down to the desired cooled temperature such as 0.degree. -
4.degree.C. The refrigerant circulated through mantle 10 may be
discharged from outlet tube 32 back to pump 34 or, if desired, to a
separate receptacle.
For use with human kidneys the opening in the top wall of membrane
16 is about 2 - 21/2 inches so that the kidney can be readily
slipped into mantle 10. This part of the margin of mantle 10 can
then be conveniently re-opposed to contain the kidney by the
application, for example, of a large curved Kelly clamp. A further
advantageous feature of this invention is the provision of silicone
rubber snap fasteners 48 to permit the size of the opening in the
top wall of the mantle to be varied in accordance with the
particular size kidney.
It has been found that in use with large human kidneys an
intermittent ballooning effect occurs which is caused by the
valve-like effect between the membrane wall and outlet tubing 32.
In order to prevent this effect from occurring, membrane 16 is
provided with a plurality of strips 46 of silicone rubber material
on the outlet side 26 of chamber 20 to keep the walls of membrane
16 and sac 12 apart.
It is also advantageous that outlet tubing 32 have at least equal
to or somewhat greater flow capacity then inlet tubing 30. FIG. 6
shows another advantageous ramification wherein outlet tubing 50 is
disposed within outlet side 26 of chamber 20 and contains a
plurality of drain holes 52 to insure proper drainage of the
refrigerant.
FIG. 8 shows the general operation of the mantle 10 wherein tubing
means 60 is provided between the mantle and receptacle 62 for
permitting communication between the mantle and submersible pump
64. Pump 64 includes suitable means 66 for connection to a power
source. Receptacle 62 contains a saline solution 68 and chipped ice
70 to provide the necessary cold solution which is supplied to
mantle 10 through tube 72 with the circulation being completed
through tube 74 of tubing 60. Advantageously tubing 60 is in the
form of double lumen tubing which is joined together between the
pump 64 and mantle 10 and then separated at the mantle and near the
pump.
FIGS. 9-11 show a modified form of this invention wherein the inner
membrane 76 and the other sac 78 are integrally secured together at
top wall 80 by being molded to shape thereby eliminating seams.
Such an integral arrangement may be created by inserting the
membrane in the sac and bonding the top edges of the membrane to
the sac with a suitable adhesive or other suitable means. As shown,
for example, in FIG. 11 tongue 79 of membrane 76 snaps into groove
81 of sac 78 and the tongue is held therein by suitable adhesive
means.
As also shown in FIGS. 8 and 11 sac 78 includes integral tubes 73
and 75. Tube 73 is joined to tube 72 by suitable connector 77 while
connector 79 joins tube 75 to tube 74. As is also apparent from
FIG. 11 inlet tube 73 is of larger diameter and flow capacity than
outlet tube 75.
FIG. 9 also illustrates another advantageous feature of this
invention wherein the flexible membrane 76 and sac 78 are
reinforced with suitable material such as dacron cloth 82 embedded
in the silicone rubber and preferably in the wall of outer sac 78
thus allowing flexibility without distensibility.
A further advantageous feature is best illustrated in FIGS. 12-13
wherein the opening in the top wall is adjusted or controlled by
the provision of U-shaped clips 84 made for example of stainless
steel. After the kidney is inserted the clips would close the
mantle by being placed on either side of the vessels to approximate
the edges thereof.
Mantle 10 effectively provides a thin layer of cold solution
between the cold hypothermic kidney and the ambient temperature
around it. This ambient temperature may for example be between
25.degree. to 37.degree.C in the recipient operative wound. The
cold barrier in chamber 20 prevents absorption of heat by the
kidney and keeps the kidney at a temperature where function is
known to be best preserved. Moreover, the shape of mantle 10 is
made to conform closely to the kidney so that minimal room is
occupied in the operative field to thereby minimize encumberance to
the surgeon.
The preferred material for the various components of mantle 10 is
silicone rubber and the preferred refrigerant is cold water. Of
course, however, other suitable materials or refrigerants may also
be used within the concepts of this invention. Similarly, the
mantle may be used for animal as well as human kidneys. Mantle 10
may in fact by proper alteration of shape be used as an enclosure
for organs other than kidneys.
* * * * *