Classifications

• • 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
  • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
  • A61N1/0595—Temporary leads
• • 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
  • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
  • A61N1/059—Anchoring means
• • 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
  • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
  • A61N1/0592—Introducing the lead through the pericardium with a needle

Definitions

• the present disclosure relates generally to a medical device, and more particularly to an implantable medical device that includes a lead for temporary electric stimulating (e.g. pacing), cardiac monitoring and/or other medical applications.
• a lead for temporary electric stimulating e.g. pacing
• cardiac monitoring e.g., cardiac monitoring and/or other medical applications.
• Temporary pacing of the heart for instance after open-heart surgery, has been found to be effective in the treatment of postoperative cardiac arrhythmias which arise, for example, as a result of damage or injury to the conduction system during the surgery, hypothermia, preoperative anti- arrhythmia therapy (beta-blockers, calcium antagonists, digoxin) local edema , or temporary and intraoperative ischemia.
• hypothermia preoperative anti- arrhythmia therapy
• beta-blockers calcium antagonists, digoxin
• the heart's performance can show marked improvement when a relatively slow heart rate is elevated by electronic pacing.
• Patients who show postoperative sinus bradycardia can achieve improvements through AV sequential pacing.
• one or more electrodes at the distal end of a lead are affixed to the heart, for instance to the epicardium or myocardium. Another electrode is attached to the outer skin surface or to the epicard or myocard as well. The distal end of the lead remains outside the body where electrical and mechanical connections to an external temporary pacemaker together with the skin electrode are made.
• proximal is closer to a first tissue (e.g. closer to the heart or cardiac tissue) wherein an element or end which is referred to as “distal” is farther from a first tissue (e.g. farther from the heart or cardiac tissue).
• One method utilizes a "zigzag" or helical shaped electrode. Prior to deployment, the zigzag or helical shaped electrode is rather compressed, but becomes spread out when pulled though the myocardium.
• Pacing electrodes of this kind are disclosed, for example, in US Patent 5,350,419 to Bendel et al. and US Patent 4,341,226 to Peters et al.
• the lead When pacing is no longer needed, or before the patient is discharged from the ward, the lead is detached from the heart by gently tugging on the external portion of the lead. The lead is then pulled out of the thorax and disposed of.
• the fixation of the lead to the heart must be stable enough to guarantee reliable heart pacing during the entire pacing period, and on the other hand, the fixation must not be too securely anchored in the heart so that it can be removed without injury upon tugging. Nonetheless, removal of an implanted lead entails a risk of damaging and/or rupturing the myocardium and/or a different part of the heart when the lead is pulled out. This can cause severe bleeding and/or cardiac tamponade, which can be a life threatening condition.
• the present disclosure provides a device useful for electrically stimulating a tissue, monitoring an electrical signal from a tissue (herein, at times, the "first tissue” or “target tissue”), and/or another medical purpose.
• a non- limiting embodiment is for heart pacing post-cardiac surgery.
• the device comprises a lead that is configured, inter-alia, for the provision of an electric link between a distal end at the body's exterior and an electrode at its proximal end portion that is embedded in or otherwise fixed to the target tissue.
• that of some embodiments of the presently disclosed subject matter includes also an anchoring element and an elastic element disposed between the anchoring element and the distal end of the lead.
• the anchoring element is used to anchor the lead to a second tissue that is other than the target tissue and when the use of the device is exhausted, the distal end is pulled away from the anchoring element against the elasticity of the elastic element, and once cut, the distal portion of the cut lead retracts back into the body.
• this eliminates injury to the cardiac tissue that often occurs in known pacing devices with a lead that extends from an electrode at its proximal end portion to the body's exterior.
• a device comprising a lead extending between a proximal end and a distal end, the lead comprising, at its proximal end portion, an electrode element configured for fixing in a first body tissue.
• the lead further comprises an anchoring element disposed between the proximal and the distal end for anchoring the device to a second tissue; and an elastic element disposed between the anchoring element and the distal end and configured so as to permit the pulling of the distal end away from the anchoring element against the biasing force of the elastic element.
• the first tissue is the heart, myocardium or epicardium and the second tissue is the diaphragm.
• the distal end is configured for connecting to monitoring or electric stimulating equipment, e.g. a heart pacing device.
• monitoring or electric stimulating equipment e.g. a heart pacing device.
• a wire or cable included in the lead is insulated.
• the device further comprises a needle at its proximal end, proximal to the electrode element.
