U.S. patent number 3,871,382 [Application Number 05/332,610] was granted by the patent office on 1975-03-18 for heart stimulator system for rapid implantation and removal with improved integrity.
This patent grant is currently assigned to Pacesetter Systems, Inc.. Invention is credited to Alfred E. Mann.
United States Patent |
3,871,382 |
Mann |
March 18, 1975 |
HEART STIMULATOR SYSTEM FOR RAPID IMPLANTATION AND REMOVAL WITH
IMPROVED INTEGRITY
Abstract
Disclosed is a quick connect-disconnect heart stimulator system
including a catheter assembly. The catheter assembly is screwed
into the remainder of the system and not only effects positive
mechanical coupling, but also positive and resilient electrical
connection and fluid-tight sealing, all in one quick operation. The
system also permits inserting and removing a catheter positioning
stylet without disconnecting the catheter from the remainder of the
system with self sealing material preventing entry of body fluids
after the stylet is withdrawn.
Inventors: |
Mann; Alfred E. (Los Angeles,
CA) |
Assignee: |
Pacesetter Systems, Inc.
(Sylmar, CA)
|
Family
ID: |
23299008 |
Appl.
No.: |
05/332,610 |
Filed: |
February 15, 1973 |
Current U.S.
Class: |
607/37 |
Current CPC
Class: |
A61N
1/3752 (20130101) |
Current International
Class: |
A61N
1/372 (20060101); A61N 1/375 (20060101); A61n
001/36 () |
Field of
Search: |
;128/404,418,419P,419R,421,422 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Ramm; W. C. Thomas, Jr.; C. H.
Sgarbossa; P. J.
Claims
I claim:
1. Heart stimulator system adapted to be implanted within a human
body, comprising:
a sealed assembly including a sealed enclosure and pulse generating
means housed therewithin, said enclosure defining an open
cavity;
a catheter having distal and proximal ends and adapted to be
coupled to a human heart adjacent said distal end, with at least
one electrode for carrying signals between said pulse generating
means and said heart, said catheter defining an axially extending
interior space;
elongated catheter support means defining a transverse passageway
coaxial with said catheter interior space and communicating
therewith at one end while being open at the other end, said
support means being joined to said catheter adjacent said proximal
end;
pierceable self-sealing means for sealing said other open
passageway end of said catheter support means;
quick connect-disconnect means for sealingly and simultaneously
coupling mechanically and electrically said assembly to said
catheter and support transversely to said passageway into a sealed
unit, including
a male threaded connector secured to said catheter support means
adjacent one end thereof, said connector including a conductive
portion therewithin insulated from the remainder of said connector,
extending to the leading end thereof, and electrically connected to
said one electrode, said catheter and said catheter support means
forming an integral elongated lever arm for said threaded
connector;
a female threaded connector adapted to receive said male connector
therethrough and secured within said cavity at the entrance
thereof, said male and female connectors defining an axis upon
being united which is transverse to that of said catheter
passageway and interior space;
a contact member mounted within said cavity and spaced inwardly
from said female connector, said contact member being electrically
connected to said pulse generating means,
resilient means positioned in said cavity inwardly from said female
connector, and responsive to the passage of said male connector
through said female connector for sealing said cavity;
said male connector conductive portion thereupon engaging said
contact member, effecting electrical as well as mechanical
connection with the sealing of said cavity simultaneously, said
connection being tensioned with said lever arm to complete a sealed
stimulator system which may be equally quickly disassembled and
whose catheter may be stylet-positioned without disturbing said
connection.
2. A system as in claim 1 in which said pierceable means for
sealing includes a plurality of membranes of pierceable resilient
self-sealing material serially mounted one behind the other within
said passageway, to permit passage therethrough of a catheter
positioning stylet into said catheter interior space, and a
subsequent resealing of said passageway upon removal of such
stylet.
3. A system as in claim 1 which further includes means for movably,
and resiliently mounting said contact member within said cavity
whereby said contact member is positively and resiliently biased
into contact with said male member conductive portion upon the
coupling of said connectors.
4. A heart stimulator system for rapid and simplified high
reliability assembly and implantation within the human body,
comprising:
a sealed stimulator assembly including a sealed enclosure and
electrical pulse generating means housed therewithin, said
enclosure defining an open cavity in the surface thereof, said
circuitry having a terminal extending into said cavity at an inner
portion thereof;
a sealed catheter assembly adapted to be coupled to a human heart
and having an elongated catheter and a catheter support portion
joining said catheter adjacent one end thereof, said catheter
having at least one electrode for carrying signals between said
pulse generating means and said heart;
a male threaded connector sealingly secured at one end thereof to
said catheter support portion with the connector axis transverse to
that of said catheter, said connector defining a central axial
aperture therethrough;
a female threaded connector adapted to receive said male connection
therethrough and secured within said cavity so as to occupy the
cavity entrance, said circuitry terminal being spaced from said
female connector;
electrical contact means coaxial with said connectors and operative
simultaneously therewith, said means including a conductor member
carried within said axial aperture of said male connector and
insulated from said male connector, said conductor member being
electrically connected adjacent said one connector end to said
electrode, said conductor member extending outwardly from the
other, leading connector end into a sharp outward projection;
and a contact member movably mounted within said cavity spaced
inwardly of and coaxially with said female connector, said contact
member being electrically connected to said terminal;
a resilient annular seal positioned in said cavity coaxially with
said female connector and inwardly thereof in contact with the wall
of said cavity, said seal engaging said conductor upon the passage
of said male connector through said female connector;
spring means for urging said contact member toward said female
connector, said conductor engaging said seal and compressing it
between said end and said wall while said conductor projection
engages said contact member upon said connectors being united,
whereby said stimulator and catheter assemblies are simultaneously
electrically and mechanically connected as well as sealed into a
unitary fluid tight system.
5. A heart stimulator system as in claim 4 in which said catheter
support portion includes an elongated connector arm extending
transversely and substantially across said support parallel to said
catheter, and to which said male connector is secured at one
connector arm end, said arm extending under said one catheter end,
said arm including a clip at the end opposite said male connector,
said clip securing said catheter upon said arm, and means potting
said connector arm and clip with said one catheter end into an
integral assembly to form a lever arm for said male connector
adapted to aid in tightening said connectors and ensure high
contact forces between said projection and said contact member.
6. A system as in claim 5 in which said catheter support portion
includes a terminal member mounted on said arm and insulated
therefrom, in a position opposite said male connector so that said
arm is therebetween, said terminal being connected electrically to
said conductive portion of said male member, as well as to said
catheter electrode.
7. A system as in claim 6, in which a passageway is defined through
said terminal member and in which said catheter defines an interior
axially extending space, said passageway and space being coaxial
and extending transversely to the axis of said male connector, and
which further includes a plurality of membranes of pierceable
resilient, self-sealing material serially mounted within said
passageway, thereby sealing said catheter and passageway yet
permitting the passage therewithin of a positioning stylet and
insuring subsequent resealing upon removal of such stylet.
8. A heart stimulator system as in claim 4 in which said conductor
member projection comprises an annular knife edge, and said contact
member includes a flat surface facing said annular knife edge,
whereby said knife edge digs into said contact surface for optimum
contact upon said connectors being united.
9. A heart stimulator system as in claim 4 wherein said contact
member includes a lower end section having at least one flat side
to limit the rotational excursion of said contact member.
10. A heart stimulator system as in claim 4 wherein said contact
member includes a flanged surface facing said sharp projection, and
said seal is captured between the periphery of said flange and said
cavity wall, said spring member biasing said contact member beneath
said flange.
Description
Artificial heart stimulations, or pacers are employed to supplement
or replace the material pacing electrical activity of a heart which
is functionally impaired due to one or more diseased conditions.
The most widely used stimulators at present comprise an implantable
body containing pacing circuitry and an endocardial catheter
connected to the pacing circuit on one end with the other end
introduced through a large vein into the right ventricle of the
heart. This conventional heart stimulator is powered by a battery
of mercury cells which have a useful life of about 18-24 months,
after which the stimulator body must be replaced. Also, catheter
lead connections for attachment to the stimulator are difficult to
make and require auxiliary tools and materials to effect sound
electrical contact and reasonable sealing against body fluids.
With the development of a heart stimulator which employs a
rechargeable long-lived nickel-cadmium cell, such as those
disclosed in copending patent applications with Ser. Nos. 154,492,
filed 6/18/71 and 267,114, filed 6/28/72, now abandoned in favor of
continuation-in-part application Ser. No. 464,441, filed Apr. 26,
1974, many of the disadvantages of the conventional stimulators
were overcome.
It is the principal object of this invention to provide an
arrangement for quick connect-disconnect of a catheter to a heart
stimulator body which has the features of high, reliable contact
pressure and fluid-tight, sealed connection.
It is another object of this invention to provide a sealed heart
stimulator system including a catheter which permits introduction
into the catheter when connected to the remainder of the system of
a positioning stylet through a body of self-sealing material which
prevents entry of body fluids into the catheter when the stylet is
withdrawn.
Other objects, features and advantages of this invention will be
apparent from a consideration of the following detailed description
in conjunction with the drawings which are briefly described as
follows:
FIG. 1 is a pictorial view of a heart stimulator system according
to this invention;
FIG. 2 is a partly sectioned elevational view of a catheter
assembly and stimulator assembly as assembled into the system
according to this invention;
FIG. 3 is a partly sectioned side view of a system in accordance
with FIG. 2;
FIG. 4 is a partial section view taken along the lines 4--4 in FIG.
2;
FIG. 5 is a partial section view taken along the lines 5--5 in FIG.
2;
FIG. 6 is a partial section view taken along the lines 6--6 in FIG.
7; and
FIG. 7 is a partial section view of the heart contacting end of a
catheter.
FIG. 1 shows an implantable stimulator system comprising a
stimulator body or assembly 10, and a catheter assembly 20. Body 10
comprises a main enclosure 11 in which an open cavity 11A is
defined in an upper corner surface thereof. Main enclosure 11
houses a power cell and pulse generating pacer circuitry and a
cover 12 which is welded to enclosure 11. Catheter 30 has a
proximal electrode 31 and a distal tip electrode 32, and defines an
axially extending interior space 30A. This particular catheter is a
dual polarity type--a single polarity type would have only a distal
tip electrode.
The construction of the catheter assembly 20, which includes both a
catheter 30 and a catheter support means 20A, is best understood
from a description of the manner in which each part is assembled
with reference to FIGS. 2-5. Catheter support means 20A is
assembled as follows. Connector arm 204 is welded transversely
across the upper end of a male connector nut 201, adjacent one end
of arm 204. Center contact member 202 is inserted through male
connector nut 201 and held in position while insulator 203 is
molded in place using an epoxy material. A catheter mounting or
terminal block 205 is slipped over the top of member 202 and
positioned upon arm 204, over insulator 203, and opposite male
connector 201, with arm 204 therebetween. Terminal mounting block
205 is provided with a transverse passageway 205A therethrough. A
plurality of silicone rubber membranes 206 are inserted in catheter
mounting block 205 in passageway 205A and then stylet funnel 207 is
screwed in place. This subassembly is then fastened to contact
member 202 by set screw 208 (FIG. 3).
To join catheter support means 20A with catheter 30 to form
catheter assembly 20, the proximal end of catheter 30 is slipped
through clip 209 which is then welded at its flanges (FIG. 5) to
connector arm 204 so that catheter interior space 30A and
passageway 205A are coaxial and in communication at the catheter
connector end. Distal coil lead 304, which comprises three coiled
wires, is inserted in a boss on catheter mounting block 205. The
three wires of this lead are led out through three slots (e.g.,
205A, see FIG. 4) and sequentially welded to catheter mounting
block 205. Proximal coil lead 302, which comprises four coiled
wires, is then attached to proximal connector arm 204 by
sequentially welding the four wire ends to separate points on arm
204.
This assembled structure is then placed in a mold and potted in an
epoxy material 208. Finally, the potted connector is placed in
another mold and coated with silicone rubber 209A, completing
assembly 20.
The connector contact portion of body 10 is assembled in this
manner. Ceramic insulator 106 is placed into the cavity 11A in body
10, preferably defined by metal support 101. In the lowermost
portion of cavity 11A, spaced from the entrance thereof, terminal
cap 105 is welded to terminal stud 104, connected in turn to the
aforementioned circuitry, and then two contact wires 108 are welded
to terminal cap 105. This assembly is inserted through support 101
and glass insulating ring 103 is cast in place, creating a hermetic
seal. Ceramic insulator 106 is then cemented in place. Belleville
springs 109 are inserted, followed by O-ring 110, and then contact
pad 107 is placed into the cavity. Contact wires 108 are welded to
contact pad 107. Finally, female connector 111 is mounted in the
cavity occupying the entrance thereof, and welded in place, and
O-ring 112 is inserted in a recess in female connector 112.
Connector 111 is oriented so that connectors 201 and 111 will upon
being united define an axis which is transverse to passageway 205A
and space 30A. After this assembly operation body 10 is inserted in
a mold and covered with silicone rubber 102.
At this point male connector 201 and female connector 111 can be
joined by screwing male connector nut 201 into female assembly 111.
The molded body of connector 20 provides a lever arm for tightening
male assembly nut 201 against the beveled contact portion of female
connector 111. O-ring 112 is compressed to aid in keeping body
fluids out of the connector. A second resilient O-ring 110 is
provided within cavity 11A coaxially with connector 111, in contact
with the cavity wall (as defined by insulation 106), and having an
annular thickness at least large enough to permit the male
connector conductive portion to engage it. As male connector nut
201 screws into female connector 111, contact member 202 encounters
contact pad 107 and an annular knife edge 202A provided on the
leading end of contact member 202 bites into the top surface of
contact pad 107 to provide intimate metal-to-metal contact.
Belleville springs resist the movement of contact pad 107 to
provide a high contact pressure, but also to absorb any cumulative
tolerance errors. At the same time, resilient O-ring 110 is
compressed to help seal out any body fluids which may enter this
part of the connector. The same Bellville springs also support
O-ring 110, to aid in compressibly sealing the electrical
connection. The two contact wires provide connection redundancy,
and the lower part of terminal pad 107 has flat sides to prevent
rotation as knife edge 202A screws into the top surface of terminal
pad 107. This prevents compressive or rotational stresses on the
relatively fragile contact wires. It will be noted that the
foregoing elements define a connect-disconnect means for coupling
body 10 to catheter assembly 20, quickly, easily, positively, and
sealingly for both mechanical and electrical purposes in one manual
operation.
As shown in FIG. 2, stylet funnel 207 and catheter mounting block
205 have apertures therethrough which communicate with the interior
of distal coil lead 304. Silicone rubber membranes 206 are adapted
to be pierced by a catheter positioning stylet (not shown) inserted
through funnel 207 into distal coil lead 304 and to reseal
themselves against entry of body fluids into catheter 30 after the
stylet is withdrawn. This arrangement permits repositioning of the
heart-contacting end of catheter 30 after connection to body 10,
without loss of pacing function. Moreover, should the catheter need
repositioning after implantation, a stylet can be inserted through
a slit in the patient's skin without exposing the whole body or
disconnecting the catheter therefrom.
Catheter 30 is constructed to have leads of low electrical
resistance and a high degree of resistance to breakage due to
flexwire stresses encountered in operation as an implanted
assembly. Distal coil 304 comprises three parallel wires wound in a
tight helix on a common mandrel. Proximal coil 302 comprises four
parallel wires wound in the same manner. Each lead carries a
silicone rubber insulating sleeve. These multiwire leads constitute
low parallel electrical resistance and provide redundant signal
communication paths should one lead happen to break. Both leads
employ a high-tensile strength corrosion resistant metal alloy.
The heart contacting end of the catheter is constructed as follows.
Proximal electrode 305 is welded with two annular welds 305A to
inner shell 306. This assembly is slipped over porximal coil 302 at
an exposed end with a short section of coil 302 extending beyond
electrode 305. Inner shell 306 is then welded to coil 302 at
several annular areas 306A. Rubber sleeve 301 is pulled up to a
point just behind electrode 305.
Distal coil 304 and its sleeve 303 are pushed through proximal coil
302; and coil 304 is pulled partially out of sleeve 303 and slipped
over shaft 308A on distal electrode 308. Distal tip 309 has
previously been welded at annular area 308B to distal electrode
308. Distal coil 304 is welded to shaft 308A at several places, and
then sleeve 303 is stretched over electrode 308.
This assembly is then inserted in a mold and partly encapsulated in
silicone rubber. This encapsulates and bonds proximal coil 302 to
proximal electrode 305 and bonds proximal sleeve 301 and distal
electrode 308 and tip 309.
Distal electrode 308 and inner proximal shell 306 are constructed
of the same material as coil leads 302 and 304. Proximal electrode
305 and distal tip 309 are constructed of highly corrosion
resistant platinum. Any corrosion occurring because of joining of
dissimilar metals will thus occur at massive interfaces rather than
at the relatively fine wires of the leads. Moreover, surrounding
body tissue will be protected from chemical reactions due to any
corrosion which occurs by the molded silicone rubber.
The resultant catheter assembly has a very high degree of
flexibility and strength. The coaxial coiled wires provide
shielding against pickup of RF interference in the distal coil
lead. In a unipolar catheter the proximal electrode is eliminated
but the proximal lead is retained to provide the RF shielding. This
shielding is an important advantage in demand heart stimulators
which sense the natural R-wave over the catheter leads.
The above descriptions are given by way of example only and
numerous modifications could be made without departing from the
scope of this invention as claimed in the following claims.
* * * * *