US20160001064A1 - Endocardial lead cutting apparatus - Google Patents
Endocardial lead cutting apparatus Download PDFInfo
- Publication number
- US20160001064A1 US20160001064A1 US14/857,621 US201514857621A US2016001064A1 US 20160001064 A1 US20160001064 A1 US 20160001064A1 US 201514857621 A US201514857621 A US 201514857621A US 2016001064 A1 US2016001064 A1 US 2016001064A1
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- United States
- Prior art keywords
- lead
- tubular member
- cutting
- blade
- distal end
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
- A61B2017/32004—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes having a laterally movable cutting member at its most distal end which remains within the contours of said end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B2018/2255—Optical elements at the distal end of probe tips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N2001/0578—Anchoring means; Means for fixing the head inside the heart having means for removal or extraction
Definitions
- This invention relates generally to an endocardial lean cutting apparatus and, more particularly, to an apparatus including at least one blade or cutting surface for cutting endocardial leads within a patient.
- endocardial leads and electrodes have been introduced into different chambers of a patient's heart, including the right ventrical, right atrial appendage, and atrium as well as the coronary sinus.
- These flexible leads usually are composed of an insulator sleeve that contains an implanted helical coil conductor that is attached to an electrode tip.
- This electrode is placed in contact with myocardial tissue by passage through a venous access, often the subclavian vein or one of its tributories, which leads, to the endocardial surface of the heart chambers.
- the tip with the electrode contact is held in place by trabeculations of myocardial tissue.
- the tips of many available leads include flexible tines, wedges, or finger-like like projections which extend radially outward and usually are molded from and integral with the insulating sheath of the lead. These tines or protrusions allow surrounding growth of tissue in chronically implanted leads to fix the electrode tip in position in the heart and prevent dislodgement of the tip during the life of the lead.
- a blood clot forms about the flanges or tines (due to enzymes released as a result of irritation of the trabeculations myocardial tissue by the presence of the electrode tip) until scar tissue eventually forms, usually in three to six months.
- the tines or wedges or finger-like projections allow better containment by the myocardial trabeculations of muscle tissue and prevent early dislodgement of the lead tip.
- endocardial leads nevertheless occasionally fail, due to a variety of reasons, including breakage of a lead, insulation breaks, breakage of the inner helical coil conductor and an increase in electrode resistance. Furthermore, in some instances, it may be desirable to electronically stimulate different portions of the heart than are presently being stimulated with the leads already implanted. There are a considerable number of patients who have one or more, and sometimes as many as four or five unused leads in their veins and heart.
- Removal of an inoperative lead sometimes can be accomplished by applying traction and rotation to the outer free end of the lead, for example, if done prior to fixation of the lead tip in the trabeculations of myocardial tissue by scar tissue formation or large clot development. Even then, it is possible that a clot has formed so the removal of the leads causes various sized emboli to pass to the lungs, producing severe complications.
- Such “channel scar” tissue prevents withdrawal because of tight encasement of the lead. Continual strong pulling or twisting of the outer free end of the lead could cause rupture of the atrial wall or the ventricular wall if there is such tight circumferential encasement of adherent channel scar tissue in the venous path. Such tight encasement by scar tissue in the venous pathway and in the trabeculations of the myocardial wall typically occurs within six months to a year of the initial placement of the lead.
- the present invention comprises an apparatus for cutting the lead as near as possible to an endocardial lead's embedded electrode.
- the present invention comprises an apparatus having a generally flexible tubular member having a proximal end and distal end. At least one blade or cutting surface is affixed to the distal end of the tubular member.
- the apparatus includes an adjustment mechanism adapted to adjust the blade or cutting surface between an extended position and a retracted position.
- FIG. 1 illustrates a perspective view of an endocardial lead cutting apparatus of a first embodiment of the present invention
- FIG. 2 illustrates a perspective view of an endocardial lead cutting apparatus of a second embodiment of the present invention
- FIG. 3 illustrates an enlarged perspective view of a distal end of an outer tubular member of the second embodiment of the present invention
- FIG. 4 illustrates to 3 enlarged perspective view of a distal end of an inner shaft of the second embodiment of the present invention
- FIG. 5A-5C illustrate end views of the endocardial lead cutting apparatus of the second embodiment of the present invention having the inner shaft rotating to cut the lead;
- FIG. 6 illustrates a cross-sectional vie of an endocardial lead cutting apparatus of a third embodiment of the present invention
- FIG. 7 illustrates an enlarged cross-sectional view of a distal end of the endocardial lead cutting apparatus of the third embodiment of the present invention
- FIG. 8 illustrates a perspective view of an endocardial lead cutting apparatus of a fourth embodiment of the present invention
- FIG. 9 illustrates a perspective view of an endocardial lead cutting apparatus of a fifth embodiment of the present invention.
- FIG. 10 illustrates a perspective view of an endocardial lead cutting apparatus of a sixth embodiment of the present invention.
- FIGS. 11A-11C illustrate enlarged perspective views of the distal end of the endocardial lead cutting apparatus of the sixth embodiment.
- FIGS. 1-11 various embodiments of an apparatus are generally referred to at 10 for cutting an endocardial lead 100 .
- the apparatus 10 of a first embodiment includes a shaft 12 having a proximal end 14 and a distal tip 16 .
- the shaft 12 is generally flexible to facilitate movement of the apparatus 10 within the patient.
- the proximal end 14 of the shaft 12 includes a handle 18 while the distal tip 16 includes at least one cutting surface 20 .
