CA2044604A1 - Pacing lead and introducer therefor - Google Patents
Pacing lead and introducer thereforInfo
- Publication number
- CA2044604A1 CA2044604A1 CA002044604A CA2044604A CA2044604A1 CA 2044604 A1 CA2044604 A1 CA 2044604A1 CA 002044604 A CA002044604 A CA 002044604A CA 2044604 A CA2044604 A CA 2044604A CA 2044604 A1 CA2044604 A1 CA 2044604A1
- Authority
- CA
- Canada
- Prior art keywords
- beams
- head
- tool
- hooks
- shoulder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
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
Abstract
2044604 9106339 PCTABS00005 A tool (20) for implanting a pacing lead (21) into heart tissue has a pair of side-by-side beams (37 and 38) pivoted together at the opposite ends thereof. The beams (37 and 38) have jaws (59 and 62) that grip a lead head (24) supporting a helical electrode (25) and a groove (43) for accommodating a section (23) of the lead (21) extended from the head (24). A releasable lock (82) interposed between the beams (37 and 38) operates to hold the beams in jaw closed position to grip the head (24) of the electrode. The lock (82) has flexible fingers (89 and 91) and a movable sleeve (88) that allows one hand operation to selectively lock and release of the jaws. The helical electrode (25) has an external layer of platinum black particles (29) resulting in decreased electrical losses at the electrode-tissue interface, increased current density, lower stimulation thresholds and increased amplitude of sensed electrical signals from the heart tissue.
Description
W091/06339 PCT/US90/0628~
-1- 2~ 34 PACING L~ AND INIRODUCER D~EFOR
FIELD OF INVENTION
The invention relates to a field of cardiac pacing leads and an improved hand tool for implanting the lead into myocardial tissue.
. ~
BACKGROUND OF THE INVENTION
Hand manipulated tools have been u~ed to screw electrodes- into body tissue. Myocardial leads comprising rigid hel~ical coils are turned into heart tis~ue with elongated rod type tools. An example of this type of tool is disclosed in U.S. Patent 3,737,579 granted to L. R.
Bolduc on June 5, 1973. The tool comprises an elongated ~-cylindri¢al device for holding a lead having a screw type electrode. The hesd of the lead is force fitted into a slot in the diotal end of the tool. A separate rod is used to separate the tool from the lead. Two hands are required to release the lead. U.S. Patent 3,875,947 granted to J.~i L. Jula and D. Zeidler on April 8, 1975 discloses an elongated generally cylindrical tool for carrying a screw type electrode at its forward end. A portion of the lead fits into an elongated linear slot and one ~ide of the tool. A linearly moveable probe fits into a central ~
passage of the tool to remove the lead from the slot and `~ -separate the head from the di~tal end of the tool after implantation of the lead. This tool requires two handed manipulation to separate the lead from the tool. U.S.
Patent 4,271,846 granted to R. L. Little on June 9, 1981 , .
~ .. ' ~ ' . ,. : ,. : .. .. ~., . i . - . .
W091/06339 Pcr/usso/o6287
-1- 2~ 34 PACING L~ AND INIRODUCER D~EFOR
FIELD OF INVENTION
The invention relates to a field of cardiac pacing leads and an improved hand tool for implanting the lead into myocardial tissue.
. ~
BACKGROUND OF THE INVENTION
Hand manipulated tools have been u~ed to screw electrodes- into body tissue. Myocardial leads comprising rigid hel~ical coils are turned into heart tis~ue with elongated rod type tools. An example of this type of tool is disclosed in U.S. Patent 3,737,579 granted to L. R.
Bolduc on June 5, 1973. The tool comprises an elongated ~-cylindri¢al device for holding a lead having a screw type electrode. The hesd of the lead is force fitted into a slot in the diotal end of the tool. A separate rod is used to separate the tool from the lead. Two hands are required to release the lead. U.S. Patent 3,875,947 granted to J.~i L. Jula and D. Zeidler on April 8, 1975 discloses an elongated generally cylindrical tool for carrying a screw type electrode at its forward end. A portion of the lead fits into an elongated linear slot and one ~ide of the tool. A linearly moveable probe fits into a central ~
passage of the tool to remove the lead from the slot and `~ -separate the head from the di~tal end of the tool after implantation of the lead. This tool requires two handed manipulation to separate the lead from the tool. U.S.
Patent 4,271,846 granted to R. L. Little on June 9, 1981 , .
~ .. ' ~ ' . ,. : ,. : .. .. ~., . i . - . .
W091/06339 Pcr/usso/o6287
-2- 2~34~ 4 discloses a tool ~or installing a screw type electrode into body tissue that includes a clamp for holding the lead head on the proximal end of the tool and an elongated rotatable member for releasing the clamp and the lead from the tool.
This manipulation procedure also requires the use of two hands.
SUMMARY OF INVENTION
~ he invention is directed to a hand tool or introducer for attaching a screw type pacing lead to the myocardium of ~ heart. The introducer allows quicX one handed release of the entire lead after attachment and fast regrasping, reloading and repositioning o~ the lead.
The tool has elongated beams that are pivotally connected ad~acent their opposite ends. The distal ends of the beams have jaws that grip the head of a pacing lead and hold the electrode mounted on the head in a position for attachment to heart tissue. The beams are moved from an open or bowed po~ition to a closed side-by-side position which moves the jaws into gripping relation with the head.
When the beams are in the open position the Jaws release the head so that the tool can be removed from the pacing lead without applying twisting or linear forces to the tool. A releasable latch or lock assembly holds the beams in the closed position. The latch assembly is operable in response to movement of the beams toward each other to lock the beams in the cloged position so that the ~aws ~irmly .
. . . ,: ~ . . . ~ - :
:
W~91/06339 PCT/US90/06287
This manipulation procedure also requires the use of two hands.
SUMMARY OF INVENTION
~ he invention is directed to a hand tool or introducer for attaching a screw type pacing lead to the myocardium of ~ heart. The introducer allows quicX one handed release of the entire lead after attachment and fast regrasping, reloading and repositioning o~ the lead.
The tool has elongated beams that are pivotally connected ad~acent their opposite ends. The distal ends of the beams have jaws that grip the head of a pacing lead and hold the electrode mounted on the head in a position for attachment to heart tissue. The beams are moved from an open or bowed po~ition to a closed side-by-side position which moves the jaws into gripping relation with the head.
When the beams are in the open position the Jaws release the head so that the tool can be removed from the pacing lead without applying twisting or linear forces to the tool. A releasable latch or lock assembly holds the beams in the closed position. The latch assembly is operable in response to movement of the beams toward each other to lock the beams in the cloged position so that the ~aws ~irmly .
. . . ,: ~ . . . ~ - :
:
W~91/06339 PCT/US90/06287
3- Z044604 grip the head of the pacing lead. This is accomplished with one hand of the operator squee~ing adjacent sections of the beams together until the latch assembly locks. The beams are also moved further together with one hand of the operator to release the latch assembly to allow the beams to spread apart and open the jaws.
The preferred embodiment of the tool has elongated beams having semi-cylindrical outer surfaces so that the over-all~shape of the tool is generally cylindrical to facilitate one hand manipulation of the tool. Each beam has a longitudinal groove adapted to accommodate a section of the electrical conductor of the lead extending from the head. Lips on the beams extend along the outsides of the grooves to-hold the conductor in the grooves., Pivot projections on oppo~ite ends of one beam fit into holes in the other beam to pivotally connect adjacent opposite ends of the beam for limited pivotal movement about generally parallel transverse axes. A biasing spring located between the beams urges the beams to move away from each other to the open bowed position thereby opening semi-circular jaws joined to the distal ends of the beams. The jaws grip opposite sides of the head when the beams are moved to the closed side-by-side position. Adjacent ends of the jaws are spaced from each other to accommodate the conductor end ~oined to the head. A releasable latch assembly having flexible fingers joined to one beam and a holder on the other beam engag~ble with the fingers retains the beams in , " ' . , ' ' ' . ~: . ' ' , , ' ' :
' ~ , .. . ... :
.': . ' ' ' ' : . , , ' ' ,, : . , ' ' -, ' ~ : ., :: . . . .
', ' ' ' , ' , ~ ~
. '. ` . ' .
204~04 the closed position and jaws gripping the head. A movable sleeve associated with the holder is engaged by the fingers to release the fingers from the holder upon further squeezing the beams toward each other. The locking and releasing of the latch is a one hand operation that does not subject the tool to twisting and linear or longitudinal forces. The electrode implanted in the heart tissue is not disturbed by releasing the jaws from the head and regrippin~ the head with the jaws.
