U.S. patent application number 09/755390 was filed with the patent office on 2001-08-09 for vibrator appliance particularly useful for dialysis.
Invention is credited to Zicherman, Yehuda.
Application Number | 20010012921 09/755390 |
Document ID | / |
Family ID | 11067818 |
Filed Date | 2001-08-09 |
United States Patent
Application |
20010012921 |
Kind Code |
A1 |
Zicherman, Yehuda |
August 9, 2001 |
Vibrator appliance particularly useful for dialysis
Abstract
A vibrator apparatus is provided. The vibrator apparatus
includes a body weight support to support the body weight of a
subject. The body weight support is attached to at least one arm,
which includes a first arm portion and a second arm portion. The
second arm is adjustably positionable with respect to the first arm
portion. The vibrator apparatus also includes a vibrator assembly
mounted on the second arm portion of the arm. The second arm
portion is positionable relative to the first arm portion to engage
an abdominal region of the subject and apply localized
inwardly-directed mechanical vibrations.
Inventors: |
Zicherman, Yehuda;
(Bnai-Brak, IL) |
Correspondence
Address: |
KENYON & KENYON
ONE BROADWAY
NEW YORK
NY
10004
US
|
Family ID: |
11067818 |
Appl. No.: |
09/755390 |
Filed: |
January 5, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09755390 |
Jan 5, 2001 |
|
|
|
09571958 |
May 15, 2000 |
|
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Current U.S.
Class: |
601/79 |
Current CPC
Class: |
A61M 1/28 20130101; A61M
1/282 20140204; A61H 2011/005 20130101; A61H 2201/0192 20130101;
A61H 2201/1628 20130101; A61H 2201/1635 20130101; A61H 23/0218
20130101; A61H 2023/0272 20130101; A61H 2201/1623 20130101; A61H
2201/1604 20130101; A61H 2205/083 20130101; A61H 2201/163 20130101;
A61H 23/0254 20130101; A61H 2023/0281 20130101 |
Class at
Publication: |
601/79 |
International
Class: |
A61H 001/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 27, 1995 |
IL |
114768 |
Jul 24, 1996 |
IL |
PCT/IL96/00064 |
Claims
1. An appliance to enhance the rate of removal of solutes during a
peritoneal dialysis treatment of a subject, comprising: a holder to
be applied to the subject; and at least one vibrator device carried
by said holder at a location thereof to engage the subject's
abdomen and to apply localized inwardly-directed mechanical
vibrations thereto at a frequency of 1-15 Hz.
2. The appliance according to claim 1, wherein said vibrator device
applies said mechanical vibrations to the subject's abdomen at a
frequency of 2-6 Hz.
3. The appliance according to either of claims 1 or 2, wherein
there are at least two vibrator devices carried by said holder at
locations to engage opposite sides of the subject's abdomen and
oriented to apply inwardly-directed mechanical vibrations towards
the central region of the subject's abdominal cavity.
4. The appliance according to any one of claims 1-3, wherein said
holder includes a loop constructed to be worn in a self-supporting
manner on the subject's body.
5. The appliance according to claim 4, wherein said holder further
includes a shoulder harness to be worn by the subject to aid in
supporting the appliance in a self-supporting manner on the
subject's body.
6. The appliance according to any one of claims 1-3, wherein said
holder includes a backrest engageable with the back of the
subject.
7. The appliance according to claim 6, wherein said holder further
includes a seat for seating the subject.
8. The appliance according to any one of claims 1-7, wherein each
of said vibratory devices includes a rotary motor driving an
eccentric arm.
9. The appliance according to any one of claims 1-7, wherein each
of said vibratory devices includes a solenoid oscillating an
armature.
10. The appliance according to any one of claims 1-7, wherein each
of said vibratory devices includes a rotary motor driving an
eccentric weight.
11. The appliance according to any one of claims 1-7, wherein each
of said vibratory devices includes a fluid driven piston
reciprocatable within a cylinder.
12. The appliance according to any one of claims 1-7, wherein each
of said vibratory devices includes an inflatable bag.
13. The appliance according to any one of claims 1-7, wherein said
holder comprises a first belt dimensioned to enclose the wearer; a
second belt dimensioned to enclose said first belt; each of said
vibrator devices comprising at least one rigid plate pivotally
mounted at its opposite ends to said first and second belts so as
to be pivotal through a plurality of positions from substantially
0.degree. to 180.degree. with respect to said belts; and a drive
for reciprocating said second belt with respect to said first belt
to thereby oscillate said rigid plates through said plurality of
positions.
14. The appliance according to claim 13, wherein each of said
vibrator devices comprises a group of said rigid plates pivotally
mounted at their opposite ends to said first and second belts at
spaced intervals therealong.
15. The appliance according to claim 14, wherein said plurality of
rigid plates are of decreasing length from one end of the group to
the opposite end of the group.
16. The appliance according to any one of claims 1-7, wherein each
of said vibrator devices includes a shaped vibrator head carried by
said holder to be in contact with the subject's abdomen and
cyclically movable inwardly and outwardly to apply said mechanical
vibrations to the subject's abdomen.
17. The appliance according to claim 16, wherein said holder
includes a flexible belt and an electrical motor for tensioning and
relaxing said belt; said vibrator heads being carried by said
flexible belt and being movable inwardly and outwardly against the
subject's abdomen by the tensioning and relaxing of said flexible
belt by said electrical motor.
18. The appliance according to claim 16, wherein said holder
includes a mounting member mounting said vibrator heads, and
further mounting an electrical motor coupled to said vibrator heads
by coupling devices which, upon energization of the motor,
cyclically move said vibrator heads inwardly and outwardly against
the subject's abdomen.
19. The appliance according to any one of claims 1-7, wherein each
of said vibrator devices includes a dashpot which is selectively
adjustable to vary the phase of the mechanical vibrations applied
thereby to the subject's abdomen.
20. The appliance according to any one of claims 1-19, wherein said
vibrator devices operate at the same frequency and phase.
21. The appliance according to any one of claims 1-19, wherein said
vibrator devices operate at the same frequency but at different
phases.
22. The appliance according to any one of claims 1-19, wherein said
vibrator devices operate at different frequencies to produce
alternating in-phase and out-of-phase movements of the subject's
abdomen.
23. A method of administering a peritoneal dialysis treatment to a
subject comprising a vibration session, including: instilling a
dialysate solution into the peritoneal cavity of the subject;
applying external localized mechanical vibrations to the abdomen of
the subject at a frequency of 1-15 Hz and an amplitude of 1-20 mm;
and draining said dialysate solution from the subject's abdominal
cavity.
24. The method according to claim 23, wherein said mechanical
vibrations are applied at a frequency of 2-6 Hz and at amplitudes
of 5-10 mm.
25. The method according to either of claims 23 or 24, wherein said
external mechanical vibrations are applied by at least two vibrator
heads to opposite sides of the subject's abdomen on opposite sides
of its center line and oriented towards the central region of the
subject's abdominal cavity.
26. The method according to any one of claims 23-25, wherein said
mechanical vibrations are applied at the same frequency and
phase.
27. The method according to any one of claims 23-25, wherein said
mechanical vibrations are applied at the same frequency but at
different phases.
28. The method according to any one of claims 23-25, wherein said
mechanical vibrations are applied at different frequencies to
produce alternating in-phase and out-of-phase movements of the
subject's abdomen.
29. The method according to any one of claims 23-28, wherein each
24-hour day is divided into two 12-hour periods, each period
including a said vibration session for 15-60 minutes, and a
non-vibration session with fresh dialysate solution for the
remainder of the period.
30. The method according to any one of claims 23-28, wherein each
24-hour day includes four vibration sessions of 15-60 minutes each,
spaced about six hours apart.
31. The method according to any one of claims 23-28, wherein each
24-hour day is divided into four 6-hour periods, at least one of
said periods including a vibration session for 15-60 minutes, and a
non-vibration session with fresh dialysate solution for the
remainder of the period, each of the remaining ones of said periods
being a non-vibration session with fresh dialysate.
32. The method according to any one of claims 23-28, wherein each
24-hour day includes a said vibration session for 15-60 minutes, a
non-vibration session with fresh dialysate solution for 10-11.5
hours, and another said vibration session with fresh dialysate for
15-60 minutes.
33. The method according to any one of claims 23-28, wherein each
24-hour day includes six equally-spaced periods of 1-1.5 hours
each, each period including instilling fresh dialysate solution for
10-15 minutes, a dwell accompanied by vibrations for 30-60 minutes,
and removing the dialysate solution for 15-20 minutes.
34. The method according to any one of claims 23-33, wherein said
mechanical vibrations are applied by vibrator devices carried by a
holder worn in a self-supporting manner on the subject's body.
35. The method according to any one of claims 23-33, wherein said
mechanical vibrations are applied by vibrator devices carried by a
backrest engageable with the back of the subject.
36. The method according to claim 35, wherein said mechanical
vibrations are applied while the subject is seated on a seat
carrying said backrest and said vibrator devices.
37. A dialysis set particularly useful with the apparatus of any
one of claims 1-22 and method of any one of claims 23-36,
comprising: two supply bags for a peritoneal dialysis solution to
be instilled into a subject's abdominal cavity; a drainage bag for
receiving the dialysis solution to be drained from the subject's
abdominal cavity; and tubing connecting said two supply bags and
said drainage bag to a catheter to be used for the peritoneal
dialysis; said tubing including first and second tubes each
connected at one of their ends to one of said supply bags and at
their opposite ends to one end of a third tube; said third tube
being connected at its opposite end to a connector for a catheter,
and at an intermediate point to a fourth tube connected to said
drainage bag; said tubing further including a breakaway valve in
each of said first and second tubes for selectively controlling the
flow of fluid from the supply bags to said catheter.
Description
FIELD AND BACKGROUND OF THE INVENTION
[0001] The present invention relates to a vibrator appliance, and
particularly to one useful for a peritoneal dialysis (PD)
treatment. The invention also relates to a dialysis method and
particularly to one utilizing the novel vibrator appliance.
[0002] Peritoneal dialysis (PD) is a medical treatment administered
when there is insufficient functioning of the kidneys. It is
performed by inserting a sterile plastic catheter into the
abdominal cavity of the subject and instilling a dialysate solution
to irrigate the peritoneum such that solutes transfer across the
peritoneal membrane into the dialysate solution from the blood in
the mesentery capillary network. This treatment does not require a
machine, such as in hemodialysis, but does require much longer
periods of time in order to achieve solute removal comparable to
that of intermittent hemodialysis. Such a treatment is commonly
performed in an ambulatory manner as a CAPD (Continuous Ambulatory
Peritoneal Dialysis) treatment.
[0003] CAPD is usually performed in four 6-hour sessions during
each 24-hour period. In each session, the dialysate solution is
instilled into the abdominal cavity of the subject and permitted to
dwell therein for a period of six hours, following which the
dialysate solution is drained, and a fresh dialysate solution is
instilled. This relatively large number of sessions greatly
disturbs the daily routine of the subject. It also increases the
risk of infection.
[0004] Various studies have been conducted on the application of
mechanical vibrations for improving the efficiency of waste removal
by PD (peritoneal dialysis); see J.Rudov et al. Nephron 46:364-366
(1987); Levitt et al. Kidney International, Vol. 35, pp. 1145-1150
(1989); and Utsunomia-T et al., Nippon-Jinzo-Gakkai-Shi; January
1995; 37(1):24-8. The Rudoy et al. publication (1987) describes an
improvement in peritoneal transfer on human subjects when subjected
to mechanical vibrations at a frequency of 24 Hz by a vibrator held
by the patient perpendicular to the patient's abdomen; the Levitt
et al. publication (1989) describes studies of the effects produced
on the rate of peritoneal transfer in rats by shaking the rats; and
the Japanese publication (1995) describes studies on the rate of
peritoneal transfer in rats by vibrating the abdominal wall at the
rate of 80 Hz.
OBJECTS AND BRIEF SUBJECT OF THE INVENTION
[0005] Objects of the present invention are to provide a vibrator
appliance particularly useful in peritoneal dialysis, and also an
improved method of peritoneal dialysis. The apparatus and method of
the present invention are particularly useful for CAPD, but may
also be used for other PD treatments, such as APD (Automated
Peritoneal Dialysis), and CCPD (Continuous Cycling Peritoneal
Dialysis) usually administered at home during the nighttime.
[0006] According to one aspect of the present invention, there is
provided an appliance to enhance the rate of removal of solutes
during a peritoneal dialysis treatment of a subject, comprising: a
holder to be applied to the subject; and at least one vibrator
device carried by the holder at a location thereof to engage the
subject's abdomen and to apply localized, inwardly-directed
mechanical vibrations thereto at a frequency of 1-15 Hz.
[0007] As will be described more particularly below, surprisingly
good results were produced when the vibrator device applies the
mechanical vibrations at a frequency of 2-6 Hz,
[0008] In the preferred embodiments of the invention described
below, there are two vibrator devices carried by the holder at
locations to engage the opposite sides of the subject's abdomen and
oriented to apply inwardly-directed mechanical vibrations towards
the central region of the subject's abdominal cavity.
[0009] According to another aspect of the invention, there is
provided a method of administering a peritoneal dialysis treatment
to a subject comprising a vibration session including: instilling a
dialysate solution into the peritoneal cavity of the subject;
applying external localized mechanical vibrations to the front side
of the abdomen of the subject at a frequency of 1-15 Hz and an
amplitude of 1-20 mm; and draining the dialysate solution from the
subject's abdominal cavity. As indicated above, and as will be more
fully described below, surprisingly good results were obtained when
the mechanical vibrations were applied, at a frequency of 2-6 Hz
and at a amplitude of 5-10 mm, especially when two vibrator heads
were used engaging the front side of the subject's abdomen on
opposite sides of its center line and oriented to direct mechanical
vibrations to the central region of the subject's abdominal
cavity.
[0010] Thus, it was found that applying the vibrations at a
frequency of over 15 Hz did not permit the vibrations to propagate
deeply into the body cavity, and therefore the 24 Hz frequency
mentioned in the J.Rudoy et al. publication cited above only
produced a limited improvement in the peritoneal dialysis
treatment. It was also found that applying the vibrations at a
frequency of less than 1 Hz also produced very limited benefits.
Surprisingly good results were found in the frequency range of 2-6
Hz, which produced an improvement of up to 150% in the solute
removal rate, as compared to an improvement of about 30-40% when
applying the mechanical vibrations at a frequency of 24 Hz as
described in the J.Rudoy et al. publication.
[0011] The optimum rate, preferably within the 2-6 Hz range, can be
determined emperically for each subject, according to the size,
build and weight of the subject.
[0012] The vibrational amplitudes are preferably in the range of
1-20 mm, best results having been obtained with amplitudes of 5-10
mm. These amplitudes are inversely related to the frequency; that
is, at the lower end of the above frequency range the vibrational
amplitudes would be at the higher end of the amplitude range, and
vice versa. Preferably, the combination of amplitude and frequency
should be just below the level producing significant pain or
discomfort to the subject, e.g., at the second limit of ISO
Standard 2631.
[0013] Further features and advantages of the invention will be
apparent from the description below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The invention is herein described, by way of example only,
with reference to the accompanying drawings, wherein:
[0015] FIG. 1 illustrates one type of vibrator appliance
constructed in accordance with the present invention utilizing an
electrically-actuated vibrator;
[0016] FIG. 2 illustrates a rotary-motor type vibrator that may be
used in the appliance of FIG. 1;
[0017] FIG. 3 illustrates a solenoid-type of vibrator that may be
used in the appliance of FIG. 1;
[0018] FIG. 4 illustrates a piston-type vibrator appliance
constructed in accordance with the present invention;
[0019] FIG. 5 illustrates an air-bag type vibratory appliance
constructed in accordance with the present invention;
[0020] FIG. 6 illustrates a moving-belt type vibrator appliance
constructed in accordance with the present invention;
[0021] FIG. 7 illustrates another vibratory appliance including a
belt supporting two electric motors rotating eccentric weights;
[0022] FIG. 8 illustrates a further appliance in which the
vibrations are effected by a pair of motors which cyclically
tension and relax a belt applied to the wearer's abdomen;
[0023] FIG. 9 is a plan view illustrating a further type of
appliance constructed in accordance with the present invention;
[0024] FIG. 10 is a rear view of the appliance of FIG. 9;
[0025] FIG. 11 is a plan view illustrating a still further
appliance constructed in accordance with the present invention;
[0026] FIG. 12 is a rear view of the appliance of FIG. 11;
[0027] FIG. 13 is a plan view of a still further appliance
constructed in accordance with the present invention;
[0028] FIG. 14 is a front view of the appliance of FIG. 13;
[0029] FIG. 15 is an artist's view of one form of vibrator
appliance constructed in accordance with the present invention;
and
[0030] FIG. 16 illustrates a dialysis set particularly useful with
the appliance and method of the present invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0031] The vibrator appliance illustrated in FIG. 1 includes a
holder 2 of a closed loop configuration to enclose the wearer's
abdomen, indicated by broken lines AB. Holder 2 carries two
vibrators 3a, 3b, each slidably mounted on the holder by a slide
4a, 4b, to enable each vibrator to be located so as to apply
mechanical vibrations to opposite sides of the abdomen of the
subject.
[0032] Holder 2 includes a back frame 2a, and a front frame 2b
mounting the two vibrators 3a, 3b. One end of front frame 2b is
pivotal, by hinge 5, to the respective end of the back frame 2a for
opening and closing the holder. The opposite end of front frame 2b
is lockable to the respective end of the back frame 2a by a lock,
schematically shown at 6, for locking the holder in its closed
condition. Both the back frame 2a and the front frame 2b include
width-adjusting means, as shown at 7 and 8, respectively, for
adjusting the size of the holder to fit persons of different sizes.
Such width adjustment means 7, 8 may be of any conventional
construction, such as slidable or telescoping sections in the
respective frames.
[0033] Holder 2 may be worn by the subject in a self-supporting
manner with the two vibrators 3a, 3b engaging the front side of the
subject's abdomen, on opposite sides of its center line. Thus, when
the two vibrators 3a, 3b are energized, they produce mechanical
vibrations which are inwardly-directed towards the center region of
the subject's abdominal cavity.
