Method and apparatus for removing an implanted pacemaker lead

Heart lead removal apparatus and method are disclosed for removing a pacemaker lead from a heart through a blood vessel leading thereto. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the pacemaker lead. A lockable mechanism grasps the proximal end of the lead, and a wire guide is inserted in the passageway of the lead to determine its size and clear any blockage therein. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the pacemaker lead. The stylet wire is rotated in a direction to unwind and expand the wire coil and engage the coiled structure, thereby securing the stylet wire to the pacemaker lead. A tie secures the insulating material to the coiled structure of the lead at the proximal end thereof to limit motion and to apply a uniform extraction force to the entire lead. A separator tube is inserted over the proximal end of the stylet wire and the lead and moved along the entire length of the lead to first separate the restricted lead from the blood vessel and then the heart cavity. The separator tube, stylet wire, and pacemaker lead are then removed from the heart cavity and blood vessel without causing any significant injury to the heart cavity wall.

TECHNICAL FIELD 
This invention relates to electrical, heart pacemaker leads and 
particularly to method and apparatus for removing a pacemaker lead 
implanted in a heart. 
BACKGROUND OF THE INVENTION 
A heart pacemaker is generally implanted subcutaneously in the chest wall 
along with a lead for conducting electrical signals, such as stimulating 
pulses, between the pacemaker and the heart. The lead is surgically 
implanted through a vein leading to a cavity of the heart. A typical heart 
lead includes one or more spirally coiled wires having a hollow inner 
passageway that extends the entire length of the coiled wires. The coiled 
structures are positioned in the lead either coaxially or laterally. The 
coiled wires are surrounded by an insulating material such as a flexible 
tube or coating comprising, for example, silicone or polyurethane for 
insulating the wires from body fluids as well as each other. However, one 
problem is that, over time, fibrotic tissue commonly encapsulates the 
heart lead especially in areas where there is low velocity blood flow. 
When small diameter veins through which the lead passes become completely 
occluded with fibrotic tissue, separating the lead from the vein is 
difficult and causes severe damage to or destruction of the vein. 
Furthermore, the separation is usually not possible without restricting or 
containing the movement of the heart lead. 
In most cases, the useful life of a heart lead lasts for many years. 
However, should the heart lead become inoperative due to corrosion or 
other effects of body fluids or should another heart lead be desired, the 
existing heart lead is typically left in place, and a new heart lead is 
implanted through another vein. One problem with leaving an implanted 
heart lead in place, particularly in the heart, is that the lead partially 
restricts the operation of the various heart valves through which the lead 
passes. If several leads passing through a heart valve are left in place, 
the operation of the heart valve and the efficacy of the heart is 
significantly impaired. 
Another problem associated with leaving heart leads in place, particularly 
in blood vessels, is that an infection may develop around the lead, 
thereby requiring surgical removal. Surgical removal of the lead from the 
heart often involves open heart surgery which is complicated, risky, and 
costly. 
One method for transvenous removal of a heart lead involves a prior art 
heart lead removal tool that utilizes a hollow, rigid tube and a beveled 
rod tip for engaging and deforming the coiled structure of the heart lead. 
However, when the heart lead cannot be removed because of some 
complication, a serious problem is that the tip of the tool is locked in 
place and cannot be removed from the heart lead. As a result, the tool and 
heart lead must be surgically removed. Furthermore, the rigid tube of the 
tool can easily puncture a blood vessel or a heart cavity wall. 
Another method is to transvenously extract the heart lead manually without 
the aid of a tool. Such method is possible only when the lead has not ben 
encapsulated in a blood vessel. Even then, this method has a number of 
problems. First, when the polyurethane or silicone insulation surrounding 
the coiled wire is damaged, the insulation can sever and cause the coiled 
structure of the lead to unwind and to damage the heart and blood vessels. 
Secondly, when both the coil structure and insulation are severed in the 
heart or a blood vessel, surgical removal is required. Thirdly, most heart 
leads typically include tines or a corkscrew at the tip or a conically 
shaped tip for securing the distal end of the heart lead to a heart cavity 
wall. After fibrotic tissue has encapsulated the tip, unaided manual 
removal of the heart lead tip from the heart cavity wall may cause an 
inward extension or inversion of the wall, or even worse, permanent damage 
to the heart such as tearing a hole in the heart cavity wall. 
SUMMARY OF THE INVENTION 
The foregoing problems are solved and a technical advance is achieved with 
illustrative apparatus for removing an electrical pacemaker lead implanted 
in a heart. The apparatus comprises a stylet wire and a wire coil attached 
about the distal end of the stylet wire. The stylet wire is insertable 
into the longitudinal passageway of the implanted lead for controlling the 
movement of the lead. When the stylet wire is inserted in the passageway 
of the lead, the coil wire is operated for securing the distal end of the 
stylet wire to the lead. 
Normally prior to insertion of the stylet wire, a wire guide is utilized 
for determining the passageway of the lead for the stylet wire. In one 
instance, the wire guide is inserted to reopen or unblock an occluded 
passageway or to detect a damaged or deformed coiled structure. A control 
mechanism is attached at the proximal end of the wire guide to rotate and 
move the wire guide through the passageway. Typically smaller in diameter 
than the stylet wire, the wire guide is used to detect and measure the 
inside diameter of another coaxially positioned coiled structure that has 
retracted into or broken off in the passageway of a larger coiled 
structure. A plurality of wire guides with different size diameters are 
utilized to determine the actual inside diameter of the coiled structure. 
This aids in the selection of a stylet wire and wire coil having a 
combined outside diameter corresponding to the inside diameter of the 
coiled structure. 
The invention also includes apparatus for grasping the pacemaker lead, for 
example, at the proximal end where the lead may have been previously cut 
exposing only a short segment extending from the subclavian vein. The 
grasping apparatus includes a pair of opposing jaws with pliable material 
affixed thereto for grasping the lead without deforming the coiled 
structure within the lead. The jaws are connected to pivotly 
interconnected elongated members that operate the jaws between open and 
closed positions. The proximal end of the members are connected to a 
locking mechanism for locking the jaws in a closed position. The pliable 
material on each jaw includes a channel for grasping the lead and applying 
pressure thereto in a uniform manner. This apparatus advantageously grasps 
the lead without deforming the coiled structure while the wire guide and 
stylet wire are inserted into the passageway of the lead. The grasping 
apparatus also prevents the coiled structure from retracting into the 
insulating material as well as preventing the lead from retracting into 
the vein. 
A control mechanism of the lead removal apparatus such as a looped handle 
formed or attached at the proximal end of the stylet wire controls the 
movement of the stylet wire. This mechanism is used to rotate the stylet 
wire in a direction opposite to the direction that the coiled structure is 
wound for operating the wire coil to engage the coiled structure. When the 
wire coil and coiled structure are engaged, the stylet wire is, as a 
result, firmly secured to the heart lead. When secured to the lead, the 
stylet wire is further rotated by the control mechanism to dislodge the 
distal end or tip of the lead from the heart tissue. Such a procedure is 
advantageously suited for a pacemaker lead having an electrode tip that is 
lodged in the heart tissue with a corkscrew mechanism. 
After the stylet wire has been secured to the lead, a tie such as nylon 
cord or suture material is secured about the proximal end of the lead to 
limit movement of the coiled structure and the insulating material. With 
the coiled structure and the insulating material secured at the proximal 
end, the stylet wire applies force both to the insulating material and the 
coiled structure during removal of the lead. Otherwise, the stylet wire 
pulls only on the coiled structure which may break or unravel leaving the 
insulating material in place and causing possible injury to surrounding 
tissue. Securing the stylet wire to the lead and the insulating material 
to the coiled structure advantageously controls and limits the movement of 
the heart lead and prevents the coiled structure and insulating material 
from stretching, unraveling, or breaking during subsequent removal and, if 
necessary, during separation from the blood vessel and heart cavity wall. 
When the pacemaker lead has tines lodging the tip to the heart tissue or 
when the movement of the lead is restricted in a blood vessel, a separator 
is inserted over the heart lead with the stylet wire secured thereto. The 
separator is preferably a tube made from a material, such as a TEFLON 
material, for moving easily over the heart lead and through the blood 
vessel. The distal end of the tube is beveled and has an edge for 
separating the heart lead from the blood vessel wall as the tube is moved 
along a length of the heart lead. A hollow metal tip having a beveled 
cutting edge is attached to the distal end of the tube to separate a 
restricted lead encapsulated, for example, by fibrotic tissue. The secured 
stylet wire advantageously limits movement of the heart lead to facilitate 
separation and also minimizes damage to the blood vessel as the tube is 
passed along a length of the heart lead separating the heart lead from the 
blood vessel wall. 
After passing through the blood vessel, the tube is moved to the distal end 
of the heart lead next to the heart cavity wall for separating the tines 
at the tip of the lead from the heart tissue without causing injury 
thereto. The tube is held in place next to the heart cavity wall or pushed 
just slightly, while the stylet wire is pulled to engage the tip of the 
heart lead against the beveled distal end of the tube. The tube is then 
rotated back and forth to cause the tines at the tip of the heart lead to 
dislodge and separate from the trabeculae and fibrotic tissue that secure 
the lead to the heart cavity wall. As a result, the tip of the heart lead 
is advantageously separated from the heart wall without causing injury to 
the heart tissue. 
Another advantage of this lead removal apparatus is when the lead cannot be 
removed because of some complication. In such case, the separator tube is 
removed from the blood vessel, and the stylet wire is rotated to unsecure 
and unscrew the wire coil and the stylet wire from the coiled structure of 
the heart lead. This advantageously permits the removal of the stylet wire 
from the coiled structure without having to perform open heart surgery. 
This represents a significant advantage over the prior art device in which 
the beveled rod and an actuating wire cannot be removed from the heart 
lead after the distal end has engaged and deformed the coiled structure. 
In such instance, open heart surgery is then required to remove the lead. 
The invention also includes the method of removing the pacemaker lead 
implanted in a heart by determining the passageway of the lead with a wire 
guide and by inserting the distal end of the stylet wire with the wire 
coil attached thereto into the longitudinal passageway formed by the 
coiled structure of the lead. A back and forth rotation of the stylet wire 
is advantageously used to free the stylet wire and wire coil if there is a 
tendency for the stylet wire to prematurely engage the coiled structure of 
the heart lead. After the stylet wire is fully inserted, the stylet is 
rotated a number of times usually in a counterclockwise direction to 
engage the wire coil with the coiled structure. As a result, the stylet 
wire is secured to the coiled structure. 
The method further includes restricting movement of the coiled structure 
within the insulating material with a tie secured at the proximal end of 
the lead. The secured stylet wire is then further rotated to dislodge the 
tip of the lead from the heart tissue. The dislodged lead is removed from 
the heart by pulling the secured stylet wire and lead from the heart. 
When a blood vessel restricts movement of the lead or the tip of the lead 
has tines, a separator tube with a metal cutting tip is inserted over the 
heart lead with the stylet wire secured thereto after the stylet wire is 
secured to the heart lead. As the separator tube is moved along the length 
of the heart lead, the stylet wire limits the movement of the heart lead 
to permit the separation of the heart lead from an encapsulating blood 
vessel. When fully inserted to the heart lead tip, the separator tube is 
held in place or pushed slightly, and the stylet wire is pulled to engage 
the tip of the heart lead with the beveled distal end of the tube. The 
separator tube is then rotated back and forth to dislodge the tines and 
separate the tip of the lead from the heart cavity wall without causing 
any trauma thereto. 
Since the coiled structure of the heart lead is commonly wound in a 
clockwise direction, the stylet wire coil is wrapped around the stylet 
wire in a counterclockwise direction opposing the direction of the coiled 
structure. This permits the easy engagement and disengagement of the 
stylet wire with the heart lead when the stylet wire is rotated in either 
a counterclockwise or clockwise direction. 
In another embodiment of the lead removal apparatus, a lock wire having a 
plurality of turns about the distal end is attached about the distal end 
of the stylet wire, and the proximal end is extended beyond the passageway 
of the lead. The proximal end of the lock wire is secured when the 
inserted stylet wire is rotated to engage the turns of the lock wire with 
the coiled structure. The stylet wire and lock wire have a combined 
diameter for passing through a deformed segment of the coiled structure. 
The deformed segment usually has a much smaller diameter than the distal 
end of the lead, and the secured proximal end of the lock wire 
advantageously permits the turns at the distal end thereof to expand and 
engage the larger diameter at the distal end of the lead.

DETAILED DESCRIPTION 
Depicted in FIG. 1 is a partial cross-sectional view of heart 215 connected 
to a plurality of arteries and veins such as the right subclavian vein 216 
through which an electrical heart pacemaker lead 204 has been implanted. 
The lead passes internally through the right subclavian vein 216, the 
superior vena cava 208 and into the right ventricle 217 of the heart. The 
distal end of the lead includes an electrode 220 for electrically 
stimulating the heart and is secured to the apex of the right ventricle 
with a plurality of tines 207, which in time become securely attached to 
the ventricle wall by endothelial tissue forming around the heart lead 
tip. Some ventricles are relatively smooth on the inside, but most have 
trabeculae amongst which the tines are secured into position. External to 
the right subclavian vein, the proximal end 221 of the lead is grasped by 
a lockable mechanism 222, which will be described hereinafter. 
Depicted in FIG. 2 is a partial cross-sectional view of a prior art tool 
100 for removing a heart lead 111 which has been secured to a heart cavity 
wall 113 via trabeculae and/or fibrotic tissue 104. The lead includes an 
electrical coiled structure 101 and insulating material 102 that is formed 
essentially into a tube for covering the outer surface of the coiled 
structure and for preventing fluids from entering the coiled structure. At 
the distal end of the heart lead are tines 103, that are formed from the 
insulating material, for securing the heart lead tip including electrode 
109 to the heart cavity wall. Tool 100 includes a hollow rigid tube 105 
and beveled rod 106 for inserting in the longitudinal passageway 110 of 
the heart lead coiled structure. In the passageway of hollow tube 105 is 
an actuating wire 107 connected to beveled rod 106. The trailing edge of 
the beveled rod and the leading edge of the hollow tube are inclined at an 
angle for moving the beveled rod across the distal end of the hollow tube 
when the actuating wire is pulled. When moved, the beveled rod engages and 
deforms the heart lead coiled structure as shown. The deformed coiled 
structure locks the hollow tube and beveled rod in place for limiting 
movement of the heart lead. However, once secured, beveled rod 106 may not 
be extracted from passageway 110 of the coiled structure since the 
deformed coiled structure prevents the beveled rod and actuating wire from 
traversing the passageway. The prior art tool also includes a hollow 
dilator 108 for sliding over the heart lead coil and separating the heart 
lead from the blood vessel. A hollow explanator 112 passes over the 
dilator and is rotated back and forth to explant the tip of the heart lead 
from the securing tissue and heart wall. 
Depicted in FIG. 3 is a flexible stylet wire 200 of the present lead 
removal apparatus invention that is insertable in the longitudinal 
passageway 210 of a heart lead coiled structure 211 for controlling and, 
in particular, limiting the movement of heart lead 204 including coiled 
structure 211. Heart lead 204 also includes insulating material 201, such 
as silicone or polyurethane, formed into a hollow tube that surrounds the 
coiled structure and prevents fluids from making contact with the coiled 
structure. Attached to the distal end of the flexible stylet wire is an 
expandable wire coil 205 consisting of approximately 25 turns of wire with 
spacing between the turns. Five to seven wraps of the wire coil are 
attached to the distal end of the stylet wire using, for example, solder 
206. The remaining wraps of the wire coil remain free for engaging the 
coiled structure when the proximal end of the stylet wire is rotated in a 
direction to unwind and expand the turns of the wire coil and engage the 
coiled structure of the heart lead. A bead 214 of high temperature silver 
solder is applied to the distal end of the stylet wire to prevent the 
distal end thereof from pulling through the wire coil during separation 
and removal of the heart lead. Positioned about the proximal end of the 
stylet wire is control mechanism 202 for rotating the stylet wire in 
either a clockwise or counterclockwise direction or for moving the wire in 
a longitudinal direction into or out of the passageway. In this 
embodiment, control mechanism 202 is a loop of wire formed from the stylet 
wire of which the physician may grasp or insert his finger. The loop may 
also be fashioned for attachment to another control mechanism for moving 
the stylet wire. Other control mechanisms such as a slidable chuck may be 
positioned at the proximal end of the stylet wire to facilitate movement 
of the stylet wire. The formed loop 202 is covered with a TEFLON material 
tubing 203 or other suitable material for facilitating the easy movement 
of the stylet wire. The looped end is also compressible for inserting 
through a separator tube 212. 
