Note: Descriptions are shown in the official language in which they were submitted.
?776
FIXATION LOOP FOR TRANSVENOUS I.EADS
Cross-References to Co'-pending Applica'tions
None.
Background of the Invention
1. Field of the Invention - The present invention
relates generally to a surgical el'ectrical applicator, and
more importantly, pertains to a closed fixation loop for
transvenous leads.
2. Description of the Prior Art - There has
never been a coaxial sliding pacing lead for connecting
between a chamber or'chambers of a heart and a pulse gener-
ator. In the past, it always has been a prior art practice
to either securely affix an electrode'or electrodes to walls
of the heart or in the alternative, to let the electrode of
a pacing lead lie adjacent to the wall.
In pacing the'atrial chamber, it has been a prior
art practice to let the'electrode of the atrial lead lie
adjacent to the atrial wall. The lead was never affixed to
the atrial wall because of the thinness of the wall and sub-
sequent damage to the wall until recent developments in
pinch-on electrodes. Prior art atrial leads have been
previously anchored by a hook or J-shape with tines on the
end but a J-shàpe requires diverging distal ends which are
not compatible with~a sliding coaxial lead. Atrial ventricle
coaxial leads usually do not hàve diverging ends.
The` present invention overcomes the disadvantages
of the prior art problems in providing a closed fixation
loop for an A-V transvenous lead.
Summary of the Invention
The present invention provides a closed fixation
loop for anchoring a catheter in any blood vessel, and more
particularly, in the heart.
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In accordance with one broad aspect of the invention there is
provided a body implantable pacing lead for insertion through a vein of the
body into a cavity of a heart comprising: fixation loop including a longi-
tudinal length of wound coil, a covering of insulation extending over and
beyond the ends of said wound coil including an overlap at each end of said
wound coil; and a transvenous lead including a wound coil, an electrode con-
nected to a distal end of said coil and a covering of insulation over said
wound coil of said lead and means joining each of said overlaps of said
fixation loop to said insulation covering of said lead substantially adjacent
to said electrode whereby said fixation loop positions said electrode within
a cavity of the heart.
In accordance with another broad aspect of the invention there is
provided a body implantable pacing lead comprising;
a. ventricular lead including a first space-wound coil, insulation
covering said first space-wound coil, ring-t-Lp electrode secured to one end
of said first space-wound coil, and a pluraliLty of tines extending outwardly
from said ring-tip electrode;
b. atrial lead including a second space-wound coil in coaxial re- `
lation over said first space-wound coil, insulation covering said second ~`
space-wound coil, a ring electrode secured to said one end of said space-
wound coil and two tines extending outwardly from said ring electrode, and;
c. fixation loop including a space-wound coil, insulation covering
said space-wound coil and extending byyond each end of said space-wound coil,
and means securing said overlapping ends to said two tines whereby said
ventricle lead coaxially slides within said atrial lead for spacing of said
ventricle ring-tip electrode into a ventricular cavity and said atrial ring
electrode in the atrial cavity.
According to another broad aspect of the invention there is provided
a fixation loop for a transvenous pacing lead including at least two tines
extending outwardly from a distal end of said transvenous lead for anchoring
said lead in a body comprising: closed fixation loop including a space-wound
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coil, insulation covering said space-wound coil and extending slightly be-
yond each end of said space-wound coil, and means securing overlapped ends -~
of said extending insulation to said two tines of said transvenous lead
whereby said closed fixation loop anchors said transvenous lead in said
body.
According to another broad aspect of the invention there is pro-
vided a body implantable lead comprising: a first conductor having a proxi-
mal end and a distal end; a sheath of an insulating material substantially
inert to body fluid covering said first conductor from said proximal end to
said distal end; a first electrode coupled to said first conductor distal of
said proximal end; a fixation loop having a first end attached to said
sheath and having a second end attached to said sheath whereby said first
electrode is urged into contact with body tissue.
