# Patent

## Title
Leadless pacemaker with radial fixation mechanism

## Abstract

A leadless cardiac pacemaker having a radial fixation mechanism is provided. The cardiac pacemaker can include fixation mechanism separate from a pacing electrode and having a diameter equal to or less than the outer diameter of the pacemaker. The fixation mechanism can allow the pacemaker to be inserted into tissue with less than 2 rotations of the pacemaker to place the pacing electrode in contact with the tissue. In some embodiments, the fixation mechanism can comprise a plurality of hooks or protrusions positioned near a distal portion of the pacemaker. The fixation mechanism(s) can be configured to penetrate the endocardium of the patient and reside mostly within the myocardium. Methods of delivering the leadless cardiac pacemaker into the heart are also provided.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Patent Application No. 61/425,064, filed Dec. 20, 2010, titled “LEADLESS PACEMAKER WITH RADIAL FIXATION MECHANISM”, which application is incorporated herein by reference in its entirety.


INCORPORATION BY REFERENCE
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
FIELD
The present disclosure relates to leadless cardiac pacemakers, and more particularly, to features and methods by which they are attached to heart tissue. More specifically, the present disclosure relates to features and methods for attaching a leadless cardiac pacemaker to tissue with a radial fixation mechanism.
BACKGROUND
Cardiac pacing by an artificial pacemaker provides an electrical stimulation of the heart when its own natural pacemaker and/or conduction system fails to provide synchronized atrial and ventricular contractions at rates and intervals sufficient for a patient's health. Such antibradycardial pacing provides relief from symptoms and even life support for hundreds of thousands of patients. Cardiac pacing may also provide electrical overdrive stimulation to suppress or convert tachyarrhythmias, again supplying relief from symptoms and preventing or terminating arrhythmias that could lead to sudden cardiac death.
Cardiac pacing by currently available or conventional pacemakers is usually performed by a pulse generator implanted subcutaneously or sub-muscularly in or near a patient's pectoral region. Pulse generator parameters are usually interrogated and modified by a programming device outside the body, via a loosely-coupled transformer with one inductance within the body and another outside, or via electromagnetic radiation with one antenna within the body and another outside. The generator usually connects to the proximal end of one or more implanted leads, the distal end of which contains one or more electrodes for positioning adjacent to the inside or outside wall of a cardiac chamber. The leads have an insulated electrical conductor or conductors for connecting the pulse generator to electrodes in the heart. Such electrode leads typically have lengths of 50 to 70 centimeters.
Although more than one hundred thousand conventional cardiac pacing systems are implanted annually, various well-known difficulties exist, of which a few will be cited. For example, a pulse generator, when located subcutaneously, presents a bulge in the skin that patients can find unsightly, unpleasant, or irritating, and which patients can subconsciously or obsessively manipulate or “twiddle”. Even without persistent manipulation, subcutaneous pulse generators can exhibit erosion, extrusion, infection, and disconnection, insulation damage, or conductor breakage at the wire leads. Although sub-muscular or abdominal placement can address some concerns, such placement involves a more difficult surgical procedure for implantation and adjustment, which can prolong patient recovery.
A conventional pulse generator, whether pectoral or abdominal, has an interface for connection to and disconnection from the electrode leads that carry signals to and from the heart. Usually at least one male connector molding has at least one terminal pin at the proximal end of the electrode lead. The male connector mates with a corresponding female connector molding and terminal block within the connector molding at the pulse generator. Usually a setscrew is threaded in at least one terminal block per electrode lead to secure the connection electrically and mechanically. One or more O-rings usually are also supplied to help maintain electrical isolation between the connector moldings. A setscrew cap or slotted cover is typically included to provide electrical insulation of the setscrew. This briefly described complex connection between connectors and leads provides multiple opportunities for malfunction.
Other problematic aspects of conventional pacemakers relate to the separately implanted pulse generator and the pacing leads. By way of another example, the pacing leads, in particular, can become a site of infection and morbidity. Many of the issues associated with conventional pacemakers are resolved by the development of a self-contained and self-sustainable pacemaker, or so-called leadless pacemaker, as described in the related applications cited above.
Self-contained or leadless pacemakers or other biostimulators are typically fixed to an intracardial implant site by an actively engaging mechanism such as a screw or helical member that screws into the myocardium.
SUMMARY OF THE DISCLOSURE
A leadless cardiac pacemaker is provided, comprising a hermetic housing, a pacing electrode disposed on a distal portion of the housing, an electronics package disposed in the housing, the electronics package configured to generate and deliver pacing signals to the pacing electrode, and a fixation mechanism separate from the pacing electrode and disposed on the distal portion of the housing, the fixation mechanism having a diameter less than or equal to an outer diameter of the hermetic housing and comprising less than two turns of rotation from a distal end of the fixation mechanism to a proximal end of the fixation mechanism.
In some embodiments, the fixation mechanism comprises less than one and a half turns of rotation from the distal end of the fixation mechanism to the proximal end of the fixation mechanism. In other embodiments, the fixation mechanism comprises less than one and a quarter turns of rotation from the distal end of the fixation mechanism to the proximal end of the fixation mechanism.
In some embodiments, the pacing electrode comprises a dome shape. In additional embodiments, the pacing electrode is attached to the housing via a compliant spring to reduce compression force against the heart tissue. In another embodiment, the pacing electrode is attached to the housing via a silicon adhesive to reduce compression force against the heart tissue.
In one embodiment, the fixation mechanism comprises a helix. In some embodiments, the helix rotates less than or equal to 450 degrees. In other embodiments, the helix at least partially surrounds the pacing electrode.
In some embodiments, the fixation mechanism comprises a constant diameter. In another embodiment, the fixation mechanism has a diameter between 2.5 mm and 5 mm.
In some embodiments, the fixation mechanism comprises a longitudinal length of less than 1.8 mm. In other embodiments, the distal portion of the housing has an outer diameter less than an outer diameter of the hermetic housing. In some embodiments, the fixation mechanism is sized and configured so that it does not perforate a myocardium of a patient when fully screwed into cardiac tissue.
In some embodiments, the fixation mechanism comprises a radial portion substantially aligned with a circumference of the housing and a connecting portion attaching the fixation mechanism to the housing. In one embodiment, the radial portion is substantially perpendicular to the connecting portion. In another embodiment, the connecting portion has a length smaller than a thickness of a myocardium layer of a heart of a patient. In yet another embodiment, the connecting portion has a length less than or equal to 1.8 mm. In additional embodiments, the radial portion of the fixation mechanism is configured to reside within a myocardium layer of a heart of a patient and substantially in contact with an endocardium layer of the heart of the patient. In various embodiments, the fixation mechanisms can further comprise a barb disposed on an interior surface of the radial portion of the fixation mechanism.
In another embodiment, the pacemaker is further configured to receive during retrieval a protective sheath having an inner diameter similar to the outer diameter of the hermetic housing.
A method of affixing a pacemaker to tissue in the heart is also provided, comprising positioning a fixation mechanism of the pacemaker adjacent to an endocardium of the heart, the fixation mechanism having a diameter less than or equal to an outer diameter of the pacemaker, piercing the endocardium with the fixation mechanism, and rotating the fixation mechanism less than one and a quarter turns to insert substantially all of the fixation mechanism into the myocardium of the heart and place a pacing electrode of the pacemaker into contact with heart tissue.
In some embodiments, the fixation mechanism comprises a helix. In some embodiments, the pacemaker comprises a leadless cardiac pacemaker.
In another embodiment, the method further comprises covering the pacemaker and fixation mechanism with a protective sheath and removing the pacemaker from the patient.



BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1A-1C illustrate a leadless cardiac pacemaker.
FIGS. 2A-2D are various views of a leadless cardiac pacemaker having a radial fixation mechanism.



DETAILED DESCRIPTION OF THE INVENTION
Various embodiments of a leadless cardiac pacemaker having at least one radial fixation mechanism are provided. A leadless cardiac pacemaker can communicate by conducted communication, representing a substantial departure from conventional pacing systems. For example, an illustrative cardiac pacing system can perform cardiac pacing that has many of the advantages of conventional cardiac pacemakers while extending performance, functionality, and operating characteristics with one or more of several improvements.
In some embodiments of a cardiac pacing system, cardiac pacing is provided without a pulse generator located in the pectoral region or abdomen, without an electrode-lead separate from the pulse generator, without a communication coil or antenna, and without an additional requirement on battery power for transmitted communication.
An embodiment of a cardiac pacing system configured to attain these characteristics comprises a leadless cardiac pacemaker that is substantially enclosed in a hermetic housing suitable for placement on or attachment to the inside or outside of a cardiac chamber. The pacemaker can have two or more electrodes located within, on, or near the housing, for delivering pacing pulses to muscle of the cardiac chamber and optionally for sensing electrical activity from the muscle, and for bidirectional communication with at least one other device within or outside the body. The housing can contain a primary battery to provide power for pacing, sensing, and communication, for example bidirectional communication. The housing can optionally contain circuits for sensing cardiac activity from the electrodes. The housing contains circuits for receiving information from at least one other device via the electrodes and contains circuits for generating pacing pulses for delivery via the electrodes. The housing can optionally contain circuits for transmitting information to at least one other device via the electrodes and can optionally contain circuits for monitoring device health. The housing contains circuits for controlling these operations in a predetermined manner.
In some embodiments, a cardiac pacemaker can be adapted for delivery and implantation into tissue in the human body. In a particular embodiment, a leadless cardiac pacemaker can be adapted for implantation adjacent to heart tissue on the inside or outside wall of a cardiac chamber, using two or more electrodes located on or within the housing of the pacemaker, for pacing the cardiac chamber upon receiving a triggering signal from at least one other device within the body.
Self-contained or leadless pacemakers or other biostimulators are typically fixed to an intracardial implant site by an actively engaging mechanism or primary fixation mechanism such as a screw or helical member that screws into the myocardium. Examples of such leadless biostimulators are described in the following publications, the disclosures of which are incorporated by reference: (1) U.S. application Ser. No. 11/549,599, filed on Oct. 13, 2006, entitled “Leadless Cardiac Pacemaker System for Usage in Combination with an Implantable Cardioverter-Defibrillator”, and published as US2007/0088394A1 on Apr. 19, 2007; (2) U.S. application Ser. No. 11/549,581 filed on Oct. 13, 2006, entitled “Leadless Cardiac Pacemaker”, and published as US2007/0088396A1 on Apr. 19, 2007; (3) U.S. application Ser. No. 11/549,591, filed on Oct. 13, 2006, entitled “Leadless Cardiac Pacemaker System with Conductive Communication” and published as US2007/0088397A1 on Apr. 19, 2007; (4) U.S. application Ser. No. 11/549,596 filed on Oct. 13, 2006, entitled “Leadless Cardiac Pacemaker Triggered by Conductive Communication” and published as US2007/0088398A1 on Apr. 19, 2007; (5) U.S. application Ser. No. 11/549,603 filed on Oct. 13, 2006, entitled “Rate Responsive Leadless Cardiac Pacemaker” and published as US2007/0088400A1 on Apr. 19, 2007; (6) U.S. application Ser. No. 11/549,605 filed on Oct. 13, 2006, entitled “Programmer for Biostimulator System” and published as US2007/0088405A1 on Apr. 19, 2007; (7) U.S. application Ser. No. 11/549,574, filed on Oct. 13, 2006, entitled “Delivery System for Implantable Biostimulator” and published as US2007/0088418A1 on Apr. 19, 2007; and (8) International Application No. PCT/US2006/040564, filed on Oct. 13, 2006, entitled “Leadless Cardiac Pacemaker and System” and published as WO07047681A2 on Apr. 26, 2007.
In addition to the primary fixation mechanism, such as a helix, some pacemakers may further include a secondary fixation mechanism to provide another feature for keeping the biostimulator in place within the body. Secondary fixation mechanisms can be either active (e.g., the secondary fixation mechanism can actively engage tissue, either within or outside the heart), or can be passive (e.g., the secondary fixation mechanism is not attached to tissue but rather prevents the biostimulator from moving around in the body in the case of accidental detachment). Further details on secondary fixation mechanisms can be found in U.S. application Ser. No. 12/698,969.
Self-contained or leadless pacemakers or other biostimulators are typically fixed to an intracardial implant site by an actively engaging mechanism such as a screw or helical member that screws into the myocardium. In case of malfunction, it is highly desirable to be able to retrieve the leadless pacemaker of biostimulators both acutely (during the implantation procedure) or chronically, after a period of time post implantation minimally invasively.
FIG. 1A shows a leadless cardiac pacemaker 100. The biostimulators can include a hermetic housing 102 with electrodes 104 and 106 disposed thereon. As shown, electrode 106 can be separated from but surrounded partially by a fixation mechanism 105, and the electrode 104 can be disposed on the housing 102. The fixation mechanism 105 can be a fixation helix, a plurality of hooks, barbs, or other attaching features configured to attach the pacemaker to tissue, such as heart tissue.
The housing can also include an electronics compartment 110 within the housing that contains the electronic components necessary for operation of the pacemaker, including, for example, a pulse generator, communication electronics, a battery, and a processor for operation. The hermetic housing 102 can be adapted to be implanted on or in a human heart, and can be cylindrically shaped, rectangular, spherical, or any other appropriate shapes, for example.
The housing can comprise a conductive, biocompatible, inert, and anodically safe material such as titanium, 316L stainless steel, or other similar materials. The housing can further comprise an insulator disposed on the conductive material to separate electrodes 104 and 106. The insulator can be an insulative coating on a portion of the housing between the electrodes, and can comprise materials such as silicone, polyurethane, parylene, or another biocompatible electrical insulator commonly used for implantable medical devices. In the embodiment of FIG. 1A, a single insulator 108 is disposed along the portion of the housing between electrodes 104 and 106. In some embodiments, the housing itself can comprise an insulator instead of a conductor, such as an alumina ceramic or other similar materials, and the electrodes can be disposed upon the housing.
As shown in FIG. 1A, the pacemaker can further include a header assembly 112 to isolate electrode 104 from electrode 106. The header assembly 112 can be made from PEEK, tecothane or another biocompatible plastic, and can contain a ceramic to metal feedthrough, a glass to metal feedthrough, or other appropriate feedthrough insulator as known in the art.
The electrodes 104 and 106 can comprise pace/sense electrodes, or return electrodes. A low-polarization coating can be applied to the electrodes, such as sintered platinum, platinum-iridium, iridium, iridium-oxide, titanium-nitride, carbon, or other materials commonly used to reduce polarization effects, for example. In FIG. 1A, electrode 106 can be a pace/sense electrode and electrode 104 can be a return electrode. The electrode 104 can be a portion of the conductive housing 102 that does not include an insulator 108.
Several techniques and structures can be used for attaching the housing 102 to the interior or exterior wall of the heart. A helical fixation mechanism 105, can enable insertion of the device endocardially or epicardially through a guiding catheter. A torqueable catheter can be used to rotate the housing and force the fixation device into heart tissue, thus affixing the fixation device (and also the electrode 106 in FIG. 1A) into contact with stimulable tissue. Electrode 104 can serve as an indifferent electrode for sensing and pacing. The fixation mechanism may be coated partially or in full for electrical insulation, and a steroid-eluting matrix may be included on or near the device to minimize fibrotic reaction, as is known in conventional pacing electrode-leads.
FIGS. 1B-1C illustrate additional close-up views of the distal portion of pacemaker 100, including fixation mechanism 105 and electrode 106. As shown in FIGS. 1B-1C, the fixation mechanism can comprise a helix that partially surrounds or rotates around the electrode 106. In some embodiments, the fixation device comprises a diameter equal to or less than the outer diameter of the housing of the pacemaker itself. In the helical embodiment, the helix can comprise a constant diameter that is less than or equal to the outer diameter of the pacemaker housing. In one embodiment, the fixation device comprises a diameter of less than 5 mm. In another embodiment, the fixation device comprises a diameter of greater than 2.5 mm and less than 5 mm. In some embodiments, the helical fixation device can have a wire diameter of 0.005′′-0.03′′ and a pitch of 0.5 mm to 1.5 mm. Utilizing a fixation mechanism having a diameter up to the diameter of the housing can increase the pull force required to remove the fixation mechanism from tissue, thereby decreasing the chances of the device coming dislodged from the heart. Furthermore, the increased diameter of the fixation mechanism can increase the surface area in contact with the endocardium layer of the heart, further improving the ability of the pacemaker to remain implanted in the patient.
The helical fixation mechanism 105 of FIGS. 1A-1C can comprise a coil having less than 2 full rotations from the leading distal edge of the mechanism to the proximal portion of the mechanism that attaches to the housing of the pacemaker. For example, in FIG. 1B, the distal leading edge 114 of the fixation mechanism 105 is approximately one and a quarter turns (approximately 450 degrees) from proximal end 116 of the fixation mechanism. As shown in FIG. 1B, a distal portion of the housing that attaches to the fixation mechanism can have an outer diameter less than the main outer diameter of the housing, so as to facilitate attachment of the fixation mechanism while allowing the fixation mechanism to have a diameter less than the main outer diameter of the housing.
The fixation mechanism 105 can also include a longitudinal length L of less than 1.8 mm, which is considered the safe length for preventing perforation of the myocardium during implantation. Thus, the fixation mechanism is thereby configured to fully screw into cardiac tissue with less than 2 turns (and preferably less than or equal to one and a quarter turns) without perforating the myocardium of the patient. When the fixation mechanism is fully screwed into the cardiac tissue, the electrode 106 of the pacemaker is in solid contact with the tissue. FIG. 1C shows a top down view of the starting and end points of distal leading edge 114 and proximal end 116 of the fixation mechanism, spanning approximately one and a quarter turns or less. In some other embodiments, the fixation mechanism can span less than 2 full turns from the distal end to the proximal end of the mechanism.
Also shown in FIGS. 1A-1C, the fixation mechanism can include anti-rotation features such as barbs or sutures to prevent counter rotation of the device once it has been screwed into tissue.
Referring to the top down view shown in FIG. 1C, the electrode 106 can comprise a “button” or dome shape that protrudes slightly distally from the distal tip of the pacemaker. The dome shaped electrode can include a diameter of 1.5-2.5 mm and can protrude distally from the end of the pacemaker approximately 0.05′′ to 0.3′′. The electrode 106 is preferably an atraumatic surface, and can protrude from the tip of the pacemaker so as to contact the tissue when fixation mechanism 105 is screwed into tissue.
The electrode 106 may be electrically and mechanically attached to the pacemaker via a compliant spring 118 and/or silicone adhesive (not shown), so as to reduce the tensile or compression force and rubbing motion imparted to the tissue to be stimulated. A reduction in force and/or rubbing motion of the electrode relative to tissue to be stimulated will result in a reduction of the tissue's inflammatory response at the electrode/tissue interface, resulting in a reduction of fibrotic tissue formation. This reduction of fibrosis results in a lower pacing voltage/current required to stimulate viable tissue.
In conventional pacemakers, it is common to integrate the pacing electrode into the fixation device itself. However, this combination can cause additional irritation to tissue since the pacing electrode contacts tissue damaged by the fixation device during insertion. By separating the electrode 106 from the fixation device 105, as shown in FIGS. 1B-1C, pacing functions performed by the electrode 106 do not contact tissues otherwise irritated by the fixation device 105. The forces generated by the weight and motion of the pacemaker are intended to be distributed to the tissue in direct contact with the fixation mechanism, and not by the tissue in contact with the electrode 106 located a short distance away. By decoupling the fixation site from the stimulation site, the resulting fibrosis at the distal tip can be reduced, resulting in a reduction of required voltage and current to stimulate viable tissue. Moreover, since the area to be stimulated does not experience irritation due to fixation trauma, the current of injury can be lowered, and low stimulation thresholds can be achieved upon immediate electrode contact.
FIGS. 2A-2C illustrate various views of a leadless pacemaker 100 having at least one radial fixation mechanism 205 configured to attach the pacemaker to heart tissue. The radial fixation mechanisms (i.e. hooks, protrusions, spears, etc) can extend radially outwards a distance of less than or equal to the maximum outer diameter (OD) of the housing of the leadless cardiac pacemaker 200, and can be located near the distal portion of the pacemaker. In some embodiments, the radial fixation mechanisms can be relied upon as a secure cardiac fixation mechanism when engaged into cardiac tissue through rotation of the pacemaker.
In the embodiment of FIGS. 2A-2C, the fixation mechanisms comprise multiple L-shaped hooks disposed around or near electrode 206. FIG. 2A shows a perspective view of one embodiment of a pacemaker including three L-shaped hooks or fixation mechanisms. FIG. 2B shows a top down view of the pacemaker of FIG. 2A, and FIG. 2C illustrates a side view of the pacemaker of FIG. 2A, showing the position of the fixation mechanisms with respect to electrode 206. The hooks can comprise a tissue piercing distal tip, as shown, for puncturing heart tissue and particularly for piercing the endocardium of the heart.
The fixation mechanisms 205 of FIGS. 2A-2C are configured to affix to tissue with a shortened radial turn or twist. Referring to FIG. 2A, each fixation mechanism can include a radial portion 209, which runs substantially parallel to a circumference of the pacemaker housing, and a connecting portion 211, which is substantially perpendicular to the radial portion and connects the radial portion to the pacemaker. The connecting portion can be, for example, approximately the same length as the average thickness of the myocardium of the heart. In use, the radial portion of the fixation mechanism is the portion that punctures and affixes to tissue. Turning or screwing the fixation mechanism into tissue will cause the radial portion to engage the tissue until reaching the connecting portion of the fixation mechanism. This can also provide a tactile response by “stopping” rotation of the device when the connecting portion contacts the tissue.
In the embodiment shown in FIGS. 2A-2C, the pacemaker 200 includes three L-shaped radial hooks or barbs. Each hook can comprise, for example, approximately 60-90 degrees or one quarter to one sixth of a turn of the pacemaker to deposit the hook within tissue. The larger the number of hooks used, and therefore the smaller the length of the hook, the fewer the number of turns is required to engage tissue with the hook.
FIG. 2D illustrates another embodiment of a pacemaker 200 having a distally curved radial hook 205. As shown in FIG. 2D, the hook can be curved distally towards the electrode 206 at an angle up to and including 45 degrees from horizontal. Curving the hooks distally towards the electrode can aid in bringing the electrode into contact with the hooks during insertion into tissue. In some embodiments, the angle of curvature can be between 30 and 60 degrees in the distal direction.
The fixation mechanisms can be enclosed in a delivery and retrieval catheter's collapsible sheath (not shown) to allow for easy delivery, repositioning, and retrieval of the leadless pacemaker to and from the right atrium or ventricle. Since the fixation mechanisms always have a diameter less than the outer diameter of the pacemaker, retrieval with a sheath is feasible. In contrast, pacemakers having barbs or hooks larger than the outer diameter of the pacemaker are difficult or unable to be retrieved from the patient due to the inability to cover the larger hooks or barbs with a protective sheath. Examples of a suitable retrieval catheter and sheath can be found in co-pending Application Ser. No. 13/324,802.
These fixation mechanisms can also include features to prevent unscrewing of the pacemaker, such a barbs 207 (a backward-facing point or feature on said fixation mechanism intended to grab tissue and increase the amount of force or torque required to remove the mechanism) and/or holes and indentations that allow for tissue adhesion and in-growth. The fixation mechanisms can be electrically isolated (floating) from the indifferent return electrode of the pacemaker. Because more than one fixation mechanism can be integrated onto the pacemaker, the idea provides redundant fixation means.
The innermost layer of tissue that lines the chamber of the heart is the thin but tough endocardium. Beneath it lays the soft myocardium, the cardiac muscle tissue comprising the majority of the thickness of the heart wall. When the fixation mechanism or mechanisms described above are engaged in acute cardiac tissue, the sharpened tip pierces the endocardium and enters the myocardium until the majority of its length resides in the myocardium. It is the thin but strong endocardium that provides the majority of the fixation mechanism's holding force in tissue. The hook design of the fixation mechanisms as shown in FIGS. 2A-2C can provide superior holding force over alternative designs (e.g. small helices) due to the large contact surface between the endocardium and the underlying the hooks. More specifically, the radial portion 209 of the hooks can be angled and aligned to maximize the contact surface between the hook and endocardium, as shown in FIG. 2D.
Moreover, the small barb features (e.g., barbs 207) implemented on each hook are configured to grab the endocardium from within as the hook slides back out of the puncture site as the pacemaker is unscrewed. Barb features may be designed quite small (on the order of 0.01′′) to sufficiently grab endocardium upon removal, but would have to be designed unacceptably large to have the same holding force in myocardium alone.
Because the small barbs 207 are designed to hold the endocardium, the number and position of the barbs on each fixation mechanism is another area of design flexibility. Each hook 205 may have one or more barbs positioned distally, proximally, and in-between. In some embodiments, two barbs per fixation mechanism is sufficient—one positioned proximally near the base of each hook, and one positioned distally near each fixation mechanism's sharpened point. When a hook is properly engaged in cardiac tissue, a majority of the hook (e.g., the radial portion of the hook) has punctured the endocardium and is disposed within the myocardium. In this case, the proximal barb would then be positioned directly behind the endocardium; after only a few degrees of angular unscrewing, these proximal barbs would immediately grab the endocardium and prevent further unscrewing. The distal barbs near the ends of the fixation mechanisms are positioned in the case the hooks are not 100% engaged in tissue; as long as a few degrees of engagement have occurred, these distal barbs would be in-tissue and can be relied upon to prevent dislodgement.
The fixation mechanisms with barbs can be created by a number of processes known to those with skill in the art. For example, an axisymmetric multiple fixation mechanism with barbs can be cut from a sheet of metal via a laser, wire EDM, or chemical etching. Metal parts can also be manufactured using metal-injection-molding techniques. Certain edges can be rounded or sharpened through electropolishing or tumbling techniques. Plastic parts may also be cut from a sheet or injection-molded.
Barbs 207 can be formed on any face or combination of faces of each individual hook, though the easiest two faces would be the surface facing inwards toward the pacemaker and the face facing outwards towards the tissue. Placing barbs only on the inward-facing surface has the advantage of achieving the anti-unscrewing design objective while leaving the outward-facing surfaces smooth, reducing the risk of snagging or ripping tissue or the catheter's protective sheath during delivery, repositioning, or retrieval.
The mechanical characteristics of the hooks and barbs can be varied through the selection of the hook material and the cross-sectional profile. They may be designed to be axially stiff by increasing their axial thickness (increasing the thickness of the sheet they are cut from) while designed to be radially flexible by reducing their cut profile strut width. The hooks can manufactured out of plastic or metal. They can be made rigid through the use of glass-filled polymers or hard metals such as MP35N, Stainless Steel, or titanium. They can also be designed to be elastic by manufacturing the hooks out of flexible polymers or superelastic nitinol. Moreover, they can be manufactured partially or entirely out of a bioabsorbable polymer so that they provide secure acute fixation but allow for easier chronic retrieval. The fixation hooks can be made porous or coated with a high-microscopic-surface-area coating to promote chronic tissue in-growth and/or adhesion. The hooks may also be coated with a steroid similar to that used for electrodes to reduce the resulting fibrotic response.
The angle of the hooks may also be adjusted to tailor the fixation performance. When the pacemaker is positioned at the apex of a ventricle and is rotated to engage tissue, the angle of the hooks can determine whether the pacemaker is pulled or pushed in the distal or proximal direction as the hooks follow their trajectory into the cardiac tissue. If the hooks are angled down (such that the sharpened tips of the hooks are more distal than the base of the hooks), then the pacemaker will move in the distal direction as the pacemaker is rotated. This additional distal motion of the pacemaker can ensure that its distal electrode is drawn closer to the distal endocardial stimulable tissue and will remain in contact with that tissue.
This configuration allows for the positioning of a conventional steroid endocardial pacing electrode along the central axis at the distal tip. This electrode can be used as the primary pacing/sensing tip electrode, located a few millimeters away from this disclosed fixation mechanism.
As for additional details pertinent to the present invention, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.

## Claims

1. A leadless cardiac pacemaker, comprising:
a hermetic housing;
a pacing electrode disposed on a distal portion of the housing, the electrode comprising an atraumatic surface not configured to penetrate heart tissue;
an electronics package disposed in the housing; and
a fixation mechanism located a distance from the pacing electrode and disposed on the distal portion of the housing, the fixation mechanism comprising a helix having a longitudinal length,
wherein the helix is configured to pierce an endocardium layer of the patient's heart and to rotate into a myocardium layer of the patient's heart, the helix remaining in contact with the endocardium layer of the heart and the pacing electrode being placed into contact with the patient's heart tissue when the helix is fully rotated into the heart tissue, and
wherein the helix comprises a constant diameter and is positioned about the pacing electrode to at least partially surround the pacing electrode so that the electrode does not contact tissue of the patient's heart that is irritated due to fixation trauma.

2. A leadless cardiac pacemaker, comprising:
a hermetic housing;
a pacing electrode disposed on a distal portion of the housing, the electrode comprising an atraumatic surface;
an electronics package disposed in the housing; and
a fixation mechanism separated from the pacing electrode and disposed on the distal portion of the housing, the fixation mechanism comprising a helix having a longitudinal length,
wherein the helix is configured to pierce an endocardium layer of the patient's heart and to screw into a myocardium layer of the patient's heart, the helix remaining in contact with the endocardium layer of the heart and the pacing electrode being placed into contact with the patient's heart tissue at a stimulation site when the fixation mechanism is fully screwed into a fixation site, and
wherein the helix comprises a constant diameter and is positioned about the pacing electrode to at least partially surround the pacing electrode so that the electrode does not contact tissue of the patient's heart that is irritated due to the fixation mechanism when the fixation mechanism is fully screwed into the fixation site.

3. The leadless cardiac pacemaker of claim 2, wherein the fixation site of the leadless pacemaker is decoupled from the stimulation site so that the stimulation site does not experience irritation due to fixation trauma during implantation of the leadless cardiac pacemaker.

4. The leadless cardiac pacemaker of claim 2, wherein the constant diameter of the fixation mechanism is equal to a diameter of the hermetic housing.

5. The pacemaker of claim 2 wherein the constant diameter of the fixation mechanism is between 2.5 mm and 5 mm, and wherein the fixation mechanism has a pitch of 0.5 mm to 1.5 mm.

6. The pacemaker of claim 2 wherein the longitudinal length of the helix is less than 1.8 mm.

7. The pacemaker of claim 2 wherein the electrode is configured not to penetrate the patient's heart.

8. A leadless cardiac pacemaker, comprising:
a hermetic housing;
a pacing electrode disposed on a distal portion of the housing;
an electronics package disposed in the housing; and
a fixation mechanism separate from the pacing electrode and disposed on the distal portion of the housing, the fixation mechanism comprising a helix having a longitudinal length, wherein the helix is configured to penetrate the endocardium layer of the patient's heart and rotate into a myocardium layer of the patient's heart, the helix configured to remain in contact with the endocardium layer of the heart when the helix is fully screwed into cardiac tissue, wherein the helix comprises a constant diameter and is positioned about the pacing electrode to at least partially surround the pacing electrode so that that the helix secures to the cardiac tissue at a fixation site that is separate and decoupled from a stimulation site contacted by the pacing electrode, wherein the pacing electrode comprises a dome shape having an atraumatic surface.

9. The pacemaker of claim 8 wherein the pacing electrode is attached to the housing via a compliant spring to reduce compression force against the heart tissue.

10. The pacemaker of claim 8 wherein the pacing electrode is attached to the housing via a silicone adhesive to reduce compression force against the heart tissue.

11. The pacemaker of claim 8 wherein the constant diameter of the fixation mechanism is between 2.5 mm and 5 mm.

12. The pacemaker of claim 8 wherein the longitudinal length of the helix is less than 1.8 mm.

13. The pacemaker of claim 8 wherein the constant diameter of the fixation mechanism is less than a diameter of the hermetic housing.

14. The pacemaker of claim 8 wherein the fixation mechanism is sized and configured so that it does not perforate the myocardium layer when fully screwed into the cardiac tissue.

15. The pacemaker of claim 8 wherein the fixation mechanism comprises a barb to resist counter rotation of the fixation mechanism when the fixation mechanism is screwed into the cardiac tissue.

16. The pacemaker of claim 8 being further configured to receive during retrieval a protective sheath having an inner diameter similar to an outer diameter of the hermetic housing.

17. The pacemaker of claim 8, wherein the constant diameter of the fixation mechanism is equal to a diameter of the hermetic housing.

18. The pacemaker of claim 8, wherein the pacing electrode protrudes approximately 0.05 to 0.3 inches from the distal portion of the housing.

19. The pacemaker of claim 8, wherein the pacing electrode is configured not to penetrate the patient's heart.

20. A leadless cardiac pacemaker, comprising:
a hermetic housing;
a pacing electrode disposed on a distal portion of the housing, the pacing electrode comprising a dome shape having an atraumatic surface;
an electronics package disposed in the housing; and
a fixation mechanism separate from the pacing electrode and disposed on the distal portion of the housing, the fixation mechanism comprising a helix configured to penetrate the endocardium layer of the patient's heart and rotate into a myocardium layer of the patient's heart, the helix configured to remain in contact with the endocardium layer of the heart when the helix is fully screwed into cardiac tissue, wherein a smallest diameter of the helix is greater than a diameter of the pacing electrode, and wherein the helix is positioned about the pacing electrode to at least partially surround the pacing electrode so that that the helix secures to the cardiac tissue at a fixation site that is separate and decoupled from a stimulation site contacted by the pacing electrode.

21. The pacemaker of claim 20 wherein the smallest diameter of the helix is greater than twice the diameter of the pacing electrode.

22. The pacemaker of claim 20 wherein the helix comprises a constant diameter.

23. A leadless cardiac pacemaker, comprising:
a hermetic housing;
a pacing electrode disposed on a distal portion of the housing, the electrode comprising an atraumatic surface not configured to penetrate heart tissue;
an electronics package disposed in the housing; and
a fixation mechanism located a distance from the pacing electrode and disposed on the distal portion of the housing, the fixation mechanism comprising a helix,
wherein the helix is configured to pierce an endocardium layer of the patient's heart and to rotate into a myocardium layer of the patient's heart, the helix remaining in contact with the endocardium layer of the heart and the pacing electrode being placed into contact with the patient's heart tissue when the helix is fully rotated into the heart tissue, and
wherein the helix comprises a constant diameter equal to a constant diameter of the distal portion of the housing, and is positioned about the pacing electrode to at least partially surround the pacing electrode so that the electrode does not contact tissue of the patient's heart that is irritated due to fixation trauma.

24. The pacemaker of claim 23 wherein a proximal portion of the housing comprises a constant diameter greater than the constant diameter of the distal portion of the housing.

25. The pacemaker of claim 24 wherein the housing further comprises an intermediate portion coupling the proximal portion to the distal portion, the intermediate portion having a diameter that transitions linearly from the constant diameter of the proximal portion to the constant diameter of the distal portion.

26. A leadless cardiac pacemaker, comprising:
a hermetic housing;
a pacing electrode disposed on a distal portion of the housing, the electrode comprising an atraumatic surface, the distal portion of the housing comprising a flat surface adjoining and surrounding the pacing electrode, and the distal portion of the housing further comprising a rounded edge adjoining and surrounding the flat surface;
an electronics package disposed in the housing; and
a fixation mechanism separated from the pacing electrode and disposed on the distal portion of the housing, the fixation mechanism comprising a helix,
wherein the helix is configured to pierce an endocardium layer of the patient's heart and to screw into a myocardium layer of the patient's heart, the helix remaining in contact with the endocardium layer of the heart and the pacing electrode being placed into contact with the patient's heart tissue at a stimulation site when the fixation mechanism is fully screwed into a fixation site, and
wherein the helix comprises a constant diameter and is positioned about the pacing electrode to at least partially surround the pacing electrode so that the electrode does not contact tissue of the patient's heart that is irritated due to the fixation mechanism when the fixation mechanism is fully screwed into the fixation site.