Implantable medical device with insertable removable element

Abstract

An implantable device includes a low profile housing having a cavity defined in a side thereof, and an element insertably removable relative to the housing in a direction substantially parallel to a surgical plane of the implantable device. The element has a first portion adapted to be received in the housing cavity. The element further includes a second portion adapted to protrude from the housing after insertion of the element into the housing cavity. The second portion includes at least one surface adapted to engage a surgical instrument for inserting and removing the element relative to the housing. A method for servicing an implantable device includes insertably and removably accessing an element in a direction substantially parallel to a surgical plane of the implantable device at an incision proximate an implantation site of the implantable device.

Description

[0001] Related applications

[0002] This application claims the benefits of U.S. Provisional Application No. 62 / 964,918, filed January 23, 2020, and U.S. Provisional Application No. 63 / 131,595, filed December 29, 2020. The entire teachings of these applications are incorporated herein by reference. Background Technology

[0003] Implantable medical devices exhibit many limitations, including the limited implant lifespan during which sensing can be reliably performed.

[0004] Implantable medical devices that need improvement. Summary of the Invention

[0005] This disclosure relates to methods, elements, and tools for inserting components into and removing components from an implantable device via minimally invasive device features and techniques (small incisions) rather than conventional surgery.

[0006] This disclosure relates to a medical device characterized by components that can be inserted into and removed from an implanted medical device through a small skin incision. These components may be, for example, magnets that cannot be retained in cases where the patient requires MRI, glucose sensors that degrade over time and require replacement, radiopaque markers, RFID tags, electronic modules, different types of sensors (personalized monitoring), and battery packs. The components have a specific shape (or specific mechanism) that allows them to be inserted and removed parallel to the surgical plane of the implantation device, requiring only minimal incisions. The geometry of the components is used to anchor them to the implantation device and also provides features that allow for easier grasping / handling using standard surgical instruments or alternatively, custom-designed instruments.

[0007] According to an aspect of this disclosure, an implantable device is provided, comprising: a low-profile housing having cavities defined in its sides; and an element capable of insertably removing relative to the housing in a direction substantially parallel to a surgical plane of the implantable device, the element having a first portion adapted to be received in the housing cavity. The element may further include a second portion adapted to protrude from the housing after the element has been inserted into the housing cavity. The second portion may include at least one surface adapted to engage with a surgical instrument for inserting and removing the element relative to the housing.

[0008] In some implementations, the components may include any of the following: magnets, batteries, sensors, electronic modules, radiopaque markers, and RFID tags.

[0009] In some implementations, the element may include reabsorbable and / or consumable materials.

[0010] In some implementations, the housing and components are made of biocompatible materials.

[0011] In some embodiments, the first portion is adapted to be frictionally fitted into the housing cavity.

[0012] In some embodiments, the housing cavity includes a cavity wall, and the first portion and the cavity wall are bonded to each other for engagement and alignment.

[0013] In some embodiments, the element can be insertably removed relative to the housing via a cut through the skin of the object, wherein the length of the cut is less than or equal to 20 mm, 10 mm, or 5 mm, or wherein the length of the cut is in the range of 5 mm to 20 mm, 5 mm to 15 mm, or 7 mm to 13 mm.

[0014] In some embodiments, the cavity is a first cavity, the side is a first side, and the element is a first element. The device also includes one or more second cavities defined in a first side or one or more corresponding second side of the low-profile housing. The device also includes one or more corresponding second elements that are insertably removable relative to the housing in one or more corresponding second directions substantially parallel to the surgical plane of the implantable device. The one or more corresponding second elements have one or more corresponding first portions adapted to be received in the housing cavity.

[0015] According to another aspect of the invention, a method for maintaining an implantable device implanted in an object is provided, wherein the method includes insertably and removably approaching the element at an incision site near the implantation location of the implantable device in a direction substantially parallel to the surgical plane of the implantable device, the implantable device including a low-profile housing and an element, the low-profile housing having a cavity defined in its sides, the element having a first portion adapted to be received in the housing cavity and a second portion adapted to protrude from the housing.

[0016] In some embodiments of the method, the second part includes at least one surface adapted to engage with a surgical instrument for inserting and removing elements relative to the housing.

[0017] In some embodiments of the method, the cavity is a first cavity, the side is a first side, the element is a first element, and the incision is a first incision. The method also includes approaching at one or more corresponding second incisions near the implantation site of the implantable device. The low-profile housing may have one or more corresponding second cavities defined on its first side or one or more corresponding second sides. The implantable device may include one or more second elements having corresponding first portions adapted to be received in the housing cavity. The approach is particularly insertable and removable approaching one or more second elements in one or more corresponding second directions substantially parallel to the surgical plane. Attached Figure Description

[0018] The foregoing will become apparent from the following more specific description of exemplary embodiments illustrated in the accompanying drawings, in which the same reference numerals refer to the same parts in different views. The drawings are not necessarily to scale, but rather focus on illustrating the embodiments.

[0019] Figure 1 A conceptual diagram illustrating an embodiment of an implantable device consistent with this disclosure is shown.

[0020] Figure 2A and Figure 2B A schematic diagram illustrating an embodiment of an implantable device in accordance with this disclosure, in which elements are inserted and removed.

[0021] Figure 3 It shows having Figure 2A and Figure 2B Illustrations of implantable devices and cochlear implants.

[0022] Figure 4 This is a flowchart illustrating the implementation process. Detailed Implementation

[0023] The following is a description of an example implementation.

[0024] Reference will now be made in detail to current embodiments of the present technology, examples of which are illustrated in the accompanying drawings. Similar reference numerals may be used to refer to similar components. However, this specification is not intended to limit this disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or substitutions of the embodiments described herein.

[0025] Figure 1A conceptual diagram of a simplified implantable device 100 including a low-profile housing 110 is shown. As used herein, a “low-profile housing” is a housing having a width 101 and a length 103 in the surgical plane of the implantable device 100, both of which are greater than the height (thickness) 105 of the device in a direction perpendicular to the surgical plane of the device. In various embodiments, the low-profile housing may be relatively flat, as with housing 110 and as described below. Figures 2A to 2B and Figure 3 The embodiments described herein are illustrative. It should also be understood that, as used herein, a “low-profile shell” is a shell sized for implantation. A low-profile shell allows the device to be implanted subcutaneously, for example, between layers of skin or flesh, or between bone and skin or other flesh, such as between the skull and the skin covering the skull. A low-profile shell can allow the device to be implanted subcutaneously, such as by screwing the device to the skull, while avoiding the need to sink the device itself into the skull or require any other intrusion into the skull, while still avoiding a significant protrusion of the device across the normal contour of the skin, which is expected without the implanted device. A subcutaneous bulge indicating the presence of the device can be substantially avoided. For this purpose, in some embodiments, the height (thickness) 105 may be less than or equal to 10 mm, for example, in the range of 2 mm to 10 mm. More preferably, the height 105 may be less than or equal to 6 mm, for example, in the range of 2 mm to 6 mm. Even more preferably, the height 105 may be less than or equal to 5 mm, for example, in the range of 2 mm to 5 mm. More preferably, the height can be less than or equal to 3 mm, for example, in the range of 2 mm to 3 mm. In some specific subcutaneous implantable embodiments for neurological applications applied to the skull, the height can be in the range of 2 mm to 5 mm. However, it should be understood that other embodiments can be applied to other body parts not near the skull.

[0026] The term "surgical plane" as used in this article should be understood to be consistent with its usage in the surgical field, particularly in the field of neuroimplantation surgery. Figure 1 The implantable device 100 in the middle, the surgical plane of the device 100 is Figure 1 The XY plane is shown. Optionally, width 101 is measured parallel to the X-axis, length 103 is measured parallel to the Y-axis, and height (thickness) 105 is measured parallel to the Z-axis. In some specific subcutaneous implantable embodiments for neurological applications to the skull, the surgical plane may be substantially parallel to the portion of the skull where the implanted device is applied. In this usage, "substantially parallel" can mean that the XY surgical plane is within 20 degrees perfectly parallel to the skull, or more preferably, within 10 degrees perfectly parallel to the skull.

[0027] Figure 1 The conceptual diagram illustrates corresponding insertable and removable elements 120 and 140 of two example types. Element 120 has a first portion 124 and a second portion 128. The first portion 124 is configured to be received in a cavity 150 defined in a first side 117 within a housing 110. The housing cavity 150 includes a cavity wall 152 that is keyed to align and engage with an opposing locking notch 126 of the first portion 124. The second portion 128 of element 120 is configured to protrude from the housing 110 after the first portion 124 of element 120 has been inserted into the housing cavity 150. The second portion 128 includes a pawl 130 configured to engage with a surgical instrument (not shown) suitable for inserting and removing element 120 relative to the housing 110.

[0028] Element 140 is generally cylindrical in shape and has a corresponding first portion 142 and a corresponding second portion 144. The first portion 142 is configured to be received in a cavity 160 defined in another second side 117 within the housing 110. The housing cavity 160 includes a cavity wall 162 defined and cylindrically bonded for alignment and engagement with an annular locking notch 146 of the first portion 124. Figure 1 The illustrated alternative to the bond-based alignment, engagement, and locking of the first portions 124 and 142, or alternatively, in other embodiments, the first portions 124 and 142 and the corresponding housing cavities 150 and 160 may be adapted for friction-based alignment, engagement, and locking. The second portion 144 of element 140 is configured to protrude from housing 110 after the first portion 142 of element 140 has been inserted into housing cavity 160. Insertion and removal of element 140 relative to housing 110 can be achieved by grasping the second portion 144 with surgical instruments or by hand.

[0029] It should be understood that the implementation is not limited to one cavity on each side of the housing. Generally, any number of corresponding cavities and corresponding corresponding insertable / removable elements, such as two or more insertable / removable elements, can be provided for a given side 117 of the housing. Furthermore, a given embodiment of the device may include one or two or more cavities and corresponding insertable / removable elements distributed on one side 117, two corresponding sides 117, or more corresponding sides of the device. It should also be understood that the implementation is not limited to any particular housing shape. While the housing 110 has a generally rectangular outline in the surgical plane (parallel to the XY plane), in other embodiments the housing may have other shapes, or may be characterized by multiple shapes of its different portions, including irregular shapes. In one example, the following is combined with… Figures 2A to 2BThe described housing 210 includes a semi-circular portion for encapsulating the coil, a generally rectangular portion for encapsulating the electronic device, and various protrusions on its sides for securing the device to the skull of the object, forming a cavity that can accommodate insertable and removable components and protect leads extending through the housing.

[0030] Furthermore, because the housing according to the embodiment can be part of the entire device forming part of the implantable device, the housing can be referred to as an "implantable housing," "surgically implantable housing," etc. More specifically, the following is combined with Figures 2A to 2B and Figure 3 The described embodiment is configured for neurological function, to be subcutaneously implanted and secured to the skull; therefore, the housing 210 of this embodiment can be described using the terms "neurological, subcutaneous, surgically implantable housing" and similar terms. Furthermore, it should be understood that in other embodiments, the "sides" of the housing need not be planar, such as side 117 of housing 110. Sides can generally be any shape or orientation capable of providing space for a cavity that can accommodate any insertable and removable element, as illustrated by the reference example. Figures 2A to 2B To understand in more detail.

[0031] For the two example elements, insertion and removal occur in corresponding directions, both parallel to the surgical plane of the housing. These corresponding directions are parallel to the X-axis of element 120 and parallel to the Y-axis of element 140. However, in other embodiments, insertion and removal occur only in directions substantially parallel to the surgical plane of the housing. In this usage of insertion and removal, "substantially parallel" to the surgical plane means insertion and removal in directions within 45 degrees of the surgical plane. To enable insertion and removal in directions that are not perfectly parallel but still substantially parallel to the surgical plane, housing cavities 150 and 160 can be oriented at corresponding angles relative to the surgical plane within 45 degrees of the surgical plane, rather than as... Figure 1 The insertion and removal are parallel to the surgical plane. In a more preferred embodiment, insertion and removal occur within 20 degrees of the surgical plane. Still more preferably, insertion and removal can occur within 10 degrees of the surgical plane. However, as combined with... Figure 1 and Figures 2A to 2B As shown and described, it is most preferred that insertion and removal are in a direction parallel to the surgical plane. "Substantially parallel" insertion and removal allows for maintenance of the element with minimal invasiveness and in a manner that avoids the device protruding significantly through the normal contours of the skin, which are the contours expected without the implanted device.

[0032] As used herein, terms such as "insert," "insertion," "insertable," and "insertable" in relation to insertable and removable components indicate insertion into the housing of the device after the insertion process is complete, under the skin, without leads or other connectors to the component protruding through the skin. Therefore, as used herein, "insert," "insertion," "insertable," and "insertable" can be understood as meaning "connectorless insertion," "connectorless insertion," "connectorless insertable," or "connectorless insertable."

[0033] The ability to insert and remove elements substantially parallel to the surgical plane of the device offers advantages because the installation, removal, or replacement of elements requires only a small incision next to the implantation site, without the need to lift and fold the skin to expose the top of the implant, as is done in the removal of cochlear implant magnets. Therefore, the method disclosed herein provides a minimally invasive implantable device. In particular, maintenance of modular replaceable elements in the implantable device can be performed in a minimally invasive manner. In one example, the insertable and removable element may include a magnet used to insert a coil (e.g., a coil that is part of the device) Figure 2A The induction coil 270 shown is aligned with a coil external to the device. While such a magnet can be used for alignment, it can interfere with the MRI process. The embodiments described herein allow for the minimally invasive removal and reinstallation of the insertable and removable magnetic element as needed. In other examples, the insertable and removable element may include a battery or sensor that requires periodic replacement, such as a glucose sensor. Replacement of such a sensor as part of the embodiment device can also be minimally invasive. Other exemplary types of insertable and removable elements within the scope of the embodiments are described herein. However, the scope covered by insertable and removable elements is not limited to these examples. Insertable and removable elements as described herein may be electrically connected to circuitry enclosed by a housing for power flow or communication between the housing and the element.

[0034] It should be understood that, in addition to Figure 1 Besides the shapes shown, a variety of shapes can be conceived for insertable and removable elements. Furthermore, other locking / engaging mechanisms can be employed, including press-fit elements relative to the housing.

[0035] By enabling insertable removal of components, it is conceivable that different modules could add features to an implantable device without replacing the entire device.

[0036] