Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-07-06
2001-02-20
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06192277
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an electrical connector used with an implantable medical device such as a pacemaker for connecting an implantable electrical lead to the electrical circuits contained within a hermetically sealed housing thereof. More particularly, the present invention relates to a connector for use with such a sealed implantable medical device that combines the connector function with the feedthrough function and that eliminates the need for the cast or other preformed epoxy connector which has previously been employed.
BACKGROUND OF THE INVENTION
While the present invention will be described in a specific manner as being applicable to a pacemaker, it will be understood that the invention is applicable to any other type of implantable medical device intended to stimulate body tissue.
Modern pacemakers monitor the activity of a heart and provide a stimulation pulse in the absence of normal heart activity. Advantageously, such devices are relatively small, light-weight and implantable. In order to sense and stimulate the heart, however, such pacemakers must be used with a pacemaker lead, an electrical conductor that carries electrical signals between the heart and the pacemaker. Advantageously, the pacemaker lead can be inserted into the heart transvenously through a relatively simple and well-known surgical procedure. Disadvantageously, one end of the lead (designated herein as the “connecting end”) must be electrically and mechanically secured to the pacemaker in a way that provides for a long-term safe and secure, yet detachable connection. Those skilled in the pacemaker art have long sought for a simple, yet reliable and safe, technique for making this detachable electrical and mechanical connection between the pacemaker device and the connecting end of the pacemaker lead.
In order to appreciate the advantages of the present invention, it will help first to have a basic understanding of the manner in which the mechanical and electrical connection functions are carried out in prior art pacemakers. The main components associated with the connection function of known prior art pacemakers are shown in
FIGS. 1 and 2
. A pacemaker
10
electrically includes a battery
14
that powers electrical circuits
12
. The pacemaker electrical circuits
12
and battery
14
are mechanically housed and hermetically sealed in a suitable housing
16
. Typically, this housing or case
16
is shaped to include a flat side or platform
20
to which a suitable epoxy connector
22
can be bonded. At least one feedthrough terminal,
18
, in electrical contact with the electrical circuits
12
, passes through the case or housing
16
and protrudes out from the platform
20
. This feedthrough terminal
18
is electrically isolated from the case
16
. A platinum wire
24
, or other suitable conductive element, connects the terminal
18
to a conductive connector block
26
that is fitted within the connector
22
. A pacemaker lead
28
, having a proximal electrode
30
, connects to the pacemaker electrical circuits by inserting the proximal electrode
30
into a receiving channel
31
of the connector
22
until the electrode
30
is in contact with the connector block
24
. A set screw
32
is then securely tightened using a torque wrench
34
to firmly hold the electrode
30
in both mechanical and electrical connection with the connector block
26
. A septum, not shown but having the construction generally described in commonly assigned U.S. Pat. No. 5,509,928 issued Apr. 23, 1996 to Acken, is typically placed over the set screw
32
in order to prevent body fluids from seeping through the set screw hole. Further, sealing ribs or ridges
36
on the connecting end of the pacemaker lead are designed to tightly engage the inside edges of the receiving channel
31
in order to prevent any body fluids from entering into the receiving channel
31
once the connecting end of the lead has been pushed into the connector
22
.
While the descriptions presented in the prior art vary greatly relative to, for example, different types of locking mechanisms for performing the mechanical connection function, or different types of arrangements for performing the electrical feedthrough function, including the use of bipolar or multiple pacemaker leads, all such systems include the use of a premolded or cast connector
22
that is bonded to a sealed pacemaker housing
16
in which the electrical circuits are located.
Typically, prior art connectors
22
are cast in place from epoxy to the platform or header
20
of the pacemaker, or a premolded connector is bonded to the platform
20
using a suitable sealing and bonding agent. Further, once the electrical connection is made from the terminal post
18
to the connector block
26
, and the connector is attached to the housing, all remaining voids within the connector
22
, not including the receiving channel
31
into which the proximal end of the pacemaker lead
28
is to be inserted, must be filled with a suitable filler material, such as a two-component epoxy or silicone rubber.
As is evident from the above description, placing a connector on a pacemaker housing is a very labor-intensive process involving many components. What is needed is a similar manner of lead attachment that provides the requisite mechanical and electrical connection functions using fewer components and less labor yet providing higher reliability. The present invention addresses these and other needs.
It was with knowledge of the foregoing state of the technology that the present invention has been conceived and is now reduced to practice.
SUMMARY OF THE INVENTION
The present invention provides a connector for a pacemaker, or other implantable medical device, that advantageously combines the connector function with the feedthrough function and eliminates the need for the cast epoxy connector previously used on prior art pacemakers. Eliminating the external cast epoxy connector advantageously eliminates the need for septums, set screws, and the feedthrough terminal and its associated platinum wires and connector blocks, as well as the whole time consuming casting process with its inherent propensity for cosmetic problems. Thus, in accordance with the invention, a connector system is provided for use with a sealed implantable medical device having at least one lead receiving channel for slidably receiving a connecting end of an electrical lead and comprises a support member fixed to the medical device having a threaded bore generally parallel to and spaced from the lead receiving channel, an annular seal member mounted on the support member at the open end of the lead receiving channel and coaxial and aligned therewith, and a plunger adapted for attachment to the medical device and having an inlet bore for reception of the electrical lead and an annular flange coaxial with the inlet bore. When positioned for attachment to the medical device, the annular flange is coaxial with the lead receiving channel and aligned and engageable with its associated annular seal member. A driver bevel gear is mounted on the plunger for rotation about a driver axis extending transverse of the inlet bore and a driven bevel gear is mounted on the plunger for rotation about a driven axis extending perpendicular to the driver axis and meshingly engaged with the driver bevel gear. The driven bevel gear includes an integral threaded stud coaxial therewith threadedly engaged with the threaded bore of the support member whereby rotation of the driver bevel gear in one direction effects rotation of the driven bevel gear and of the threaded stud and draws the plunger from a withdrawn position to an attached position with the annular flanges sealingly engaged with their respective annular seals.
It is a feature of the present invention to provide a connector system that eliminates the need for the cast epoxy type of connectors used in prior art pacemakers, and the many problems and excessive cost associated with the use of such cast connectors.
It is a further feature of the present i
Lim Wisit
Truex Buehl E.
Getzow Scott M.
Pacesetter Inc.
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