US3198195A - Implantable controls for cardiac pacemakers - Google Patents
Implantable controls for cardiac pacemakers Download PDFInfo
- Publication number
- US3198195A US3198195A US231349A US23134962A US3198195A US 3198195 A US3198195 A US 3198195A US 231349 A US231349 A US 231349A US 23134962 A US23134962 A US 23134962A US 3198195 A US3198195 A US 3198195A
- Authority
- US
- United States
- Prior art keywords
- pacemaker
- implantable
- housing
- controls
- skin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/37512—Pacemakers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37235—Aspects of the external programmer
- A61N1/37247—User interfaces, e.g. input or presentation means
Definitions
- pacemaker devices have been developed for providing suitable stimulating current pulses to the heart. Some of these devices are external, some are suitable for complete implantation within the body, and some are partly external and operate by induction through the intact skin to a subcutaneous coil.
- the completely implantable units have the advantage, over those which are entirely or partially external, that the patient need not carry about or be concerned with any external attachments or appliances.
- completely implantable pacemakers heretofore have had the relative disadvantage that the rate and amplitude of the current pulse could not be adjusted.
- they had the further disadvantage that they commenced operation as soon as their manufacture was completed, and could not be turned off prior to use. For this reason, prolonged storage in sterile condition was not possible with out encroaching upon some of the battery life.
- Amplitude control is desirable, to permit stimulation at levels just above the threshold requirements of the particular patient.
- Any greater amplitude merely reduces the total battery life, and may produce undesired physiological results.
- a primary object of my invention is to provide rate and amplitude controls for implantable pacemaker devices, which controls are implantable with the pacemaker and can be actuated by making a simple percutaneous puncture.
- Another object of my invention is to provide completely implantable rate and amplitude controls as aforesaid which can be located and identified, after implantation, by palpation through the intact skin.
- Still another object of my invention is to provide an on-olf control implantable with the pacemaker and which can be actuated by making a simple percutaneous puncture.
- -A pacemaker control constructed in accordance with my invention is characterized in one aspect thereof by the provision, in combination with an implantable cardiac pacemaker, of an adjustable component operable to vary an output characteristic of the pacemaker, and means .for adjusting the component including means for receiving a skin puncturing instrument, the adjusting means being encased within a puncturable shield of material compatible with the human body as an environment for subcutaneous implantation of said control with said paceis characterized by the provision, in combination with an ice implantable cardiac pacemaker having a housing of an adjustable component operable to vary an output function of the pacemaker, and means for adjusting the component, the adjusting means including means for receiving a skin puncturing instrument, the control being implantable with the pacemaker and the instrument receiving means projecting beyond the main portion of the pacemaker housing for location by palpation.
- FIG. 1 is a plan view of an implantable pacemaker incorporating the rate and amplitude controls of my invention, the electrode leads being broken away for convenience in illustration;
- FIG. 2 is a view on an enlarged scale, partly in longitudinal section and partly in elevation, through one of the controls of FIG. 1;
- FIG. 3 is a side elevational view of a standard bayonet type Keith skin needle, with which the rate and amplitude controls of my invention can be percutaneously actuated;
- FIG. 4 is a side elevational view of an adaptor form ing part of the control of FIG. 2;
- FIG. 5 is an end elevation thereof
- FIG. 6 is a view similar to that of FIG 2 but with certain parts omitted for ease of illustration and show ing a modified construction
- FIG. 7 is a diagrammatic view of a control portion of the pacemaker pulse producing circuit.
- FIG. 1 an implantable pacemaker having a housing generally denoted 1 and comprising, with the exception of the rate and amplitude controls to be described, a pacemaker of a type which is known per se.
- pacemakers have for some time been manufactured by Medtronics, Inc., Minneapolis, Minnesota under the name Chardack-Greatbatch Pacemaker, and are of the type described in detail in Patent 3,057,356 issued October 9, 1962 in the name of Wilson Greatbatch, to which reference is hereby made for such details.
- pacemaker housing 1 comprises a pulse producing circuit in the form of a mercury cell driven, miniaturized blocking oscillator and amplifier, cast in a potting compound (such as the epoxy resin shown at '19 in FIG. 2) and enclosed in a thin envelope of suitable material, such as the inner silicone rubber layer 22 of FIG. 2.
- a potting compound such as the epoxy resin shown at '19 in FIG. 2
- the rate and amplitude of the output pulse are controlled, in accordance with my invention, by adjustable com ponents, such as the variable otentiometers generally denoted 2.
- the pulse is transmitted via leads 3 to a pair of electrodes, not shown, preferably of the type set forth in my pending application Serial No. 171,189 filed February 5, 1962.
- each potentiometer 2 contains a worm wheel 4 or the like to which a movable potentiometer element 23' ('FIG. 7) is connected for being driven across resistance 23 upon rotation of wheel 4 by worlm 5.
- a movable potentiometer element 23' ('FIG. 7) is connected for being driven across resistance 23 upon rotation of wheel 4 by worlm 5.
- These parts are enclosed within a chamber defining enclosure 6, from which extend leads 24 into the pacemaker circuit being controlled.
- the potentiometer 2 shown in FIG. 2 is conventional, per se, and alternative types of potentiometers obviously can be used.
- Worm 5 extends through enclosure 6, terminating externally thereof in an enlarged head 7 slotted to receive a screwdriver bit.
- a locking key 8 engages a groove in the worm shaft, to hold worm 4 in axial position, and a seal 9, such as an O-ring of neoprone rubber, is carried by enclosure 6 in sealing engagement with the worm shaft.
- potentiometer 2 can be varied by rotating head 7 and worm 4.
- the needle shaft is guided into engagement with adaptor slot 12 by an outer sleeve 16 having an enlarged bore receiving and containing the adaptor for rotation therein.
- Adjacent thereto, sleeve 16 has a frusto-conical bore 18 tapering inwardly toward the adaptor recess 12.
- Sleeve 16 has a flat-sided extension 19 extending downwardly along one side of potentiometer enclosure 6 and abutting the same to prevent rotation of the sleeve thereon.
- Sleeve extension 19 is secured to enclosure 6 by an adhesive epoxy resin.
- the pacemaker and its controls must be body fluid proof, and this presents a problem which is solved as follows.
- the sleeve bores 17 and 18, and adaptor recess 12, are filled with a sealing material 20 penetrable by needle shaft 13.
- Material 20 should be well tolerated by surrounding body tissue, and non-adherent to needle 14 so as not .to be carried outwardly thereby when the needle is withdrawn.
- a suitable material is a silicone high vacuum grease.
- Several layers 21 and 21" of a shielding material are then applied over the assembled potentiometer 2, adaptor 10 and sleeve 16.
- Material 21 and 21" must be non-toxic to surrounding body tissue and compatible with the human body as an environment. Dow Corning silicone rubber compound-s are Preble, and some of these have the added advantage of bonding to metal. The entire assembly then is sterilized by heat, prior to incorporation into the pacemaker.
- the rate and amplitude controls are completely implanted with the pacemaker. This poses the problem of locating and identifying the controls when adjustment is required.
- sleeve 16 and the surrounding shielding layers are arranged to provide each control with a nubbin 2-2 projecting from the main portion of the pacemaker housing 1, as shown in FIG. 1.
- Nubbins 22 are of sufiicient diameter and length as to be readily palpatable.
- one of the .control nubbins 22 is positioned closer to the juncture of leads 3 with body 1 than the other control nubbin 22.
- the amplitude control nubbin 22 which is closest to the juncture of electrode leads 3 and body 1, and which therefore is the left hand nubbin in FIG. 1.
- the physician being also able to palpate the leads 3 at their juncture with body 1, can determine by feel alone, through the intact skin, which control nubbin is the one he wants. He then can manipulate that control by inserting needle 14 through the skin, and through theshielding portion 23 overlying the outer end of sleeve bore 18. The needle will be guided by the sleeve 16 into the adaptor recess 12. Once it is received therein, as determined by the resistance to further insertion, the physician rotates the needle in the direction required to achieve the desired adjustment.
- the silicone shielding material at least in the area of portion 21', is sufficiently resiliently yieldable to expand and thereby accommodate displacement of the silicone grease 2i) upon insertion of needle .13. This prevents displacement of the grease along the needle shaft through the needle juncture in the shielding portion 21.
- FIG. 6 shows a modified arrangement in which potentiometer 2 is provided with a worm head 7' having a recess 12 for directly receiving the skin needle, in which case the separate adaptor It can be dispensed with. The operation remains the same as described above.
- potentiometer 23-23 can be substituted for resistor 22 in the timing circuit shown in the aforesaid Patent 3,057,- 356.
- potentiometer 23-23 can be connected in series in the output circuit of said patent, as indicated at 24 (FIG. 7).
- Each potentiometer is provided with an off position, whereby the pacemaker can be turned on and off by percutaneous puncture.
- my invention fully accomplishes its intended objects, and provides completely implantable pacemaker rate and amplitude controls which can be activated by simple percutaneous puncture. While I have disclosed in detail only one embodiment of my invention, and a modification in a part thereof, that has been done by way of illustration only, it being my intention to be limited only by the scope of the appended claims.
- percutaneously actuated controls implantable with said pacemaker beneath the skin of the human body for varying different output characteristics of said pacemaker comprising a first adjustable component in said housing operable to vary one output characteristic of said pacemaker, a second adjustable component in said housing operable to vary another output characteristic of said pacemaker, means for adjusting said first component including first means carried by said housing for receiving a skin puncturing instrument, means for adjusting said second component including second means carried by said housing for receiving a skin puncturing instrument, said first and second means projecting from the main portion of said pacemaker housing in spaced relation to each other and to the juncture of said lead and said housing, and one of said first and second means being positioned closer to said juncture than the other thereof, whereby said first and second adjusting means can be located and identified by palpation, said projecting adjusting means being encased within a shield of material puncturable by a skin puncturing
- a percutaneously actuated control implantable with said pacemaker beneath the skin of the human body for varying an output characteristic of said pacemaker comprising an adjustable com ponent in said housing operable to vary such output characteristic, and means for adjusting said component including a part carried by said housing and engageable by a skin puncturing instrument and a sleeve carried by said housing and associated with said part for guiding a skin puncturing instrument into engagement therewith, said sleeve projecting from the main portion of said housing for location by palpation, said projecting sleeve being encased within a shield of material puncturable by a skin puncturing instrument and compatible With the human body as an environment.
- a percutaneously actuated control implantable With said pacemaker beneath the skin of the human body for varying an output characteristic of said pacemaker comprising an adjustable component operable to vary such output characteristic, and means for adjusting said component including a part engageable by a skin puncturing instrument and a sleeve associated with said part for guiding such an instrument into engagement therewith, the interior of said sleeve being filled with a sealing grease, and a shield of puncturable material enclosing said sleeve, said material being compatible with the human body as an environment.
- a percutaneously actuated control implantable with with said pacemaker beneath the skin of the human body for varying an output characteristic of said pacemaker comprising an adjustable component operable to vary such output characteristic, a member connected to said component and movable to adjust the same, and means connected to said member and engageable with a skin puncturing instrument for movement thereby to so move said member, said component, member and means being carried by said pacemaker and being encased within a puncturable shield of material compatible with the human body as an environment for subcutaneous implantation of said control with said pacemaker, wherein said component is enclosed within a chamber defining enclosure, said member being journaled in said enclosure and having a part exteriorly of said enclosure, said part having a first tool receiving formation, said means comprising an adaptor engaging said first tool receiving formation and having a second formation engageable with a skin puncturing instrument.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Electrotherapy Devices (AREA)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NL299486D NL299486A (fr) | 1962-10-18 | ||
NL125526D NL125526C (fr) | 1962-10-18 | ||
US231349A US3198195A (en) | 1962-10-18 | 1962-10-18 | Implantable controls for cardiac pacemakers |
GB41187/63A GB1064376A (en) | 1962-10-18 | 1963-10-18 | Improvements in percutaneously activated controls for implantable cardiac pacemakers |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US231349A US3198195A (en) | 1962-10-18 | 1962-10-18 | Implantable controls for cardiac pacemakers |
Publications (1)
Publication Number | Publication Date |
---|---|
US3198195A true US3198195A (en) | 1965-08-03 |
Family
ID=22868857
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US231349A Expired - Lifetime US3198195A (en) | 1962-10-18 | 1962-10-18 | Implantable controls for cardiac pacemakers |
Country Status (3)
Country | Link |
---|---|
US (1) | US3198195A (fr) |
GB (1) | GB1064376A (fr) |
NL (2) | NL299486A (fr) |
Cited By (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3311111A (en) * | 1964-08-11 | 1967-03-28 | Gen Electric | Controllable electric body tissue stimulators |
US3313289A (en) * | 1964-06-23 | 1967-04-11 | Frank A Kapral | Implant chamber |
US3508538A (en) * | 1967-11-22 | 1970-04-28 | Cordis Corp | Method and apparatus for positioning the ventricular lead of a cardiac pacer |
US3690325A (en) * | 1969-11-03 | 1972-09-12 | Devices Ltd | Implantable electric device |
US3766928A (en) * | 1972-03-24 | 1973-10-23 | American Optical Corp | Pacer with magnetic coupling means for external rate adjustment |
US3871382A (en) * | 1973-02-15 | 1975-03-18 | Pacesetter Syst | Heart stimulator system for rapid implantation and removal with improved integrity |
US3901247A (en) * | 1972-01-13 | 1975-08-26 | Medtronic Inc | End of life increased pulse width and rate change apparatus |
US3908668A (en) * | 1974-04-26 | 1975-09-30 | Medtronic Inc | Tissue stimulator with sealed lead connector |
US3998222A (en) * | 1974-04-15 | 1976-12-21 | Shihata Alfred A | Subcutaneous arterio-venous shunt with valve |
US4217913A (en) * | 1977-10-10 | 1980-08-19 | Medtronic, Inc. | Body-implantable lead with protected, extendable tissue securing means |
EP0052690A1 (fr) * | 1980-11-21 | 1982-06-02 | Precimed S.A. | Dispositif de fixation de l'électrode-sonde à la borne de sortie d'un stimulateur cardiaque |
US4365633A (en) * | 1980-02-22 | 1982-12-28 | Telectronics Pty. Ltd. | Patient-operated pacemaker programmer |
US4479489A (en) * | 1981-04-20 | 1984-10-30 | Cordis Corporation | Mechanically self-sealing closure |
FR2568477A1 (fr) * | 1984-07-31 | 1986-02-07 | Inst Nat Sante Rech Med | Dispositif pour l'alimentation energetique transcutanee notamment d'une prothese implantee |
US4585006A (en) * | 1982-08-18 | 1986-04-29 | Cordis Corporation | Cardiac pacer having stimulation threshold measurement circuit |
DE3521874A1 (de) * | 1985-06-19 | 1987-01-02 | Osypka Peter | Herzschrittmacher |
DE3613283A1 (de) * | 1986-04-19 | 1987-10-22 | Osypka Peter | Herzschrittmacher mit einem steuerteil zur erhoehung der herz-ruhefrequenz |
US5072730A (en) * | 1990-06-14 | 1991-12-17 | Minnesota Mining And Manufacturing Company | Key programmed transcutaneous electric stimulator |
US5370666A (en) * | 1992-06-05 | 1994-12-06 | Siemens-Elema Ab | Pacemaker with power-consuming component inhibited during storage |
US5895414A (en) * | 1996-04-19 | 1999-04-20 | Sanchez-Zambrano; Sergio | Pacemaker housing |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3050695A (en) * | 1959-09-10 | 1962-08-21 | W W Henry Co Inc | Pulse generator for human treatment |
US3057356A (en) * | 1960-07-22 | 1962-10-09 | Wilson Greatbatch Inc | Medical cardiac pacemaker |
US3057344A (en) * | 1957-05-21 | 1962-10-09 | Abella Carlos Alberto | Capsule for the study of the digestive tract and method of using the same |
US3093136A (en) * | 1960-05-25 | 1963-06-11 | Mine Safety Appliances Co | Ventricular defibrillator |
US3109430A (en) * | 1959-01-29 | 1963-11-05 | Electronic Aids Inc | Cardiac nerve control device |
-
0
- NL NL125526D patent/NL125526C/xx active
- NL NL299486D patent/NL299486A/xx unknown
-
1962
- 1962-10-18 US US231349A patent/US3198195A/en not_active Expired - Lifetime
-
1963
- 1963-10-18 GB GB41187/63A patent/GB1064376A/en not_active Expired
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3057344A (en) * | 1957-05-21 | 1962-10-09 | Abella Carlos Alberto | Capsule for the study of the digestive tract and method of using the same |
US3109430A (en) * | 1959-01-29 | 1963-11-05 | Electronic Aids Inc | Cardiac nerve control device |
US3050695A (en) * | 1959-09-10 | 1962-08-21 | W W Henry Co Inc | Pulse generator for human treatment |
US3093136A (en) * | 1960-05-25 | 1963-06-11 | Mine Safety Appliances Co | Ventricular defibrillator |
US3057356A (en) * | 1960-07-22 | 1962-10-09 | Wilson Greatbatch Inc | Medical cardiac pacemaker |
Cited By (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3313289A (en) * | 1964-06-23 | 1967-04-11 | Frank A Kapral | Implant chamber |
US3311111A (en) * | 1964-08-11 | 1967-03-28 | Gen Electric | Controllable electric body tissue stimulators |
US3508538A (en) * | 1967-11-22 | 1970-04-28 | Cordis Corp | Method and apparatus for positioning the ventricular lead of a cardiac pacer |
US3690325A (en) * | 1969-11-03 | 1972-09-12 | Devices Ltd | Implantable electric device |
US3901247A (en) * | 1972-01-13 | 1975-08-26 | Medtronic Inc | End of life increased pulse width and rate change apparatus |
US3766928A (en) * | 1972-03-24 | 1973-10-23 | American Optical Corp | Pacer with magnetic coupling means for external rate adjustment |
US3871382A (en) * | 1973-02-15 | 1975-03-18 | Pacesetter Syst | Heart stimulator system for rapid implantation and removal with improved integrity |
US3998222A (en) * | 1974-04-15 | 1976-12-21 | Shihata Alfred A | Subcutaneous arterio-venous shunt with valve |
US3908668A (en) * | 1974-04-26 | 1975-09-30 | Medtronic Inc | Tissue stimulator with sealed lead connector |
US4217913A (en) * | 1977-10-10 | 1980-08-19 | Medtronic, Inc. | Body-implantable lead with protected, extendable tissue securing means |
US4365633A (en) * | 1980-02-22 | 1982-12-28 | Telectronics Pty. Ltd. | Patient-operated pacemaker programmer |
EP0052690A1 (fr) * | 1980-11-21 | 1982-06-02 | Precimed S.A. | Dispositif de fixation de l'électrode-sonde à la borne de sortie d'un stimulateur cardiaque |
US4479489A (en) * | 1981-04-20 | 1984-10-30 | Cordis Corporation | Mechanically self-sealing closure |
US4585006A (en) * | 1982-08-18 | 1986-04-29 | Cordis Corporation | Cardiac pacer having stimulation threshold measurement circuit |
FR2568477A1 (fr) * | 1984-07-31 | 1986-02-07 | Inst Nat Sante Rech Med | Dispositif pour l'alimentation energetique transcutanee notamment d'une prothese implantee |
DE3521874A1 (de) * | 1985-06-19 | 1987-01-02 | Osypka Peter | Herzschrittmacher |
DE3613283A1 (de) * | 1986-04-19 | 1987-10-22 | Osypka Peter | Herzschrittmacher mit einem steuerteil zur erhoehung der herz-ruhefrequenz |
US5072730A (en) * | 1990-06-14 | 1991-12-17 | Minnesota Mining And Manufacturing Company | Key programmed transcutaneous electric stimulator |
US5370666A (en) * | 1992-06-05 | 1994-12-06 | Siemens-Elema Ab | Pacemaker with power-consuming component inhibited during storage |
US5895414A (en) * | 1996-04-19 | 1999-04-20 | Sanchez-Zambrano; Sergio | Pacemaker housing |
Also Published As
Publication number | Publication date |
---|---|
GB1064376A (en) | 1967-04-05 |
NL299486A (fr) | |
NL125526C (fr) |
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