U.S. patent number 3,908,668 [Application Number 05/464,488] was granted by the patent office on 1975-09-30 for tissue stimulator with sealed lead connector.
This patent grant is currently assigned to Medtronic, Inc.. Invention is credited to Lee R. Bolduc.
United States Patent |
3,908,668 |
Bolduc |
September 30, 1975 |
Tissue stimulator with sealed lead connector
Abstract
A method and apparatus for connecting a lead to a pulse
generator for producing and applying electrical stimulation pulses
to remote body tissue. The lead connector is associated with the
pulse generator and is engageable and operable by a tool to connect
the lead to the pulse generator and comprises sealing means
puncturable by the tool in engagement with the connector and
resealable upon removal of tool for providing a sterilizeable,
insulating, inert seal between the connector and body tissue. In
addition, the tool further comprises means for preventing the
application of too great a force to the lead connector to prevent
its damage. The lead connector may further comprise a receptacle
for receiving the lead and retaining means associated with the
receptacle and engageable by the tool for retaining the lead in the
receptacle. In addition, the retaining means may further comprise
means movable by the tool into contact with the lead for retaining
the lead in stationary relationship in the receptacle, and the
receptacle may further comprise means for preventing the release of
the movable means by the tool from the receptacle.
Inventors: |
Bolduc; Lee R. (Minneapolis,
MN) |
Assignee: |
Medtronic, Inc. (Minneapolis,
MN)
|
Family
ID: |
23844140 |
Appl.
No.: |
05/464,488 |
Filed: |
April 26, 1974 |
Current U.S.
Class: |
607/37;
439/814 |
Current CPC
Class: |
H01R
4/36 (20130101); A61N 1/3752 (20130101) |
Current International
Class: |
A61N
1/375 (20060101); A61N 1/372 (20060101); H01R
4/36 (20060101); H01R 4/28 (20060101); A61N
001/36 () |
Field of
Search: |
;128/419C,419E,419P,419R
;339/6R,65,66R,75R,272A,272R ;85/1K,1SS |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Medtronic, Inc., Publication No. TC68101R, December, 1968, pp.
1-21, only page 6 relied on..
|
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Rappaport; Irving S. Breimayer;
Joseph F.
Claims
1. In combination with a tissue stimulator having pulse generator
means for producing tissue stimulation pulses, housing means of a
surface material compatible with the human body as an environment
enclosing said pulse generator means, lead means adapted to conduct
the stimulation pulses to body tissue remote from said pulse
generator means upon connection of said lead means to said pulse
generator means and lead connector means coupled with said pulse
generator means and situated at a predetermined position within
said housing means engageable by tool means in the operation of
connecting said lead means to said pulse generator means; the
improvement comprising:
sealing means of a homogeneous material compatible with the human
body as an environment puncturable by said tool means to engage
said connecter means and resealable upon removal of said tool means
for providing an inert, electrically insulating seal between said
connector means and body fluids and tissues, said sealing means
being conformed to extend from the surface of said housing means
through a gap in said housing means to said predetermined position
of said connector means and in contact therewith; and
means associated with said housing means for maintaining said
sealing means
2. The tissue stimulator of claim 1 wherein said lead connector
means further comprises:
a. receptable means for receiving said lead means; and
b. retaining means associated with said receptacle means and
engageable by said tool means for retaining said lead means in said
receptacle means.