• the electrode has a shape so as to increase zone of contact with the first tissue. In some of these embodiments, the electrode has a zigzag or helical shape.
• the device further comprises a needle at its distal end.
• the elastic element is a helical spring or an element made of an elastic material.
• the elastic element is fixed to a first point or section of a wire or cable included in the lead and to a second point or section of the wire or cable which is distanced from the first point by a first distance measured along the wire or cable that is longer than the length of the elastic element between the first point or section and second point or section in a relaxed state thereof.
• the elastic element is a hollow element with a lumen that accommodates a portion of a wire or cable included in the lead and that can elastically deform from a first, resting state to a second, strained state in which it is biased to re-deform into the first state, the deformation from the first to the second state being induced by pulling the proximal end away from the anchoring element.
• the elastic element is formed from a segment of a wire or cable included in the lead.
• the anchoring element is constituted by a loop formed from a wire or cable included in the lead.
• the anchoring element is an element attached to a wire or cable included in the lead.
• an implantable device comprising: a lead extending between a proximal end and a distal end, the lead comprising, at its proximal end portion, an electrode configured for fixing onto a subject's heart or into a cardiac tissue, a distal end of the lead being configured to be inserted through a chest wall and skin from interior to exterior, the lead further comprising: an anchoring element disposed between the proximal and the distal end for anchoring the device to the patient's diaphragm, and an elastic element disposed between the anchoring element and the distal end and configured so as to permit the pulling of the distal end away from the anchoring element against the biasing force of the elastic element.
• a cardiac pacemaker system comprising one or more devices according to any one of the embodiments disclosed herein.
• a method of implanting a device that comprises a lead extending between a proximal end and a distal end, the lead comprising an elastic element, an electrode element between a proximal end of the lead and the elastic element, and an anchoring element between the electrode element and the elastic element, the method comprising: securing the electrode element to a first tissue; fixing the anchoring element to a second tissue; and inserting the distal end of the lead through a body wall and skin from interior to exterior.
• the method further comprises: pulling a distal end of the lead away from the skin surface, thereby causing the elastic element to be in a stretched state; and cutting the lead above the skin surface to leave a cut portion extending into the body, and releasing the lead to enable the biasing force of the elastic element to cause it to revert to a relaxed contracted state, and consequently retract the cut portion into the body.
• Fig. 1 shows a device comprising a lead, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 2A shows an elastic element in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 2B shows the elastic element of Fig. 2A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 3A shows an elastic element in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 3B shows the elastic element of Fig. 3 A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 4A shows an elastic element in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 4B shows the elastic element of Fig. 4A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 5A shows an elastic element in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 5B shows the elastic element of Fig. 5 A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 6A shows an anchoring element, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 6B shows an anchoring element, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 6C shows an anchoring element, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 6D shows an example where there is sufficient distance between an elastic element and an electrode element to allow for later addition of an anchoring element, in accordance with some embodiments of the presently disclosed subject matter.
• Fig. 7 shows a device comprising a lead having an elastic element in accordance with some embodiments of the presently disclosed subject matter, the elastic element being shown in a contracted relaxed state;
• Fig. 8 shows the device with the elastic element in a stretched state, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 9A shows implantation of the device of Figs. 7 and 8, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 9B shows the device of Figs. 7 and 8 after completion of the implantation, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 10A shows stretching of the elastic element in the implanted device, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 10B shows retraction of the exposed portion of the lead into the body after cutting off the end of the lead, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 11 is a flowchart of a method of implanting a device, in accordance with some embodiments of the presently disclosed subject matter
• Fig. 12 is a flowchart of a method performed after an implanted device is no longer needed, in accordance with some embodiments of the presently disclosed subject matter.
• Fig. 13 is a flowchart of a method of manufacturing a device, in accordance with some embodiments of the presently disclosed subject matter.
• the device may comprise a lead.
• the lead may comprise an elastic element, an electrode element at a proximal end of the lead or between a proximal end of the lead and the elastic element, and an anchoring element, or sufficient distance to allow for later addition of an anchoring element, between the elastic element and the electrode element.
• the device in some of these embodiments may comprise a lead extending between a proximal end and a distal end, the lead comprising, at its proximal end portion, an electrode element configured for fixing in a first body tissue, the lead further comprising: an anchoring element disposed between the proximal and the distal end for anchoring the device to a second tissue; and an elastic element disposed between the anchoring element and the distal end and configured so as to permit the pulling of the distal end away from the anchoring element against the biasing force of the elastic element.
• the electrode element is at the proximal end portion of the lead, this means that the electrode element may be at the proximal end, but not necessarily.
• the electrode element may alternatively be anywhere between the proximal end and the anchoring element or anywhere between the proximal end and the future location of the anchoring element which will be added later.
• proximal end of the device corresponds to the proximal end of the lead comprised in the device
• distal end of the device corresponds to the distal end of the lead comprised in the device
• an elastic element is an element which has the property of elasticity (up to an elastic limit). Therefore an elastic element deforms from a relaxed contracted state (also referred to as relaxed state or resting state, or any variant thereof) to a stretched state (also referred to as strained state or any variant thereof) when a pulling force is applied to the elastic element. This pulling force is against the biasing force (also referred to as restoring force or any variant thereof) exerted by the elastic element. When in the stretched state the elastic element is biased to re-deform (also referred to as revert or any variant thereof) into the relaxed state so that when the pulling force is no longer applied, the elastic element reverts to the relaxed contracted state due to the biasing force exerted by the elastic element.
• the maximum biasing force which would restore the elastic element to the relaxed contracted state is limited so that retraction of the exposed portion of the lead into the body (described below) does not cause internal injury.
• the biasing force F -kx where k is a constant and x is a displacement
• the value of k and/or of x may be limited so that the biasing force is also limited.
• there may not be a limit on the maximum biasing force for instance if the device is implanted in a way which minimizes the likelihood that such a retraction would cause internal injury.
• An elastic element may be for example, a coiled (also referred to as helical or any variant thereof) spring, an element made of an elastic material (e.g. elastic fiber or cable), etc.
• the disclosure also does not limit the amount that an elastic element may be stretched.
• the lead may be lengthened between the proximal and distal ends by up to 2-3 cm when included elastic element(s) is/are stretched from a relaxed contracted state.
• the lead may be lengthened by a larger or smaller amount.
• an electrode element may have a shape which increases the zone of contact with the first tissue.
• an electrode element may have a zigzag or helical shape. In other embodiments, an electrode element may not have such a shape.
• the disclosure also does not limit the type of anchoring element.
• the device may be initially manufactured with or without an anchoring element. Therefore after the initial manufacturing of the device, an anchoring element may not necessarily be present, as long as an anchoring element is present when the device is being implanted into a body. If the device excludes an anchoring element when originally manufactured, the device should be configured in a manner which allows for an anchoring element to be added at a later time. For instance the device may be manufactured in a manner that ensures that there will be sufficient distance between an elastic element and an electrode element to later add an anchoring element.
• This "sufficient" distance may be equivalent to the sum of the desired distance between an elastic element and an anchoring element and the desired distance between the anchoring element and an electrode element, or may be a larger distance than the sum of the desired distances. For instance, the distance may be larger if a segment of a wire or cable included in the lead which connects between the elastic element and the electrode element will later be used to form the anchoring element, as in some embodiments described below.
• the disclosure also does not limit the distances between the various elements included in the device, and depending on the embodiment there may be any suitable distances between the various elements.
• any suitable distances between the various elements for the purpose of illustration only, one example of possible distances is now provided. In this example, there is a distance of about 6 cm between a distal end of the lead and an elastic element, a distance of about 3-5 cm between an elastic element and an anchoring element, and a distance of about 5-10 cm between an anchoring element and an electrode element.
• each of these distances may be larger or smaller.
• the lead may also comprise one or more other elements, of the same type (e.g. additional electrode element(s), additional elastic element(s), additional anchoring element(s)). and/or of different type(s) (e.g. needle(s), wire(s), cable(s), etc) , between the distal and proximal ends of the lead.
• additional electrode element(s) e.g. additional electrode element(s), additional elastic element(s), additional anchoring element(s)
• different type(s) e.g. needle(s), wire(s), cable(s), etc
• a needle e.g. a circular needle
• a needle for instance a straight pointed needle, at the distal end of the lead, which may be included in the device that is being implanted, having been added during the initial manufacturing of the device or at a later time.
• the anchoring, elastic and/or electrode elements mentioned above may be fixed (i.e. attached) to such a wire or cable, and/or such a wire or cable may be formed into one or more of these elements.
• an elastic element may be fixed to a wire or cable, or for instance a segment of a wire or cable may be formed into an elastic element.
• An anchoring element for instance, may be attached to a wire or cable, or for instance a segment of a wire or cable may be formed into an anchoring element.
• An electrode element may be attached to a wire or cable, or for instance a segment of a wire or cable may be formed into an electrode element.
