Heart monitoring device

Abstract

An exemplary implantable medical device includes: a housing configured to house a control circuit, the control circuit configured to control operation 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 physiological parameter of the patient via the electrodes. The implantable medical device also includes an absorbable antibacterial layer disposed on the housing. An implantable medical device including an absorbable antibacterial layer is configured to be received within an implant tool and delivered out of the implant tool and into 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 for curatively treating or monitoring one or more physiological and / or neurological conditions of patients. Such devices may be suitable for monitoring or treating conditions or functions related to the heart, muscles, nerves, brain, stomach, endocrine organs or other organs and their associated functions. Advances in the design and manufacture of miniaturized electronics and sensing devices enable the development of implantable devices with therapeutic and diagnostic functions, such as pacemakers, cardioversion devices, defibrillators, biochemical sensors, implantable loop recorders, and pressure sensors. 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 may have the ability to wirelessly transmit data to another device implanted in the patient or another instrument positioned outside the patient's body or both.

[0003] Although the implantation of some devices requires surgery (e.g., pacemakers, defibrillators, etc.), other devices may be small enough to be delivered and placed at the intended implantation site in a relatively non-invasive manner, such as via a percutaneous delivery catheter, intravenously, or using a subcutaneous delivery tool. As an example, subcutaneous implantable monitors have been proposed and used to monitor heart rate and rhythm and other physiological parameters, such as patient posture and activity level. Such direct in vivo measurements of physiological parameters can provide clinicians with important information to facilitate diagnostic and treatment decisions. Summary of the invention

[0004] The present disclosure describes implantable medical devices including absorbable antimicrobial materials and associated techniques, structures, and components that are configured to provide reduction, prevention, and / or elimination of infections associated with medical devices implanted in a patient. An implantable medical device (IMD) may include an absorbable antimicrobial layer disposed on a portion of a housing of the device. The absorbable antimicrobial layer may be applied to an outer surface of the housing and configured to reduce, prevent, and / or eliminate infection and / or migration of the IMD. The absorbable antimicrobial layer may be configured to be compatible with an implantation tool configured to implant the IMD, which may provide improved IMD implantation and improved sensing performance and reliability. The absorbable antimicrobial layer may be configured to be compatible with an implantation tool configured to implant the IMD and the absorbable antimicrobial layer into a patient.

[0005] In one example, the present disclosure describes an implantable medical device comprising: a shell configured to accommodate a control circuit, wherein the control circuit is configured to control the operation of the implantable medical device; an electrode positioned on an outer surface of the shell and connected to the control circuit, wherein the control circuit is configured to monitor a physiological parameter of a patient via the electrode; and an absorbable antimicrobial layer disposed on the shell, wherein the implantable medical device including the absorbable antimicrobial layer is configured to be received within an implantation tool and delivered out of the implantation tool and into a patient's body.

[0006] In another example, the present disclosure describes a system comprising: an implantable medical device according to any one of claims 1 to 25; and an implantation tool comprising: a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, wherein the tool body is configured to receive a medical device in the channel; and a plunger that is slidably engaged in the channel and capable of moving in the channel toward the distal opening, wherein the distal end of the plunger is configured to push the proximal end of the medical device out of the channel through the distal opening, wherein the absorbable antimicrobial layer, when disposed on the housing of the implantable medical device, is configured to be compatible with the implantation tool.

[0007] In another example, the present disclosure describes a kit comprising: an implantable medical device according to any one of claims 1 to 24; and an implantation tool comprising: a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, wherein the tool body is configured to receive a medical device in the channel; and a plunger that is slidably engaged in the channel and capable of moving in the channel toward the distal opening, wherein the distal end of the plunger is configured to push a proximal end of the medical device out of the channel through the distal opening, wherein the absorbable antimicrobial layer, when disposed on the housing of the implantable medical device, is configured to be compatible with the implantation tool.

[0008] In another example, the present disclosure describes an article comprising: a material layer having a first thickness; and an absorbable antimicrobial material disposed on or at least one of the material layer, the absorbable antimicrobial material being configured to be absorbed from the material layer by the patient when the article is implanted in the patient's body, wherein the material layer is configured to be disposed on a housing of an implantable medical device, wherein the material layer, when disposed on the housing, is configured to be compatible with an implantation tool.

[0009] The present disclosure is intended to provide an overview of the subject matter described in the present disclosure. It is not intended to provide an exclusive or exhaustive explanation of the apparatus and methods described in detail in the following figures and description. The details of one or more aspects of the present disclosure are set forth in the following figures and description. Other features, objects, and advantages will become apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0011] Figure 1 is a conceptual diagram illustrating an example medical device system in conjunction with a patient according to various examples described in the present disclosure.

[0012] Figure 2 It is a diagram illustrating various examples described in the present disclosure. Figure 1 Conceptual side view of an exemplary configuration of an implantable medical device (IMD) and an absorbable antimicrobial layer of a medical system.

[0013] Figure 3 It is a diagram illustrating various examples described in the present disclosure. Figure 1 A functional block diagram of an exemplary configuration of an implantable medical device (IMD) for a medical system.

[0014] Figure 4 is a perspective view of an exemplary implant tool handle according to various examples described in the present disclosure.

[0015] Figure 5 is a perspective view of an example implant tool plunger according to various examples described in the present disclosure.

[0016] Fig. 6A According to various examples described in this disclosure Figure 4 Distal end view of an exemplary tool handle.

[0017] Figure 6B According to various examples described in this disclosure Figure 4 A cross-sectional view of an exemplary tool handle.

[0018] Figure 6C According to various examples described in this disclosure Figure 4 A top view of an exemplary tool handle.

[0019] Fig.6D According to various examples described in this disclosure Figure 4 A bottom view of an exemplary tool handle.

[0020] Fig. 6E According to various examples described in this disclosure Figure 4 Proximal end view of an exemplary tool handle.

[0021] Fig. 7A According to various examples described in the present invention Figure 4 An exemplary tool handle is as follows Figure 6C A cross-sectional view along line BB shown in FIG.

[0022] Figure 7B According to various examples described in this disclosure Figure 4 An exemplary tool handle is as follows Figure 6C A cross-sectional view along line CC shown in FIG.

[0023] Figure 8 is a perspective view of another example implant tool handle having an example IMD including an example absorbable antimicrobial layer received within a channel of the implant tool handle according to various examples described in the present disclosure.

[0024] Fig. 9 is a flow chart of an exemplary method of manufacturing an implantable medical device including an absorbable antimicrobial layer according to various examples described in the present disclosure.

[0025] Fig.10 is a flow chart of an exemplary method of implanting an implantable medical device including an absorbable antimicrobial layer according to various examples described in the present disclosure.

[0026] In the accompanying drawings, the use of the same reference numerals or the same reference numerals with letter extensions may be used to indicate the same or corresponding devices or elements when used in the same drawing or in different drawings. In addition, unless otherwise indicated, devices and / or other objects such as patients, implantable medical devices, or electrical devices (such as electrical coils) are not necessarily illustrated to scale relative to each other and / or relative to actual examples of the items illustrated. Specifically, the various figures provided by the present disclosure illustrate a "patient" represented by a humanoid outline, and unless otherwise expressly indicated in the drawings, such as by a size indicator or otherwise described, such as in the text of the present disclosure, it 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. DETAILED DESCRIPTION

[0027] Various types of medical devices sense a patient's cardiac electrogram (EGM) and / or other physiological signals or parameters. Some medical devices that sense cardiac EGM and / or other physiological signals or parameters are non-invasive, such as using multiple electrodes placed in contact with an external portion of the patient (such as placed at various locations on the patient's skin to sense cardiac EGM). As an example, the electrodes used to monitor cardiac EGM in these non-invasive processes can be attached to the patient using an adhesive, a cloth tape, a belt, or a vest, and electrically coupled to a monitoring device, such as an electrocardiograph, a Holter monitor, or other electronic device. The electrodes are configured to sense electrical signals associated with 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 of the electrical signals. Non-invasive devices and methods can be utilized on a temporary basis, such as to monitor patients during a clinical visit, such as during a doctor's appointment, or, for example, within a predetermined time period, such as a day (twenty-four hours), or a period of several days.

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

[0029] Some implantable medical devices (IMDs) also sense and monitor cardiac EGMs. The electrodes used by the IMD to sense the cardiac EGMs are typically integrated with the housing of the IMD and / or coupled to the IMD via one or more elongated leads. Exemplary IMDs that monitor cardiac EGMs include: pacemakers and implantable cardioverter-defibrillators, which may be coupled to intravascular or extravascular leads; and pacemakers having a housing configured for implantation within the heart, which may be leadless. An example of a pacemaker configured for intracardiac implantation is the Micra 1000, commercially available from Medtronic. TM Transcatheter pacing systems. Some IMDs that do not provide therapy (eg, implantable patient monitors) sense cardiac EGMs. An example of such an IMD is the Reveal LINQ TMAn insertable cardiac monitor (ICM), which can be inserted subcutaneously. Such an IMD can facilitate relatively long-term monitoring of a patient during normal daily activities and can periodically transmit the collected data to a web service, such as Medtronic's Carelink TM network.

[0030] Some IMDs may include sensors and / or electrodes on one side of the device. Migration of the IMD (e.g., movement of the IMD after implantation, such as translation and / or rotation of the IMD) may then 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 migration may occur after implantation and before tissue is formed around the IMD in the pocket. In some cases, the IMD may be repositioned, for example, via a subcutaneous 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 absorbable antimicrobial materials and / or layers, for example to reduce infection of an IMD that has been repositioned. In addition, the IMD may benefit from absorbable antimicrobial materials and / or layers configured to reduce and / or eliminate IMD migration.

[0031] According to examples of the present disclosure, absorbable antimicrobial materials and / or layers are configured to be disposed on the housing of an IMD and are configured to be compatible with an implantation tool of the IMD. In some examples, the absorbable antimicrobial material may be disposed within a material layer and configured to be absorbed by the patient when the IMD is implanted in the patient's body. In some examples, an absorbable antimicrobial layer (e.g., including an absorbable antimicrobial material) may be configured to be disposed on the housing of an IMD and configured not to interfere with a sensor of the IMD. For example, the absorbable 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 the sensor. In some examples, the sensor may be an electrode connected to a control circuit that is configured to monitor a physiological parameter of the patient via the electrode, and the absorbable antimicrobial layer is disposed on the housing so as not to interfere with the parameters sensed / detected by the electrode.

[0032] In some examples, the absorbable antimicrobial material and / or layer is configured to be disposed on a housing of an external device and / or monitor. In some examples, the absorbable antimicrobial layer can be configured to be disposed on a housing of an external device and configured to not interfere with a sensor of the external device. For example, the absorbable antimicrobial layer can be positioned, disposed, adhered, patterned, etc. on at least a portion of an outer surface of the housing of the external device that does not include the sensor, and can also be in contact with the patient, thereby allowing the absorbable antimicrobial material to be absorbed by the patient. In some examples, the sensor can be an electrode of an external device connected to a control circuit that is configured to monitor a physiological parameter of the patient via the electrode, and the absorbable 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 absorbable antimicrobial layer can be configured to reduce migration of the IMD when the IMD is implanted in a patient. For example, the absorbable antimicrobial layer can increase friction between the patient's tissue and the IMD and reduce the amount of rotation and / or translation of the IMD, such as until tissue is formed around the IMD after implantation. In other examples, the absorbable antimicrobial layer can be configured to reduce migration by providing a means for attaching the IMD to the patient's tissue. For example, the absorbable antimicrobial layer can include a mesh layer configured to adhere to the IMD housing and suture to the patient's tissue.

[0034] According to the disclosed systems, articles and techniques, an absorbable antimicrobial layer is configured to be compatible with an implant tool and / or device. The absorbable antimicrobial layer is configured to be received within an implant tool and, for example, delivered out of the implant tool and into a patient along with an IMD. For example, the implant tool may include a channel configured to receive an IMD, and a plunger that slidably fits within the channel and is configured to push the IMD out of the channel to implant the IMD. The channel may include mechanical features, such as a guide configured to hold and / or guide the IMD as it is pushed along the channel. The absorbable antimicrobial layer may be configured to be disposed on the housing of the IMD and not interfere with the mechanical features of the tool. For example, placing the IMD in a housing such as a Tyrx XT may be performed by placing the IMD in a housing such as a Tyrx XT. TM An absorbable antimicrobial bag in a bag may not allow an IMD to be implanted via an implant tool because the bag may get stuck on mechanical features of the tool, or simply will not fit within a channel of the tool, etc. In contrast, and in accordance with the present disclosure, an absorbable antimicrobial layer may be configured to be disposed on a portion of an IMD housing and be compatible with an implant tool, e.g., to fit within a channel of an implant tool when disposed on the IMD and be implantable with the IMD without interfering with mechanical features of the implant tool. In some examples, the implant tool may be a syringe.

[0035] Figure 1 1 is a conceptual diagram illustrating an exemplary 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 exemplary configuration of an absorbable antimicrobial layer 16 disposed on an IMD 14, as described with respect to Figure 1as illustrated and described. For purposes of this description, an understanding of cardiovascular anatomy and function is assumed, and details are omitted except to the extent necessary or desired to explain the context of the technology of the present disclosure. System 10 includes an IMD 14 having an absorbable antimicrobial layer 16, which is implanted at or near the site of heart 18 of patient 12, and an external computing device 24. The systems, devices, and methods described herein may provide infection control and migration control of IMD 16. For illustrative purposes, the present disclosure may illustrate an IMD 14 having an absorbable antimicrobial layer 16 implanted at or near the site of heart 18 of patient 12; however, IMD 14 may also be inserted at any other suitable anatomical location, including, but not limited to, the head, neck, torso, upper extremities, and lower extremities.

[0036] The exemplary techniques may be used with an IMD 14 that may communicate with an external device 24 and Figure 1 In some examples, IMD 14 is implanted outside the chest of patient 12 (e.g., subcutaneously). Figure 1 The IMD 14 may be positioned near the sternum at or just below the level of the heart of the patient 12, for example at least partially within the outline of the heart. The IMD 14 includes a plurality of electrodes 48 ( Figure 5 ) and is configured to sense a cardiac electrogram (EGM) via a plurality of electrodes. In some examples, IMD 14 employs LINQ TM ICM form, or similar to LINQ for example TM Although primarily described in the context of examples where IMD 14 is an ICM, in various examples, IMD 14 may represent a cardiac monitor, a defibrillator, a cardiac resynchronization pacemaker / defibrillator, a pacemaker, an implantable pressure sensor, a neurostimulator, or any other implantable or external medical device.

[0037] In some examples, IMD 14 is defined by length L, width W, and thickness or depth D, and is in the form of an elongated rectangular prism, wherein length L is much greater than width W, which in turn is greater than depth D. In one example, the geometry of IMD 14, particularly width W, which is greater than depth D, is selected to allow IMD 14 to be inserted under the patient's skin using minimally invasive surgery and to remain in a desired orientation during insertion. For example, IMD 14 includes radial asymmetry (particularly a rectangular shape) along the longitudinal axis that maintains the device in the correct orientation after insertion. For example, in one example, the spacing between electrode 48A and electrode 48B can be in the range of 30 millimeters (mm) to 55 mm, 35 mm to 55 mm, and 40 mm to 55 mm, and can be any range or a separate spacing from 25 mm to 60 mm. In another example, the spacing between electrode 48A and electrode 48B can be in the range of 15 mm to 30 mm, 17 mm to 28 mm, and 20 mm to 28 mm, and can be any range or a separate spacing from 12 mm to 30 mm. In addition, IMD 14 can have a length L in the range of 30 mm to about 70 mm. In other embodiments, length L can be in the range of 40 mm to 60 mm, 45 mm to 60 mm, and can be any length or range of lengths between about 30 mm to about 70 mm. In some examples, IMD 14 can have a length L in the range of 15 mm to about 35 mm, 20 mm to 30 mm, 22 mm to 30 mm, and can be any length or range of lengths between about 15 mm to about 35 mm. In addition, the width W of the major surface of IMD 14 (e.g., insulating cover 76 in the illustrated example) can be in the range of 3 mm to 10 mm, and can be any single width or range of widths between 3 mm to 10 mm, or can be in the range of 1.5 mm to 5 mm, and can be any single width or range of widths between 1.5 mm to 5 mm. The thickness of depth D of IMD 14 can 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 IMD 14 can be in the range of 2 mm to 5 mm and can be any single depth or range of depths from 2 mm to 9 mm, or can be in the range of 1 mm to 2.5 mm and can be any single depth or range of depths from 1 mm to 4.5 mm. In addition, IMD 14 according to examples of the present invention has a geometry and size designed for ease of implantation and patient comfort.Examples of IMD 14 described in the present disclosure may have a volume of 3 cubic centimeters (cm3) or less, 1.5 cubic centimeters or less, or any volume between 3 cubic centimeters and 1.5 cubic centimeters, or may have a volume of 1.5 cubic centimeters (cm3) or less, 0.75 cubic centimeters or less, or any volume between 1.5 cubic centimeters and 0.75 cubic centimeters.

[0038] External device 24 may be a computing device having a display viewable by a user and an interface (i.e., a user input mechanism) for providing input to external device 24. In some examples, external device 24 may be a laptop computer, a tablet computer, a workstation, one or more servers, a cellular phone, a personal digital assistant, or another computing device that can run an application that enables the computing device to interact with IMD 14. External device 24 is configured to communicate with IMD 14 and, optionally, with another computing device (e.g., a computer) via wireless communication. Figure 1 For example, the external device 24 may communicate via near field communication technology (e.g., inductive coupling, NFC, or other communication technology that can operate at a range of less than 10 cm to 20 cm) and far field communication technology (e.g., according to 802.11 or RF telemetry or other communication technologies that can operate at a range greater than near field communication technologies) based on a set of specifications.

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

[0040] In various examples, IMD 14 may include one or more additional sensor circuits configured to sense specific physiological or neural parameters associated with patient 12, or may include multiple sensor circuits that may be located at various and / or different positions relative to patient 12 and / or relative to each other, and may be configured to sense one or more physiological parameters associated with patient 12.

[0041] For example, IMD 14 may include a sensor operable to sense the body temperature of patient 12 at the location of IMD 14 or at a location of the patient where a temperature sensor is coupled to IMD 14 by a lead. In another example, IMD 14 may include a sensor configured to sense motion, such as steps taken by patient 12, and / or the position or posture of patient 12. In various examples, IMD 14 may include a sensor configured to detect the respiration of patient 12. In various examples, IMD 14 may include a sensor configured to detect the heartbeat of patient 12. In various examples, IMD 14 may include a sensor configured to measure the systemic blood pressure of patient 12.

[0042] In some examples, IMD 14 including one or more of these sensors may be implanted within patient 12, i.e., below at least the level of the patient's skin. In some examples, one or more of the sensors of IMD 14 may be located external to patient 12, e.g., as part of a cuff or as a wearable device, such as a device embedded in clothing worn by patient 12. In various examples, 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 external device 24, as represented by a lightning bolt coupling IMD 14 to external device 24.

[0043] In various examples, data transmission from IMD 14 to external device 24 may be performed via wireless transmission, e.g., using any of the formats described above for wireless communication. In various examples, IMD 14 may wirelessly communicate with an external device (e.g., one or more instruments) in addition to or in addition to external device 24, such as a transceiver or access point that provides a wireless communication link between IMD 14 and a network. Figure 1 Examples of communication techniques used by any of the described devices may include radio frequency (RF) telemetry, which may be via RF link established by Wi-Fi or Medical Implant Communications Service (MICS).

[0044] In some examples, system 10 may include Figure 1More or fewer components as shown. For example, in some examples, system 10 may include multiple additional IMDs implanted in patient 12, such as implantable pacemaker devices or other IMDs. In these examples, IMD 14 may serve as a hub device for the other IMDs. For example, the additional IMDs may be configured to communicate with IMD 14, which will then communicate with an external device 24, such as a user's smartphone, via a low-energy telemetry protocol. IMD 14 may provide a theoretically unlimited energy capacity because IMD 14 may not need to be replaced or otherwise removed. Therefore, IMD 14 may provide more frequent telemetry information and the ability to more proactively titrate therapy.

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

[0046] Figure 2 It's a picture. Figure 1 A conceptual side view of an exemplary configuration of an implantable medical device (IMD) 14 and an absorbable antimicrobial layer 16 of a medical system 10 is shown. Figure 2 In the example shown, IMD 10 may include a leadless, subcutaneously implantable monitoring device having a container 15 and an insulating cover 76. Electrodes 48A and 48B (collectively referred to as "electrodes 48") may be formed or disposed on an outer surface of cover 76. Figure 3 The described circuits 36 to 42 may be formed or placed on the inner surface of the cover 76 or within the container 15. In the illustrated example, the antenna 26 is formed or placed on the inner surface of the cover 76, but in some examples, may be formed or placed on the outer surface. In some examples, the insulating cover 76 may be positioned over the open container 15 so that the container 15 and the cover 76 form the housing 20 and surround the antenna 26 and the circuits 36 to 42 and protect the antenna and the circuits from fluids (such as body fluids).

[0047] One or more of antenna 26 or circuits 36 to 42 may be formed on the inside of insulating cover 76, such as by using flip chip technology. Insulating cover 76 may be flipped over onto container 15. When flipped over and placed onto container 15, the components of IMD 10 formed on the inside of insulating cover 76 may be positioned in gap 78 defined by container 15. Electrode 48 may be electrically connected to sensing circuit 42 (eg, vias) formed through insulating cover 76. Figure 3). Insulating cover 76 may be formed of sapphire (i.e., corundum), glass, parylene, and / or any other suitable insulating material. Container 15 may be formed of titanium or any other suitable material (e.g., a biocompatible material). Electrode 48 may be formed of any of stainless steel, titanium, platinum, iridium, or alloys thereof. In addition, electrode 48 may be coated with a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings for such electrodes may be used.

[0048] Absorbable antimicrobial layer 16 is disposed on housing 20. In the example shown, absorbable antimicrobial layer 16 is disposed on insulating cover 76. In some examples, absorbable antimicrobial layer 16 may be disposed on all or a portion of any exterior surface of IMD 14 and / or housing 20. For example, absorbable antimicrobial layer 16 may be disposed on all or a portion of container 15, insulating cover 76, or on at least a portion of both container 15 and insulating cover 76. In some examples, absorbable antimicrobial layer 16 may be disposed on greater than or equal to 20% of the surface area of ​​housing 20, greater than or equal to 50% of the surface area of ​​housing 20, greater than or equal to 75% of the surface area of ​​housing 20, greater than or equal to 90% of the surface area of ​​housing 20, or any suitable surface area of ​​housing 20. In some examples, absorbable antimicrobial layer 16 may be disposed on substantially all of the surface area of ​​housing 20 that is not a sensor electrode (e.g., electrode 48A or 48B). In some examples, absorbable antimicrobial layer 16 may be disposed on greater than 55% of the surface area of ​​housing 20 that is not electrodes 48A or 48B, and in some other examples, absorbable antimicrobial layer 16 may be disposed on greater than 90% of the surface area of ​​housing 20 that is not electrodes 48A or 48B.

[0049] In some examples, the amount of surface area of ​​housing 20 where absorbable antimicrobial layer 16 is disposed corresponds to the time period over which the antimicrobial material is absorbed by the patient. For example, an IMD 14 including an absorbable antimicrobial layer 16 disposed on 20% of the surface area of ​​housing 20 may be configured to deliver (via absorption) the antimicrobial material to the patient within a first time period when IMD 14 is implanted, and an IMD 14 including an absorbable antimicrobial layer 16 disposed on 80% of the surface area of ​​housing 20 may be configured to deliver the antimicrobial material to the patient within a second time period greater than the first time period when IMD 14 is implanted. In some examples, IMD 14 including absorbable antimicrobial layer 16 is configured to be received within an implant tool and delivered out of the implant tool and into the patient, for example, as described below in Figures 4 to 8 Further illustrated and described herein.

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

[0051] Absorbable antimicrobial layer 16 may be configured to not interfere with the effectiveness of IMD 14 (e.g., electrode 48) in receiving physiological signals. In some examples, absorbable antimicrobial layer 16 may be configured to be substantially transparent to physiological signals, e.g., such that electrode 48 may receive physiological signals through absorbable antimicrobial layer 16. In other examples, absorbable antimicrobial layer 16 may be disposed on housing 20 so as not to interfere with electrode 48 receiving physiological signals. In the illustrated example, absorbable antimicrobial layer 16 is disposed on an area of ​​insulating cover 76 that does not include electrode 48. In some examples, absorbable antimicrobial layer 16 is configured to not interfere with IMD 14, e.g., antenna 26, receiving and / or transmitting communication signals. For example, absorbable antimicrobial layer 16 may be disposed on an area of ​​insulating cover 76 that is not opposite antenna 26, e.g., absorbable antimicrobial layer 16 is not disposed above antenna 26, such as a portion of the insulating cover 76 that is not opposite antenna 26. Figure 2 As shown. In some examples, absorbable antimicrobial layer 16 may be disposed on housing 20 in a pattern. For example, antimicrobial layer 16 may be disposed on a first region of housing 20 and not disposed on a second region of housing 20. In some examples, absorbable antimicrobial layer 16 may be etched to form a pattern. For example, absorbable antimicrobial layer 16 may be disposed on housing 20 and may be removed and / or etched away at one or more regions of housing 20 (e.g., regions of electrode 48 and / or regions opposite to and / or including antenna 26). In other examples, absorbable antimicrobial layer 16 may be patterned by etching or any suitable method and then disposed on housing 20. For example, the pattern of patterned absorbable antimicrobial layer 16 may be aligned with features of IMD 14, e.g., the etched and / or removed portions of absorbable antimicrobial layer 16 may be aligned with one or more of electrode 48, antenna 26, or any other suitable features.

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

[0053] Absorbable antimicrobial layer 16 may be configured to prevent and / or reduce migration of IMD 14 implanted in patient 12. For example, absorbable antimicrobial layer 16 may include a surface configured to increase friction and / or the force required to move IMD 14 within patient 14. In some examples, absorbable antimicrobial layer 16 may include a pattern or surface relief structure, a mesh, a mesh including a plurality of filaments, a woven material, a nonwoven material, or any suitable material and / or surface configured to prevent and / or reduce migration of IMD 14 within patient 12. In some examples, absorbable antimicrobial layer 16 is configured to receive sutures, for example, absorbable antimicrobial layer 16 may be attached to IMD 14 (such as by an adhesive) and absorbable antimicrobial layer 16 may also be attached to tissue of patient 12 (such as by sutures). In some examples, absorbable antimicrobial layer 16 is configured to promote and / or receive ingrowth of tissue within absorbable antimicrobial layer 16, for example, to reduce and / or prevent migration of IMD 14 within patient 12.

[0054] In some examples, absorbable antimicrobial layer 16 may be configured to release from the tissue of patient 14, for example, when IMD 14 is removed from patient 12. For example, absorbable antimicrobial layer 16 may be configured to be sutured to the tissue of patient 12, and after a period of time, for example, after IMD 14 and absorbable antimicrobial layer 16 are implanted in a pocket within patient 14 to form tissue, absorbable antimicrobial layer 16 may subsequently weaken and / or at least partially dissolve, such that absorbable antimicrobial layer 16 may be easily pulled away from the tissue and / or sutures when it is desired to remove IMD 14 from patient 14. In some examples, absorbable antimicrobial layer 16 may be configured to prevent and / or reduce ingrowth of tissue within absorbable antimicrobial layer 16.

[0055] In some examples, absorbable antimicrobial layer 16 is configured to be attached to housing 20. For example, absorbable antimicrobial layer 16 may be adhered to housing 20 via an adhesive. In other examples, absorbable antimicrobial layer 16 may be configured to be disposed on housing 20 via a compression fit. For example, absorbable antimicrobial layer 16 may form a container or “pouch” configured to receive IMD 14. Absorbable antimicrobial layer 16 may be configured to stretch upon receiving IMD 14 and exert a compressive force on IMD 14, thereby remaining attached to IMD 14 via a compression fit and / or a friction fit. In such examples, absorbable antimicrobial layer 16 may be patterned and / or include open areas corresponding to features such as electrodes 48 and / or antenna 26, for example, such that areas of housing 20 corresponding to electrodes 48 and / or antenna 26 are open or not covered by absorbable antimicrobial layer 16.

[0056] In some examples, the absorbable antimicrobial layer 16 may include a material layer having a certain thickness (e.g., at least 25 microns thick, at least 100 microns thick, at least 1 millimeter thick, at least 5 millimeters thick, at least 10 millimeters thick, or any suitable thickness). The material layer may include an absorbable antimicrobial material (such as rifampicin, minocycline, or any suitable antibiotic) disposed on an outer surface of the material layer and / or disposed within the material layer. In some examples, the material layer may include a woven material or a nonwoven material, and the absorbable antimicrobial material may be on the surface of one or more fibers or within one or more fibers of the material. In some examples, the material layer may include a mesh. In some examples, the absorbable antimicrobial layer 16 is configured to be cut, folded, and / or resized, for example, by a clinician and / or user using scissors or a blade. In some examples, the absorbable antimicrobial layer 16 may include Tyrx. TM The absorbable antimicrobial material is configured to be absorbed from the material layer by the patient when the absorbable antimicrobial layer 16 is implanted in the patient's body.

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

[0058] Figure 3 It's a picture. Figure 1 1 is a functional block diagram of an exemplary configuration of an implantable medical device (IMD) of a medical system of the present invention. In the example shown, IMD 14 includes processing circuitry 40, memory 36, communication circuitry 38, communication antenna 26, sensing circuitry 42, sensor 44, accelerometer 46, and electrodes 48A and 48B (collectively referred to as "electrodes 48"). Although the example shown includes two electrodes 48, in some examples, an IMD that includes or is coupled to one electrode 48 or more than two electrodes 48 may also implement the techniques of the present disclosure.

[0059] Processing circuitry 40 may include fixed function circuitry and / or programmable processing circuitry. Processing circuitry 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 circuitry. In some examples, processing circuitry 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 circuitry. The functionality attributed to processing circuitry 40 herein may be embodied in software, firmware, hardware, or any combination thereof.

[0060] The sensing circuit 42 is coupled to the electrode 48 and is configured to monitor one or more physiological parameters of the patient. The sensing circuit 42 can sense signals from the electrode 48, for example to generate a cardiac EGM, so as to monitor the electrical activity of the heart. The sensing of the cardiac EGM can be performed to determine the heart rate or heart rate variability, or to detect arrhythmias (e.g., tachyarrhythmias or bradycardia). The sensing circuit 42 can also monitor impedance or other electrical phenomena through the electrode 48. The sensing circuit 42 can also monitor signals from the sensor 44, which can include one or more accelerometers 46, pressure sensors, and / or optical sensors, as examples. In some examples, the sensing circuit 42 may include one or more filters and amplifiers for filtering and amplifying signals received from the electrode 48 and / or the sensor 44. In some examples, the sensing circuit 42 can sense or detect physiological parameters such as heart rate, blood pressure, respiration, and other physiological parameters associated with the patient.