- the at least one cutting surface 20 is defined by a groove 22 at the distal tip 16 .
- the groove 22 is illustrated as generally v-shaped. Accordingly, as illustrated, the v-shaped groove 22 defines two cutting surfaces 20 . Further, the cutting surfaces 20 are comprised of a generally hardened material, such as carbide and the like. While illustrated as a v-shaped groove 22 , other configurations, such as u-shaped, c-shaped and the like are contemplated by the present invention.
- a shroud (not shown) is positioned about the shaft 12 such that a distal end of the shroud extends outwardly of the distal tip 16 of the shaft 12 .
- the shroud is made of a generally pliable material to prevent damage to tissue of the patient prior to use of the apparatus 10 .
- the apparatus 10 may include a device (not shown) to provide an additional form of energy to cut the endocardial lead.
- the device may be a laser generating device, an ultrasonic device, a vibration device and the like.
- the exemplary devices would apply radiation, ultrasonic waves or vibrations, respectively, to the lead 100 to assist in cutting the lead 100 .
- an optical fiber (not shown) would be disposed within the shaft 12 to transmit radiation from the proximal end 14 to the distal tip 16 .
- the first embodiment of apparatus 10 of FIG. 1 is inserted within a patient's heart (not shown) and the lead 100 (shown in phantom) is received within the groove 23 at the distal tip 16 .
- the pliable shroud When positioned to receive the lead 100 the pliable shroud is urged away from the distal tip 16 to expose the groove 22 and cutting surfaces 20 .
- Linear and rotation motion is applied by way of the handle 18 to the shaft 12 .
- the cutting surfaces 20 of the groove 22 then engages the lead.
- additional pressure is applied the cutting surfaces 20 cut the lead and the apparatus 10 is removed from the patient.
- the additional forms of energy such as radiation, ultrasound or vibration is applied to the lead to assist in cutting the lead 100 .
- FIGS. 2-5 A second embodiment of the apparatus 10 is shown in FIGS. 2-5 .
- the second embodiment includes an outer tubular member 212 having a proximal end 214 and a distal end 216 .
- the outer tubular member 212 is generally flexible to facilitate movement of the apparatus 10 within the patient.
- the distal end 216 includes a groove 220 for receiving the lead 100 .
- the groove 220 is generally v-shaped for receiving, the lead 100 ; however, other configurations are also contemplated by the present invention.
- An inner shaft 222 is received within the outer tubular member 212 .
- the inner shaft 222 includes a proximal end 224 and a distal end 226 . Further, the inner shaft 222 is generally flexible and includes a handle 228 disposed at the proximal end 224 . Positioned at the distal end 226 of the inner shaft is a blade 230 .
- the blade 230 and the inner shaft 222 is made from a generally hardened material, such as carbide and the like, and rotates within the outer tubular member 212 to cut the lead 100 received within the groove 220 of the outer tubular member 212 .
- the inner shaft 222 and blade 230 are rotatable in either direction.
- the apparatus 10 may include a shroud (not shown).
- the shroud is positioned about the outer tubular member 212 such that a distal end of the shroud extends outwardly of the distal end 216 of the outer tubular member 212 .
- the shroud is made of a generally pliable material to prevent damage to tissue of the patient prior to use of the apparatus 10 .
- the second embodiment of apparatus 10 of FIGS. 2-5 is inserted within a patient's heart and the lead 100 is received within the groove 220 at the distal end. 216 of the outer tubular member 212 .
- the inner shaft 222 and blade 230 are in a home position such that the blade 230 is generally offset from the groove 220 .
- a positioning mechanism (not shown) may be included to bias the inner shaft 222 and blade 230 to the home position within the outer tubular member 212 .
- the pliable shroud is urged away from the distal end 216 to expose the groove 220 and blade 230 .
- the handle 228 of the inner shaft 222 is rotated and the blade 230 contacts the lead. Further rotation of the inner shaft 222 and the blade 230 cuts the lead 100 . The apparatus 10 is then removed from the patient.
- the apparatus 10 includes a tubular member 312 having a proximal end 314 and a distal end 316 .
- the tubular member 312 is generally flexible and preferably made from a plastic or elastomeric material.
- a housing 318 is generally disposed at the distal end 316 of the tubular member 312 .
- the housing 318 includes an opening 320 for receiving the endocardial lead 100 .
- the housing 318 is made of stainless steel and is joined to the distal end 316 of the tubular member 312 by use of an adhesive.
- any technique for joining the housing 318 and the distal end 316 of the tubular member 312 is contemplated by the present invention.
- a blade 322 and a plunger 324 Disposed within the housing 318 are a blade 322 and a plunger 324 .
- the blade 322 is received within the plunger 324 , preferably by press-fitting the blade 322 within the plunger 324 .
- the blade 322 is made of carbide and moveable between an extended position and a retracted position. When in the extended position, the blade 322 is received within the opening 320 of the housing 318 to cut the lead 100 received therein.
- the tubular member 312 includes a handle 326 .
- the handle 326 is joined to the proximal end 314 of the tubular member 312 by adhesive and the like. Alternately, the handle 326 is press fit within the proximal end 314 of the tubular member 312 .
- the handle 326 is utilized to actuate the blade 322 between the extended and retracted positions.
- the apparatus 10 of the third embodiment includes an adjustment mechanism generally referred to at 328 .
- the adjustment mechanism 328 moves the blade 322 between the extended and retracted positions.
- the adjustment mechanism 328 may comprise a screw 330 .
- a first end 332 of the screw 330 is received at a proximal end 334 of the plunger 324 .
- a second end 336 of the screw 330 extends through a retainer 338 .
- the retainer 338 is generally disposed at a proximal end 340 of the housing 318 .
- the adjustment mechanism 328 further includes a universal joint 342 and drive wire 344 .
- the universal joint 342 is disposed at the second end 336 of the screw 330 .
- the universal joint 342 is also attached to the drive wire 344 .
- the drive wire 344 extends through the tubular member 312 and attaches to the handle 326 .
- the handle 326 includes a knob 346 .
- the knob 346 rotates to adjust the blade 322 between the extended and retracted positions.
- the apparatus 10 of the third embodiment of the present invention of FIGS. 6-7 is inserted within a patient's heart and receives the lead 100 within the opening 320 of the housing 318 .
- the adjustment mechanism 328 is actuated by rotating the knob 346 .
- Rotational motion from the knob 346 is transferred through the drive wire 344 and universal joint 342 to rotate the screw 330 .
- Rotation of the screw 330 advances the screw through the retainer 338 to move the plunger 324 and blade 322 from the retracted position to the extended position.
- the blade 322 is received in the opening 320 of the housing 318 and contacts the endocardial lead 100 .
- the lead 100 is then cut by further extension of the blade 322 and the apparatus 10 is removed from within the patient.
- the apparatus 10 includes a tubular member 412 having a proximal end 414 and a distal end 416 .
- the distal end 416 is generally u-shaped to define a first cutting surface 418 .
- a handle 420 At the proximal end 414 of the tubular member 412 is a handle 420 .
- the tubular member 412 may be generally flexible to move within the patient.
- the tension member 422 Disposed within the tubular member 412 is a tension member 422 .
- the tension member 422 includes a proximal end 424 and a distal end 426 .
- the proximal end 424 of the tension member 422 is fixed to a lever 428 .
- the distal end 426 of the tension member 422 is fixed to a blade 430 .
- the blade 430 is pivotally connected to the distal end 416 of the tubular member 412 and actuation of the lever 428 about the handle 420 pivots the blade 430 to capture the lead 100 between the blade and the first cutting surface 418 .
- blade 430 has a generally s-shaped configuration and defines a first end 432 , a second end 434 and a connecting leg 436 extending therebetween.
- the first end 432 includes an inner surface that defines a second cutting surface 438 .
- the second end 434 is fixed to the proximal end 424 of the tension member 422 .
- the connecting leg 436 of the blade 430 is pivotally connected to the distal end 416 of the tubular member 412 . As illustrated the blade 430 is connected to the distal end 416 of the tubular member 412 generally at the midpoint of the connecting leg 436 .
- alternative fastening positions or techniques are easily contemplated by one skilled in the art.
- the apparatus 10 of the fourth embodiment is placed within a patient and the lead 100 is received within the u-shaped distal end 416 of the tubular member 412 such that the first cutting surface 418 contacts the lead 100 .
- the lever 428 is actuated about the handle 420 to draw the tension member 422 away from the distal end 416 and pivot the blade 430 thereabout.
- the second cutting surface 438 of the first end 432 also contacts the lead 100 to capture the lead 100 therebetween. Further actuation of the lever 428 and the cutting surfaces 418 , 438 cut through the endocardial lead 100 .
- the apparatus 10 includes a tubular member 512 having a proximal end 514 and a distal end 516 .
- the distal end 516 is generally c-shaped to define a first cutting surface 518 .
- a handle 520 At the proximal end 514 of the tubular member 512 is a handle 520 .
- the tubular member 512 may be generally flexible to move within the patient.
- the tension member 522 Disposed within the tubular member 512 is as tension member 522 .
- the tension member 522 includes a proximal end 524 and a distal end 526 .
- the proximal end 524 of the tension member 522 is fixed to a lever 528 .
- the distal end 526 of the tension member 522 is fixed to a blade 530 .
- the blade 530 is received within the tubular member 512 and disposed at the distal end 516 . Actuation of the lever 528 about the handle 520 linearly moves the blade 530 to capture the lead 100 between the blade 530 and the first cutting surface 518 .
- the blade 530 defines a second cutting surface 532 and capturing the lead 100 between the blade 530 and the first cutting surface 518 cuts the lead 100 .
- the apparatus 10 of the fifth embodiment is placed within a patient and the lead 100 is received within the c-shaped distal end 516 of the tubular member 512 such that the first cutting surface 518 contacts the lead 100 .
- the lever 528 is actuated about the handle 520 to draw the tension member 522 away from the distal end 516 and move the blade 530 linearly.
- the second cutting surface 532 of the blade 530 also contacts the lead 100 to capture the lead 100 between the blade 530 and the first cutting surface 518 . Further actuation of the lever 528 and the cutting surfaces 518 , 532 cut through the endocardial lead 100 .
- the apparatus 10 includes a tubular member 612 having a proximal end 614 and a distal end 616 .
- the distal end 616 includes a housing 618 while the proximal end 614 includes an adjustment mechanism 620 .
- the tubular member 612 may be generally flexible to move within the patient and optionally include reinforcements such as a braid or compressed coil to strengthen tubular member 612 and resist compression during operation.
- the tension member 622 Disposed within the tubular member 612 is a tension member 622 .
- the tension member 622 includes a proximal end 624 and a distal end 626 .
