Heart monitor device

Abstract

An example of an implantable medical device includes a housing configured to house a control circuit configured to control the functions of the implantable medical device, and an electrode positioned on an outer surface of the housing and connected to the control circuit. The control circuit is configured to monitor a patient's physiological parameters via the electrode. The implantable medical device also includes an absorbent antibacterial layer disposed on the housing. The implantable medical device having the absorbent antibacterial layer is configured to be received within an implantation tool and delivered from the implantation tool to a patient.

Description

Technical Field

[0001] The present disclosure relates to implantable medical devices.

Background Art

[0002] Various implantable medical devices (IMDs) have been clinically implanted or proposed to therapeutically treat or monitor one or more physiological and / or neurological conditions of a patient. Such devices can be adapted to monitor or treat conditions or functions related to the heart, muscles, nerves, brain, stomach, endocrine organs or other organs and their related functions. Advances in the design and manufacture of miniaturized electronic and sensing devices have enabled the development of implantable devices capable of therapeutic and diagnostic functions, such as pacemakers, cardioverters, defibrillators, biochemical sensors, implantable loop recorders, and pressure sensors, among others. Such devices may be associated with leads that position electrodes or sensors at desired locations, or may be leadless with electrodes integrated into the device housing. These devices can have the ability to wirelessly transmit data to either another device implanted in the patient or another instrument located outside the patient, or both.

[0003] The implantation of some devices requires surgical procedures (e.g., pacemakers, defibrillators, etc.), while other devices can be delivered to and placed in the intended implantation site in a relatively non-invasive manner, such as by a transcutaneous delivery catheter, transvenously, or without using a subcutaneous delivery tool, if they are small enough. As an example, subcutaneous implantable monitors have been proposed and used to monitor physiological parameters such as heart rate and rhythm, as well as other physiological parameters such as the patient's posture and activity level. Such direct in vivo measurements of physiological parameters can provide important information to assist clinicians in making diagnostic and treatment decisions.

Summary of the Invention

[0004] The present disclosure describes implantable medical devices comprising absorbent antimicrobial materials, and related techniques, structures, and assemblies configured to reduce, prevent, and / or eliminate infections associated with medical devices implanted within a patient. An implantable medical device (IMD) may comprise an absorbent antimicrobial layer disposed on a portion of the housing of the device. The absorbent antimicrobial layer may be applied on an outer surface of the housing and may be configured to reduce, prevent, and / or eliminate infection and / or migration of the IMD. The absorbent antimicrobial layer may be configured to be compatible with an implantation tool configured to implant the IMD, thereby providing improved implantation of the IMD, as well as improved sensing performance and reliability. The absorbent antimicrobial layer may be configured to be compatible with an implantation tool configured to implant the IMD and the absorbent antimicrobial layer within a patient.

[0005] In one example, the present disclosure describes an implantable medical device comprising a housing configured to contain a control circuit, the control circuit being configured to control the functions of the implantable medical device, an electrode positioned on an outer surface of the housing and connected to the control circuit, the control circuit being configured to monitor a physiological parameter of a patient via the electrode, and an absorbent antimicrobial layer disposed on the housing, wherein the implantable medical device comprising the absorbent antimicrobial layer is configured to be received within an implantation tool and delivered from the implantation tool to a patient.

[0006] In another example, the present disclosure is a system comprising an implantable medical device according to any one of claims 1 to 25, and an implantation tool, the implantation tool being a tool body defining a channel extending along a longitudinal axis, the channel having a distal opening, the tool body being configured to receive the medical device within the channel, a plunger slidably fitted within the channel and movable within the channel toward the distal opening, a distal end of the plunger being configured to push out a proximal end of the medical device from the channel through the distal opening, and an absorbent antibacterial layer being configured to be compatible with the implantation tool when disposed on a housing of the implantable medical device.

[0007] In another example, the present disclosure is a kit comprising an implantable medical device according to any one of claims 1 to 24, and an implantation tool, the implantation tool being a tool body defining a channel extending along a longitudinal axis, the channel having a distal opening, the tool body being configured to receive the medical device within the channel, a plunger slidably fitted within the channel and movable within the channel toward the distal opening, a distal end of the plunger being configured to push out a proximal end of the medical device from the channel through the distal opening, and an absorbent antibacterial layer being configured to be compatible with the implantation tool when disposed on a housing of the implantable medical device.

[0008] In another example, the present disclosure is an article comprising a material layer having a first thickness, and an absorbent antibacterial material disposed on or within the material layer, the absorbent antibacterial material being configured to be absorbed by a patient from the material layer when the article is implanted within the patient, the material layer being configured to be disposed on an implantable medical device and being configured to be compatible with an implantation tool when disposed on a housing.

[0009] This summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive description of the apparatus and methods detailed in the accompanying drawings and the following description. Details of one or more aspects of the disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages will be apparent from the description, the drawings, and the claims.

Brief Description of the Drawings

[0010] Details of one or more examples of the disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the disclosure will be apparent from the description, the drawings, and the claims.

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[0026] In the drawings, the use of the same reference numerals or reference numerals with character extensions may be used to indicate the same or corresponding devices or elements when used in the same or different drawings. Additionally, unless otherwise indicated, devices and / or other objects such as patients, implantable medical devices, or electronic devices such as electrical coils are not necessarily shown to scale relative to each other and / or relative to the actual examples of the items illustrated. In particular, the various drawings provided with the present disclosure illustrate a "patient" represented by the outline of a human shape and, for example, by dimension indicators, should not be considered to be drawn to scale relative to an actual human patient or relative to other objects illustrated in the same figure unless specifically shown otherwise in the figure or, for example, as described in the text of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0027] Various types of medical devices sense a patient's electrogram (EGM) and / or other physiological signals or parameters. Some medical devices that sense cardiac EGM and / or other patient signals or parameters are non-invasive and use, for example, multiple electrodes placed in contact with an external part of the patient, such as various positions on the patient's skin, to sense the cardiac EGM. The electrodes used to monitor the cardiac EGM in these non-invasive processes are attached to the patient using, for example, adhesives, straps, belts, or vests and can be electrically coupled to a monitoring device such as an electrocardiograph, Holter monitor, or other electronic device. The electrodes are configured to sense electrical signals related to the electrical activity of the patient's heart or other cardiac tissue and provide these sensed electrical signals to an electronic device for further processing and / or display. Non-invasive devices and methods can be used to temporarily monitor a patient, for example, during a clinical visit, such as during a physician's appointment, or for a predetermined period, such as for one day (24 hours) or for several days.

[0028] External devices that can be used to non-invasively sense and monitor cardiac EGM include wearable devices equipped with electrodes configured to contact the patient's skin, such as patches, watches, or necklaces. An example of a wearable physiological monitor configured to sense cardiac EGM is the SEEQ™ Mobile Cardiac Telemetry System available from Medtronic plc, Dublin, Ireland. Such external devices may facilitate relatively long-term monitoring of a patient during normal daily activities and may transmit the collected data periodically to a network service, such as the Medtronic Carelink™ Network.

[0029] Some implantable medical devices (IMDs) also sense and monitor cardiac electrograms (EGMs). Electrodes used by an IMD to sense cardiac EGMs are typically integrated with the housing of the IMD and / or coupled to the IMD via one or more elongated leads. Examples of IMDs that monitor cardiac EGMs include pacemakers and implantable defibrillators that may be coupled to intravascular or extravascular leads, and pacemakers having a housing configured to be implanted within the heart that may be leadless. One example of a pacemaker configured for implantation within the heart is the Micra™ Transcatheter Pacing System available from Medtronic plc. Some IMDs that do not provide therapy, such as implantable patient monitors, sense cardiac EGMs. One example of such an IMD is the Reveal LINQ™ implantable cardiac monitor (ICM) available from Medtronic plc, which may be inserted subcutaneously. Such IMDs may facilitate relatively long-term monitoring of a patient during normal daily activities and may periodically transmit the collected data to a network service, such as the Medtronic Carelink™ Network.

[0030] Some IMDs may include sensors and / or electrodes on one side of the device. Movement of the IMD, such as translational and / or rotational movement of the IMD after implantation, may reduce the amount / amplitude of the cardiac EGM sensed by the IMD. For example, a subcutaneous pocket may be formed during implantation of the IMD, and movement may occur after implantation and before tissue forms around the IMD within the pocket. In some cases, the IMD may be repositioned, for example, via a percutaneous procedure and / or by removing the IMD and replacing it in the correct position and / or orientation. In some cases, the IMD may benefit from an absorbent antimicrobial material and / or layer, for example, to reduce infection of the repositioned IMD. Additionally, the IMD may benefit from an absorbent antimicrobial material and / or layer configured to reduce and / or eliminate movement of the IMD.

[0031] According to examples of the present disclosure, the absorbent antimicrobial material and / or layer is configured to be disposed on the housing of the IMD and to be compatible with the IMD implantation tool. In some examples, the absorbent antimicrobial material may be disposed within a layer of material and configured to be absorbed by the patient when the IMD is implanted in the patient. In some examples, the absorbent antimicrobial layer (e.g., including the absorbent antimicrobial material) may be configured to be disposed on the housing of the IMD and to not interfere with the sensors of the IMD. For example, the absorbent antimicrobial layer may be positioned, disposed, adhered, patterned, etc. on at least a portion of the outer surface of the housing of the IMD that does not include sensors. In some examples, the sensors may be electrodes connected to a control circuit configured to monitor a patient's physiological parameters via the electrodes, and the absorbent antimicrobial layer is disposed on the housing so as not to interfere with the parameters sensed / detected by the electrodes.

[0032] In some examples, the absorbent antimicrobial material and / or layer is configured to be disposed on the housing of an external device and / or monitor. In some examples, the absorbent antimicrobial layer is configured to be disposed on the housing of the external device and may be configured not to interfere with the sensors of the external device. For example, the absorbent antimicrobial layer may be positioned, disposed, adhered, patterned, etc. on at least a portion of the outer surface of the housing of the external device that does not include sensors, and it may also come into contact with the patient, enabling the absorbent antimicrobial material to be absorbed by the patient. In some examples, the sensor may be an electrode of an external device connected to a control circuit configured to monitor a patient's physiological parameter via the electrode, and the absorbent antimicrobial layer is disposed on the housing so as not to interfere with the parameter sensed / detected by the electrode.

[0033] In some examples, the absorbent antimicrobial layer may be configured to reduce movement of the IMD when the IMD is implanted within the patient. For example, the absorbent antimicrobial layer can increase the friction between the patient's tissue and the IMD and reduce the amount of rotation and / or translation of the IMD, for example, until tissue forms around the IMD after implantation. In other examples, the absorbent antimicrobial layer may be configured to reduce movement by providing means for attaching the IMD to the patient's tissue. For example, the absorbent antimicrobial layer may include a mesh layer that is adhered to the IMD housing and configured to be sutured to the patient's tissue.

[0034] According to the disclosed systems, articles, and techniques, the absorbent antimicrobial layer is configured to be compatible with the implant tool and / or device. The absorbent antimicrobial layer is configured to be received within the implant tool and delivered from the implant tool to the patient, for example, together with an IMD. For example, the implant tool may comprise a channel configured to receive the IMD, and a plunger slidably fitted within the channel and configured to push the IMD out of the channel to implant the IMD. The channel may comprise mechanical features, such as a guide configured to hold and / or direct the IMD as it is being pushed along the channel. The absorbent antimicrobial layer may be disposed on the housing of the IMD and configured not to interfere with the mechanical features of the tool. For example, placing the IMD within an absorbent antimicrobial bag, such as a Tyrx™ bag, may prevent the IMD from being implanted via the implant tool because the bag may catch on the mechanical features of the tool or simply not fit within the channel of the tool. In contrast, according to the present disclosure, the absorbent antimicrobial layer is disposed on a portion of the IMD housing and configured to be compatible with the implant tool such that, for example, it fits within the channel of the implant tool while disposed on the IMD and can be implanted with the IMD without interfering with the mechanical features of the implant tool. In some examples, the implant tool may be a syringe.

[0035] FIG. 1 is a conceptual diagram showing an example of a medical system 10 in combination with a patient 12 according to various examples described in the present disclosure. The systems, devices, and methods described in the present disclosure may include an example configuration of an absorbent antibacterial layer 16 disposed on an IMD 14 as illustrated and described with respect to FIG. 1. For the purposes of this description, knowledge of cardiovascular anatomy and function is assumed and details are omitted except to the extent necessary or desirable to explain the context of the technology of the present disclosure. The system 10 includes an IMD 14 having an absorbent antibacterial layer 16 implanted at or near a site of a patient 12's heart 18, and an external computing device 24. The systems, devices, and methods described herein may provide infection control and migration control of the IMD 16. For purposes of illustration, the present disclosure may show an IMD 14 having an absorbent antibacterial layer 16 implanted at or near a site of a patient 12's heart 18. However, the IMD 14 may also be inserted at any other suitable anatomical location including, but not limited to, the head, neck, torso, upper limbs, and lower limbs.

[0036] The technical example can be used with an IMD 14 that can wirelessly communicate with at least one of the external device 24 and other devices not shown in FIG. 1. In some examples, the IMD 14 is implanted outside the patient 12's thoracic cavity (e.g., subcutaneously at the chest position shown in FIG. 1). The IMD 14 may be positioned near the height of the patient 12's heart, or near the sternum just below it, for example, at least partially within the contour of the heart. The IMD 14 includes a plurality of electrodes 48 (FIG. 5) and is configured to sense an electrogram (EGM) via the plurality of electrodes. In some examples, the IMD 14 takes the form of a LINQ™ ICM, or another ICM similar to the LINQ™ ICM, for example, in its embodiment or modification. Although mainly described in the context of an example where the IMD 14 is an ICM, in various examples, the IMD 14 can represent a heart monitor, defibrillator, cardiac resynchronization pacer / defibrillator, pacemaker, implantable pressure sensor, nerve stimulator, or any other implantable or external medical device.

[0037] In some examples, the IMD14 is defined by a length L, a width W, and a thickness or depth D, and has the form of a rectangular prism with an elongated bottom surface, where the length L is much larger than the width W, and the width is larger than the depth D. In one example, the geometric shape of the IMD14, particularly the width W being larger than the depth D, is selected such that the IMD14 can be inserted under the patient's skin using minimally invasive techniques and remain in the desired orientation during insertion. For example, the IMD14 may include a radial asymmetry (particularly, a rectangular shape) along the longitudinal axis that maintains the device in the appropriate orientation after insertion. For example, in one example, the distance between electrode 48A and electrode 48B may be in the range of 30 millimeters (mm) to 55 mm, 35 mm to 55 mm, and 40 mm to 55 mm, or may be any range or individual interval in the range of 25 mm to 60 mm. In another example, the distance between electrode 48A and electrode 48B may be in the range of 15 mm to 30 mm, 17 mm to 28 mm, and 20 mm to 28 mm, or may be any range or individual interval in the range of 12 mm to 30 mm. Additionally, the IMD14 may have a length L in the range of 30 mm to about 70 mm. In other embodiments, the length L may be in the range of 40 mm to 60 mm, 45 mm to 60 mm, or may be any length or range of lengths between about 30 mm and about 70 mm. In some examples, the IMD14 may have a length L in the range of 15 mm to about 35 mm, or 20 mm to 30 mm, 22 mm to 30 mm, or may be any length or range of lengths between about 15 mm and about 35 mm. Additionally, the width W of the main surface of the IMD14, for example, the insulating cover 76 in the example shown, may be in the range of 3 mm to 10 mm, may be any single or range of widths between 3 mm and 10 mm, or may be in the range of 1.5 mm to 5 mm, may be any single or range of widths between 1.5 mm and 5 mm. The thickness of the depth D of the IMD14 may be in the range of 2 mm to 9 mm, or 1.5 mm to 4.5 mm. In other embodiments, the depth D of the IMD14 may be in the range of 2 mm to 5 mm, may be any single or range of depths in the range of 2 mm to 9 mm, or may be in the range of 1 mm to 2.5 mm, may be any single or range of depths in the range of 1 mm to 4.5 mm.In addition, the IMD14 according to an example of the present invention has a geometric shape and size designed for ease of implantation and patient comfort. Examples of the IMD14 described in this disclosure may have a volume of 3 cubic centimeters (cm3) or less, 1.5 cubic centimeters or less, or any volume between 3 and 1.5 cubic centimeters, or 1.5 cubic centimeters (cm) or less, 0.75 cubic centimeters or less, or any volume between 1.5 and 0.75 cubic centimeters.

[0038] The external device 24 can be a computing device having a display visible to the user and an interface for providing input to the external device 24 (i.e., a user input mechanism). In some examples, the external device 24 can be a notebook computer, a tablet computer, a workstation, one or more servers, a mobile phone, a personal digital assistant, or another computing device capable of running an application that enables the computing device to interact with the IMD14. The external device 24 is configured to communicate with the IMD14 and optionally another computing device (not shown in FIG. 1) via wireless communication. The external device 24 can communicate, for example, via short-range communication technologies (e.g., inductive coupling, NFC, or other communication technologies operable in a range of less than 10 to 20 cm), and long-range communication technologies (e.g., 802.11 or Bluetooth® specification sets, or RF telemetry by other communication technologies operable over a wider range than short-range communication technologies).

