All publications, including patents and patent applications, mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.
The present disclosure relates to leadless cardiac pacemakers, and more particularly, to features and methods by which they are affixed within the heart. More specifically, the present disclosure relates to features and methods for preventing a leadless cardiac pacemaker from unscrewing itself out of tissue.
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 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.
The potential of detachment of the leadless biostimulator from the implant site would represent an immediately serious event, as for example, a pacemaker lost from the right ventricle can exit the heart via the pulmonic valve and lodge in the lung.
A leadless biostimulator is provided, comprising a housing sized and configured to be implanted within a heart of a patient, a primary fixation device attached to the housing and configured to affix the biostimulator to a wall of the heart, and an anti-unscrewing feature disposed on the primary fixation device, the anti-unscrewing feature configured to prevent the primary fixation device from disengaging the wall of the heart.
In some embodiments, the primary fixation device is a fixation helix.
In other embodiments, the anti-unscrewing feature is at least one barb. In some embodiments, the at least one barb is pointed generally proximally away from a distal end of the fixation device.
In some embodiments, a first torque required to insert the fixation device into the wall of the heart is less than a second torque required to remove the fixation device from the wall of the heart.
In some embodiments, the anti-unscrewing feature is at least one rounded feature. In other embodiments, the anti-unscrewing feature is at least one through-hole. In additional embodiments, the anti-unscrewing feature is at least one depression.
A leadless biostimulator is provided, comprising a housing sized and configured to be implanted within a heart of a patient, a primary fixation helix attached to the housing and configured to affix the biostimulator to a wall of the heart, and an anti-unscrewing helix wound in an opposite direction of the primary fixation helix, the anti-unscrewing helix attached to the housing.
In some embodiments, the primary fixation helix is a right-handed helix and the anti-unscrewing helix is a left-handed helix. In other embodiments, the primary fixation helix is longer than the anti-unscrewing helix. In additional embodiments, the anti-unscrewing helix is positioned outside of the primary fixation helix.
In some embodiments, the primary fixation helix is an electrode.
In other embodiments, the anti-unscrewing helix is configured to compress against tissue as the primary fixation helix is affixed to the wall of the heart.
The leadless biostimulator of claim 9 wherein the anti-unscrewing helix is configured to engage the wall of the heart in the event the biostimulator unscrews from the wall of the heart.
A leadless biostimulator, comprising: a housing sized and configured to be implanted within a heart of a patient; a primary fixation device attached to the housing and configured to affix the biostimulator to a wall of the heart; and an anti-unscrewing feature disposed on the housing, the anti-unscrewing feature configured to prevent the primary fixation device from disengaging the wall of the heart.
In some embodiments, the primary fixation device comprises a fixation helix.
In some embodiments, the anti-unscrewing feature comprises a plurality of teeth, barbs, or other sharpened features. In many embodiments, the teeth, barbs, or other sharpened features are disposed on a distal surface of the housing. In some embodiments, the teeth, barbs, or other sharpened features are disposed on a tapered surface of the housing. In other embodiments, the teeth, barbs, or other sharpened features are arranged asymmetrically to provide resistance only in an unscrewing direction of the primary fixation device.
In one embodiment, a first torque required to insert the fixation device into the wall of the heart is less than a second torque required to remove the fixation device from the wall of the heart.
In some embodiments, the anti-unscrewing feature is a cleat. In one embodiment, the cleat is positioned on the housing beneath the fixation device. In other embodiments, the cleat is directed towards the fixation device and configured to grab heart tissue between the cleat and the fixation device to resist unintentional detachment of the fixation device from the wall of the heart.
In some embodiments, the anti-unscrewing feature is at least one through-hole. In other embodiments, the anti-unscrewing feature is at least one depression.
A leadless biostimulator is provided, comprising a housing sized and configured to be implanted within a heart of a patient, a primary fixation device attached to the housing and configured to affix the biostimulator to a wall of the heart, and at least one through-hole disposed in the housing, the at least one through-hole configured to promote tissue in-growth into the through-hole to prevent the primary fixation device from disengaging the wall of the heart.
In some embodiments, the at least one through-hole extends horizontally into the housing. In other embodiments, the at least one through-hole extends along a longitudinal axis of the housing. In some embodiments, the at least one through-hole has a diameter of approximately 0.005″ to 0.04″. In other embodiments, the at least one through-hole extends partially across a diameter of the housing. In additional embodiments, the at least one through-hole extends fully across a diameter of the housing. In some embodiments, the at least one through-hole is filled with a bioabsorbable material.
A method of preventing unintentional detachment of a leadless biostimulator from a heart of a patient is provided, comprising applying torque to the leadless biostimulator in a first direction to affix the leadless biostimulator to heart tissue with a primary fixation device, applying torque to the tissue in a second direction with an anti-unscrewing device to prevent disengagement of the leadless biostimulator from tissue.
In some embodiments, the torque in the second direction is greater than the torque in the first direction.
A method of preventing detachment of a leadless biostimulator from a patient is provided, comprising implanting the leadless biostimulator into heart tissue of the patient, preventing the leadless biostimulator from detaching from the heart tissue with a bioabsorbable anti-unscrewing feature, and allowing the bioabsorbable anti-unscrewing feature to be absorbed by the patient in less than 3 months.
In some embodiments, the anti-unscrewing feature is a suture. In additional embodiments, the suture is bio-absorbable.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
a-2f illustrate embodiments of anti-unscrewing features disposed on a fixation device of a leadless cardiac pacemaker.
a-3c illustrate various embodiments of anti-unscrewing helixes on a leadless cardiac pacemaker.
a-4f illustrate embodiments of anti-unscrewing features disposed on a housing of a leadless cardiac pacemaker.
a-5p illustrate various embodiments of leadless cardiac pacemakers having tine assemblies and anti-unscrewing features.
a-6e illustrate various embodiments of through-hole or partial through-holes incorporated into a leadless cardiac pacemaker.
a-7b illustrate embodiments of a leadless cardiac pacemaker having an anti-unscrewing feature comprising a suture.
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.
Various embodiments of a system comprising one or more leadless cardiac pacemakers or biostimulators are described. 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 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 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.
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
As shown in
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 platinum, platinum-iridium, iridium, iridium-oxide, titanium-nitride, carbon, or other materials commonly used to reduce polarization effects, for example. In
Several techniques and structures can be used for attaching the housing 102 to the interior or exterior wall of the heart. A helical fixation device 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
Various anti-unscrewing features can be included on the biostimulator to provide a feature that requires that the torque necessary to unscrew the biostimulator from tissue is greater than the torque necessary to unscrew the biostimulator without such a feature. In some embodiments, the torque necessary to unscrew the biostimulator from tissue is greater than the torque necessary to either further screw, engage, or re-engage the biostimulator into tissue. When an anti-unscrewing feature provides this function, the chances of a biostimulator accidentally unscrewing or disengaging itself from the tissue is reduced. It should be noted that the torque necessary to initially insert a biostimulator into tissue is greater due to the puncturing or piercing of tissue and the formation of a helical cavity. Thus, in some embodiments, the anti-unscrewing features need only provide that the torque necessary to unscrew the biostimulator from tissue be greater than the torque necessary to unscrew the biostimulator from tissue after the biostimulator has already been implanted in tissue (i.e., after the tissue has been pierced).
Referring now to
In
Various other embodiments of anti-unscrewing features disposed on or within the fixation device are illustrated in
Referring to
Referring now to
f illustrates another embodiment where an anti-unscrewing feature comprising a barb 214 is combined with scallops 215 (or other cutout features) to promote tissue ingrowth and provide friction preventing anti-rotation.
In some embodiments described above, the anti-unscrewing feature(s) are stamped, cut, welded onto, etched onto, or otherwise attached to or disposed on the fixation device. In one embodiment, the fixation device can be wire-wound and the anti-unscrewing feature(s) can be added onto the fixation device by an additive process. In another embodiment, the fixation device can be subtractively cut from a tube and the anti-unscrewing feature(s) can be formed during the same process.
a-3c illustrate additional embodiments of a anti-unscrewing feature configured to prevent disengagement of a biostimulator from tissue. In contrast to the embodiments described above in
Referring to the top-down view of biostimulator 300 in
The anti-unscrewing helix can be a single helix, double helix, triple helix, etc. In some embodiments, referring to
c shows a side-view of the biostimulator 300 of
a-4b illustrate additional embodiments of anti-unscrewing features separate from the fixation device or helix. For example, in
c illustrates yet another embodiment of a biostimulator including an anti-unscrewing feature separate from the fixation device.
In
e illustrates another embodiment of a biostimulator having teeth 427 arranged in a radial direction around the biostimulator which are configured to apply force in an unscrewing direction opposite the direction that a fixation device 405 is inserted/engaged into tissue.
Referring now to
In
In the embodiment of
Similarly, in
In
f-5h illustrate additional embodiments comprising a tine or tines 530 providing anti-unscrewing features to the biostimulator. In
Other tine arrangements are shown in
In another embodiment, as shown in
n illustrates a variation of the embodiment shown in
a-6e illustrate other embodiments of a biostimulator having an anti-unscrewing feature for preventing disengagement of the biostimulator from tissue. In
Furthermore, the through-holes do not necessarily have to extend through the entire assembly. Referring to
a-7b illustrate side and top-down views, respectively, of yet another embodiment of a biostimulator having an anti-unscrewing feature for preventing disengagement of the biostimulator from tissue. In
Features such as cavities and through-holes that promote tissue in-growth into and through the biostimulator can increase fixation of the device to tissue and prevent anti-unscrewing and disengagement of the biostimulator from tissue. Although many of the embodiments described herein include features to promote tissue in-growth, it should be understood that many of the anti-unscrewing features described herein are configured to prevent unintentional detachment of the biostimulator from tissue immediately after implant, but before tissue has had time to grow into the device. In one embodiment, the through-holes are angled with an orifice on a distal face of the biostimulator.
The through-holes described herein can be open and free of any obstructing material, or alternatively, can be filled with a fast-dissolving substance, such as mannitol, or with a slowly bioabsorbable material. The advantage of filling the through-holes or cavities prior to implantation of the biostimulator is that it eliminates the risk of trapped air embolism and cavities that can serve as a nidus for bacterial growth.
The anti-unscrewing features described herein are intended to prevent a biostimulator from unintentionally unscrewing or disengaging from tissue. These features are most critical at the time shortly following implantation of the biostimulator (e.g., within 1-3 months of implantation). After 1-3 months post-implantation, endothelialization will have had sufficient time to occur such that the biostimulator is fully encapsulated by tissue. The probability of a fully encapsulated biostimulator inadvertently unscrewing itself from tissue is assumed to be relatively low.
Features to prevent unscrewing may be designed to be most effective in the short time period post-implant (e.g., within the first 1-3 months after implantation). These anti-unscrewing features can therefore be manufactured out of a bio-absorbable material. Once they are no longer needed to prevent unscrewing of the biostimulator, they can bioabsorb and disappear. Thus, any of the anti-unscrewing features described herein, including tines, barbs, teeth, secondary or anti-unscrewing helixes, and through-holes may be manufactured out of bioabsorbable materials to be absorbed by the body after the initial 1-3 month time period post-implant.
Various other embodiments of anti-unscrewing features disposed on or within the fixation device are illustrated in
A fixation device can comprise cut-outs or indentations along the length of the fixation device. The cut-outs can comprise semi-circular cutouts into the fixation device. These cut-outs allow for tissue ingrowth after the fixation device has been inserted into tissue. Although not shown, the cut-outs can comprise other shapes, including triangular, square, rectangular, etc. shaped cut-outs.
Another embodiment of a fixation device includes anti-unscrewing features. A fixation device can include through-holes and barbs. The through-holes can be disposed along the length of the fixation device. In one embodiment of
In some embodiments of a leadless cardiac pacemaker in the electrode is separate from the fixation device. An electrode is mounted on a flexible arm which extends outwardly from the body of the pacemaker. The flexible arm can extend radially outwards from the pacemaker to provide additional resistance against tissue in the event that the pacemaker begins to unscrew or become dislodged from tissue. The arm can include additional anti-unscrewing features, such as through-holes, barbs, teeth, etc., to further prevent anti-unscrewing. In some embodiments, the flexible arm is flexible in only one direction of rotation (e.g., the direction of rotation that would allow for the leadless pacemaker to unscrew from tissue), and is stiff or non-flexible in the other direction of rotation.
In an alternative embodiment a pacemaker has an electrode nestled within the fixation device. The pacemaker can be attached to tissue by screwing fixation device into the tissue, which brings the electrode into contact with the tissue. Anti-unscrewing features can be added to prevent the pacemaker from accidentally dislodging or unscrewing itself from tissue. The anti-unscrewing features can extend distally from the body of the pacemaker, as shown, to engage tissue as the pacemaker is implanted.
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.
This application claims the benefit under 35 U.S.C. 119 of U.S. Provisional Patent Application No. 61/392,886, filed Oct. 13, 2010, titled “Leadless Cardiac Pacemaker with Anti-Unscrewing Feature”, and U.S. Provisional Patent Application No. 61/422,618, filed Dec. 13, 2010, titled “Leadless Cardiac Pacemaker with Anti-Unscrewing Feature”, both of which are incorporated herein by reference in their entirety.
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Number | Date | Country | |
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20120116489 A1 | May 2012 | US |
Number | Date | Country | |
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61392886 | Oct 2010 | US | |
61422618 | Dec 2010 | US |