An epicardial pacing lead

Abstract

The present disclosure provides a solution for an implantable cardiac pacing lead that is intended to operate temporarily in the body of the patient it is implanted in. The pacing lead comprises a biodegradable, distal part that is made of biodegradable materials. Instead of extracting the entire pacing lead at the end of the temporal operation, the distal part that is attached to an epicardial tissue is separated from the proximal part of the lead and is maintained in the body of the patient. Over time, the distal part is dissolved in the body of the patient and leaving no or insignificant trace. The separation of the proximal part from the distal part is performed by a certain manipulation by a practitioner, such as a physician or other caregiver that treats the patient. The manipulation can be mechanical manipulation, electrical manipulation or a combination of both.

Description

[0001] AN EPICARDIAL PACING LEAD

[0002] FIELD OF THE INVENTION

[0003] The present invention discloses a temporary pacing lead that comprises at least partially dissolving materials that can be used e.g., in cardiac pacemakers and implantable cardioverter defibrillators (I CDs).

[0004] BACKGROUND OF THE INVENTION

[0005] Arrhythmias are a known complication after cardiac surgery and represent a major cause of morbidity, increased length of hospital stay, and economic costs. The clinical significance of each arrhythmia depends upon its duration, ventricular response rate, underlying cardiac function, and comorbidities.

[0006] The current practice involves placement unipolar pacing wires in all patients undergoing surgery. It is commonly used for the diagnosis and treatment of arrhythmias in the acute post operative period after surgery for cardio related disease. Furthermore, such implants have been used in diverse embodiments in modem medical technology and are used, e.g., in cardiac pacemakers, ICDs, CRT-Ds and neurostimulators.

[0007] It is known that parts of the permanently implantable electrode can fuse at least partially with endogenous tissue due to the longer residence times in the human body. To reduce this unwanted effect, electrodes or probes are currently provided with surface coatings that are inhibitive in this regard. For example, it is known that a steroid elution counteracts adhesion of electrodes or probes to endogenous tissue. In addition, to improve explanation properties, an objective is to create a surface of the implant that is as entirely smooth as possible, e.g., by embedding the shock coil of an ICD electrode in the electrode body. As an additional measure, an implant design that is isodiametric or tapers in the distal direction is frequently selected. Despite these measures, adhesion of electrode leads or probes in endogenous tissue cannot be fully prevented over the long term. This can lead to difficulties when performing explanations, since it cannot be ruled out that parts of the tissue will be destroyed in the process. Such tissue damage can lead to serious complications depending on the region of the body that is involved.

[0008] On the other hand, leaving deactivated electrodes or probes in the body is not unproblematic, as considered from other perspectives. If such implants are left in the body, complications such as vascular occlusions, interactions of a deactivated electrode with active electrodes, or a contraindication to MRT can result.

[0009] Temporary epicardial leads are removed just before the patient is discharged from the intensive care unit. However, the use thereof is not free from risk of epicardial pacing. Complications of epicardial wires include infection, myocardial damage, ventricular arrhythmias, perforation, and tamponade. While temporary pacing leads are removed by gentle traction, ECG should be monitored (observing for arrhythmias) and the patient should be observed for a few hours after lead removal because of the risk of tamponade. Leaving the lead implanted for longer than a few days is in contrary to the labelling and manufacturing instructions thereof and may result in difficulty or inability to extract the lead and / or bleeding.

[0010] GENERAL DESCRIPTION

[0011] The present disclosure provides a solution for an implantable cardiac pacing lead that is intended to operate temporarily in the body of the patient it is implanted in. The pacing lead comprises a biodegradable, distal part that is made of biodegradable materials. Instead of extracting the entire pacing lead at the end of the temporal operation, the distal part that is attached to an epicardial tissue is separated from the proximal part of the lead and is maintained in the body of the patient. Over time, the distal part is dissolved in the body of the patient and leaving no or insignificant trace. The separation of the proximal part from the distal part is performed by a certain manipulation by a practitioner, such as a physician or other caregiver that treats the patient. The manipulation can be mechanical manipulation, electrical manipulation or a combination of both.

[0012] The requirements from such an implantable cardiac pacing lead are to provide continuous electrical conduction between the pacemaker and the epicardial tissue through the proximal part and the distal part while allowing a simple and convenient coupling of the proximal part from the distal part on demand.

[0013] The present disclosure aims to provide reliable and low-cost solutions that will comply with the above requirements.

[0014] In one aspect, the present disclosure thus provides an implantable epicardial pacing lead for treatment of various tissues. The pacing lead has a unitary structure constituted by two functionally different wire portions physically attached / connected to one another. In some embodiments, a first portion formed by a first material composition (e.g., biocompatible material(s)) and configured to contact the treated tissue, and a second portion formed by a second material composition (e.g., biodegradable metallic -based) and connected to the first portion outside of the treated tissue and configured to be retracted out of the body of the treated subject upon detachment from the first portion. Optionally, but in some embodiments preferably, the first portion has at least one area / sub-portion excitable by one or more external stimuli to thereby cause localized at least partial breakdown (e.g., degrade or dissolve) of the sub-portion. As a result, the first and second portions can be detached from each other such that the first portion is maintained in contact with the treat tissue while the second portion can be retracted / pulled out of the body of the treated subject.

[0015] In some embodiments, implantable epicardial pacing lead is associated with at least one sensing element configured for measuring at least one pacing lead condition parameter of the epicardial pacing lead associated with degradation / dissolvement degree of the sub-portion being excitable by the one or more external stimuli, and for generating data indicative of a change of the at least one pacing lead condition parameter.

[0016] In some embodiments, the pacing lead may be provided with at least one indicator in data communication with the implantable epicardial pacing or with the at least one sensor element and configured to generate instructions, based on the generated data indicative of the change of the at least one pacing lead condition parameter, to a practitioner of the pacing lead indicating that the second portion of the pacing lead may be safely pulled out / removed from the body of the treated subject. The instructions may be provided in response to fulfillment of predefined safety prerequisites associated with a predefined required change of the at least one condition parameter of the pacing lead indicative.

[0017] It is one object of the present invention to provide an implantable epicardial pacing lead for treating at least one tissue, comprising: at least one biodegradable metallic-based lead wire adapted for implantation within said tissue; said at least one biodegradable metallic-based lead wire comprising at least one degradable portion adapted, upon external excitation thereto, to locally degrade; at least one non degradable metallic-based lead wire comprising a biocompatible material in physical contact with at least a portion of said at least one biodegradable metallic-based lead wire; and, at least one indicator in communication with at least one selected from a group consisting of said biodegradable metallic-based lead wire, at least one degradable portion, at least one non degradable metallic -based lead wire and any combination thereof; wherein said indicator is adapted to provide indication upon at least partial degradation of said at least one degradable portion.

[0018] It is to be noted that the term "communication" with respect to the indicator and portions of the biodegradable metallic-based lead wire or the non-degradable metallic - based lead wire should be understood as a physical communication, electrical communication, ultrasonic communication, thermal communication, or any other type of communication that allows to sense a degradation change so as to provide indication thereof.

[0019] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said external excitation is provided on demand, when is required by the caregiver.

[0020] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said implantable epicardial pacing lead is in communication with at least one sensor adapted to monitor at least one parameter of the patient such that, upon change thereof, at least one of the following is being performed (a) said implantable epicardial pacing lead is self-activated, such that said at least one external excitation is provided; (b) said change is notified; (d) any combination thereof.

[0021] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said sensor is selected from a group consisting of accelerometer, impedance measurement, Photoplethysmography, PPG sensor, pH sensor, ultrasound sensor, temperature meter, heart pulse rate, glucose sensor, any sensor indicating a change in cardiac output, any sensor indicating blood pressure, and any combination thereof.

[0022] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said sensor is adapted to sense at least one parameter selected from a group consisting of impedance, PPG signal, pH, acoustic signal, temperature, heart rate, glucose level, blood pressure, and any combination thereof.

[0023] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said sensor is selected from a group consisting of a sensor implanted in said patient, integrated within said implantable epicardial pacing lead, a sensor being worn by said patient, a remote sensor outside the patient’s body and any combination thereof.

[0024] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said parameter is selected from a group consisting of position of the patient, engagement in physical activity, decrease in NO levels in said at least one vessel or tissue, tissue perfusion, impedance, PPG signal, pH, acoustic signal, temperature, heart rate, glucose level, blood pressure, and any combination thereof and any combination thereof.

[0025] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein, upon change of said at least one parameter, at least one notification is being sent to said patient or any care giver thereof.

[0026] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein at least one selected from a group consisting of said at least one biodegradable metallic-based lead wire, said at least one non degradable metallic -based lead wire, said at least one degradable portion and any combination thereof is at least partially enclosed in an external protective layer comprised of a biocompatible material.

[0027] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said at least one non degradable metallic-based lead wire comprising stainless steel.

[0028] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said degradation of said at least one degradable portion is performed by electrolytic corrosion.

[0029] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein the degradation comprises forming a local perforation in the protective layer.

[0030] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said indication is provided by at least one selected from a group consisting of visual, audio, sensible and any combination thereof.

[0031] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein the external excitation is selected from a group consisting of an electric voltage, electric current and any combination thereof applied to said at least one degradable portion using epicardial pacing lead.

[0032] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said external excitation is adapted to enhance degradation of said biodegradable metallic -based lead wire.

[0033] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein change of at least one parameter of said external excitation results in change of at least one degradation parameter of said at least one degradable portion.

[0034] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said parameter is selected from a group consisting of phase, an operating frequency, power, intensity, operating amplitude, duration and any combination thereof.

[0035] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said degradation parameter is selected from a group consisting of rate of degradation, location of degradation and any combination thereof.

[0036] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said indicator is impedance meter, such that upon impedance change, said indication is provided that said at least one degradable portion has either at least partially degrade or fully degrade.

[0037] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said biodegradable metallic-based lead wire comprises magnesium or magnesium-based alloy.

[0038] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said at least one biodegradable metallic -based lead wire at least partially dissolved upon contact with bodily medium.

[0039] It is another object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein the electrode or probe implant is permanently implantable.

[0040] It is still an object of the present invention to provide the implantable epicardial pacing lead as defined above, wherein said lead is wither unipolar or bipolar. It is still an object of the present invention to provide the implantable epicardial pacing lead as defined above, integrated within at least one selected from a group consisting of pacemakers, implantable cardioverter defibrillators and any combination thereof.

[0041] It is another object of the present invention to provide a method for extracting an epicardial pacing lead from a subject. The method comprising: (i) applying excitation on a degradable portion of an implantable epicardial pacing lead; wherein said implantable epicardial pacing lead comprises: (1) at least one biodegradable metallic -based lead wire adapted for implantation within said tissue, said at least one biodegradable metallic-based lead wire comprising at least one degradable portion adapted, upon at least one external excitation thereto, to locally degrade, and (2) at least one non degradable metallic-based lead wire comprising a biocompatible material in physical contact with at least a portion of said at least one biodegradable metallic-based lead wire; (ii) sensing the degradable portion or a portion associated with the degradable portion to identify a change of at least one parameter indicating at least partial degradation of the degradable portion, such as a change of conductivity, resistivity, capacity, heat, ultrasonic conductivity, etc.; and (iii) upon identifying said change of at least one parameter, providing at least one indication upon at least partial degradation of said at least one degradable portion.

[0042] It is another object of the present invention to provide a method of treating at least one tissue, comprising steps of:

[0043] (a) providing at least one implantable epicardial pacing lead for treating at least one tissue, comprising: at least one biodegradable metallic-based lead wire adapted for implantation within said tissue; said at least one biodegradable metallic-based lead wire comprising at least one degradable portion adapted, upon at least one external excitation thereto, to locally degrade; at least one non degradable metallic-based lead wire comprising a biocompatible material in physical contact with at least a portion of said at least one biodegradable metallic-based lead wire; and, at least one indicator in communication with at least one selected from a group consisting of said biodegradable metallic-based lead wire, at least one degradable portion, at least one non degradable metallic -based lead wire and any combination thereof; wherein said indicator is adapted to provide indication upon at least partial degradation of said at least one degradable portion;

[0044] (b) applying excitation on at least a portion of at least one degradable portion; and,

[0045] (c) providing at least one indication upon at least partial degradation of said at least one degradable portion.

[0046] It is another object of the present invention to provide the method as defined above, wherein said external excitation is provided on demand, when is required by the caregiver.

[0047] It is another object of the present invention to provide the method as defined above, wherein said implantable epicardial pacing lead is in communication with at least one sensor adapted to monitor at least one parameter of the patient such that, upon change thereof, at least one of the following is being performed (a) said implantable epicardial pacing lead is selfactivated, such that said at least one external excitation is provided; (b) said change is notified;

[0048] (d) any combination thereof.

[0049] It is another object of the present invention to provide the method as defined above, wherein said sensor is selected from a group consisting of accelerometer, impedance measurement, Photoplethysmography, PPG sensor, pH sensor, ultrasound sensor, temperature meter, heart pulse rate, glucose sensor, any sensor indicating a change in cardiac output, any sensor indicating blood pressure, and any combination thereof.

[0050] It is another object of the present invention to provide the method as defined above, wherein said sensor is adapted to sense at least one parameter selected from a group consisting of impedance, PPG signal, pH, acoustic signal, temperature, heart rate, glucose level, blood pressure, and any combination thereof.

[0051] It is another object of the present invention to provide the method as defined above, wherein said sensor is selected from a group consisting of a sensor implanted in said patient, integrated within said implantable epicardial pacing lead, a sensor being worn by said patient, a remote sensor outside the patient’s body and any combination thereof.

[0052] It is another object of the present invention to provide the method as defined above, wherein said parameter is selected from a group consisting of position of the patient, engagement in physical activity, decrease in NO levels in said at least one vessel or tissue, tissue perfusion, impedance, PPG signal, pH, acoustic signal, temperature, heart rate, glucose level, blood pressure, and any combination thereof and any combination thereof.

[0053] It is another object of the present invention to provide the method as defined above, wherein, upon change of said at least one parameter, at least one notification is being sent to said patient or any care giver thereof.

[0054] It is another object of the present invention to provide the method as defined above, wherein at least one selected from a group consisting of said at least one biodegradable metallic-based lead wire, said at least one non degradable metallic -based lead wire, said at least one degradable portion and any combination thereof is at least partially enclosed in an external protective layer comprised of a biocompatible material.

[0055] It is another object of the present invention to provide the method as defined above, wherein said at least one non degradable metallic-based lead wire comprising stainless steel.

[0056] It is another object of the present invention to provide the method as defined above, wherein said degradation of said at least one degradable portion is performed by electrolytic corrosion.

[0057] It is another object of the present invention to provide the method as defined above, wherein the degradation comprises forming a local perforation in the protective layer.

[0058] It is another object of the present invention to provide the method as defined above, wherein said indication is provided by at least one selected from a group consisting of visual, audio, sensible and any combination thereof.

[0059] It is another object of the present invention to provide the method as defined above, wherein the external excitation is selected from a group consisting of an electric voltage, electric current and any combination thereof applied to said at least one degradable portion using epicardial pacing lead.

[0060] It is another object of the present invention to provide the method as defined above, wherein said external excitation is adapted to enhance degradation of said biodegradable metallic-based lead wire.

[0061] It is another object of the present invention to provide the method as defined above, wherein change of at least one parameter of said external excitation results in change of at least one degradation parameter of said at least one degradable portion. It is another object of the present invention to provide the method as defined above, wherein said parameter is selected from a group consisting of phase, an operating frequency, power, intensity, operating amplitude, duration and any combination thereof.

[0062] It is another object of the present invention to provide the method as defined above, wherein said degradation parameter is selected from a group consisting of rate of degradation, location of degradation and any combination thereof.

[0063] It is another object of the present invention to provide the method as defined above, wherein said indicator is impedance meter, such that upon impedance change, said indication is provided that said at least one degradable portion has either at least partially degrade or fully degrade.

[0064] It is another object of the present invention to provide the method as defined above, wherein said biodegradable metallic-based lead wire comprises magnesium or magnesium- based alloy.

[0065] It is another object of the present invention to provide the method as defined above, wherein said at least one biodegradable metallic-based lead wire at least partially dissolved upon contact with bodily medium.

[0066] It is another object of the present invention to provide the method as defined above, wherein the electrode or probe implant is permanently implantable.

[0067] It is another object of the present invention to provide the method as defined above, wherein said lead is wither unipolar or bipolar.

[0068] It is another object of the present invention to provide the method as defined above, integrated within at least one selected from a group consisting of pacemakers, implantable cardioverter defibrillators and any combination thereof.

[0069] It is another object of the present invention to provide the method as defined above, wherein said at least one indicator is in at least one selected from a group consisting of electrical, physical, mechanical, fluid communication with at least one selected from a group consisting of said biodegradable metallic-based segment, at least one degradable portion, at least one non degradable metallic-based segment and any combination thereof.

[0070] It is another object of the present invention to provide the method as defined above, wherein said at least one indicator is adapted to send said notification to said patient or any care giver thereof. Various other objects, aspects and advantages of the present inventive disclosure can be obtained from a study of the specification, the drawings, and the appended claims.

[0071] Yet another aspect of the present disclosure provides a cardiac pacing lead. The lead comprises a proximal part, serving as a conductive wire, extending between a first end and a second end and is configured for electrically coupling with a pacemaker or a controller of the pacemaker. The pacing lead further comprises a distal part, serving as the electrode and therefore it is intended to come into contact with an epicardial tissue for transmitting the electrical signals generated by the pacemaker to the heart. The distal part is coupled to the proximal part and configured for electrically transmitting an electrical signal generated by the pacemaker to a cardiac tissue. The distal part is separable from the proximal part.

[0072] It is to be noted that any combination of the described embodiments with respect to any aspect of this present disclosure is applicable. In other words, any aspect of the present disclosure can be defined by any combination of the described embodiments.

[0073] In some embodiments of the cardiac pacing lead, the distal part is separable from the proximal part upon a predetermined manipulation.

[0074] In some embodiments of the cardiac pacing lead, the predetermined manipulation results in physical decoupling of the proximal part from the distal part, wherein the predetermined manipulation is a mechanical manipulation, electrical manipulation or a combination of mechanical manipulation and electrical manipulation.

[0075] In some embodiments of the cardiac pacing lead, the mechanical manipulation is a cut of the proximal part, typically at any part thereof that is exposed for the practitioner.

[0076] In some embodiments of the cardiac pacing lead, the distal part comprises an epicardial engaging section for engaging with an epicardial tissue for conducting the electrical signals deriving from the pacemaker thereto.

[0077] In some embodiments of the cardiac pacing lead, the epicardial engaging section comprises a needle for facilitating attachment to the epicardial tissue.

[0078] In some embodiments, the cardiac pacing lead comprises a separating mechanism, or separator, for allowing separation of the distal part from the proximal part. In some embodiments of the cardiac pacing lead, the proximal part comprises a conducting proximal element extending between a proximal end and a distal end thereof and is configured for conducting a pacing signal from the pacemaker to the distal part or to the distal part conducting element. The proximal part further comprises a proximal part insulation element covering at least the proximal end portion of the conducting proximal element, but typically it covers its entirety. The conducting proximal element is configured for said electrically coupling with a pacemaker, namely for allowing the conduction of electrical signals generated by the pacemaker. The distal part comprises a conducting distal element, typically a metallic wire, and a distal part insulation element covering at least the majority of the conducting distal element. The conducting distal element and the distal part insulation element are each made of one or more biodegradable materials and being separable from the proximal part. The proximal part insulation element and the distal part insulation element are insulating covers that are covering the respective conducting elements to avoid any undesired electricity conduction to an organ or a vessel other than the epicardial tissue that the distal part is coupled or attached to. It is to be noted that any reference to an insulation in the present disclosure is referred to an electrical insulation.

[0079] In some embodiments of the cardiac pacing lead, the proximal and the distal insulation elements are in the form of a sleeve. The proximal conducting element is accommodated, at least partially, in the proximal insulation element that is in the form of a sleeve. The distal conducting element is accommodated, at least partially, in the distal insulation element that is in the form of a sleeve.

[0080] In some embodiments, the cardiac pacing lead further comprises a separating mechanism transitionable between (i) a first state, in which the conducting proximal element and the conducting distal element are in physical contact, and (ii) a second state, in which the conducting proximal element and the conducting distal element are physically disconnected, therefore, no electrical signals are passing and the proximal part can be separated from the distal part for its extraction.

[0081] In some embodiments of the cardiac pacing lead, the separating mechanism is a priori found in the first state. This means that when it is received by the practitioner for using it in a cardiac procedure, the separating mechanism is in the first state and ready to be implanted in the subject. Only after a manipulation that is performed in demand by the practitioner, the separating mechanism is transitioned to the second state. In some embodiments of the cardiac pacing lead, the distal conducting element comprises an exposed proximal portion protruding proximally from the distal part insulation element and not covered by the distal part insulation element, namely the distal part insulation element ends when the exposed proximal portion begins. In said first state of the separating mechanism, the exposed proximal portion extends into the proximal part insulation element and in physical contact with the conducting proximal element, wherein in said second state, the exposed proximal portion is disconnected or decoupled from the conducting proximal element.

[0082] In some embodiments of the cardiac pacing lead, the separating mechanism comprises a tension element extending at least along a portion of the proximal part. In said first state, the tension element is in a tense state, in which the tension element is tensed proximally, namely the tension element is pulled to the proximal direction constantly and is under tension that pulls it to the proximal direction. The tension results in said physical contact between the conducting proximal element and the conducting distal element. In said second state, the tension element is in a released state, or a non-tense state, resulting in said physically disconnection between the conducting proximal element and the conducting distal element and transition of the separating mechanism to the second state. The tension of the tension element causing the conducting distal element to urge against the conducting proximal element to allow the conduction of the signal from the pacemaker. The tension element is found a-priori at the tense state and only when it is decided that the operation of the temporary cardiac pacing lead is over, the user, such as a physician, performs a mechanical manipulation that causes the tension element to transition to its released state and therefore the separating mechanism is transitioned to its second state and the proximal part can be separated from the distal part.

[0083] In some embodiments of the cardiac pacing lead, the conducting proximal element comprises an internal cavity or a lumen, said tension element extends through said internal cavity.

[0084] In some embodiments of the cardiac pacing lead, said exposed proximal portion comprises a hooking portion, i.e. a portion with a shape of a hook or a closed loop. The tension element is a thread with its two ends being held in position, e.g. by being coupled or attached to a portion of the proximal part. The thread is hooked on said hooking portion, the hooking portion has a greater dimension than the internal cavity such that when the tension element is in its tense state and pulls the hooking portion to the proximal direction, portions of the hooking portions touch the proximal conducting element and therefore allowing conductivity of the signals from the pacemaker. Namely, the thread passes through the loop and performs a U- tum. The two ends of the thread are held such that it is in a tense state. When a user of the lead releases the two ends, the tension is released and the thread transitioned to its released state and the hooking portion, and the entire distal conducting element, retracts towards the distal direction and decoupled from the proximal conducting element. At this stage, the proximal part can be pulled by the user, and the exposed proximal portion will exit the proximal insulation element, and the proximal part will be separated from the distal part. In case that after pulling and extracting the proximal part from the body of the subject the thread remains hung on the hooking portion, by pulling it from one of its ends it will also be extracted from the body.

[0085] In some embodiments of the cardiac pacing lead, the transition of the separating mechanism from the first state to the second state is performed upon releasing at least one end of the two ends of the tension element that are being held in position, e.g. cutting the proximal part at a certain location that leads to freeing two ends of the tension element.

[0086] In some embodiments of the cardiac pacing lead, said internal cavity comprises a first cavity portion in which the tension element extends therethrough, and a second cavity portion that is configured to receive the exposed proximal portion of the distal conducting element. The tension element comprises an engaging distal head distally projecting from the first cavity portion, i.e. the engaging distal head exits from the first cavity portion towards the distal direction, and the engaging distal head having a dimension that is greater than the first cavity portion so when the tension element is pulled to the proximal direction it cannot enter into the first cavity portion. In the first state of the separating mechanism, the exposed proximal portion is received in the second cavity portion and the engaging distal head urges against the exposed proximal portion to hold it in position within the second cavity portion and in physical contact with the proximal conducting element. Since the engaging distal head is larger than the dimension of the first cavity portion, it also covers an area that includes part of the second cavity portion and while it is maintained in its tense state it urges both against the edge of the proximal conducting element and the exposed proximal portion and ensures that it remains in physical contact with the proximal conducting element.

[0087] In some embodiments of the cardiac pacing lead, the first and the second cavity portions are continuous, namely, there is no separation between the first cavity portion and the second cavity portion. In some embodiments of the cardiac pacing lead, the engaging distal head is in the form of a sphere or a cone.

[0088] In some embodiments of the cardiac pacing lead, the tension element is being a priori held in position, e.g. by attaching its proximal end to a portion of the proximal part, to assume its tense state. Upon releasing the tension element or a part thereof from its hold, the engaging distal head is biased distally, and it stops urging against the exposed proximal portion, thereby releasing the exposed proximal portion and allowing the separation of the proximal part and the distal part. When the engaging distal head is biased distally, a gap is formed between the exposed proximal portion and the tension element and there is no friction that holds the exposed proximal portion in position.

[0089] In some embodiments of the cardiac pacing lead, the proximal conducting element is in the form of a spring biased to be normally open. In the first state of the separating mechanism the exposed proximal portion is held between loops of the spring and the tension element is coupled to a distal end of the spring causing the loops of the spring to clamp portions of the exposed proximal portion and therefore the exposed proximal portion is retained in physical contact with the conducting proximal element.

[0090] In some embodiments of the cardiac pacing lead, the tension element is being a priori held in position, e.g. by attaching its proximal end to a portion of the proximal part, to assume its tense state, wherein upon releasing the tension element or a part thereof from its hold, the loops of the spring are biased to be opened, namely spaced apart from one another, and the exposed proximal portion can be released to separate the proximal part from the distal part.

[0091] In some embodiments of the cardiac pacing lead, the distal conducting element comprises an exposed proximal portion protruding proximally from the distal part insulation element and not covered by the distal part insulation element, namely the distal part insulation element ends when the exposed proximal portion begins, which is the portion that is adjacent the proximal part. In said first state of the separating mechanism, the exposed proximal portion extends into the proximal part insulation element and is electrically connected and physically coupled with the conducting proximal element, the physical coupling may also be performed through another element. In said second state, the exposed proximal portion is electrically and physically disconnected or decoupled from the conducting proximal element. The conducting proximal element comprises an internal cavity or a lumen. The exposed proximal portion comprises a hooking portion, i.e. a portion with a shape of a hook or a closed loop. The separating mechanism comprises an electrical conducting element and a fuse element, the electrical conducting element extends through at least a portion of the internal cavity. In said first state the fuse element, e.g. a conducting wire that is configured to be broken or burned upon exposure to a high voltage or current, extends between the conducting proximal element and the electrical conducting element and passing through the hooking portion such that it is hooked thereon, therefore the fuse element allows conduction of the signals of the pacemaker in the first state.

[0092] In some embodiments of the cardiac pacing lead, upon application of a voltage or current above a certain threshold, the fuse element is configured to be broken or tom to be released from being hooked on the hooking portion to thereby result in transition to the second state of the separating mechanism, thereby allowing the separation of the proximal part from the distal part.

[0093] In some embodiments of the cardiac pacing lead, the proximal part is continuous with the distal part, and the proximal part and the distal part are separable at a detachment point.

[0094] In some embodiments of the cardiac pacing lead, the distal part comprises a biodegradable metal covered or coated with one or more biodegradable polymers.

[0095] In some embodiments of the cardiac pacing lead, the one or more biodegradable polymers comprise biodegradable polyesters.

[0096] In some embodiments of the cardiac pacing lead, the biodegradable polyesters comprise aliphatic polyesters.

[0097] In some embodiments of the cardiac pacing lead, the aliphatic polyesters comprise any one of: Polyglycolic acid (PGA), poly(lactid acid) (PLA), poly(caprolactone) PCL, or any combination thereof.

[0098] In some embodiments of the cardiac pacing lead, the one or more biodegradable polymers comprise a copolymer of two or more of said PGA, PLA and PCL; wherein the ratios between said two or more of said PGA, PLA and PCL is determined based on a predetermined time period of degradation. The predetermined time period of degradation is determined based on the medical condition indicating the desired time period for the temporal pacemaker to be implanted and operated in the body of the patient. There can be different ratios selected for different medical conditions. In some embodiments of the cardiac pacing lead, the one or more biodegradable polymers comprise a copolymer of PLA and PGA, wherein the copolymer comprises between 35%-75% PCL and the remaining percentages are PGA.

[0099] In some embodiments of the cardiac pacing lead, the copolymer comprises about 65% PLA and the remaining is PGA.

[0100] In some embodiments of the cardiac pacing lead, the copolymer comprises about 50% PLA.

[0101] In some embodiments of the cardiac pacing lead, the proximal part comprises at least one non degradable metallic -based wire.

[0102] In some embodiments of the cardiac pacing lead, the proximal part comprises a biocompatible material.

[0103] In some embodiments, the cardiac pacing lead further comprises an indicator for providing an indication of an electrical coupling between the proximal part and the distal part.

[0104] Yet another aspect of the present disclosure provides a method for extracting the proximal part of the cardiac pacing lead of any one of the above-described embodiments of the cardiac pacing lead or any combination thereof. The method comprises performing a predetermined manipulation causing the proximal part to physically separate from the distal part; and extracting the proximal part from the body.

[0105] In some embodiments of the method, said predetermined manipulation comprises cutting the proximal part at a certain location.

[0106] In some embodiments of the method, said predetermined manipulation further comprises applying an electrical current that passes through at least one element located in the proximal part, either the electrical conducting element, the proximal conducting element or to an electrical circuit that comprises both.

[0107] BRIEF DESCRIPTION OF THE DRAWINGS The inventive subject matter will be described in greater detail in the following using preferred embodiments, with reference to the drawings and the reference characters noted therein. In the drawings:

[0108] Fig. 1 illustrates the epicardial pacing lead according to the present invention.

[0109] Figs. 2A-2B illustrates the epicardial pacing lead according to the present invention before and after at least partial dissolving thereof and the indication of safe removal of the remaining leads.

[0110] Figs. 3A-3B are schematic illustrations of an example of a cardiac pacing lead according to an embodiment of the present disclosure. Fig. 3A is a schematic side view; and Fig. 3B is a schematic illustration of the cutting manipulation of the proximal part.

[0111] Figs. 4A-4C are schematic illustrations of different views of a non-limiting example of a separating mechanism. Fig. 4A is a side view showing the coupling area between the proximal part and the distal part with the proximal insulation element and the proximal conducting element being semi-transparent; Fig. 4B is a schematic illustration of the cutting manipulation; Fig. 4C is a side view showing the coupling area between the proximal part and the distal part, after the cutting manipulation, with the proximal insulation element and the proximal conducting element being semi-transparent.

[0112] Figs. 5A-5H are schematic illustrations of different views of a non-limiting example of a separating mechanism. Fig. 5A is a side view showing the coupling area between the proximal part and the distal part with the proximal insulation element and the proximal conducting element being semi-transparent; Fig. 5B is a perspective view of the proximal conducting element; Fig. 5C is a perspective view of the proximal conducting element with only the exposed proximal portion of the distal conducting element received in its cavity; Fig. 5D is a perspective view of the proximal conducting element with the exposed proximal portion of the distal conducting element and the tension element received in its cavity; Fig. 5E is a perspective view exemplifying the engaging distal head in the shape of a cone; Fig. 5F is a cross-sectional view exemplifying the engaging distal head in the shape of a cone; Fig. 5G is a schematic illustration of the cutting manipulation; Fig. 5H is a side view showing the coupling area between the proximal part and the distal part, after the cutting manipulation, with the proximal insulation element and the proximal conducting element being semi-transparent.

[0113] Figs. 6A-6E are schematic illustrations of different views of a non-limiting example of a separating mechanism. Fig. 6A is a side view showing the coupling area between the proximal part and the distal part with the proximal insulation element and the proximal conducting element being semi-transparent; Fig. 6B is a cross-sectional view of the coupling area between the proximal part and the distal part; Fig. 6C is a schematic illustration of the cutting manipulation; Figs. 6D-6E are side views showing the coupling area between the proximal part and the distal part, after the cutting manipulation, with the proximal insulation element and the proximal conducting element being semi-transparent.

[0114] Figs. 7A-7C are schematic illustrations of different views of a non-limiting example of a separating mechanism. Fig. 7A is a cross-sectional view of the coupling area between the proximal part and the distal part; Fig. 7B is a schematic illustration of the electrical manipulation on the fuse; Fig. 7C is a cross-sectional view of the coupling area between the proximal part and the distal part after the electrical manipulation.

[0115] DETAILED DESCRIPTION

[0116] The present invention, in some embodiments thereof, relates to a temporary pacing lead which combines at least partially self-dissolving materials that can be used e.g., in cardiac pacemakers and implantable cardioverter defibrillators (ICDs). According to the present invention, the temporary pacing lead is integrated with indicators to indicate full (or partial) degradation thereof.

[0117] As used herein with reference to quantity or value, the term “about” means a deviation of ± 20 % of the nominal value.

[0118] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0119] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range.

[0120] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical, and medical arts.

[0121] As used herein the term “biocompatibility” refers to the capability of a material to evoke an appropriate tissue response in a specific medical application. This includes an adaptation of the chemical, physical, biological, and morphological surface properties of an implant to the recipient tissue, with the objective of establishing a clinically desired interaction. The biocompatibility of the implant material is furthermore dependent on the timing of the response of the biosystem in which the implant is placed. For example, irritations and inflammations, which can cause tissue changes, occur over the relatively short term. Biological systems therefore respond differently depending on the properties of the implant material. Depending on the response of the biosystem, implant materials can be subdivided into bioactive, bioinert, and degradable / resorbable materials.

[0122] As specified above, the present invention discloses a temporary, biocompatible epicardial pacing lead that combines at least partially self-dissolving materials (or a breakable portion) that can be used e.g., in cardiac pacemakers and implantable cardioverter defibrillators (ICDs). By combining a portion (made of biodegradable material) which is locally degradable by external excitation of, predefined parts of an epicardial lead / electrode structure — or the entire lead / electrode structure — can degrade (by a predesigned corrosion process). Thus, an initially one-piece epicardial pacing lead / electrode implant breaks down into at least two separable components due to the degradation of at least one predetermined region (e.g., area 50, in Figs. 2a-2b) induced by external excitation.

[0123] It is within the scope of the present invention where the placement and number of regions that can be stimulated to degrade or dissolve by way of the external excitation of control elements can be varied within wide limits depending on the type and application of the implant. For example, either only predefined points or parts of the existing electrode structure or probe can be excited to dissolve while other regions remain unchanged, or, for example, the dissolution process induced by stimulation can affect an entire implanted electrode or probe, thereby reducing the volume thereof overall or even completely dissolving the electrode or probe.

[0124] It is furthermore within the scope of the present invention to provide an epicardial pacing lead / electrode with specifically electrolytically dissolve regions, that, by applying appropriate external voltage / electrical current using different potential differences. Furthermore, it is appreciated that the rate of the individual dissolution process is controllable, as will be disclosed hereinafter, by the selection of the metallic material and the applied potential difference. The procedure can therefore be adjusted to provide the desired dissolvement is achieved while compatibility to the tissue (e.g., the heart) is ensured during the entire dissolution procedure.

[0125] It should be further noted that the rate of dissolvement of the biodegradable metallicbased lead is controllable. The external excitation as a trigger for the degradation processes can also take place, in an alternative manner, by the administration of drugs or the application of special chemical substances that induce dissolution of local regions of the electrode structure, e.g., by catalytic action.

[0126] According to one embodiment, such temporary pacing lead is provided with indicators designated to indicate full (or, at least partial) degradation thereof. According to another embodiment, once external stimulus (e.g., electrical current, voltage) is applied thereto, at least a portion of said epicardial pacing lead wires dissolve, break and any combination thereof.

[0127] According to another embodiment of the present invention, the external excitation is provided on demand, when is required by the caregiver.

[0128] According to another embodiment of the present invention, the temporary pacing lead will comprise (or otherwise be in communication with) at least one sensor adapted to monitor at least one parameter of the patient such that, upon change thereof, at least one of the following is being performed (a) said temporary pacing lead is self-activated, such that the at least one external excitation is provided (to result in the at least partial degradation thereof); (b) the change is notified; (d) any combination thereof.

[0129] According to another embodiment of the present invention, the sensor is selected from a group consisting of accelerometer, impedance measurement, Photoplethysmography, PPG sensor, pH sensor, ultrasound sensor, temperature meter, heart pulse rate, glucose sensor, any sensor indicating a change in cardiac output, any sensor indicating blood pressure, and any combination thereof.

[0130] According to another embodiment of the present invention, the sensor is adapted to sense at least one parameter selected from a group consisting of impedance, PPG signal, pH, acoustic signal, temperature, heart rate, glucose level, blood pressure, and any combination thereof. According to another embodiment of the present invention, the sensor could be a sensor implanted in the patient, integrated within the temporary pacing lead, a sensor being worn by said patient, a remote sensor outside the patient’s body and any combination thereof.

[0131] According to another embodiment of the present invention, the parameter sensed by the sensor is selected from a group consisting of position of the patient, engagement in physical activity, decrease in NO levels in said at least one vessel or tissue, tissue perfusion, impedance, PPG signal, pH, acoustic signal, temperature, heart rate, glucose level, blood pressure, and any combination thereof and any combination thereof.

[0132] According to another embodiment of the present invention, upon change of said at least one parameter, at least one notification is being sent to said patient or any care giver thereof.

[0133] According to another embodiment of the present invention, as noted above, the external excitation is adapted to enhance at least partial degradation of the temporary pacing lead.

[0134] According to another embodiment of the present invention, any change of at least one parameter of said external excitation results in change of at least one degradation parameter of the at least one degradable portion.

[0135] According to another embodiment of the present invention, the parameter is selected from a group consisting of phase, an operating frequency, power, intensity, operating amplitude, duration, and any combination thereof.

[0136] According to another embodiment of the present invention, the degradation parameter is selected from a group consisting of rate of degradation, location of degradation and any combination thereof.

[0137] Reference is now made to Fig. 1 which illustrates the epicardial pacing lead 100 of the present invention being implanted (in this example, sutured to) heart 10. Known, off the shelf, typical epicardial pacing leads are usually made of at partially insulated wire(s) made of stainless steel wires. In contrary, the epicardial pacing lead of the present invention is made of dissolvable metal / metal alloy (e.g., Magnesium) 20 interweaved with stainless steel wires 30. It should be noted that the field of biodegradable metallic materials is known and has been researched in the literature. Magnesium or pure iron are typically used, as are biodegradable base alloys of the elements magnesium, iron, zinc, molybdenum, tungsten, or aluminum. In addition, alloys of the aforementioned base elements additionally comprising one element from the group of alkaline metals or alkaline-earth metals are known. Alloys based on magnesium, iron and zinc are described as being particularly suitable. Minor constituents of the alloys can be, for example, manganese, cobalt, nickel, chromium, copper, cadmium, lead, tin, thorium, zirconium, silver, gold, palladium, platinum, silicon, calcium, lithium, aluminum, zinc and iron.