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?776
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According to one embodiment of the present
invention, there is provided transvenous leads inclu~ing
a ventricular lead having a wound coil, insulation covering
the wound coil, an electrode'secured to an end of the wound
coil and a plurality of tines extending outwardly from the
electrode; an atrial lead having wound coil in coaxial
alignment over the ventricular lead, insulation covering the
wound coil, a ring electrode secured to an end of the wound
coil, and two tines extending outwardly from the ring electrode,
and; a fixation loop having a wound coil, insulation covering
the wound coil and extending beyond each end of the wound coil
of the fixation loop and secured over the tines of the ring
electrode whereby the'ventricu'lar lead slides within the
atrial lead for spacing of the ventricular electrode in the
ventricular cavity and the atrial ring electrode in the atrium
of the heart. A two-pronged connector includes a silicone
body which securely affixes the'atrial lead to one of the
connector sleeves while the'ventricular lead slideable moves
within the other connector sleeve and is secured thereto
with an O-ring which'forms a liquid seal betwen the silicone
rubber and the insulation. ~
A significant aspect and feature of the present
invention is a closed fixation loop secured to a pacing
lead for positioning and securing of the lead.
Another significant aspect and feature of the
present invention is an atrial-ventricular coaxial lead.
The atrial-ventricular coaxial lead provides for dual
chamber pacing with a passage of one single'lead through
the body.
The atrial ventricular coaxial lead positioning
is simpler and less time consuming in positioning the lead
in the heart. The positioning of the lead is less traumatic
than anchoring of electrodes in the chambers of the heart.
77~i
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Brief Description of the Drawings
Other objects-and many of the attendant advantages
of this invention will be'readily appreciated as the same
become'better understood by reference to the'following
detailed description when considered in connection with the
accompanying drawings, in which like reference numerals
designate like parts throughout the FIGURES therebf and
wherein:
Fig. 1 illustrates a plan view of transvenous
leads with'a closed fixation loop;
Fig. 2 illustrates an end view taken along line
2-2 of Fig. l;
Fig. 3 illustrates an exploded view of the
fixation loop at an atrial ring electrode partially cutaway;
Fig. 4 illustrates' an eIectrical connector; and, '~
Fig. 5 illustrates a cross-sectional view taken
along line 5-5 of Fig. 4.
Detailed Description of the Preferred Embodiments
Fig. 1I which'illustrates a plan view of trans-
venous leads with'a closed fixation loop, shows transvenous '~ '
leads 10 including a ventricular lead 12, an atrial lead
14, a closed fixation loop 16, and a connector 18. The
ventricular lead 12 as also illustrated in figures 2 and 3
includes a quadra-filar space wound coil 20 such as an ~P35N
alloy by way of example and for purposes of illustration only
extending a longitudinal distance, a ventricular electrode 22
secured to one end of the wound coil 20 and a proximal tip
24 at the other end of the wound coil 20. A polyurethane
insulation coating 26 extends the distance of the wound coil
20 between the electrode 22 and the proximal tip 24. A tine
support body 28 including a plurality of outwardly extending
tines 28a-28d by way of example and for purposes of illustra-
tion only axially secures over the electrode 22 and abuts
against a shoulder not illustraded in the figure of the
electrode. The othe`r end of the ventricular lead 12 slides
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through one connector sleeve 18b of the connector 18 as
later described in detail in Figs. 4 and 5. A quadra-
filar space wound coil 30 of similar structure and of a
larger diameter' than of the'wound coil 20 coaxially extends
over the polyurethane insulation coating 26 of ventricular
lead 12'and is shorter in length'with'respect to the
ventricular lead 12. An atrial ring electrode 32 connects
to one end of the wound coil 30 and a connector pin 34
connects to the'other end of the wound coil 30. A poly-
urethane'insulation coating 36 extends the distance of the
wound coil 30 between the' ring electrode 32 and the connector
pin 34. A tine support body 38 including tines 38a and 38b
illustrated in Fig. 2'axially secures to the atrial ring
electrode'32 and abuts against a shoulder 32a of the atrial
ring electrode 32. The'fixation loop 16 includes a longi- ,~
tudinal portion of quadra-filar space wound coil 40 similar
in diameter to the` wound coil 20 covered with polyurethane
insulation coating 42 and having overlapping ends 44a and
44b of polyurethane insulation coating 42 axially secures
over the tines 38a and 38b, and abuts up against and to
the'tine support body 38 as illustrated in Fig. 3 forming
the closed fixation loop 16.
Figure 2 illustrates an end view taken along line
2-2 of Fig. 1 where all numerals correspond to those elements
previously delineated. The closed fixation loop 16 assumes
a teardrop shape from the tines 38a and 38b of the tine
support body 38.
Figure 3 illustrates an exploded view of the
closed fixation loop 16 secured to the tine support body 36
where all elements correspond to those elements previously
delineated.
Figure 4, which illustrates the electrical
connector 18, shows the wound coil 30 of the atrial lead
14 electrically affixed to a connector pin 34 through one
sleeve 18a of the elongated "Y" connector 18. The end 46a
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Of the sleeve 18a is configured to functionally engage
with a pulse gener'ator. Sealing rings 48a, 48b, and
48c by way of example and for`purposes of illustration
only provide a seal between the'pulse generator and the
one sleeve 18a. Adhesive can be injected betwee`n the sleeve
18a and the connector pin 34 further sealing the two members
together. The wound co'il 20 including the'polyurethane
insulation coating 26 of the ventrical lead 12 slides
through the other sleeve 18b 'of the connector 18 for a
finite distance beyond the end 46b of the sleeve 18b.
The other end 46b is likewise'configured as is the end
46a. Two sealing rings 50a and 50b are likewise provided.
An O-ring groove 52 positions between the sealing ring
50b and the end 46b as also illustrated in figure 5 and
accepts an O-ring 54 which forms a liquid seal 56 between
the connector sleeve 18b and the poly~lrethane insulation
coating 26 of the wound coil 20.
Figure 5, which illustrates the cross sectional
view taken along line 5-5 o figure 4, shows numerals
corresponding to elements previously delineated.
Preferred ~ode of Operation
The transvenous leads 10 are inserted in through
an appropriate vein in the'human body towards the heart
with the aid of a stylet and fluoroscope for precise
positioning of the lead. Initially, the leads 12 and 14
are pushed together in a joint relationship down the vein
until the outer lead 14 with the attached closed fixation
loop 16 lodges in the atrium of the heart providing a
sensory digital feedback signal to the medical personnel
who subsequently pushes the inner lead 12 into the ventricle
of the heart. Once proper positioning of the leads 10 has
been achieved with the ventricle lead sliding within the
other sleeve 18b of the connector 18, the O-ring 54, is
positioned in the O-ring groove 52 thereby frictionally
engaging the other sleeve 18b of the connector 18 to the
polyurethane insulation coating 26 of the wound coil 20 of
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The ventricle lead 12. Subsequently the proximal tip 24
and the connector pin 34 is secured in the pulse generator
for subsequent pacing of the individuals heart.
The diameter of the fixation loop 16 can be in
the range of 20mm to 105mm by way of example and for purposes
of illustration only. The French size of the atrial lead
14 and the fixatlon loop 16 can be in the range of 12 French
by way of example and for purposes of illustration only.
Various modifications can be made to the fixation
loop 16 for transvenous electrodes 10 of the present inven-
tion without departing from the apparent scope of the present
invention. For instance, the length of the fixation loop
16 can be predetermined to fit any vein or cavity of the
heart. The fixation loop 16 is not strictly limited to use
with the leads 10 as disclosed but can be used with any
surgical electrical lead.
Having thus described the present invention,
there is claimed as new and desired to be secured by
Letters Patent:
