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Publication numberUS3683933 A
Publication typeGrant
Publication dateAug 15, 1972
Filing dateJun 22, 1970
Priority dateJun 22, 1970
Publication numberUS 3683933 A, US 3683933A, US-A-3683933, US3683933 A, US3683933A
InventorsMansfield Peter B
Original AssigneeMansfield Peter B
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Implantable tissue stimulator with a porous anchoring enclosure
US 3683933 A
Abstract
An implantable cardiac pacer housing comprising a fabric panel having suture flaps extending from a central compartment receiving the power supply and circuit container of a plug connected pacer, a port being provided in said compartment to pass connectors on the container for mating with the plug of a flexible probe and a flap enabling removal and replacement of the container.
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Description  (OCR text may contain errors)

Waite States Patent Mansfield [54] TMPLANTABLE TISSUE STIMULATOR WIITH A POROUS ANCHORING ENCLOSURE [72] Inventor: Peter B. Mansfield, 159 Washington Ave., Needham, Mass. 02192 [22] Filed: June 22, 1970 [21] App]. No.: 48,379

[52] US. Cl ..128/4l9 P [51] int. C1. ..A6ln H36 [58] FieldoiSearch ..128/418,419 P,419 11,421, 128/422 [56] References Cited UNITED STATES PATENTS 3,474,791 10/1969 Bentov ..128/4l9 P 3,253,595 5/1969 Murphy, Jr. et a1. 128/419 P 3,486,506 12/1969 Avphan 128/419 P 3,244,174 4/1966 Wesly et a1. ..128/418 Auphan ..128/419 P [151 3,683,933 51 Aug. 15, 1972 OTHER PUBLICATIONS Cammilliet al. Surgical Forum," 1966, pp. 165- 168 Morris et al. Annals of the New York Academy of Sciences," Vol. 167, Art. 2, Oct. 30, 1969, pp. 987- 994 Primary Examiner-William E. Kamm Att0rneyRich & Ericson [5 7] ABSTRACT An implantable cardiac pacer housing comprising a fabric panel having suture flaps extending from a central compartment receiving the power supply and circuit container of a plug connected pacer, a port being provided in said compartment to pass connectors on the container for mating with the plug of a flexible probe and a flap enabling removal and replacement of the container.

4 Claims, 5 Drawing Figures Patented Aug. 15, 1972 3,683,933

| I /W RG. g FIG.5

[3 M5 I I I INVENTOR PETIER B. MANSFIELD EL 0 BY M L@ FIG. 4

ATTORNEYS IMPLANTABLE TISSUE STIMULATOR WITH A POROUS ANCHORING ENCLOSURE My invention relates to cardiac pacers, and particularly to a novel implantable housing for the same.

Considerable progress has been made in the development of cardiac pacers for use in supplying electrical stimulatingpulses to regulate the mammalian cardiac function in the absence of naturally occurring pulses. For optimum prosthetic efficiency, it is desirable that such devices be entirely implanted in the body of the host. It is usually desired to apply the stimulating pulses directly to the heart, and for example, to the myocardium. On the other hand, the size of the basic elements used for producing the stimulating pulses, namely, the power supply and the pulse generating circuit ener' gized thereby, require a natural or incised body cavity larger than is available directly adjacent the heart. Thus, it is the practice to implant the power package, containing the power supply and pulse generating circuit for the pacer, in the nearest convenient location, and to connect it to a stimulating electrode or electrodes at the heart by means of a flexible insulated cable. The power package is allowed to rest in the selected body cavity. Since the power package is of significant size and weight, trauma may result from movements of the host, or simply from friction incidental to slight shiftings about incident to normal respiration and cardiac function. The object of my invention is to facilitate the anchoring of the power package of a cardiac pacer without interfering with its electrical function.

Briefly, the above and other objects of my invention are attained by a novel pacer support comprising a fabric body formed to provide suture panels for attachment to tissue at the wall of the cavity in which the pacer is to be implanted. The fabric body is further formed with a receptacle for receiving and holding the pacer power package while permitting the exterior of the package to serve as a return electrode for the pulse generating circuit, and admitting electrical and mechanical connections to a flexible probe for connecting a remote stimulating electrode to the power package. In practice, the power package, in its support, is implanted in the selected cavity, and the electrode probe assembly is electrically and mechanically connected to the power package. The suture panels of the support are then sewn to the tissue wall of the cavity, and the surgical entry is closed. Thereafter, scar tissue growth occurring in and about the fabric support anchors the package to the wall of the cavity, supplanting the sutures as they are absorbed by the body. This tissue growth process does not interfere with the electrical return path provided by the metal housing of the pacer power package.

The manner in which the apparatus of my invention is constructed, and its mode of operation, will best be understood in the light of the following detailed description together with the accompanying drawings, of a preferred embodiment thereof.

In the drawings,

FIG. 1 is a schematic orthogonal sketch of a pacer power package provided with a support in accordance with my invention;

FIG. 2 is a schematic elevational sketch of a complete pacer, together with the support of my invention, with parts shown in cross-section and parts broken away; I

FIG. 3 is a schematic plan view of the apparatus of FIG. 2, with parts broken away;

FIG. 4 is a schematic cross-sectional elevational sketch of a portion of the apparatus of FIGS. 2 and 3, taken substantially along the lines 4--4 in FIG. 3, with parts omitted and parts broken away; and

FIG. 5 is a schematic plan view of a fabric panel adapted to form a support in accordance with my invention.

Referring to FIG. 1, I have shown the power package of a pacer enclosed in a fabric support and container generally designated 1. The power package may be of any conventional construction, in accordance with my invention in its broader aspects, but preferably comprises a relatively thin, flat generally rectangular metal case 3, of stainless steel or the like, forming a sealed conductive enclosure about a pulse generating circuit, to be described briefly below. Protruding from and electrically continuous with the -case3 are a support post 5, a flange 7 tapped and threaded to receive a connecting screw, and an insulated connector post 9. The post 5, flange 7 and the exterior portion 11 of the connector post 9 may be of stainless steel or the like, welded to or otherwise formed integral with the case 3.

As best shown in FIG. 4, the metal case 3 encloses a battery 13 connected between the case and a conventional pulse generating circuit 15. The pulse output circuit extends between the case 3 and an active output lead 17. The lead 17 extends through the post 11, and is spaced, sealed to and insulated from the post 11 by means of an intermediate glass-to-metal seal 19.

With reference to FIGS. 2, 3 and 4, the active output lead 17 is connected to an exposed body contacting stimulating electrode 21, of stainless steel or the like, over a flexible conductor 23. The conductor 23 preferably comprises a helical coil of wire, and most preferably a construction comprising two parallel wires wound into parallel congruent concentric contiguous helices in the manner shown and described in copending US. Pat., application Ser. No. 41,980 filed by Jean E. Bellerose on June 1, 1970 for Flexible Electrical Probe and assigned to the assignee of this application.

The conductor 23 is covered and insulated by a layer 25 of silicone rubber or the like, and extends from the electrode 21 to a termination within the body of an insulating plug 27, also of silicone rubber or the like. The plug 27 may be bonded to or otherwise formed integral with the insulating layer 25.

As schematically indicated in FIG. 4, the lead 23 is electrically and mechanically secured within the plug 27 to a contact 29 adapted to engage the lead 17 when the plug is engaged with the housing 3. As shown, the plug 27 is formed with recesses cooperatively receiving the posts 5 and 11 to seal the latter and form a firm mechanical connection. The plug is secured to the housing by means of a screw 31 engaging the threaded flange 7 and received in suitable recesses formed in the plug 27 as shown in FIG. 4.

The pacer support 1 may be made from a fabric panel of the general configuration shown in FIG. 5. Preferably, the panel is made from relatively open machine knitted mesh, such as MIERSILENE polyester fiber mesh made and sold by Ethicon, Inc. of Somerville, New Jersey, and manufactured from DACRON polyester fiber. Comparing FIGS. 1, 2, 3 and 5, the pacer support comprises a pairof suture panels 33 and 35 at the sides of a box-like container formed by a back panel 37, a top panel 39, a bottom panel 41, a front panel 43, and two side panels 45 and 47. The top panel 39 is provided with one or more apertures such as 49 to pass the connector posts 5 and 9 and the flange 7.

The side panels 45 and 47 are each secured to the front panel 37, bottom panel 41 and top panel 39 by suitable means, as by sewing with DACRON thread, in the same manner illustrated in detail for the panel 45. As shown, the panel 45 is secured to the bottom panel 41 by a seam 51, to the back panel 37 (at its juncture with the suture panel 33) by a seam 53, and to the top panel 39 by a seam 55. The seam 55 is sewn after insertion of the case 3. The front panel 43 is then sewn to the top panel 39 to form a seam 57, and a seam 59 corresponding to the seam 55 is sewn to secure the side panel 47 to the top panel 39.

The case 3 is preferably encased in the support 1 before implantation. In general, the flexible probe comprising the cable 23, its insulating cover 25, the electrode 21 and the plug 27 are implanted as one unit, and the case 3 and its support 1 are then implanted. Connection of the plug 27 to the case 3 is then made, and secured by installation of the screw 31. The suture panels 33 and 35 are then sutured to the wall of the selected cavity, as by stitches 61, FIG. 2. As a result, the electrode 21 is precluded from leaving the desired site for stimulation, as might occur if the case 3 were free to move in its assigned cavity. Tissue ingrowth occurring between the tissue wall to which the suture panels are secured and the anchoring network provided by the strands of the fabric support assembly then proceeds, whereupon the support becomes firmly secured to the body.

While designed for maximum operating life, the power supply for a pacer will ultimately be exhausted, requiring replacement. The support apparatus of my invention is especially well adapted to facilitate the process of replacement. Following a suitable surgical entry, the screw 31 is removed, and the plug 27 disconnected from the case 3. An incision is next made in the top panel 39 sufficient to permit the withdrawal of the case 3. A replacement case is inserted in the support 1, and the top panel refastened with a few stitches. The plug,27 is then replaced, and the screw 31 is installed. The support 1 remains anchored in the body, and thus serves as a permanent repository for the power supply package.

While I have described my invention with respect to the details of a preferred embodiment thereof, many changes and variations will occur to those skilled in the art upon reading my description, and such can obviously be made without departing from the scope of my invention.

Having thus described my invention, what I claim is: 1. An implantable body tissue stimulator adapted to be anchored and stored in a selected body cavity, comprising:

a housing; means within said housing for generating electrical tissue stimulatin signals" and porous means su stantially totally enclosing said housing for securing it to living tissue and adapted to anchor it in place in said selected cavity by enabling body processes to interact with said enclosing means, said means including flap means enabling later removal and replacement of said housing without interfering with the anchoring in place of said enclosing means.

2. The stimulator of claim 1 wherein:

said stimulator is a cardiac pacer.

3. The-pacer of claim 2, wherein:

said housing is conductive and effectively provides a terminal for an electric circuit; and

said enclosing means is formed from a mesh and includes a gauze suture panel for securing said enclosed pacer to living tissue.

4. The pacer of claim 3, wherein:

said enclosing means includes a set of flaps sewn together to form a bag for receiving and retaining said housing; and

said suture panel includes a pair of flaps sewn to opposite sides of said bag for suturing to living tissue.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3244174 *Jan 31, 1964Apr 5, 1966Gen ElectricBody implantable conductor
US3253595 *Aug 7, 1963May 31, 1966Cordis CorpCardiac pacer electrode system
US3474791 *Mar 24, 1966Oct 28, 1969Brunswick CorpMultiple conductor electrode
US3486506 *Oct 5, 1966Dec 30, 1969Philips CorpHeart-actuated,spring driven cardiac stimulator
US3572345 *Jan 27, 1969Mar 23, 1971Philips CorpStrap for a heart stimulator
Non-Patent Citations
Reference
1 *Cammilli et al. Surgical Forum, 1966, pp. 165 168
2 *Morris et al. Annals of the New York Academy of Sciences, Vol. 167, Art. 2, Oct. 30, 1969, pp. 987 994
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3822707 *Apr 17, 1972Jul 9, 1974Cardiac Pacemakers IncMetal-enclosed cardiac pacer with solid-state power source
US3884243 *Jun 15, 1973May 20, 1975Corsan Engineering IncImplantable heart pacer or the like with internal cell electrode
US3943936 *Oct 9, 1973Mar 16, 1976Rasor Associates, Inc.Self powered pacers and stimulators
US4013081 *Apr 19, 1976Mar 22, 1977Arco Medical Products CompanyPediatric cardiac pacer system
US4444206 *Apr 29, 1982Apr 24, 1984Cordis CorporationMesh tip pacing lead assembly
US4461194 *Apr 28, 1982Jul 24, 1984Cardio-Pace Medical, Inc.Tool for sealing and attaching a lead to a body implantable device
US5385574 *Jul 24, 1992Jan 31, 1995Cardiac Pacemakers, Inc.Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US5433730 *Oct 7, 1993Jul 18, 1995Intermedics, Inc.Conductive pouch electrode for defibrillation
US5895414 *Apr 10, 1997Apr 20, 1999Sanchez-Zambrano; SergioPacemaker housing
US6999814Jun 19, 2001Feb 14, 2006Cardiac Pacemakers, Inc.Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US7054692 *May 15, 2002May 30, 2006Advanced Bionics CorporationFixation device for implantable microdevices
US7236829 *Aug 30, 2004Jun 26, 2007Pacesetter, Inc.Implantable leadless cardiac device with flexible flaps for sensing
US7522959Dec 30, 2004Apr 21, 2009Cardiac Pacemakers, Inc.Subcutaneous cardiac rhythm management
US7756582 *Oct 21, 2005Jul 13, 2010Intrapace, Inc.Gastric stimulation anchor and method
US8224449 *Jun 29, 2009Jul 17, 2012Boston Scientific Neuromodulation CorporationMicrostimulator with flap electrodes
US20130178702 *Nov 30, 2012Jul 11, 2013Olympus Medical Systems Corp.Antenna apparatus, antenna, antenna holder, and body-insertable apparatus system
EP0006281A1 *Apr 5, 1979Jan 9, 1980Medtronic, Inc.Body implantable stimulator and connector therefor
EP0453761A1 *Mar 19, 1991Oct 30, 1991Cardiac Pacemakers, Inc.Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
Classifications
U.S. Classification607/36
International ClassificationA61N1/372, A61N1/375
Cooperative ClassificationA61N1/375
European ClassificationA61N1/375