The choice of the stylet wire and coil wire varies with the internal 
diameter of the coiled structure which varies from 0.016" to about 0.028" 
for most heart leads. The diameter of the stylet wire would then range 
from 0.009" to 0.015", with the coil wire ranging in diameter from 0.003" 
to 0.006". The use of stainless steel wire is preferable. The stylet wire 
should be hardened wire, but ductable wire may be used for the coil wire. 
Before the stylet wire is inserted into passageway 210 of the lead, the 
inside diameter of the coiled structure and the outside diameter of the 
insulating material are determined. First, lockable mechanism 222 is first 
applied to the proximal end 221 of the lead between opposing semicircular 
jaws 223 and 224. The details of mechanism 222 are depicted in FIGS. 5 and 
6. Semicylindrical pliable material 225 and 226, such as latex, are 
affixed with medical grade adhesive to the opposing faces of the jaws. 
Semicylindrical pliable material 225 includes semicylindrical channels 227 
and 229 having different radii, and pliable material 226 includes 
semicylindrical channels 228 and 230 with radii corresponding to channels 
227 and 229, respectively. When jaws 223 and 224 are in a closed position, 
the opposing surfaces 231 and 232 of respective pliable material 225 and 
226 are in contact with opposing channels 227 and 228 forming one hollow 
cylindrical passageway with a first diameter and opposing channels 229 and 
230 forming a second hollow cylindrical passageway with a second larger 
diameter. The two different size diameter passageways in the pliable 
material accommodate a number of different size diameter pacemaker leads 
and are designed to grasp and apply pressure to insulating material 201 in 
a uniform manner. 
When proximal end 221 of lead 204 is inserted and grasped in the hollow 
passageway formed by channels 229 and 230, insulating material 201 is 
compressed onto coiled structure 211, thus limiting the movement of the 
structure within the insulating material. When the physician cuts the lead 
for access to the passageway of the lead, the compressed insulating 
material prevents the coiled structure from retracting into the passageway 
of the lead. 
Pivotly interconnected elongated members 233 and 234 are connected to 
respective opposing jaws 223 and 224 to operate the jaws between open and 
closed positions. The proximal ends 235 and 236 of the members are curved 
as shown in FIG. 5 to oppose each other and have a respective plurality of 
teeth 237 and 238 that interlock to form a locking mechanism. The locking 
mechanism is actuated by squeezing the proximal ends of the members and 
opposingly positioning the teeth thereon. When so positioned, the teeth of 
mechanism 222 interlock and maintain opposing jaws 223 and 224 in a closed 
position. 
When lockable mechanism 222 is in a closed position with the proximal end 
of the lead grasped between jaws 223 and 224 and the passageway of the 
lead exposed, the physician selects a wire guide 239, as shown in FIG. 3, 
having a diameter less the diameter of the lead passageway. The physician 
determines the passageway by inserting the wire guide therein and sensing 
for any blockages. The guide includes a control mechanism such as a 
knurled cylindrical chuck 240 positionable about the proximal end thereof. 
The physician grasps the knob to extend the guide into the lead passageway 
and to rotate the guide back and forth to clear or break through any 
blockages caused by tissue or occluding material. The guide is also used 
to determine or size the inside diameter of a second coiled structure that 
may be coaxially positioned inside coiled structure 211. When utilized as 
a control mechanism for stylet wire 200, the chuck may also include 
appendages 260 for rotating and counting the number of times the stylet 
wire is rotated. Having determined the lead passageway with the wire 
guide, several other guides similar to guide 239 are individually inserted 
in the passageway to determine the actual inside diameter at the proximal 
end. Guide 239 is also utilized to determine if coiled structure 211 has 
been deformed or damaged and to determine the smallest diameter of the 
coiled structure and passageway. 