3. The tissue stimulator of claim 2 wherein said retaining means
further comprises means movable by said tool means into contact
with said lead means for retaining said lead means in stationary
relationship in said receptacle means; and said receptacle means
further comprises means for preventing the release of said movable
means by said tool means from said
4. The tissue stimulator of claim 1 wherein said sealing means
comprises an
5. In combination with a tissue stimulator having pulse generator
means for producing stimulation pulses, housing means of a surface
material substantially inert to body fluids and tissue enclosing
said pulse generator means, lead means adapted to conduct the
stimulation pulses to remote body tissue upon connection of the
lead means to the pulse generator means, said lead means having an
electrically conductive connector pin at its proximal end to be
electrically connected to said pulse generator means, and lead
connector apparatus coupled with said pulse generator means and
situated at a predetermined position within said housing means
engageable by tool means in the operation of connecting said lead
means to said pulse generator means, said lead connector means
further comprising electrically conductive, receptacle means for
receiving said connector pin, and retaining means associated with
said receptacle means engageable by said tool means for retaining
said connector pin in electrically conductive, stationary
relationship in said receptacle means; the improvement
comprising:
sealing means of a homogeneous material compatible with the human
body as an environment puncturable by said tool means to engage
said retaining means and resealable upon removal of said tool means
for providing an inert, electrically insulating seal between said
receptacle means and said retaining means and body fluids and
tissues, said sealing means being conformed to extend from the
surface of said housing means through a gap in said housing means
to said predetermined position of said connector means and in
contact therewith; and
means associated with said housing means for maintaining said
sealing means
6. The tissue stimulator of claim 5 wherein said lead means further
comprises an electrically insulated conductor having a conductive
stimulating electrode at its distal end and said electrically
conductive
7. The tissue stimulator of claim 6 wherein said pulse generator
means further comprises a source of electrical energy and
electrical circuit means connected to said source of electrical
energy for producing periodic, electrical stimulation pulses, and
said housing means comprises encapsulating means substantially
inert to body fluids and tissue for enclosing and covering said
source of electrical energy and said electrical circuit means; and
wherein said lead connector means further comprises resilient boot
means substantially inert to body fluids and tissue and associated
with said receptacle means for guiding said connector pin to said
receptacle means and engageable with the electrical insulated
conductor at its distal end for inhibiting the entrance of body
8. The tissue stimulator of claim 5 wherein said sealing means
comprises a
9. The tissue stimulator of claim 5 wherein said retaining means
further comprises movable means engageable by said tool means and
responsive to rotation of said tool means in a first direction to
move into contact with
10. The tissue stimulator of claim 9 wherein said retaining means
further comprises means associated with said retaining means for
preventing said movable means from being released from said
retaining means upon engagement by said tool means and by turning
said movable means in the
11. In combination with a tissue stimulator having pulse generator
means for producing periodic, stimulation pulses, housing means of
a surface material substantially inert to body fluids and tissue
enclosing said pulse generator means, lead means adapted to conduct
the stimulation pulses to remote body tissue upon connection of the
lead means to said pulse generator means, said lead means
comprising an electrically insulated conductor having a conductive
stimulating electrode at its distal end and an electrically
conductive, elongated connector pin at its proximal end adapted to
be electrically connected to said pulse generator means and lead
connector means coupled with said pulse generator means and
situated at a predetermined position within said housing means
engageable by driving tool means in the operation of connecting
said lead means to said pulse generator means, said lead connector
means further comprising electrically conductive, connector block
means having an elongated receptacle for receiving said connector
pin and a threaded bore extending perpendicular to and from said
receptacle through said connector block means and screw means
threaded in said threaded bore and engageable by said tool means
for turning said screw means in a first direction to make
electrical contact with and tighten said connector pin in said
receptacle; the improvement comprising:
sealing means of a homogeneous material compatible with the human
body as an environment puncturable by said tool means to engage
said connector block means and resealable upon removal of said tool
means for providing an inert, electrically insulating seal between
said connector block means and body fluids and tissue,
said sealing means being conformed to extend from the surface of
said housing means through a gap in said housing means to said
predetermined position of said connector means and in contact
therewith; and
means associated with said housing means for maintaining said
sealing means
12. The tissue stimulator of claim 11 wherein said connector block
means further comprises means in contact with said threaded bore
for preventing the removal of said screw means from said threaded
bore when said screw means is turned in a second direction upon
engagement by said tool means.
13. The tissue stimulator of claim 11 wherein said pulse generator
means further comprises a source of electrical energy and
electrical circuit means connected to said source of electrical
energy for producing the periodic, electrical stimulation pulses,
and said housing means comprises encapsulating means substantially
inert to body fluids and tissue for enclosing and covering said
source of electrical energy and said electrical circuit means; and
wherein said lead connector means further comprises resilient boot
means substantially inert to body fluids and tissue and associated
with said receptacle means for guiding said connector pin to said
receptacle and engageable with the electrical insulated conductor
at its distal end for preventing the entrance of body
14. The tissue stimulator of claim 11 wherein said sealing means
comprises
15. The tissue stimulator of claim 11 wherein said screw means and
said connector block means are composed of a relatively hard,
corrosion resistant metal.
Description
This invention relates to electrical tissue stimulating devices,
and to an improved method and apparatus for attaching a lead to a
pulse generator.
BACKGROUND OF THE INVENTION
Implantable electrical medical tissue stimulating devices are
well-known in the art. For example, one of the better-known tissue
stimulators is the cardiac pacer, as shown, for example, in U.S.
Pat. No. 3,057,356 to Wilson Greatbatch. These devices, such as the
cardiac pacer, generally comprise a pulse generator further
comprising a power source and associated electrical circuitry
embedded in, and encapsulated in, or protected by a substance or
substances substantially inert to body fluids and tissue. The
electrical circuitry of the pulse generator is adapted to be
connected by a lead or leads to one or more electrodes which are
adapted to be placed adjacent to a remote, desired spot within the
human body, such as adjacent to or within myocardial tissue. The
cardiac pacer, for example, supplies electrical stimulating pulses
to regulate cardiac function in the absence of naturally occurring
cardiac pulses.
In implantation of pulse generator and lead, it is common practice
for the surgeon in intravenously position or surgically attach the
electrode at the distal end of the lead to the desired spot within
the human body, that is, in or adjacent to myocardial tissue, and
to thereafter connect the lead to a connector assembly associated
with the electrical circuitry of the pulse generator in order to
commence electrical stimulation of the heart tissue. Prior to
making the electrical connection, the surgeon usually measures the
electrical stimulation threshold level sufficient to maintain
capture of the heart and the sensing threshold level sufficient to
trigger the sense amplifier, if any, in the pulse generator
circuitry to inhibit the generation of electrical stimulating
pulses in the event the heart is functioning normally.
Thereafter, if the threshold levels are adequate, the surgeon
usually creates a subcutaneous pocket to receive the encapsulated
pulse generator in connective tissue lying just beneath the skin.
After the pulse generator is slipped into the pocket, the incision
is closed and precautions are taken to avoid build-up of inert body
fluids in the pocket and to guard against infections.
One problem which has been encountered, and is known to those
skilled in the art, involves the point in the surgical procedure
when the proximal ends of the lead are connected to the lead
connector apparatus of the pulse generator. Many leads, such as the
Medtronic Model 5818 Bipolar, Endocardial, Transvenous Lead,
comprise a flexible insulated conductor having a pair of proximal
ends adapted for connection to the pulse generator and a distal end
portion comprising a pair of electrodes adapted to be positioned
within the left ventricle of the patient's heart in contact with
endocardial tissue. The proximal ends comprise a pair of conductive
terminal pins each uninsulated for a portion of its length and
insulated by an oversized sleeve at the point where the terminal
pin is electrically connected to the conductor. Associated pulse
generators, such as the Medtronic Model 5842 Implantable, Bipolar
Demand Pulse Generator, have a pair of conductive receptacles
adapted to receive the terminal pins of the associated Medtronic
Bipolar Leads, through a corresponding pair of silicone rubber
boots. The silicone rubber boots have an opening diameter
dimensioned with respect to the outside diameter of the sleeve of
the lead connector ends to insure a fairly close fit.
Connecting such a lead to a pulse generator of the type noted
hereinbefore consists of five steps. The first step is to coat the
lead connector ends including the terminal pins and the insulated
nylon sleeves with a silicone oil lubricant that is compatible with
the silicone rubber portion of the lead and silicone rubber boots
and is inert to body fluids and tissue. Thereafter, the lead
connector ends are pushed into the terminal until each lead collar
snaps into place in the silicone rubber boot and the terminal pin
is visible through a set screw hole. A relatively small set screw
is then placed on a hex wrench tool and inserted into a threaded
set screw bore in the connector block containing the terminal pin
receptacle. The set screw is tightened with the hex wrench while
making certain that the lead terminal pin does not retract as the
set screw is tightened. Thereafter a nylon filler screw with an
O-ring in place is inserted in a filler screw hole in line with the
socket set screw to seal the set screw and connector block assembly
from body fluids and tissue. Finally, each rubber boot is tightened
around the insulated portion of the conductor by means of a
non-absorbable ligament or suture tied in a groove around the
rubber boot. This procedure is repeated for each lead connector end
of a bipolar lead.