- the proximal end 624 of the tension member 622 is fixed to the adjustment mechanism 620 while the distal end 626 is connected to two blades 628 .
- the adjustment mechanism 620 moves the tension member 622 and the blades 628 between an extended position and a retracted position.
- the adjustment mechanism 620 it a handle 630 for actuating the tension member 622 and blades 628 between the extended and retracted positions.
- Pivotally connected to the handle 630 is a lever 632 with a biasing mechanism 634 , such as a spring and the like, disposed therebetween.
- the biasing mechanism 634 urges the lever 632 about the handle 630 and hence, the tension member 622 and blades 628 to one of either the extended or retracted positions.
- the adjustment mechanism 620 may also include a knob 636 for actuating the tension member 622 and blades 628 to a position opposite of the bias of the handle 630 and lever 632 configuration.
- various alternatives for actuating the tension member 622 and blades 628 between positions are contemplated by the present invention, especially techniques previously described in the present application.
- the blades 628 of the present embodiment pivotally connected and may generally be described as have a scissor cutting action.
- the blades 628 are made of a generally hardened material such as hardened steel, carbide and the like.
- the blades 628 are general arcuate to define an inner cutting surface 638 .
- Each blade 628 includes a first end 640 and a second end 642 .
- the first ends 640 of the blades 628 are generally rounded or blunt-tipped to minimize damage to surrounding tissue when within a patient.
- the second ends 642 of the blades 628 are connected to the distal end 626 of the tension member 622 .
- the blades 628 are received within the housing 618 disposed at the distal end 616 of the tubular member 612 .
- the housing 618 is preferably made from plastic and includes tapered sides 644 .
- the tapered sides 644 urge the blades 628 to pivot about each other when moved from the extended position o the retracted position within the housing 618 .
- the apparatus 10 of the sixth embodiment may also include a capture mechanism (not shown).
- the capture mechanism is disposed within the tubular member 612 .
- the capture mechanism is preferably a wire, more preferably a deflectable guide or snare wire, made of a flexible or bendable material and having a biased arcuate distal end (also not shown).
- the capture mechanism is moveable between an extended position and a retracted position similar to the tension member 622 and the blades 628 .
- the biased arcuate distal end wraps around the endocardial lead 100 , by way of example only, by snaring the lead, to draw the lead 100 close to the distal end 616 and housing 618 of the tubular member 612 .
- the biased arcuate distal end is generally longitudinal and received within the housing 618 and tubular member 612 .
- the apparatus 10 of the sixth embodiment is placed within a patient.
- the capture mechanism is extended and the biased arcuate distal end wraps about the endocardial lead 100 .
- the capture mechanism is retracted to draw the lead 100 dose to the distal end 616 and housing 618 of the tubular member 612 .
- the tension member 622 and blades 628 are extended as shown in FIG. 11A .
- the adjustment mechanism 620 is actuated and the tension member 622 and blades 628 are moved to the retracted position.
- the blades 628 pivot, about each other at the second end 642 to capture the lead 100 between the inner cutting surfaces 638 of the blades 628 . Further actuation and retraction of the tension member 622 and blades 628 cuts through the lead 100 as shown in FIG. 11C .
- the apparatus 10 is then removed from within the patient.
Abstract
Description
- This invention relates generally to an endocardial lean cutting apparatus and, more particularly, to an apparatus including at least one blade or cutting surface for cutting endocardial leads within a patient.
- In the past, various types of endocardial leads and electrodes have been introduced into different chambers of a patient's heart, including the right ventrical, right atrial appendage, and atrium as well as the coronary sinus. These flexible leads usually are composed of an insulator sleeve that contains an implanted helical coil conductor that is attached to an electrode tip. This electrode is placed in contact with myocardial tissue by passage through a venous access, often the subclavian vein or one of its tributories, which leads, to the endocardial surface of the heart chambers. The tip with the electrode contact is held in place by trabeculations of myocardial tissue.
- The tips of many available leads include flexible tines, wedges, or finger-like like projections which extend radially outward and usually are molded from and integral with the insulating sheath of the lead. These tines or protrusions allow surrounding growth of tissue in chronically implanted leads to fix the electrode tip in position in the heart and prevent dislodgement of the tip during the life of the lead. In “acute placement” of the electrode or lead tip, a blood clot forms about the flanges or tines (due to enzymes released as a result of irritation of the trabeculations myocardial tissue by the presence of the electrode tip) until scar tissue eventually forms, usually in three to six months. The tines or wedges or finger-like projections allow better containment by the myocardial trabeculations of muscle tissue and prevent early dislodgement of the lead tip.
- Although the state of the art in implemented pulse generator or pacemaker technology and endocardial lead technology has advanced considerably, endocardial leads nevertheless occasionally fail, due to a variety of reasons, including breakage of a lead, insulation breaks, breakage of the inner helical coil conductor and an increase in electrode resistance. Furthermore, in some instances, it may be desirable to electronically stimulate different portions of the heart than are presently being stimulated with the leads already implanted. There are a considerable number of patients who have one or more, and sometimes as many as four or five unused leads in their veins and heart.