As shown in FIG. 3, stylet wire 200 is inserted into longitudinal 
passageway 210 of coiled structure 211. The diameter of the coil wire and 
stylet wire have been selected to form a combined overall diameter which 
approximates the diameter of the longitudinal passageway of the heart lead 
coiled structure within a predetermined tolerance such as one or two 
thousandths of an inch. Stylet wire 200 is then fed through the entire 
length of the passageway to the distal end of the heart lead coiled 
structure which is secured to the wall of heart cavity tissue 213. When 
fully inserted into the heart lead, the distal ends of the stylet wire and 
heart lead coiled structure should be in close proximity. It is not 
necessary, but probably more advantageous, that the stylet wire be 
attached to the distal end of the heart lead. For separating the heart 
lead from adjacent tissue, the stylet wire may be secured anywhere along 
the passageway of the coiled structure past the restricting tissue. To 
secure the stylet wire to coiled structure 211, looped end 202 of the 
stylet wire is operated in a circular direction to unwind and expand wire 
coil 205. As a result, the turns of the wire coil and coiled structure 
engage and intermesh, thereby firmly securing the stylet wire to the heart 
lead. This prevents any extension or stretching of the heart lead and also 
controls and limits the movement of the lead when separator tube 212 is 
moved along the length of coiled structure 211 and insulating material 201 
of the heart lead. 
After the stylet wire is secured to the lead and prior to inserting 
separator tube 212 over the stylet wire and lead, a tie 241 of, for 
example, nylon cord or suture material is wrapped around proximal end 221 
of the lead to secure insulating material 201 to coiled structure 211. The 
tie controls or limits the movement of the coiled structure within the 
insulating material. With the insulating material secured to the coiled 
structure at the proximal end, removal force is applied not only to the 
coiled structure, but also to the insulating material of the lead as well. 
This maintains the integrity of the heart lead during subsequent tissue 
separation from the insulating material. In those instances where the 
stylet wire has not been fully inserted to the distal end of the lead, the 
tie also prevents the coiled structure from unravelling, breaking or 
separating from electrode 220 or the rest of the lead. 
As previously suggested, the looped proximal end of the stylet wire can be 
compressed to permit separator tube 212 to be inserted thereover and over 
the insulating material of the heart lead. Separator tube 212 comprises a 
semi-rigid material, such as a TEFLON material for sliding easily through 
the blood vessel and over the insulating material of the heart lead. In 
order to place the separator tube over the stylet, the stylet should 
extend at least 12 inches beyond the person's body so that the looped end 
can be grasped to apply tension to the stylet. With the separator tube 10 
to 12 inches long, the stylet is typically three feet long. 
Depicted in FIG. 4 is fibrotic tissue 209 encapsulating heart lead 204 in 
blood vessel 216. When this occurs in small diameter veins where blood 
flow has been restricted or prevented, separation and removal of the lead 
from the tissue is difficult and often causes severe damage or destruction 
to the vein. Without tension on stylet wire 200, separation is usually not 
possible in these situations. 
As shown, the distal end of the separator tube 212 is beveled and includes 
a cutting edge or edge having a number of teeth for separating heart lead 
insulating material 201 from encapsulating fibrotic tissue 209. As 
depicted in FIG. 7, hollow separator tube 212 has a metal beveled tip 242 
attached to the distal end thereof with, for example, a medical grade 
adhesive. The metal tip provides a more durable edge for separating or 
cutting encapsulating fibrotic tissue from the lead. 
Returning the reader's attention to FIG. 3, separator tube 212 is moved and 
rotated along the outer surface of insulating material 201 of the heart 
lead to separate the lead from the blood vessel wall. After the separator 
tube has been moved along the entire length of the heart lead, it will 
abut next to the heart cavity wall as shown by phantom lines 219. The 
distal end of the heart lead is typically secured to the heart cavity wall 
by trabeculae or fibrotic tissue 218 that has encapsulated tines 207 
positioned at the distal end of the lead. The separator tube 212 is 
positioned next to the heart cavity wall or pushed slightly while the 
stylet wire is tensioned in the opposite direction. The separator tube is 
then rotated back and forth to dislodge and separate tines 207 and the 
distal end of the heart lead from fibrotic tissue 218 and heart cavity 
wall 213. As a result, the heart lead has now been completely separated 
from the blood vessel and the heart cavity wall for subsequent removal. 
The separator tube, the stylet wire, and the heart lead are then removed 
from the heart cavity and surrounding blood vessel. 
However, should the removal of the heart lead be prevented for whatever 
reason, the stylet wire is rotated in a clockwise direction to unsecure 
the stylet and wire coil from the heart lead coiled structure. The time 
for this operation is lessened by attaching a rotating mechanism such as 
an electrical screwdriver to the proximal end of the stylet wire. 
Depicted in FIG. 7 is another illustrative embodiment of the lead removal 
apparatus of this invention. In this embodiment, pacemaker lead 243 is 
similar to the lead shown in FIG. 3; however, the distal end of the lead 
is of a different configuration. In particular, electrode 244 has two 
cavities therein. One cavity is for receiving the coiled structure 245 of 
the lead. The second cavity is for receiving and securing anchoring coil 
246 secured in the cavity with insulating material 247 in a well-known 
manner. The distal end of anchoring coil 246 is cut to form a beveled or 
sharpened edge for turning or corkscrewing the coil into heart cavity wall 
213. Anchoring coil 246, as a result, securely attaches electrode 244 to 
the heart tissue to establish good electrical contact for stimulating the 
heart tissue with electrical pacing pulses from the pacemaker. Insulating 
material 248 surrounds coiled structure 245 and partially surrounds 
electrode 244. Since anchoring coil 246 is utilized in this configuration, 
the insulating material is molded over the coiled structure and electrode 
without forming tines for the endothelial tissue to form therearound. 
Stylet wire 249 of this lead removal apparatus and lock wire 250 attached 
to the distal end thereof have a combined diameter much less than the 
inside diameter of coil structure 245 of the lead. This is particularly 
advantageous for those situations when the coiled structure of the lead 
has been deformed, unraveled, or in some way damaged. In this embodiment, 
lock wire 250 has a plurality of turns 251 wrapped around the distal end 
of the stylet wire. Turns 251 of the lock wire at the distal end of the 
stylet wire are closely wrapped and attached to the distal end of the 
stylet wire using, for example, a silver solder. Turns 252 of the lock 
wire are more loosely wrapped and are approximately 75 in number. The 
unwrapped proximal end 253 of the lock wire extends beyond the passageway 
of the lead and is secured and positioned by, for example, the physician's 
hand 258 when the stylet wire is rotated to expand lock wire turns 252 and 
engage the turns of coiled structure 245. 
Control mechanism 254 such as a loop of malleable wire is wrapped around 
and secured to the proximal end of the stylet wire using, for example, 
silver solder 257. Slidable chuck 240 is also suitable for use as the 
control mechanism for stylet wire 249. A TEFLON material coating 255 
surrounds the interconnection to prevent possible injury to the physician 
or patient. Control loop 254 is provided for the physician to move the 
stylet wire in and out of the passageway of the lead as well as rotate the 
stylet wire to engage the coiled structure of the lead. When the stylet 
wire is secured to the pacemaker lead, loop 254 is used to extract stylet 
wire and pacemaker lead from the patient. 
To unravel the turns of the lock wire, a tool such as an electrical 
screwdriver is attached to the control mechanism loop to rotate the stylet 
wire and expand the turns of the lock wire. While the stylet wire is being 
rotated, the physician secures the position of the proximal end 253 of the 
lock wire to permit lock wire turns 252 to tangle and form a bundle 259 
that engages the coiled structure as depicted in FIG. 8. The stylet may 
have to rotate 50 to 100 turns to form bundle 259 and engage coiled 
structure 245. 
After the lock wire has secured the stylet wire to the pacemaker lead, the 
physician grasps control loop 254 and continues to rotate the stylet wire 
and pacemaker lead to dislodge anchoring coil 246 from the heart tissue. 
Should the blood vessels encapsulate the pacemaker lead, separator tube 
212 is inserted over the stylet wire and pacemaker lead as previously 
described to separate the lead from the encapsulating blood vessel tissue. 
The separator tube may also be extended to the distal end of the pacemaker 
lead to turn and dislodge the distal end of the pacemaker lead from the 
heart tissue. 
Of course, it will be understood that the aforementioned lead removal 
apparatus and method is merely illustrative of the application of the 
principles of this invention and that numerous other arrangements may be 
devised by those skilled in the art without departing from the spirit and 
scope of the invention. In particular, a number of other control 
mechanisms may be attached to the proximal end of the stylet wire for 
operating the stylet wire in either a clockwise or counterclockwise 
direction as well as moving the wire longitudinally. Furthermore, this 
apparatus may be utilized for removing electrical leads from body ducts 
and passages as well as body tissue that has encapsulated the lead and 
restricted its movement.