• a wire or cable included in the lead is an insulated wire or cable with the insulation made, for instance from a biocompatible material, such as polyethylene, and with the diameter of the insulated wire or cable being e.g. around 0.45 mm, the electrode element may or may not be formed from an uninsulated segment of the wire or cable More details on these instances are provided below.
• the device is described below with respect to a cardiac application, where the first tissue is the heart or a cardiac tissue (e.g. epicardium or myocardium) and the second tissue is non-cardiac tissue.
• the device may be used for other applications, where the first tissue is not the heart or a cardiac tissue, with similar description to what is disclosed below, mutatis mutandis.
• an electrode element included in the lead is fixed onto a patient's (i.e. subject's) heart or into a cardiac tissue e.g. in the epicardium or myocardium.
• An anchoring element is anchored to a non- cardiac tissue, for instance to the diaphragm, and the distal end of the lead is inserted through the chest wall and skin from the interior to the exterior, for instance in order to be connected to monitoring equipment, electric stimulating equipment (e.g. pacemaker, also known as heart pacing device) or any other medical equipment.
• electric stimulating equipment e.g. pacemaker, also known as heart pacing device
• the exposed distal end of the lead is pulled away from the skin surface on the chest wall, causing the elastic element to be stretched.
• the elastic element permits the pulling of the distal end away from the anchoring element against the biasing force of the elastic element.
• the lead is cut above the skin surface, for example with a pair of scissors. Cutting the lead causes the elastic element to spontaneously revert to a contracted state. This causes the exposed (distal) portion of the lead to retract into the body through the skin and chest wall.
• the truncated lead may remain in the body, and the electrode element does not need to be detached from the heart, unless it is desired to do so.
• a medical system may comprise one or more of the devices and optionally other element(s) such as any medical equipment to which the device(s) is/are capable of being connected, etc.
• a cardiac pacemaker system may comprise one or more of the devices.
• the cardiac pacemaker system may also comprise other element(s) such as a pacemaker (i.e. heart pacing device), any other electric stimulating equipment, etc.
• a monitoring system may comprise one or more of the devices.
• the monitoring system may also comprise other element(s) such as monitoring equipment, etc.
• Fig. 1 shows a device comprising a lead 100, in accordance with some embodiments of the presently disclosed subject matter.
• lead 100 is shown as including a single elastic element 110 and a single electrode element 180 between a distal end 105 and a proximal end 195, but in some embodiments lead 100 may include a plurality of elastic elements and/or electrode elements.
• lead 100 is shown as including, between elastic element 110 and electrode element 180 a single anchoring element or sufficient distance 140 to allow for later addition of an anchoring element. In some embodiments, however, there may be a plurality of anchoring elements or sufficient distance to allow the later addition of a plurality of anchoring elements.
• Elastic element 110, anchoring element/sufficient distance 140, and electrode element 180 are shown connected by a dotted line in Fig. 1 so as to indicate that these elements are located between distal end 105 and proximal end 195 of lead 100 in the order shown, namely electrode element 180 at proximal end 195 or between proximal end 195 and elastic element 110, and anchoring element/sufficient distance 140 between elastic element 110 and electrode element 180.
• lead 100 may include one or more other elements, as discussed above.
• Fig. 2A shows an example of an elastic element 210 in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter.
• Elastic element 210 is an example of elastic element 110 shown in Fig 1.
• elastic element 210 is a coiled spring which is attached to a wire or cable 204 included in lead 100 at a first point or section 218 of wire or cable 204, and at a second point or section 220 of wire or cable 204.
• Wire or cable 204 continues beyond elastic element 210 in both directions, proximally and distally, although not necessarily all the way between proximal end 195 and distal ends 105.
• First and second points or sections 218 and 220 of wire or cable 204 are distanced from each other by a distance measured along the wire or cable that is longer than the length of elastic element 210 between points/sections 218 and 220 when elastic element 210 is in a relaxed state. Therefore, wire or cable 204 is shown bulging out around elastic element 210 between points/sections 218 and 220 when the elastic element is in a relaxed contracted state.
• first and second points or sections 218 and 220 of wire or cable 204 are distanced from each other by a distance measured along wire or cable 204 that is longer than the distance between the two ends of elastic element 210 in a relaxed state.
• Fig. 2B shows elastic element 210 of Fig 2A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter.
• Fig. 3A shows another example of an elastic element 310 in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter.
• Elastic element 310 is an example of elastic element 110 shown in Fig 1.
• elastic element 310 is in the shape of an omega shape, U shape, or any other appropriate shape.
• Elastic element 310 may or may not be hollow.
• Elastic element 310 is attached to a wire or cable 304 of lead 100 at a first point or section 318 of wire or cable 304, and at a second point or section 320 of wire or cable 304.
• Wire or cable 304 continues beyond elastic element 310 in both directions, proximally and distally although not necessarily all the way between proximal end 195 and distal ends 105.
• First and second points or sections 318 and 320 of wire or cable 304 are distanced from each other by a distance measured along wire or cable 304 that is longer than the length of elastic element 310 between points/sections 318 and 320 when elastic element 310 is in a relaxed state. Therefore, wire or cable 304 is shown bulging out around elastic element 310 between points/sections 318 and 320 when the elastic element is in a relaxed contracted state.
• first and second points or sections 318 and 320 of wire or cable 304 are distanced from each other by a distance measured along the wire or cable that is longer than the distance between the two ends of elastic element 310 in a relaxed state.
• Fig. 3B shows elastic element 310 of Fig 3A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter.
• Fig 4A shows another example of an elastic element 410 in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter.
• Elastic element 410 is an example of elastic element 110 shown in Fig 1.
• elastic element 410 is in the shape of an omega shape, U shape, or any other appropriate shape.
• Elastic element 410 is hollow and a lumen of elastic element 410 accommodates a portion of a wire or cable 404 included in lead 100. Wire or cable 404 continues beyond elastic element 410 in both directions, proximally and distally although not necessarily all the way between proximal end 195 and distal ends 105.
• elastic element 410 may be attached to wire or cable 404 at a first point or section of wire or cable 404, and at a second point or section of wire or cable 404, however in other embodiments attachment may not be necessary.
• Fig. 4B shows elastic element 410 of Fig 4A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter.
• Fig. 5A shows another example of an elastic element 510 in a relaxed contracted state, in accordance with some embodiments of the presently disclosed subject matter.
• Elastic element 510 is an example of elastic element 110 shown in Fig 1.
• elastic element 510 is formed from a segment of wire or cable 504 included in lead 100 by coiling the segment of wire or cable 504. Wire or cable 504 continues beyond the elastic element in both directions, proximally and distally although not necessarily all the way between proximal end 195 and distal ends 105.
• elastic element 510 may be formed from a segment of wire or cable 504 in any other appropriate way.
• Fig. 5B shows elastic element 510 of Fig 5A in a stretched state, in accordance with some embodiments of the presently disclosed subject matter.
• any type of (elastic) element which has the property of elasticity may be used in lead 100.
• lead 100 may include one or more elastic elements.
• the elastic elements may all be of the same type, or the elastic elements may be of two or more different types.
• the type or types of elastic elements may include any of the examples of elastic elements illustrated in Figs 2A, 2B, 2C, 2D, 3A, 3B, 4A, 4B, 5A, 5B and/or may include any other example(s).
• the configuration of the elastic elements with respect to one another may be of any suitable configuration.
• the configuration may include serial elastic elements and/or parallel elastic elements, but this is not necessarily so.
• FIG.6A shows an example of an anchoring element 6401, in accordance with some embodiments of the presently disclosed subject matter.
• Anchoring element 6401 is an example of anchoring element 140 shown in Fig. 1.
• anchoring element 6401 is constituted by a loop formed from a wire or cable 6041 included in lead 100 (e.g. by creating a fixed loop in wire or cable 6041). Wire or cable 6041 continues beyond anchoring element 6401 in both directions, distally and proximally, and therefore at least runs part of the way between elastic element 110 and electrode element 180.
• FIG. 6B shows an example of an anchoring element 6402, in accordance with some embodiments of the present disclosed subject matter.
• Anchoring element 6402 is an example of anchoring element 140 shown in Fig. 1.
• anchoring element 6402 is an element in the form of a loop which is attached to one point on a wire or cable 6042 included in lead 100, or is attached to a section of wire or cable 6042 included in lead 100. Wire or cable 6042 continues beyond anchoring element 6402 in both directions, distally and proximally, and therefore at least runs part of the way between elastic element 110 and electrode element 180.
• Fig. 6C shows an example of an anchoring element 6403, in accordance with some embodiments of the presently disclosed subject matter.
• Anchoring element 6403 is an example of anchoring element 140 shown in Fig. 1. As shown in Fig. 6C, anchoring element 6403, which is an element that is not in the form of a loop, is attached to one point on a wire or cable 6043 included in lead 100, or is attached to a section of wire or cable 6043 included in lead 100. Anchoring element 6403 may include one or more pieces. Wire or cable 6043 continues beyond anchoring element 6403 in both directions, distally and proximally, and therefore at least runs part of the way between elastic element 110 and electrode 180.
• Fig. 6D shows an example where there is sufficient distance 6404 between elastic element 110 and electrode element 180 of lead 100 to allow for later addition of an anchoring element, in accordance with some embodiments of the presently disclosed subject matter.
• Sufficient distance 6404 is an example of sufficient distance 140 shown in Fig. 1.
• An anchoring element which may be added later may be an anchoring element as illustrated in Fig 6 A, 6B, 6C or any other suitable anchoring element.
• an anchoring element which will be added later will be formed from a wire or cable included in lead 100 which at least runs part of the way between elastic element 110 and electrode element 180.
• "sufficient" distance which would allow such a loop to be formed may equal e.g. the sum of the amount of wire or cable which will be used for forming the loop, the desired distance between the loop and elastic element 110, and the desired distance between the loop and electrode 180 element, or may be higher.
• Figs. 6A, 6B, 6C are provided for the purpose of illustration only, and any type of anchoring element may be used which enables the firm fixation of a point or section of lead 100 between elastic element 110 and electrode element 180, so that when a pulling force is applied to distal end 105 of lead 100 and assuming the fixation is maintained, little or no pulling force is experienced by any element of lead 100 (e.g. electrode element 180) proximal from the fixed point or section.
• lead 100 may include one or more anchoring elements and/or sufficient distance to allow for the later addition of one or more anchoring elements.
• the anchoring elements may all be of the same type, or the anchoring elements may be of two or more different types.
• the type or types of anchoring elements may include any of the examples of anchoring elements illustrated in Figs 6A, 6B, 6C, and/or may include any other example(s).
• the configuration of the anchoring elements with respect to one another may be of any suitable configuration.
• the configuration may 5 include serial anchoring elements and/or parallel anchoring elements, but this is not necessarily so.
• a device comprising a lead 2
• Figs 7, 8, 9 A, 9B, 10A, 10B Lead 2 is an example of lead 100 shown in Fig 1.
• Lead 2 has an elastic element 16 in accordance with embodiments
• Figs. 7 and 8 show a device comprising lead 2 in accordance with some embodiments of the presently disclosed subject matter.
• Lead 2 comprises an insulated
• wire or cable 4 having a distal end 6 and a proximal end 8.
• wire or cable 4 is an example of distal end 105 of lead 100 and proximal end 8 of wire or cable 4 is an example of proximal end 195 of lead 100 (see Fig 1).
• the insulation of wire or cable 4 may be made for example from a biocompatible material, such as polyethylene.
• the diameter of the insulated wire or cable may be, for example, around 0.45 mm. Attached
• Electrode 12 Adjacent to proximal end 8 is an electrode 12 which is formed from an uninsulated segment of wire or cable 4. Electrode 12 is an example of electrode element 180 (Fig. 1) and is configured to be fixed (i.e. embedded) in a first tissue such as the heart or a cardiac tissue (e.g. myocardial or epicardial tissue). In the embodiments shown in Figs 7 and 8, electrode
• Wire or cable 4 terminates at its distal end 6 in a straight pointed needle 14.
• Lead 2 further comprises elastic element 16 that may be for example, a coiled spring or an elastic fiber or cable.
• Elastic element 16 is attached to wire or cable 4 at a first point 18 of wire or cable 4, and at a second point 20 of wire or cable 4.
• elastic element 16 is shown in its relaxed, contracted configuration. It is assumed that the ends of elastic element 16 are attached to first and second points 18 and 20. First and second points 18 and 20 are distanced from each other by a distance measured along wire or cable 4 that is longer than the distance between the two ends of elastic element 16 in the relaxed contracted state. Therefore wire or cable 4 is shown bulging out around the elastic element 16 between the points 18 and 20 when elastic element 16 is in the relaxed contracted state.
• elastic element 16 is shown after having been stretched.
• anchoring element 15 Between elastic element 16 and electrode 12 is anchoring element 15 that may be formed, for example, by creating a fixed loop in wire or cable 4.
• the anchoring element is for anchoring the device to a second tissue such as a non-cardiac tissue (e.g. a diaphragm 17)
• Fig. 9A shows implantation of the device comprising lead 2, in accordance with some embodiments of the presently disclosed subject matter.
• the curved suture needle 10 has been looped through the epicardium or myocardium 26 with elastic element 16 in its contracted state shown in Fig. 7.
• Electrode 12 is fixed in the heart or into a cardiac tissue, for example in the epicardium or myocardium 26 of the right ventricle or right atrium.
• Anchoring element 15 has been sutured to a non-cardiac tissue such as diaphragm 17.
• Straight needle 14 has been inserted through the chest wall 22 and skin from the interior to the exterior.
• wire or cable 4 is not tensioned, so that no pulling force is applied by wire or cable 4 to epicardium or myocardium 26.
• the suturing of anchoring element 15 to diaphragm 17 is sufficiently secure so that anchoring element 15 remains anchored to diaphragm 17 even if a pulling force of reasonable proportion or less is applied to distal end 6.
• Reasonable proportion may vary depending on the embodiment. For instance a pulling force of reasonable proportion may be equal to or larger than the pulling force expected when distal end 6 is pulled away from the skin surface as described below with reference to Fig. 9B.
• Fig. 9B shows the device after completion of the implantation, in accordance with some embodiments of the presently disclosed subject matter.
• Curved suture needle 10 was cut off from wire or cable 4 prior to closing the chest wall 22.
• the tip of the straight needle 14 has also been cut off to produce a straight blunt probe which can be connected to monitoring equipment, electric stimulating equipment (e.g. pacemaker), or any other medical equipment (not shown).
• electric stimulating equipment e.g. pacemaker
• a medical system may be considered to comprise one or more of the devices described herein.
• the medical system may also comprise other element(s), for instance any medical equipment (e.g. monitoring, electric stimulating, or any other medical equipment) to which the device(s) is/are capable of being connected, etc.
• any medical equipment e.g. monitoring, electric stimulating, or any other medical equipment
• Fig. 10A which shows the stretching of elastic element 16 in the implanted device
• Fig. 10B which shows retraction of the exposed portion of the lead into the body after cutting off the end of the lead, in accordance with some embodiments of the presently disclosed subject matter.
• distal end 6 of wire or cable 4 can be disconnected from the electric stimulating equipment, monitoring equipment, or any other medical equipment to which it was connected.
• Distal end 6 of the wire or cable 4 is then pulled away from the skin surface on chest wall 22.
• Elastic element 16 permits the pulling of distal end 6 away from anchoring element 15 against the biasing force of elastic element 16.
• the anchoring of anchoring element 15 to diaphragm 17 the pulling on distal end 6 and the stretching of elastic element 16 results in little or no pulling force on epicardium or myocardium 26. Then, as shown in Fig.
• wire or cable 4 is cut above the skin surface, for example, with a pair of scissors. Cutting wire or cable 4 causes elastic element 16 to spontaneously revert to its contracted configuration. This causes the exposed (distal) portion of the cut end of wire or cable 4 to be retracted into the body through the skin and chest wall 22. The truncated lead can remain in the body, if desired, thus avoiding the need to detach electrode 12 from epicardium or myocardium 26.
• Fig. 11 is a flowchart of a method 1100 of implanting a device, in accordance with some embodiments of the presently disclosed subject matter.
• the device provided for implantation comprises lead 100 for which some embodiments are described herein.
• electrode element 180 is secured to a first tissue.
• the first tissue may be, for example, the heart or a cardiac tissue such as the epicardium or myocardium of a patient.
• a needle such as a curved suture needle attached to a proximal end of lead 100 may be used for suturing distal end 195 of lead 100 to a first tissue.
• anchoring element 140 is fixed to a second tissue.
• the second tissue may be non-cardiac tissue, such as the diaphragm of the patient.
• a needle such as one not attached to lead 100, may be used for suturing anchoring element 140 to the second tissue.
• stages 1102 and 1104 may be reversed.
• distal end 105 of lead 100 is inserted through a body wall (e.g. a chest wall) and skin of the patient from interior to exterior.
• a needle such as a straight needle attached at a proximal end of lead 100 may be used for inserting.
• the needle may be cut away prior to closing the wall of the patient.
• the tip of the needle may be cut off to produce a straight blunt probe which may be connected to a pacemaker or other medical equipment.
• Fig. 12 is a flowchart of a method 1200 performed after an implanted device is no longer needed, in accordance with some embodiments of the presently disclosed subject matter. It is assumed that the device comprises lead 100 for which some embodiments are described herein.
• stage 1202 distal end 105 of lead 100 is pulled away from the skin surface, thereby causing elastic element 110 of lead 100 to be in a stretched state.
• anchoring element 140 due to the anchoring by anchoring element 140, little or no pulling force is exerted on the first tissue as a consequence.
• lead 100 is cut above the skin surface to leave a cut portion extending into the body.
• Lead 100 is released by way of the cutting or otherwise. The releasing of lead 100 enables the biasing force of elastic element 110 to cause elastic element 110 to revert to a relaxed contracted state, and consequently retract the cut portion of lead 100 into the body.
• the disclosure does not impose a limitation on the amount that elastic element 110 is stretched in stage 1202 nor on the amount of lead 100 which is cut in stage 1204.
• the exposed portion of lead 100, after the cutting should not be more than the difference between the length of lead 100 after elastic element 110 was stretched in stage 1202, and the length of lead 100 before the stretching (i.e. when elastic element 110 was in a relaxed contracted state before stage 1202), so that the exposed portion of cut lead 100 retracts into the body.
• the truncated lead which remains in the body after stage 1206, does not need to be removed from the body of the patient, unless it is desired to do so.
• Fig. 13 is a flowchart of a method 1300 of manufacturing a device comprising a lead, in accordance with some embodiments of the presently disclosed subject matter. It is assumed that the lead is lead 100 for which some embodiments are described herein.
• a wire or cable for instance which is insulated, is fed through a lumen of a hollow elastic element, for instance elastic element 410 illustrated in Figs 4A and 4B.
• two points or sections of elastic element 110 are attached to two points or sections on the wire or cable.
• the attachment may use any procedure such as cold or hot welding, tying, infusion (i.e. casting), glue, any combination of the above, etc.
• the elastic element may for instance be the elastic element illustrated in any of Figs 2A, 2B, 3 A, 3B, 4A, 4B.
• Stage 1304 may or may not be optional for an elastic element such as elastic element 410 illustrated in Figs 4 A and 4B.
• stages 1304 and 1306, when both performed, may alternatively be reversed.
• the insulation is removed from a segment of the wire or cable at proximal end 195 of lead 100, or between elastic element 110 and proximal end 195 of lead 100, so as to form electrode element 180.
• Electrode element, 18- may be at a sufficient distance proximally from elastic element 110 to allow for anchoring element 140. (It is noted that anchoring element 140 may have been previously included in lead 100 during manufacturing method 1300, or may be added to lead 100 later in manufacturing method 1300 or after the manufacturing method 1300 has been completed).
• stage 1306 may be performed earlier on in method 1300, for instance before stage 1302 or 1304 rather than in the order illustrated in Fig. 13. In some embodiments, stage 1306 may be omitted, for instance if electrode element 180 is not formed by removing insulation from a segment of the wire or cable.
• Optionally manufacturing method 1300 may include any of the following procedures: attaching electrode(s), forming and/or attaching anchoring element(s), and/or attaching needle(s), etc. Depending on the embodiment, any of these procedures may be performed before or after any of stages 1302, 1304, and/or 1306.
• Optionally manufacturing method 1300 may include performing stage 1302, 1304 and/or 1306 for additional elastic element(s) and/or electrode element(s), and/or may include forming additional elastic element(s) and/or electrode(s) from wire(s) and/or cable(s) of the lead.
• any anchoring element 140 may be made up of any material which is strong enough to allow anchoring element 140 to remain intact when a pulling force of reasonable proportion or less is applied to distal end 105 of lead 100. Any anchoring element 140 may be attached to a wire or cable included in lead 100 using any suitable attaching method so that anchoring element 140 remains attached even if a pulling force of reasonable proportion or less is applied to distal end 105 of lead 100.
• the attaching method may include tying, gluing, hot and/or cold welding, any combination of the above, or any other method which would allow anchoring element 140 to remain attached to the wire or cable even if a pulling force of reasonable proportion or less is applied to distal end 105 of lead 100.
• Reasonable proportion may vary depending on the embodiment. For instance a pulling force of reasonable proportion may be equal to or larger than the pulling force expected when distal end 105 of lead 100 is pulled away from the skin surface such as in stage 1202 of method 1200 discussed above.
• a method of implanting a device a method performed after an implanted device is no longer needed, and/or a method of manufacturing a device may include fewer, more and/or different stages than those discussed herein.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Cardiology (AREA)
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• 2013
  • 2013-01-01 WO PCT/IL2013/050005 patent/WO2014106834A1/en active Application Filing
  • 2013-01-01 KR KR1020157020272A patent/KR20150103128A/ko not_active Application Discontinuation
  • 2013-01-01 JP JP2015550203A patent/JP6099766B2/ja not_active Expired - Fee Related
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