- Although it obviously would be desirable to easily remove such unused leads, in the past surgeons usually have avoided attempts to remove inoperative leads because the risk of removing them exceeded the risk of leaving them in. The risks of leaving unused myocardial leads in the heart and venous path include increased likelihood that an old lead may facilitate infection, which in turn may necessitate removal of the lead to prevent continued bacteremia and abcess formation. Furthermore, there is an increased likelihood of the formation of blood clots in the atrial chamber about entangled leads. Such clots may embolize to the lung and produce severe complications and even fatality. Furthermore, the presence of unused leads in the venous pathway and inside the heart can cause considerable difficulty in the positioning and attachment of new endocardial leads in the heart.
- Removal of an inoperative lead sometimes can be accomplished by applying traction and rotation to the outer free end of the lead, for example, if done prior to fixation of the lead tip in the trabeculations of myocardial tissue by scar tissue formation or large clot development. Even then, it is possible that a clot has formed so the removal of the leads causes various sized emboli to pass to the lungs, producing severe complications.
- In cases where the lead tip has become attached by scar tissue to the myocardial wall, removal of the lead always has presented major problems and risks. Porous lead tips that are sometimes used may have an ingrowth of scar tissue attaching them to the myocardial wall. Sufficient traction on such leads in a removal attempt could cause disruption of the myocardial wall prior to release of the embedded lead tip, The tines or flanges of other types of leads that are not tightly scarred to the myocardial wall present similar risks. Even if screw-in tip electrodes are used, wherein the tips theoretically can be unscrewed from the myocardial wall, unscrewing of such tips may be prevented by a channel of scar tissue and endothelium that surrounds the outer surface of the lead along, the venous pathway. Such “channel scar” tissue prevents withdrawal because of tight encasement of the lead. Continual strong pulling or twisting of the outer free end of the lead could cause rupture of the atrial wall or the ventricular wall if there is such tight circumferential encasement of adherent channel scar tissue in the venous path. Such tight encasement by scar tissue in the venous pathway and in the trabeculations of the myocardial wall typically occurs within six months to a year of the initial placement of the lead.
- The risks of removing the lead by such traction and rotation of the lead are so high that, if it becomes imperative that the lead be removed (as in the case of infection), most surgeons have elected to open the patient's chest and surgically remove the load rather than attempt removal by applying traction and rotation thereto.
- Clearly, there is a need for an apparatus for extracting endocardial leads from a patient's heart with minimal risk to the patient.
- To address these and other drawbacks, in some embodiments, without limitation, the present invention comprises an apparatus for cutting the lead as near as possible to an endocardial lead's embedded electrode.
- Specifically, the present invention comprises an apparatus having a generally flexible tubular member having a proximal end and distal end. At least one blade or cutting surface is affixed to the distal end of the tubular member. In some embodiments, the apparatus includes an adjustment mechanism adapted to adjust the blade or cutting surface between an extended position and a retracted position.
- Other aspects of the invention will be apparent to those skilled in the art after reviewing the drawings and the detailed description below.
- The present invention will now be described, by way of example, with reference to the accompanying drawings, in which:
-
FIG. 1 illustrates a perspective view of an endocardial lead cutting apparatus of a first embodiment of the present invention; -
FIG. 2 illustrates a perspective view of an endocardial lead cutting apparatus of a second embodiment of the present invention; -
FIG. 3 illustrates an enlarged perspective view of a distal end of an outer tubular member of the second embodiment of the present invention; -
FIG. 4 illustrates to 3 enlarged perspective view of a distal end of an inner shaft of the second embodiment of the present invention; -
FIG. 5A-5C illustrate end views of the endocardial lead cutting apparatus of the second embodiment of the present invention having the inner shaft rotating to cut the lead; -
FIG. 6 illustrates a cross-sectional vie of an endocardial lead cutting apparatus of a third embodiment of the present invention; -
FIG. 7 illustrates an enlarged cross-sectional view of a distal end of the endocardial lead cutting apparatus of the third embodiment of the present invention; -
FIG. 8 illustrates a perspective view of an endocardial lead cutting apparatus of a fourth embodiment of the present invention; -
FIG. 9 illustrates a perspective view of an endocardial lead cutting apparatus of a fifth embodiment of the present invention; -
FIG. 10 illustrates a perspective view of an endocardial lead cutting apparatus of a sixth embodiment of the present invention; and -
FIGS. 11A-11C illustrate enlarged perspective views of the distal end of the endocardial lead cutting apparatus of the sixth embodiment. - Referring generally to
FIGS. 1-11 and without limiting the scope of the embodiments of the invention, various embodiments of an apparatus are generally referred to at 10 for cutting anendocardial lead 100. - Referring to
FIG. 1 , theapparatus 10 of a first embodiment includes ashaft 12 having aproximal end 14 and adistal tip 16. Theshaft 12 is generally flexible to facilitate movement of theapparatus 10 within the patient. Theproximal end 14 of theshaft 12 includes ahandle 18 while thedistal tip 16 includes at least onecutting surface 20. - The at least one