Another feature of the invention is the cardiac pacing lead connectable to a pacemaker for transmitting electric current to heart tissue. The lead has an elongated flexible conductor wire and a sheath of non-electrical conductive material surrounding said conductor wire. An electrical connector attached to the wire is adapted to be connected to a pacemaker. A head of non-electrical conductive material connected to said conductor wire and sheath, support an electrode, such as a rigid helical wire. The helical wire has a portion located externally of said head adapted to be turned into heart tissue to secure the lead to the heart muscle and to transmit pacemaking electrical signals thereto. The helical wire has a sheath of non-electrical conductive material surrounding the wire except for the distal one half turn thereof which represents the electrode. The external portion of the electrode has an outer surface covered with a layer of platinum black particles. The .... .. . . .
' : ' , .
, W O 91/06339 PC~r/US90/06287 -5- Z04q~604 .
layer of platinum black particles has substantially uniform particles size and uniform distribution on the outsr surface whereby sa1d layer of platinum black particles has a uniform microporous outer surface being in surface contact with the heart tissue to decrease electrical losses at the electrode-tissue interface, increase the current density to said heart tissue, establish intimate contact between the electrode and myocardium tissue, lower stimulation thresholds, and increase amplitude of electrical signals from the myocardium.
DESCRIPTION OF DRAWING . -Figure 1 is a perspective view of the introducer of the invention accommodating a myocardial lead;
Figure 2 is an enlarged perspective view of a myocardial lead such as ~een in Figure 1 separated from the ..
introducer;
Figure 3 is an enlarged sectional view taken along the line 3-3 of Figure 2;
Figure 4 is an enlarged sectional view taken along line 4-4 of Figure 2; ~ ;
Figure 5 is an enlarged sectional view taken along line 5-5 of Figure 1; .
Figure 6 iB an enlarged side elevational view of the introducer in the closed position without the lead;
Figure 7 is an enlarged end view of the proximal end of the introducer of Figure 6; : --.~ :; ' ".
;,~ ., , . ,. . - - .
;::, ' ' . . , ~, . . .
:, ~ . : . : : ~ , : ,: . . . -. .
.
WO91/06339 rCT/US90/06287 Figure 8 i9 an enlarged end view of the distal end of the introducer of Figure 6;
Figure 9 is an enlarged sectional view taken along the line 9-9 of Figure 6;
Figure 10 is an enlarged sectional view taken along the line 10-10 of Figure 6;
Figure 11 is an enlarged sectional view taken along the line 11-11 of Figure 1;
Figure 12 is an enlarged sectional view taken along the line 12-12 of Figure 1;
Figurel 3 is an enlarged sectional view taken along line 13-13 of Figure 12;
Figures 14 and 15 are sectional views similar to Figure 12 showing the releasing of the lock assembly of the introducer; and Figure 16 is a side elevational view of the introducer in the open position.
DESCRIPTION OF PREFERRED EMBODIMENT
Referring to Figure 1, there is shown the myocardial lead installation tool of the invention, known as an introducer, indicated generally at 20 holding a cardiac lead indicated generally at 21 prior to the implantation of the electrode of the lead into the myocardium of a heart. Introducr 20 is diclosed in U.S.
Application Serial No. 430,596, incorporated herein by reference. Lead 21 has a connector 22 at the proximal end , . . . . .
,. . ~ .:, , , ... : . . ' ' ' . .
. , .; , . ~ . .
' . ' W09l/~6339 PCT/US90/06287 7 20~604 thereof adapted to be connected to terminal of a pacemaker that generates heart pacing currents. Connector 22 is joined to an elongated flexible electrical conductor 23 having a distal end joined to a generally cylindrical head 24. Head 24 is made of non-elsctrical conductive material that i9 biocompatible, such as medical grade silicone rubber. A rigid helical electrode 25 having several convolutions i9 mounted on the center of head 24. As shown in Figure'3, electrode 25 has an end 26 embedded in head 24 and connected to conductor wire 35 of conductor 23. Wire 35 is a multifi~ar conductor coil made of nickel cobalt wire or other suitable conducting material. Wire 35 is enclosed within a non-conductive sheath 40 that is biocompatible, such as medical grade silicone rubber. A
generally flat circular netting 27 surrounds electrode 25.
Netting 27 is joined to head 24 by bonding it directly to the plastic material of head 24 or suitable connecting materials. The outer peripherial edge of netting 27 pro;ects radially outward from head 24 to increase the surface engagement with the heart tissue. Netting 27 can be porous polyester fiber that enhances fibrotic growth to insure a secure connection of electrode 26 to the heart tissue.
Helical electrode 25 is a rigid helical wire 28 terminating in a pointed end 31. A sheath 30 of non-electrical conductive material, such as medical grade silicone rubber, covers wire 28 except for about the end v;, ~ , ,, :' ~ ',, ,;,; ., . , ~.:
. . , . . :
.. ' . :.. '. , ., ; - :. . . ' ':
:. . , . . . . ; . .
:' . . : ', : ' : :
:, . - .
.: . :
.::
-8- ~04~6~4 one half turn section thereof; such as between 160 to 190 degrees of the end section of wire 28. This section of wire 28 comprises the active electrode. Wire 28 can be made of a platinum/irridium. The entire exposed exterior surface of the end one half turn section of wire 28 is completely covered with a coat or layer of platinum black particles to substantially reduce electrode polarization.
Wire 28 i9` platinized to develop the coating of platinum black par~ticles 29. The platinum black i8 a micro porous surface of submicron size particles. The platinum black particles 29 ar~ electrochemically plated onto the outer surface of the wire or substrate 28. The exterior end portion of wire 28 is placed in a platinum ion plating solution and subjected to an electric d.c. current. The plating solution and wire 28 are also subjected to intermittent ultrasonic vibrations that agitate the platinum ions. The electric current is terminated during the vibration period. The time period between vibration episodes can be varied. An oscillating piezoelectric ceramic is used to generate vibrations at a selected frequency that produces uniform particle size and particle distribution. The submicron size particles of platinum black are bonded to the entire outside surface of wire 28 up to head 24 as seen in Figure 3. The platinum black particles 29 have substantially uniform particle size and particle distribution resulting in uniform current density over the layer of platinum black particles 29 and lower .
" `, . ~
_9_ Z~4~04 stimulation threæholds. The current carried by lead 21 i9 delivered to the heart muscle electrolyte almost exclusively through the platinum black particles 29. As shown in Figure 3 and 4, the layer of platinum black particle~ 29 has a continuous microporous qurface which provides for intimate contact between the end section of electrode 25 and the myocardial tissue and an increase in real surface area with a resulting decrease in electrode-tisæue interface electrical losses and an increase the current density to the stimulatable tissue of the heart and thereby lower stimulation thresholds and higher intracardiac electrical signal sensing. ~
Referring to Figure 6, introducer 20 comprises a ~; - -pair of side-by-side elongated beams 37 and 38 having adjacent opposite end sectiohs pivotally connected together with transverse pivot assemblies 47 and 48. The outer surfaces of beams 37 and 38 have generally semi-cylindrical shapes. When introducer 20 is in its closed position, as ~ -shown in Figure 6, beams 37 and 38 have a generally over all elongated cylindrical configuration so that introducer 20 can be operated and manipulated with the fingers of one hand of the operator.
~ eferring to Figure 5, beam 37 has a longitudinal side groove 39 open along one side of introducer 20. A
longitudinal lip 41 partially closing groove 39 retains a section of conductor 23 in groove 39. Beam 38 has a side groove 43 open along the other æide of introducer 20. A
." .. . . . . . .
.. .
- . - . . . . .
- :
~ . . : .
,~.: .. , . . :, : ~ .. " :,.
, :. : .. - .
: ' ' , ~ '. - ' ' . ' :
:. ' .
. .. - . - ... . . . : :.
WO91~06339 PCT/US90/06287 -_1 o- ;~04~604 portion of the electrical conductor 23 fits into groove 43 and is retained therein by a short lip 44 along one edge of beam 38. Beam 38 has a generally flat transverse face 42 facing groove 39 and a longitudinal groove 43 with an outside lip 4L opposite a transverse face 46 of beam 37.
Electrical conductor 23 is located in groove 43 and retained therein when beams 37 and 38 are in their closed positions. Alternatively, conductor 23 can be positioned and retained in groove 39 during the insertion procedure.
As shown in Figure 6, opposite ends of groove 43 have enlarged portiQns or openings in lip 44 for accommodating the portion of lead 23 that enters and exits groove 43 as seen in Figure 1. These openings prevent pinching and compression of lead 23. Groove 39 has similar openings in lip 41 for accommodating lead 23 when placed in groove 39.
Pivot assemblies 47 and 48 are identical in structure. The following description is directed to pivot assembly 48 shown in detail in Figure 9. Beam 38 has a transverse bore 49 having an enlarged outer recess 51. An annular shoulder 52 joins recess 51 with bore 49. Beam 37 has a transverse projection or split body 53 located in bore 49. Body 53 has outer cylindrical surfaces 54 that ride on the surface of bore 49 to form a bearing. Body 53 has a central split bore 55 that separates body 53 into four quarter circular parts. The outer end of body 53 has a split head 56 that extends outwardly from body 53 and engages shoulder 52 to retain beams 37 and 38 in pivotal :
. ,; :, . ~ ' ' ~ ' !' ' , ','' :.:-' : . ' .
-11- 204a~04 assembled relation. Head 56 ha9 8 cone shaped outcr surface 57 which allows body 53 to be moved through bore 49 and snapped into locking position with shoulder 52.
Referring to Figures 8 and 11, the distal end 58 of beam 37 has a first forwardly directed jaw 59 located opposite the distal end 61 of beam 38. A second jaw 62 on end 61 faces jaw 59. As shown in Figure 8, jaws 59 and 62 have generally arcuate shapes and surround a generally circular pocket 63. Head 24 of the lead fits into pocket 63 as shown in Figure 11. - -Returning to Figure 8, jaw 59 has a convex shape with opposite ends 64 and 66 that face opposite ends 67 and 68 of jaw 62. Adjacent ends 64, 67 and 66, 68 are circumferentially spaced from each other forming side : :
openings 69 and 71. Openings 69 and 71 are in general .
longitudinal alignment with longitudinal grooves 39 and 43 in beams 37 and 38. In use side openings 69 and 71 selectively accommodate the portion of electrical conductor ~ :
23 that immediately projects from the side of body 24 and extends the length of tool 20, as shown in Figure 1.
Referring to Figure 10, the proximal end of beams 37 and 38 have aligned bores 72 and 73 accommodating a coil :
spring 74. Spring 74 biases the beams to outward bowed positions, as shown in Figure 1 6, thereby opening 3aws 59 and 62. When jaws 59 and 62 are open they release the gripping force on head 24 of the lead so that tool 20 can be removed from the lead. Alternatively, the tool with the ,~_.~.. .... . .
-., -.....
.. ~ .
W09lt06339 PCT/US90/06287 -12- 204~604 open jaws 59 and 62 can be positioned about head 2~ to regrip the head 24 as hereinafter described.
As shown in Figure 11, the distal end of beam 38 has a bore 76 leading to an enlarged recess 77 having an annular shoulder 78 separating the bottom of recess 77 from bore 76. A body or split projection 79 joined to beam 37 proiZects through bore 76 into recess 77. Body 79 has an enlarged cone shaped or tapered head 81 adapted to engage shoulder 78 to limit the outward movements of beams 37 and 38. Body 79 and bore 76 co-act with each other to guide relative movemZants between beams 37 and 38.
Beams 37 and 38 are retained in their closed or locked position with a releasable lock assembly indicated generally at 82. Referring to Figure 12, lock assembly 82 i8 in the hold or lock position whereby beams 37 and 38 reZtain ~jaws 59 and 62 in firm gripping relation with the opposite outside portions of head 24 of pacing lead 21.
Beam 38 has an upwardly directed cylindrical projection 83 which accommodates a head 84. Head 84 is sonic welded or otherwise permanently joined to the end of projection 83. -... .:.
Head 84 has upwardly and inwardly tapered side wall 86 and inwardly directed annular shoulder 87. A cylindrical sleeve 88 i9 slideably interposed about projection 83 between shoulder 87 and the inside wall of beam 38. Sleeve 88 has a length shorter than the distance between shoulder 87 and-beam 38 whereby sleeve 88 is free to move between head 84 and beam 38.
...... .. ,, ;
: :. :
: .: , . ::
:. ,.,, . . : ,.: ., "Z' :'-, , ~ ' , ' ' . - .
'. ' ' " ' ~ - ::
... .. . . . .:
WOgl/0633s PCT/US90/06287 Z04~604 As shown in Figure 13, sleeve 88 has an outside diameter that is slightly larger than the outside diameter of head 84. A pair jof downwardly directed flexible latch fingers 89 and 91 are joined to beam 37 and project downwardly adjacent opposite portions of head 84. Latch finger 89 has an inwardly directed shoulder or hook 92 and a downwardly and outwardly tapered face 93. Latch finger 91 has an inwardly directed shoulder or hook 94 and a downwardl~ and outwardly tapered face 96. Hooks 92 and 94 are in generally the same plane and engage opposite portions of shQulder 87 to hold beams 37 and 38 in their closed or locked positions. As shown in Figure 13, shoulders 92 and 94 fit under diametrically opposite portions of head 84 above the outer circumferential surface of sleeve 88. As shown in Figures 6 and 16, beam 38 has a pair of ribs 97 and 98 on opposite sides of lock assembly 82 that function as fulcrums during the release of the lock assembly as hereinafter described. Beam 37 also has a guide pin 99 that fits into a hole or recess 101 in beam 38 to prevent relative lateral displacements of beams 37 and 38 and insure that lock assembly 82 remains locked.
Referring to Figure 14, when lock assembly 82 is to be released opposite squeezing forces indicated by arrows 102 and 103 are applied to beams 37 and 38 on opposite sides of lock assembly 82. Beams 37 and 38 are biased together against the force of spring 74 until beam 37 engages ribs 97 and 98 on beam 38. An increased force on .
.- , ~ ' ` '' ` ' .
.
.; ' , . ' `.. - ' ' .
", , ' : .-~' . .
_14_ 2 ~4604 beams sections opposite lock assembly 82 causes these beam sections to ful~crum or pivot on ribs 97 and 98 and deflect inwardly or toward each other. Latch fingers 89 and 91 move downwardly from head 84 and onto sleeve 88. The linear edge 104 of latch finger 89 grips one side of sleeve 88. Simultaneously the linear edge 106 of latch finger 91 engages an opposite portion of sleeve 88. Latch fingers 89 and 91 are biased outwardly as they slide over the tapered side wall~ 86 of head 84 onto sleeve 88. When forces 102 and 103 are released from beams 37 and 38, as indicated by arrows 107 and 108 in Figure 15, beams 37 and 38 will move away from each other to bowed or open positions as shown in Figure 16, due to the biasing forces of beams 37 and 38 and spring 74. Latch fingers 89 and 91 will carry sleeve 88 up into engagement with shoulder 87 of head 84. The continued spreading apart of beams 37 and 38 carry latch fingers 89 and 91 over head 84 since the diameter of sleeve 88 is . : :
larger than the diameter of head 84. When beams 37 and 38 . are in their open position, as shown in Figure 16, latch fingers 89 and 91 are spaced from head 84. Jaws 59 and 62 are spread apart in their open position.
In u~e, introducer 20 is initially in the closed position as shown in Figure 1. Head 24 of pacing lead 21 is located in the pocket 63 with conductor 23 projecting from side opening 71. The electrical conductor 23 is located in groove 43 and retained therein by lip L4. The helical electrode 25 projects in a forward direction 90 ~, ., . ~ . , ~ ' ,,. , , .
, .. - . ., -: :
,, , ~ , . . .. . .
-.
WO9l/0633s PCT/US90/06287 20'1''161~4 that it can be screwed into the heart tissue by rotating introducer 20. Alternatively, the electrical conductor 23 can be located in groove 39 with the end of the conductor joined to the head 24 passing through side opening 69.
Beams 37 and 38 are held together by flexible latch fingers 89 and 91 fitting over head 84 whereby shoulders 92 and 94 engage shoulder 8? f head to hold beams 37 and 38 in their locked closed positions. The jaws 59 and 62 firmly grip opposite side~ of head 24.
Introducer 20 permits a quick one handed release of the entire lead-after attachment. This is accomplished by using one hand applying a squeezing force to beams 37 and 38 on opposite sides of the lock assembly 82 as shown in Figure 14. When the force is released, as shown in Figure ~-15, lock Q~sembly 82 will automatically disengage without the assistance of the other hand of the user or another person. The one handed operation can be used to also grip head 24 80 that the Iead can be removed from the myocardium and repositioned.
- During the implant procedure the pointed end 31 of the electrode 25 is placed against the heart tissue and introducer 20 is rotated as indicated by the curved arrow 109 in Figure 1. As introducer 20 is rotated, helical electrode 25 is firmly screwed into the heart tissue or myocardium until netting 27 firmly contacts the outer surface of the tissue. Netting 27 provides a secure and permanent placement of electrode 25 in the tissue in that ,:. . . ~ . .
.
: . . .
::
:, , ,; . ~: . ., : "
'' ' : ' ' -....... . . .
the netting promotes rapid fibrosis in and around the netting as well as around the head 24. The platinum black particles 29 are in continuous intimate contact with the heart tissue throughout the helical length of the exterior section of electrode 25 which results in decreased electrical losses at the electrode-tissue interface, increased current density to the heart tissue, uniform current density lowering stimulation thresholds and increasing intracardiac electrical signal amplitudes.
