U.S. patent number 3,817,237 [Application Number 05/283,274] was granted by the patent office on 1974-06-18 for regulatory apparatus.
This patent grant is currently assigned to Medtronic, Inc.. Invention is credited to Lee R. Bolduc.
United States Patent |
3,817,237 |
Bolduc |
June 18, 1974 |
**Please see images for:
( Certificate of Correction ) ** |
REGULATORY APPARATUS
Abstract
A regulatory apparatus for controlling the movement of fluids,
cells and energy in conveying structure, as spermatazoa in the
ductus deferens or signals in nerve fibers. The regulatory
apparatus has a stepped down gear train driven in response to a
remote magnetic field to selectively expand and contract a flexible
member. A valving device connected to the flexible member is
operable to selectively open and close a passageway coupled to the
conveying structure in response to the expansion and contraction of
the flexible member.
Inventors: |
Bolduc; Lee R. (Minneapolis,
MN) |
Assignee: |
Medtronic, Inc. (Minneapolis,
MN)
|
Family
ID: |
23085300 |
Appl.
No.: |
05/283,274 |
Filed: |
August 24, 1972 |
Current U.S.
Class: |
128/843;
128/DIG.25; 604/250; 600/30 |
Current CPC
Class: |
A61F
6/24 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/24 (20060101); A61b
019/00 () |
Field of
Search: |
;128/1R,274,346,DIG.25
;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Kusserow Trans. Amer. Soc. Art Inter. Orgs, 1960, Vol. VI, pp.
292-294..
|
Primary Examiner: Truluck; Dalton L.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. An apparatus for implantation in the body of an animal operable
to control the functioning of a body fluid conveying means and
being responsive to a remote moving magnetic field comprising: case
means hermetically enclosing a space, said case means having
imperforate flexible wall means having an inside surface and
outside surface at one portion of the case means, first means for
selectively expanding and contracting said flexible wall means,
said first means including a first member attached to the inside
surface of said flexible wall means and a second member threadably
engaged with the first member, said second member being rotatable
to selectively axially move the first member to thereby selectively
expand and contract said flexible wall means, power transmission
means connected to said second member for transmitting rotational
motion to the second member, magnet means connected to the power
transmission means, said magnet means being responsive to the
remote moving magnetic field to operate the power transmission
means, said first means, power transmission means and magnet means
being located within the case means and valve means secured to the
case means externally of the case means, said valve means having
tubular means connected to the body fluid conveying means and
plunger means secured to the outside surface of said flexible wall
means and engageable with the tubular means, said plunger means
movable in response to expansion and contraction of the flexible
wall means to selectively open and close the tubular means to
control the functioning of the body fluid conveying means.
2. The apparatus of claim 1 wherein: said flexible wall means is a
flexible diaphragm.
3. The apparatus of claim 1 wherein: said flexible wall means is a
flexible diaphragm located across one end of the case means, said
second member being attached to a center portion of the
diaphragm.
4. The apparatus of claim 1 wherein: the first member includes a
sleeve secured to the wall means, said sleeve having a threaded
bore, said second member having a head threaded into said threaded
bore.
5. The apparatus of claim 1 wherein: said case means includes an
expandable and contractable side wall.
6. The apparatus of claim 1 wherein: said power transmission means
is a stepped down gear train having an input shaft connected to the
magnet means and an output shaft connected to the second
member.
7. The apparatus of claim 1 wherein: said magnet means comprises at
least one bar magnet having north and south magnetic poles at
opposite ends thereof.
8. The apparatus of claim 1 wherein: the valve means has a body
secured to the case means, said body having a passage accommodating
the plunger means to control the functioning of the conveying
means.
9. The apparatus of claim 8 wherein: the valve means has a pair of
tubular members connected to the conveying means, said plunger
means having a pair of movable members secured to the flexible wall
means, one of said movable members being engageable with one
tubular member and the other movable member being engageable with
the other tubular member, said movable members being responsive to
expansion movement of the flexible wall means to collapse the
tubular members and responsive to contraction of said flexible
means to permit the tubular members to open.
10. The apparatus of claim 1 including: means securing the valve
means to the case means, said valve means having a tubular member
connected to the conveying means, and a body having a passage
accommodating the plunger means whereby said plunger means is
engageable with the tubular member so that on expansion of the
flexible wall means, the plunger means closes the tubular member
and on contraction of the flexible wall means the plunger means
permits the tubular member to open.
