IMPLANTABLE MEDICAL DEVICE WITH INSERTABLE / REMOVABLE ELEMENT - Patent application

Abstract

The implantable device includes a low-profile housing having a recess formed in a side thereof and an element insertable and removable relative to the housing in a direction generally parallel to a surgical surface of the implantable device. The element has a first portion configured to be received in the recess of the housing. The element further has a second portion configured to protrude from the housing when the element is inserted into the recess of the housing. The second portion has at least one surface configured to engage with a surgical instrument for inserting and removing the element relative to the housing. A method of performing an operation on an implantable device includes moving the element insertably and removable in a direction generally parallel to the surgical surface of the implantable device through an incision adjacent to an implantation site of the implantable device.

Description

Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 964,918, filed January 23, 2020, and U.S. Provisional Patent Application No. 63 / 131,595, filed December 29, 2020, the entire teachings of which are incorporated herein by reference. [Background technology]

[0002] Implantable medical devices have a number of limitations, including a limited implantable lifetime during which they can reliably perform sensing. Summary of the Invention [Problem to be solved by the invention]

[0003] A demand exists for improved implantable medical devices. [Means for solving the problem]

[0004] The present disclosure relates to methods, elements and tools for inserting and removing components from implanted devices using less invasive instrumentation and techniques (smaller incisions) than conventional surgery.

[0005] The present disclosure is directed to a medical device characterized by an element that can be inserted and removed from the already implanted medical device through a small skin incision. The element can be, for example, a magnet that cannot remain implanted if the patient has to undergo an MRI scan, a glucose sensor that degrades over time and needs to be replaced, a radio-opaque marker, an RFID tag, an electronic module, a variety of sensors (personalized monitoring), a battery pack, etc. The element has a special shape (or a special mechanism) that allows it to be inserted and removed parallel to the surgical plane of the implanted device, thus requiring a small incision. The shape of the element is such that it can be fastened to the implanted device and is easily grasped / handled by common surgical or specially designed instruments.

[0006] In one aspect of the disclosure, an implantable device is provided, the device comprising: a low-profile housing having a recess formed in a side thereof; and an element having a first portion configured to be received in the recess of the housing and insertable and removable relative to the housing in a direction generally parallel to a surgical surface of the implantable device. The element may further have a second portion configured to protrude from the housing upon insertion of the element into the recess of the housing. The second portion may have at least one surface configured to engage a surgical instrument for inserting and removing the element relative to the housing.

[0007] In some embodiments, the elements may include any of the following: a magnet, a battery, a sensor, an electronic module, a radiopaque marker, and an RFID tag.

[0008] In some embodiments, the elements may include bioresorbable and / or bioconsumable materials.

[0009] In some embodiments, the housing and element are constructed from a biocompatible material.

[0010] In some embodiments, the first portion is configured to friction fit into a recess in the housing.

[0011] In some embodiments, the housing recess has a recess wall, and the first portion and the recess wall are keyed together to provide engagement and alignment.

[0012] In some embodiments, the element is insertable and removable from the housing through an incision in the subject's skin that is 20 mm or less, 10 mm or less, or 5 mm or less in length, or in the range of 5 mm to 20 mm, 5 mm to 15 mm, or 7 mm to 13 mm in length.

[0013] In some embodiments, the recess is a first recess, the side is a first side, and the element is a first element. The device further comprises at least one second recess formed in the first side or at least one second side of the low profile housing. The device further comprises at least one second element insertable and removable relative to the housing in at least one second direction generally parallel to the surgical surface of the implantable device. The at least one second element has at least one first portion configured to be received in a recess of the housing.

[0014] In another aspect of the present disclosure, a method is provided for performing an operation on an implantable device implanted in a subject, the method comprising: moving an element having a thin housing with a recess formed in a side thereof and a first portion configured to be received in the recess of the housing and a second portion configured to protrude from the housing, the element being insertably and removably moved in a direction generally parallel to a surgical surface of the implantable device at an incision adjacent to an implantation site of the implantable device.

[0015] In some embodiments of the method, the second portion has at least one surface configured to engage a surgical instrument for inserting and removing the element relative to the housing.

[0016] In some embodiments of the method, the recess is a first recess, the side is a first side, the element is a first element, and the incision is a first incision. The method further comprises moving at least one second incision proximate the implantation location of the implantable device. The low profile housing may have at least one second recess formed in the first side or at least one second side. The implantable device may include at least one second element having a first portion configured to be received in the recess of the housing. Specifically, the moving comprises insertably and removably moving the at least one second element in at least one second direction generally parallel to the surgical plane. [Brief description of the drawings]

[0017] The above arrangements will become apparent from the following detailed description of exemplary embodiments that are illustrated in the accompanying drawings. The same reference characters refer to the same structures / parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the embodiments. [Figure 1] FIG. 1 is a conceptual diagram illustrating one embodiment of an implantable device consistent with the present disclosure. [Figure 2A] 1 is a schematic diagram of one embodiment of an implantable device according to the present disclosure, showing an element inserted. FIG. [Figure 2B] 2 is a schematic diagram of the embodiment of an implantable device according to the present disclosure with elements removed. FIG. [Diagram 3] FIG. 2C is a perspective view of a subject equipped with the implantable device of FIGS. 2A and 2B and a cochlear implant device. [Figure 4] FIG. 1 is a flow diagram illustrating a procedure of one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] In the following, exemplary embodiments are described.

[0019] The embodiment of the present technology will now be described in detail, examples of which are illustrated in the accompanying drawings. When referring to similar structures / components, similar reference numerals may be used. However, the description is not intended to limit the present disclosure to a particular embodiment, but rather should be construed to encompass various modifications and / or equivalents and / or variations of the embodiments described herein.

[0020] FIG. 1 is a schematic diagram illustrating an exemplary embodiment of a simplified implantable device 100. The implantable device 100 includes a low-profile housing 110. As used herein, a "low-profile housing" refers to a housing in which both the width 101 and the length 103 of the implantable device 100 at the surgical plane are greater than the device's height (thickness) 105 perpendicular to the surgical plane. The low-profile housing of each embodiment may be relatively flat, as illustrated in the embodiment of the housing 110 and in connection with FIGS. 2A, 2B, and 3 below. It should also be understood that a "low-profile housing" as used herein refers to a housing that is sized for implantation. The low-profile housing allows the device to be implanted subcutaneously, such as between layers of skin or flesh, between a bone and skin or other flesh, for example, between the skull and the skin covering the skull. The thin housing may allow the device to be subcutaneously implanted, such as by screwing it to the skull, without the need to embed the device in the skull or provide other protrusions into the skull, and without the device protruding significantly beyond the normal contour of the skin that would be expected if the device were not implanted. A bulge beneath the skin that would reveal the device's presence may be substantially avoided. In some embodiments, for this purpose, the height (thickness) 105 may be 10 mm or less, such as within a range of 2 mm to 10 mm (2 mm to 10 mm). More preferably, the height 105 may be 6 mm or less, such as within a range of 2 mm to 6 mm. Even more preferably, the height 105 may be 5 mm or less, such as within a range of 2 mm to 5 mm. Even more preferably, the height may be 3 mm or less, such as within a range of 2 mm to 3 mm. In some specific embodiments of a subcutaneous implant for use in a skull-located neural implant application, the height may be in the range of 2 mm to 5 mm, but it should be understood that other embodiments may be located at other body sites other than near the skull.

[0021] The use of "surgical plane" herein should be understood to be consistent with the use of the term in the field of surgery, and in particular in the field of neural implant surgery. For the implantable device 100 of FIG. 1, the surgical plane of the device 100 is the XY plane shown in FIG. 1. Arbitrarily, the width 101 is measured parallel to the X axis, the length 103 is measured parallel to the Y axis, and the height (thickness) 105 is measured parallel to the Z axis. In some specific embodiments of subcutaneous implants used in skull-located neural implant applications, the surgical plane may be approximately parallel to the portion of the skull in which the implanted device is located. The use of "approximately parallel" herein may indicate that the XY surgical plane is within 20° of being completely parallel to the skull, and more preferably within 10° of being completely parallel to the skull.

[0022] Two example removable insertable elements 120, 140 are depicted in the schematic diagram of FIG. 1. The element 120 has a first portion 124 and a second portion 128. The first portion 124 is configured to be received in a recess 150 formed in the first side 117 of the housing 110. The housing recess 150 has recess walls 152 that are keyed to align and engage with locking indents 126 on either side of the first portion 124. The second portion 128 of the element 120 is configured to protrude from the housing 110 when the first portion 124 of the element 120 is inserted into the housing recess 150. The second portion 128 has a detent 130 that is configured to engage a surgical instrument (not shown) configured to insert and remove the element 120 from the housing 110.

[0023] The element 140 is generally cylindrical in shape and has a first portion 142 and a second portion 144. The first portion 142 is configured to be received in a recess 160 formed in the second side 117 of the housing 110. The housing recess 160 is formed with a recess wall 162. The recess wall 162 is cylindrically keyed to align and engage with the annular latched portion 146 of the first portion 124. In other embodiments, instead of or in addition to the keyed alignment, engagement, and locking with the first portions 124, 142 as shown in FIG. 1, the first portions 124, 142 and the housing recesses 150, 160 may be configured to align, engage, and lock with each other via a friction fit. Second portion 144 of element 140 is configured to protrude from housing 110 when first portion 142 of element 140 is inserted into recess 160 of the housing. Insertion and removal of element 140 from housing 110 can be performed by grasping second portion 144 with a surgical instrument or by hand.

[0024] It should be understood that embodiments are not limited to one recess per side of the housing. Generally speaking, any number of recesses and corresponding removable insertable elements may be provided on any side 117 of the housing, for example, two or more removable insertable elements. Moreover, a given embodiment of the device may have one, two, or more than three recesses and corresponding removable insertable elements distributed across one side 117, two sides 117, or more than three sides of the device. It should also be understood that embodiments are not limited to a particular housing shape. Although the housing 110 is shown to have a generally rectangular profile in the operative surface (parallel to the XY plane), in other embodiments the housing may have a different shape or may be characterized by a variety of portions of a variety of shapes, including irregular shapes. As an example, the housing 210, described below in connection with Figures 2A and 2B, consists of a semicircular section that houses the coil, a generally rectangular section that houses the electronics, and various protrusions at the corners that are useful for securing the device to the subject's skull, forming recesses that can accommodate insertable and removable elements, as well as protecting the lead wires that extend within the housing.

[0025] The housing of the embodiment may also be referred to as an "implantable housing" or a "surgically implantable housing" since it may be part of an entire device that is a component of an implantable apparatus. More specifically, the embodiment described below in connection with Figures 2A, 2B, and 3 is configured for neural implant function that is implanted subcutaneously and secured to the skull, so the housing 210 of the embodiment may also be referred to as a "surgically implantable neural implant housing". It should also be understood that the "sides" of the housing of other embodiments do not have to be planar, such as side 117 of housing 110. Generally speaking, the sides may be of any shape or orientation as long as they provide space for a recess that can accommodate an insertable / removable element, as can be seen from the examples of Figures 2A and 2B.

[0026] In both of the above examples, the elements are inserted and removed in a direction parallel to the surgical surface of the housing. In the case of element 120, these directions are parallel to the X-axis, and in the case of element 140, they are parallel to the Y-axis. However, in other embodiments, the insertion and removal is performed in a direction that is only approximately parallel to the surgical surface of the housing. The use of "approximately parallel" to the surgical surface in this context means that the insertion and removal is performed in a direction within 45° of the surgical surface. To enable insertion and removal in a direction that is not completely parallel to the surgical surface but is approximately parallel to the surgical surface within 45° of the surgical surface, the recesses 150, 160 of the housing may be oriented not parallel to the surgical surface but tilted by a corresponding amount from the surgical surface as shown in FIG. 1. In a more preferred embodiment, the insertion and removal is performed in a direction within 20° of the surgical surface. Even more preferably, the insertion and removal may be performed in a direction within 10° of the surgical surface. However, as shown and described in connection with Figures 1, 2A and 2B, the most preferred configuration has the insertion and removal occur in a direction parallel to the surgical plane. "Nearly parallel" insertion and removal allows the element to be worked on in a minimally invasive manner and without the device protruding significantly beyond the normal contours of the skin that would be expected if the device were not implanted.

[0027] As used herein, "inserting," "insertion," and the like, with respect to an insertable / removable element, refers to an insertion into the housing of the subcutaneous device that is completed with no leads or other connections to the element protruding from the skin. That is, as used herein, "inserting," "insertion," and the like, should be understood to mean "connectorlessly inserting," "connectorless insertion," and the like.

[0028] The ability to insert and remove elements substantially parallel to the surgical plane of the device is advantageous because it allows for placement, removal, or replacement of the elements by making a small incision near the implantation site, without the need to lift a skin flap to expose the top of the implant, as is the case with cochlear implant magnet removal. Thus, the disclosed approach provides a minimally invasive implantable device. In particular, the implantable device may be minimally invasive to work with modular replaceable elements. In one example, the removable element may include a magnet that is used to align a coil that is part of the device, such as the induction coil 270 shown in FIG. 2A, with a coil that is external to the device. While such magnets may be useful for alignment, they may be a hindrance during MRI scans. The embodiments described herein allow for minimally invasive removal and re-installation of the removable magnet element as needed. In another example, the removable element may include a battery or a sensor that requires periodic replacement, such as a glucose sensor. As part of the device of the embodiments, such sensors can also be replaced in a minimally invasive manner. Other exemplary types of insertable and removable elements within the scope of the embodiments are described herein. However, the scope of insertable and removable elements is not limited to these examples. The insertable and removable elements described herein may be electrically coupled to electrical circuitry contained within the housing to allow power flow and communication between the housing and the element.

[0029] It should be appreciated that various shapes for the removable insertable element may be envisioned other than that depicted in Figure 1. Additionally, other locking / engagement mechanisms may be utilized, including a friction fit of the element to the housing.

[0030] It is envisioned that by making the elements insertable and removable, it will be possible to add functionality to an embedded device through various modules without having to replace the entire device.

[0031] 2A and 2B are schematic diagrams of an exemplary embodiment of an implantable device 200 with elements inserted (FIG. 2A) and partially removed (FIG. 2B). The device 200 includes a low-profile housing 210 that contains several components, including an inductive coil 270 and (within the housing) an electronic circuit 280. The electronic circuit described herein may also be referred to as at least one "electronic module." Leads 290 connect to the sensor 280. The housing includes a skull mounting structure 219 that secures the housing to the subject's skull. In this embodiment, the skull mounting structure 219 is a hole that threads the device into the skull. In other embodiments, other types of mounting structures may optionally be provided for mounting to other bones or for securing the device to other subcutaneous locations.

[0032] In some embodiments, electronic circuitry 280 may include a processor, such as a microprocessor, that receives and processes information from at least one removable insertable element. In some embodiments, electronic circuitry 280 may include a processor that transmits information or instructions to at least one removable insertable element. Instructions may include activating the at least one element to perform a function. In some embodiments, electronic circuitry 280 includes a communication interface configured to transmit information to a receiving portion outside the housing, device, or subject. In some embodiments, electronic circuitry 280 includes a communication interface configured to receive information, commands, or other instructions from a transmitting portion outside the housing, device, or subject.

[0033] The housing 210 further includes insertable and removable elements 220A and 220B. In particular, the elements 220A and 220B are magnets enclosed in titanium housings that are configured to fit into respective recesses of the housing 210 for insertion and removal along a direction parallel to the surgical surface of the housing. The surgical surface of the housing 210 is parallel to the XY plane shown in FIG. 2A.

[0034] The housing 210 may be made of a biocompatible material, such as, for example, silicone and / or titanium.

[0035] FIG. 3 is a perspective view of the skull of a subject 311 equipped with a subcutaneous implant including the implantable device 200 of FIG. 2A and the cochlear implant device 315. The surgical plane of the device 200, which is the XY plane in the figure, is approximately parallel to the skull at the implantation site. The perspective view illustrates relatively small linear incisions (straight lines S1 307, S2 309) for element insertion and / or removal in the immediate vicinity of the implantation site, in contrast to the highly invasive and relatively large arcuate incision (C313) required for the flap lift procedure for the cochlear implant. In one embodiment of the device, the S (for "straight") incisions 307, 309 are approximately 10 mm long, while the C313 (for "C" incision) is roughly 55 mm long. However, the element in each embodiment may be insertable and removable from the housing through an incision in the skin of the subject, having a length of 20 mm or less, 10 mm or less, or 5 mm or less, or a length range of 5 mm to 20 mm, preferably 5 mm to 15 mm or 7 mm to 13 mm.

[0036] Generally speaking, the smaller the incision, the fewer complications it will cause. Thus, two short, straight incisions S are preferable to larger, curvilinear incisions C. Furthermore, vertical straight incisions are preferable to C-shaped incisions because the blood vessels that perfuse the scalp run in a generally vertical pattern from the base of the skull to the top of the head. Thus, making the incisions vertically straight to insert and remove the elements of the device of the embodiment may reduce the chance of severing blood vessels, which would reduce the blood supply to the scalp distal to the incision. Thus, the device of the embodiment is not only easier to operate, but is also much safer than existing cochlear implants.

[0037] 4 is a flow diagram showing a procedure 400 of one embodiment for performing an operation on an implantable device. At 431, the implantable device includes a low-profile housing having a recess formed in a side thereof and an element having a first portion configured to be received in the recess of the housing and a second portion configured to protrude from the housing, and the element is inserted and removed by moving the element in a direction generally parallel to the surgical surface of the implantable device at an incision adjacent to the implantation site of the implantable device. Within the procedures of the embodiment for performing an operation on an implantable device using only one element, only 431 is performed. However, procedure 400 includes a step shown at 433 for performing an operation using an additional element of the device of one embodiment.

[0038] At 433, the recess is considered to be a first recess, the side is considered to be a first side, the element is considered to be a first element, and the incision is considered to be a first incision. The method further comprises moving the implantable device at at least one second incision proximate the implantation location. The low-profile housing may have at least one second recess formed in the first side or at least one second side. The implantable device may include at least one second element having a first portion configured to be received in the recess of the housing. Specifically, the moving is a step of insertably and removably moving the at least one second element in at least one second direction generally parallel to the surgical plane, as will be understood from the description of other embodiments herein.

[0039] In some embodiments of the method, the second portion has at least one surface configured to engage a surgical instrument for inserting and removing the element relative to the housing, and the method may be modified to utilize or use or work with any of the features of the previously described embodiments.

[0040] As used herein, the terms "comprises" (and all derivatives thereof, such as "comprises" and "comprising"), "has" (and all derivatives thereof, such as "has" and "had"), "including" (and all derivatives thereof, such as "includes" and "included"), and "containing" (and all derivatives thereof, such as "containing" and "contained") are understood to indicate the presence of stated structures and / or integers and / or steps and / or operations and / or components and / or parts, but do not exclude the presence or addition of at least one other structure and / or integers and / or steps and / or operations and / or components and / or parts and / or combinations thereof.

[0041] In addition, although the terms "first", "second", "third", etc. may be used herein to describe various limitations and / or components and / or parts and / or regions and / or layers and / or portions, it should be understood that these limitations and / or components and / or parts and / or regions and / or layers and / or portions should not be limited by such terms. These terms are used only to distinguish one limitation, component, part, region, layer or portion from another limitation, component, part, region, layer or portion. Thus, the "first" limitation, "first" component, "first" part, "first" region, "first" layer or "first" portion described above may also be termed a "second" limitation, "second" component, "second" part, "second" region, "second" layer or "second" portion without departing from the teachings of this application.

[0042] Additionally, when referring to an element being "on," "attached to," "connected to," or "coupled to" another element, it should be understood that the element may be directly "on," immediately "above," directly "connected to," or directly "coupled" to the other element, or there may be at least one intervening element between them. In contrast, when referring to an element being "directly on," "directly attached to," "directly connected to," or "directly coupled to" another element, there are no intervening elements between them. Other language used to express relationships between elements (e.g., "between" vs. "directly / directly between," "adjacent" vs. "directly / directly adjacent," etc.) should be interpreted in a similar manner.

[0043] Additionally, when a first element is referred to as being "on" and / or "on" and / or "within" a second element, it should be understood that the first element may be disposed within an interior space of the second element and / or within a portion of the second element (e.g., within a wall of the second element) and / or on an exterior surface of the second element and / or on an interior surface of the second element and / or at least one combination thereof.

[0044] The term "proximate," as used herein to describe a first component or location near a second component or location, should be interpreted to include one or more locations being near, at, on, and / or within the second component or location. For example, a component located proximate to an anatomical location (e.g., a target tissue location) is intended to include a component located near, at, on, and / or within the anatomical location.

[0045] Spatially relative terms such as "lower," "below," "bottom," "upper," "top," and the like may be used to describe the relationship of one or more components and / or structures to another component and / or structure, e.g., as depicted in the figures. These spatially relative terms should be understood to encompass orientations of the device when in use and / or operation other than those depicted in the figures. For example, if the device in the figures is turned over, a component described as being "below" and / or "below" one component or structure will be oriented "above" the other component or structure. The device can be oriented in any way (e.g., rotated 90 degrees, oriented in a different way, etc.), and the spatially relative terms used herein should be interpreted accordingly.

[0046] As used herein, the term "and / or" should be construed as specifically disclosing both the two described structures or components alone as well as together with the other. For example, "A and / or B" should be construed as specifically disclosing (i) A alone, (ii) B alone, and (iii) both A and B, all as if each was individually listed herein.

[0047] The term "functional element" as used herein should be construed to encompass at least one element constructed and arranged to perform a function. A functional element may include a sensor and / or a transducer. In some embodiments, a functional element (e.g., a functional element configured as a treatment element, etc.) is configured to deliver energy and / or other treatment to tissue. Alternatively or additionally, a functional element (e.g., a functional element including a sensor, etc.) may be configured to record at least one parameter, such as a physiological parameter of the subject and / or an anatomical parameter of the subject (e.g., a tissue shape parameter, etc.) and / or an environmental parameter of the subject and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., collect data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., deliver a therapeutic energy and / or a therapeutic agent). In some embodiments, the functional elements include at least one element constructed and arranged to perform a function selected from the group consisting of: delivery of energy, withdrawal of energy (e.g., cooling a component, etc.), delivery of a drug or other agent, manipulation of a system component or a target tissue, recording or sensing a parameter, such as a physiological parameter of a subject, a system parameter, and at least one combination thereof.

[0048] The term "transducer" as used herein should be construed to encompass any part or combination of parts that receives energy or some input and produces an output. For example, a transducer may have an electrode that distributes the received electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, the transducer converts an electrical signal into some output, such as light (e.g., a transducer having a light emitting diode or a light bulb), and / or sound (e.g., a transducer having a piezoelectric crystal configured to deliver ultrasonic energy), and / or pressure, and / or heat energy, and / or cold energy, and / or chemical energy, and / or mechanical energy (e.g., a transducer having a motor or a solenoid), and / or magnetic energy, and / or another electrical signal (e.g., a Bluetooth element or other wireless communication element). Alternatively or additionally, a transducer may convert a physical quantity (e.g., a change in a physical quantity) into an electrical signal. The transducer may have any component that delivers energy and / or drugs to tissue, such as, for example, a transducer configured to deliver one or more of electrical energy to tissue (e.g., a transducer having at least one electrode), optical energy to tissue (e.g., a transducer having a laser and / or a light emitting diode and / or an optical element such as a lens, a prism, etc.), mechanical energy to tissue (e.g., a transducer having a tissue manipulation element), acoustic energy to tissue (e.g., a transducer having a piezoelectric crystal), chemical energy, electromagnetic energy, magnetic energy, and at least one combination thereof.

[0049] As used herein, the term "fluid" may refer to a liquid, gas, gel, or any flowable substance, such as a substance that can be extruded from a lumen and / or opening.

[0050] It will be appreciated that certain features of the invention that are for clarity described in the context of separate embodiments may also be provided together in a single embodiment. Conversely, various features of the invention that are for clarity described in the context of the same embodiment may also be provided separately or in any suitable subcombination. For example, it will be appreciated that any features recited in each claim (whether independent or dependent) may be combined in any manner.

[0051] It should be understood that at least some of the drawings and the specification of the present invention have been simplified to focus attention on elements relevant to a clear understanding of the present invention, and other elements that a person skilled in the art would recognize as comprising part of the present invention have not been mentioned for the sake of clarity of the description, however, descriptions of such elements are not provided herein, not only because they are well known in the art, but also because they are not necessarily helpful to a more detailed understanding of the present invention.

[0052] All patents, published patent applications and publications cited herein are incorporated by reference in their entirety for their teachings.

[0053] While exemplary embodiments have been specifically shown and described, those skilled in the art will recognize that various changes in form and detail may be made therein without departing from the scope of the embodiments encompassed by the appended claims. The present invention includes the following embodiments. [Aspect 1] 1. An implantable device comprising: A thin housing having a recess formed on a side thereof; an element having a first portion configured to be received in a recess of the housing and insertable and removable relative to the housing in a direction generally parallel to a surgical surface of the implantable device; An apparatus comprising: [Aspect 2] 2. The device of claim 1, wherein the element further has a second portion configured to protrude from the housing when the element is inserted into the recess of the housing. [Aspect 3] 3. The device of claim 2, wherein the second portion has at least one surface configured to engage with a surgical instrument for inserting and removing the element relative to the housing. [Aspect 4] 4. The apparatus of any one of the preceding aspects, wherein the element comprises a magnet. [Aspect 5] The device of any one of the preceding embodiments, wherein the element comprises a battery. [Aspect 6] The device of any one of the preceding embodiments, wherein the element comprises a sensor. [Aspect 7] 7. The apparatus of any one of the preceding embodiments, wherein the element comprises an electronic module. [Aspect 8] The device according to any one of the preceding aspects, further comprising: an electronic circuit within the housing; An apparatus comprising: [Aspect 9] 9. The apparatus of claim 8, wherein the element is configured to be electrically coupled to the electronic circuit. [Aspect 10] 10. The device of any one of the preceding aspects, wherein the element comprises a radiopaque marker. [Aspect 11] 11. The apparatus of any one of the preceding aspects, wherein the element comprises an RFID tag. [Aspect 12] 12. The device of any one of the preceding aspects, wherein the element comprises a bioabsorbable material. [Aspect 13] 13. The device of any one of the preceding aspects, wherein the element comprises a bioconsumable material. [Aspect 14] 14. The device of any one of the preceding aspects, wherein the housing and elements are comprised of a biocompatible material. [Aspect 15] 15. The device of any one of the preceding aspects, wherein the first portion is configured to frictionally fit into a recess in the housing. [Aspect 16] 16. The device of any one of the preceding embodiments, wherein the housing recess has a recess wall, and the first portion and the recess wall are keyed together to engage and align. [Aspect 17] 17. The device of any one of aspects 1 to 16, wherein the element is insertable and removable from the housing through an incision in the skin of the subject having a length of 20 mm or less, 10 mm or less, or 5 mm or less, or a length ranging from 5 mm to 20 mm, 5 mm to 15 mm, or 7 mm to 13 mm. [Aspect 18] 18. The apparatus of any one of the first to seventeenth aspects, wherein the recess is a first recess, the side is a first side, and the element is a first element, further comprising: at least one second recess formed in the first side or at least one second side of the low profile housing; at least one second element having at least one first portion configured to be received in a recess of the housing and insertable and removable in at least one second direction relative to the housing generally parallel to the surgical surface of the implantable device; An apparatus comprising: [Aspect 19] 1. A method of performing an operation on an implantable device, comprising: The implantable device includes a low-profile housing having a recess formed in a side thereof, and an element having a first portion configured to be received in the recess of the housing, the step of insertably and removably moving the element in a direction generally parallel to a surgical surface of the implantable device at an incision adjacent to an implantation site of the implantable device; A method comprising: [Aspect 20] 20. The method of claim 19, wherein the element further has a second portion configured to protrude from the housing. [Aspect 21] 21. The method of claim 20, wherein the second portion has at least one surface configured to engage with a surgical instrument for inserting and removing the element relative to the housing. [Aspect 22] 22. The method of any one of embodiments 19 to 21, wherein the moving step includes removing the element from a recess in the housing. [Aspect 23] 23. The method of any one of embodiments 19 to 22, wherein the moving step includes inserting the element into a recess in the housing. [Aspect 24] A method according to any one of aspects 19 to 23, wherein the moving step is performed through an incision in the subject's skin having a length of 20 mm or less, 10 mm or less, or 5 mm or less, or a length ranging from 5 mm to 20 mm, from 5 mm to 15 mm, or from 7 mm to 13 mm. [Aspect 25] 25. The method of any one of claims 19-24, wherein the recess is a first recess, the side is a first side, the element is a first element, the cutout is a first cutout, at least one second recess is formed in the first side or at least one second side of the low profile housing, and the implantable device comprises at least one second element having a first portion configured to be received in a recess of the housing, the method further comprising: insertably and removably moving the at least one second element in at least one second direction generally parallel to the surgical plane through at least one second incision proximate the implantation location of the implantable device; A method comprising: [Aspect 26] A method according to any one of embodiments 19 to 25, wherein the method is carried out using any one of the apparatus or elements of the apparatus according to any one of embodiments 1 to 18.

Claims

1. 1. An implantable device comprising: The X-direction and Y-direction of the surgical surface, which is an XY plane of the implantable device, are width and length directions, and both the width and length on the surgical surface are greater than the height in a direction perpendicular to the surgical surface, and a thin housing is formed on a side thereof with a recess; an element having a first portion configured to be received in a recess of the housing and insertable and removable relative to the housing in a direction within 45° of the surgical surface of the implantable device; Equipped with the element further having a second portion configured to protrude from the housing when the element is inserted into the recess of the housing; The second portion has at least one surface configured to engage a surgical instrument for inserting and removing the element relative to the housing.

2. The apparatus of claim 1 , wherein the element comprises a magnet.

3. 3. The apparatus of claim 1 or 2, wherein the element comprises a battery.

4. 4. The apparatus of claim 1, wherein the element comprises a sensor.

5. 5. Apparatus according to any one of claims 1 to 4, wherein the element comprises an electronic module.

6. The apparatus according to any one of claims 1 to 5, further comprising: an electronic circuit within the housing; An apparatus comprising:

7. The apparatus of claim 6 , wherein the element is configured to be electrically coupled to the electronic circuit.

8. 8. The apparatus of claim 1, wherein the element comprises a radiopaque marker.

9. 9. The apparatus of claim 1, wherein the element comprises an RFID tag.

10. 10. The device of claim 1, wherein the element comprises a bioabsorbable material.

11. 11. The device of claim 1, wherein the element comprises a bioconsumable material.

12. 12. The device of claim 1, wherein the housing and elements are constructed from a biocompatible material.

13. 13. Apparatus according to any one of claims 1 to 12, wherein the first portion is configured to friction fit into a recess in the housing.

14. 14. Apparatus according to any one of claims 1 to 13, wherein the housing recess has a recess wall, and the first portion and the recess wall are keyed together for engagement and alignment.

15. 15. The device of any one of claims 1 to 14, wherein the element is insertable and removable from the housing through an incision in a subject's skin.

16. 16. The apparatus of any one of claims 1 to 15, wherein the recess is a first recess, the side is a first side, and the element is a first element, the apparatus further comprising: at least one second recess formed in the first side or at least one second side of the low profile housing; at least one second element having at least one first portion configured to be received in a recess of the housing and insertable and removable in at least one second direction relative to the housing, the second direction being within 45° of the surgical plane of the implantable device; An apparatus comprising:

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