[0039] The external device 24 may be used to configure the operating parameters of the IMD 14. The external device 24 may be used to retrieve data from the IMD 14. The retrieved data may include values of physiological parameters measured by the IMD 14, indications of arrhythmias or other medical episodes detected by the IMD 14, and physiological signals recorded by the IMD 14. For example, the external device 24 may retrieve a cardiac EGM segment recorded by the IMD 14, for example, due to the IMD 14 determining that an episode of arrhythmia or other medical condition occurred during the segment, or in response to a request from the patient 12 or another user to record a segment. In some examples, one or more remote computing devices may interact with the IMD 14 in a manner similar to the external device 24 to program the IMD 14 and / or retrieve data from the IMD 14, for example, via a network.

[0040] In various examples, the IMD 14 may include one or more additional sensor circuits configured to sense specific physiological or neurological parameters associated with the patient 12, or may include a plurality of sensor circuits that may be located at various locations with respect to the patient 12 and / or with respect to each other, or may be configured to sense one or more physiological parameters associated with the patient 12.

[0041] For example, the IMD 14 may include a sensor operable to sense the body temperature of patient 12 at the location of the IMD 14 or at the location of the patient where a temperature sensor connected by leads to the IMD 14 is located. In another example, the IMD 14 may include a sensor configured to sense movements such as foot tapping performed by patient 12 and / or the position or change in position of patient 12. In various examples, the IMD 14 may include a sensor configured to detect the respiration performed by patient 12. In various examples, the IMD 14 may include a sensor configured to detect the heart beat of patient 12. In various examples, the IMD 14 may include a sensor configured to measure the body blood pressure of patient 12.

[0042] In some examples, one or more of the sensors that make up the IMD 14 may be embedded within patient 12, i.e., at least below the level of the patient's skin. In some examples, one or more of the sensors of the IMD 14 may be located external to patient 12, for example, as part of a cuff or as a wearable device such as a device embedded in clothing worn by patient 12. In various examples, the IMD 14 may be configured to sense one or more physiological parameters associated with patient 12 and transmit data corresponding to the sensed one or more physiological parameters to an external device 24, as represented by a lightning bolt connecting the IMD 14 to the external device 24.

[0043] In various examples, the transmission of data from the IMD 14 to the external device 24 may be performed via wireless transmission, using, for example, any of the formats for wireless communication described above. In various examples, the IMD 14 may be wirelessly communicated to an external device (e.g., one or more appliances) other than, or in addition to, the external device 24, such as a transceiver or access point that provides a wireless communication link between the IMD 14 and the network. Examples of communication technologies used by any of the devices described above with respect to FIG. 1 may include radiofrequency (RF) telemetry, which may be an RF link established via Bluetooth®, Wi-Fi, or medical implant communication service (MICS).

[0044] In some examples, the system 10 may comprise more or fewer components than shown in FIG. 1. For example, in some examples, the system 10 may include a plurality of additional IMDs, such as an implantable pacemaker device or other IMD implanted within the patient 12. In these examples, the IMD 14 may function as a hub device for the other IMDs. For example, the additional IMDs may be configured to communicate with the IMD 14, and the IMD 14 may then communicate to an external device 24, such as the user's smartphone, via a low energy telemetry protocol. The IMD 14 can provide a theoretically infinite energy capacity in that the IMD 14 may not need to be replaced or removed in other ways. Thus, the IMD 14 can provide the ability to more frequently telemeter information and more active titration of therapies.

[0045] For the remainder of this disclosure, general references to the medical device system may collectively refer to any example of the medical device system 10, general references to the IMD 14 may collectively refer to any example of the IMD 14, general references to the sensor circuitry may collectively refer to any example of the sensor circuitry of the IMD 14, and general references to the external device may collectively refer to any example of the external device 24.

[0046] FIG. 2 is a conceptual side view showing one example configuration of the implantable medical device (IMD) 14 and the absorbent antibacterial layer 16 of the medical system 10 of FIG. 1. In the example shown in FIG. 2, the IMD 10 may comprise a leadless subcutaneous implantable monitoring device having a container 15 and an insulating cover 76. Electrodes 48A and 48B (collectively "electrodes 48") may be formed or disposed on the outer surface of the cover 76. The circuits 36-42 described below with respect to FIG. 3 may be formed or disposed on the inner surface of the cover 76 or within the container 15. In the illustrated example, the antenna 26 may be formed or disposed on the inner surface of the cover 76, although in some examples it may be formed or disposed on the outer surface. In some examples, the insulating cover 76 may be positioned over the open container 15 such that the container 15 and the cover 76 form a housing 20 that surrounds the antenna 26 and the circuits 36-42 and protects the antenna and circuits from fluids such as body fluids.

[0047] One or more of the antenna 26 or the circuits 36-42 may be formed on the inside of the insulating cover 76, such as by using flip-chip technology. The insulating cover 76 may be turned over on the container 15. When turned over and disposed on the container 15, the components of the IMD 10 formed on the inside of the insulating cover 76 may be positioned within the gap 78 defined by the container 15. The electrode 48 may be electrically connected to the sensing circuit 42 (shown in FIG. 3) via one or more vias (not shown) formed through the insulating cover 76. The insulating cover 76 may be formed of sapphire (i.e., corundum), glass, parylene, and / or any other suitable insulating material. The container 15 may be formed of titanium or any other suitable material (e.g., a biocompatible material). The electrode 48 may be formed of any of stainless steel, titanium, platinum, iridium, or an alloy thereof. Additionally, the electrode 48 may be coated with a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings may be used for such electrodes.

[0048] The absorbent antibacterial layer 16 is disposed on the housing 20. In the example shown, the absorbent antibacterial layer 16 is disposed on the insulating cover 76. In some examples, the absorbent antibacterial layer 16 may be disposed on all or a portion of any outer surface of the IMD 14 and / or the housing 20. For example, the absorbent antibacterial layer 16 may be disposed on the container 15, all or a portion of the insulating cover 76, or at least a portion of both the container 15 and the insulating cover 76. In some examples, the absorbent antibacterial layer 16 may be disposed on 20% or more, 50% or more, 75% or more, 90% or more of the surface area of the housing 20, or on any suitable surface area of the housing 20. In some examples, the absorbent antibacterial layer 16 may be disposed on substantially all of the surface area of the housing 20 that is not a sensor electrode, such as electrode 48A or 48B. In some examples, the absorbent antibacterial layer 16 may be disposed on more than 55% of the surface area of the housing 20 that is not electrode 48A or 48B, and in some other examples, the absorbent antibacterial layer 16 may be disposed on more than 90% of the surface area of the housing 20 that is not electrode 48A or 48B.

[0049] In some examples, the absorbent antibacterial layer 16 may be disposed in an amount of the surface area of the housing 20 that corresponds to the period during which the antibacterial material is absorbed by the patient. For example, an IMD 14 comprising an absorbent antibacterial layer 16 disposed on 20% of the surface area of the housing 20 may be configured to deliver the antibacterial material to the patient (via absorption) over a first period of time when the IMD 14 is implanted, and an IMD 14 comprising an absorbent antibacterial layer 16 disposed on 80% of the surface area of the housing 20 may be configured to deliver the antibacterial material to the patient over a second period of time that is longer than the first period of time when the IMD 14 is implanted. In some examples, an IMD 14 comprising the absorbent antibacterial layer 16 is configured to be received within an implantation tool and delivered from the implantation tool to the patient, as further illustrated and described below with reference to FIGS. 4-8, for example.

[0050] In some examples, the absorbent antimicrobial layer 16 is configured to provide an absorbent antimicrobial material over a period of time. For example, the absorbent antimicrobial layer 16 may be configured such that 45% to 55% of the absorbent antimicrobial material constituting the absorbent antimicrobial layer 16 is absorbed by the patient within 30 to 60 days. In some examples, the absorbent antimicrobial layer 16 may be configured such that 65% to 85% of the absorbent antimicrobial material constituting the absorbent antimicrobial layer 16 is absorbed by the patient within 90 days.