Description
BACKGROUND OF THE INVENTION
Magnetic couplings have been used to drive devices implanted in the
body. Remotely actuated servomechanisms have been developed to
control a potentiometer and impart rotary motion to a pump. Bolduc
in U.S. Pat. No. 3,569,894 discloses a magnetic servo apparatus
having a gear train for operating a potentiometer. Dorman et al. in
U.S. Pat. No. 3,608,088 shows an exterior remote drive magnet for
operating an implanted rotary blood pump.
At the present time the one certain way for men to prevent
conception is to have a vasectomy. This operation is irreversible,
as the ductus deferens is severed. Efforts have been made to
connect the served ductus deferens with a valve that can be closed
to stop the flow of sperm or opened to allow it to flow in the
ductus deferns. These valves can only be regulated through a
surgical procedure and cannot be remotely operated.
SUMMARY OF THE INVENTION
The invention relates to a regulatory apparatus that is implantable
in the body of an animal to control the functioning of a
bioconveying and biotransmitting means. The regulatory apparatus is
responsive to a remote moving magnetic field located outside the
body to effect a control of the conveying means. The regulatory
apparatus has a case hermetically enclosing a space. The case has a
flexible means. Enclosed within the space is a first means for
selectively expanding and contracting the flexible means. A power
transmitting means is connected to the first means for transmitting
movement of the first means. The power transmitting means is
operated by a magnetic means. The first means, power transmitting
means and magnet means are all located within the case means.
Located externally of the case means is a second control means
operable in response to expansion and contraction of the flexible
means to control the functioning of the conveying means. The second
means is mounted on the case means and comprises a valve device
operable to selectively open and close the conveying means thereby
controlling the functioning of the conveying means. The conveying
means can be a member having a passageway connected to a duct or
canal conveying liquid as blood, lymph, semen or spermatazoa. The
conveying means can also be used in conjunction with a chord or
nerve fiber to control the transmission of nerve signals.
It is an object of the invention to provide an implantable
apparatus which can be operated externally of the body to control
the functioning of a conveying means, as the ductus deferens to
control the flow of spermatazoa. Another object of the invention is
to provide an implantable apparatus with a hermetically sealed case
enclosing a power transmitting means operable to actuate a control
member located outside of the case.
IN THE DRAWINGS
FIG. 1 is an elevational view, partly sectioned, of the
reproductive parts of a male primate having the regulatory
apparatus of the invention;
FIG. 2 is an enlarged end view of the regulatory apparatus shown in
FIG. 1;
FIG. 3 is an enlarged sectional view taken along the line 3--3 of
FIG. 2;
FIG. 4 is an enlarged sectional view taken along the line 4--4 of
FIG. 2;
FIG. 5 is a sectional view similar to FIG. 4 of a modification of
the valving device of the regulatory apparatus; and
FIG. 6 is a side elevational view of a modified regulatory
apparatus of the invention.
Referring to the drawings, there is shown in FIG. 1 the
reproductive parts of a male primate indicated generally at 10. The
drawings are in diagram form to facilitate understanding the
invention and are not to any scale. The scale varies from one view
to another. For example, the remote actuator 17 hereinafter
described can be much larger in size than the implanted regulatory
apparatus 16. Parts 10 are shown by way of example only as the
regulatory apparatus 16 of the invention can be used not only in
male and female humans but in animals and fowl and like creatures.
Parts 10 include the male reproductive glands or testes 11 and the
ductus deferens 12, which functions as a vas or duct for carrying
the male gamete or spermatazoa from gland 11 to the ejaculatory
duct. Gland 11 and duct 12 are located in a musculocutaneous sac or
scrotum 13 formed of skin and a network of muscular fibers. The
regulatory apparatus 16 can be located in other body cavities and
used to control the flow of ovum in the uterine tube of a female.
Signals in selected nerve fibers can also be controlled with the
regulatory apparatus to restrict and temporarily block transmission
of nerve signals. The invention is hereinafter described as
relating to the control of spermatazoa in the ductus deferens, it
being understood that the regulatory apparatus is useable as a
control in other parts of the anatomy. Two regulatory apparatuses
can be used with the two ductus deferens. Alternatively, one ductus
deferens can be severed.
Implanted within scrotum 13 is the regulatory apparatus of the
invention indicated generally at 16. Apparatus 16 is a device
operable to selectively close and open the passage of the ductus
deferens 12, thereby controlling the emission of spermatazoa. When
the ductus deferens is closed for both testes, it is impossible to
have zygosis with an ovum.
Referring to FIG. 3, the regulatory apparatus 16 has a cup-shaped
case or housing 18 having an outwardly directed annular lip 19 at
the open end thereof. Case 18 is formed from a rigid material which
is electrically insulative and biologically inert, as ceramic
material, polycarbonate resin or polypropylene. Case 18 can also be
formed from stainless steel or titanium. A flexible diaphragm 21 is
hermetically sealed to lip 19 to form a sealed chamber 22 within
housing 18 impervious to body fluids and tissue. A power
transmitting apparatus 23 located in chamber 22 has a pair of
spaced plates 24 and 25 carrying a stepped down gear train 26.
Preferably, the gear train 26 has a power ratio of 1500:1. Other
gear ratios can be used. The gear train 26 is illustrated as a spur
gear assembly having a plurality of interengaging gears. Other
types of gear mechanisms, such as planetary gears, can be used for
the gear train. Lubricant, as oil, is contained within the
hermetically sealed housing 18 for the power transmitting means.
Plate 24 is in engagement with an annular sleeve 27 spacing the
plate from diaphragm 21. Opposite plate 25 engages an annular
sleeve 28 which rests on the bottom wall of the housing. Sleeves 27
and 28 are preferably of non-magnetic, electrically insulative
material such as polyethylene, Nylon, Teflon or Delrin. Power
transmitting apparatus 23 has power input shaft 29 carrying
outwardly directed rod magnets 31 and 32. The magnets are formed
from a high energy magnetic material as
iron-aluminum-nickel-cobalt-copper alloys or magnetic
platinum-cobalt alloys. Magnet 31 has a south polarity. Magnet 32
has a noth polarity. Concentrically aligned with input shaft 29 is
an output shaft 33. Bearings 34 on plate 24 rotatably mount the
output shaft 33. Output shaft 33 has a threaded head 36. Head 36 is
threaded into a nut or sleeve 37 secured to the center portion of
the inside of diaphragm 21. The head 36 and sleeve 37 are
cooperating means operable to move the diaphragm 21. Head 36 can be
a cylindrical member or sleeve that is threaded onto a bolt-like
member secured to the center portion of the inside of diaphragm 21.
The cooperating threaded members 36 and 37 can be located within
the confines of gear train 26 between plates 24 and 25 to reduce
the overall height of the housing 18.
A control or valve device indicated generally at 38 is mounted on
the housing 18 adjacent the outside of diaphragm 21. Valve device
38 has a support 39. Device 38 and support 39 can be enclosed with
a cover to prevent fibrosis around the device. As shown in FIG. 2,
support 39 extends across the midsection of diaphragm 21. The
center portion of support 39 carries a holder or body 41 having a
transverse passage 42. Extended through passage 42 is an elongated
tubular member 43. Member 43 is made of flexible material that can
be closed or collapsed and will return to its open position. For
example, member 43 can be a silicone rubber tube. Opposite ends of
tubular member 43 extend outwardly in opposite directions from the
body 41 and carry the ductus deferens 12, whereby the tube 43
provides a continuous passage for the spermatazoa. A body 41 has a
stem 44 carrying a nut 46 operable to secure the body to support
39. Stem 44 has a passage carrying a movable plunger or valving
element 47. As shown in FIGS. 3 and 4, valving element 47 is
secured to the center portion of the flexible diaphragm 21 in
alignment with the axis of nut 37. The outer end of plunger 47
engages the flexible tube 43 and is movable in the opposite
direction, as indicated by arrow 48, to a position to close the
passage and tube 43, shown by broken lines in FIG. 3, and to open
the passage, as shown in full lines in FIG. 3. Body 41 can be an
integral part of support 39.
In operation, the regulatory apparatus 16 is surgically implanted
in the body cavity shown in FIG. 1 and connected to the ductus
deferens 12. Housing 18 and diaphragm 21 are hermetically sealed
together whereby the chamber 22 is not affected by body fluids or
other corrosive media, tissue ingrowth and the like. The remote
actuator 17 includes a motor 66 having a rotatable shaft 67. A
magnet 68 is secured to shaft 67 and is rotated on operation of
motor 66. Magnet 68 is shown as a bar magnet having a north pole
and a south pole. Motor 66 can be a reversible type and have switch
means for selecting its direction of rotation. Motor 66 is enclosed
in housing 69. Suitable counting means (not shown) may be attached
to the motor 66 or shaft 67 to count the number of turns in either
direction of rotation of the magnet 68.
On energization of motor 66, the shaft 67 rotates magnet 68. The
actuator 17 is held in close proximity to the regulatory apparatus
16, as shown in FIG. 1, to provide a magnetic coupling. There is no
physical connection between the actuator 17 and regulatory
apparatus 16. The moving flux lines or magnetic force of magnet 68
will affect magnets 31 and 32 to cause rotation of shaft 29. The
rotation of input shaft 29 will transmit force via the power
transmitting apparatus 23 to the output shaft 33. The rotation of
output shaft 33 will turn the threaded head 36 relative to the
fixed nut 37. The relative rotation between head 36 and nut 37 will
cause the diaphragm to move outwardly, as shown in broken lines, or
inwardly depending on the direction of drive of input shaft 29.
When the motor 56 is operated in a forward direction, the threaded
head 36 will rotate to flex the diaphragm 21 in an outward
direction, as shown by broken lines in FIG. 3. This moves the
plunger 47 in an outward direction, flexing tube 43 to the closed
or blocked position, shown in broken lines in FIG. 3. This will cut
off the flow of spermatazoa through the ductus deferens 12.
In the event it is desired to resume the flow of spermatazoa
through the ductus deferens 12, the regulatory apparatus 16 can be
actuated to its open position with remote actuator 17. Motor 16 is
operated in a reverse or off direction, thereby rotating magnet 68
in a direction which will reverse the power transmitting apparatus
23 and rotate the threaded head 36 in a direction which will move
the flexible diaphragm back to its initial position in the cavity
22, shown in full lines in FIG. 3. Plunger 46, being attached to
the diaphragm, will retract away from tube 43. Tube 43, being of a
flexible material, will move back to its initial open position,
thereby allowing the flow of spermatazoa in the ductus deferenes
12.
Referring to FIG. 5, there is shown a modification of a valve
device, indicated generally at 50, for accommodating a plurality of
tubes 54 and 56. The structure is identical in the valve device 50
and the regulatory apparatus is indicated with the same reference
numerals having the suffix "A." The valve device has a body or
holder 51 having a pair of generally aligned passages 52 and 53 for
carrying tubes 54 and 56. Body 51 has a stem 57 extended through
the hole in support 39A. A nut 58 threaded on the stem holds the
body in assembled relation with support 39A. Secured to the center
portion of diaphragm 21A are a pair of plungers 61 and 62. Plungers
61 and 62 can be attached to a cross member pivotally connected to
the diaphragm. Plunger 61 has an outer end that extends into a
passage in body 51 and is engageable with tube 54. In a similar
manner, plunger 62 has an outer end extended into passage 53 and is
engageable with tube 56. On rotation of threaded head 36A, flexible
diaphragm 21A can move in opposite directions as indicated by arrow
63. When 36A is rotated in a first or forward direction, the
plungers 61 and 62 move into engagement with tubes 54 and 56,
flexing the tubes and thereby blocking the passage in the tubes to
prevent the flow of spermatazoa. On operation of the threaded head
36A in the opposite direction, flexible diaphragm 21A moves away
from the body, thereby carrying the plungers 61 and 62 away from
tubes 54 and 56, thereby opening the passages in the tubes.
Referring to FIG. 6, there is shown a modification of the
regulatory apparatus indicated generally at 70. Apparatus 70 has a
hermetically sealed housing 71. The outer circumferential wall of
the housing has an accordion or corrugated shape which will allow
longitudinal expansion and contraction of the housing side wall on
operation of the gear train and jack screw mechanism hermetically
sealed within the housing. Mounted on one end of the housing is a
valve device 72 similar to the valve device 38 shown in FIG. 4 for
carrying a tube 73. On operation of the regulatory apparatus 70
with the use of a remote actuator similar to actuator 17, the side
wall of housing 71 will expand, thereby effectuating a closing of
valve device 72. On operation of the remote actuator in the
opposite direction, the side wall of housing 71 will contract,
thereby opening valve device 72.
The above description relates to preferred embodiments of the
invention; however, it is understood that various other embodiments
and changes in size, material, power transmission means and valving
mechanisms may be made by those skilled in the art without
departing from the spirit of the invention. Furthermore, the
invention is not intended to be particularly limited to the control
of spermatazoa in the ductus deferens of a male primate. The
invention is useable with other vas, ducts or canals carrying
fluids such as blood, lumph and the like. Also, the invention is
useable with other biocontrol means, as nerve fibers and can
function to temporarily restrict and block impulses in nerve
fibers.
* * * * *