Source: http://www.google.com/patents/US5267564?dq=6948823
Timestamp: 2014-04-25 07:35:37
Document Index: 784315380

Matched Legal Cases: ['art 18', 'art 18', 'art 18', 'art 18', 'application No. 07', 'application No. 07']

Patent US5267564 - Pacemaker lead for sensing a physiologic parameter of the body - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe present invention includes a body implantable lead having a multi-polar proximal connector, at least a first conductor coupled to at least one stimulating electrode, a sensor for sensing at least one physiologic parameter of the body, and a second and a third conductor coupled to the sensor. The...http://www.google.com/patents/US5267564?utm_source=gb-gplus-sharePatent US5267564 - Pacemaker lead for sensing a physiologic parameter of the bodyAdvanced Patent SearchPublication numberUS5267564 APublication typeGrantApplication numberUS 07/716,032Publication dateDec 7, 1993Filing dateJun 14, 1991Priority dateJun 14, 1991Fee statusPaidAlso published asEP0518364A2, EP0518364A3, US5304219, US5438987, US5490323Publication number07716032, 716032, US 5267564 A, US 5267564A, US-A-5267564, US5267564 A, US5267564AInventorsJames E. Barcel, Shahram Moaddeb, James R. Thacker, Alvin H. WeinbergOriginal AssigneeSiemens Pacesetter, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (11), Referenced by (66), Classifications (15), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetPacemaker lead for sensing a physiologic parameter of the bodyUS 5267564 AAbstract The present invention includes a body implantable lead having a multi-polar proximal connector, at least a first conductor coupled to at least one stimulating electrode, a sensor for sensing at least one physiologic parameter of the body, and a second and a third conductor coupled to the sensor. The sensor is hermetically sealed in a D-shaped housing. Sensor components are mounted onto a microelectronic substrate which is advantageously placed on an inner flat portion of the D-shaped housing. End caps having glass frit sealing rings are used to seal the ends of the shell. A hermetic seal is easily achieved by heating the glass frit such that the glass frit reflows between the end caps and the shell. Advantageously, the sensor terminals are sized to fit snugly within a narrow bore of the end cap which is then welded closed. The D-shaped sensor is placed on a carrier having at least two lumens. At least the first and second conductors pass through the lumens for connection with the stimulating electrode and the distal end of the sensor. Advantageously, the D-shaped housing reduces the area that needs to be hermetically sealed by more than half, and thus reduces the overall diameter of the lead. Advantageously, the conductors coupled to the sensor function independently from the stimulation conductors so that interference with basic operation of the pacemaker is prevented.
What is claimed is: 1. A body implantable lead, the lead including a plurality of electrode terminals at a proximal end, at least one stimulating electrode delivering stimulation pulses at a distal end, and a first conductive means for electrically connecting the stimulating electrode to one of the plurality of electrode terminals, the implantable lead comprising:sensing means for sensing a specified characteristic of the body, the sensing means having a proximal and a distal sensor terminal; a tubular D-shaped shell having a flat surface with the sensing means mounted thereon, the shell having two open ends; two end caps dimensioned to fit into the two open ends of the shell, respectively, each end cap having a channel therethrough, allowing one of the sensor terminals to pass therethrough; means for hermetically sealing the end caps to the shell; a carrier having a flat side mounting the D-shaped shell thereon, the carrier further having at least a first and second lumen therethrough, wherein the first conductive means passes through the first lumen in the carrier; a second conductive means for electrically connecting another one of the plurality of proximal electrode terminals to the distal sensor terminal, the second conductive means passing through the second lumen in the carrier; a third conductive means for electrically connecting another one of the plurality of proximal electrode terminals to the proximal sensor terminal; and means for insulating the first, second, and third conductive means for each other. 2. The body implantable lead, as recited in claim 1, wherein the carrier is a multi-lumen tube having a recess therein, the recess having a flat surface mounting the sensing means thereon.
3. The body implantable lead, as recited in claim 1, wherein:the implantable lead includes a ring electrode and a fourth conductive means electrically connected between the ring electrode and another one of the plurality of electrode connectors; the carrier includes a third lumen passing the fourth conductive means therethrough; and the insulating means further includes means for insulating the fourth conductive means from the first, second, and third conductive means. 4. The body implantable lead, as recited in claim 1, wherein the insulating means is a multi-lumen lead body made of body compatible material.