cutting surface 20 is defined by agroove 22 at thedistal tip 16. Thegroove 22 is illustrated as generally v-shaped. Accordingly, as illustrated, the v-shaped groove 22 defines twocutting surfaces 20. Further, thecutting surfaces 20 are comprised of a generally hardened material, such as carbide and the like. While illustrated as a v-shaped groove 22, other configurations, such as u-shaped, c-shaped and the like are contemplated by the present invention. - Optionally, a shroud (not shown) is positioned about the
shaft 12 such that a distal end of the shroud extends outwardly of thedistal tip 16 of theshaft 12. The shroud is made of a generally pliable material to prevent damage to tissue of the patient prior to use of theapparatus 10. - Further, as an additional optional feature, the
apparatus 10 may include a device (not shown) to provide an additional form of energy to cut the endocardial lead. By way of example, the device may be a laser generating device, an ultrasonic device, a vibration device and the like. The exemplary devices would apply radiation, ultrasonic waves or vibrations, respectively, to thelead 100 to assist in cutting thelead 100. In the example of as laser generating device, an optical fiber (not shown) would be disposed within theshaft 12 to transmit radiation from theproximal end 14 to thedistal tip 16. - In operation, the first embodiment of
apparatus 10 ofFIG. 1 is inserted within a patient's heart (not shown) and the lead 100 (shown in phantom) is received within the groove 23 at thedistal tip 16. When positioned to receive thelead 100 the pliable shroud is urged away from thedistal tip 16 to expose thegroove 22 and cutting surfaces 20. Linear and rotation motion is applied by way of thehandle 18 to theshaft 12. The cutting surfaces 20 of thegroove 22 then engages the lead. As additional pressure is applied the cutting surfaces 20 cut the lead and theapparatus 10 is removed from the patient. Optionally, when thelead 100 is received in thegroove 22 the additional forms of energy such as radiation, ultrasound or vibration is applied to the lead to assist in cutting thelead 100. - A second embodiment of the
apparatus 10 is shown inFIGS. 2-5 . The second embodiment includes an outertubular member 212 having aproximal end 214 and adistal end 216. The outertubular member 212 is generally flexible to facilitate movement of theapparatus 10 within the patient. Thedistal end 216 includes agroove 220 for receiving thelead 100. As illustrated, thegroove 220 is generally v-shaped for receiving, thelead 100; however, other configurations are also contemplated by the present invention. - An
inner shaft 222 is received within the outertubular member 212. Theinner shaft 222 includes aproximal end 224 and adistal end 226. Further, theinner shaft 222 is generally flexible and includes ahandle 228 disposed at theproximal end 224. Positioned at thedistal end 226 of the inner shaft is ablade 230. Theblade 230 and theinner shaft 222 is made from a generally hardened material, such as carbide and the like, and rotates within the outertubular member 212 to cut thelead 100 received within thegroove 220 of the outertubular member 212. Theinner shaft 222 andblade 230 are rotatable in either direction. - Further, as described with respect to the first embodiment of
FIG. 1 , theapparatus 10 may include a shroud (not shown). The shroud is positioned about the outertubular member 212 such that a distal end of the shroud extends outwardly of thedistal end 216 of the outertubular member 212. The shroud is made of a generally pliable material to prevent damage to tissue of the patient prior to use of theapparatus 10. - In operation, the second embodiment of
apparatus 10 ofFIGS. 2-5 is inserted within a patient's heart and thelead 100 is received within thegroove 220 at the distal end. 216 of the outertubular member 212. When receiving, thelead 100 within thegroove 220, theinner shaft 222 andblade 230 are in a home position such that theblade 230 is generally offset from thegroove 220. A positioning mechanism (not shown) may be included to bias theinner shaft 222 andblade 230 to the home position within the outertubular member 212. When positioned to receive thelead 100 the pliable shroud is urged away from thedistal end 216 to expose thegroove 220 andblade 230. When thedistal end 216 of the outertubular member 212 is positioned as close as possible to the embedded electrode of the lead, thehandle 228 of theinner shaft 222 is rotated and theblade 230 contacts the lead. Further rotation of theinner shaft 222 and theblade 230 cuts thelead 100. Theapparatus 10 is then removed from the patient. - Now referring to
FIGS. 6-7 , a third embodiment of theapparatus 10 of the present invention is illustrated. Theapparatus 10 includes atubular member 312 having aproximal end 314 and adistal end 316. Thetubular member 312 is generally flexible and preferably made from a plastic or elastomeric material. - A
housing 318 is generally disposed at thedistal end 316 of thetubular member 312. Thehousing 318 includes anopening 320 for receiving theendocardial lead 100. Preferably, thehousing 318 is made of stainless steel and is joined to thedistal end 316 of thetubular member 312 by use of an adhesive. However, any technique for joining thehousing 318 and thedistal end 316 of thetubular member 312 is contemplated by the present invention. - Disposed within the
housing 318 are ablade 322 and aplunger 324. Theblade 322 is received within theplunger 324, preferably by press-fitting theblade 322 within theplunger 324. Theblade 322 is made of carbide and moveable between an extended position and a retracted position. When in the extended position, theblade 322 is received within theopening 320 of thehousing 318 to cut thelead 100 received therein. - The
tubular member 312 includes ahandle 326. Thehandle 326 is joined to theproximal end 314 of thetubular member 312 by adhesive and the like. Alternately, thehandle 326 is press fit within theproximal end 314 of thetubular member 312. Thehandle 326 is utilized to actuate theblade 322 between the extended and retracted positions. - Further, the
apparatus 10 of the third embodiment includes an adjustment mechanism generally referred to at 328. Theadjustment mechanism 328 moves theblade 322 between the extended and retracted positions. Specifically, theadjustment mechanism 328 may comprise ascrew 330. Afirst end 332 of thescrew 330 is received at aproximal end 334 of theplunger 324. Asecond end 336 of thescrew 330 extends through aretainer 338. Theretainer 338 is generally disposed at aproximal end 340 of thehousing 318. - The
adjustment mechanism 328 further includes auniversal joint 342 and drivewire 344. Theuniversal joint 342 is disposed at thesecond end 336 of thescrew 330. Theuniversal joint 342 is also attached to thedrive wire 344. Thedrive wire 344 extends through thetubular member 312 and attaches to thehandle 326. Further, thehandle 326 includes aknob 346. Theknob 346 rotates to adjust theblade 322 between the extended and retracted positions. - In operation, the
apparatus 10 of the third embodiment of the present invention ofFIGS. 6-7 is inserted within a patient's heart and receives thelead 100 within theopening 320 of thehousing 318. Theadjustment mechanism 328 is actuated by rotating theknob 346. Rotational motion from theknob 346 is transferred through thedrive wire 344 anduniversal joint 342 to rotate thescrew 330. Rotation of thescrew 330 advances the screw through theretainer 338 to move theplunger 324 andblade 322 from the retracted position to the extended position. Accordingly, theblade 322 is received in theopening 320 of thehousing 318 and contacts theendocardial lead 100. Thelead 100 is then cut by further extension of theblade 322 and theapparatus 10 is removed from within the patient. - Referring to
FIG. 8 , the fourth embodiment of theapparatus 10 of the present invention is illustrated. Theapparatus 10 includes atubular member 412 having aproximal end 414 and adistal end 416. Thedistal end 416 is generally u-shaped to define afirst cutting surface 418. At theproximal end 414 of thetubular member 412 is ahandle 420. Thetubular member 412 may be generally flexible to move within the patient. - Disposed within the
tubular member 412 is atension member 422. Thetension member 422 includes aproximal end 424 and adistal end 426. Theproximal end 424 of thetension member 422 is fixed to alever 428. Thedistal end 426 of thetension member 422 is fixed to ablade 430. Theblade 430 is pivotally connected to thedistal end 416 of thetubular member 412 and actuation of thelever 428 about thehandle 420 pivots theblade 430 to capture thelead 100 between the blade and thefirst cutting surface 418. - Further,
blade 430 has a generally s-shaped configuration and defines afirst end 432, asecond end 434 and a connectingleg 436 extending therebetween. Thefirst end 432 includes an inner surface that defines asecond cutting surface 438. Thesecond end 434 is fixed to theproximal end 424 of thetension member 422. The connectingleg 436 of theblade 430 is pivotally connected to thedistal end 416 of thetubular member 412. As illustrated theblade 430 is connected to thedistal end 416 of thetubular member 412 generally at the midpoint of the connectingleg 436. However, alternative fastening positions or techniques are easily contemplated by one skilled in the art. - In operation, the
apparatus 10 of the fourth embodiment is placed within a patient and thelead 100 is received within the u-shapeddistal end 416 of thetubular member 412 such that thefirst cutting surface 418 contacts thelead 100. Thelever 428 is actuated about thehandle 420 to draw thetension member 422 away from thedistal end 416 and pivot theblade 430 thereabout. When theblade 430 is pivoted, thesecond cutting surface 438 of thefirst end 432 also contacts thelead 100 to capture thelead 100 therebetween. Further actuation of thelever 428 and the cutting surfaces 418, 438 cut through theendocardial lead 100. - Referring to a fifth embodiment of
FIG. 9 , theapparatus 10 includes atubular member 512 having aproximal end 514 and adistal end 516. Thedistal end 516 is generally c-shaped to define afirst cutting surface 518. At theproximal end 514 of thetubular member 512 is ahandle 520. Thetubular member 512 may be generally flexible to move within the patient. - Disposed Within the
tubular member 512 is astension member 522. Thetension member 522 includes aproximal end 524 and adistal end 526. Theproximal end 524 of thetension member 522 is fixed to alever 528. Thedistal end 526 of thetension member 522 is fixed to ablade 530. Theblade 530 is received within thetubular member 512 and disposed at thedistal end 516. Actuation of thelever 528 about thehandle 520 linearly moves theblade 530 to capture thelead 100 between theblade 530 and thefirst cutting surface 518. Theblade 530 defines asecond cutting surface 532 and capturing thelead 100 between theblade 530 and thefirst cutting surface 518 cuts thelead 100. - In operation, the
apparatus 10 of the fifth embodiment is placed within a patient and thelead 100 is received within the c-shapeddistal end 516 of thetubular member 512 such that thefirst cutting surface 518 contacts thelead 100. Thelever 528 is actuated about thehandle 520 to draw thetension member 522 away from thedistal end 516 and move theblade 530 linearly. When theblade 530 is moved, thesecond cutting surface 532 of theblade 530 also contacts thelead 100 to capture thelead 100 between theblade 530 and thefirst cutting surface 518. Further actuation of thelever 528 and the cutting surfaces 518, 532 cut through theendocardial lead 100. - Now referring to
FIGS. 10-11 , the sixth embodiment ofapparatus 10 of the present invention is illustrated. Theapparatus 10 includes atubular member 612 having aproximal end 614 and adistal end 616. Thedistal end 616 includes ahousing 618 while theproximal end 614 includes anadjustment mechanism 620. Thetubular member 612 may be generally flexible to move within the patient and optionally include reinforcements such as a braid or compressed coil to strengthentubular member 612 and resist compression during operation. - Disposed within the
tubular member 612 is atension member 622. Thetension member 622 includes aproximal end 624 and adistal end 626. Theproximal end 624 of thetension member 622 is fixed to theadjustment mechanism 620 while thedistal end 626 is connected to twoblades 628. Theadjustment mechanism 620 moves thetension member 622 and theblades 628 between an extended position and a retracted position. - The