[0034] In the embodiment illustrated in FIG. 1, the two vibrators
3a, 3b, are electrically-driven. FIG. 2 illustrates one example of
such a vibrator, in the form of a rotary motor 10 rotating a disc
11 eccentrically mounting an arm 12 enclosed within a bellows 13
having a head 14 engageable with the user's abdomen such that
energization of motor 10 reciprocates the eccentric arm 12 and its
head 14 to apply mechanical vibrations to the wearer's abdomen.
FIG. 3 ilustrates another example of vibrator, in the form of a
solenoid 15 reciprocating an armature 16 enclosed within a bellows
17 and having a head 18 engaging the wearer's abdomen to apply
mechanical vibrations thereto upon the energization of the
solenoid. A still further example, including an electric motor
driving eccentric weights is described below with reference to FIG.
7. The displacements of the vibrations may be adjusted or changed
by changing the eccentricity of arm 12 in the appliance of FIG. 2,
the current through the solenoid 15 in the appliance of FIG. 3, and
the weights in the appliance of FIG. 7.
[0035] The use of the vibrator appliance illustrated in FIGS. 1-3
has been found to enable a CAPD treatment to be divided into two
12-hour sessions, rather than four 6-hour sessions as in the
conventional CAPD treatment. Following is one example of such a
two-session treatment:
[0036] In each session, dialysate solution is instilled into the
abdominal cavity of the subject, and the two vibrators 3a, 3b are
driven to cause them to apply mechanical vibrations to the abdomen,
at a frequency of 1-15 Hz, at a vibrational amplitude of 1-20 mm,
and for a period of 15-60 minutes. After this dwell period, the
dialysate solution is drained from the suject; fresh dialysate
solution is instilled and permitted to dwell in the subject for the
remaining 12-hour period of that session; and the dialysate
solution is then drained. This completes one 12-hour session,
whereupon the next 12-hour session is started, and the foregoing
sequence of steps is repeated. As indicated earlier, when the
frequency was 2-6 Hz, the vibrational amplitude was 5-10 mm, and
the dwell period was from about 30-40 minutes, surpringly improved
results were obtained producing an improvement of up to about 150%,
as compared to a 30-40% improvement mentioned in the above-cited
J.Rudoy et al. publication using 24 Hz vibrations.
[0037] These improved results enabled the normal four session CAPD
treatment to be reduced to two sessions, each session involving
e.g., a 40-minute dwell period accompanied by the vibrations, and
immediately followed by, e.g., an 11-hour 20-minute dwell period
not accompanied by vibrations. Thus, the 40-minute dwell period
accompanied by vibrations was found to remove substantially the
same amount of solutes as a normal 6-hour session in the
conventional CAPD treatment. Such a 2-session regimen is not only
much more convenient and substantially less disruptive of the daily
routine of the patient than the usual 4-session regimen, but also
substantially reduces the possibility of infection.
[0038] The two vibrators may be operated at the same constant
frequency, at different frequencies, or with changing frequencies.
They may be operated in the same phase or in different phases. One
or both vibrators may also be operated in a continuously changing
phase angle. Best results were obtained when both vibrators were
operated within the range of 2-4.5 Hz, with one vibrator operating
at a slightly different frequency than the other (such as 2.5 Hz
and 2.6 Hz, respectively) to produce alternating in-phase and
out-of-phase movements of the subject's abdomen. The subject may be
in a sitting, lying or standing position during the first part of
each session when the vibrations are applied, but best results were
obtained when the subject was in a sitting or supine position.
[0039] FIG. 4 illustrates a vibrator appliance, similar to that of
FIG. 1 except that the vibrators, therein designated 23a, 23b,
respectively, are in the form of fluid pistons movable within
cylinders to apply the vibrations to the wearer's abdomen. In FIG.
4, each of the vibrators 23a, 23b is shown as including a bellows
24a, 24b, enclosing the piston of the respective vibrator. The
pistons in vibrators 23a, 23b, may be operated pneumatically or
hydraulically. FIG. 4 schematically illustrates a pump or
compressor 25 for operating these pistons. In all other respects,
the vibrator appliance illustrated in FIG. 4 is constructed and
operates in substantially the same manner as described above with
respect to FIG. 1, and therefore the corresponding elements of the
appliance are identified by the same reference numerals to
faciliate understanding.
[0040] FIG. 5 illustrates another form of vibrator appliance
wherein the holder is in the form of a belt 32 to enclose the
subject, and the vibrators are in the form of inflatable air bags
33a, 33b carried by the belt on the opposite sides of the wearer's
abdomen. The air bags 33a, 33b are inflatable and deflatable at the
desired frequency by a compressor 35.
[0041] Belt 32 includes a stiff back 36 and a front adjustment 37
for adjusting the belt to fit persons of different sizes. While
FIG. 5 illustrates a compressor 35 for both vibrators, it will be
appreciated each vibrator could be provided with its own compressor
particularly if they are to be operated at different frequencies or
phases. The same apllies with respect ot the appliance of FIG.
4.
[0042] FIG. 6 illustrates a further vibrator appliance, in which
the holder includes a frame 40 to engage the back of the wearer, a
first belt 41 to be applied around the wearer, and a second belt 42
to be applied around the first belt 41. This appliance also
includes two vibrators applying mechanical vibrations to the
opposite sides of the wearer's abdomen. In this case, each vibrator
includes a plurality of plates 43 pivotally mounted at one end to
the inner belt 41, and at the opposite end to the outer belt 42.
The arrangement is such that when belt 42 is reciprocated, in the
direction of arrows 44, the two groups of plates 43 are pivotted
through a plurality of positions from 0.degree. to 180.degree., and
during such pivotal movements of these plates, they apply
mechanical vibrations to the wearer's abdomen. Thus, when the
plates are 0.degree. to the two belts 41, 42, the vibrational
amplitude is zero, but as the plates move to positions of
90.degree. to the two belts, they apply mechanical vibrations to
the wearer's abdomen at amplitudes corresponding to the widths of
the plates.
[0043] Each vibrator thus includes one group of plates 43 pivotally
mounted between the two belts 41, 42. The width of each plate 43
decreases from the rear side to the front side of the respective
vibrator so that the vibrational amplitudes are correspondingly
decreased from the rear side towards the front side of the
vibrator.
[0044] FIG. 6 schematically illustrates the front belt 42 as being
reciprocated by a pair of motors 45, 46, at the opposite ends of
the rear frame 40. An adjustment 47 for the rear frame 40, and an
adjustment 48 for the two belts 41, 42, enable the appliance to fit
persons of different sizes.
[0045] FIG. 7 illustrates another appliance, including a belt 50
having a back adjustment 51 and a front adjustment 52 to enable the
appliance to be fitted to different size individuals. Belt 50
carries a pair of vibrators 53a, 53b on its opposite sides to
engage the opposite sides of the wearer's abdomen. Each vibrator
53a, 53b includes an electric motor 54a, 54b, driving a pair of
eccentric weights 55a, 55b which, upon energization of the
respective motors, apply mechanical vibrations to the wearer's
abdomen.
[0046] FIG. 8 illustrates an even more simplified construction,
including a back frame 60 having an adjustment 61, and front belts
62, 63 having a front adjustment 64. The back frame 60 carries a
pair of electric motors 65, 66 engaging the opposite ends of belts
62, 63 such that energization of the electric motors cyclically
tensions and relaxes the belts to cause them to apply mechanical
vibrations to the opposite sides of the wearer's abdomen engaged by
the belts.
[0047] FIGS. 9 and 10 illustrate another appliance 70 also
including a holder in the form of a loop to be worn by the subject
in a self-supporting manner. In this case, the appliance includes
two base members 71, 72 coupled together by a hinge 73 and mounted
to a stiff or rigid back plate 74 adapted to engage the back of the
subject. The base members 71, 72 mount electrical motors 75, 76
which are eccentrically coupled to one end of a pair of flexible
belts 77, 78 adapted to engage the front side of the subject's
abdomen. The opposite ends of belts 77, 78 are coupled together by
a locking device or buckle 79.
[0048] A pair of vibrator heads 80, 81 are carried by the two belts
77, 78. Heads 80, 81 extend inwardly of the loop to contact the
front side of the subject's abdomen on opposite sides of its center
line and are oriented towards the central region of the subject's
abdominal cavity. Thus, when the two electrical motors 75, 76 are
energized, their eccentric connections to the flexible belt 77, 78
cyclically tension and relax the belts causing the vibrator heads
80, 81 to apply mechanical vibrations directed to the central
region of the subject's abdominal cavity.
[0049] The front buckle or lock 79 is adjustable to permit the
diameter of the loop to be adjusted according to the size of the
subject. The two vibrator heads 80, 81 are slidable on the belts
77, 78 to permit them to be optimally positioned in order to direct
the mechanical vibrations to the central region of the subject's
abdominal cavity. The two hinged base members 71, 72 may also be
adjustable on the back plate 74. Thus, as shown in FIG. 10, the
back plate 74 carries two parallel screws 82, 83 rotate together by
another screw 84. Screws 82, 83 on the back plate 74 are received
within nuts 85, 86 on the two base members 71, 72, such that
rotation of the two screws 82, 83 by the common screw 84 moves the
two base members 71, 72 up or down according to the direction of
rotation of screws 84.
[0050] FIGS. 11 and 12 illustrate a similar appliance as in FIGS. 9
and 10, and therefore the same reference numerals have been used
for the same parts. In the appliance of FIGS. 11 and 12, however,
the ends of the two base members 71, 72 are not hinged together,
but rather are formed with parallel slots 91, 92 receiving threaded
pins 93, 94. In addition, each base member 71, 72 has secured
thereto a transverse rigid strip 95, 96 adapted to be received
within grooves 97, 98 formed in the back plate 74. Strips 95, 96
carried by the base members 71, 71, and grooves 97, 98 in the back
plate 74, are formed with a plurality of openings extending along
the length of the strips and grooves, respectively, adapted to
selectively receive threaded pins 99. Thus, by threading pins 99 in
selected openings in the strips 95, 96, and grooves 97, 98, the
position of the base members 71, 72 may be adjusted along the
length of the back plate; and by tightening the threaded pins 93,
94 in their respective slots 91, 92, the diameter of the appliance
may be adjusted to fit different sized persons.
[0051] FIGS. 13 and 14 illustrate another appliance 100 which
includes a loop enabling the appliance to be worn by the user in a
self-supporting manner, but further includes a pair of shoulder
harnesses 102, 103 to aid the loop in supporting the appliance on
the subject.
[0052] The appliance 100 illustrated in FIGS. 13 and 14 includes a
base member 104 at the front of the appliance, i.e., to engage the
front side of the subject's abdomen, and a back plate 105 at the
opposite side of the appliance to engage the subject's back. The
base member 104 is connected to the back plate 105 by a pair of
flexible belts 101a, 101b, to thereby define the closed loop 101
enabling the appliance to be worn by the subject. Each of the
flexible belts includes a locking member or buckle 106, 107 of the
type which permits the lenght of the belt to be adjusted and
locked, to thereby enable the appliance to fit different sized
persons.
[0053] Base member 104 at the front side of the appliance carries
an electrical motor 111 having an output shaft 112 eccentrically
coupled at its opposite ends to a pair of shaped vibrator heads
113, 114 carried by plates 115, 116 pivotally mounted to he base
member 104. Each of the eccentric couplings between the motor
output shaft 112 and the vibrator heads 113, 114 includes a dashpot
device 117, 118 pivotally mounted to plates 115, 116. Each dashpot
device 117, 118 includes an adjustment, indicated by screws 117a,
118a, which permits manual adjustment of the retarding action of
the respective dashpot. The retarding action of each dashpot may
also be remotely adjusted via electrical or hydraulic means. These
adjustments may be used not only for adjusting the cushioning
forces applied by the vibrator heads 113, 114 against the subject's
abdomen, but also for changing the relative phases of the forces so
applied, upon rotation of the electrical motor 111.
[0054] FIG. 15 illustrates the external appearance of a vibrator
appliance 120 constructed in accordance with the present invention.
The appliance includes a backrest 121, a seat 122 and a pair of
arms 123, 124, each having a rear section 123a, 124a, pivotally
mounted to the backrest 121, and a front section 123b, 124b,
carrying a vibrator head 125, 126 to engage the front side of the
subject's abdomen. The rear arm sections 123a, 124a are pivotally
mounted to the backrest 121, as schematically indicated by integral
hinge 127, and may be fixed in any pivotted position by any
suitable means such as a screw and nut arrangement (not shown).
Similarly, the front arm sections 123b, 124b are pivotally mounted
to their respective rear arm sections 123a, 123b, as indicated by
integral hinges 127, and may also be fixed in any pivotted
position, to thereby enable the appliance to be used with respect
to persons of different sizes. The vibrator heads 125, 126 carried
by the front arm sections 123b, 124b, may be driven electrically,
hydraulically, or pneumatically, according to any of the
above-described arrangements.
[0055] FIG. 16 illustrates a dialysis set particularly useful with
respect to the above-described appliance. The illustrated set
includes two supply bags 131, 132 for containing fresh dialysis
solution, and a drainage bag 133 to receive the solution after
drained from the subject. The three bags are connected to a
connector 134 for the dialysis catheter (not shown) by tubing
generally designated 135. Tubing 135 includes two tubes 136, 137,
connected at one of their ends to the respective supply bag 131,
132, and at their opposite ends to a third tube 138 leading to the
catheter connector 134. Tube 138 is connected to a fourth tube 139
leading to the drainage bag 133.
[0056] Each tube 136, 137 includes a valve 140, 141 which is
normally closed, but which can be manipulated to open and thereby
to permit the respective supply bag 131, 132 to instill its fluid
to the patient via the catheter connected to connector 134. Valves
140, 141 may be breakaway valves which are normally closed, but
which may be manually broken-away to open the valve.
[0057] In use of the dialysis set illustrated in FIG. 16, the two
supply bags 131, 132 would be mounted at a higher elevation than
the catheter connector 134, and the drainage bag 133 would be
mounted at a lower elevation than the catheter connector. In
addition, an external clamp (not shown) would be applied to tube
139 to prevent the dialysis solution from passing to the drainage
bag 133 during instillation phase. With a clamp thus applied to
tube 139, valve 140 would be manipulated to open, thereby
permitting the fluid to flow by gravity from supply bag 131 via the
catheter into the abdominal cavity, whereupon the vibrator
appliance would be energized to enhance the rate of solute removal.
After the appropriate dwell time, the clamp would be removed from
tube 139 to permit the solution to drain into the drainage bag 133,
whereupon the clamp would then be reapplied to tube 139 and valve
141 of supply bag 132 would be opened to permit the solution in
that bag to flow by gravity into the abdominal cavity of the
subject.
[0058] The dialysis set illustrated in FIG. 16 may thus be
connected to the patient's catheter during two successive
exchanges, thereby substantially reducing the possibility of an
infection and also reducing the disruption to the patient's daily
routine.
[0059] Generally speaking, it was found that a 40-minute dialysate
treatment accompanied by mechanical vibrations applied in any of
the above-described appliances effects about the same solute
transfer as a 6-hour dialysate treatment not accompanied by
mechanical vibrations. Accordingly, such an appliance permits
various treatments to be applied, according to the nature of each
case and the convenience of the subject. Following are examples of
such treatments:
[0060] (1) Each 24-hour day is divided into two 12-hour periods,
each period including a vibration session for 15-60 minutes, and a
non-vibration session with fresh dialysate solution for the
remainder of the period.
[0061] (2) Each 24-hour day includes four vibration sessions of
15-60 minutes each, spaced about six hours apart.
[0062] (3) Each 24-hour day is divided into four 6-hour periods, at
least one of these periods including a vibration session for 15-60
minutes, and a non-vibration session with fresh dialysate solution
for the remainder of the period, each of the remaining periods
being a non-vibration session with fresh dialysate.
[0063] (4) Each 24-hour day includes a vibration session for 15-60
minutes, a non-vibration session with fresh dialysate solution for
10-11.5 hours, and another vibration session with fresh dialysate
for 15-60 minutes.
[0064] (5) Each 24-hour day includes six equally-spaced 1-1.5 hours
each, each period including instilling fresh dialysate solution for
10-15 minutes, a dwell accompanied by vibrations for 30-60 minutes,
and removing the dialysate solution for 15-20 minutes.
[0065] In all the above treatments except treatment (4) above, each
session (vibrating or non-vibrating) should involve the
instillation of 2-2.5 liters of the dialysate fluid. However, in
treatment (4) above, since there are a total of only three sessions
during the 24-hour day, each session should involve the
instillation of about 2.5-3.0 liters of the dialysate fluid.
[0066] Each vibration session should be between 15-60 minutes, a 40
minute period having been found to be preferred in most cases. In
addition, after each vibration session the dialysate should be
drained and fresh dialysate added for the next session.
[0067] When the vibrator appliance is used for a continuous 24-hour
day (CAPD) treatment, it may be constructed as described above so
as to be worn on the user, thereby enabling the user to perform
daily routines in the least-disruptive manner. However, when the
vibrator appliance is not to be used continuously, it may be
incorporated in a self-supporting structure, such as a chair as
described above, or a stand or table.
[0068] It was further surprisingly found that when the vibrator
appliance was operated at the lower frequencies, e.g., 1-3 Hz, it
promoted sleep on the part of the wearer. Actually, during clinical
experiments, the wearers frequently went to sleep when the
appliance was operated at these lower frequencies 1-3 Hz, but
immediately awoke when the vibrations were stopped or the frequency
was increased to the 2-6 Hz range. The illustrated appliance may
therefore be advantageously used also for promoting sleep.
[0069] While the invention has been described with respect to
several preferred embodiments, it will be appreciated that these
are set forth merely for purposes of example, and that many
variations may be made. For example, in all the described devices,
the two vibrators can be operated at the same frequency but with
different phases, at different frequencies, or at progressively
changing frequencies. In addition, whereas the above described
embodiments include two vibrators engaging opposite sides of the
subject's abdomen, a different number of vibrators could be used.
Also, the dashpot devices illustrated in FIGS. 13 and 14 may be
used with any of the other vibrator devices between the vibrator
heads and the respective drives. Many other variations,
modifications and applications of the invention will be
apparent.
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