5. The body implantable lead, as recited in claim 3, wherein the insulating means comprises a thin polymer coating about the first, second, third and fourth conductive means.
Although the preferred embodiment of the present invention is directed towards the construction and hermetic sealing of an oxygen saturation sensor onto a pacemaker lead, the present invention is not limited to an oxygen saturation sensor. Any physiologic sensor that would be desirable to locate on a lead could be mounted by utilizing this method.
The pacemaker lead 10 illustrated in FIG. 1 is shown connected to bipolar lead. Bipolar stimulation is achieved between the tip electrode 14 and a ring electrode 20 approximately one-half inch from the tip electrode 14. Although a bipolar lead is shown in the preferred embodiment, it is evident to one skilled in the art that a unipolar lead could also be used, if desired. In addition, the pacemaker 12 illustrated is a single-chamber pacemaker, although the principles of the present invention are equally applicable to both single and dual-chamber pacemakers.
An oxygen sensor 22 is positioned within an area of a living body where blood is able to come in contact with the light energy emitted by the oxygen sensor 22. The oxygen sensor 22 may be placed either within a vein that is carrying blood back to the heart 18, within the right atrium 24, or within the right ventricle 16 itself. In the preferred embodiment, the oxygen sensor 22 is positioned on the pacemaker lead 10 proximal to the ring electrode 20 so as to place the oxygen sensor 22 within the right atrium 24 of the heart 18. It is believed that sensing oxygen saturation of the blood within the right atrium is a more sensitive indicator of exercise. Further, when positioned properly within the heart 18, the pacemaker lead 10 is curved in a manner that causes the oxygen sensor 22 to face blood just prior to the blood's passage through the tricuspid valve 46 of the heart 18. For a complete discussion of the use of an oxygen sensor placed in the right atrium as the control mechanism for a rate-responsive pacemaker, see copending U.S. patent application No. 07/555,965, now U.S. Pat. No. 5,076,271 filed on Jul. 19, 1990, which is assigned to the assignee of the present invention. U.S. Pat. No. 5,076,271. filed on Jul. 19, 1990, is hereby incorporated herein by reference.
In the preferred embodiment shown in FIG. 3, the pacemaker lead 10 is a bipolar lead. The pacemaker lead 10 includes a lead body 57 having four conductors 48, 50, 52, 54 (FIG. 2) therein. The pacemaker lead 10 further includes a multi-polar connector assembly 58 which is designed to mate with the pacemaker 12 by way of a multi-polar pacemaker electrode connector 44 (FIG. 2). Thus, the multi-polar connector assembly 58 includes four electrical contacts 60, 62, 64 and 66. The electrical contact 60 is connected to the tip electrode 14. The electrical contact 62 is connected to the ring electrode 20. The electrical contacts 64, 66 are connected to a first and second sensor terminal 34, 36, respectively. In a unipolar lead body configuration, a tripolar electrode connector would be employed, thus eliminating the need for contact 62 for the ring electrode 20. In the preferred embodiment, the sensor 22 is combined with the bipolar lead in the area of 59. As is known in the art, sensing cardiac events occurs using the same electrodes as for stimulation. Advantageously, both terminals 34, 36 of the oxygen sensor 22 are connected to separate conductors 48, 50, respectively, of the pacemaker lead 10, which are electrically independent of the conductors 52, 54 which are used for stimulation.
It is believed that the best way of describing the present invention is to describe the apparatus at the lowest level of assembly and then to describe the construction of the body implantable lead. FIG. 4 shows a tubular shell 68 which is used for housing the sensor electronics. A plan view and a cross-sectional view of the shell 68 may be seen in FIGS. 5 and 6, respectively. The shell 68 may be made of any hermetic material, such as stainless steel, ceramic, glass, etc. For an oxygen saturation sensor, the shell 68 should be a transparent material, such as glass, and more particularly, in the preferred embodiment it is soda lime glass. In the preferred embodiment, the shape of the shell 68 is "D-shaped."
In FIGS. 7 and 8 is the preferred embodiment of an end cap 70 that may be used to seal the shell 68. The end cap 70 has an inner cap 72 and an outer cap 82. As seen in FIG. 8, the inner cap 72 comprises a tubular section of metal, preferably 90 percent Platinum and 10 percent Iridium, having a channel 76 therethrough. At one end, the inner cap 72 has a preformed glass frit sealing ring 78. At the other end, the inner cap 72 has a protruding lip 80.
In FIGS. 9 and 10, an alternate embodiment of an end cap that may be used to seal the shell 68 is shown. An end cap 100 has a center portion 101 having an outer radius and shape substantially identical to the outer radius and shape of the shell 68. The end cap 100 may be made of metal, and is preferably made of a material which is 90 per cent Platinum and 10 percent Iridium. The end cap 100 has on one end a protruding portion 102 which has an outer radius and shape substantially identical to the inner radius and shape of the shell 68. The end cap 100 also has a preformed glass frit sealing ring 103. On the other end of the end cap 100 is a tubular portion 104. Each end cap 100 has a bore 106 therethrough to permit passage of a conductive wire (not shown) which will form one of the sensor output terminals. The purpose of the tubular portion 104 will be explained below in the description of the hermetic sealing.
In FIGS. 11 and 12, an alternate embodiment of an end cap that may be used to seal the shell 68 is shown. An end cap 110 has a portion 111 having an outer radius and shape substantially identical to the outer radius and shape of the shell 68. The end cap 110 has on one end a protruding portion 112 which has an outer radius and shape substantially identical to the inner radius and shape of the shell 68. The end cap 110 also has a preformed glass frit sealing ring 113. Each end cap 110 has a bore 116 therethrough with a larger counterbore 118 at one end to permit passage of a sensor terminal. As shown in FIG. 12, glass frit 119 is preformed within the counterbore 118, the purpose of which will be explained below in the description of the hermetic sealing.
A complete description of the sensor electronics of the preferred embodiment of an oxygen sensor 22 may be found in copending U.S. patent application No. 07/403,208, now U.S. Pat. No. 5,040,538 filed on Sep. 5, 1989, which patent application is assigned to the assignee of the present invention. U.S. Pat. No. 5,040,538 is hereby incorporated by reference. For convenience, the most pertinent figure of the application is reproduced herein as FIG. 13. Although the present invention is discussed specifically with the incorporation of U.S. Pat. No. 5,040,538, the invention is believed equally applicable to other circuit configurations for an oxygen saturation sensor.
In the embodiment shown in FIG. 19, a hermetic seal is achieved as follows. First, the inner caps 72, 72' and the D-shaped shell 68 are hermetically sealed by reflowing the glass frit sealing rings 78, 78'. A hermetic seal has been achieved using a firing oven at about 500 degrees Celsius for approximately 30 minutes, but other combinations of time and temperature may be possible. Although a firing oven is the preferred method of reflowing the glass frit sealing rings to the housing, alternate methods of localized heating, such as laser welding and resistive heating, are possible. The substrate 138, with preattached conductive wires 154, 156, is then inserted into the shell 68. Next, the outer caps 82, 82' are received within the inner caps 72, 72'. The conductive wires 154, 156, extend through the narrow portions 94, 94' of the channels 86, 86', respectively. The inner caps 72, 72' and the outer caps 82, 82' are hermetically sealed by localized welding circumferentially at 71, 71'. In the preferred embodiment this is achieved using laser welding. Finally, the conductive wires 154, 156, are hermetically sealed by circumferentially welding at 95, 95' of the outer caps 82, 82'.
Advantageously, the reflowing of the glass frit is performed before the substrate is inserted within the housing, thus, eliminating the possibility of damaging the delicate circuits. The localized welding of the inner cap 72 to the outer cap 82 is also designed to have negligible effect on the sensor circuits. Since the outer cap 82 acts like a heat sink, the localized welding at the narrow portion 94 of the channel 86 has minimal effect on the sensor circuits.
In an alternate embodiment shown in FIG. 20, the substrate 138, with pre-attached conductive wires 154, 156, is place on the flat surface inside the shell 68. The end caps 100, 100' may be inserted into the ends of the shell 68 such that the conductive wires 154, 156 pass through the bores 106, 106', respectively. A hermetic seal may be achieved by reflowing the glass frit sealing rings 103, 103' using resistance heating at about 325 degrees Celsius for approximately 1 minute. This resistance heat weld process permits a hermetic seal while preventing excessive heat from damaging the delicate microelectronic circuits. In the alternate embodiment shown in FIG. 20, the tubular portions 104, 104' of the end caps 100, 100' may be crimped against the conductive wires 154, 156, respectively. The conductive wires 154, 156 may then be laser or gap welded to hermetically seal the remaining opening.
In the other alternate embodiment shown in FIGS. 22 and 23, the substrate 138, with pre-attached conductive wires 154, 156, is also placed on the flat surface inside the shell 68. The end caps 110, 110' may be inserted into the ends of the shell 68 such that the conductive wires 154, 156 pass through the bores 116, 116', respectively. A hermetic seal may be achieved by reflowing the glass frit sealing rings 113, 113', 119, 119' using resistance heating at about 350 degrees Celsius for approximately one minute.
In the preferred embodiment shown in FIGS. 25 and 26, a multi-lumen carrier 160 is used for mounting the shell 68 thereon. Preferably, the carrier 160 is D-shaped and complimentary in size to the D-shaped sensor 22 (FIG. 28). The carrier 160 has three lumens 162, 164, 166 for inserting conductors 172, 174, and 176, respectively, therein. Conductor 172 is made of a conductive tube so that a guidewire (not shown) may be inserted therethrough. (Guidewires are used only during the placement of the electrode tip to provide extra stiffness in the lead.) Thus, the lumen 162 must be larger than the lumens 164 and 166. To further ensure that the conductors 172, 174, and 176, do not short to each other they are insulated by a thin polyimide tube (not shown). The outer flat side of the D-shaped sensor 22 is then place against a flat side 168 of the carrier 160, as best seen in FIG. 28.
In the preferred embodiment, the carrier 160 is made of epoxy and is cast (together with the conductors 172, 174, 176) onto the D-shaped shell 68. Once cast, the shell 68 and the carrier 160 are encased in a thin layer of polyurethane cover tubing 178, or other transparent body compatible material that will not obscure the optical window. Suitable materials include the polyurethane material sold under the trademark PELLATHANE and manufactured by Dow, or an elastomer material manufactured by Dow Corning, such as Elastomer #Q7-4765, or equivalent type of silicone rubber.
The shell 68, now attached to the carrier 160, is spliced between two identical pieces of the lead body 57 as shown in FIG. 30. The lead body 57 insulates the conductors 48, 50, 52 and 54 from each other in a multi-lumen tubing made of body compatible material. For readability purposes, the complimentary elements of the distal portion of the lead body 57 will be referred to as primed, e.g., lead body 57'. In the preferred embodiment, as shown in FIGS. 29 and 30, the lead body 57, 57' is made of a multi-lumen tubing. As shown in FIG. 29, the multi-lumen lead body 57 of the preferred bipolar configuration requires four lumens, or holes, 182, 184, 186, 188 within a tube of body compatible material. The lumen 182 for the stimulating conductor 52 is larger than the other lumens due to the need to also pass a guidewire, which is used to position the lead into the heart.
In the area of 175, shown in FIG. 30, the conductor 172 is spot-welded or otherwise connected to conductor 52' which in turn is connected to the tip electrode 14. The conductor 174 is spot-welded or otherwise connected to conductor 54' which is connected to the ring electrode 20. The conductor 176 for the sensor 22 is laser welded or otherwise connected to the outer cap 82'.
In the area of 177, the conductor 172 is spot-welded or otherwise connected to conductor 52 which in turn is connected to the electrical contact 60 (FIG. 3). The conductor 174 is spot-welded or otherwise connected to the conductor 54 which is connected to the electrical contact 62 (FIG. 3). The conductor 176 for the sensor 22 is laser welded or otherwise connected to conductor 50 (not shown) which is connected to electrical contact 64 (FIG. 3). The outer cap 82 is electrically connected to conductor 48 and to electrical contact 66 (FIG. 3).
The shell 68, the carrier 160, and a small portion of the lead body 57, 57' are then covered by silicone rubber splice tubing 191. Medical adhesive is used to fill any gaps between the lead body 57, 57', the carrier 160, and the shell 68. A window 193 in the silicone rubber splice tubing 191, located over the light source and the light receiver, helps to minimize light losses.
In an alternate embodiment, shown in FIG. 31, an alternate carrier 190 is shown. The carrier 190 is a modified piece of multi-lumen tubing having four lumens, or holes, 192, 194, 196, 198 therein. The substrate 138 is placed on the flat portion 200 of the carrier 190 so that the overall diameter is equal to the diameter of the lead 10. As shown in FIG. 32, conductors 202, 204, and 206 are inserted into the lumens 192, 194, 196, respectively. Electrical connection between the conductors 202, 204, and 206 and the conductors 48, 50, 52, and 54 are made in a similar fashion as described above in conjunction with FIG. 30.
In an alternate embodiment shown in FIGS. 33 and 34, the lead 10 comprises a "thin bipolar"configuration. "Thin bipolar" is used herein to refer to a coaxial bipolar lead wherein individual filars are electrically insulated from each by a thin polymer insulative coating and then coaxially wound together. The insulative coating may be the polymer materials sold under the trademarks TEFLON and TEFZEL, manufactured by DuPont, which materials have good electrical insulating properties without adding significant bulk. Each conductor 48, 50, 52, 54 (FIG. 2) is comprised of two filars for redundancy. The coiled filars which make up the stimulating conductors 52 and 54 are insulated by a layer of body compatible material to form an inner lead body 222 (FIG. 34). The filars which make up the sensor conductors 48 and 50 are coiled about the inner lead body 222 and spot-welded to the sensor terminals 34 and 36, respectively (FIG. 33).
FIGS. 38-42 show one possible configuration of a multi-polar connector assembly 58 for the lead 10. FIG. 38 shows the four spaced apart electrical contacts 60, 62, 64 and 66 which are injection molded in a body compatible material 240. Suitable materials include the polyurethane material sold under the trademark PELLATHANE and manufactured by Dow, or an elastomer material manufactured by Dow Corning, such as Elastomer #Q7-4765, or equivalent type of silicone rubber. To improve the mechanical strength and the bonding between the body compatible material and the electrical contacts, circular holes 242, 243, 244 and 246 (FIG. 40) are formed within the electrical contacts 62, 64 and 66 enabling the body compatible material to "lock" into the electrical contacts 62, 64 and 66. Electrical contact 60 has a "dog bone" shape at one end 248 which also helps the body compatible material to "lock" into the electrical contact 60.
As seen in the end view (FIG. 39), there are four conductors 260, 262, 264 and 266 which are also injection molded in the body compatible material 240. The conductor 260 is a conductive tube so that a guidewire (not shown) may pass therethrough. The proximal end of the conductor 260 is connected to the electrical contact 60 at location 261, as shown in the cross-sectional view of FIG. 40. The conductor 262 is connected at the proximal end to the electrical contact 62 at location 263. The conductor 264 is connected at the proximal end to the electrical contact 64 (not shown). The conductor 266 (FIG. 38) is connected at the proximal end to the electrical contact 66 (not shown). Advantageously, conductors 262, 264 and 266 are straight wires (i.e., not coiled) made of a noncorroding metal, preferably MP35N stainless steel, having a diameter of 0.012 inch. This configuration thereby eliminates unnecessary bulk in the multi-polar connector assembly 58.
Injection molded seal rings 270, 272 shown in FIG. 41 are used to prevent bodily fluids from creating a low impedance between the tip electrode 14, the ring electrode 20 and sensor terminal 34. The seal rings 270 and 272 are either stretched and slid into place or they may be expanded by soaking them in a solvent such as isopropyl alcohol or the material sold under the trademark FREON and manufactured by Dupont. Alternately, the seal rings 270, 272 may be injection molded together with the electrical contacts 60, 62, 64 and 66. Seal rings could also be placed between electrical contacts 64 and 66, and between electrical contact 66 and the body. However, in the preferred embodiment, these seal rings are located within the multi-polar pacemaker electrode connector 44 itself.