adjustment mechanism 620 it ahandle 630 for actuating thetension member 622 andblades 628 between the extended and retracted positions. Pivotally connected to thehandle 630 is alever 632 with abiasing mechanism 634, such as a spring and the like, disposed therebetween. Thebiasing mechanism 634 urges thelever 632 about thehandle 630 and hence, thetension member 622 andblades 628 to one of either the extended or retracted positions. Optionally, theadjustment mechanism 620 may also include aknob 636 for actuating thetension member 622 andblades 628 to a position opposite of the bias of thehandle 630 andlever 632 configuration. Further, various alternatives for actuating thetension member 622 andblades 628 between positions are contemplated by the present invention, especially techniques previously described in the present application. - Referring to
FIGS. 11A-11C , theblades 628 of the present embodiment pivotally connected and may generally be described as have a scissor cutting action. Theblades 628 are made of a generally hardened material such as hardened steel, carbide and the like. Theblades 628 are general arcuate to define aninner cutting surface 638. Eachblade 628 includes afirst end 640 and asecond end 642. The first ends 640 of theblades 628 are generally rounded or blunt-tipped to minimize damage to surrounding tissue when within a patient. The second ends 642 of theblades 628 are connected to thedistal end 626 of thetension member 622. - The
blades 628 are received within thehousing 618 disposed at thedistal end 616 of thetubular member 612. Thehousing 618 is preferably made from plastic and includes tapered sides 644. The taperedsides 644 urge theblades 628 to pivot about each other when moved from the extended position o the retracted position within thehousing 618. - Optionally, the
apparatus 10 of the sixth embodiment may also include a capture mechanism (not shown). The capture mechanism is disposed within thetubular member 612. The capture mechanism is preferably a wire, more preferably a deflectable guide or snare wire, made of a flexible or bendable material and having a biased arcuate distal end (also not shown). The capture mechanism is moveable between an extended position and a retracted position similar to thetension member 622 and theblades 628. When extended, the biased arcuate distal end wraps around theendocardial lead 100, by way of example only, by snaring the lead, to draw thelead 100 close to thedistal end 616 andhousing 618 of thetubular member 612. When retracted, the biased arcuate distal end is generally longitudinal and received within thehousing 618 andtubular member 612. - In operation, the
apparatus 10 of the sixth embodiment is placed within a patient. The capture mechanism is extended and the biased arcuate distal end wraps about theendocardial lead 100. The capture mechanism is retracted to draw thelead 100 dose to thedistal end 616 andhousing 618 of thetubular member 612. Thetension member 622 andblades 628 are extended as shown inFIG. 11A . Theadjustment mechanism 620 is actuated and thetension member 622 andblades 628 are moved to the retracted position. As seen inFIG. 11B , theblades 628 pivot, about each other at thesecond end 642 to capture thelead 100 between the inner cutting surfaces 638 of theblades 628. Further actuation and retraction of thetension member 622 andblades 628 cuts through thelead 100 as shown inFIG. 11C . Theapparatus 10 is then removed from within the patient. - While the present invention has been particularly shown and described with reference to the foregoing preferred and alternative embodiments, it should be understood by those skilled in the art that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention without departing from the spirit and scope of the invention as defined in the following claims. It is intended that the following claims define the scope of the invention and that the apparatus within the scope of these claims and their equivalents be covered thereby. This description of the invention should be understood to include all novel and non-obvious combinations of elements described herein, and claims may be present in this or a later application to any novel and non-obvious combination of these elements. The foregoing embodiments are illustrative, and no single feature or element is essential to all possible combination that may be claimed in this or a later application. Where the claims recite “a” or “a first” element of the equivalent thereof, such claims should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements.
Claims (20)
Priority Applications (2)
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US14/857,621 US20160001064A1 (en) | 2005-07-22 | 2015-09-17 | Endocardial lead cutting apparatus |
US15/218,444 US10258792B2 (en) | 2005-07-22 | 2016-07-25 | Endocardial lead cutting apparatus |
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US18755305A | 2005-07-22 | 2005-07-22 | |
US14/857,621 US20160001064A1 (en) | 2005-07-22 | 2015-09-17 | Endocardial lead cutting apparatus |
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US15/218,444 Division US10258792B2 (en) | 2005-07-22 | 2016-07-25 | Endocardial lead cutting apparatus |
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US15/218,444 Expired - Fee Related US10258792B2 (en) | 2005-07-22 | 2016-07-25 | Endocardial lead cutting apparatus |
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US10258792B2 (en) * | 2005-07-22 | 2019-04-16 | The Spectranetics Corporation | Endocardial lead cutting apparatus |
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BR112013021463A2 (en) | 2011-02-24 | 2016-11-01 | Eximo Medical Ltd | tissue resection hybrid catheter |
CN111317565B (en) | 2014-05-18 | 2023-05-09 | 爱克斯莫医疗有限公司 | System for tissue ablation using pulsed lasers |
CN109414292A (en) | 2016-05-05 | 2019-03-01 | 爱克斯莫医疗有限公司 | Device and method for cutting off and/or melting unwanted tissue |
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US10258792B2 (en) * | 2005-07-22 | 2019-04-16 | The Spectranetics Corporation | Endocardial lead cutting apparatus |
Also Published As
Publication number | Publication date |
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US10258792B2 (en) | 2019-04-16 |
US20160339232A1 (en) | 2016-11-24 |
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