Introducer 20 is released from head 24 without further rotatiQ~ or axial movement. No forces are exerted on head 2L to release the clamping of jaws 59 and 62 from head 24. The introducer 20 can be axially withdrawn from head 24 after jaws 59 and 62 have been released. This is accompliqhed by a mere squeezing and releasing action on beams 37 and 38 on opposite sides of lock assembly 82 as illustrated in Figures 14 and 15.
The invention has been described with particular reference to a perferred embodiment thereof, but it will be understood that variations and modifications can be made by one skilled in the art without departing from the ~-invention. ~ -~,; 1.' " .. ~ ~ . . .. ..
~ ' ! . . .
.'j;: . ,., . .. .
... .' ' , ' . ' ~ , . .
" '' ' " ' : '
The preferred embodiment of the tool has elongated beams having semi-cylindrical outer surfaces so that the over-all~shape of the tool is generally cylindrical to facilitate one hand manipulation of the tool. Each beam has a longitudinal groove adapted to accommodate a section of the electrical conductor of the lead extending from the head. Lips on the beams extend along the outsides of the grooves to-hold the conductor in the grooves., Pivot projections on oppo~ite ends of one beam fit into holes in the other beam to pivotally connect adjacent opposite ends of the beam for limited pivotal movement about generally parallel transverse axes. A biasing spring located between the beams urges the beams to move away from each other to the open bowed position thereby opening semi-circular jaws joined to the distal ends of the beams. The jaws grip opposite sides of the head when the beams are moved to the closed side-by-side position. Adjacent ends of the jaws are spaced from each other to accommodate the conductor end ~oined to the head. A releasable latch assembly having flexible fingers joined to one beam and a holder on the other beam engag~ble with the fingers retains the beams in , " ' . , ' ' ' . ~: . ' ' , , ' ' :
' ~ , .. . ... :
.': . ' ' ' ' : . , , ' ' ,, : . , ' ' -, ' ~ : ., :: . . . .
', ' ' ' , ' , ~ ~
. '. ` . ' .
204~04 the closed position and jaws gripping the head. A movable sleeve associated with the holder is engaged by the fingers to release the fingers from the holder upon further squeezing the beams toward each other. The locking and releasing of the latch is a one hand operation that does not subject the tool to twisting and linear or longitudinal forces. The electrode implanted in the heart tissue is not disturbed by releasing the jaws from the head and regrippin~ the head with the jaws.
Another feature of the invention is the cardiac pacing lead connectable to a pacemaker for transmitting electric current to heart tissue. The lead has an elongated flexible conductor wire and a sheath of non-electrical conductive material surrounding said conductor wire. An electrical connector attached to the wire is adapted to be connected to a pacemaker. A head of non-electrical conductive material connected to said conductor wire and sheath, support an electrode, such as a rigid helical wire. The helical wire has a portion located externally of said head adapted to be turned into heart tissue to secure the lead to the heart muscle and to transmit pacemaking electrical signals thereto. The helical wire has a sheath of non-electrical conductive material surrounding the wire except for the distal one half turn thereof which represents the electrode. The external portion of the electrode has an outer surface covered with a layer of platinum black particles. The .... .. . . .
' : ' , .
, W O 91/06339 PC~r/US90/06287 -5- Z04q~604 .
layer of platinum black particles has substantially uniform particles size and uniform distribution on the outsr surface whereby sa1d layer of platinum black particles has a uniform microporous outer surface being in surface contact with the heart tissue to decrease electrical losses at the electrode-tissue interface, increase the current density to said heart tissue, establish intimate contact between the electrode and myocardium tissue, lower stimulation thresholds, and increase amplitude of electrical signals from the myocardium.
DESCRIPTION OF DRAWING . -Figure 1 is a perspective view of the introducer of the invention accommodating a myocardial lead;
Figure 2 is an enlarged perspective view of a myocardial lead such as ~een in Figure 1 separated from the ..
introducer;
Figure 3 is an enlarged sectional view taken along the line 3-3 of Figure 2;
Figure 4 is an enlarged sectional view taken along line 4-4 of Figure 2; ~ ;
Figure 5 is an enlarged sectional view taken along line 5-5 of Figure 1; .
Figure 6 iB an enlarged side elevational view of the introducer in the closed position without the lead;
Figure 7 is an enlarged end view of the proximal end of the introducer of Figure 6; : --.~ :; ' ".
;,~ ., , . ,. . - - .
;::, ' ' . . , ~, . . .
:, ~ . : . : : ~ , : ,: . . . -. .
.
WO91/06339 rCT/US90/06287 Figure 8 i9 an enlarged end view of the distal end of the introducer of Figure 6;
Figure 9 is an enlarged sectional view taken along the line 9-9 of Figure 6;
Figure 10 is an enlarged sectional view taken along the line 10-10 of Figure 6;
Figure 11 is an enlarged sectional view taken along the line 11-11 of Figure 1;
Figure 12 is an enlarged sectional view taken along the line 12-12 of Figure 1;
Figurel 3 is an enlarged sectional view taken along line 13-13 of Figure 12;
Figures 14 and 15 are sectional views similar to Figure 12 showing the releasing of the lock assembly of the introducer; and Figure 16 is a side elevational view of the introducer in the open position.
DESCRIPTION OF PREFERRED EMBODIMENT
Referring to Figure 1, there is shown the myocardial lead installation tool of the invention, known as an introducer, indicated generally at 20 holding a cardiac lead indicated generally at 21 prior to the implantation of the electrode of the lead into the myocardium of a heart. Introducr 20 is diclosed in U.S.
Application Serial No. 430,596, incorporated herein by reference. Lead 21 has a connector 22 at the proximal end , . . . . .
,. . ~ .:, , , ... : . . ' ' ' . .
. , .; , . ~ . .
' . ' W09l/~6339 PCT/US90/06287 7 20~604 thereof adapted to be connected to terminal of a pacemaker that generates heart pacing currents. Connector 22 is joined to an elongated flexible electrical conductor 23 having a distal end joined to a generally cylindrical head 24. Head 24 is made of non-elsctrical conductive material that i9 biocompatible, such as medical grade silicone rubber. A rigid helical electrode 25 having several convolutions i9 mounted on the center of head 24. As shown in Figure'3, electrode 25 has an end 26 embedded in head 24 and connected to conductor wire 35 of conductor 23. Wire 35 is a multifi~ar conductor coil made of nickel cobalt wire or other suitable conducting material. Wire 35 is enclosed within a non-conductive sheath 40 that is biocompatible, such as medical grade silicone rubber. A
generally flat circular netting 27 surrounds electrode 25.
Netting 27 is joined to head 24 by bonding it directly to the plastic material of head 24 or suitable connecting materials. The outer peripherial edge of netting 27 pro;ects radially outward from head 24 to increase the surface engagement with the heart tissue. Netting 27 can be porous polyester fiber that enhances fibrotic growth to insure a secure connection of electrode 26 to the heart tissue.
Helical electrode 25 is a rigid helical wire 28 terminating in a pointed end 31. A sheath 30 of non-electrical conductive material, such as medical grade silicone rubber, covers wire 28 except for about the end v;, ~ , ,, :' ~ ',, ,;,; ., . , ~.:
. . , . . :
.. ' . :.. '. , ., ; - :. . . ' ':
:. . , . . . . ; . .
:' . . : ', : ' : :
:, . - .
.: . :
.::
-8- ~04~6~4 one half turn section thereof; such as between 160 to 190 degrees of the end section of wire 28. This section of wire 28 comprises the active electrode. Wire 28 can be made of a platinum/irridium. The entire exposed exterior surface of the end one half turn section of wire 28 is completely covered with a coat or layer of platinum black particles to substantially reduce electrode polarization.
Wire 28 i9` platinized to develop the coating of platinum black par~ticles 29. The platinum black i8 a micro porous surface of submicron size particles. The platinum black particles 29 ar~ electrochemically plated onto the outer surface of the wire or substrate 28. The exterior end portion of wire 28 is placed in a platinum ion plating solution and subjected to an electric d.c. current. The plating solution and wire 28 are also subjected to intermittent ultrasonic vibrations that agitate the platinum ions. The electric current is terminated during the vibration period. The time period between vibration episodes can be varied. An oscillating piezoelectric ceramic is used to generate vibrations at a selected frequency that produces uniform particle size and particle distribution. The submicron size particles of platinum black are bonded to the entire outside surface of wire 28 up to head 24 as seen in Figure 3. The platinum black particles 29 have substantially uniform particle size and particle distribution resulting in uniform current density over the layer of platinum black particles 29 and lower .
" `, . ~
_9_ Z~4~04 stimulation threæholds. The current carried by lead 21 i9 delivered to the heart muscle electrolyte almost exclusively through the platinum black particles 29. As shown in Figure 3 and 4, the layer of platinum black particle~ 29 has a continuous microporous qurface which provides for intimate contact between the end section of electrode 25 and the myocardial tissue and an increase in real surface area with a resulting decrease in electrode-tisæue interface electrical losses and an increase the current density to the stimulatable tissue of the heart and thereby lower stimulation thresholds and higher intracardiac electrical signal sensing. ~
Referring to Figure 6, introducer 20 comprises a ~; - -pair of side-by-side elongated beams 37 and 38 having adjacent opposite end sectiohs pivotally connected together with transverse pivot assemblies 47 and 48. The outer surfaces of beams 37 and 38 have generally semi-cylindrical shapes. When introducer 20 is in its closed position, as ~ -shown in Figure 6, beams 37 and 38 have a generally over all elongated cylindrical configuration so that introducer 20 can be operated and manipulated with the fingers of one hand of the operator.
~ eferring to Figure 5, beam 37 has a longitudinal side groove 39 open along one side of introducer 20. A
longitudinal lip 41 partially closing groove 39 retains a section of conductor 23 in groove 39. Beam 38 has a side groove 43 open along the other æide of introducer 20. A
." .. . . . . . .
.. .
- . - . . . . .
- :
~ . . : .
,~.: .. , . . :, : ~ .. " :,.
, :. : .. - .
: ' ' , ~ '. - ' ' . ' :
:. ' .
. .. - . - ... . . . : :.
WO91~06339 PCT/US90/06287 -_1 o- ;~04~604 portion of the electrical conductor 23 fits into groove 43 and is retained therein by a short lip 44 along one edge of beam 38. Beam 38 has a generally flat transverse face 42 facing groove 39 and a longitudinal groove 43 with an outside lip 4L opposite a transverse face 46 of beam 37.
Electrical conductor 23 is located in groove 43 and retained therein when beams 37 and 38 are in their closed positions. Alternatively, conductor 23 can be positioned and retained in groove 39 during the insertion procedure.
As shown in Figure 6, opposite ends of groove 43 have enlarged portiQns or openings in lip 44 for accommodating the portion of lead 23 that enters and exits groove 43 as seen in Figure 1. These openings prevent pinching and compression of lead 23. Groove 39 has similar openings in lip 41 for accommodating lead 23 when placed in groove 39.
Pivot assemblies 47 and 48 are identical in structure. The following description is directed to pivot assembly 48 shown in detail in Figure 9. Beam 38 has a transverse bore 49 having an enlarged outer recess 51. An annular shoulder 52 joins recess 51 with bore 49. Beam 37 has a transverse projection or split body 53 located in bore 49. Body 53 has outer cylindrical surfaces 54 that ride on the surface of bore 49 to form a bearing. Body 53 has a central split bore 55 that separates body 53 into four quarter circular parts. The outer end of body 53 has a split head 56 that extends outwardly from body 53 and engages shoulder 52 to retain beams 37 and 38 in pivotal :
. ,; :, . ~ ' ' ~ ' !' ' , ','' :.:-' : . ' .
-11- 204a~04 assembled relation. Head 56 ha9 8 cone shaped outcr surface 57 which allows body 53 to be moved through bore 49 and snapped into locking position with shoulder 52.
Referring to Figures 8 and 11, the distal end 58 of beam 37 has a first forwardly directed jaw 59 located opposite the distal end 61 of beam 38. A second jaw 62 on end 61 faces jaw 59. As shown in Figure 8, jaws 59 and 62 have generally arcuate shapes and surround a generally circular pocket 63. Head 24 of the lead fits into pocket 63 as shown in Figure 11. - -Returning to Figure 8, jaw 59 has a convex shape with opposite ends 64 and 66 that face opposite ends 67 and 68 of jaw 62. Adjacent ends 64, 67 and 66, 68 are circumferentially spaced from each other forming side : :
openings 69 and 71. Openings 69 and 71 are in general .
longitudinal alignment with longitudinal grooves 39 and 43 in beams 37 and 38. In use side openings 69 and 71 selectively accommodate the portion of electrical conductor ~ :
23 that immediately projects from the side of body 24 and extends the length of tool 20, as shown in Figure 1.
Referring to Figure 10, the proximal end of beams 37 and 38 have aligned bores 72 and 73 accommodating a coil :
spring 74. Spring 74 biases the beams to outward bowed positions, as shown in Figure 1 6, thereby opening 3aws 59 and 62. When jaws 59 and 62 are open they release the gripping force on head 24 of the lead so that tool 20 can be removed from the lead. Alternatively, the tool with the ,~_.~.. .... . .
-., -.....
.. ~ .
W09lt06339 PCT/US90/06287 -12- 204~604 open jaws 59 and 62 can be positioned about head 2~ to regrip the head 24 as hereinafter described.
As shown in Figure 11, the distal end of beam 38 has a bore 76 leading to an enlarged recess 77 having an annular shoulder 78 separating the bottom of recess 77 from bore 76. A body or split projection 79 joined to beam 37 proiZects through bore 76 into recess 77. Body 79 has an enlarged cone shaped or tapered head 81 adapted to engage shoulder 78 to limit the outward movements of beams 37 and 38. Body 79 and bore 76 co-act with each other to guide relative movemZants between beams 37 and 38.
Beams 37 and 38 are retained in their closed or locked position with a releasable lock assembly indicated generally at 82. Referring to Figure 12, lock assembly 82 i8 in the hold or lock position whereby beams 37 and 38 reZtain ~jaws 59 and 62 in firm gripping relation with the opposite outside portions of head 24 of pacing lead 21.
Beam 38 has an upwardly directed cylindrical projection 83 which accommodates a head 84. Head 84 is sonic welded or otherwise permanently joined to the end of projection 83. -... .:.
Head 84 has upwardly and inwardly tapered side wall 86 and inwardly directed annular shoulder 87. A cylindrical sleeve 88 i9 slideably interposed about projection 83 between shoulder 87 and the inside wall of beam 38. Sleeve 88 has a length shorter than the distance between shoulder 87 and-beam 38 whereby sleeve 88 is free to move between head 84 and beam 38.
...... .. ,, ;
: :. :
: .: , . ::
:. ,.,, . . : ,.: ., "Z' :'-, , ~ ' , ' ' . - .
'. ' ' " ' ~ - ::
... .. . . . .:
WOgl/0633s PCT/US90/06287 Z04~604 As shown in Figure 13, sleeve 88 has an outside diameter that is slightly larger than the outside diameter of head 84. A pair jof downwardly directed flexible latch fingers 89 and 91 are joined to beam 37 and project downwardly adjacent opposite portions of head 84. Latch finger 89 has an inwardly directed shoulder or hook 92 and a downwardly and outwardly tapered face 93. Latch finger 91 has an inwardly directed shoulder or hook 94 and a downwardl~ and outwardly tapered face 96. Hooks 92 and 94 are in generally the same plane and engage opposite portions of shQulder 87 to hold beams 37 and 38 in their closed or locked positions. As shown in Figure 13, shoulders 92 and 94 fit under diametrically opposite portions of head 84 above the outer circumferential surface of sleeve 88. As shown in Figures 6 and 16, beam 38 has a pair of ribs 97 and 98 on opposite sides of lock assembly 82 that function as fulcrums during the release of the lock assembly as hereinafter described. Beam 37 also has a guide pin 99 that fits into a hole or recess 101 in beam 38 to prevent relative lateral displacements of beams 37 and 38 and insure that lock assembly 82 remains locked.
Referring to Figure 14, when lock assembly 82 is to be released opposite squeezing forces indicated by arrows 102 and 103 are applied to beams 37 and 38 on opposite sides of lock assembly 82. Beams 37 and 38 are biased together against the force of spring 74 until beam 37 engages ribs 97 and 98 on beam 38. An increased force on .
.- , ~ ' ` '' ` ' .
.
.; ' , . ' `.. - ' ' .
", , ' : .-~' . .
_14_ 2 ~4604 beams sections opposite lock assembly 82 causes these beam sections to ful~crum or pivot on ribs 97 and 98 and deflect inwardly or toward each other. Latch fingers 89 and 91 move downwardly from head 84 and onto sleeve 88. The linear edge 104 of latch finger 89 grips one side of sleeve 88. Simultaneously the linear edge 106 of latch finger 91 engages an opposite portion of sleeve 88. Latch fingers 89 and 91 are biased outwardly as they slide over the tapered side wall~ 86 of head 84 onto sleeve 88. When forces 102 and 103 are released from beams 37 and 38, as indicated by arrows 107 and 108 in Figure 15, beams 37 and 38 will move away from each other to bowed or open positions as shown in Figure 16, due to the biasing forces of beams 37 and 38 and spring 74. Latch fingers 89 and 91 will carry sleeve 88 up into engagement with shoulder 87 of head 84. The continued spreading apart of beams 37 and 38 carry latch fingers 89 and 91 over head 84 since the diameter of sleeve 88 is . : :
larger than the diameter of head 84. When beams 37 and 38 . are in their open position, as shown in Figure 16, latch fingers 89 and 91 are spaced from head 84. Jaws 59 and 62 are spread apart in their open position.
