|Publication number||US3835864 A|
|Publication date||Sep 17, 1974|
|Filing date||Sep 21, 1970|
|Priority date||Sep 21, 1970|
|Also published as||CA1003904A, CA1003904A1, DE2147308A1|
|Publication number||US 3835864 A, US 3835864A, US-A-3835864, US3835864 A, US3835864A|
|Inventors||Rasor N, Spickler J|
|Original Assignee||Rasor Ass Inc|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (3), Non-Patent Citations (2), Referenced by (278), Classifications (12), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
llnited States Patent Rasor et a1.
[4 1 Sept. 17, 1974 INTRA-CARDIAC STIMULATOR US. Cl. 128/419 P, 128/418, 128/421 Int. Cl A6ln 1/36 Field of Search 128/404, 418, 419 P, 421,
 References Cited UNITED STATES PATENTS 3,087,486 4/1963 Kilpatrick ..128/404 3,516,412 5/1970 Ackerman 128/418 FOREIGN PATENTS OR APPLICATIONS 246,004 11/1969 U.S.S.R. 128/419 P OTHER PUBLICATIONS Hopps et al., Surgery, Volv 36, No. 4, Oct., 1954, pp. 833-849 (only p. 834 relied on).
Frei et a1. Medical Research Engineering, 4th Quarter, 1956, pp. 11-18.
Primary Examiner-William E. Kamm I 5 7 ABSTRACT A stimulator device for insertion in a living body and having particular advantage for intra-cardiac use comprising a structure having a body form of a size and configuration to enable its transvenous or transarterial insertion, the surface of said body form providing electrode means for contact with a portion of the living body to be stimulated by said electrode means, and means mounted to project outwardly of and peripherally of said body form including anchor portions locating in a position displaced from said electrode means and providing means for engaging in portions of said living body to establish said electrode means in a required position of use, said electrode means having in connection therewith means to energize the same once said body form is located in its required po sition of use.
7 Claims, 14 Drawing Figures IO SHlELDING 1 3| k 35 33 32 24 I i a m J f PATENIEUSEPI mm D m l- CONSTANT CURRENT ELEMENT TRANSISTOR SWITCH POWER SOURCE PAIENIEUSEPIYIW 3.8%.884
SHEET 3 0F 4 FIG -8 FIG 9DYNAMIC TRIGGER INPUT HEMO IMPULSES FROM ATRIAL CONTRggTION I 035 13g;
f w ENERGY CONSTANT PULSE. 32 MECHANICAL STORAGE *"CURRENT FORMING- TRANSDUCER ELEMENT ELEMENT CIRCUIT INPUT POWER FROM. v VENTRICLE CONTRACTION STIMULATION ELECTRODE III! FIG-H INTRA-CAIRDIAC STIMULATOR employed for the long-term treatment of atrioventricular (A-V) block. Such Pacemaker devices commonly employ flexible leads which connect a remotely positioned power pack with electrodes which are placed in contact with or attached to the myocardium. The techniques of implanting and using such Pacemakers, and many Pacemaker which have been used experimentally and in practice, are described by Siddons and Sowton, Cardiac Pacemakers 1967), published by Charles C. Thomas, Springfield, Illinois, Library of Congress Card No. 67-12042. Pacemakers having energy sources responsive to heart movement are shown in US. Pat. Nos. 3,358,690 and 3,486,506.
Such Pacemakers, or other biological stimulators working on these principles, have inherently suffered from certain disadvantages. The leads to the electrodes are commonly routed through veins leading into the heart itself. The movement of the heart and normal activity of the individual tend to put a strain on these leads and may result in lead breakage or dislodgement of the electrodes. The leads themselves, retained in situ, are frequently a source of irritation and infection. Further, since the electrical contact with the heart is made at the point or region of mechanical support or implantation, the normal fibrosis of tissue at these regions often results in a marked increase power required to pace, known as an increase in threshold. For example, the threshold has been found to increase on the order of ten times its original value until a plateau is reached over a period of two to three weeks. This requires a correspondingly greater power input to the electrodes, in the minimum of 3:1 over threshold, in order to achieve consistent pacing.
The remote power pack itself is a cause of discomfort and often a cause of difficulty. It is commonly implanted in a subcutaneous pocket beneath the pectoralis major or within the abdomen. Again, this provides a further opportunity for infection. Difficulty has been encountered in preventing migration of the power pack. Further, surgery is required from time to time to expose and replace the power pack due to exhaustion of the mercury cells. Prior pacing devices which derive their energy from the heart movement or pressures have commonly required thoracic surgery for attachment to the epicardium, and have employed flexible leads to the electrodes.
SUMMARY OF THE INVENTION The present invention is directed to a wholly selfcontained stimulator which is particularly adapted for use as a Pacemaker. It is contained within a package or housing which is sufficiently small to be implanted by catheter insertion (transvenous or transarterial) into a chamber of the heart where it is attached to the endocardium. The stimulating electrodes are formed integrally with the unit, without external leads, and thus make contact with the endocardium. As used herein, catheter" refers to an inserting device embodying a sheath-like element of small bore tube form.
A Pacemaker device made according to the present invention is intended primarily for long-term use. It can be used without discomfort to the user. The likelihood of a failure due to dislodgement of electrode contact, increase of threshold, or occurrence of infection is substantially reduced. Failure due to electrode lead breakage is eliminated entirely. The device can be implanted by a catheter device and technique which require only minor surgery and temporary discomfort to the patient. It can be recovered if desired or, if failure should occur it may simply be left in place and a new device inserted.
In one form of the invention a nucleonic battery is employed for providing a power source to the pulse generator circuits contained within the housing. This arrangement provides for an overall life which may be well beyond the normal life expectancy of the patient. For example, Pu 238 has a half life of 86 years, while Pm-l47, which may be preferred because of lower costs, has a half life of 2.7 years. Suitable electronics in the converting and pulse generating portion are available which operate efficiently over three or more half lives. Operation over such a large power range is made possible in part by the fact that the device of the present invention does not cause a material or significant increase in threshold, and therefore can continue to operate after decay to very low power levels.
Three forms of the invention are disclosed which employ a biologically energized power source and thus derive their power requirements from the body itself. Prior attempts have obtained insufficient power from normal heart activity to provide reliable and continuous pacing. However, the apparatus of the present invention is one which does not result in a significant increase in threshold power and accordingly reliable pacing may be affected over an extended period of time with modest lower power requirements. The energy required for each stimulation pulse may be in the order of one microjoule or less, corresponding to a total power input to the electronics on the order of six microwatts or less. The mechanical work which is available substantially exceeds this.
In one form of the invention, a movable wall or diaphragm transforms hemodynamic pressure into electric energy by means of a suitable transducer. In other forms of the invention, a mass is suspended in such a manner that movements of the heart set up a sympathetic or harmonic movement of the mass, and this movement may be electromechanically coupled to produce energy. For example, the transducer may comprise a permanent magnet in combination with a nonmoving electric coil. In another form, the mass may be connected to stress a piezoelectric crystal.
The body or housing structure of the present invention may also be used as the electrode structure for existing Pacemakers, as it offers certain advantages over the endocardial electrodes which are presently in use.
Another important object of the invention is the provision of a bioelectric stimulator which is fully self coritained and implantable at the site of stimulation, and an improved electrode structure therefor.
A further object of the invention is the provision of a stimulator, heart Pacemaker, or an electrode structure for a Pacemaker, in which the region of attachment is spaced from the region of stimulation to avoid the adverse effects of tissue fibrosis at the region of attachment.
A further object of the invention is a provision of a catheter for inserting the Pacemaker or electrode assembly therefor, as described above, and the further provision of the combination of a novel catheter and Pacemaker or electrode assembly therefor. The catheter is preferably a triaxial arrangement in which one of three concentric elements is removably secured to the body of the device, a second element forms a torque tube which may be used to assist in implanting the device and for removing the first element from the device, and the third element comprises an outer removable sheath which preferably extends at least partially over the body of the device during transvascular passage and may be employed to retain the body-attaching members on the device in a retracting or inoperative position until the device has been positioned, as desired. Thereafter, the sheath may be retracted to expose the body of tissue-attaching members, or extended to cover these members for removal of the device from the heart.
These and other objects and advantages of the invention will be apparent from the following description, the accompanying drawings and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded view of the stimulator and catheter devices of the invention;
FIG. 2 shows parts of FIG. 1 in an assembled condition;
FIG. 3 is an enlarged sectional view, partially in diagrammatic form, of the stimulator of FIG. 1 adapted particularly for use as a heart pacer;
FIG. 4 is an end view of the device of FIG. 3;
FIGS. 5a, 5b and 5c are, respectively, diagrams illustrating the method of implanting the pacer using the catheter device of this invention;
FIG. 6 is a schematic drawing showing a pulsing circuit which may be used with this invention;
FIG. 7 is a diagram of a modified form of the circuit of FIG. 6 particularly adapted for use with a nucleonic or other varying power source;
FIG. 8 shows a modified form of the invention adapted to respond to hemodynamic pressure changes;
FIG. 9 is a block diagram of the pacer of FIG. 8;
FIG. 10 is a further modification showing a biologically powered pacer according to the present invention;
FIG. 11 is a still further modification showing another form of the biologically powered pacer; and
FIG. 12 is a modified catheter and an improved Pacemaker electrode assembly according to the teachings of this invention.
DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIGS. l-4, a self-contained stimulator 10, particularly is adapted as a heart pacer, and a catheter 11 is adapted for use with such pacer. The pacer 10 is formed with an elongated capsule-like, generally cylindrical body 12. Preferably, the body 12 is formed exclusively on its outer surfaces of biologically compatable materials, the major portion of which may be stainless steel. While the outer surface of the body 12 is shown in the drawings as being formed essentially of smooth inert material, such as stainless steel, it is within the scope of this invention to provide the body with a compatible flocking material, such as a dacron weave to promote the formation of neointima once the unit has been implanted.
The device can be implanted in any of the four chambers of the heart where patho-physiology would be optimum for a particular patient. However, the preferred embodiment herein will emphasize implantation within the right ventricle where the greatest clinical and experimental experience has been concentrated to date. When the stimulator, or pacer 10, is adapted for implantation directly within a heart ventricle, it should have a maximum overall length not substantially exceeding 30mm and preferably in the order of 18mm or less. The diameter of the body 12 should not substantially exceed 10mm and is preferably 8mm or less. Such dimensions provide a self-contained Pacemaker which is sufficiently small to permit catheter transvascular insertion into a ventricle, and permit it to be received within such ventricle without disturbing the proper function of the heart.
The forward end of the body 12 is provided with means for attaching the pacer 10 to the myocardium. A preferred form of the attachment comprises a pair of oppositely directed spiral stainless steel attaching points or wires 15 and 16, as best shown in FIG. 4. The wires have inner ends attached to the circumference of the body 12 and free outer ends. These attaching wires are adapted to be retained in a retracted position in closely surrounding relation to the circumference of the body 12, but when released, spring out to the expanded or operative position, as shown.
Catheter means for transvenous implanting of the Pacemaker 10 preferably consists of the triaxial device illustrated generally at 11 in FIGS. 1 and 2. This arrangement comprises a central rod 22 which is formed with a threaded end 23 which is adapted to be attached or received with a suitable internally threaded nut 24 formed on the rear wall 24' of the body 12, as shown in FIG. 3. A torque tube 25 is slidably received over the rod 22 and, at its forward end, is formed with an internal socket portion 26 adapted to be received over the nut 24 in driving engagement with the Pacemaker 10. The catheter is further provided with an axially slidable sheath 27 which has a forward metallic end portion 28 of a diameter sufficiently to be received at least partially over the body of the Pacemaker 10. In use, the sleeve 28 substantially covers the Pacemaker and retains the attaching wires 15 and 16 in their retracted position substantially as shown in FIG. 2. The use of the catheter 11 is further described in connection with the illustration of FIGS. 5a-c.
This entire catheter system may be rigid with defined bends or may be flexible or may be steerable. In the preferred fonn, a central rod 22 and the torque tube 25 are flexible, while the forward end of the sheath 27 is formed with a predetermined bend as indicated at 27 in FIG. 5a. The bend which may be formed within 2-4 inches of the end of the catheter assembly, may have an angle of approximately 30 in order to permit the catheter and the attached Pacemaker to be steerable around comers and bends.
Referring particularly to FIG. 3, the Pacemaker 10 is shown as including a forward body portion 12a and a cylindrically continuous rear body portion 12b. The forward portion is hollow and contains the electronic pulsing circuit 30, illustrative examples of which are shown in FIGS. 6 and 7. It has been found that relatively simple circuits are totally satisfactory and are in fact preferred over the more complicated circuits shown, for example, in the reference text referred to under the Background section of the specification. The simpler circuits generally have lower losses and greater overall reliability. Such circuits can easily be fitted within the activity defined with the body section 12a without the necessity of reverting to microminiature or integrated circuits. However, such circuits permit even further miniaturization, but the overall size of the stimulator of this invention is dictated not so much by the circuit requirements but by the space requirements of the power source.
The body sections 12a and 1212 may be threaded together and sealed as shown at 31, but it is within the scope of this invention to make the body 12 of simple one-piece construction. The rear wall 24' is preferred welded to the case 12b by electron beam welding. There is some advantage in the two-piece body construction of FIG. 3 in that it permits the body parts to be separated and adjustments to be made to the circuit prior to insertion.
One of the important advantages of the stimulator of the present invention resides in the fact that the pacing electrodes are formed integrally with outer surfaces of the body 12. To this end, the body portions 12a and 12b themselves define the positive pulsing electrode which, as previously noted, may be formed preferably of stainless steel. The negative pulsing electrode 32 is formed preferably of platinum and supported on a forwardly extending dielectric pedestal 33. The pedestal is preferably formed of an inert ceramic, defining a hollow co-axial insulator. The insulator 33 may thus have an outer curved surface 34 leading smoothly from the electrode end 32 and flaring outwardly at the body 12a to assist in guiding the device during insertion. A tubular portion 35 extends into the interior of the body 12a. The forward end of the body 12a is formed with an annular ledge 36 to provide support for the insulator and for the electrode 32.
The stimulating electrode 32 may also be of the differential current density type, known as the Parsonnet Electrode and described by George H. Myers and Victor Parsonnet in Engineering in the Heart and Blood Vessels, (1969) John Wiley & Sons, New York, N.Y.
The arrangement as shown has several important advantages. In the first place, it will be noted that, unlike prior devices, the electrodes do not themselves form or comprise the attaching devices. Rather, the pacing electrodes are well spaced axially from the barbs l5 and 16. Thus, once these electrodes have made reliable pacing contact with the heart tissue, they do not transmit the destructive forces of attachment and retention to this tissue, and they remain free of the adverse affects of fibrosis which invariably occurs at the regions of attachment or forcible retention. In devices where the electrodes themselves are directly attached or are forcibly retained by pressing against the tissue, an approximately l0 times increase in the threshold is not uncommon. This occurs over approximately a two to three week period subsequent to implanting and then reaches a plateau. Such a substantial increase in threshold requires a corresponding increase in power requirements simply to overcome the threshold and to effect reliable stimulation. The elimination of the cause of threshold rise permits reliable pacing with substantially lower power consumption.
Another important advantage of the construction of FIG. 3 is the total elimination of external flexible leads between the pacing circuit and the tissue to be stimulated. This then results in the elimination of the lead placement and breakage difficulties which are inherently associated with remotely positioned pacer circuit.
A further important advantage of the pacer of this invention is the fact that it can be reliably powered from a suitable nucleonic power source 40. There are available in the present state of the art a number of nucleonic conversion devices which may be contained within the physical dimensions of the body portion 12b, and suitably shielded and sealed therein. A preferred form of such device is a betavoltaic converter which is, in effect, a stack of semiconductor photocells which are coated with a radioactive material and which are irradiated by beta particles to produce an unidirectional current electric output. Beta sources may include Pm-147 which has a 2.7 years half life. It is within the state of the art to provide an electronic circuit which will operate effectively over more than three half-lives of such power sources within the volume available. The use of tritium, with a half life of 12.6 years, is also possible.
A power source 40 using radioisotope fuel may also be of the thermionic type, the thermoelectric type or the double conversion type. In the thermionic and thermoelectric types, heat from the radioisotopic fuel is transformed into electric power by electron transport through a thermionic diode or thermocouple respectively. In the double conversion type, radiation from the radiosotope fuel is employed to excite a lightemitting phosphor, and the photons in turn excite a semiconductor photocell. All three of these types can use Pu-238, which is a desirable fuel for biological applications and has a half life of 86 years. The choice of fuel and type of convertor will depend upon the cost of the source material and fabrication, the half life, and the efficiency of conversion as well as the shielding required. Suitable radioisotope-fueled batteries are made by Donald W. Douglas Laboratories, 2955 George Washington Way, Richland, Washington and sold under the tradenames Betacel and Isomite, representing beta-voltaic and thermionic types respectively. While nucleonic power sources are preferred by reason of long life, it is within the scope of the invention to employ rechargeable batteries, or mercury cells. The latter may be satisfactory for short term pacing, in view of the relatively high overall efficiency of the device.
As shown in FIG. 3, an insulated plate 41 in contact with the power source is hermetically sealed by an insulator 42, and leads 43 extend to the circuit contained within the body section 12a. The case 12 is negative with respect to the power source but is positive with respect to the biological load.
The diagram of FIG. 6 illustrates one form of the pulsing circuit in which a power source 40 is shown as providing an output voltage of approximately 39 volts. This output is applied through charging resistor 44 and through the load 45 to a capacitor 46. The time required to charge the capacitor will depend upon the charging time constant of the circuit, and since the biological load 45 is normally less than 1,000 ohms it forms a small part of the total resistance in the charging circuit. However, as long as the load 45 is present the circuit will charge.
The transistors 48 and 49 comprise a transistor switch. This switch automatically becomes conductive to connect one side of the capacitor 46 to ground at some predetermined potential during the charging of the capacitor 46, and thus provides a low impedence grounding circuit permitting a discharge of the capacitor through the load 45. The peak load voltage may be 1.3 volts, and the transistor switch may be conductive for 3ms. Thereafter, the current through the switching circuit drops to the point where it becomes nonconductive, and recharging of the capacitor 46 resumes through resistor 44, at a repetitive rate depending on the R-C constant.
It might also be noted that since the capacitor 46 is charged through the biological load a current reversal takes place between the negative pulsing electrode 32 and the case 12 which has the effect of reducing or eliminating polarization which otherwise occurs when electrodes are pulsed in the same direction in an electrolytic solution.
The diagram of FIG. 7 is essentially for the same circuit as shown in FIG. 6 except for the addition of a constant current element 50 which may comprise a constant current transistor. This circuit is useful to maintain a constant pulse height and rate when the pulsing circuit is used with nucleonic power source whose output decays with time, or with biologically activated power sources whose output varies with the amount of biological activity.
The method of implanting the Pacemaker of the present invention using the improved catheter is illustrated diagrammatically in FIG. 5. The Pacemaker is assembled with the catheter 11 as shown in FIG. 2. The catheter is formed with a fixed or predetermined bend 27 about two to three inches from the end, of about 2040 to enable it to turn corners while it is being in serted. The insertion technique itself is essentially the same as currently in use for the transvenous implantation of endocardiac electrodes and other cardiac catherization procedures. The Pacemaker may, for instance, be inserted in the right external jugular vein and advanced through the superior vena cava and through the right atrium into the apex of the right ventricular cavity. This is the position illustrated in FIG. a. This is accomplished, of course, under fluoroscopic observation.
Prior to attaching the Pacemaker, the effectiveness of its resting position may first be observed with an electrocardiograph to assure that it is functioning normally and that it has captured the heart. The end 28 of the sheath 27 is preferably made of conductive material, such as stainless steel, so that the electrode formed on the body 12 will conduct through the sheath.
Having determined a proper position, the sheath may be partially retracted as shown in FIG. 5b to expose the barbs, and the torque tube 25 rotated clockwise to imbed the barbs in the myocardium. The entire Pacemaker, in this condition, will be wedged into the trabeculae making contact both with the case and with the tip electrode 32.
Once attachment in this manner is made, the torque tube 25 may be held against rotation and the rod 23 unscrewed from the internal threads in the nut 24. The entire catheter may then be extracted leaving the Pacemaker imbedded essentially as shown in FIG. 5c. The Pacemaker can be extracted from the heart by reversing the foregoing procedure.
The invention is not limited to heart pacing as such. Other examples of the direct implantation of the selfcontained stimulator at the site of the stimulation without separate electrical leads include baropacing (stimulation of the baroreceptors in the neck or aortic arch), stimulation of the diaphragm for breathing (stimulation of the phrenic nerve), stimulation of the numerous sphincter muscles which control the flow of various body fluids and solids (at the sphincter site), and other such functions which have been shown to respond to electrical stimulation and which small size and absence of electrical leads would render feasible or more practical. In most such cases the self-contained stimulator described in FIG. 3 would deliver a pulse approximately every 20 milliseconds during activation of the biological function instead of about one pulse per second as in the cardiac Pacemaker. Activation of the pulse train could beaccomplished by external command via an electromagnetic or magnetic signal from outside the body.
The invention is not limited to an arrangement which contains an internal source of power. In FIG. 8 there is illustrated an embodiment of the invention which is responsive to hemodynamic pressure. The body section 12b is replaced by a flexible or movable section which incorporates a rubber diaphragm or metal bellows 60 which moves under the influence of pressure changes within the heart cavity. Forces and motions arising from such pressure changes are applied to an electromechanical transducer 62 the output of which may be applied to a suitable energy storing circuit 63. The transducer may be of the magnetic induction type or may be a piezoelectric generator. The storage device 63 may be a diode-isolated full-wave rectifier with capacitor storage. The energy thus stored is available for subsequent release to the stimulation electrodes by a pulse forming circuit substantially as previously described. The storage device will be kept charged by the succession of heart beats and therefore serves the function of the power source previously described.
For example, if the effective area of the movable section 65 is about /2Cm and moves 1mm under the influence of a 20 torr average pressure pulse, each beat would produce about microjoules of mechanical work. Since less than 10 microjoules of electric energy is required for each pulse, a large margin of reserve power is available.
A circuit diagram at FIG. 9 shows an arrangement of the pacer of FIG. 8 adapted as a synchronous pacer, to obtain the benefits from synchronous pacing by slaving the unit to the atriol systole. After storing the large power pulse generated by the transducer during the ventricular contraction, the pulse-forming circuit is armed;" i.e. it reaches a condition in which the next significant electrical signal from the transducer will cause the circuit to tire and deliver an electrical pulse to the stimulating electrodes. Therefore, the pressure impulse from the next atrial contraction is transmitted through the tricuspid valve to generate an electrical signal from the transducer which tires the circuit. The stimulated ventricular contractions thereby become synchronized with the atrial contractions. It may be desirable to construct the circuit so that arming is delayed until after the refractory period of the heartbeat to avoid premature firing by reverberations from the ventricular contraction. Also it may be desirable physiologically to provide a delay between the signal from the atrial contraction and the Pacemaker output pulse, similar to the delay in the A-V node.
FIGS. 10 and 11 illustrate additional arrangements by means of which the heart movement itself can be used to provide a suitable source of energy. Observation has shown that an implanted Pacemaker undergoes transient displacements of about 1cm within a 24th of a second. Assuming constant acceleration, a mm displacement relative to the capsule over l/24th second of an armature weighing 4 grams would produce a force of about 2500 dynes acting over this distance, to produce about 120 microjoules of work per beat, again substantially in excess of the requirements of the Pacemaker. Referringto FIG. 10, a mass 70 is mounted in the manner of a pendulum on the end of a leaf spring 72. The natural oscillation rate of the mass 70 on the spring 72 may be that of the paced heart rate. The lower end of the spring 72 is joint with a magnetic armature 75 received between the poles 76 and 77 of a permanent magnet 78.
The lower end of the armature is retained in a V- shaped recess 79 by the magnetic attraction and is correspondingly formed with a knife or V-edge 80 to provide a pivotal movement. The poles 76 and 77 are spaced apart so that the armature 75 can assume either one of two stable positions, as shown by the full lines and broken lines. In one position, the flux is induced through the armature in one direction while in the other position it is induced in the opposite direction.
Since the pendulum formed by the mass 70 and spring 72 oscillates in resonance with the sinus rate of the heart, the bending moment of the spring 72 lifts the armature 75 from one pole face whereupon it abruptly moves to the opposite pole face, resulting in a sudden reversal of the flux and inducing an electric current in the surrounding coil 82. The coil output may be applied to the storage device 63, as described in connection with FIG. 8. FIG. 11 is similar to FIG. except that the mass 70 and the spring 72 are connected to stress a piezoelectric crystal 85. In this embodiment, the periodic rate of the mass and spring may be substantially greater than that of the heart, to produce a ringing effect with each beat.
Certain of the teachings and advantages of the present invention may be used to improve the performance of existing pacemakers which presently use endocardinal electrodes. The body Pacemaker 10 may be modified for this purpose to perform the function of the electrodes only and an arrangement for this purpose is illustrated at 100 in FIG. 12. In this case, the cartridge body 112 is made similarly to the body 12 except that it does not contain any pulsing circuitry or power source, but merely comprises means for making electrical contact. Thus, the body 112 may conveniently be made to a smaller length and/or diameter than that which has previously been described. The outer surface of the body 112 thus comprises one of the electrodes, while stimulating electrode 132 may be made and supported on a ceramic pedestal spaced from the body 1 12 in the manner which has been described in connection with the electrode 32 of FIG. 3.
The electrode assembly 100 will be connected by flexible leads to a conventional remote pacer by means of a flexible electrical conduit or lead 122. The lead 122 may be a coaxial conductive cable, which has one of its leads connected to the case or body 112 and the other connected to the electrode 132. The assembly may be used with remote pacers which employ a single electrode lead or a pair of leads. Where a single lead is used, it would be connected inside the body 112 to the electrode 132.
The electrode assembly of this invention is provided with a somewhat modified form of attachment comprising a pair of generally axially extending retaining wires 115 and 116. The forward ends of the wires are attached or secured to the body 12. The wires extend rearwardly and outwardly, and are movable between a retracted position in which the wires lie adjacent to the outer surface of the body, to a spread apart position, substantially as shown.
The general technique of inserting and implanting the electrode assembly 100 does not differ substantially from that described in connection with the pacemaker 10. The torque tube 25 and the sheath 27 may be used, with the rod 22 removed. The cylindrical conductive end 28 would be received partially over the body 112 with the attaching wires 115 and 116 collapsed and retained within end 28. The electrical lead 122 is threaded through the hollow torque tube 25.
It would be expected that the electrode assembly would be inserted well into the apex of the ventricle cavity accompanied by some stretching of the heart muscle. The torque tube 25 could be employed to provide axial forces as well as rotational alignment. The sheath 27 would then be retracted exposing the ends of the attachment wires 115 and 116, and when the axial force is released the ends of the wires would tend to imbed themselves within the heart muscle. If necessary, some pull could be placed on the lead 122 to complete the attachment, andthen the catheter may be extracted leaving the electrode assembly 100 in place.
The electrode assembly 100 provides to a remote Pacemaker certain of the advantages of the present invention. Principally, the electrodes, which are formed as integral and discrete surface portions of the assembly, are not prone to dislodgement, movement, penetration or breakage. Further, they define regions of stimulation which are spaced from the region of attachment, as in the case of the Pacemaker 10, and thus remain free of the adverse affects of fibrosis.
It is accordingly seen that this invention provides a novel self-contained biological stimulator, which is particularly adapted for use as a Pacemaker, and an electrode assembly useful with existing Pacemakers. It is intended for long-term treatment of partial or complete A-V block. Synchronous pacing may be used, as desired, and the circuit can be modified as known in the art for demand pacing. For synchronous pacing of de vices of the types of FIGS. 3, 10 or 11, a short sensing or trigger electrode wire may extend axially from the rear wall 24 of the body 12b through the tricuspid valve into the right atrium to pick up the atrium pulse as a control signal for the circuit 30. For demand pacing, the surface electrode 32 may be used to pick up the ventricle pulse and suppress the trigger circuit in the manner taught for example by Keller US. Pat. No. 3,431,912 or Greatbatch US. Pat. No. 3,478,746. The physical size of the capsules which form the bodies is sufficiently small to permit long-term treatment, such as in the case of a child. The apparatus and method of the attachment and implanting is one which results in minimum discomfort to the patient. In the event of failure, the size of the Pacemaker is sufficiently small to make it feasible to simply leave it in place and to insert a new one, although intervenous removal by catheter also is possible.
While the forms of apparatus herein described constitute preferred embodiments of the invention, it is to be understood that the invention is not limited to these precise forms of apparatus, and that changes may be made therein without departing from the scope of the invention.
What is claimed is:
1. A stimulator device for insertion in a living body and having particular advantage for intracardiac use comprising a structure having a body form for transvenous or transarterial insertion, electrode means on the surface of said body form for contact with a portion of the living body to be stimulated by said electrode means, and means mounted to project outwardly of and peripherally of said body form including anchor portions locating in a position displaced from said electrode means and providing means for engaging in portions of said living body to establish said electrode means in a required position of use, said electrode means having in connection therewith means to energize the same once said body form is located in its required position of use.
2. A stimulator device as in claim 1 wherein said means to energize said electrode means includes a power source positioning in a location remote from said body form.
3. A stimulator device as in claim 1 wherein said means to energize said electrode means includes a power source embodied within said body fonn.
4. A stimulator device as in claim 1 wherein spaced surface portions of said body form define separate electrode means.
5. A structure as in claim 1 wherein said anchor portions are defined by wire like segments connected with and biased to normally project outwardly from said body form to facilitate the establishment of a connection thereof with said living body in an area displaced from said electrode means.
6. A stimulator device as in claim 1 wherein said electrode means have a fixed positioning in respect to said body form and comprise at least two electrodes, and said body form includes insulator means separating said electrodes.
7. A stimulator device as in claim 1 characterized by said body form being a unitized structure having means for guiding the same for transvenous or transarterial insertion.
v dm' rrb STAEES PATENT eFwcE CERT?FECAXJEfi? QUREC'HQN Patent No. 3,835,864 Dated September 17, 1974 Inventor(s)@ Nd S Raqn-r and jincn nh W qgirdz'lar It is certified that error appears in the above-identified patent and that said Letters Patent are hereby corrected as shown below:
Col. 5, line 6, "activity" has been correoted to read cavity line 1.6, "preferred" has been corrected to read preferably Col. line 32, "radiosotope" has been corrected to I Q read radioisotope Signed and sealed this 18th day of February-1975.
' C. MARSHALL DANN RUTH C. MASON Commissioner of Parents Arresting Officer and Trademarks
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3087486 *||Mar 5, 1959||Apr 30, 1963||Cenco Instr Corp||Cardiac electrode means|
|US3516412 *||Mar 5, 1969||Jun 23, 1970||Electro Catheter Corp||Bipolar electrode having irregularity at inserting end thereof and method of insertion|
|SU246004A *||Title not available|
|1||*||Frei et al. Medical Research Engineering, 4th Quarter, 1956, pp. 11 18.|
|2||*||Hopps et al., Surgery, Vol. 36, No. 4, Oct., 1954, pp. 833 849 (only p. 834 relied on).|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US3902501 *||Jun 21, 1973||Sep 2, 1975||Medtronic Inc||Endocardial electrode|
|US3920888 *||Jun 4, 1974||Nov 18, 1975||Nuclear Battery Corp||Electrical feed-through assembly suitable for electronic devices implantable in a human body|
|US3926198 *||May 2, 1975||Dec 16, 1975||Arco Med Prod Co||Cardiac pacer|
|US3976082 *||Feb 24, 1975||Aug 24, 1976||German Schmitt||Intracardial stimulation electrode|
|US4010758 *||Sep 3, 1975||Mar 8, 1977||Medtronic, Inc.||Bipolar body tissue electrode|
|US4014346 *||Jun 26, 1975||Mar 29, 1977||Research Corporation||Hermetically sealed cardiac pacer system and recharging system therefor|
|US4066085 *||May 20, 1976||Jan 3, 1978||Cordis Corporation||Contact device for muscle stimulation|
|US4134408 *||Nov 12, 1976||Jan 16, 1979||Research Corporation||Cardiac pacer energy conservation system|
|US4140132 *||Mar 23, 1978||Feb 20, 1979||Dahl Joseph D||Variable rate timer for a cardiac pacemaker|
|US4142531 *||Dec 2, 1977||Mar 6, 1979||Coratomic, Inc.||Catheter|
|US4144890 *||Dec 19, 1976||Mar 20, 1979||Cordis Corporation||Contact device for muscle stimulation|
|US4157720 *||Sep 16, 1977||Jun 12, 1979||Greatbatch W||Cardiac pacemaker|
|US4233992 *||Jul 19, 1978||Nov 18, 1980||Bisping Hans Juergen||Implantable electrode|
|US4254764 *||Mar 1, 1979||Mar 10, 1981||Neward Theodore C||Clip electrode|
|US4256115 *||Jan 14, 1980||Mar 17, 1981||American Technology, Inc.||Leadless cardiac pacer|
|US4299239 *||Feb 5, 1979||Nov 10, 1981||Intermedics, Inc.||Epicardial heart lead assembly|
|US4301815 *||Jan 23, 1980||Nov 24, 1981||Telectronics Pty. Limited||Trailing tine electrode lead|
|US4369791 *||Apr 13, 1981||Jan 25, 1983||Medtronic, Inc.||Body implantable electrode|
|US4414986 *||Jan 29, 1982||Nov 15, 1983||Medtronic, Inc.||Biomedical stimulation lead|
|US4452254 *||Jul 13, 1981||Jun 5, 1984||Goldberg Edward M||Cardiac electrode and method for installing same|
|US4501276 *||Jul 16, 1982||Feb 26, 1985||Illinois Tool Works Inc.||Fetal electrode apparatus|
|US4564023 *||Mar 28, 1983||Jan 14, 1986||Cordis Corporation||Retention skirt for pacing electrode assembly|
|US4590949 *||Nov 1, 1984||May 27, 1986||Cordis Corporation||Neural stimulating lead with stabilizing mechanism and method for using same|
|US4669488 *||Oct 7, 1985||Jun 2, 1987||Cordis Corporation||Retention skirt for pacing electrode assembly|
|US4690143 *||Jan 24, 1986||Sep 1, 1987||Cordis Corporation||Pacing lead with piezoelectric power generating means|
|US4799499 *||Aug 8, 1986||Jan 24, 1989||Bisping Hans Juergen||Implantable electrode with active fixation means|
|US4825871 *||May 18, 1987||May 2, 1989||Societe Anonyme Dite: Atesys||Defibrillating or cardioverting electric shock system including electrodes|
|US4832032 *||Sep 8, 1987||May 23, 1989||La Jolla Technology, Inc.||Electrical apparatus protective interconnect|
|US5133353 *||Apr 25, 1990||Jul 28, 1992||Cardiac Pacemakers, Inc.||Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode|
|US5385574 *||Jul 24, 1992||Jan 31, 1995||Cardiac Pacemakers, Inc.||Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode|
|US5709644 *||Jun 14, 1996||Jan 20, 1998||Pacesetter, Inc.||Implantable suture sleeve modified to reduce tissue ingrowth|
|US5713945 *||Jun 13, 1996||Feb 3, 1998||Pacesetter, Inc.||Implantable lead modified to reduce tissue ingrowth|
|US5908447 *||Feb 6, 1998||Jun 1, 1999||Intermedics Inc.||Breakaway structure for body implantable medical device|
|US5941904 *||Sep 12, 1997||Aug 24, 1999||Sulzer Intermedics Inc.||Electromagnetic acceleration transducer for implantable medical device|
|US6200260||Oct 2, 1998||Mar 13, 2001||Fore Flow Corporation||Implantable heart assist system|
|US6299575||Apr 25, 2000||Oct 9, 2001||Orqis Medical Corporation||Implantable heart assist system|
|US6387037||Dec 23, 1999||May 14, 2002||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US6390969||Apr 21, 2000||May 21, 2002||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US6405091 *||Jul 20, 1999||Jun 11, 2002||Pacesetter, Inc.||Lead assembly with masked microdisk tip electrode and monolithic controlled release device|
|US6428464||Apr 9, 1999||Aug 6, 2002||Orqis Medical Corporation||Implantable heart assist system|
|US6480740||Dec 26, 2000||Nov 12, 2002||Cardiac Pacemakers, Inc.||Safety pacing in multi-site CRM devices|
|US6493586||Aug 30, 2000||Dec 10, 2002||Cardiac Pacemakers, Inc.||Site reversion in cardiac rhythm management|
|US6584362||Aug 30, 2000||Jun 24, 2003||Cardiac Pacemakers, Inc.||Leads for pacing and/or sensing the heart from within the coronary veins|
|US6610004||Feb 15, 2002||Aug 26, 2003||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US6654638 *||Apr 6, 2000||Nov 25, 2003||Cardiac Pacemakers, Inc.||Ultrasonically activated electrodes|
|US6685621||Jun 11, 2002||Feb 3, 2004||Orois Medical Corporation||Implantable heart assist system and method of applying same|
|US6754536||Jan 30, 2002||Jun 22, 2004||Medtronic, Inc||Implantable medical device affixed internally within the gastrointestinal tract|
|US6827682||Dec 19, 2001||Dec 7, 2004||Mogens Bugge||Implantable device for utilization of the hydraulic energy of the heart|
|US6889082||Nov 6, 2002||May 3, 2005||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US6922589||Dec 9, 2002||Jul 26, 2005||Cardiac Pacemakers, Inc.||Site reversion in cardiac rhythm management|
|US6963774||Nov 8, 2002||Nov 8, 2005||Cardiac Pacemakers, Inc.||Safety pacing in multi-site CRM devices|
|US6999814||Jun 19, 2001||Feb 14, 2006||Cardiac Pacemakers, Inc.||Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode|
|US7058449||May 5, 2004||Jun 6, 2006||Cardiac Pacemakers, Inc.||Safety pacing in multi-site CRM devices|
|US7081084 *||Jul 16, 2002||Jul 25, 2006||University Of Cincinnati||Modular power system and method for a heart wall actuation system for the natural heart|
|US7125376||Apr 7, 2003||Oct 24, 2006||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US7139614||May 7, 2003||Nov 21, 2006||Cardiac Pacemakers, Inc.||Leads for pacing and/or sensing the heart from within the coronary veins|
|US7144365||Dec 5, 2003||Dec 5, 2006||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US7158838||Jan 31, 2003||Jan 2, 2007||Medtronic, Inc.||Arrangement for implanting a miniaturized cardiac lead having a fixation helix|
|US7252005||Aug 18, 2004||Aug 7, 2007||Alfred E. Mann Foundation For Scientific Research||System and apparatus for sensing pressure in living organisms and inanimate objects|
|US7331921||Jun 28, 2004||Feb 19, 2008||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US7445592||Jun 10, 2004||Nov 4, 2008||Orqis Medical Corporation||Cannulae having reduced flow resistance|
|US7458929||May 3, 2005||Dec 2, 2008||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US7509174 *||Nov 14, 2002||Mar 24, 2009||Intrapace, Inc.||Gastric treatment/diagnosis device and attachment device and method|
|US7513863||Jun 28, 2004||Apr 7, 2009||Orqis Medical Corporation||Implantable heart assist system and method of applying same|
|US7522959||Dec 30, 2004||Apr 21, 2009||Cardiac Pacemakers, Inc.||Subcutaneous cardiac rhythm management|
|US7529589||Jun 4, 2004||May 5, 2009||Synecor Llc||Intravascular electrophysiological system and methods|
|US7532933||Oct 20, 2004||May 12, 2009||Boston Scientific Scimed, Inc.||Leadless cardiac stimulation systems|
|US7596413||Jun 8, 2004||Sep 29, 2009||Cardiac Pacemakers, Inc.||Coordinated therapy for disordered breathing including baroreflex modulation|
|US7617007||Oct 29, 2004||Nov 10, 2009||Synecor Llc||Method and apparatus for retaining medical implants within body vessels|
|US7623926||Apr 5, 2004||Nov 24, 2009||Cvrx, Inc.||Stimulus regimens for cardiovascular reflex control|
|US7630765||Jun 1, 2006||Dec 8, 2009||Cardiac Pacemakers, Inc.||Safety pacing in multi-site CRM devices|
|US7647109||Jan 12, 2010||Boston Scientific Scimed, Inc.||Leadless cardiac stimulation systems|
|US7650186||Jan 19, 2010||Boston Scientific Scimed, Inc.||Leadless cardiac stimulation systems|
|US7658705||Dec 8, 2005||Feb 9, 2010||Cardioenergetics, Inc.||Actuation mechanisms for a heart actuation device|
|US7715918||Oct 18, 2006||May 11, 2010||University Of Cincinnati||Muscle energy converter with smooth continuous tissue interface|
|US7734343||May 31, 2006||Jun 8, 2010||Synecor, Llc||Implantable intravascular device for defibrillation and/or pacing|
|US7747323||Jun 29, 2010||Cardiac Pacemakers, Inc.||Adaptive baroreflex stimulation therapy for disordered breathing|
|US7747335 *||Jun 29, 2010||Synecor Llc||Implantable medical device having pre-implant exoskeleton|
|US7753837||Jul 13, 2010||The University Of Cincinnati||Power system for a heart actuation device|
|US7801614||Oct 23, 2006||Sep 21, 2010||Cvrx, Inc.||Stimulus regimens for cardiovascular reflex control|
|US7813812||Oct 12, 2010||Cvrx, Inc.||Baroreflex stimulator with integrated pressure sensor|
|US7840271||Jul 20, 2005||Nov 23, 2010||Cvrx, Inc.||Stimulus regimens for cardiovascular reflex control|
|US7840281||Nov 23, 2010||Boston Scientific Scimed, Inc.||Delivery of cardiac stimulation devices|
|US7850729||Dec 14, 2010||The University Of Cincinnati||Deforming jacket for a heart actuation device|
|US7890191||Feb 15, 2011||Medtronic, Inc.||Implantable medical device system with fixation member|
|US7894914||Aug 28, 2007||Feb 22, 2011||Cardiac Pacemakers, Inc.||Medical device electrodes including nanostructures|
|US7899554||Mar 1, 2011||Synecor Llc||Intravascular System and Method|
|US7904179||Mar 8, 2011||Medtronic, Inc.||Implantable medical device system with fixation member|
|US7925352||Apr 12, 2011||Synecor Llc||System and method for transvascularly stimulating contents of the carotid sheath|
|US7933661 *||Apr 26, 2011||Medtronic, Inc.||Lead retention means|
|US7937148||May 3, 2011||Nanostim, Inc.||Rate responsive leadless cardiac pacemaker|
|US7937161||May 3, 2011||Boston Scientific Scimed, Inc.||Cardiac stimulation electrodes, delivery devices, and implantation configurations|
|US7945333||Oct 13, 2006||May 17, 2011||Nanostim, Inc.||Programmer for biostimulator system|
|US7949400||May 24, 2011||Cvrx, Inc.||Devices and methods for cardiovascular reflex control via coupled electrodes|
|US7974710||Apr 28, 2005||Jul 5, 2011||Medtronic, Inc.||Guide catheters for accessing cardiac sites|
|US7979127||May 25, 2010||Jul 12, 2011||Intrapace, Inc.||Digestive organ retention device|
|US7991480||Aug 28, 2007||Aug 2, 2011||Cardiac Pacemakers, Inc.||Medical device electrodes having cells disposed on nanostructures|
|US8003879 *||Mar 5, 2007||Aug 23, 2011||Cardiac Pacemakers, Inc.||Method and apparatus for in vivo thermoelectric power system|
|US8010209||Aug 30, 2011||Nanostim, Inc.||Delivery system for implantable biostimulator|
|US8039727||Oct 18, 2011||Cardiac Pacemakers, Inc.||Method and apparatus for shunt for in vivo thermoelectric power system|
|US8050774||Nov 1, 2011||Boston Scientific Scimed, Inc.||Electrode apparatus, systems and methods|
|US8050775||Oct 29, 2009||Nov 1, 2011||Cardiac Pacemakers, Inc.||Coronary vein lead having pre-formed biased portions for fixation|
|US8060206||Nov 15, 2011||Cvrx, Inc.||Baroreflex modulation to gradually decrease blood pressure|
|US8086314 *||Dec 27, 2011||Cvrx, Inc.||Devices and methods for cardiovascular reflex control|
|US8109879||Jan 10, 2006||Feb 7, 2012||Cardiac Pacemakers, Inc.||Assessing autonomic activity using baroreflex analysis|
|US8116883||Feb 2, 2007||Feb 14, 2012||Synecor Llc||Intravascular device for neuromodulation|
|US8185213||Oct 22, 2010||May 22, 2012||Boston Scientific Scimed, Inc.||Delivery of cardiac stimulation devices|
|US8204605||Feb 4, 2009||Jun 19, 2012||Cardiac Pacemakers, Inc.||Multi-site atrial electrostimulation|
|US8260417||Sep 4, 2012||Cardiac Pacemakers, Inc.||Safety pacing in multi-site CRM devices|
|US8290595 *||Oct 16, 2012||Cvrx, Inc.||Method and apparatus for stimulation of baroreceptors in pulmonary artery|
|US8290600||Jul 21, 2006||Oct 16, 2012||Boston Scientific Scimed, Inc.||Electrical stimulation of body tissue using interconnected electrode assemblies|
|US8295939||Oct 23, 2012||Nanostim, Inc.||Programmer for biostimulator system|
|US8301248||Oct 30, 2012||Boston Scientific Neuromodulation Corporation||Sequenced and simultaneous stimulation for treating congestive heart failure|
|US8311633||Dec 4, 2007||Nov 13, 2012||Synecor Llc||Intravascular implantable device having superior anchoring arrangement|
|US8332029||Jun 28, 2006||Dec 11, 2012||Bioness Inc.||Implant system and method using implanted passive conductors for routing electrical current|
|US8332036||Mar 8, 2007||Dec 11, 2012||Boston Scientific Scimed, Inc.||Leadless cardiac stimulation systems|
|US8340780||May 7, 2007||Dec 25, 2012||Scimed Life Systems, Inc.||Leadless cardiac stimulation systems|
|US8352025||Oct 13, 2006||Jan 8, 2013||Nanostim, Inc.||Leadless cardiac pacemaker triggered by conductive communication|
|US8352028||Apr 26, 2010||Jan 8, 2013||Medtronic, Inc.||Intravascular medical device|
|US8369954||Mar 7, 2011||Feb 5, 2013||Synecor Llc||System and method for transvascularly stimulating contents of the carotid sheath|
|US8403866||Mar 26, 2013||Medtronic, Inc.||Guide catheters for accessing cardiac sites|
|US8406886||Mar 9, 2009||Mar 26, 2013||Rehabtronics, Inc.||Method of routing electrical current to bodily tissues via implanted passive conductors|
|US8442638||May 17, 2010||May 14, 2013||Cardiac Pacemakers, Inc.||Adaptive baroreflex stimulation therapy for disordered breathing|
|US8457742||Oct 13, 2006||Jun 4, 2013||Nanostim, Inc.||Leadless cardiac pacemaker system for usage in combination with an implantable cardioverter-defibrillator|
|US8467880||Jun 18, 2013||Bioness Inc.||System for transmitting electrical current to a bodily tissue|
|US8478408||Mar 8, 2007||Jul 2, 2013||Boston Scientific Scimed Inc.||Leadless cardiac stimulation systems|
|US8483820||Oct 4, 2007||Jul 9, 2013||Bioness Inc.||System and method for percutaneous delivery of electrical stimulation to a target body tissue|
|US8498721||Oct 3, 2011||Jul 30, 2013||Cardiac Pacemakers, Inc.||Coronary vein leads having pre-formed biased portions for fixation|
|US8504156||Aug 26, 2011||Aug 6, 2013||Medtronic, Inc.||Holding members for implantable cardiac stimulation devices|
|US8527068||Feb 2, 2010||Sep 3, 2013||Nanostim, Inc.||Leadless cardiac pacemaker with secondary fixation capability|
|US8535222||Mar 13, 2007||Sep 17, 2013||Cardiac Pacemakers, Inc.||Sleep detection using an adjustable threshold|
|US8538517||Sep 14, 2012||Sep 17, 2013||Bioness Inc.||Implant, system and method using implanted passive conductors for routing electrical current|
|US8538529||Mar 5, 2007||Sep 17, 2013||Cardiac Pacemakers, Inc.||Power converter for use with implantable thermoelectric generator|
|US8543205||Oct 12, 2011||Sep 24, 2013||Nanostim, Inc.||Temperature sensor for a leadless cardiac pacemaker|
|US8571662||Jan 29, 2008||Oct 29, 2013||Simon Fraser University||Transvascular nerve stimulation apparatus and methods|
|US8583236 *||Mar 8, 2010||Nov 12, 2013||Cvrx, Inc.||Devices and methods for cardiovascular reflex control|
|US8594794||Jul 17, 2008||Nov 26, 2013||Cvrx, Inc.||Baroreflex activation therapy with incrementally changing intensity|
|US8606356||Aug 17, 2004||Dec 10, 2013||Cardiac Pacemakers, Inc.||Autonomic arousal detection system and method|
|US8606359||Apr 13, 2007||Dec 10, 2013||Cvrx, Inc.||System and method for sustained baroreflex stimulation|
|US8615310||Dec 13, 2011||Dec 24, 2013||Pacesetter, Inc.||Delivery catheter systems and methods|
|US8630710 *||Mar 1, 2007||Jan 14, 2014||The Board Of Trustees Of The Leland Stanford Junior University||Implanted cardiac device for defibrillation|
|US8634912||Jan 17, 2012||Jan 21, 2014||Pacesetter, Inc.||Dual-chamber leadless intra-cardiac medical device with intra-cardiac extension|
|US8644934||Sep 13, 2007||Feb 4, 2014||Boston Scientific Scimed Inc.||Cardiac stimulation using leadless electrode assemblies|
|US8670842||Dec 14, 2012||Mar 11, 2014||Pacesetter, Inc.||Intra-cardiac implantable medical device|
|US8700181||Jan 17, 2012||Apr 15, 2014||Pacesetter, Inc.||Single-chamber leadless intra-cardiac medical device with dual-chamber functionality and shaped stabilization intra-cardiac extension|
|US8712531||May 24, 2012||Apr 29, 2014||Cvrx, Inc.||Automatic baroreflex modulation responsive to adverse event|
|US8718789||Apr 19, 2010||May 6, 2014||Cvrx, Inc.||Electrode structures and methods for their use in cardiovascular reflex control|
|US8738137||Dec 1, 2009||May 27, 2014||Bioness Inc.||System for transmitting electrical current to a bodily tissue|
|US8738147||Jan 29, 2009||May 27, 2014||Cardiac Pacemakers, Inc.||Wireless tissue electrostimulation|
|US8781605||Jan 17, 2012||Jul 15, 2014||Pacesetter, Inc.||Unitary dual-chamber leadless intra-cardiac medical device and method of implanting same|
|US8788035||Dec 7, 2012||Jul 22, 2014||Pacesetter, Inc.||Leadless cardiac pacemaker triggered by conductive communication|
|US8788053||Oct 17, 2012||Jul 22, 2014||Pacesetter, Inc.||Programmer for biostimulator system|
|US8798745||Apr 19, 2013||Aug 5, 2014||Pacesetter, Inc.||Leadless cardiac pacemaker system for usage in combination with an implantable cardioverter-defibrillator|
|US8818504||Dec 16, 2004||Aug 26, 2014||Cardiac Pacemakers Inc||Leadless cardiac stimulation device employing distributed logic|
|US8838246 *||Sep 27, 2006||Sep 16, 2014||Cvrx, Inc.||Devices and methods for cardiovascular reflex treatments|
|US8855789||Jul 26, 2011||Oct 7, 2014||Pacesetter, Inc.||Implantable biostimulator delivery system|
|US8862225||Sep 16, 2013||Oct 14, 2014||Bioness Inc.||Implant, system and method using implanted passive conductors for routing electrical current|
|US8880190||Nov 30, 2012||Nov 4, 2014||Cvrx, Inc.||Electrode structures and methods for their use in cardiovascular reflex control|
|US8914131||Feb 21, 2014||Dec 16, 2014||Pacesetter, Inc.||Method of implanting a single-chamber leadless intra-cardiac medical device with dual-chamber functionality and shaped stabilization intra-cardiac extension|
|US8956295||Sep 9, 2013||Feb 17, 2015||Cardiac Pacemakers, Inc.||Sleep detection using an adjustable threshold|
|US8996109||May 31, 2012||Mar 31, 2015||Pacesetter, Inc.||Leadless intra-cardiac medical device with dual chamber sensing through electrical and/or mechanical sensing|
|US9002467||Oct 9, 2014||Apr 7, 2015||Cardiac Pacemakers, Inc.||Modular antitachyarrhythmia therapy system|
|US9008777 *||Jun 21, 2012||Apr 14, 2015||Pacesetter, Inc.||Leadless intra-cardiac medical device with reduced number of feed-thrus|
|US9014819||Nov 12, 2013||Apr 21, 2015||Cardiac Pacemakers, Inc.||Autonomic arousal detection system and method|
|US9017341||Jan 17, 2012||Apr 28, 2015||Pacesetter, Inc.||Multi-piece dual-chamber leadless intra-cardiac medical device and method of implanting same|
|US9020611||Oct 12, 2011||Apr 28, 2015||Pacesetter, Inc.||Leadless cardiac pacemaker with anti-unscrewing feature|
|US9026231||Sep 26, 2014||May 5, 2015||Simon Fraser University||Transvascular nerve stimulation apparatus and methods|
|US9044609||Nov 18, 2011||Jun 2, 2015||Cvrx, Inc.||Electrode structures and methods for their use in cardiovascular reflex control|
|US9060692||May 23, 2013||Jun 23, 2015||Pacesetter, Inc.||Temperature sensor for a leadless cardiac pacemaker|
|US9072886||Feb 14, 2014||Jul 7, 2015||Rehabtronics, Inc.||Method of routing electrical current to bodily tissues via implanted passive conductors|
|US9072896||Dec 1, 2010||Jul 7, 2015||Bioness Inc.||System for transmitting electrical current to a bodily tissue|
|US9072911||Jun 27, 2013||Jul 7, 2015||Boston Scientific Scimed, Inc.||Leadless cardiac stimulation systems|
|US9072913||Apr 29, 2011||Jul 7, 2015||Pacesetter, Inc.||Rate responsive leadless cardiac pacemaker|
|US9108058||Jul 31, 2014||Aug 18, 2015||Simon Fraser University||Transvascular nerve stimulation apparatus and methods|
|US9108059||Jul 31, 2014||Aug 18, 2015||Simon Fraser University||Transvascular nerve stimulation apparatus and methods|
|US9126032||Dec 13, 2011||Sep 8, 2015||Pacesetter, Inc.||Pacemaker retrieval systems and methods|
|US9155479||Dec 12, 2005||Oct 13, 2015||Tor Peters||Intra cardiac device, system and methods|
|US9168377||Jul 31, 2014||Oct 27, 2015||Simon Fraser University||Transvascular nerve stimulation apparatus and methods|
|US9168383||Oct 19, 2011||Oct 27, 2015||Pacesetter, Inc.||Leadless cardiac pacemaker with conducted communication|
|US9192774||Jun 27, 2014||Nov 24, 2015||Pacesetter, Inc.||Cardiac pacemaker system for usage in combination with an implantable cardioverter-defibrillator|
|US9216298||Oct 13, 2006||Dec 22, 2015||Pacesetter, Inc.||Leadless cardiac pacemaker system with conductive communication|
|US9220898||Oct 2, 2013||Dec 29, 2015||Simon Fraser University||Transvascular nerve stimulation apparatus and methods|
|US9227077||Nov 23, 2010||Jan 5, 2016||Pacesetter, Inc.||Leadless cardiac pacemaker triggered by conductive communication|
|US9242102||Dec 20, 2011||Jan 26, 2016||Pacesetter, Inc.||Leadless pacemaker with radial fixation mechanism|
|US9242113||Mar 5, 2015||Jan 26, 2016||Cardiac Pacemarkers, Inc.||Modular antitachyarrhythmia therapy system|
|US9259342||Dec 8, 2014||Feb 16, 2016||Intrapace, Inc.||Feedback systems and methods to enhance obstructive and other obesity treatments, optionally using multiple sensors|
|US9265436||Jan 17, 2012||Feb 23, 2016||Pacesetter, Inc.||Leadless intra-cardiac medical device with built-in telemetry system|
|US9265962 *||Feb 24, 2015||Feb 23, 2016||Pacesetter, Inc.||Leadless intra-cardiac medical device with reduced number of feed-thrus|
|US9272155||Aug 14, 2013||Mar 1, 2016||Pacesetter, Inc.||Leadless cardiac pacemaker with secondary fixation capability|
|US9278218||Feb 24, 2015||Mar 8, 2016||Pacesetter, Inc.||Leadless intra-cardiac medical device with dual chamber sensing through electrical and/or mechanical sensing|
|US9289612||Dec 11, 2014||Mar 22, 2016||Medtronic Inc.||Coordination of ventricular pacing in a leadless pacing system|
|US9308374||May 21, 2012||Apr 12, 2016||Boston Scientific Scimed, Inc.||Delivery of cardiac stimulation devices|
|US9352164||Jun 1, 2015||May 31, 2016||Cardiac Pacemakers, Inc.||Modular antitachyarrhythmia therapy system|
|US9358387||Mar 27, 2014||Jun 7, 2016||Biotronik Se & Co Kg||Leadless pacemaker|
|US9358400||Oct 13, 2006||Jun 7, 2016||Pacesetter, Inc.||Leadless cardiac pacemaker|
|US20030069468 *||Nov 6, 2002||Apr 10, 2003||Bolling Steven F.||Implantable heart assist system and method of applying same|
|US20030144708 *||May 17, 2002||Jul 31, 2003||Starkebaum Warren L.||Methods and apparatus for retarding stomach emptying for treatment of eating disorders|
|US20030167025 *||Nov 14, 2002||Sep 4, 2003||Imran Mir A.||Gastric treatment/diagnosis device and attachment device and method|
|US20030176894 *||Dec 9, 2002||Sep 18, 2003||Cardiac Pacemakers, Inc.||Site reversion in cardiac rhythm management|
|US20040015039 *||Jul 16, 2002||Jan 22, 2004||The University Of Cincinnati||Modular power system and method for a heart wall actuation system for the natural heart|
|US20040172116 *||Jan 31, 2003||Sep 2, 2004||Medtronic, Inc.||Arrangement for implanting a miniaturized cardiac lead having a fixation helix|
|US20050004606 *||May 5, 2004||Jan 6, 2005||Cardiac Pacemakers, Inc.||Safety pacing in multi-site CRM devices|
|US20050061079 *||Aug 18, 2004||Mar 24, 2005||Schulman Joseph H.||System and apparatus for sensing pressure in living organisms and inanimate objects|
|US20050119707 *||Dec 30, 2004||Jun 2, 2005||Cardiac Pacemakers, Inc.||Subcutaneous cardiac rhythm management|
|US20050256547 *||Jul 22, 2005||Nov 17, 2005||Cardiac Pacemakers, Inc.||Site reversion in cardiac rhythm management|
|US20060085039 *||Oct 20, 2004||Apr 20, 2006||Hastings Roger N||Leadless cardiac stimulation systems|
|US20060135999 *||Dec 16, 2004||Jun 22, 2006||Jeff Bodner||Leadless cardiac stimulation device employing distributed logic|
|US20060155159 *||Dec 8, 2005||Jul 13, 2006||Melvin David B||Power system for a heart actuation device|
|US20060155160 *||Dec 8, 2005||Jul 13, 2006||Melvin David B||Actuation mechanisms for a heart actuation device|
|US20060178551 *||Dec 8, 2005||Aug 10, 2006||Melvin David B||Securement system for a heart actuation device|
|US20060187550 *||Dec 8, 2005||Aug 24, 2006||Melvin David B||Deforming jacket for a heart actuation device|
|US20060206156 *||Jun 1, 2006||Sep 14, 2006||Cardiac Pacemakers, Inc.||Safety pacing in multi-site crm devices|
|US20060224225 *||May 31, 2006||Oct 5, 2006||Terrance Ransbury||Implantable intravascular device for defibrillation and/or pacing|
|US20060247751 *||Apr 28, 2005||Nov 2, 2006||Seifert Kevin R||Guide catheters for accessing cardiac sites|
|US20060253193 *||May 3, 2005||Nov 9, 2006||Lichtenstein Samuel V||Mechanical means for controlling blood pressure|
|US20070021798 *||Jul 7, 2006||Jan 25, 2007||Cvrx, Inc.||Baroreflex stimulation to treat acute myocardial infarction|
|US20070078492 *||Oct 3, 2005||Apr 5, 2007||Piergiorgio Tozzi||Method and device to convert cardiac and other body movements into electricity to power any implantable medical system|
|US20070088394 *||Oct 13, 2006||Apr 19, 2007||Jacobson Peter M||Leadless cardiac pacemaker system for usage in combination with an implantable cardioverter-defibrillator|
|US20070088398 *||Oct 13, 2006||Apr 19, 2007||Jacobson Peter M||Leadless cardiac pacemaker triggered by conductive communication|
|US20070251244 *||Mar 5, 2007||Nov 1, 2007||Cardiac Pacemakes, Inc.||Method and apparatus for in vivo thermoelectric power system|
|US20070251565 *||Mar 5, 2007||Nov 1, 2007||Cardiac Pacemakers, Inc.||Method and apparatus for shunt for in vivo thermoelectric power system|
|US20070253227 *||Mar 5, 2007||Nov 1, 2007||Cardiac Pacemakers, Inc.||Power converter for use with implantable thermoelectric generator|
|US20070270928 *||May 18, 2007||Nov 22, 2007||Erlebacher Jay A||Lead retention means|
|US20070276444 *||May 24, 2006||Nov 29, 2007||Daniel Gelbart||Self-powered leadless pacemaker|
|US20070287879 *||Jun 13, 2006||Dec 13, 2007||Daniel Gelbart||Mechanical means for controlling blood pressure|
|US20070293904 *||Jun 20, 2006||Dec 20, 2007||Daniel Gelbart||Self-powered resonant leadless pacemaker|
|US20080058886 *||Oct 31, 2007||Mar 6, 2008||Williams Michael S||Implantable medical device having pre-implant exoskeleton|
|US20080065051 *||Oct 31, 2007||Mar 13, 2008||Williams Michael S||Implantable medical device having pre-implant exoskeleton|
|US20080109054 *||May 7, 2007||May 8, 2008||Scimed Life Systems, Inc.||Leadless Cardiac Stimulation Systems|
|US20080147168 *||Dec 4, 2007||Jun 19, 2008||Terrance Ransbury||Intravascular implantable device having detachable tether arrangement|
|US20080167702 *||Dec 4, 2007||Jul 10, 2008||Terrance Ransbury||Intravascular implantable device having superior anchoring arrangement|
|US20080208247 *||Feb 28, 2008||Aug 28, 2008||Rutten Jean J G||Implantable medical device system with fixation member|
|US20080208248 *||Feb 28, 2008||Aug 28, 2008||Rutten Jean J G||Implantable medical device system with fixation member|
|US20080208303 *||Feb 28, 2008||Aug 28, 2008||Rutten Jean J G||Implantable medical device system with fixation member|
|US20080208339 *||Feb 28, 2008||Aug 28, 2008||Rutten Jean J G||Implantable medical device system with fixation member|
|US20080243216 *||Oct 4, 2007||Oct 2, 2008||Yitzhak Zilberman||System and method for percutaneous delivery of electrical stimulation to a target body tissue|
|US20090018605 *||Sep 23, 2008||Jan 15, 2009||Intrapace, Inc.||Gastric Treatment/Diagnosis Device and Attachment Device and Method|
|US20090054952 *||Aug 25, 2008||Feb 26, 2009||Arkady Glukhovsky||System for transmitting electrical current to a bodily tissue|
|US20090062894 *||Aug 28, 2007||Mar 5, 2009||Cardiac Pacemakers, Inc.||Medical device electrodes having cells disposed on nanostructures|
|US20090062895 *||Aug 28, 2007||Mar 5, 2009||Cardiac Pacemakers, Inc.||Medical device electrodes including nanostructures|
|US20090149902 *||Mar 1, 2007||Jun 11, 2009||Kumar Uday N||Implanted cardiac device for defibrillation|
|US20090149910 *||Feb 12, 2009||Jun 11, 2009||Inrapace, Inc.||Gastric Treatment/Diagnosis Device and Attachment Device and Method|
|US20090171404 *||Mar 19, 2007||Jul 2, 2009||Leland Standford Junior University||Energy generating systems for implanted medical devices|
|US20090171408 *||Dec 12, 2005||Jul 2, 2009||Jan Otto Solem||Intra Cardiac Device, System And Methods|
|US20090198252 *||Apr 14, 2009||Aug 6, 2009||Seifert Kevin R||Guide catheters for accessing cardiac sites|
|US20090222053 *||Mar 9, 2009||Sep 3, 2009||Robert Andrew Gaunt||Method of routing electrical current to bodily tissues via implanted passive conductors|
|US20090326602 *||Dec 31, 2009||Arkady Glukhovsky||Treatment of indications using electrical stimulation|
|US20100016929 *||Sep 23, 2009||Jan 21, 2010||Arthur Prochazka||Method and system for controlled nerve ablation|
|US20100076533 *||Dec 1, 2009||Mar 25, 2010||Amit Dar||System for transmitting electrical current to a bodily tissue|
|US20100198298 *||Jun 28, 2006||Aug 5, 2010||Arkady Glukhovsky||Implant system and method using implanted passive conductors for routing electrical current|
|US20100318166 *||Jun 14, 2010||Dec 16, 2010||Terrance Ransbury||Methods and systems for anti-thrombotic intravascular implantable devices|
|US20110004288 *||Jun 14, 2010||Jan 6, 2011||Terrance Ransbury||Intravascular implantable device having integrated anchor mechanism|
|US20110071585 *||Mar 24, 2011||Terrance Ransbury||Intravascular implantable device having superior anchoring arrangement|
|US20110125163 *||May 26, 2011||Medtronic, Inc.||Implantable medical device system with fixation member|
|US20110238077 *||Apr 26, 2010||Sep 29, 2011||Medtronic, Inc.||Intravascular medical device|
|US20130345770 *||Jun 21, 2012||Dec 26, 2013||Pacesetter, Inc.||Leadless intra-cardiac medical device with reduced number of feed-thrus|
|US20150165221 *||Feb 24, 2015||Jun 18, 2015||Pacesetter, Inc.||Leadless intra-cardiac medical device with reduced number of feed-thrus|
|USRE28990 *||Feb 6, 1975||Oct 5, 1976||Corometrics Medical Systems, Inc.||Bipolar electrode structure for monitoring fetal heartbeat and the like|
|USRE41394||Jan 17, 2006||Jun 22, 2010||Mogens Bugge||Implantable device for utilization of the hydraulic energy of the heart|
|CN101578067B||Oct 13, 2006||Jul 17, 2013||内诺斯蒂姆股份有限公司||Leadless cardiac pacemaker and system|
|DE2506694A1 *||Feb 18, 1975||Sep 11, 1975||Medtronic Inc||Implantable elektrodenanordnung|
|DE3016497A1 *||Apr 26, 1980||Jul 30, 1981||Telectronics Pty Ltd||Elektrodenleitung mit sich nach hinten erstreckenden zinken|
|EP0003948A1 *||Jul 14, 1978||Sep 19, 1979||Hans-Jürgen Dipl.-Ing. Bisping||Implantable electrode|
|EP0004967A2 *||Apr 17, 1979||Oct 31, 1979||Werner Dr.Dr. Mohl||Anchoring means for a probe head, particularly a cardiac probe|
|EP0041254A1 *||May 29, 1981||Dec 9, 1981||Hans-Jürgen Dipl.-Ing. Bisping||Implantable pacemaker leads|
|EP1508295A1 *||Aug 20, 2004||Feb 23, 2005||Alfred E. Mann Foundation for Scientific Research||System and apparatus for sensing pressure in living organisms and inanimate objects|
|EP1969998A3 *||Aug 20, 2004||Oct 8, 2008||Alfred E. Mann Foundation for Scientific Research||System and apparatus for sensing pressure in living organisms and inanimate objects|
|EP2097851A2 *||Oct 5, 2007||Sep 9, 2009||Bioness Inc.||System and method for percutaneous delivery of electrical stimulation to a target body tissue|
|EP2789368A1 *||Apr 1, 2014||Oct 15, 2014||BIOTRONIK SE & Co. KG||Leadless pacemaker|
|EP2879758A4 *||Aug 1, 2013||Jan 27, 2016||Nanostim Inc||Biostimulator circuit with flying cell|
|EP2954930A1||Jun 1, 2015||Dec 16, 2015||BIOTRONIK SE & Co. KG||Delivery system for an implantable medical device|
|WO2000078376A1 *||Jun 26, 2000||Dec 28, 2000||Anagram Consultants Ag||Implantable device for utilisation of the hydraulic energy of the heart|
|WO2007047681A2 *||Oct 13, 2006||Apr 26, 2007||Nanostim, Inc.||Leadless cardiac pacemaker and system|
|WO2007047681A3 *||Oct 13, 2006||Sep 25, 2008||Nanostim Inc||Leadless cardiac pacemaker and system|
|WO2007068284A1 *||Dec 12, 2005||Jun 21, 2007||Synergio Ag||Intra cardiac device, system and methods|
|WO2009032485A1||Aug 11, 2008||Mar 12, 2009||Cardiac Pacemakers, Inc.||Medical device electrodes having cells disposed on nanostructures|
|WO2013032624A2 *||Aug 2, 2012||Mar 7, 2013||Medtronic, Inc.||Holding members for implantable cardiac stimulation devices|
|WO2013032624A3 *||Aug 2, 2012||Jul 4, 2013||Medtronic, Inc.||Holding members for implantable cardiac stimulation devices|
|U.S. Classification||607/36, 607/35, 607/126|
|International Classification||A61N1/375, A61N1/05, A61N1/378|
|Cooperative Classification||A61N1/375, A61N1/0573, A61N1/3785|
|European Classification||A61N1/05N4A, A61N1/375, A61N1/378B|
|Apr 6, 1982||AS02||Assignment of assignor's interest|
Owner name: INTERMEDICS, INC., A CORP. OF TEX.
Effective date: 19820318
Owner name: RASOR ASSOCIATES, INC.,
|Apr 6, 1982||AS||Assignment|
Owner name: INTERMEDICS, INC., A CORP. OF TEX.
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:RASOR ASSOCIATES, INC.,;REEL/FRAME:003968/0071
Effective date: 19820318