[0061] Sensing circuit 42 and / or processing circuit 40 may be configured to detect cardiac depolarization (e.g., a P wave for atrial depolarization or an R wave for ventricular depolarization) when the cardiac EGM amplitude exceeds a sensing threshold. In some examples, for cardiac depolarization detection, sensing circuit 42 may include a rectifier, a filter, an amplifier, a comparator, and / or an analog-to-digital converter. In some examples, sensing circuit 42 may output an indication to processing circuit 40 in response to sensing of cardiac depolarization. In this manner, processing circuit 40 may receive an indication of detected cardiac depolarization corresponding to the presence of detected R and P waves in corresponding chambers of the heart. Processing circuit 40 may use the indication of detected R and P waves to determine depolarization intervals, heart rate, and detect arrhythmias, such as tachyarrhythmias and asystole.

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

[0063] Communication circuitry 38 may include any suitable hardware, firmware, software, or any combination thereof, for communicating with another device, such as external device 24, another networked computing device, or 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 send uplink telemetry to it, via an internal or external antenna, such as antenna 26. In addition, processing circuitry 40 may communicate with an external device, such as an external device 24, via an external device 24, or via an external antenna, such as antenna 26. Figure 1 external device 24) and such as Medtronic The antenna 26 and the communication circuit 38 may be configured to send 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. The communication antenna 26 may be configured to transmit and / or receive signals via a computer network such as a WLAN network or a wireless communication network. The communication antenna 26 may transmit and receive telemetry data at a high frequency such as approximately 2.4 gigahertz (GHz).

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

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

[0066] Figures 4 to 51 and 2 are perspective views of an exemplary implant tool handle 100 and plunger 300, respectively, according to an exemplary embodiment of the present invention. Handle 100 and plunger 300 together may comprise an implant tool configured to receive a medical device (eg, IMD 14) within a channel of the implant tool. Figures 4 to 5 The handle 100 and plunger 300 are illustrated prior to the plunger 300 being 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 the opening in the proximal end 110 of the handle 100 and into the channel 102 of the handle.

[0067] Handle 100 (also referred to herein as tool body 100) may define a longitudinal axis 140 and a channel 102 extending along longitudinal axis 140. Channel 102 may include a distal opening 108 and may be configured to receive a medical device, such as IMD 14 including an absorbable antimicrobial layer 16. For example, IMD 14 including an absorbable antimicrobial layer 16 may be inserted into distal opening 108 of channel 102 and advanced proximally until IMD 14 including an absorbable antimicrobial layer 16 is adjacent to an internal stop surface (not shown) within handle 100. The open upper portion of channel 102 may allow for visual verification that IMD 14 including an absorbable antimicrobial layer 16 is properly inserted into channel 102. Tunneler 104 may extend distally along longitudinal axis 140 and adjacent to distal opening 108 of channel 102. Distal end 106 of tunneler 104 can be configured to be placed into an incision in a patient, e.g., with an upper surface of tunneler 104 facing the exterior of the patient's body. Tunneler 104 can be configured to be advanced within the patient to provide blunt dissection of the patient's subcutaneous tissue, e.g., advanced distally until distal opening 108 is substantially proximal to the incision. Handle 100 can then be rotated 180 degrees about axis 140 so that tunneler 104 can help temporarily enlarge the incision (e.g., via pressure applied to handle 100). IMD 14, including absorbable antimicrobial layer 16, can then be advanced distally within channel 102 by distal movement of plunger 300 and out of distal opening 108 and into the incision and dissected tissue of the patient along tunneler 104, e.g., until IMD 14, including absorbable antimicrobial layer 16, is properly positioned within the tissue and is displaced a short distance distally from the opening of the incision. The markings 112 help remind the physician to rotate the handle 100 prior to inserting the plunger 300 and advancing the device.

[0068] The plunger 300 may be provided with a groove 306 extending along the length of the lower surface of the plunger 300 until the distal stop surface ( Fig. 6E), and the plunger 300 can be configured to slidably fit within the channel 102 and be movable within the channel 102. The opening in the proximal end 110 of the handle includes a protrusion that corresponds to the groove in the lower surface of the plunger 300, thereby ensuring its proper orientation within the handle 100. The markings 308 adjacent to the proximal end 310 of the plunger 300 help the physician determine that the plunger 300 is in the proper orientation for insertion into the handle 100.

[0069] Plunger 300 may be advanced distally, thereby pushing the proximal end of IMD 14 including absorbable antimicrobial layer 16 within passageway 102 into the incision in the patient and along the subsequent inwardly facing surface of tunneler 104. IMD 14 including absorbable antimicrobial layer 16 follows the path defined by tunneler 104 to ensure proper placement within the patient's tissue. After insertion of IMD 14 including absorbable antimicrobial layer 16, handle 100 and plunger 300 are removed, e.g., to remove tunneler 104 from the patient.

[0070] Various medical grade materials can be used to form various parts of implantation tools, such as plastics, metals, rubbers, sterilizable materials, etc. Exemplary embodiments of implantation tools can be inexpensive, disposable. Implantation tools can also be configured to be used with known automated injection systems that use, for example, compressed air or other inert gases to operate plunger 300 or replace plunger 300.

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

[0072] Fig. 7A It is along the Figure 6C A cross-sectional view of the tool handle 100 along line BB is shown, and Figure 7B It is along the Figure 6C A cross-sectional view of the tool handle 100 is shown along line CC. Fig. 7AThe arrangement of interior corner surfaces 120, 122, 124, and 126 is illustrated. These surfaces, as well as side surfaces 128 and 130, are arranged to generally correspond to the corners and side surfaces of IMD 14 including absorbable antimicrobial layer 16, thereby preventing IMD 14 including absorbable antimicrobial layer 16 from rotating within handle 100. Figure 7B The distally facing surface of the protrusion 114 is illustrated.

[0073] Figure 8 is a perspective view of another exemplary implant tool handle 400 having IMD 14 including absorbable antimicrobial layer 16 received within passageway 102 according to various examples described in the present disclosure. Another exemplary implant tool handle 400 having IMD 14 including absorbable antimicrobial layer 16 received within passageway 102 according to various examples described in the present disclosure. Handle 400 may be substantially similar to handle 100 described above, except that handle 400 includes guides 402a and 402b (collectively, “guides 402”).

[0074] Guide 402 is configured to releasably retain IMD 14 within an implantation tool (e.g., channel 102) via a friction fit. Guide 402 may be configured to apply force and / or pressure to IMD 14 via a spring force, for example, guide 402 may be or include a spring-loaded lever arm having contact points 404a and 404b (collectively referred to as "contact points 404"). Guide 402 may cause contact points 404 to apply force to the opposite side of IMD 14. For example, when IMD 14 is pushed out of distal opening 108 and into an incision in a patient, if IMD 14, which is a distal end portion of IMD 14, leaves channel 102 and enters the patient (e.g., a "tissue pocket" created at least in part by tunneler 104 as described above), the force applied by guide 402 to the opposite side of IMD 14 may provide support to the proximal portion. In some examples, guide 402 may be configured to retain IMD 14 within channel 14. For example, the IMD 14 may be loaded within the channel 102, e.g., a user and / or clinician introduces the IMD 14 into the channel 102 via the distal opening 108 and pushes the IMD 14 in a proximal direction until the distal end of the IMD 14 is located proximal to the contact point 404. The guide 402 may be configured to position the contact point 404 within the channel 402 so as to retain the IMD 14 within the channel 102, e.g., the contact point 402 may prevent the IMD 14 from sliding out of the distal opening 108. The guide 402 may be configured to open when a threshold amount of force is applied to the contact point 404, e.g., by pushing the IMD 14 in a distal direction via the plunger 300. The contact points 404 may then separate laterally, thereby allowing the IMD 14 to move distally within the channel 102, while the guide 402 causes the contact points 404 to apply force to each opposing side of the IMD 14 as it moves through the channel. The lateral forces applied by the contact points 404 to the opposite sides of the IMD 14 induce frictional forces that oppose the movement of the IMD 14 within the channel 102, wherein the amount of friction is proportional to the amount of force applied by the guides 402, which depends on the shape and amount of surface area of ​​the contact points 404 contacting the opposite sides of the IMD 14. In addition to providing lateral stability during insertion, the frictional forces induced by the guides 402 may also improve the degree of control that the clinician has when implanting the IMD 14 and the responsiveness of the IMD 14 to manipulation of the handle 100 and plunger 300, for example, the ability to control the speed at which the IMD 14 is pushed out and to provide a force to stop the movement of the IMD 14 in the channel 102 when the clinician stops pushing the plunger.

[0075] In some examples, guide 402 is configured to maintain the orientation and / or position of IMD 14 including absorbable antimicrobial layer 16 as plunger 300 pushes IMD 14 including absorbable antimicrobial layer 16 out of distal opening 108 and into the patient. For example, guide 402 may be configured to apply pressure to the sides of IMD 14 as IMD 14 moves along passageway 102 to reduce and / or prevent misalignment of IMD 14 when implanted subcutaneously, such as movement of IMD 14 in a lateral direction, such as movement having a directional component perpendicular to longitudinal axis 140 (translation or rotation of IMD 14).

[0076] Absorbable antimicrobial layer 16 is configured to be compatible with handle 100 and plunger 300 (e.g., an implantation tool). For example, absorbable antimicrobial layer 16 is configured to not interfere with the movement of IMD 14 within channel 102. Absorbable antimicrobial layer 16 can be configured to not interfere with the interaction of guide 402 or contact point 404, or plunger 300 with handle 100 (e.g., a protrusion of handle 100 and / or a corresponding groove of a lower surface of plunger 300). For example, absorbable antimicrobial layer 16 can be configured to not interfere with the engagement of plunger 300 with channel 102, such as the engagement of a groove of plunger 300 with a protrusion of handle 100.

[0077] In the example shown, absorbable antimicrobial layer 16 is disposed on a surface of IMD 14 opposite slot 116, e.g., on a "top" surface of IMD 14. Thus, as IMD 14 moves within channel 102, absorbable antimicrobial layer 16 may contact or rub against portions or surfaces of IMD 14, but not contact contact point 404 or a protrusion of handle 100 or a recess of plunger 300. Absorbable antimicrobial layer 16 may alternatively be disposed on an opposite "bottom" surface of IMD 14, e.g., adjacent to slot 116 of handle 100. Similarly, as IMD 14 moves within channel 102, such disposed absorbable antimicrobial layer 16 may contact or rub against a surface of IMD 14 (such as an inner surface of the bottom of channel 102), but not contact contact point 404 or interfere with a protrusion of handle 100 or a recess of plunger 300. In some examples, absorbable antimicrobial layer 16 may be disposed on the opposite side of IMD 14 from that in contact with contact point 404. Absorbable antimicrobial layer 16 may be configured to slide along contact point 404, e.g., absorbable antimicrobial layer 16 may be a substantially smooth, low friction surface and / or coating, etc. In the example shown, absorbable antimicrobial layer 16 on top of IMD 14 has a mesh structure. In some examples, absorbable antimicrobial layer 16 disposed on one or both sides of IMD 14 in contact with contact point 404 may have a relatively smoother surface and / or structure, e.g., a finer mesh and / or a smoother surface configured not to be caught or damaged by contact point 404. In some examples, guide 402 may have a reduced force, e.g., so that contact point 404 exerts a reduced force on these sides of IMD 14 and / or absorbable antimicrobial layer 16. In some examples, the surface area of ​​contact point 404 may be configured to be compatible with absorbable antimicrobial layer 16, e.g., a reduced surface area to reduce friction with absorbable antimicrobial layer 16 disposed on the sides of IMD 14. In some examples, the contact surface of contact point 404 may be configured to be compatible with absorbable antimicrobial layer 16, e.g., the curvature and / or surface roughness of contact point 404 may be reduced to provide a smoother contact area between contact point 404 and absorbable antimicrobial layer 16.

[0078] Fig. 9 is a flow chart of an exemplary method of manufacturing an implantable medical device including an absorbable antimicrobial layer according to various examples described in the present disclosure. Figures 1 to 8 The medical system 10, IMD 14, absorbable antimicrobial layer 16, handle 100, and plunger 300 are described. Fig. 9 but Fig. 9 The exemplary techniques may be performed using any system including an implantable medical device described herein that includes an absorbable antimicrobial layer. Fig. 9 The techniques may be performed by any suitable user, such as a clinician or the like.

[0079] The manufacturer may assemble the IMD including the control circuitry within the housing (902). For example, the manufacturer may assemble IMD 14 including circuits 36 to 42 within housing 20. The manufacturer may dispose absorbable antimicrobial layer 16 on the housing of IMD 14 such that absorbable antimicrobial layer 16 does not interfere with IMD 14 being received within an implant tool (e.g., passage 102) and delivered out of the implant tool and into the patient (904). In some examples, the manufacturer may dispose absorbable antimicrobial layer 16 on the housing of IMD 14 by applying an adhesive to the absorbable antimicrobial layer, positioning the absorbable antimicrobial layer on the housing, and applying pressure to the adhesive to attach the absorbable antimicrobial layer to the housing. In some examples, the manufacturer may dispose absorbable antimicrobial layer 16 on at least a portion of insulating cover 76 that does not include an electrode. In some examples, a manufacturer may provide absorbable antimicrobial layer 16 on a surface of the housing of IMD 14 opposite insulating cover 76 and / or on at least a portion of a surface of the housing of IMD 14 adjacent to insulating cover 76. The manufacturer may package a kit including IMD 14 having absorbable antimicrobial layer 16 on housing 20 with an implantation tool (e.g., an implantation tool including handle 100 and plunger 300) (906).

[0080] Fig.10 is a flow chart of an exemplary method of implanting an implantable medical device including an absorbable antimicrobial layer according to various examples described in the present disclosure. Figures 1 to 8 The medical system 10, IMD 14, absorbable antimicrobial layer 16, handle 100, and plunger 300 are described. Fig. 9 but Fig. 9 The exemplary techniques may be performed using any system including an implantable medical device described herein that includes an absorbable antimicrobial layer. Fig. 9 The techniques may be performed by any suitable user, such as a clinician or the like.

[0081] The manufacturer may assemble the IMD including the control circuitry within a housing (902), such as described above. The manufacturer may package a kit including IMD 14, absorbable antimicrobial layer 16, and an implantation tool (eg, an implantation tool including handle 100 and plunger 300) (1004).

[0082] The user and / or clinician may retrieve IMD 14, absorbable antimicrobial layer 16, and implant tool from the packaging (1006). The user and / or clinician may dispose absorbable antimicrobial layer 16 on the housing of IMD 14 such that absorbable antimicrobial layer 16 does not interfere with IMD 14 being received within an implant tool (e.g., channel 102) and being delivered out of the implant tool and into the patient (1008). In some examples, the user and / or clinician may dispose absorbable antimicrobial layer 16 on the housing of IMD 14 by applying an adhesive to the absorbable antimicrobial layer, positioning the absorbable antimicrobial layer on the housing, and applying pressure to the adhesive to attach the absorbable antimicrobial layer to the housing. In some examples, the user and / or clinician may dispose absorbable antimicrobial layer 16 on at least a portion of insulating cover 76 that does not include an electrode. In some examples, a user and / or clinician may position absorbable antimicrobial layer 16 on a surface of the housing of IMD 14 opposite insulating cover 76 and / or on at least a portion of a surface of the housing of IMD 14 adjacent to insulating cover 76. In some examples, a manufacturer may position absorbable antimicrobial layer 16 on the housing of IMD 14 such that absorbable antimicrobial layer 16 does not interfere with IMD 14 being received within an implantation tool, e.g., in accordance with (904) above, and include at step (1004) IMD 14 with absorbable antimicrobial layer 16 on housing 20 and / or insulating cover 76, in which case step (1006) may be omitted.

[0083] The user and / or clinician may implant IMD 14 and absorbable antimicrobial layer 16 into a patient 1010. For example, the user and / or clinician may position IMD 14, including absorbable antimicrobial layer 16, within an implantation tool such that absorbable antimicrobial layer 16 does not interfere with movement of IMD 14 within passageway 102 of IMD 14. The clinician may then implant IMD 14 (e.g., including absorbable antimicrobial layer 16) into the patient.

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

[0085] Embodiment 1: An implantable medical device, comprising: a shell, the shell being configured to accommodate a control circuit, wherein the control circuit is configured to control the operation of the implantable medical device; electrodes, the electrodes being positioned on an outer surface of the shell and connected to the control circuit, wherein the control circuit is configured to monitor a patient's physiological parameters via the electrodes; and an absorbable antimicrobial layer disposed on the shell, wherein the implantable medical device including the absorbable antimicrobial layer is configured to be received in an implantation tool and delivered out of the implantation tool and into a patient's body.

[0086] Embodiment 2: The implantable medical device according to embodiment 1, wherein the physiological parameter is a cardiac parameter of the patient.

[0087] Embodiment 3: The implantable medical device of Embodiment 1 or Embodiment 2, wherein the control circuit is configured to sense electrical signals associated with electrical activity of the patient's heart or other cardiac tissue via the electrodes.

[0088] Embodiment 4: The implantable medical device of any one of Embodiments 1 to 3, wherein the housing comprises a non-metallic portion attached to a metallic portion.

[0089] Embodiment 5: The implantable medical device of embodiment 4, wherein the absorbable antimicrobial layer is disposed on the non-metallic portion.

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

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

[0092] Embodiment 8: The implantable medical device of Embodiment 7, wherein the absorbable antimicrobial layer is disposed on an area of ​​the non-metallic portion that does not include the electrode.

[0093] Embodiment 9: An implantable medical device according to Embodiment 7 or 8, wherein the electrode comprises a first electrode, the implantable medical device further comprises a second electrode, and wherein the absorbable antibacterial layer is disposed on an area of ​​the non-metallic part that does not include the first electrode or the second electrode.

[0094] Embodiment 10: According to the implantable medical device described in any one of Embodiments 4 to 9, the implantable medical device also includes an antenna located within the housing of the implantable medical device and connected to the non-metallic part, the antenna is connected to the control circuit and is configured to send and receive communication signals, wherein the absorbable antibacterial layer is disposed on an area of ​​the non-metallic part that is not opposite to the antenna.

[0095] Embodiment 11: The implantable medical device of any one of Embodiments 1 to 3, wherein the absorbable antimicrobial layer is disposed on an area of ​​the housing that does not include the electrode.

[0096] Embodiment 12: According to any one of embodiments 1 to 3 or 11, the implantable medical device also includes an antenna located within the housing of the implantable medical device, the antenna is connected to the control circuit and is configured to send and receive communication signals, wherein the absorbable antibacterial layer is disposed on an area of ​​the housing that is not opposite to the antenna.

[0097] Embodiment 13: An implantable medical device according to any one of Embodiments 1 to 12, wherein the absorbable antimicrobial layer is arranged on the shell in a pattern, and the pattern includes the absorbable antimicrobial layer arranged on a first area of ​​the shell and the absorbable antimicrobial layer not arranged on a second area of ​​the shell.

[0098] Embodiment 14: The implantable medical device according to Embodiment 13, wherein the absorbable antimicrobial layer is etched into the pattern.

[0099] Embodiment 15: The implantable medical device according to Embodiment 13 or 14, wherein the pattern is configured so as not to interfere with the efficacy of the electrode in receiving physiological signals.

[0100] Embodiment 16: The implantable medical device of any one of Embodiments 1 to 15, wherein the absorbable antimicrobial layer is configured to at least one of prevent or reduce the growth of bacteria in a patient.

[0101] Embodiment 17: The implantable medical device of any one of Embodiments 1 to 16, wherein the absorbable antimicrobial layer comprises at least one of rifampicin or minocycline.

[0102] Embodiment 18: The implantable medical device of any one of Embodiments 1 to 17, wherein the absorbable antimicrobial layer is configured to reduce migration of the implantable medical device when the implantable medical device is implanted in the patient.

[0103] Embodiment 19: The implantable medical device according to Embodiment 18, wherein the absorbable antimicrobial layer comprises a surface relief structure, wherein the surface relief structure is configured to reduce migration of the implantable medical device when the implantable medical device is implanted in the patient's body.

[0104] Embodiment 20: The implantable medical device of any one of Embodiments 1 to 19, wherein the absorbable antimicrobial layer is a mesh comprising a plurality of filaments.

[0105] Embodiment 21: The implantable medical device of any one of Embodiments 1 to 20, wherein the absorbable antimicrobial layer is configured to receive a suture.

[0106] Embodiment 22: The implantable medical device of any one of Embodiments 1 to 21, wherein the absorbable antimicrobial layer is further configured to be released from the patient's tissue when the implantable medical device is removed from the patient.

[0107] Embodiment 23: The implantable medical device of any one of Embodiments 1 to 22, wherein the absorbable antimicrobial layer is disposed on the housing via an adhesive.

[0108] Embodiment 24: The implantable medical device of any one of Embodiments 1 to 23, wherein the absorbable antimicrobial layer is disposed on the housing via a compression fit.

[0109] Embodiment 25: The implantable medical device of any one of Embodiments 1 to 24, wherein the absorbable antimicrobial layer is disposed on greater than or equal to 20% of the outer surface of the housing.

[0110] Embodiment 26: The implantable medical device of any one of Embodiments 1 to 25, wherein the absorbable antimicrobial layer is disposed on substantially all of the surface area of ​​the outer surface of the housing other than the electrode.

[0111] Embodiment 27: The implantable medical device of any one of Embodiments 1 to 26, wherein the absorbable antimicrobial layer has a thickness of 0.025 millimeters (mm) to 10 mm.

[0112] Embodiment 28: The implantable medical device of any one of Embodiments 1 to 27, wherein the absorbable antimicrobial layer has a thickness of 1 mm to 5 mm.

[0113] Embodiment 29: The implantable medical device of any one of Embodiments 1 to 28, wherein the absorbable antimicrobial layer is configured such that between 45% and 55% of the absorbable antimicrobial material comprising the absorbable antimicrobial layer is absorbed by the patient within 30 to 60 days.

[0114] Embodiment 30: The implantable medical device of any one of Embodiments 1 to 28, wherein the absorbable antimicrobial layer is configured such that between 65% and 75% of the absorbable antimicrobial material comprising the absorbable antimicrobial 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 comprising: a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, wherein the tool body is configured to receive the medical device in the channel; and a plunger, which is slidably engaged in the channel and capable of moving in the channel toward the distal opening, wherein the distal end of the plunger is configured to push the proximal end of the medical device out of the channel through the distal opening, wherein the absorbable antimicrobial layer, when disposed on the housing of the implantable medical device, is configured to be compatible with the implantation tool.

[0116] Embodiment 32: The system of Embodiment 31, wherein the absorbable antimicrobial layer is configured to not interfere with movement of the implantable medical device within the channel.

[0117] Example 33: A system according to Example 31 or Example 32, wherein the tool body defines a first protrusion that enters the channel, wherein the plunger defines a groove that corresponds to the first protrusion that enters the channel and engages with the first protrusion, and wherein the absorbable antimicrobial layer is configured to not interfere with the engagement of the plunger with the channel.

[0118] Example 34: A system according to Example 33, wherein the tool body further includes: a guide configured to releasably retain the medical device within the implant tool via a friction fit, wherein the guide is configured to control the orientation of the implantable medical device while the plunger pushes the proximal end of the medical device out of the channel through the distal opening, wherein the absorbable antimicrobial layer is configured not to interfere with the guide.

[0119] Embodiment 35: A kit comprising: an implantable medical device according to any one of claims 1 to 24; and an implantation tool, the implantation tool comprising: a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, wherein the tool body is configured to receive the medical device in the channel; and a plunger slidably engaged in the channel and capable of moving in the channel toward the distal opening, wherein the distal end of the plunger is configured to push the proximal end of the medical device out of the channel through the distal opening, wherein the absorbable antimicrobial layer, when disposed on the housing of the implantable medical device, is configured to be compatible with the implantation tool.

[0120] Embodiment 36: According to the kit of embodiment 35, the kit also includes a sterile container, and the sterile container is configured to receive the implantable medical device and the implantation tool.

[0121] Embodiment 37: The kit of Embodiment 36, wherein the absorbable antimicrobial layer is separate from the housing and configured to be disposed on the housing, wherein the absorbable antimicrobial layer, the implantable medical device, and the implantation tool are disposed within the sterile container.

[0122] Embodiment 38: An article comprising: a material layer having a first thickness; and an absorbable antimicrobial material disposed on or at least one of the material layer, the absorbable antimicrobial material being configured to be absorbed from the material layer by the patient when the article is implanted in the patient's body, wherein the material layer is configured to be disposed on a housing of an implantable medical device, wherein the material layer, when disposed on the housing, is configured to be compatible with an implantation tool.

[0123] Example 39: A method for manufacturing an implantable medical device as described in any one of Examples 1 to 30, comprising: setting the absorbable antibacterial layer on the shell of the implantable medical device so that the absorbable antibacterial layer does not interfere with the implantable medical device being received in the implant tool and being delivered out of the implant tool and into the patient's body.

[0124] Example 40: A method according to Example 39, wherein setting the absorbable antibacterial layer on the shell of the medical device includes: applying an adhesive to the absorbable antibacterial layer; positioning the absorbable antibacterial layer on the shell; and applying pressure to the adhesive to attach the absorbable antibacterial layer to the shell.

[0125] Example 41: A method according to Example 39 or Example 40, wherein the housing of the implantable medical device includes a first surface, the first surface includes an electrode, and wherein disposing the 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 the electrode.

[0126] Embodiment 42: The method of Embodiment 41, further comprising marking the absorbable antimicrobial layer to be cut to be disposed on the portion of the first surface that does not include the electrode.

[0127] Embodiment 43: The method of Embodiment 41, further comprising cutting the absorbable antimicrobial layer into a size compatible with the portion of the first surface that does not include the electrode.

[0128] Embodiment 44: A method according to Embodiment 41, wherein the housing of the implantable medical device includes a second surface opposite to the first surface, wherein disposing the antimicrobial layer on the housing of the implantable device includes disposing the antimicrobial layer on at least a portion of the second surface.

[0129] Example 45: A method for implanting an implantable medical device as described in any one of Examples 1 to 30, comprising: positioning the implantable medical device within the implantation tool so that the absorbable 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's body via the implantation tool.

[0130] The technology of the present disclosure can be implemented in a wide range of computing devices, medical devices, or any combination thereof. Any of the units, modules, or components can be implemented together or individually as discrete but interoperable logic devices. Describing different features as modules or units is intended to highlight different functional aspects, and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. On the contrary, the functions associated with one or more modules or units can be performed by separate hardware or software components, or integrated in common or separate hardware or software components.

[0131] The techniques described in the present disclosure may be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, various aspects of the techniques 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 circuit systems, and any combination of such components, embodied in a programmer (such as a physician or patient programmer), a stimulator, or other device. The terms "processor," "processor circuit," "processing circuit," "controller," or "control module" may generally refer to any of the aforementioned logic circuits, alone or in combination with other logic circuits, or any other equivalent circuit, alone or in combination with other digital or analog circuits.

[0132] For various aspects implemented in software, at least some of the functionality attributed to the systems and devices described in this disclosure may be embodied as instructions on a tangible computer-readable storage medium (e.g., 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.). Computer-readable storage media may be referred to as non-transitory. A server, client computing device, or any other computing device may also include a more portable type of removable memory to enable easy data transfer or offline data analysis. The instructions may be executed to support one or more aspects of the functionality described in this disclosure.

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

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

Claims

1. An implantable medical device, comprising: a housing configured to house a control circuit, wherein the control circuit is configured to control operation of the implantable medical device; an electrode positioned on an outer surface of the housing and connected to the control circuit, wherein the control circuit is configured to monitor a physiological parameter of a patient via the electrode; and an absorbable antibacterial layer, the absorbable antibacterial layer being disposed on the shell, The implantable medical device including the absorbable antimicrobial layer is configured to be received within an implantation tool and delivered out of the implantation tool and into a patient's body.

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

3. An implantable medical device according to claim 1 or claim 2, wherein the control circuit is configured to sense electrical signals associated with electrical activity of the patient's heart or other cardiac tissue via the electrodes.

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

5. The implantable medical device of claim 4, wherein the absorbable antimicrobial layer is disposed on the non-metallic portion.

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

7. An 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 part.

8. The implantable medical device of claim 7, wherein the absorbable antimicrobial layer is disposed on an area of ​​the non-metallic portion that does not include the electrode.

9. The implantable medical device according to claim 7 or 8, wherein the electrode comprises a first electrode, and the implantable medical device further comprises a second electrode, wherein the absorbable antimicrobial layer is disposed on an area of ​​the non-metallic part that does not include the first electrode or the second electrode.

10. The implantable medical device according to any one of claims 4 to 9, further comprising an antenna located within the housing of the implantable medical device and connected to the non-metallic part, the antenna being connected to the control circuit and configured to send and receive communication signals, wherein the absorbable antimicrobial layer is disposed on an area of ​​the non-metallic part that is not opposite to the antenna.

11. The implantable medical device of any one of claims 1 to 3, wherein the absorbable antimicrobial layer is disposed on an area of ​​the housing that does not include the electrode.

12. The implantable medical device according to any one of claims 1 to 3 or 11, further comprising an antenna located within the housing of the implantable medical device, the antenna being connected to the control circuit and configured to send and receive communication signals, wherein the absorbable antimicrobial layer is disposed on an area of ​​the housing that is not opposite to the antenna.

13. A system, comprising: implantable medical devices; and An implantation tool, comprising: a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, wherein the tool body is configured to receive the medical device within the channel; and a plunger slidably engaged within the channel and movable within the channel toward the distal opening, wherein the distal end of the plunger is configured to push the proximal end of the medical device out of the channel through the distal opening, The absorbable antimicrobial layer, when disposed on the housing of the implantable medical device, is configured to be compatible with the implantation tool.

14. A kit, comprising: implantable medical devices; and An implantation tool, comprising: a tool body defining a longitudinal axis and a channel extending along the longitudinal axis, the channel having a distal opening, wherein the tool body is configured to receive the medical device within the channel; and a plunger slidably engaged within the channel and movable within the channel toward the distal opening, wherein the distal end of the plunger is configured to push the proximal end of the medical device out of the channel through the distal opening, The absorbable antimicrobial layer, when disposed on the housing of the implantable medical device, is configured to be compatible with the implantation tool.

15. An article, comprising: a material layer having a first thickness; and an absorbable antimicrobial material disposed at least one of on or within the material layer, the absorbable antimicrobial material being configured to be absorbed from the material layer by the patient when the article is implanted in the patient, wherein the material layer is configured to be disposed on a housing of an implantable medical device, The material layer, when disposed on the housing, is configured to be compatible with an implantation tool.

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