In u~e, introducer 20 is initially in the closed position as shown in Figure 1. Head 24 of pacing lead 21 is located in the pocket 63 with conductor 23 projecting from side opening 71. The electrical conductor 23 is located in groove 43 and retained therein by lip L4. The helical electrode 25 projects in a forward direction 90 ~, ., . ~ . , ~ ' ,,. , , .
, .. - . ., -: :
,, , ~ , . . .. . .
-.
WO9l/0633s PCT/US90/06287 20'1''161~4 that it can be screwed into the heart tissue by rotating introducer 20. Alternatively, the electrical conductor 23 can be located in groove 39 with the end of the conductor joined to the head 24 passing through side opening 69.
Beams 37 and 38 are held together by flexible latch fingers 89 and 91 fitting over head 84 whereby shoulders 92 and 94 engage shoulder 8? f head to hold beams 37 and 38 in their locked closed positions. The jaws 59 and 62 firmly grip opposite side~ of head 24.
Introducer 20 permits a quick one handed release of the entire lead-after attachment. This is accomplished by using one hand applying a squeezing force to beams 37 and 38 on opposite sides of the lock assembly 82 as shown in Figure 14. When the force is released, as shown in Figure ~-15, lock Q~sembly 82 will automatically disengage without the assistance of the other hand of the user or another person. The one handed operation can be used to also grip head 24 80 that the Iead can be removed from the myocardium and repositioned.
- During the implant procedure the pointed end 31 of the electrode 25 is placed against the heart tissue and introducer 20 is rotated as indicated by the curved arrow 109 in Figure 1. As introducer 20 is rotated, helical electrode 25 is firmly screwed into the heart tissue or myocardium until netting 27 firmly contacts the outer surface of the tissue. Netting 27 provides a secure and permanent placement of electrode 25 in the tissue in that ,:. . . ~ . .
.
: . . .
::
:, , ,; . ~: . ., : "
'' ' : ' ' -....... . . .
the netting promotes rapid fibrosis in and around the netting as well as around the head 24. The platinum black particles 29 are in continuous intimate contact with the heart tissue throughout the helical length of the exterior section of electrode 25 which results in decreased electrical losses at the electrode-tissue interface, increased current density to the heart tissue, uniform current density lowering stimulation thresholds and increasing intracardiac electrical signal amplitudes.
Introducer 20 is released from head 24 without further rotatiQ~ or axial movement. No forces are exerted on head 2L to release the clamping of jaws 59 and 62 from head 24. The introducer 20 can be axially withdrawn from head 24 after jaws 59 and 62 have been released. This is accompliqhed by a mere squeezing and releasing action on beams 37 and 38 on opposite sides of lock assembly 82 as illustrated in Figures 14 and 15.
The invention has been described with particular reference to a perferred embodiment thereof, but it will be understood that variations and modifications can be made by one skilled in the art without departing from the ~-invention. ~ -~,; 1.' " .. ~ ~ . . .. ..
~ ' ! . . .
.'j;: . ,., . .. .
... .' ' , ' . ' ~ , . .
" '' ' " ' : '
Claims (49)
1. A tool used to implant a pacing lead to heart tissue, said lead having an elongated electrical conductor connectable to a pacemaker, and a head supporting a helical electrode connected to the conductor comprising: a first beam having a first end portion and a second end portion, a second beam having a first end portion and a second end portion positioned laterally of the first beam, first pivot means connecting the first end portions of the first and second beams, second pivot means connecting the second end portions of the first and second beams, jaw means joined to the first end portions of the first and second beams adapted to be moved to a closed position to grip the head of the lead and hold the head and electrode in a selected position and moved to an open position to release said head and electrode, biasing means mounted on the first and second beams operable to bias the jaw means to the open position thereof, and releasable lock means mounted on the first and second beams operable to hold the jaw means in the closed position to grip said head whereby the helical electrode can be turned into heart tissue upon rotation of the tool and operable to release said head whereby the tool can be removed from said lead.
2. The tool of Claim 1 wherein: at least one of said beams has a longitudinal groove for accommodating a portion of said electrical conductor when the head is gripped by the jaw means.
3. The tool of Claim 2 wherein: said at least one of said beams has a longitudinal lip extended along one side of the groove to retain a portion of said electrical conductor in said groove.
4. The tool of Claim 1 wherein: said first and second beams each have a longitudinal groove for selectively accommodating a portion of said electrical conductor when the head is gripped by the jaw means, said groove of the first beam being located along one side of the tool, and said groove of the second beam being located along a side opposite said one side of the tool.
5. The tool of Claim 4 wherein: said first and second beams each have a longitudinal lip extended along one side of the groove therein to retain a portion of said electrical conductor in the groove.
6. The tool of Claim 1 wherein: said first and second pivot means each includes a lateral projection joining one of said beams and a hole in the other of said beams accommodating said projection to pivotally connect said first and second beams, said projection and other of said beams having cooperating means to hold the projection in assembled pivotal relationship on said other of said beams.
7. The tool of Claim 6 wherein: said cooperating means includes a split head on said projection and an annular shoulder on said other of said beams surrounding said hole, said split head engagable with said shoulder to retain the projection in said hole.
8. The tool of Claim 1 wherein: the jaw means include a first arcuate shaped jaw joined to the first end portion of the first beam and a second arcuate shaped jaw joined to the first end portion of the second beam, said first and second jaws facing each other to grip opposite portions of said head.
9. The tool of Claim 8 wherein: said first and second jaws each have opposite ends, said opposite ends of the first jaw being located adjacent the opposite ends of the second jaw, said opposite ends of the first and second jaws being spaced from each other to accommodate a portion of said electrical conductor adjacent said head.
10. The tool of Claim 1 wherein: said first and second beams have generally aligned facing bores, said biasing means including a coil spring located in said bores to bias the first and second beams apart to move the jaw means to open position.
11. The tool of Claim 1 wherein: the releasable lock means including first means secured to the first beam, second means secured to the second beam, said first and second means having releasable cooperating means to hold the first and second beams adjacent each other whereby the jaw means is retained in the closed position and to release the first and second beams whereby the first and second beams move away from each other and the jaw means moves to the open position.
12. The tool of Claim 11 wherein: the first means includes finger means secured to the first beam, the second means includes holding means engagable with the finger means to hold the first and second beams adjacent each other, said cooperating means includes means to release the finger means from the holding means allowing the first and second beams to move away from each other.
13. The tool of Claim 12 wherein: the finger means comprise a pair of flexible fingers having hooks, said holding means including a head engagable with the hooks to hold the first and second beams adjacent each other, said means of the cooperating means being operable to release the hooks from the head when the first and second beams are moved toward each other.
14. The tool of Claim 1 wherein: the releasable lock means includes finger means secured to one beam, a projection secured to the other beam, a head mounted on said projection, said finger means engagable with said head to hold the first and second beams adjacent each other, and sleeve means surrounding said projection adapted to be engaged by said finger means to release the finger means from said head on movement of the finger means onto said sleeve means whereby the first and second beams move away from each other to release said jaw means.
15. The tool of Claim 14 wherein: the finger means include a pair of flexible fingers having hooks, said head having a shoulder engagable with the hooks to hold the first and second beams adjacent each other, said sleeve means being spaced from said shoulder to allow the hooks to engage the shoulder, said hooks being movable onto the sleeve means to disengage the hooks from the shoulder to allow the first and second beams to move away from each other.
16. The tool of Claim 15 wherein: said shoulder has a diameter, and said sleeve has an outside diameter larger than the diameter of the shoulder whereby the sleeve means allows the hooks to clear the shoulder to release the lock means.
17. A tool used to implant a pacing lead to heart tissue, said lead having an elongated electrical conductor connectable to a pacemaker, and a head supporting an electrode connected to the conductor comprising: a first beam having a distal end, a first jaw mounted on said end, a second beam having a distal end, a second jaw mounted on said end of the second beam, pivot means pivotally connecting said first and second beams locating said first and second jaws adjacent each other, said first and second beams being selectively movable to a first position to locate the jaws in a grip position about said head and to a second position to release said jaws from said head, and releasable lock means mounted on the first and second beams operable to hold the jaws in the grip position about the head whereby the electrode can be attached to heart tissue and operable to release the jaws from the head whereby the tool can be removed from the lead.
18. The tool of Claim 1 wherein: at least one of said beams has a longitudinal groove for accommodating a portion of said electrical conductor when the head is gripped by the jaws.
19. The tool of Claim 18 wherein: said one of said beams has longitudinal lip means extended along one side of the groove to retain a portion of said electrical conductor in said groove.
20. The tool of Claim 1 wherein: said first and second beams each have a longitudinal groove for selectively accommodating a portion of said electrical conductor when the head is gripped by the jaws, said groove of the first beam being located along one side of the tool, and said groove of the second beam being located along a side opposite said one side of the tool.
21. The tool of Claim 20 wherein: said first and second beams each have longitudinal lip means extended along one side of the groove therein to retain a portion of said electrical conductor in the groove.
22. The tool of Claim 17 wherein: said pivot means comprises first and second pivot members located in opposite end sections of the first and second beams, each pivot member having a lateral projection joining one of said beams and a hole in the other of said beams accommodating said projection to pivotally connect said first and second beams, said projection and other of said beams having cooperating means to hold the projection in assembled pivotal relationship on said other of said beams.
23. The tool of Claim 22 wherein: said cooperating means includes a split head on said projection and an annular shoulder on said other of said beams surrounding said hole, said split head engagable with said shoulder to retain the projection in said hole.
24. The tool of Claim 17 wherein: each jaw has an arcuate shape forming a pocket for said head.
25. The tool of Claim 24 wherein: each jaw has opposite ends, said opposite ends of the first jaw being located adjacent and spaced from opposite ends of the second jaw to accommodate a portion of said electrical conductor adjacent said head.
26. The tool of Claim 17 wherein: said first and second beams have generally aligned facing bores, and biasing means including a coil spring located in said bores to bias the first and second beams apart thereby move the jaws to an open position to release said head.
27. The tool of Claim 17 wherein: the releasable lock means including first means secured to the first beam, second means secured to the second beams, said first and second means having releasable cooperating means to hold the first and second beams adjacent each other whereby the jaws are retained in the closed position and to release the first and second beams whereby the first and second beams move away from each other and the jaws move to the open position.
28. The tool of Claim 27 wherein: the first means includes finger means secured to the first beam, the second means includes holding means engagable with the finger means to hold the first and second beams adjacent each other in the first position, said cooperating means includes means to release the finger means from the holding means allowing the first and second beams to move away from each other to the second position.
29. The tool of Claim 28 wherein: the finger means comprise a pair of flexible fingers having hooks, said holding means including a head engagable with the hooks to hold the first and second beams adjacent each other, said cooperating means being operable to release the hooks from the head when the first and second beams are moved toward each other.
30. The tool of Claim 17 wherein: the releasable lock means includes finger means secured to one beam, a projection secured to the other beam, a head mounted on said projection, said finger means engagable with said head to hold the first and second beams adjacent each other, and sleeve means surrounding said projection adapted to be engaged by said finger means to release the finger means from said head on movement of the finger means onto said sleeve means whereby the first and second beams move away from each other to release said jaws.
31. The tool of Claim 30 wherein: the finger means include a pair of flexible fingers having hooks, said head having a shoulder engagable with the hooks to hold the first and second beams adjacent each other, said sleeve means being spaced from said shoulder to allow the hooks to engage the shoulder, said hooks being movable onto the sleeve means to disengage the hooks from the shoulder to allow the first and second beams to move away from each other.
32. The tool of Claim 31 wherein: said shoulder has a diameter, and said sleeve means has an outside diameter larger than the diameter of the shoulder whereby the sleeve means allows the hooks to clear the shoulder to release the lock means.
33. A cardiac pacing lead connectable to a pacemaker for transmitting electric current to the myocardium of a heart and receiving electrical signals from the myocardium of the heart comprising: an elongated flexible conductor wire, sheath means of non-electrical conductive material surrounding said conductor wire, an electrical connector attached to the wire adapted to be connected to a pacemaker, a head of non-electrical conductive material connected to said conductor wire and sheath means, a helical electrode having a first end section extended into said head and connected to said conductor wire and a helical second end section extended from said head adapted to be screwed into the myocardium of a heart, said second end section having an outer helical surface terminating in a point, a layer of platinum black particles attached to substantially the entire outer helical surface of the second end section, said layer of platinum black particles having substantially uniform particle size and uniform distribution on said outer surface of the second end section of the electrode whereby said layer has a continuous and uniform micro porous outer platinum black surface locatable in surface contact with the myocarduim of the heart whereby said layer of platinum black particles decreases electrical losses at the electrode-tissue interface, establishes intimate contact between the electrode and myocardium, and increases the current density to said myocardium and lowers stimulation thresholds and increases amplitude of sensed electrical signals from the myocardium.
34. The lead of Claim 33 including: porous means secured to the head surrounding said helical second end section to enhance fibrotic growth to connect the head and second end section to the myocardium.
35. The lead of Claim 34 wherein: the porous means is a generally circular and flat fabric secured to the head.
36. The lead of Claim 33 wherein: said layer of platinum black particles are electrochemically plated on the entire outer surface of the exposed external second section of the electrode by placing the second section in a platinum ion plating solution and sequentially subjecting the solution to dc current and ultrasonic vibrations.
37. The lead of Claim 33 including: sheath means of non-electrical conductive material extended from said head covering a portion of the helical second section of said electrode, said second section having an end portion projected from said sheath means, said end portion having a outer surface covered with said platimum black particles.
38. The lead of Claim 33 including: sheath means of non-electrical conductive material joined to the head covering a portion of the helical second section of said electrode) said helical electrode having about one half turn end portion extended from said sheath, said end portion having an outer surface covered with said platinum black particles.
39. A cardiac pacing lead connectable to a pacemaker for transmitting electric current to a heart and receiving electrical signals from the heart comprising: an elongated flexible conductor wire, sheath means of non-electrical conductive material surrounding said conductor wire, an electrical connector attached to the wire adapted to be connected to a pacemaker, a head of non-electrical conductive material connected to said conductor wire and sheath means, an electrode having a first section extended into said head and connected to said conductor wire and a second section extended from said head adapted to be placed in engagement with heart tissue, said second section having an outer surface, a layer of platinum black particles attached to substantially the entire outer surface of the second section, said layer of platinum black particles having substantially uniform particle size and uniform distribution on said outer surface of the second end section of the electrode whereby said layer has a continuous and uniform micro porous outer platinum black surface locatable in surface contact with the heart tissue whereby said layer of platinum black particles decreases electrical losses at the electrode-tissue interface, establishes intimate contact between the electrode and heart tissue, increases the current density to said heart tissue and lowers stimulation thresholds and increases amplitude of sensed electrical signals from the heart tissue.
40. The lead of Claim 39 including: porous means secured to the head surrounding said second end section to enhance fibrotic growth to connect the head and second section to the heart tissue.
41. The lead of Claim 40 wherein: the porous means is a generally circular and flat fabric secured to the head.
42. The lead of Claim 39 wherein: said layer of platinum black particles are electrochemically plated on the entire outer surface of the external second section of the electrode by placing the second section in a platinum ion plating solution and sequentially subjecting the solution to dc current and ultrasonic vibrations.
43. The lead of Claim 39 including:
non-electrical conductive means extended from said head covering a portion of the second section of the electrode, said second section having an end portion projected from said non-electrical conductive means, said end portion having an outer surface covered with said platinum black particles.
non-electrical conductive means extended from said head covering a portion of the second section of the electrode, said second section having an end portion projected from said non-electrical conductive means, said end portion having an outer surface covered with said platinum black particles.
44. The lead of Claim 43 wherein: said end portion includes the terminal end of said second section of the electrode.
45. A releasable lock assembly for selectively connecting and releasing first and second members comprising: finger means secured to the first member, holding means secured to the second member engagable with the finger means to hold the first and second members adjacent each other, and means to release the finger means from the holding means on movement of the first and second members toward each other thereby allowing the first and second members to move away from each other.
46. The lock assembly of Claim 45 wherein: the finger means comprise a pair of flexible fingers having hooks, said holding means including a head engagable with the hooks to hold the first and second members adjacent each other, said means to release the finger means being operable to release the hooks from the head when the first and second members are moved toward each other.
47. The lock assembly of Claim 45 wherein:
holding means includes, a projection secured to the second member, a head mounted on said projection, said finger means engagable with said head to hold the first and second members adjacent each other, and sleeve means surrounding said projection adapted to be engaged by said finger means to release the finger means from said head on movement of the finger means onto said sleeve means whereby the first and second members move away from each other.
holding means includes, a projection secured to the second member, a head mounted on said projection, said finger means engagable with said head to hold the first and second members adjacent each other, and sleeve means surrounding said projection adapted to be engaged by said finger means to release the finger means from said head on movement of the finger means onto said sleeve means whereby the first and second members move away from each other.
48. The lock assembly of Claim 47 wherein: the finger means include a pair of flexible fingers having hooks, said head having a shoulder engagable with the hooks to hold the first and second members adjacent each other, said sleeve being spaced from said shoulder to allow the hooks to engage the shoulder, said hooks being movable onto the sleeve to disengage the hooks from the shoulder when the first and second members are moved toward each other to allow the first and second members to move away from each other.
49. The lock assembly of Claim 48 wherein: said shoulder has a diameter, and said sleeve has an outside diameter larger than the diameter of the shoulder whereby the sleeve allows the hooks to clear the shoulder to release the lock assembly.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US430,596 | 1989-11-02 | ||
| US07/430,596 US4972847A (en) | 1989-11-02 | 1989-11-02 | Pacing lead and introducer therefor |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2044604A1 true CA2044604A1 (en) | 1991-05-03 |
Family
ID=23708241
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002044604A Abandoned CA2044604A1 (en) | 1989-11-02 | 1990-10-30 | Pacing lead and introducer therefor |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US4972847A (en) |
| EP (1) | EP0451262A4 (en) |
| JP (1) | JPH04502724A (en) |
| CA (1) | CA2044604A1 (en) |
| WO (1) | WO1991006339A1 (en) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5139033A (en) * | 1991-03-04 | 1992-08-18 | Cardiac Pacemakers, Inc. | Sutureless myocardial lead implantation device |
| US5246014A (en) * | 1991-11-08 | 1993-09-21 | Medtronic, Inc. | Implantable lead system |
| SE9201600L (en) * | 1992-05-21 | 1993-11-22 | Siemens Elema Ab | The electrode device |
| US5304218A (en) * | 1992-06-02 | 1994-04-19 | Incontrol, Inc. | Cardiac lead implanting arrangement and method |
| US5653729A (en) * | 1996-02-01 | 1997-08-05 | Innomedica | Medical instrument with releasable lock |
| US5876420A (en) * | 1996-02-01 | 1999-03-02 | Innomedica | Medical instrument with relesable lock |
| US5902331A (en) * | 1998-03-10 | 1999-05-11 | Medtronic, Inc. | Arrangement for implanting an endocardial cardiac lead |
| US6132456A (en) * | 1998-03-10 | 2000-10-17 | Medtronic, Inc. | Arrangement for implanting an endocardial cardiac lead |
| US7270669B1 (en) * | 2002-03-14 | 2007-09-18 | Medtronic, Inc. | Epicardial lead placement for bi-ventricular pacing using thoracoscopic approach |
| US20030220678A1 (en) * | 2002-05-21 | 2003-11-27 | Tronnes Carole A. | Adjustable implantable captivation fixation anchor-stop |
| US7151965B2 (en) * | 2002-07-19 | 2006-12-19 | Oscor Inc. | Device and method for delivering cardiac leads |
| US7120504B2 (en) * | 2002-07-25 | 2006-10-10 | Oscor Inc. | Epicardial screw-in lead |
| US8303511B2 (en) | 2002-09-26 | 2012-11-06 | Pacesetter, Inc. | Implantable pressure transducer system optimized for reduced thrombosis effect |
| ATE536201T1 (en) | 2002-09-26 | 2011-12-15 | Pacesetter Inc | CARDIOVASCULAR ANCHORING DEVICE |
| US7544197B2 (en) * | 2003-05-06 | 2009-06-09 | Greatbatch Ltd. | Rotatable lead introducer |
| US9008782B2 (en) * | 2007-10-26 | 2015-04-14 | Medtronic, Inc. | Occipital nerve stimulation |
| US20100030227A1 (en) * | 2008-07-31 | 2010-02-04 | Medtronic, Inc. | Medical lead implantation |
| US20110160823A1 (en) * | 2009-12-30 | 2011-06-30 | Andrew De Kock | Implantable leads with a low coefficient of friction material |
| US8728562B2 (en) * | 2009-12-30 | 2014-05-20 | Cardiac Pacemakers, Inc. | Implantable leads with a unitary silicone component |
| US9814874B2 (en) * | 2009-12-30 | 2017-11-14 | Cardiac Pacemakers, Inc. | Implantable lead electrode with asymmetrically distributed current density and methods for imparting current density directionality in lead electrodes |
| US8463398B2 (en) * | 2009-12-30 | 2013-06-11 | Cardiac Pacemakers, Inc. | Electrode surface modification for imparting current density directionality in lead electrodes |
| CN103298521B (en) | 2010-10-29 | 2015-09-16 | Cvrx有限公司 | For the implanting instrument of Wicresoft's program and the electrode design of improvement |
| US9370655B1 (en) | 2013-03-07 | 2016-06-21 | Subhajit Datta | Lead and conduit placement device and method |
| US9511219B1 (en) | 2014-03-24 | 2016-12-06 | Subhajit Datta | Dual vacuum device for medical fixture placement including for thoracoscopic left ventricular lead placement |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3737579A (en) * | 1971-04-19 | 1973-06-05 | Medtronic Inc | Body tissue electrode and device for screwing the electrode into body tissue |
| US3749101A (en) * | 1972-02-09 | 1973-07-31 | Cordis Corp | Nonpolarizable muscle stimulating electrode |
| BR7408329D0 (en) * | 1973-10-15 | 1975-08-26 | Medtronic Inc | IMPLANTABLE BODY ELECTRODE LIDE IMPLANTABLE IN BODY AND LEADS HOLDER SYSTEM |
| US3875947A (en) * | 1974-02-19 | 1975-04-08 | James L Jula | Device for screwing body tissue electrode into body tissue |
| US4011861A (en) * | 1974-04-03 | 1977-03-15 | Case Western Reserve University | Implantable electric terminal for organic tissue |
| US4010758A (en) * | 1975-09-03 | 1977-03-08 | Medtronic, Inc. | Bipolar body tissue electrode |
| DE2613086B2 (en) * | 1976-03-26 | 1979-10-11 | Siemens Ag, 1000 Berlin Und 8000 Muenchen | Endocardial electrode |
| US4146037A (en) * | 1977-12-12 | 1979-03-27 | Cardiac Pacemakers, Inc. | Cardiac pacer electrode and lead insertion tool |
| US4207903A (en) * | 1978-04-28 | 1980-06-17 | Medtronic, Inc. | Device for screwing body tissue electrode into body tissue |
| US4271846A (en) * | 1979-04-23 | 1981-06-09 | Daig Corporation | Lead installation tool |
| US4502492A (en) * | 1983-04-28 | 1985-03-05 | Medtronic, Inc. | Low-polarization low-threshold electrode |
| US4750977A (en) * | 1986-12-17 | 1988-06-14 | Bacharach, Inc. | Electrochemical plating of platinum black utilizing ultrasonic agitation |
| US4922927A (en) * | 1987-12-30 | 1990-05-08 | Intermedics, Inc. | Transvenous defibrillating and pacing lead |
-
1989
- 1989-11-02 US US07/430,596 patent/US4972847A/en not_active Expired - Lifetime
-
1990
- 1990-10-30 WO PCT/US1990/006287 patent/WO1991006339A1/en not_active Application Discontinuation
- 1990-10-30 JP JP3500455A patent/JPH04502724A/en active Pending
- 1990-10-30 EP EP19900917634 patent/EP0451262A4/en not_active Withdrawn
- 1990-10-30 CA CA002044604A patent/CA2044604A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| US4972847A (en) | 1990-11-27 |
| EP0451262A1 (en) | 1991-10-16 |
| EP0451262A4 (en) | 1992-08-26 |
| WO1991006339A1 (en) | 1991-05-16 |
| JPH04502724A (en) | 1992-05-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US4972847A (en) | Pacing lead and introducer therefor | |
| US5179962A (en) | Cardiac lead with retractible fixators | |
| US5143090A (en) | Cardiac lead | |
| US5255693A (en) | Cardiac lead | |
| US5217028A (en) | Bipolar cardiac lead with drug eluting device | |
| US3978865A (en) | Implantable pacemaker and electrode member therefor | |
| US10543125B2 (en) | Cartridge for an electrode array insertion device | |
| US4011875A (en) | Medical electrodes | |
| US5782892A (en) | Medical lead adaptor for external medical device | |
| US4444207A (en) | Method of anchoring a temporary cardiac pacing lead | |
| US4624266A (en) | Introducer tool for screw-in lead | |
| JP4418470B2 (en) | Medical lead adapter assembly | |
| EP0979123B1 (en) | Intracardiac defibrillation system | |
| US8301255B2 (en) | Retention assemblies for implantable electric stimulation systems and methods of making and using | |
| US4917106A (en) | Conductive tips of cardiac stimulation probes | |
| US5139033A (en) | Sutureless myocardial lead implantation device | |
| US4607644A (en) | Self-suturing porous epicardial electrode assembly | |
| JP2020518376A (en) | Implant delivery and retrieval system and method | |
| EP0536096B2 (en) | An actively anchored electrode for electrode catheters | |
| US5040545A (en) | Releasable lock assembly | |
| US20080015668A1 (en) | Test Connector for Implantable Leads | |
| US5127421A (en) | Implantation of leads | |
| EP0085967B1 (en) | Cardiac pacing lead with biodegradable fixation means | |
| US5170788A (en) | Needle electrode and method of assembly thereof | |
| US4142531A (en) | Catheter |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |