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
  • A61N1/056—Transvascular endocardial electrode systems

Definitions

• the invention relates to electrodes and leads for conducting electrical signals to and from muscle tissue, and especially to electrodes and leads useful for intra ⁇ venously conducting such signals to and from endocardial electrodes.
• a typical endocardial lead includes a sleeve composed of silicone rubber, which is resistent to deterioration caused by body fluids and does not cause adverse reaction by the pa- tient's body.
• a helical coil embedded in the silicone rubber sleeve is electrically connected to a distal electrode which is introduced into the heart and a proximal electrode electrically connected to the opposite end of the helical coil conductor to allow electrical connection of the lead to electronic equip ⁇ ment, such as an electronic pacemaker.
• a stylet made of thin spring steel wire and having a handle at one end thereof is removably inserted through the length of the helical coil conductor. Turning of the handle permits a physician to manipu ⁇ late and control the distal end of the lead as it is intravenously introduced into the heart.
• bipolar leads including two helical con-
• AV sequential pacing makes it possible for the heart of a patient to achieve maximum cardiac output by causing the upper and lower chambers of the heart to fire in optimum time sequence such that the receiving chamber can receive an optimum
• cephalic veins at the shoulder level or the internal or external jugular veins in the neck of a patient are surgically opened and endo ⁇ ar-
• dial leads are introduced through the respective venous openings.
• the desirability of inserting two endocardial leads to achieve AV sequential pacing has posed a problem to the surgeon, since two (rather than only one) incisions must be made in two veins which
• Patent 4,057,067 discloses a single bipolar lead structure having an atrial elec ⁇ trode structure which assumes a J-shaped configuration, enabling the atrial electrode to be hooked onto the atrial appendage at the time the ventricular component and the electrode thereon is firmly engaged against the right ventricular wall.
• a stylet maintains the atrial component in a linear configuration.
• the atrial component springs into the desired J-shaped configuration.
• This device has the problem that the lengths of the ventricle and atrial tips cannot be adjusted for various sized hearts or anatomical configuration. Further, the ventricle tip can become dislodged when the atrial component is released by withdrawing the stylet.
• the device is not suitable for stimulating tissue in the coronary sinus. It is another object of the invention to provide a multiple lead endocardial lead assembly which allows independent adjustment of the depth of one of the leads after another of the leads has been positioned in the heart, and is suitable for insertion of one lead into either the coronary sinus or the atrial appendage and is also suitable for insertion of another lead into the right ventricle.
• the device disclosed in Patent 4,154,247 discloses a bipolar lead including a sheath having an insulating layer which, when heated, by immersing it into boiling water, enables the lead to be formed into a particular configuration. When the lead cools, it "sets” into a new deformable configuration.
• the device has the short ⁇ coming that it is a bipolar lead having two electrodes disposed along a single lead. It relies on its deformed configuration to maintain spring pressure of the elec ⁇ trode against suitable portions of the ventricle and atrium. This results in unreliable electrical contact to tissue in a beating heart.
• the device is not suit- able for contacting muscle tissue both of the ventricle and the coronary sinus, and provides minimal capacity for manipulation of the electrodes by a physician.
• Another object of the invention is to provide a multiple lead endocardial assembly and method which overcomes the above shortcomings of prior endocardial leads.
• the invention provides an intravenous composite lead assembly for conducting signals between an electronic floating device such as an atrioventricu- lar pacemaker and various muscles in a patient's heart.
• the composite lead assembly includes a channel lead and a core lead, each of which has a proximal end for connection to the pacemaker unit and a distal end for connection to electrodes which electrically contact endocardial tissue.
• the channel lead includes an elongated channel which extends along a substantial portion of the channel lead to a port located at a predetermined, distance from the distal end of the channel lead.
• the port may be either an end port or a side port.
• the core lead can be slid through the channel of the channel lead and caused to extend from the side port.
• the channel lead and core lead are each formed of silicone rubber, and each includes at least one flexible conductor surrounded by silicone rubber and extending from the proximal end of the lead to an electrode located at or near the distal end of that lead.
• the channel lead can be introduced into a venous path leading to the heart through only one incision, usually made in the cephallic vein, the sub- sclavian vein, or the internal jugular vein.
• the channel lead normally assumes a J-shaped configuration or an L-shaped config- uration to allow convenient positioning of the distal electrode of the channel lead with tissue of the right atrial appendage or the coronary sinus.
• a wire stylet which maintains the distal end of the channel lead in a relatively straight configuration is withdrawn when the distal end of the channel lead is advanced to a particular location in the heart. This causes the distal end of the channel electrode to spring into its normal J-shaped or L-shaped configuration.
• the core lead is passed through the channel lead, and exits from the channel through the side port and into the right ventricle.
• the vein will be tied around the channel lead to maintain it in proper posi ⁇ tion before the core lead is passed through the channel.
• ties are utilized to tighten the proximal end of the channel against the outer surface of the core lead to prevent leakage of blood out of the heart through the channel. Sealing ridges are provided on the proximal ends of the channel lead and core lead. The distal ends of the conductors of the core lead and channel lead are plugged into receptacles of a pace ⁇ maker unit.
• the pacemaker unit has flexible sleeve receptacles which slide over sealing ridges of the respective proximal ends of the channel electrode and core electrode. Ties are utilized to tighten the flexible receptacles against the sealing rings to pre ⁇ vent leakage of blood into the pacemaker unit.
• the core lead and channel lead can be either uni ⁇ polar or bipolar, the unipolar leads each having two flexible conductors and two distal electrodes, and the unipolar leads having only one flexible conductor and one distal electrode.
• the core lead may be positioned in the channel of the channel lead and the composite assembly may be entered as a unit through the single venous in ⁇ cision. If desired, a core lead can be preformed, so that it can spring into an L-shaped or J-shaped config ⁇ uration when a stylet or stylets of the core lead are withdrawn; the distal end of the channel lead in this case must be initially fed into the right ventricle.
• Fig. 1A is a partial perspective view of a uni ⁇ polar composite lead assembly.
• Fig. IB is a partial perspective view of a uni ⁇ polar core lead in the composite lead assembly of Fig. 1A.
• Fig. 1C is a partial perspective view of the proxi ⁇ mal end of a unipolar channel lead of the composite lead assembly of Fig. 1A.
• Fig. 2 discloses a sectional view along section lines 2-2 of Fig. 1A.
• Figs. 3 and 4 disclose alternate sectional con ⁇ figurations which can be used for a unipolar composite lead assembly similar to that of Fig. 1A.
• Fig. 5 is a partial exploded perspective view of a composite bipolar channel lead assembly.
• Fig. 6 is a partial cutaway side view of the proxi ⁇ mal end of the bipolar core lead assembly of Fig. 5 with the core lead inserted in the channel lead.
• Fig. 7 is a section view along section lines 7-7 of Fig. 5.
• Fig. 8 is a partial side view of a bipolar elec ⁇ trode tip which can be used on the bipolar core or channel leads of the composite lead assembly of Fig.5.
• Fig. 9 is a side view of another bipolar electrode tip which can be used with a bipolar core lead or channel lead.
• Fig. 10 is a side view of another bipolar elec- trode tip which can be used with a bipolar core lead or channel lead.
• Fig. 11 is a side view of the proximal end of a composite lead assembly including a channel lead with an end port through which a core lead extends.
• Fig. 12 shows a partial view of a human heart with the composite endocardial lead assembly of Fig. 5 positioned in the heart so that the channel lead proxi ⁇ mal electrodes contact tissue of the right atrial appendage and the core lead distal electrodes contact tissue of the right -ventricle.
• Fig. 13 is a partial view of a human heart showing the composite unipolar channel lead assembly of Fig. 1A, with its core lead distal electrode contacting tissue of the right ventricle and its channel lead distal electrode contacting tissue in the coronary sinus.
• Fig. 14 discloses a composite electrode, wherein the channel lead has an end port with an end port electrode connected to contact the atrial tissue and a core lead extending into the right ventricle.
• Fig. 15 is a flow chart useful in explaining one embodiment of the invention.
• core lead 1 is a typical endo ⁇ cardial lead including an elongated flexible silicone rubber sheath 13 through which a helical coil conductor 9 extends.
• Tip 1' ' includes electrode 11 for conducting electrical signals to or from muscle tissue electrically contacted by electrode 11 (which is refer- red to as a distal electrode) .
• a proximal prong or electrode 5 electrically contacts helical coil conductor 9 and ex ⁇ tends beyond silicone rubber sleeve 13.
• a fine spring wire stylet 7 having a predetermined bend therein ex- tends through helical coil conductor 9 to the distal end of core lead 1.
• Stylet 7 has a small handle 11' attached thereto. Handle 11* can be used for rotating stylet 7 to control the distal end 1* ' of core lead 1 and can also be used to withdraw stylet 7 from core lead 1, whereupon proximal electrode or prong 5 can be inserted into an electrical connector of a suitable electronic device, such as a cardiac pacemaker.
• channel lead 3 includes a bifurcated Y-shaped proximal end structure 3' including a helical coil conductor 25 extending through one leg of the structure and through the main portion 26 of the channel lead.
• a second prong or electrode 23 extends from the first leg of the structure, and electrically contacts the proximal end of helical coil conductor 25.
• a suitable electrode such as 35, is attached to the distal e d of helical coil con ⁇ ductor 25.
• a hollow channel 17 extends through the second leg of channel lead 3' and continues parallel to helical coil conductor 25 through the main portion 26 of channel lead 3' .
• a wire stylet 21 having a handle 19 connected thereto extends through helical coil con ⁇ ductor 25 in the same manner that stylet 5 extends through core conductor 1.
• Fig. lA shows the proximal end.27* of a composite channel lead 27 including channel lead 3' of Fig. 1C and core lead 1 of Fig. IB inserted through channel 17 of channel lead 3' .
• a pa-i . of ties 36 causes the end of leg 17 to be crimped to frictionally engage the outer surface of core lead 1, maintaining it in fixed re ⁇ lationship to channel lead 3' , preventing body fluid from being pumped out of the heart through the space between the outer wall of core lead 1 and the inner wall of channel 17 of channel lead 3 ' .
• FIG. 1A also shows the distal end 27' ' of composite unipolar channel lead 27, wherein it is seen that chan ⁇ nel 17 of channel lead 3 terminates in a side port 29 of distal end section 27' '.
• Side port 29 includes a concave curved surface which directs core lead 1 out ⁇ ward from side port 29.
• Fig. 3 shows a sectional view of a slightly modified embodiment of the composite lead assembly wherein body section 26 of the channel lead 3' has an eliptical con ⁇ figuration.
• Fig. 4 discloses a sectional view of another embodi- ent wherein section 26 of the channel lead has a chan ⁇ nel 17 with a semicircular configuration and wherein the core lead 1 has a corresponding semicircular cross- sectional configuration.
• the semicircular configura ⁇ tion of the channel and core lead prevents any rota- tion of the core lead in the channel as the core lead is slid through the channel lead, which may have been previously intravenously introduced into the patient's heart.
• bipolar channel lead assembly 41 which in ⁇ cludes bipolar channel lead 37 and bipolar core lead 39 is shown.
• the proximal end 1' of bipolar channel lead 37 includes a silicone rubber sleeve 49 having a bifurcated end with legs 37A and 37B which joint to form a unitary shaft 37C.
• a channel 57 similar in purpose to channel 17 of Fig. IB, has an enlarged entrance opening 55 disposed between legs 37A and 37B.
• a first helical coil con ⁇ ductor 53 extends through leg 37A and through unitary section 37C on one side of channel 57.
• a second heli ⁇ cal coil conductor 53B extends through leg 37B and through unitary section 37C on the opposite side of channel 57.
• Prongs or proximal electrodes 47A and 47B extend from the silicone rubber material of legs 37A and 37B and are electrically connected to helical coils 53A and 53B, respectively.
• Spring wire stylus 45A extends through prong 47A and helical conductor 53A.
• Stylus 45B extends in similar fashion through prong 47B and helical conductor 53B.
• Handles 43A and 43B are res ⁇ pectively connected to the proximal ends of stylets 45A and 45B.
• bipolar core lead 39 which mates with bipolar channel lead 37 of Fig. 3A, also includes a pair of bifurcated leg sections 39A and 39B and a unitary section 73.
• Helical conductor 69A extends through leg 39A and unitary section 73.
• Wire stylet 61A extends through helical conductor 69A.
• helical coil conductor 69B extends through leg 39B and unitary section 73.
• the body of bi ⁇ polar core lead 39 supports and surrounds helical con ⁇ ductor 69A and 69B and is formed of silicone rubber.
• Prongs or proximal electrodes 63A and 63B are con ⁇ nected to the proximal ends of helical coil conductors 39A and 39B, and extend from the proximal ends of legs 39A and 39B, respectively.
• Handles 59A and 59B permit manipulation of stylii 61A and 6IB, respectively.
• Legs 39A and 39B of bipolar core lead 39 some to ⁇ gether at a tapered section 67, which terminates at a cylindrical ridge 71. Cylindrical ridge 71 fits into enlarged channel opening 55 of Fig. 6, thereby limiting the extent to which unitary section 73 can be inserted into channel 57 of bipolar channel lead 37.
• FIG. 6 a side view of the compo- site bipolar channel lead assembly 41 is shown.
• the side view bipolar channel lead assembly 41 in Fig. 6 includes bipolar channel lead 37 with bipolar core lead 39 inserted in place, with section 73 of bipolar core lead 39 extending through channel 57 of bipolar channel lead 37.
• Ties 65 compress channel opening 55 against the ridge 71 of unitary section 73, causing bipolar core lead 39 to remain in fixed relationship with bipolar channel lead 37 and prevent body fluids from being pumped through the space between the wall of channel 57 and unitary section 73 of core lead 39.
• FIG. 5 The distal end of composite bipolar channel lead assembly 41 is shown in Fig. 5, a sectional view of which is shown in Fig. 7.
• Fig. 5 it is seen that channel 57 terminates in side port 77 (in the same manner that channel 17 of Fig. 1A terminates in side port 29).
• Concave surface 79 causes shaft 73 of bi ⁇ polar core lead 39 to be directed outwardly from the axis of bipolar channel lead section 37C as unitary section 73 is forced through channel 57 and out of side port 77.
• bipolar core lead 39 This facilitates controlling the orientation of bipolar core lead 39 by a surgeon as he attempts to insert the distal end of bipolar core lead 39 into the right ventricle of the patient's heart after the core lead has first been positioned in the coronary sinus or the right atrial appendage.
• Figs. 8-10 illustrate several lead tips which can be used with the above described bipolar channel lead and core lead.
• Fig. 8 shows a bipolar lead tip which includes spaced electrodes 113 and 114, electrode 114 being spaced from the extreme end of the bipolar tip.
• This bipolar lead tip can be attached to the end of any bipolar channel lead or core lead.
• Fig. 9 discloses a conventional bipolar lead tip with a wedge shaped electrode at its extreme end and a cylindrical elec ⁇ trode spaced from the wedge shaped electrode.
• Fig. 11 discloses another bipolar lead tip including a pair of folding tine electrodes at its extreme end and a cylindrical electrode spaced from the tine electrode.
• a laterally slidable cap 123 causes the tines to fold in, as indicated by 105A, or extend out, as indicated by 105.
• the laterally slidable cap 123 slides lateral ⁇ ly when the enlarged electrode at the extreme right hand end of section 1' ' in Fig. 11 is forced out of end port. 29' .
• Figs. 12, 13, and 14 show several ways in which the composite leads 27 (Fig. 1) and 37 (Fig. 5) can be positioned in a patient's heart.
• Fig. 12 shows the bipolar composite channel lead assembly 37 of Fig. 5 extending through the cephallic vein 89, the subclavian vein 87, and the innominate vein 91.
• the distal end 37'' of channel lead assembly 37 springs into a J-shaped configuration as shown in Fig. 12 when stylii 45A and 45B (Fig. 5) are withdrawn.
• the electrodes on the end of channel lead 37 then make electrical contact with the right atrial appendage.
• Section 73 of core lead 39 extends from side port 77 so that its two electrodes 85 and 85' electrically contact appropriate tissue in the right ventricle.
• the handles of stylii 45A and 45B are not shown as being withdrawn in Fig. 12, even though distal end 73'' has sprung into the J-shaped configuration.
• Arrows 108 of Fig. 12 indicate that stylii 45A and 45B (Fig.5) are with- drawn to allow distal end 73'' to spring into the J-
• a surgeon can completely insert composite channel lead assembly 37 into the heart with the core lead 39 inserted into channel 57 but not extending out of side port 77, withdraw stylii 45A and 45B so that distal end 37'' bends to contact the right atrial appendage, and then slide core lead 39 further through channel 57 so that section 73 of core lead 39 extends out of side port 77 and travels a predetermined distance into the right ventricle 83.
• the surgeon can first insert channel lead 37 alone through the cephallic, subclavian, and innominate veins, withdraw stylii 45A and 45B, causing the distal end 37' ' to bend to contact the right atrial appendage.
• the surgeon can insert core lead 39 into channel 57 and slide it through channel 57 until distal end 73 of core lead 37 passes out of side port 77 and reaches the appropriate part of the right ven ⁇ tricle.
• the physician tightens "ties" 65 (Fig. 6) around flexible receptacle 55, sealing channel 57 with respect to core lead 37 to prevent blood from seeping through channel 57.
• the pacemaker unit has silicone rubber receptacle sleeves which slide over sealing ridges 51 and terminal sealing ridges 51' of the proxi- mal ends of the respective leads. Ties similar to ties 65 (Fig. 6) are utilized to seal the proximal ends of channel lead 37 and core lead 39 with respect to the pacemaker unit (not shown) to prevent blood from seeping into the pacemaker electrode receptacles.
• unipolar channel lead assembly 27 has been introduced into the heart through cephallic vein 89, subclavian vein 87, and innominate vein 91.
• Distal end 3' ' and its corresponding electrode extend into coronary sinus 111.
• Distal end 1** of core lead 1 ex ⁇ tends out of side port 29 of channel lead 3 into ven ⁇ tricle 83.
• the presently preferred technique is to utilize a channel lead 3 which is performed so that when wire stylet 21 is withdrawn, distal end 3 1 ' springs into an L-shaped configuration which causes distal end 3' ' to move into coronary sinus 111.
• core lead 1 is inserted into channel 17 of core lead 3 and passed through channel 17 until distal end 1' ' passes out of side port 29 and extends into the desired location of right ventricle 83.
• composite channel electrode 27 can be introduced as a unit through the venous path shown in Fig. 13.
• ties such as 36 (Fig.
• Fig. 14 discloses unipolar channel lead assembly 27 inserted through internal jugular vein 1, innom ⁇ inate . vein 91 through the atrium and into right ven ⁇ tricle 83.
• the embodiment of bipolar channel lead assembly 27 shown in Fig. 14 has an end port 29.
• Fig. 11 shows in detail the structure of the distal electrodes of Fig. 14, wherein electrode tines 105 are attached to the extreme end of channel lead 5.
• the channel of channel lead 5 terminates in an end port 29 ' located at the extreme distal end 3' ' of channel lead 3.
• the distal end 1' ' of core lead 1 extends out of end port 29) .
• Electrode 103 of distal end 3 1 ' of channel lead 3 has a pair of tines 105 which are actuated by forward movement of the above mentioned laterally * slidable cap 123 to hook into the atrial tissue.
• Distal end 1*' of core lead 1 has electrode 11' , which engages muscle tissue in the right ventricle 83.
• Ties 36 seal the channel of chan ⁇ nel lead 3 with respect to core lead 1.
• compo ⁇ site channel lead assembly 27 can be fed into heart 81 as a single unit, or channel lead 3 first can be intro ⁇ quizd into the heart alone, and then core lead 1 can be slid through channel 17 of channel lead 3, so that the distal end 1' ' of core lead 1 passes through end port 29' until it reaches its final destination in ventricle 83.
• a channel lead into a patient's heart can be accomplish ⁇ ed with the core lead positioned in the channel at the time of introduction of the channel lead and through an appropriate venous entry site.
• the channel lead may be introduced into an appropriate venous incision, through an intravenous pathway to the heart, and into the appropriate heart chamber without the core lead being positioned in the channel of the channel lead.
• the open channel of the channel lead first can be filled with a sterile intravenous solution, such as normal saline solution.
• the proximal channel opening can then be connected to a pump that produces a controlled rate of intravenous infusion of normal saline solution, so that no blood will flow into the channel (possibly producing clots or blood loss) during the passage of the open-channel channel lead into the venous entry site.
• the flow chart of Fig. 15 illustrates the fore ⁇ going procedure.
• the proximal end of the channel can be capped during introduction of the open-channel channel lead into the selected venous entry site.

Landscapes

• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Cardiology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Electrotherapy Devices (AREA)

Applications Claiming Priority (1)

Publications (1)

Family

ID=22168012

Family Applications (1)

Country Status (3)

Families Citing this family (6)

Family Cites Families (3)

• 1982
  • 1982-05-24 EP EP19820902125 patent/EP0108752A1/de not_active Withdrawn
  • 1982-05-24 WO PCT/US1982/000704 patent/WO1983004181A1/en not_active Ceased
  • 1982-05-24 AU AU86856/82A patent/AU8685682A/en not_active Abandoned

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events