[0138] According to the inventive disclosure, in this embodiment, the electrode / lead comprises regions (e.g., area 50 in Figs. 2a-2b) in which a degradation process can be triggered by external excitation. Due to the partial or complete dissolution of these regions 50, the adhesion / connection between the stainless-steel wires and the metal / metal alloy-based wires of the implanted epicardial lead / electrode (and, thus, coupling of the stainless-steel wires and the surrounding tissue (e.g., heart 10)) is considerably reduced, and the risk of tissue being damaged upon by the implant being pulled out is markedly reduced.

[0139] According to one embodiment of the present invention, the metal (e.g., Magnesium, Mg) dissolvable alloy wires will be sutured to the heart 10 while the stainless-steel wires will extend externally from the heart outside the body. As discloses above, a dedicated degradation area will be disposed, in such a way that upon application of external stimuli, the dissolvable metal / metal alloy that is secured to the tissue (e.g., heart 10) will maintained within the body, while the stainless-steel wires will be extracted out without causing any damage.

[0140] In other words, the use of dissolvable metal alloy enables a safe removal of the epicardial pacing lead of the present invention due to the application of electrical current or voltage through the stainless steel wires 30 will result in electrolysis and degradation of the dissolvable metal alloy wires in predefined areas (e.g., are 50, illustrated in Figs. 2a-2b) and weakening (or, fully dissolving) the disconnection of the dissolvable metal alloy wires sutured to the heart. And thus, the lead can be safely pulled out.

[0141] According to one embodiment, the kinetics of the dissolvement of the dissolvable metal alloy of the epicardial pacing lead of the present invention is controllable. For example, should it be desired to accelerate the same, an increase in the applied electrical currcnt\voltagc would be applied or an increase in the exposure duration time will be applied; alternatively, should it be desired to deceleration the same, a decrease in the applied electrical currcnt\voltagc would be applied or a decrease in the exposure duration time will be applied. Thus, according to a preferred embodiment of the present invention a control unit for controlling the application of external stimuli (and thus, the dissolvement) of the dissolvable metal alloy wire, is provided. Furthermore, controlling the lead’s failure (i.e., dissolvement) position and timing could be provided by e.g., a combination of non-dissolving metals (such as stainless still or platinum iridium) and dissolving metal (such as magnesium alloy) can be implemented as part of the lead. According to another embodiment, the dissolving of the lead is intended to be located adjacently to the entry point to the stimulated tissue (e.g., the heart).

[0142] Furthermore, the dissolving process can be controlled by the selection of the metallic material / alloy and the potential difference. Thus, the dissolving procedure can therefore be adjusted such that compatibility and safety is ensured during the procedure.

[0143] According to another embodiment, it could be that there will be several degradations area that will be dissolved upon application of the external stimuli. According to another embodiment, there can be degradable regions (that degrades by external excitation) and insulation layers / regions that separates between said degradations area. Such insulation layer is generally not biodegradable and can contain, e.g., poly-L-lactide or be composed thereof, or another representative of the polyesters, such as, but not limited to, PDLLA, PLGA, or mixtures or copolymers thereof. As an alternative or in addition thereto, the protective layer can contain Parylene (Parylene C or other derivatives), nitrocellulose, methylcellulose and / or carboxymethyl cellulose. The protective layer can also comprise polyvinyl alcohols.

[0144] According to another embodiment, the epicardial pacing leads of the present invention is either unipolar or bipolar.

[0145] According to another embodiment, at least a portion of the epicardial pacing leads (either the biodegradable metallic-based lead wire, the stainless-steel wire, and any combination thereof) is at least partially enclosed in an external protective layer comprised of a biocompatible material.

[0146] According to another embodiment, the stainless steel wires of the epicardial pacing leads are Polytetrafluoroethylene, PTEE, coated.

[0147] According to another embodiment, the epicardial pacing leads are integrated with an external pacemaker and / or implantable cardioverter defibrillators (ICDs).

[0148] It should be noted that according to another embodiment of the present invention, the epicardial pacing leads comprises at least one breakable portion, that upon external activation will break. It is within the scope of the present invention to provide an implantable epicardial pacing lead comprising (a) at least one biodegradable metallic-based lead wire adapted for implantation within a tissue; said at least one biodegradable metallic-based lead wire comprising at least one degradable portion adapted, upon external excitation thereto, to locally degrade; and (b) at least one non degradable metallic-based lead wire (e.g., stainless steel) comprising a biocompatible material, in physical contact with at least a portion of said at least one biodegradable metallicbased lead wire. Thus, upon external activation of e.g., voltage, the location where the combined wires of the non-degradable metallic-based lead and biodegradable metallic-based lead is converted into biodegradable metallic-based lead is the breakable portion due to the smaller diameter thereof said location will be characterized by higher voltage change which, eventually will result in higher degradation rate of this location relatively to the remaining epicardial pacing lead.

[0149] According to another embodiment of the present invention, to ensure the full / partial dissolving of the leads has occurred (as designed and desired), an indication to the user will be provided. Such indication could be impedance measurement and monitoring. Any change in measurement of the impedance during the application of the external stimuli (the application of current / voltage), would indicate the dissolvement (at least in part of the leads). Thus, such indication of impedance change (that have been the result degradation of the dissolvable metalbased leads) by either visually (light e.g., LED), audio (e.g., sound), sensible (e.g., vibration) and any combination thereof. Reference is now made to Figs. 2a-2b which illustrate the epicardial pacing leads 100 after being sutured to the heart 10. Also seen in the Figs, is the impedance measuring device 40.

[0150] Fig. 2a illustrates the epicardial pacing leads 100 before application of external stimuli (electrical current / voltage) and partial dissolvement thereof. As seen in the Fig. the epicardial pacing leads are fully implanted / sutured to the treated tissue (in this case, the heart 10). Also illustrated in the Fig. is the impedance measuring device 40 which indicates (via visual means; in this case red light) that the leads are not dissolved and thus, pulling of the same is not advisable. Also viewed in the Fig. is area 50. Said location is the planned location where the dissolving metal / metal alloy-based leads will occur, subjected to external stimuli.

[0151] Reference is now made to Fig. 2b, which illustrates the epicardial pacing leads 100 after external stimuli has been applied. As seen in the Fig. the impedance measuring device 40 indicates (via visual means; in this case green light) that the leads are dissolved and thus, pulling of the same can be applied. Also seen in the Fig. area 50, which is the planned location where the dissolving metal / metal alloy-based leads has occurred after the external stimuli was provided. It should be noted that, as the greatest potential difference is provided in area 50, said area is likely to dissolve first thereby enabling the safe removal of the lead.

[0152] Reference is now being made to Figs. 3A-3B, which are schematic illustrations of an example of a cardiac pacing lead according to an embodiment of the present disclosure. The cardiac pacing lead 300 comprises a proximal part 302 and a distal part 304 coupled thereto. The distal part may end with a distal needle 306 that is intended to be inserted into an epicardial tissue to remain the lead 300 in electrical coupling to it to allow its pacing. The proximal part 202 may be coupled or include a proximal needle 308 that can be coupled to a pacemaker (not shown) for conducting signals from the pacemaker to the epicardial tissue. It is to be noted that the parts are shown not to scale as typically the proximal part 302 is much longer than the distal part 304.

[0153] Each of the proximal part 302 and the distal part 304 includes a respective conducting element (not shown) that is covered or encapsulated by an insulation to ensure that the signals from the pacemaker arrive at the epicardial tissue to pace the heart.

[0154] The proximal part 302 and the distal part 304 are separable such that when the operation of the lead 300 is over, the distal part 304 remains in the body of the subject and the proximal part 302 is extracted. The distal part 304 is made of biodegradable materials such that it degrades over time and dissolves in the body. For example, the conducting element of the distal part may be made of Magnesium, Zinc, Iron, Molybdenum, Tungsten, or any combination thereof; the insulation of the distal part may be made of Poly(lactic acid) (PLA), Polycaprolactone (PCL), Polyhydroxyalkanoates (PHAs) (e.g., Poly (3 -hydroxybutyrate) (PHB), Polyglycolic Acid (PGA), Polybutylene Succinate (PBS), Silk Fibroin, Starch-Based Biopolymers, or any combination thereof.

[0155] Typically, the proximal part is made of non-degradable materials due to their lower cost, though it is to be noted that the proximal part is not limited to be made of non-degradable materials and can also be made, at least partially, from biodegradable materials.

[0156] The separation of the proximal part 302 from the distal part 304 is triggered by a manipulation that is performed by a user of the lead, e.g. a physician treating the subject in which the lead 300 is implanted. Figs. 4-7 exemplify different separating mechanisms that are a-priori found in a state that the proximal part and the distal part are coupled together and electricity that is generated by the pacemaker is conducted from the proximal part to the distal part, and upon changing the state of the separating mechanisms by performing the manipulation, the proximal part is separated from the distal part, both physically and electrically, and can be extracted from the body of the subject. The term a-priori means that the lead is manufactured or prepared such that it is first used when the proximal part and the distal part are physically and electrically coupled to one another. For the examples of Figs. 4- 7, there is at least one common manipulation that comprises cutting the proximal part at a certain location 310 as exemplified in Fig. 3B. The cutting location 310 can be an arbitrary location that is accessible to the physician that performs the treatment to the subject. It is to be noted that the separating mechanisms may have an additional function to retain the proximal part and the distal part coupled together before the manipulation is performed.

[0157] Reference is now being made to Figs. 4A-4C, which are schematic illustrations of a non-limiting example of a separating mechanism. The proximal part 402 comprises a proximal conducting element 412 that is accommodated within a proximal insulation element 414 in the form of insulating casing that covers the proximal conducting element 412, or alternatively the proximal conducting element 412 is coated with the proximal insulation element 414. The distal part 404 comprises a distal conducting element 416 that is accommodated within a distal insulation element 418 in the form of insulating casing that covers the distal conducting element 416, or alternatively the distal conducting element 416 is coated with the distal insulation element 418. The distal conducting element 416 comprises an exposed proximal portion 420 that proximally projects from the distal insulation element 418. At the operating, a-priori state, the proximal end portion 422 of the distal part 404 is received within the proximal insulation element 414 such that the entire exposed proximal portion 420 is within the proximal insulation element 414 and optionally also a portion of the distal conducting element 416 that is accommodated in the distal insulation element 418. The exposed proximal portion 420 comprises a hooking portion 422 formed by a loop or a hook shape of the proximal portion of the distal conducting element 416. The proximal conducting element 412 comprises a lumen or a cavity 425. The separating mechanism 426 comprises a thread 428 or a wire that is extended through the cavity 425 of the proximal conducting element 412 and is hooked to the hooking portion 422 and is maintained with a certain tension such that it constantly pulls the hooking portion 422, and therefore the entire distal part 404, towards the proximal direction and towards the proximal conducting element 412. Since the hooking portion 422 is larger than the dimension of the cavity 425, when it is pulled by the thread 428 it is urged against portions of the proximal conducting element 412 and therefore electrically and physically coupled to the proximal conducting element 412. Upon cutting the proximal part 402, the tension of the thread 428 is released and the exposed proximal portion 420 is no longer held by the thread 428. After the cut in the proximal part 402, as exemplified in Fig. 4B, the thread 428 has two loose ends and the proximal part 402 is free to be extracted. The thread 428 may be extracted with the proximal part 402 or can be left hung on the hooking portion 422 after the extraction, which requires the pulling of one of its loose ends in order to extract it as well. The distal part 404 is maintained in the body and degrades overtime. Fig. 4C exemplifies a state in which one of the loose ends is pulled such that it is released from the hook portion 422.

[0158] Reference is now being made to Figs. 5A-5H, which are schematic illustrations of another non-limiting example of a separating mechanism. In this example the exposed proximal portion 520 of the distal conducting element 516 is also received in the proximal insulation element 514. The majority of the distal conducting element 516 is accommodated in the distal insulation element 518. The proximal conducting element 512 comprises a cavity 525 that has a first cavity portion 530 through which a tension element 528 of the separating mechanism 526 is extended. The tension element 528 has an engaging distal head 532 distally projecting from the first cavity portion 530. The engaging distal head 532 may have the shape of a sphere, as exemplified in Figs. 5A, 5D and 5H or a cone, as exemplified in Figs. 5E-5F. The tension element 528 is maintained with tension such that it is pulled back towards the first cavity portion 530, but since the engaging distal head 532 has a greater dimension than the first cavity portion 530 it is urged against the edge 534 of the proximal conducting element 512 and blocked from entering the first cavity portion 530. The cavity 525 comprises a second cavity portion 536 continuous to the first cavity portion 530 and the exposed proximal portion 520 is received, at least partially, within the second cavity portion 536. When the engaging distal head 532 of the tension element 528 is proximally pulled, it is deflected towards the exposed proximal portion 520 such that it is also urged against portions of the exposed proximal portion 520 to retain it in position and in physical and electrical contact with the proximal part 502. Upon cutting the proximal part 502, as exemplified in Fig. 5G, the tension element 528 is released from its tension and it is no longer urged against the exposed proximal portion 520, and the proximal part 502 can be separated from the distal part 504 and then extracted from the body of the subject, as exemplified in Fig. 5H.

[0159] Reference is now being made to Figs. 6A-6E, which are schematic illustrations of another non-limiting example of a separating mechanism. In this example the exposed proximal portion 620 is also received in the proximal insulation element 614. The proximal conducting element 612 comprises a cavity 625 through which a tension element 628 of the separating mechanism 626 is extended. The tension element 628 is maintained with tension such that it is constantly pulled proximally. The proximal conducting element 612 is a spring that has at least a distal portion that is normally open, namely, there are gaps between its coils when there is no force applying on it. The exposed proximal portion 620 has portions between the coils of the spring 612 and the tension element 628 is coupled to the distal end of the spring 612 such that is pulls so as to close the gaps between the coils and to lock the exposed proximal portion 620 in position between them. When trapped between the coils of the spring 612, the exposed proximal portion 620 forms a physical and an electrical coupling between the proximal part 602 and the distal part 604. Upon cutting the proximal part 602, as exemplified in Fig. 6C, the tension of the tension element 628 is released and the gap between the coils trapping the exposed proximal portion 620 is opened (as can be seen in Fig. 6D) so as to allow the release of the exposed proximal portion 620 from the spring 612 and the separation of the proximal part 602 from the distal part 604, as exemplified in Fig. 6E.

[0160] Reference is now being made to Figs. 7A-7C, which are schematic illustrations of another non-limiting example of a separating mechanism. In this example the exposed proximal portion 720 is also received in the proximal insulation element 714. The exposed proximal portion 720 comprises a hooking portion 722 formed by a loop or a hook shape of the proximal portion of the distal conducting element 716. The proximal conducting element 712 comprises a cavity 725 through which an electrical conducting element 728 is extended. The cavity 725 may include an internal insulation element 740 that insulates the electrical conducting element 728 from the proximal conducting element 712. The separating mechanism 726 comprises a fuse element 742 that has a first end 744 coupled to the electrical conducting element 728 and a second end 746 coupled to the proximal conducting element 712. The fuse element 742 passes through the hooking portion 722 such that it is hooked to or hung on the hooking portion 722, thereby forming a physical and electrical connection between the proximal part 702 and the distal part 704. By being coupled both to the proximal conducting element 712 and the distal conducting element 716, the fuse element 742 conducts the electrical signals coming from the pacemaker from the proximal conducting element 712 to the distal conducting element 716. Upon cutting the proximal part 702, a portion of the electrical conducting element 728 and the proximal conducting element 712 are exposed and can be coupled to an electrical detachment system 748 that applies current at a certain level that bums or breaks the fuse (as can be seen in Fig. 7C), resulting in physical and electrical separation between the proximal part 702 and the distal part 704. It is to be noted that a terminal of the electrical detachment system 748 can be coupled to a proximal needle element, that is electrically coupled to the proximal conducting element, instead of the proximal conducting element itself.

[0161] Although certain embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a wide variety of alternative or equivalent embodiments or implementations, calculated to achieve the same or similar purposes, may be substituted for the embodiments illustrated and described herein without departing from the scope of the present invention. Those of skill in the art will readily appreciate that embodiments in accordance with the present invention may be implemented in a very wide variety of ways. This application is intended to cover any and all adaptations and / or variations of the embodiments discussed herein.

[0162] The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, to exclude equivalents of the features shown and / or described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims that follow.

[0163] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range.

Claims

Claims1. A cardiac pacing lead comprising: a proximal part extending between a first end and a second end and is configured for electrically coupling with a pacemaker; and a distal part coupled to the proximal part and configured for electrically transmitting an electrical signal generated by the pacemaker to a cardiac tissue, the distal part is separable from the proximal part.

2. The cardiac pacing lead of claim 1, wherein the distal part is separable from the proximal part upon a predetermined manipulation.

3. The cardiac pacing lead of claim 2, wherein the predetermined manipulation results in physical decoupling of the proximal part from the distal part, wherein the predetermined manipulation is a mechanical manipulation, electrical manipulation or a combination of mechanical manipulation and electrical manipulation.

4. The cardiac pacing lead of claim 3, wherein the mechanical manipulation is a cut of the proximal part.

5. The cardiac pacing lead of any one of claims 1-4, wherein the proximal part comprises a conducting proximal element extending between a proximal end and a distal end thereof and is configured for conducting a pacing signal from the pacemaker to the distal part, the proximal part further comprises a proximal part insulation element covering the conducting proximal element, the conducting proximal element is configured for said electrically coupling with a pacemaker; the distal part comprises a conducting distal element and a distal part insulation element covering at least the majority of the conducting distal element, wherein the conducting distal element and the distal part insulation element are each made of one or more biodegradable materials and being separable from the proximal part.

6. The cardiac pacing lead of claim 5, comprising a separating mechanism transitionable between (i) a first state, in which the conducting proximal element and the conducting distal element are in physical contact, and (ii) a second state, in which the conducting proximal element and the conducting distal element are physically disconnected.

7. The cardiac pacing lead of claim 6, wherein the distal conducting element comprises an exposed proximal portion protruding proximally from the distal part insulation element and not covered by the distal part insulation element; wherein in said first state of the separating mechanism, the exposed proximal portion extends into the proximalpart insulation element and in physical contact with the conducting proximal element, wherein in said second state, the exposed proximal portion is disconnected from the conducting proximal element.

8. The cardiac pacing lead of claim 7, wherein the separating mechanism comprises a tension element extending at least along a portion of the proximal part; wherein in said first state, the tension element is in a tense state, in which the tension element is tensed proximally, resulting in said physical contact between the conducting proximal element and the conducting distal element; wherein in said second state, the tension element is in a released state resulting in said physically disconnection between the conducting proximal element and the conducting distal element and transition of the separating mechanism to the second state.

9. The cardiac pacing lead of claim 8, wherein the conducting proximal element comprises an internal cavity, said tension element extends through said internal cavity.

10. The cardiac pacing lead of claim 9, wherein said exposed proximal portion comprises a hooking portion, said tension element is a thread, with its two ends being held in position, hooked on said hooking portion, the hooking portion has a greater dimension than the internal cavity such that when the tension element is in its tense state, portions of the hooking portions touching the proximal conducting element.

11. The cardiac pacing lead of claim 10, wherein the transition of the separating mechanism from the first state to the second state is performed upon releasing at least one end of the two ends of the tension element that are being held in position.

12. The cardiac pacing lead of claim 9, wherein said internal cavity comprises a first cavity portion in which the tension element extends therethrough, and a second cavity portion that is configured to receive the exposed proximal portion of the distal conducting element, wherein the tension element comprises an engaging distal head distally projecting from the first cavity portion and having a dimension that is greater than the first cavity portion; wherein in the first state of the separating mechanism, the exposed proximal portion is received in the second cavity portion and the engaging distal head urges against the exposed proximal portion to hold it in position within the second cavity portion and in physical contact with the proximal conducting element.

13. The cardiac pacing lead of claim 12, wherein the first and the second cavity portions are continuous.

14. The cardiac pacing lead of claim 13, wherein the engaging distal head is in the form of a sphere or a cone.

15. The cardiac pacing lead of claim 14, wherein the tension element is being a-priori held in position to assume its tense state; wherein upon releasing the tension element or a part thereof from its hold, the engaging distal head is biased distally and it stops urging against the exposed proximal portion.

16. The cardiac pacing lead of claim 9, wherein the proximal conducting element is in the form of a spring; wherein in the first state of the separating mechanism the exposed proximal portion is held between loops of the spring and the tension element is coupled to a distal end of the spring causing the loops of the spring to clamp portions of the exposed proximal portion.

17. The cardiac pacing lead of claim 16, wherein the tension element is being a-priori held in position to assume its tense state; wherein upon releasing the tension element or a part thereof from its hold, the loops of the spring are biased to be opened and the exposed proximal portion can be released to separate the proximal part from the distal part.

18. The cardiac pacing lead of claim 6, wherein the distal conducting element comprises an exposed proximal portion protruding proximally from the distal part insulation element and not covered by the distal part insulation element; wherein in said first state of the separating mechanism, the exposed proximal portion extends into the proximal part insulation element and is electrically connected and physically coupled with the conducting proximal element, wherein in said second state, the exposed proximal portion is electrically and physically disconnected from the conducting proximal element; wherein the conducting proximal element comprises an internal cavity; wherein said exposed proximal portion comprises a hooking portion; the separating mechanism comprises an electrical conducting element and a fuse element, the electrical conducting element extends through at least a portion of the internal cavity; wherein in said first state the fuse element extends between the conducting proximal element and the electrical conducting element and passing through the hooking portion such that it is hooked thereon.

19. The cardiac pacing lead of claim 18, wherein upon application of a voltage or current above a certain threshold, the fuse element is configured to be broken or tom to be released from being hooked on the hooking portion to thereby result in transition to the second state of the separating mechanism.

20. The cardiac pacing lead of any one of claims 1-19, wherein the distal part comprises a biodegradable metal covered or coated with one or more biodegradable polymers.

21. The cardiac pacing lead of claim 20, wherein the one or more biodegradable polymers comprise biodegradable polyesters.

22. The cardiac pacing lead of claim 21, wherein the biodegradable polyesters comprise aliphatic polyesters.

23. The cardiac pacing lead of claim 22, wherein the aliphatic polyesters comprise any one of: Polyglycolic acid (PGA), poly(lactid acid) (PLA), poly(caprolactone) PCL, or any combination thereof.

24. The cardiac pacing lead of claim 23, wherein the one or more biodegradable polymers comprise a copolymer of two or more of said PGA, PLA and PCL; wherein the ratios between said two or more of said PGA, PLA and PCL is determined based on a predetermined time period of degradation.

25. The cardiac pacing lead of any one of claims 20-24, wherein the one or more biodegradable polymers comprise a copolymer of PLA and PGA, wherein the copolymer comprises between 35%-75% PCL and the remaining percentages are PGA.

26. The cardiac pacing lead of claim 10, wherein the copolymer comprises about 65% PLA.

27. The cardiac pacing lead of claim 25, wherein the copolymer comprises about 50% PLA28. The cardiac pacing lead of any one of claims 1-26, wherein the proximal part comprises at least one non degradable metallic-based wire.

29. The cardiac pacing lead of any one of claims 1-28, wherein the proximal part comprises a biocompatible material.

30. The cardiac pacing lead of any one of claims 1-29, comprising an indicator for providing an indication of an electrical coupling between the proximal part and the distal part.

31. A method for extracting the proximal part of the cardiac pacing lead of any one of claims 1-30 from a body of a subject, comprising: performing a predetermined manipulation causing the proximal part to physically separate from the distal part; and extracting the proximal part from the body.

32. The method of claim 31, wherein said predetermined manipulation comprises cutting the proximal part at a certain location.

33. The method of claim 32, wherein said predetermined manipulation further comprises applying an electrical current that passes through at least one element located in the proximal part.

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