Among the difficulties that arise at this point in the operation
lies with the number of components and separate tools that are
required to effect the complete connection of the lead to the pulse
generator and to insure that the various components of the
connector apparatus are not affected by body fluids and tissue.
Normally, the manufacturer supplies with each pulse generator, a
separate set screw, an associated hex wrench tool, a nylon filler
screw, an O-ring, and a separate common screwdriver. The socket set
screw, the nylon filler screw and the O-ring are all rather small
in view of the relatively small size of the pulse generator and its
components. It is necessary in the practice of the aforemention
procedure to place the socket set screw on the tip of the hex
wrench tool, and to thereafter insert the set screw into the
threaded bore of the connector block. The risk is great that the
set screw will not remain in place on the tip of the tool and may
be lost. The fact that a separate screwdriver is necessary to
tighten the nylon filler screw adds to the cost of the entire pulse
generator package. Also, when the head of the filler screw is wet,
it is slippery and difficult to engage with the screwdriver
blade.
If, on the other hand, the surgeon prefers to fill the access hole
to the connector block with a medical adhesive, it then becomes
necessary at the time the pulse generator is to be replaced to dig
out the medical adhesive with a tool in order to reach the set
screw.
Another problem that occasionally occurs results from the fact that
the surgeon may apply too much torque to the hex wrench in
engagement with the set screw thereby stripping the threads of the
threaded bore of the connector block or the set screw itself. In
addition, it may happen that the lead terminal pin retracts out of
the receptacle as the set screw is tightened down, and poor
electrical contact may result.
The apparatus of this invention and the method set fourth herein
for connecting a lead to a pulse generator advantageously and
economically overcome these problems.
SUMMARY OF THE INVENTION
Briefly described, the apparatus of this invention and its
associated method described herein involves lead connector means
engageable and operable by tool means for connecting a lead to the
pulse generator and sealing means puncturable by the tool means in
engagement with the connector means and resealable upon removal of
the tool means for providing an inert, electrically insulating seal
between the connector means and body fluids and tissue. The sealing
means replaces the aforementioned disadvantageous nylon filler
screw and associated O-ring or medical adhesive. The lead connector
means may further comprise receptable means for receiving the lead
and retaining means associated with the receptacle means and
engageable by the tool means for retaining the lead in the
receptacle means. Furthermore, the retaining means may further
comprise means movable by the tool means into contact with lead
means for retaining the lead means in stationary relationship in
the receptacle means.
As another aspect of the invention, the receptacle means may
comprise means for preventing the release of the movable means from
the receptacle means by the tool means.
As a further aspect of the invention, the tool means comprises
means for preventing the application of more than a predetermined
force to the lead connector means to prevent damage to the lead
connector means.
In a preferred embodiment of the invention, the receptacle means
comprises a connector block having a receptacle bore for receiving
the lead terminal pin, and the retaining means comprises a socket
set screw in a threaded bore in operative relationship with the
receptacle in the connector block. The components of the connector
assembly are encapsulated in epoxy encapsulent, except for the
sealing means which is maintained by the epoxy encapsulent in
position between the retaining means and the atmosphere. The
sealing means further comprises an implantable grade silicone
rubber compound that is puncturable by the hex wrench tool means
engaging the socket set screw but reseals itself upon withdrawal of
the hex wrench tool. In addition, means are provided for preventing
withdrawal of the set screw from the threaded bore of the connector
block.
To practice the method contemplated by this invention the surgeon
simply grasps the encapsulated pulse generator with one hand,
pushes the terminal pin into the receptacle and inserts the tool
means through the sealing means to engage the retaining means.
Threshold measurements may be taken from the tool means. After
tightening the lead in the connector means, the tool means may then
be simply withdrawn, and the sealing means will reseal to provide
electrical insulation between the connector means and body fluids
and tissue.
The apparatus and method of this invention advantageously
eliminates a number of separate components and steps necessary to
connect a lead to a pulse generator.
Further advantages of this invention are elucidated in reference to
the drawings. All parts not necessary for a complete understanding
of the apparatus and its operation have been omitted from the
drawings for sake of simplicity.
BRIEF DESCRIPTION OF THE DRAWINGS
In the detail description of the preferred embodiment of the
invention presented below, reference is made to the accompanying
drawings in which:
FIG. 1 is a cutaway pictorial view of a prior art connector
apparatus associated with a pulse generator and the associated
lead, tools and components necessary to effect a connection of the
lead to the pulse generator;
FIG. 2 is a cutaway pictorial view of the connector apparatus and
associated tool of the present invention in relation to a lead and
pulse generator; and
FIG. 3 is a perspective illustration of a manipulative step in the
connection of a lead to a pulse generator in accordance with the
present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Before describing the invention in detail, it should be noted that
in the drawings, all parts not necessary for a complete
understanding of the device have been omitted.
Turning now to the drawings and first to FIG. 1, there is shown in
partial perspective a section of prior art lead connector assembly
associated with a tissue stimulating device. In FIG. 1, the device,
for example, comprises a cardiac pacer, e.g. the Medtronic Model
5842 Implantable Bipolar Demand Pulse Generator and the Medtronic
Model 5818 Bipolar, Endocardial, Transvenous Lead. The Model 5842
is a bipolar, demand, pulse generator of the ventricular-inhibited
type. Programmed from the QRS heart complex, it senses the R-wave
and delivers its impulses only when the patient's ventricular rate
falls below the pre-set pacing rate of the pulse generator.
The pulse generator 10 may comprise a battery-power source and a
miniaturized electrical circuit for sensing the R-wave and for
delivering electrical stimulating impulses at a pre-set pacing
rate. The electrical components of the pulse generator 10 are
encapsulated in a transparent epoxy resin encapsulent 12 that is
compatible with and substantially inert to body fluids and tissue.
Of course, the Model 5842 Pulse Generator is illustrated as
representative of the state of the prior art and other unipolar or
bipolar pulse generators could be shown with the prior art lead
connector assembly to be described.
Referring to the lead 16, depicted in part, it comprises a pair of
electrically conductive, tissue stimulating electrodes (not shown)
at its distal end, a corresponding pair of braided electrical
conductors 18 and 20 electrically connected to the electrodes and
electrically insulated from the surrounding body fluids and tissue
by a covering of silicone rubber 22. At the proximal ends of the
conductors 18 and 20 are electrically conductive, terminal pins 24
and 26, respectively. Lead collars 28 fabricated of the same
silicone rubber covering 22 cover and encircle the electrical
connections between the terminal pins 24 and 26 and the conductors
18 and 20.
Turning now to the prior art connector assembly depicted in FIG. 1,
it comprises a pair of elongated, silicone rubber boots 30 and 32
with grooves 31 for receiving nonabsorbable sutures, the boots 30
and 32 projecting from the encapsulated pulse generator 10 and
adapted to receive the proximal ends of the lead 16 comprising the
terminal pins 24 and 26 and their associated lead collars 28. The
silicone rubber boots 30 and 32 cooperate with a pair of connector
sleeves 34 (only one shown) manufactured from a nonconductive hard
plastic material and a pair of electrically conductive connector
blocks 36 (only one shown) that are adapted to be electrically
connected to the electrical components of the pulse generator 10.
Encircling the boots 30 and 32 are grooves 31 to receive
nonabsorbable sutures.
The connector block 36 further comprises a first bore or receptacle
38 for receiving the terminal pin of the lead and a second,
threaded bore 40 adapted to receive a socket set screw 42. Situated
between the connector block 36 and the external surface 14 of the
encapsulent 12 is a nylon seat 44 that is to receive a rubber
O-ring 46 and a nylon filler screw 48. Of course, each of the
aforementioned connector assembly elements are duplicated as shown
in the figure for a bipolar pulse generator.
The following prior art method of attaching the lead 16 to the
pulse generator 10 is taken in part from the manual provided by
Medtronic, Inc. with the sale of each Model 5842 Pulse Generator.
The method of attachment comprises the following enumerated
steps:
1. After the lead is brought out of the body at the position where
the pulse generator is to be implanted, the surgeon cleans the lead
connector ends and coats the terminal pins and lead collars with a
silicone oil lubricant to facilitate entry into the silicone rubber
boots of the pulse generator terminal assembly;
2. After checking the proper polarity of the lead connector end
with respect to the positive and negative connector terminals of
the pulse generator, the surgeon pushes the correct polarity lead
connector ends into the respective silicone rubber boots until each
lead collar snaps into place in the silicone rubber boots and both
terminal pins are visible through the set screw holes;
3. After placing a socket set screw on a hex wrench (both items
provided with the pulse generator by the manufacturer), the surgeon
inserts and tightens the respective set screw against the terminal
pins with the hex wrench while making certain that the terminal
pins do not retract as the set screw is tightened;
4. After the two set screws are tightened down, the surgeon then
selects the proper nylon filler screw and rubber O-ring and
tightens the filler screw into the seat and the threaded bore of
the connector block with a second tool which comprises an ordinary
screwdriver (all items provided with the pulse generator by the
manufacturer); and
5. Thereafter, the surgeon tightens each silicone rubber boot with
respect to the lead by means of nonabsorbable sutures placed in the
grooves encircling the silicone rubber boots.
The described prior art method applies to implantable tissue
stimulators, such as cardiac pacers, manufactured by many different
organizations. Some manufacturers, however, alter step 4 by
eliminating the nylon filler screw 48 and instead recommending that
the physician seal the holes to the set screws with a medical
adhesive. This medical adhesive must be cut away when it becomes
necessary to replace the pulse generator. In any event, the prior
art methods require a number of components, such as the set screws
42 and the filler screws 48, that must be separately attached to
the connector assembly by separate tools, such as the hex wrench
42, and the common screwdriver 49, respectively. Since the
attachment procedure takes place at the incision, there is danger
that the lead connector ends or the set screw holes may become
contaminated by body fluids before the connection is completed.
Also, the physician may find it difficult to place the relatively
tiny set screw in the set screw hole under surgical operating
conditions. Finally, either the set screws 42 or the filler screws
48, or the tools 43 and 49 used to connect either item may be lost
during the procedure.
In addition, when the patient's heart is being paced during the
operation by an external pulse generator attached to the lead
connector pins, it is necessary to switch from the external pulse
generator to the implantable pulse generator without losing capture
of the heart. In this case, additional steps are involved to
provide electrical connections between the pulse generators during
the switch-over from the external pulse generator and the internal
pulse generator. This procedure is usually accomplished by
sequentially screwing a rather long, machine screw (not shown) into
the threaded bores 40 of the pulse generator 10 to allow for
electrical connection by means of alligator clips attached to the
protruding portion of the machine screws. The use of the machine
screw involves an additional item that must be accounted for during
the operation and adds further complicating steps to the
aforementioned prior art method.
Turning now to FIGS. 2 and 3, the improved connector assembly and
the improved method of connecting the pulse generator to the lead
are shown in cutaway pictorial and perspective views, respectively.
The connector assembly depicted in FIG. 2 is partially sectioned to
show elements of one of the two bipolar connector, and the lead 16'
is shown in place in the sectioned connector assembly. The lead 16'
is identical in all respects with the lead 16 shown in FIG. 1; the
other elements of the connector assembly that correspond to
elements of the prior art connector shown in FIG. 1 will be
indicated by hyphenated numerals.
The pulse generator 10' as shown in FIG. 2 similarly comprises a
power source and electrical circuitry that are encapsulated in a
transparent epoxy encapsulent 12'. The bipolar boot 30' is
manufactured from an implantable grade silicone rubber, but in this
FIG. 2 has a slightly different outline than the boots 30 and 32
disclosed in FIG. 1. It will be understood that the bipolar boot
30' has a pair of longitudinal bores adapted to accept the proximal
connector ends of the bipolar lead 16'. The single suture groove
31' is shown encircling the entire bipolar boot 30'. It will be
understood that the bipolar boot 30' could take the same shape as
the prior art bipolar boots 30 and 32. Associated with the bipolar
boot 30' is a respective bipolar connector sleeve 34' that may also
be constructed of a nonconductive plastic material.
The electrically conductive connector block 36' also has an
elongated receptacle 38' adapted to receive the connector pin 26,
and a threaded bore 40' in which a movable, socket set screw 42' is
permanently situated. An extension 37' of the connector block 36'
encasing the receptacle 42' is wedged into a corresponding cavity
of the connector sleeve 34'. It will be understood that a second
connector block 36' and set screw 42' are similarly engaged by a
similar connector sleeve 34'. Also, the pair of connector sleeves
34' may be unitary in structure.
As mentioned earlier, the threaded bore 40' and the set screw 42'
are so dimenstioned with respect to the diameter of the receptacle
38' that the length of the set screw 42' is greater than the
diameter of the receptacle 38'. Consequently, the set screw 42' may
be screwed down in the absence of a connector pin in the receptacle
38' without danger of its being released by the threaded bore 40'
into the elongated receptacle 38'.
The top surface 52 of the connector block 36' is staked or deformed
over the upper-most portion of the threaded bore 40' to reduce its
actual diameter after the set screw 42' is screwed into the
threaded bore 40' during manufacture, so that the set screw 42' may
not be retracted out of the threaded bore 40'. The deformation
should be sufficient in area to prevent removal of the set screw
42' but should not be so large as to impede the application of a
hex wrench tool to the set screw 42'. The deformation or staking
should withstand at least 24 inch-ounces of torque applied to the
set screw 42' in an attempt to remove it.
Situated above the set screw 42' and surrounding a portion of the
connector block 36' is a bipolar, self-sealing grommet 54 which may
be manufactured from implantable grade silicone rubber and, in
reference to FIG. 1, replaces the seat 44, the O-ring 46 and the
filler screw 48. The grommet 54 may be of one piece sufficiently
long to cover and mate with both connector blocks 36' and set
screws 42' of the depicted bipolar connector assembly. The grommet
54 consists of an external portion 56 contacting and protruding
from the external surface 14' of the encapsulent 12' and an
internal portion 58. The internal portion 58 is slipped over the
upward projection 39' of the connector block 36'. The grommet 54
provides a sterilizeable, electrically insulating, inert seal
between the components comprising the socket set screw 42' and the
connector block 36', and body fluids and tissue.
During manufacture of the connector assembly of FIG. 2, the boot
30', the connector sleeve or sleeves 34', the connector block 36'
and a plastic pre-form (not shown) are assembled substantially as
shown in a device (not shown) that also positions the pulse
generator circuit (not shown), and the power source (not shown),
and all electrical connections are then completed. Thereafter, the
entire assembly is encapsulated in a mold by the transparent epoxy
encapsulent 12' to achieve the general dimensions shown. A
removable mold (not shown) extending from receptacles 42' creates
cavities 59 in the encapsulent. The pre-form is extracted from the
encapsulated pulse generator 10 and the grommet 54 is cemented in
place with medical adhesive forming a thin layer (not shown)
between the epoxy encapsulent 12 and the grommet 54. In this
manner, the entire connector assembly is permanently and securely
assembled. The various depicted ribs of the internal portion 58 of
the grommet 54 help to maintain it in position during and after
encapsulation.
The grommet 54 also comprises a pair of protrusions 60 and 62 which
are molded into the grommet 54 at respective positions directly in
line with the set screws 42'. Due to the self-sealing nature of the
silicone rubber of which the grommet 54 is manufactured, the
grommet 54 may be pierced down through the protrusions 60 and 62 by
a tool 64 (FIG. 3) in order to reach the socket of the set screw
42'. After the tool 64 is removed or withdrawn from the grommet 54,
the silicone rubber operates to close the puncture that the tool 64
makes through the silicone rubber. The protrusions 60 and 62 of the
silicone rubber provide guides allowing the surgeon to press the
working end of the tool 64 through the protrusion 60 or 62 and down
to the mating end of the set screw 42'.
Turning now to FIG. 3, there is shown in partial perspective the
step of puncturing the self-sealing silicone rubber grommet 54 with
the tool 64. At this point in the procedure, both of the lead
connector ends have been positioned in the connector assembly in
the manner described hereinbefore. Accurate placement of the lead
connector ends is visually verified by observation of the terminal
pins 24' and 26' protruding through the connector blocks 36' and
extending into pre-formed cavities 59 in the transparent epoxy
encapsulent 12'.
The tool 64 comprises an electrically conductive driver portion 66,
such as a hex wrench, adapted to mate with the socket set screw
42', an enlarged extension 68 of the conductive hex wrench 66, and
a nonconductive handle 70 that is ribbed to provide a gripping
surface so that the tool 64 may be readily rotated.
The tool 64 may also be designed to prevent the surgeon from
stripping the threads of the set screw 42' or the threaded bore 40'
in an attempt to tighten the set screw 42' with too much torque.
This may be accomplished, in the preferred embodiment of this
invention, by manufacturing the set screw 42' and the connector
block 36' of a relatively hard, corrosion resistant metal, such as
a titanium alloy and pure titanium, respectively, and manufacturing
the hex end 66 of the tool 64 of a relatively harder metal. The
composition and dimensions of the metal of the hex wrench 66 may be
selected so that any attempt to apply excessive torque to the set
screw 42' will not result in breaking off the hex end 66 while it
is in the socket set screw 42'.
However, means are provided for preventing the surgeon from
exerting a destructive torque on the threaded bore 40' or the set
screw 42' which means comprise the handle 70 of the tool 64. The
handle 70 is comprised of a plastic material engaging a knurled end
of the portion 68 which has an outside diameter of about 1/4 inch.
The plastic handle 70 is longitudinally ribbed to provide a
frictional surface for the surgeon to grip. However, as shown in
FIG. 3, the handle 70 of the tool 64 is relatively small with
respect to the surgeon's fingers and, consequently, the inch-ounces
of torque that can be applied by a strong hand will be less than
that torque necessary to either strip the threads of the set screw
42' or the threaded bore 40' or to break the hex end 66 of the tool
64.
Normally, a pair of tools 64 will be supplied with each pulse
generator 10' embodying the connector assembly of this invention.
The pair of tools 64 may be used by the surgeon during the
procedure of switching from the external pulse generator to the
implantable pulse generator 10' and also may be used to take
threshold measurements. To this end, both of the tools 64 may be
inserted into the set screws 42' in the manner shown in FIG. 3 to
provide electrically conductive paths through the insulating
grommet 54 external to the pulse generator 10'. Alligator clips
(not shown) may be attached to the enlarged, metal portion 68 of
each tool 64 to provide the requisite electrical paths. The
enlarged portion 68 preferably is about 1/8 inch in diameter and
1/2 inch long.
Turning now to the simplified and improved method of attaching lead
16' to the pulse generator 10' equipped with the connector assembly
of this invention, the operative steps comprise the following:
1. After the lead is brought through the skin at the position where
the pocket for the pulse generator is to be made, the surgeon
cleans the first lead connector end to be attached and coats it,
and lead collars of that lead connector end with lubricant to
facilitate entry of the lead connector ends into the silicone
rubber boot of the pulse generator terminal assembly;
2. After ascertaining the polarity of the lead connector terminal
pins with respect to the polarity of the pulse generator output
terminals, the surgeon pushes the first lead connector end into the
respective boot until it is visible in the cavity of the
transparent epoxy encapsulent;
3. As shown in FIG. 3, the surgeon then grasps the pulse generator
body with one hand and inserts the tool through the rubber grommet
until the wrench engages the set screw and then (after measuring
acceptable threshold levels) rotates the set screws clockwise with
the tool until resistance is felt while making certain that the
lead terminal pins do not retract as the set screw is tightened;
and
4. Following connection of the second terminal pin in the manner
set forth in steps 1 to 3, the silicone rubber boot is tightened
about the two connector ends with a nonabsorbable ligature placed
in the groove provided in the boot.
As can be seen from the description provided above, the operative
procedure is considerably simplified and the chances of losing the
various components in the incision are eliminated. Since the step
of filling the prior art access hole to the connector assembly is
eliminated, at least one operative step in the method of attachment
of the lead to the pulse generator is eliminated, thus saving both
time and materials. Also, the electrical transfer from an external
pulse generator to the implantable pulse generator does not require
additional components and can be accomplished more quickly.
Although the invention has been described with respect to a bipolar
pulse generator and a bipolar lead, it will be apparent that the
novel connector assembly described may be applied as well to the
unipolar pulse generators and leads. Furthermore, although the
invention has been described in particular with respect to an
implantable cardiac pacer, it will be apparent to those skilled in
the art that the invention has application in other tissue
stimulators, both implantable and external.
The invention has been described in detail with particular
reference to preferred embodiments thereof, but it will be
understood that variations and modifications can be affected within
the spirit and scope of the invention.
* * * * *