[0051] The absorbent antimicrobial layer 16 may be configured so as not to interfere with the effectiveness of the IMD 14 (e.g., electrode 48) that receives physiological signals. In some examples, the absorbent antimicrobial layer 16 may be configured to be substantially transparent to physiological signals such that, for example, the electrode 48 can receive physiological signals through the absorbent antimicrobial layer 16. In other examples, the absorbent antimicrobial layer 16 may be disposed on the housing 20 so as not to interfere with the electrode 48 that receives physiological signals. In the example shown, the absorbent antimicrobial layer 16 is disposed on a region of the insulating cover 76 that does not include the electrode 48. In some examples, the absorbent antimicrobial layer 16 is configured so as not to interfere with the IMD 14, e.g., the antenna 26 that receives and / or transmits communication signals. For example, the absorbent antimicrobial layer 16 may be disposed on a region of the insulating cover 76 that does not face the antenna 26, e.g., the absorbent antimicrobial layer 16 is not disposed on the antenna 26 as shown in FIG. 2. In some examples, the absorbent antimicrobial layer 16 may be disposed on the housing 20 in a pattern. For example, the antimicrobial layer 16 may be disposed on a first region of the housing 20 and may not be disposed on a second region of the housing 20. In some examples, the absorbent antimicrobial layer 16 may be etched to form a pattern. For example, the absorbent antimicrobial layer 16 may be disposed on the housing 20 and may be removed and / or etched away in one or more regions of the housing 20, e.g., regions facing and / or including the electrode 48 and / or the antenna 26. In other examples, the absorbent antimicrobial layer 16 may be patterned via etching or any suitable method and then disposed on the housing 20. For example, the pattern of the patterned absorbent antimicrobial layer 16 may be aligned with the features of the IMD 14, e.g., the etched away and / or removed portions of the absorbent antimicrobial layer 16 may be aligned with one or more of the electrode 48, the antenna 26, or any other suitable feature.

[0052] The absorbent antimicrobial layer 16 may be configured to prevent and / or reduce the growth of bacteria in the patient 12. In some examples, the absorbent antimicrobial layer 16 may include an antibiotic such as rifampin, minocycline, or any suitable antibiotic.

[0053] The absorbent antimicrobial layer 16 may be configured to prevent and / or reduce movement of the IMD 14 implanted in the patient 12. For example, the absorbent antimicrobial layer 16 may comprise a surface configured to increase the friction and / or force necessary to move the IMD 14 within the patient 14. In some examples, the absorbent antimicrobial layer 16 may comprise a pattern or surface relief structure thereof, a mesh, a mesh comprising a plurality of filaments, a woven material, a non-woven material, or any suitable material and / or surface configured to prevent and / or reduce movement of the IMD 14 within the patient 12. In some examples, the absorbent antimicrobial layer 16 is configured to receive a suture. For example, the absorbent antimicrobial layer 16 may be attached to the IMD 14 (such as by an adhesive), and the absorbent antimicrobial layer 16 may also be attached to the tissue of the patient 12 by a suture or the like. In some examples, the absorbent antimicrobial layer 16 is configured to promote and / or receive ingrowth of tissue within the absorbent antimicrobial layer 16, for example, to reduce and / or prevent movement of the IMD 14 within the patient 12.

[0054] In some examples, the absorbent antimicrobial layer 16 is configured to be released from the tissue of the patient 14, for example, when the IMD 14 is removed from the patient 12. For example, the absorbent antimicrobial layer 16 may be configured to be sutured to the tissue of the patient 12, and after a period of time, for example, after tissue has formed within the pocket in which the IMD 14 and the absorbent antimicrobial layer 16 are implanted within the patient 14, the absorbent antimicrobial layer 16 may then be weakened and / or at least partially dissolved such that the absorbent antimicrobial layer 16 can be easily detached from the tissue and / or suture when it is time to remove the IMD 14 from the patient 14. In some examples, the absorbent antimicrobial layer 16 may be configured to prevent and / or reduce ingrowth of tissue within the absorbent antimicrobial layer 16.

[0055] In some examples, the absorbent antimicrobial layer 16 is configured to be attached to the housing 20. For example, the absorbent antimicrobial layer 16 may be adhered to the housing 20 via an adhesive. In other examples, the absorbent antimicrobial layer 16 may be configured to be disposed on the housing 20 via a compression fit. For example, the absorbent antimicrobial layer 16 may form a container or “sock” configured to receive the IMD 14. The absorbent antimicrobial layer 16 may be configured to expand when receiving the IMD 14 and apply a compressive force to the IMD 14, thereby remaining attached to the IMD 14 via a compression fit and / or a friction fit. In such examples, the absorbent antimicrobial layer 16 may be patterned, for example, to leave open the area of the housing 20 corresponding to the electrodes 48 and / or the antenna 26, or to remain uncovered by the absorbent antimicrobial layer 16, corresponding to features such as the electrodes 48 and / or the antenna 26, and / or may include open areas.

[0056] In some embodiments, the absorbent antimicrobial layer 16 may include a layer of material having a thickness, for example, of at least 25 micrometers, at least 100 micrometers, at least 1 millimeter, at least 5 millimeters, at least 10 millimeters, or any suitable thickness. The layer of material may include an absorbent antimicrobial material (such as rifampin, minocycline, or any suitable antibiotic) disposed on the outer surface of the layer of material and / or disposed within the layer of material. In some examples, the layer of material may include a woven or non-woven material, and the absorbent antimicrobial material may be on the surface of and / or within one or more fibers of the material. In some examples, the layer of material may include a mesh. In some examples, the absorbent antimicrobial layer 16 is configured to be cut, folded, and / or sized by a clinician and / or user, for example, using scissors or a blade. In some examples, the absorbent antimicrobial layer 16 may include Tyrx (trademark). The absorbent antimicrobial material is configured to be absorbed by the patient from the layer of material when the absorbent antimicrobial layer 16 is implanted within the patient.

[0057] In some examples, the absorbent antimicrobial layer 16 may be provided to the clinician and / or user as part of a kit. For example, the kit may include a sterile container configured to receive any or all of the IMDs 14, an implantation tool (such as those described below in FIGS. 4 - 8), the absorbent antimicrobial layer 16, and optionally, an adhesive configured to attach the absorbent antimicrobial layer 16 to the surface of the IMD 14. In some examples, the sterile container may include a sterile bag. In some examples, the absorbent antimicrobial layer 16 may be provided as a kit pre - attached to the IMD 14. For example, the absorbent antimicrobial layer 16 may be a "sock" and friction fit with the IMD 14 as described above. In other examples, the absorbent antimicrobial layer 16 may be attached to and / or laminated to one or more sides or surfaces of the IMD 14 via an adhesive. In still other examples, the absorbent antimicrobial layer 16 may be provided as one or more sheets that are optionally cuttable, together with a separate adhesive layer configured to be attached to the absorbent antimicrobial layer 16, then to the IMD 14, or vice versa.

[0058] FIG. 3 is a functional block diagram showing an example configuration of an implantable medical device (IMD) of the medical system of FIG. 1. In the illustrated example, the IMD 14 includes a processing circuit 40, a memory 36, a communication circuit 38, a communication antenna 26, a sensing circuit 42, a sensor 44, an accelerometer 46, and electrodes 48A and 48B (collectively "electrodes 48"). The illustrated example includes two electrodes 48, but in some examples, an IMD having one electrode 48, or more than two electrodes 48, or connected thereto, may implement the techniques of the present disclosure.

[0059] The processing circuit 40 may include fixed-function circuits and / or programmable processing circuits. The processing circuit 40 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuits. In some examples, the processing circuit 40 may include multiple components such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, and other discrete or integrated logic circuits. The functions attributed to the processing circuit 40 herein may be embodied as software, firmware, hardware, or any combination thereof.

[0060] The sensing circuit 42 is coupled to the electrodes 48 and is configured to monitor one or more physiological parameters of the patient. The sensing circuit 42 may sense signals from the electrodes 48 to generate, for example, a cardiac EGM to facilitate monitoring of the electrical activity of the heart. Sensing of the cardiac EGM may be performed to determine the heart rate or heart rate variability, or to detect arrhythmias (e.g., tachyarrhythmias or bradyarrhythmias). The sensing circuit 42 may further monitor impedance or other electrical phenomena via the electrodes 48. The sensing circuit 42 may also monitor signals from a sensor 44 that may include, by way of example, one or more accelerometers 46, pressure sensors, and / or optical sensors. In some examples, the sensing circuit 42 may include one or more filters and amplifiers for filtering and amplifying signals received from the electrodes 48 and / or the sensor 44. In some examples, the sensing circuit 42 may sense or detect physiological parameters such as heart rate, blood pressure, respiration, and other physiological parameters related to the patient.