FIG. 29 shows an end view of the multi-lumen lead body;
FIG. 30 shows a partial cross-sectional view of the multi-lumen lead body in the area of the sensor;
FIG. 35 shows a first alternate embodiment for attaching the sensor housing onto the "thin bipolar"lead body;
FIG. 36 shows a second alternate embodiment for attaching the sensor housing onto the "thin bipolar"lead body;
FIG. 37 shows a third alternate embodiment for attaching the sensor housing onto the "thin bipolar"lead body;
FIG. 38 shows a profile view of a multi-polar connector subassembly for the lead;
FIG. 39 shows an end view of the multi-polar connector subassembly shown in FIG. 38;
FIG. 40 shows a cross-sectional profile view of a multi-polar connector subassembly shown in FIG. 38;
FIG. 41 shows a profile view of the multi-polar connector subassembly, including the sealing rings; and
FIG. 42 shows a profile view of the multi-polar connector assembly, including the sealing rings and the protective sleeve.
SUMMARY OF THE INVENTION The disadvantages and limitations of the background art discussed above are overcome by the present invention. The present invention includes a body implantable lead having a proximal connector, a lead body having at least one conductor, and at least one stimulating electrode. In addition, the present invention includes two additional conductors, coupled to a hermetically sealed sensor, for sensing at least one physiologic parameter of the body. Advantageously, the conductors coupled to the sensor function independently from the stimulation conductors so that interference with basic operation of the pacemaker is prevented. Overvoltage protection circuitry for protecting the sensor circuitry is located within the pacemaker. Thus, the sensor is unaffected by electrosurgery signals, a cardioversion pulse, or a defibrillation pulse.
In the preferred embodiment, the lead body comprises a multi-lumen bipolar configuration, that is, a silicone or polyurethane tube with at least four lumens, or holes, therein. Each of the four conductors occupies one of the lumens.
In the preferred embodiment, the body implantable lead includes a sensor for sensing a specified characteristic of body fluid, such as the oxygen content of blood. In this configuration, a light-emitting source is used to transmit light through a transparent tubular housing to the body tissue. Light that is reflected back from the body due to the oxygen level of the blood is received by a light detector also located within the housing. To prevent light from impinging directly from the light-emitting source to the light detector, an insulating light barrier is disposed therebetween.
In the preferred embodiment, the housing is D-shaped and is preferably made of soda lime glass. The sensor components are mounted onto a microelectronic substrate which is advantageously placed on an inner flat portion of the D-shaped housing. End caps are used to seal the ends of the shell. Advantageously, each end cap has a glass frit sealing ring and a narrow bore for allowing one of the sensor terminals to pass therethrough. A hermetic seal is easily achieved by heating the glass frit such that the glass frit reflows between the shell and the end caps. Advantageously, the sensor terminals are sized to fit snugly within the narrow bore. The gap between the sensor terminals and the narrow bore is then sealed by localized welding, or otherwise sealing, the sensor terminals to the end cap.
In the preferred embodiment, at least one end cap includes an inner and an outer cap. The inner cap includes the glass frit sealing ring and a channel wide enough to slide the substrate therethrough. Advantageously, the inner cap and the end cap may be simultaneously refired in a firing oven to produce a superior hermetic seal. After the glass frit is fired, the substrate is slid through the wide channel of the inner cap onto the flat side of the D-shaped shell. The outer cap is sized to fit snugly within the inner cap and includes a narrow bore for allowing one of the sensor terminals to pass therethrough. After the substrate is in place, the outer cap is hermetically welded to the inner cap using localized welding. Thus, the sensor is reliably and hermetically sealed without damaging the delicate microelectronic circuits.
The D-shaped sensor assembly is placed on a carrier. The carrier may comprise a portion of a multi-lumen lead body which has a flat cavity therein for mounting the D-shaped sensor assembly thereon. In the preferred embodiment, the carrier is a separately molded part with lumens molded therein for making appropriate electrical contact between the lead body and the sensor.
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