[0061] The sensing circuit 42 and / or the processing circuit 40 may be configured to detect cardiac depolarization (e.g., the P wave of atrial depolarization or the R wave of ventricular depolarization) when the cardiac EGM amplitude exceeds a sensing threshold. For cardiac depolarization detection, the sensing circuit 42 may, in some examples, comprise a rectifier, a filter, an amplifier, a comparator, and / or an analog-to-digital converter. In some examples, the sensing circuit 42 may output a display to the processing circuit 40 in response to sensing cardiac depolarization. In this way, the processing circuit 40 may receive detected cardiac depolarization indicators corresponding to the occurrence of detected R and P waves in each cardiac chamber. The processing circuit 40 may use the display of the detected R and P waves to determine the intervals between depolarizations, the heart rate, and detect arrhythmias such as tachyarrhythmias and asystole.

[0062] The sensing circuit 42 may also provide one or more digitized cardiac EGM signals to the processing circuit 40 for analysis, e.g., for use in cardiac rhythm discrimination. In some examples, the processing circuit 40 may store the digitized cardiac EGM in the memory 36. The processing circuit 40 of the IMD 14, and / or the processing circuit of another device that retrieves data from the IMD 14, may analyze the cardiac EGM.

[0063] Communication circuitry 38 may comprise any suitable hardware, firmware, software, or any combination thereof for communicating with an external device 24, another networked computing device, or another device such as another IMD or sensor. Under the control of processing circuitry 40, communication circuitry 38 may receive downlink telemetry from external device 24 or another device and transmit uplink telemetry to external device 24 or another device, with the aid of an internal or external antenna, such as antenna 26. Additionally, processing circuitry 40 may communicate with networked computing devices via an external device (e.g., external device 24 of FIG. 1) and a computer network, such as the Medtronic CareLink® Network. Antenna 26 and communication circuitry 38 may be configured to transmit and / or receive signals via inductive coupling, electromagnetic coupling, Near Field Communication (NFC), radio frequency (RF) communication, Bluetooth, Wi-Fi, or other proprietary or non-proprietary wireless communication schemes. Communication antenna 26 may be capable of telemetering data at a high frequency, such as about 2.4 gigahertz (GHz).

[0064] In some examples, memory 36, when executed by processing circuitry 40, includes computer-readable instructions that cause IMD 14 and processing circuitry 40 to perform various functions attributed herein to IMD 14 and processing circuitry 40. Memory 36 can include any volatile, non-volatile, magnetic, optical, or electrical medium, such as random-access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital medium. Memory 36 can store, by way of example, programmed values of one or more operating parameters of IMD 14 and / or data collected by IMD 14 for transmission to another device using communication circuitry 38, such as posture, heart rate, activity level, respiratory rate, and other parameters, as well as digitized forms of physiological signals sensed by IMD 14.

[0065] In the illustrated example, IMD 14 includes, as described above, processing circuitry 40 and associated memory 36, sensing circuitry 42, one or more sensors 44, and communication circuitry 38 coupled to antenna 26. However, IMD 14 need not include all of these components or may include additional components.

[0066] Figures 4-5 are perspective views of an example of an implant tool handle 100 and a plunger 300, respectively, according to an exemplary embodiment of the present invention. The handle 100 and the plunger 300 may both include an implant tool configured to receive a medical device (e.g., IMD 14) within a channel of the implant tool. Figures 4-5 show the handle 100 and the plunger 300 before the plunger 300 is inserted into the handle 100. To insert the plunger 300 into the handle 100, the distal end 302 of the plunger 300 may be inserted into an opening within the proximal end 110 of the handle 100 and within the channel 102 of the handle.

[0067] The handle 100 (also referred to herein as the tool body 100) may define a longitudinal axis 140 and a channel 102 extending along the longitudinal axis 140. The channel 102 may include a distal opening 108 and may be configured to receive a medical device, such as an IMD 14 having an absorbent antimicrobial layer 16. For example, the IMD 14 having the absorbent antimicrobial layer 16 may be inserted into the distal opening 108 of the channel 102 and advanced proximally until the IMD 14 having the absorbent antimicrobial layer 16 is disposed adjacent to an internal stop surface (not shown) within the handle 100. The open upper portion of the channel 102 may enable visual confirmation that the IMD 14 having the absorbent antimicrobial layer 16 is properly inserted within the channel 102. The tunneler 104 may extend distally along the longitudinal axis 140 adjacent to the distal opening 108 of the channel 102. The distal end 106 of the tunneler 104 may be configured to be disposed within an incision in the patient, for example, with the upper surface of the tunneler 104 facing the outside of the patient's body. The tunneler 104 may be configured to be advanced within the patient to provide a blunt dissection of the patient's subcutaneous tissue, for example, advanced distally until the distal opening 108 is substantially adjacent to the incision. The handle 100 may then be rotated 180° about the axis 140 such that the tunneler 104 can assist in temporarily expanding the incision (e.g., via pressure applied to the handle 100). Next, for example, the IMD 14 having the absorbent antimicrobial layer 16 is advanced distally within the channel 102 by moving the plunger 300 distally until the IMD 14 having the absorbent antimicrobial layer 16 is properly positioned within the tissue and displaced distally a short distance from the opening of the incision, exiting the distal opening 108 and entering the patient's incision and dissected tissue along the tunneler 104. The logo 112 helps remind the physician to rotate the handle 100 prior to insertion of the plunger 300 and advancement of the device.

[0068] The plunger 300 may be provided with a groove 306 whose length on the lower surface of the plunger 300 extends to the distal stop surface of the protrusion 114 (FIG. 6E), and the plunger 300 may be slidably fitted within the channel 102 and configured to be movable within the channel 102. The opening at the proximal end 110 of the handle comprises a protrusion corresponding to the groove within the lower surface of the plunger 300, thereby ensuring its proper orientation within the handle 100. The marking 308 adjacent to the proximal end 310 of the plunger 300 assists the physician in determining that the plunger 300 is in the proper orientation for insertion into the handle 100.

[0069] The plunger 300 may be advanced in the distal direction and push the proximal end of the IMD 14 comprising the absorbent antimicrobial layer 16 within the channel 102 into the incision within the patient and then along the surface facing the inside of the tunneler 104. The IMD 14 comprising the absorbent antimicrobial layer 16 follows the path defined by the tunneler 104 to ensure proper positioning within the patient's tissue. After insertion of the IMD 14 comprising the absorbent antimicrobial layer 16, the handle 100 and the plunger 300 are removed, and for example, the tunneler 104 is removed from the patient.

[0070] Various medical grade materials, such as plastics, metals, rubbers, sterilizable materials, etc. may be used to form the various components of the implant tool. Exemplary embodiments of the implant tool may be inexpensive and disposable. The implant tool may also be configured to be used with known automated injection systems that use, for example, compressed air or other inert gases to operate the plunger 300 or instead of the plunger 300.

[0071] Figures 6A-6E are, respectively, a distal end view, a cut-away view, a top view, a bottom view, and a proximal end view of the tool handle 100. In the example shown, the tool handle 100 includes a protrusion 114. The protrusion 114 provides a stop surface facing in the distal direction that limits insertion of the IMD 14 with the absorbent antimicrobial layer 16 into the channel 102. The protrusion 114 is further configured to engage a groove 306 in the lower surface of the plunger 300, for example, for proper orientation of the plunger 300 within the handle 100. The protrusion 114 also provides a stop surface facing in the proximal direction that limits distal movement of the plunger 300. The handle 100 may also optionally include a slot 116 in its lower surface (e.g., the lower surface that at least partially defines the channel 102), through which advancement of the plunger 300 and the IMD 14 with the absorbent antimicrobial layer 16 may be observed.

[0072] Figure 7A is a cross-sectional view of the tool handle 100 taken along line B-B shown in Figure 6C, and Figure 7B is a cross-sectional view of the tool handle 100 taken along line C-C shown in Figure 6C. Figure 7A shows the arrangement of the inner corner surfaces 120, 122, 124, and 126. These surfaces are arranged to substantially correspond to the corners and sides of the IMD 14 with the absorbent antimicrobial layer 16, along with the side surfaces 128 and 130, to prevent rotation of the IMD 14 with the absorbent antimicrobial layer 16 within the handle 100. Figure 7B shows the surface of the protrusion 114 facing in the distal direction.

[0073] Figure 8 is a perspective view of another example of an embedded tool handle 400 having an IMD 14 with an absorbent antimicrobial layer 16 received within a channel 102, according to various examples described in the present disclosure. The handle 400 may be substantially similar to the handle 100 described above, except that the handle 400 includes guides 402a and 402b (collectively "guides 402").

[0074] The guide 402 is configured to releasably hold the IMD 14 within an implant tool, such as the channel 102, via frictional engagement. The guide 402 may be configured to apply force and / or pressure to the IMD 14 via a spring force. For example, the guide 402 may be or include a spring-loaded lever arm having contact points 404a and 404b (collectively "contact points 404"). The guide 402 can apply a force to opposite sides of the IMD 14 at the contact points 404. For example, when the IMD 14 is pushed out of the distal opening 108 and into the patient's incision, the force applied to opposite sides of the IMD 14 by the guide 402 can provide support to the proximal portion of the IMD 14 as it exits the channel 102 and enters the patient (e.g., a "tissue pocket" at least partially created by the tunneler 104 described above). In some examples, the guide 402 may be configured to hold the IMD 14 within the channel 14. For example, the IMD 14 may be loaded into the channel 102 by, for example, a user and / or clinician introducing the IMD 14 into the channel 102 via the distal opening 108 and pushing the IMD 14 in the proximal direction until the distal end of the IMD 14 is proximal to the contact points 404. The guide 402 may be configured to position the contact points 404 within the channel 402 to hold the IMD 14 within the channel 102. For example, the contact points 402 may prevent the IMD 14 from slipping out of the distal opening 108. The guide 402 may be configured to release when a threshold amount of force is applied to the contact points 404, for example, by pushing the IMD 14 distally via a plunger 300. The contact points 404 then separate laterally, allowing the IMD 14 to move distally within the channel 102, while the guide 402 applies a force to each opposite side of the IMD 14 by the contact points 404 as the IMD 14 moves through the channel.The lateral force applied by the contact point 404 to the opposing side of the IMD 14 causes a frictional force that opposes the movement of the IMD 14 within the channel 102, and the amount of friction is proportional to the amount of force applied by the guide 402 such that it depends on the shape and surface area of the contact point 404 that contacts the opposing side of the IMD 14. In addition to providing lateral stability during insertion, the frictional force caused by the guide 402 can improve the degree of control when the clinician embeds the IMD 14, as well as the responsiveness of the IMD 14 to the operation of the handle 100 and the plunger 300, for example, the ability to control the speed at which the IMD 14 is pushed out, and the ability to provide a force that stops the movement of the IMD 14 within the channel 102 when the clinician stops pushing the plunger.

[0075] In some examples, the guide 402 is configured to maintain the orientation and / or position of the IMD 14 with the absorbent antimicrobial layer 16 when the plunger 300 pushes the IMD 14 with the absorbent antimicrobial layer 16 from the distal opening 108 into the patient. For example, the guide 402 applies pressure to the side of the IMD 14 as the IMD 14 moves along the channel 102 to reduce and / or prevent lateral movement of the IMD 14, such as misalignment of the IMD 14 when it is implanted subcutaneously, for example, movement with a component perpendicular to the longitudinal axis 140 (translation or rotation of the IMD 14).

[0076] The absorbent antimicrobial layer 16 is configured to be compatible with the handle 100 and the plunger 300 (e.g., the implantation tool). For example, the absorbent antimicrobial layer 16 is configured not to interfere with the movement of the IMD 14 within the channel 102. The absorbent antimicrobial layer 16 may be configured not to interfere with the guide 402 or the contact point 404, or the interaction between the plunger 300 and the handle 100, for example, the protrusions of the handle 100 and / or the corresponding grooves on the lower surface of the plunger 300. For example, the absorbent antimicrobial layer 16 may be configured not to interfere with the grooves of the plunger 300 that engage with the channel 102, for example, the grooves of the plunger 300 that engage with the protrusions of the handle 100.

[0077] In the example shown, the absorbent antibacterial layer 16 is disposed on the surface of the IMD 14 on the side opposite the slot 116, for example, on the "upper" surface of the IMD 14. Thus, the absorbent antibacterial layer 16 may contact or rub against a portion or surface of the IMD 14, but does not contact the contact point 404 or the protrusion of the handle 100 or the groove of the plunger 300 when the IMD 14 is moving within the channel 102. The absorbent antibacterial layer 16 may be further disposed, for example, adjacent to the slot 116 of the handle 100, on the opposite "bottom" surface of the IMD 14. Similarly, the absorbent antibacterial layer 16 disposed in such a manner may contact or rub against the surface of the IMD 14 (such as the inner surface of the bottom of the channel 102), but does not contact the contact point 404 or interfere with the protrusion of the handle 100 or the groove of the plunger 300 when the IMD 14 is moving within the channel 102. In some examples, the absorbent antibacterial layer 16 may be disposed on both opposite sides of the IMD 14 that contact the contact point 404. The absorbent antibacterial layer 16 may be configured to slide along the contact point 404. For example, the absorbent antibacterial layer 16 may be substantially smooth and may have a lower friction surface and / or coating, etc. In the example shown, the absorbent antibacterial layer 16 on top of the IMD 14 has a mesh-type structure. In some examples, the absorbent antibacterial layer 16 disposed on one or both sides of the IMD 14 that contact the contact point 404 may have a relatively smoother surface and / or structure, for example, a finer mesh and / or a smoother surface configured not to be trapped or damaged by the contact point 404. In some examples, the guide 402 may have a reduced force, for example, such that the contact point 404 applies a reduced force to the side of the IMD 14 and / or the absorbent antibacterial layer 16. In some examples, the surface area of the contact point 404 may be configured to be compatible with the absorbent antibacterial layer 16. For example, the surface area may be reduced to reduce friction against the absorbent antibacterial layer 16 disposed on the side of the IMD 14. In some examples, the contact surface of the contact point 404 may be configured to be compatible with the absorbent antibacterial layer 16. For example, the curvature and / or surface roughness of the contact point 404 may be reduced to provide a smoother contact area between the contact point 404 and the absorbent antibacterial layer 16.

[0078] FIG. 9 is a flow diagram of an example method of manufacturing an implantable medical device having an absorbent antimicrobial layer according to various examples described in the present disclosure. That example technique of FIG. 9 is described with respect to the medical system 10, IMD 14, absorbent antimicrobial layer 16, handle 100, and plunger 300 of FIGS. 1 - 8, but that example technique of FIG. 9 may be performed using any system having an implantable medical device with an absorbent antimicrobial layer described herein. The technique of FIG. 9 may be performed by any suitable user, such as a clinician.

[0079] The manufacturer may assemble an IMD having a control circuit within a housing (902). For example, the manufacturer may assemble an IMD 14 having circuits 36 - 42 within housing 20. The manufacturer may place the absorbent antimicrobial layer 16 on the housing of the IMD 14 such that the absorbent antimicrobial layer 16 is received within an implantation tool, e.g., channel 102, and does not interfere with the delivery of the IMD 14 from the implantation tool to the patient (904). In some examples, the manufacturer may place the absorbent antimicrobial layer 16 on the housing of the IMD 14 by applying an adhesive to the absorbent antimicrobial layer, positioning the absorbent antimicrobial layer on the housing, and applying pressure to the adhesive to attach the absorbent antimicrobial layer to the housing. In some examples, the manufacturer may place the absorbent antimicrobial layer 16 on at least a portion of the insulating cover 76 that does not include electrodes. In some examples, the manufacturer may place the absorbent antimicrobial layer 16 on at least a portion of the surface of the housing of the IMD 14 that faces the insulating cover 76 and / or on at least a portion of the surface of the housing of the IMD 14 that is adjacent to the insulating cover 76. The manufacturer may package a kit comprising an IMD 14 having the absorbent antimicrobial layer 16 on the housing 20 and an implantation tool, e.g., a handle 100 and a plunger 300 (906).

[0080] FIG. 10 is a flow diagram of an example method of implanting an implantable medical device having an absorbent antimicrobial layer according to various examples described in the present disclosure. That technical example of FIG. 9 is described with respect to the medical system 10, IMD 14, absorbent antimicrobial layer 16, handle 100, and plunger 300 of FIGS. 1-8, but that technical example of FIG. 9 may be performed using any system comprising an implantable medical device having an absorbent antimicrobial layer described herein. The technique of FIG. 9 may be performed by any suitable user, such as a clinician.

[0081] The manufacturer may, for example, assemble an IMD having a control circuit in a housing as described above (902). The manufacturer may package a kit comprising the IMD 14, the absorbent antimicrobial layer 16, and an implantation tool, such as an implantation tool comprising a handle 100 and a plunger 300 (1004).

[0082] A user and / or clinician may retrieve the IMD 14, the absorbent antimicrobial layer 16, and the implantation tool from the package (1006). The user and / or clinician may dispose the absorbent antimicrobial layer 16 on the housing of the IMD 14 such that the absorbent antimicrobial layer 16 is received within the implantation tool, e.g., within channel 102, and does not interfere with delivery of the IMD 14 from the implantation tool to the patient (1008). In some examples, the user and / or clinician may dispose the absorbent antimicrobial layer 16 on the housing of the IMD 14 by applying an adhesive to the absorbent antimicrobial layer, positioning the absorbent antimicrobial layer on the housing, and applying pressure to the adhesive to attach the absorbent antimicrobial layer to the housing. In some examples, the user and / or clinician may dispose the absorbent antimicrobial layer 16 on at least a portion of the insulating cover 76 that does not include electrodes. In some examples, the user and / or clinician may dispose the absorbent antimicrobial layer 16 on at least a portion of the surface of the housing of the IMD 14 that faces the insulating cover 76 and / or on at least a portion of the surface of the housing of the IMD 14 that is adjacent to the insulating cover 76. In some examples, the manufacturer disposes the absorbent antimicrobial layer 16 on the housing of the IMD 14 such that the absorbent antimicrobial layer 16 does not interfere with the IMD 14 received within the implantation tool, e.g., according to (904) above, and in step (1004), the IMD 14 having the absorbent antimicrobial layer 16 on the housing 20 and / or the insulating cover 76 may be provided, in which case step (1006) may be omitted.

[0083] A user and / or clinician may implant the IMD 14 and the absorbent antimicrobial layer 16 within the patient (1010). For example, the user and / or clinician may position the IMD 14 with the absorbent antimicrobial layer 16 within the implantation tool such that the absorbent antimicrobial layer 16 does not interfere with movement of the IMD 14 within channel 102 of the IMD 14. Next, the clinician may implant the IMD 14, e.g., with the absorbent antimicrobial layer 16, within the patient.

[0084] The present disclosure includes the following non-limiting examples.

[0085] Example 1: An implantable medical device comprising a housing configured to accommodate a control circuit, the control circuit being configured to control the functions of the implantable medical device, the housing, an electrode positioned on the outer surface of the housing and connected to the control circuit, the control circuit being configured to monitor a patient's physiological parameters via the electrode, and an absorbent antibacterial layer disposed on the housing, wherein the implantable medical device comprising the absorbent antibacterial layer is configured to be received within an implantation tool and delivered from the implantation tool to a patient.

[0086] Example 2: The implantable medical device according to Example 1, wherein the physiological parameter is a patient's cardiac parameter.

[0087] Example 3: The implantable medical device according to Example 1 or Example 2, wherein the control circuit is configured to sense an electrical signal related to the electrical activity of a patient's heart or other cardiac tissue via the electrode.

[0088] Example 4: The implantable medical device according to any one of Examples 1 to 3, wherein the housing includes a non-metallic portion attached to a metallic portion.

[0089] Example 5: The implantable medical device according to Example 4, wherein the absorbent antibacterial layer is disposed on the non-metallic portion.

[0090] Example 6: The implantable medical device according to Example 4 or Example 5, wherein the control circuit is formed on the non-metallic portion and is located within the housing of the implantable medical device.

[0091] Example 7: The implantable medical device according to any one of Examples 4 to 6, wherein the electrode is positioned on the outer surface of the non-metallic portion.

[0092] Example 8: The implantable medical device according to Example 7, wherein the absorbent antibacterial layer is disposed on a region of the non-metallic portion that does not include the electrode.

[0093] Example 9: The implantable medical device according to Example 7 or 8, wherein the electrode includes a first electrode, the implantable medical device further includes a second electrode, and the absorbent antibacterial layer is disposed on a region of a non-metallic portion that does not include the first electrode or the second electrode.

[0094] Example 10: The implantable medical device according to any one of Examples 4 to 9, further comprising an antenna within the housing of the implantable medical device and connected to a non-metallic portion, the antenna being configured to transmit and receive communication signals by being connected to a control circuit, and the absorbent antibacterial layer being disposed on a region of a non-metallic portion that does not face the antenna.

[0095] Example 11: The implantable medical device according to any one of Examples 1 to 3, wherein the absorbent antibacterial layer is disposed on a region of the housing that does not include an electrode.

[0096] Example 12: The implantable medical device according to any one of Examples 1 to 3 or 11, further comprising an antenna within the housing of the implantable medical device, the antenna being configured to transmit and receive communication signals by being connected to a control circuit, and the absorbent antibacterial layer being disposed on a region of the housing that does not face the antenna.

[0097] Example 13: The implantable medical device according to any one of Examples 1 to 12, wherein the absorbent antibacterial layer is disposed on the housing in a certain pattern, the pattern includes an absorbent antibacterial layer disposed on a first region of the housing, and the absorbent antibacterial layer is not disposed on a second region of the housing.

[0098] Example 14: The implantable medical device according to Example 13, wherein the absorbent antibacterial layer is etched into the pattern.

[0099] Example 15: The implantable medical device according to Example 13 or 14, wherein the pattern is configured not to interfere with the effectiveness of an electrode for receiving physiological signals.

[0100] Example 16: An implantable medical device according to any one of Examples 1 to 15, wherein the absorbent antibacterial layer is configured to perform at least one of preventing or reducing the growth of bacteria in a patient.

[0101] Example 17: An implantable medical device according to any one of Examples 1 to 16, wherein the absorbent antibacterial layer contains at least one of rifampin or minocycline.

[0102] Example 18: An implantable medical device according to any one of Examples 1 to 17, wherein the absorbent antibacterial layer is configured to reduce the movement of the implantable medical device when the implantable medical device is implanted in a patient.

[0103] Example 19: An implantable medical device according to Example 18, wherein the absorbent antibacterial layer has a surface relief structure configured to reduce the movement of the implantable medical device when the implantable medical device is implanted in a patient.

[0104] Example 20: An implantable medical device according to any one of Examples 1 to 19, wherein the absorbent antibacterial layer is a mesh containing a plurality of filaments.

[0105] Example 21: An implantable medical device according to any one of Examples 1 to 20, wherein the absorbent antibacterial layer is configured to receive a suture.

[0106] Example 22: An implantable medical device according to any one of Examples 1 to 21, wherein the absorbent antibacterial layer is further configured to be released from the patient's tissue when the implantable medical device is removed from the patient.

[0107] Example 23: An implantable medical device according to any one of Examples 1 to 22, wherein the absorbent antibacterial layer is disposed on the housing via an adhesive.

[0108] Example 24: The implantable medical device according to any one of Examples 1 to 23, wherein the absorbent antibacterial layer is disposed on the housing via a compression fit.

[0109] Example 25: The implantable medical device according to any one of Examples 1 to 24, wherein the absorbent antibacterial layer is disposed on 20% or more of the outer surface of the housing.

[0110] Example 26: The implantable medical device according to any one of Examples 1 to 25, wherein the absorbent antibacterial layer is disposed substantially entirely on the surface area of the outer surface of the housing that is not an electrode.

[0111] Example 27: The implantable medical device according to any one of Examples 1 to 26, wherein the absorbent antibacterial layer has a thickness of 0.025 millimeters (mm) to 10 mm.

[0112] Example 28: The implantable medical device according to any one of Examples 1 to 27, wherein the absorbent antibacterial layer has a thickness of 1 mm to 5 mm.

[0113] Example 29: The implantable medical device according to any one of Examples 1 to 28, wherein the absorbent antibacterial layer is configured such that 45% to 55% of the absorbent antibacterial material constituting the absorbent antibacterial layer is absorbed by the patient within 30 to 60 days.

[0114] Example 30: The implantable medical device according to any one of Examples 1 to 28, wherein the absorbent antibacterial layer is configured such that 65% to 75% of the absorbent antibacterial material constituting the absorbent antibacterial layer is absorbed by the patient after 90 days.

[0115] Example 31: A system comprising an implantable medical device according to any one of claims 1 to 25, and an implantation tool, the implantation tool being a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, the tool body being configured to receive the medical device within the channel, a tool body, a plunger slidably fitted within the channel and movable within the channel toward the distal opening, the distal end of the plunger being configured to push out the proximal end of the medical device from the channel through the distal opening, a plunger, and an absorbent antibacterial layer configured to be compatible with the implantation tool when disposed on the housing of the implantable medical device.

[0116] Example 32: The system according to Example 31, wherein the absorbent antibacterial layer is configured not to interfere with the movement of the implantable medical device within the channel.

[0117] Example 33: The system according to Example 31 or Example 32, wherein the tool body defines a first protrusion into the channel, the plunger defines a groove corresponding to and engaging with the first protrusion into the channel, and the absorbent antibacterial layer is configured not to interfere with the plunger engaging the channel.

[0118] Example 34: The system according to Example 33, wherein the tool body further comprises a guide configured to releasably hold the medical device within the implantation tool via a friction fit, the guide being configured to control the orientation of the implantable medical device while the plunger is pushing the proximal end of the medical device out of the channel through the distal opening, and the absorbent antibacterial layer is configured not to interfere with the guide.

[0119] Example 35: A kit comprising an implantable medical device according to any one of claims 1 to 24 and an implantation tool, the implantation tool being a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, the tool body being configured to receive the medical device within the channel, a plunger slidably fitted within the channel and movable within the channel towards the distal opening, the distal end of the plunger being configured to push out the proximal end of the medical device from the channel through the distal opening, and the absorbent antibacterial layer being configured to be compatible with the implantation tool when disposed on the housing of the implantable medical device.

[0120] Example 36: The kit according to Example 35, further comprising a sterilization container configured to receive the implantable medical device and the implantation tool.

[0121] Example 37: The kit according to Example 36, wherein the absorbent antibacterial layer is separate from the housing and configured to be disposed on the housing, and the absorbent antibacterial layer, the implantable medical device, and the implantation tool are disposed within the sterilization container.

[0122] Example 38: An article comprising a material layer having a first thickness and an absorbent antibacterial material disposed on or within the material layer at least in part, the absorbent antibacterial material being configured to be absorbed by a patient from the material layer when the article is implanted within the patient, the material layer being configured to be disposed on the implantable medical device and configured to be compatible with the implantation tool when disposed on the housing.

[0123] Example 39: A method for manufacturing an implantable medical device according to any one of Examples 1 to 30, the method including disposing an absorbent antibacterial layer on the housing of the implantable medical device such that the absorbent antibacterial layer is received within an implantation tool and does not interfere with the implantable medical device being delivered from the implantation tool to a patient.

[0124] Example 40: The method according to Example 39, wherein disposing an absorbent antibacterial layer on the housing of a medical device includes applying an adhesive to the absorbent antibacterial layer, positioning the absorbent antibacterial layer on the housing, and applying pressure to the adhesive to attach the absorbent antibacterial layer to the housing.

[0125] Example 41: The housing of the implantable medical device comprises a first surface including electrodes, and disposing an antibacterial layer on the housing of the implantable device includes disposing the antibacterial layer on a portion of the first surface that does not include electrodes, the method according to Example 39 or Example 40.

[0126] Example 42: The method according to Example 41, further including marking the absorbent antibacterial layer to be cut so as to be disposed on a portion of the first surface that does not include electrodes.

[0127] Example 43: The method according to Example 41, further including cutting the absorbent antibacterial layer to a size that fits a portion of the first surface that does not include electrodes.

[0128] Example 44: The housing of the implantable medical device comprises a second surface facing the first surface, and disposing an antibacterial layer on the housing of the implantable device includes disposing the antibacterial layer on at least a portion of the second surface, the method according to Example 41.

[0129] Example 45: A method of implanting an implantable medical device according to any one of Examples 1 to 30, comprising positioning the implantable medical device within an implantation tool such that the absorbent antibacterial layer does not interfere with the movement of the implantable medical device within the channel of the implantable medical device, and implanting the implantable medical device into a patient via the implantation tool.

[0130] The techniques of the present disclosure can be implemented in a variety of computing devices, medical devices, or any combination thereof. Any of the described units, modules, or components can be implemented together or separately as discrete but interoperable logic devices. The depiction of different features as modules or units is intended to emphasize different functional aspects, and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, the functionality associated with one or more modules or units can be performed by separate hardware components or software components, or can be integrated within common or separate hardware components or software components.

[0131] The techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of the technology may be implemented in one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, and any combination of such components, embodied in a programmer such as a physician or patient programmer, a stimulation device, or other device. The terms "processor," "processor circuit," "processing circuit," "controller," or "control module" generally may refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry or any other equivalent circuitry, and alone or in combination with other digital or analog circuitry.

[0132] In aspects implemented in software, at least some of the functions resulting from the systems and devices described in this disclosure may be embodied as instructions on a tangible computer-readable storage medium such as random access memory (RAM), read only memory (ROM), non-volatile random access memory (NVRAM), electrically erasable programmable read only memory (EEPROM), FLASH memory, magnetic media, optical media, etc. The computer-readable storage medium may be referred to as non-transitory. A server, client computing device, or any other computing device may also include more portable removable memory types to enable easy data transfer or offline data analysis. The instructions may be executed to support one or more aspects of the functions described in this disclosure.

[0133] In some examples, the computer-readable storage medium comprises a non-transitory medium. The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, the non-transitory storage medium may store data that may change over time (e.g., in RAM or a cache).

[0134] Various aspects of the present disclosure have been described. These examples and other aspects are within the scope of the following claims.

Claims

1. An implantable medical device, comprising a housing configured to accommodate a control circuit, the control circuit being configured to control the functions of the implantable medical device, and an electrode positioned on an outer surface of the housing and connected to the control circuit, the control circuit being configured to monitor a physiological parameter of a patient via the electrode, and an absorbent antibacterial layer disposed on the housing, and wherein, the implantable medical device comprising the absorbent antibacterial layer is configured to be received within an implant tool and delivered from the implant tool to a patient.

2. The implantable medical device according to claim 1, wherein the physiological parameter is a cardiac parameter of the patient.

3. The implantable medical device according to claim 1 or 2, wherein the control circuit is configured to sense an electrical signal related to the electrical activity of the heart or other cardiac tissue of the patient via the electrode.

4. The implantable medical device according to any one of claims 1 to 3, wherein the housing includes a non-metallic portion attached to a metallic portion.

5. The implantable medical device according to claim 4, wherein the absorbent antibacterial layer is disposed on the non-metallic portion.

6. The implantable medical device according to claim 4 or 5, wherein the control circuit is formed on the non-metallic portion and is located within the housing of the implantable medical device.

7. The implantable medical device according to any one of claims 4 to 6, wherein the electrode is positioned on an outer surface of the non-metallic portion.

8. The implantable medical device according to claim 7, wherein the absorbent antibacterial layer is disposed on a region of the non-metallic portion that does not include the electrode.

9. The electrode includes a first electrode, the implantable medical device further includes a second electrode, and the absorbent antibacterial layer is disposed on a region of the non-metallic portion that does not include the first electrode or the second electrode. The implantable medical device according to claim 7 or 8.

10. The implantable medical device further includes an antenna that is within the housing of the implantable medical device and is connected to the non-metallic portion, the antenna is connected to the control circuit and is configured to transmit and receive communication signals, and the absorbent antibacterial layer is disposed on a region of the non-metallic portion that does not face the antenna. The implantable medical device according to any one of claims 4 to 9.

11. The implantable medical device according to any one of claims 1 to 3, wherein the absorbent antibacterial layer is disposed on a region of the housing that does not include the electrode.

12. The implantable medical device further includes an antenna within the housing of the implantable medical device, the antenna is connected to the control circuit and is configured to transmit and receive communication signals, and the absorbent antibacterial layer is disposed on a region of the housing that does not face the antenna. The implantable medical device according to any one of claims 1 to 3 or 11.

13. A system comprising: An implantable medical device; An implant tool; And the implant tool includes: A tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, and the tool body being configured to receive the medical device within the channel. A plunger that is slidably fitted within the channel and is movable within the channel toward the distal opening, wherein the distal end of the plunger is configured to push out the proximal end of the medical device from the channel through the distal opening. Comprising A system, wherein the absorbent antibacterial layer is configured to be compatible with the implant tool when disposed on the housing of the implantable medical device. Claim 14 A kit comprising An implantable medical device An implant tool Comprising, wherein the implant tool Is a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, and the tool body being configured to receive the medical device within the channel. A plunger that is slidably fitted within the channel and is movable within the channel toward the distal opening, wherein the distal end of the plunger is configured to push out the proximal end of the medical device from the channel through the distal opening. Comprising A kit, wherein the absorbent antibacterial layer is configured to be compatible with the implant tool when disposed on the housing of the implantable medical device. Claim 15 An article comprising A material layer having a first thickness An absorbent antibacterial material disposed on or at least one of within the material layer, the absorbent antibacterial material being configured to be absorbed by a patient from the material layer when the article is implanted within the patient. Comprising The material layer is configured to be disposed on the housing of the implantable medical device. An article, wherein when the material layer is disposed on the housing, it is configured to be compatible with an embedding tool.

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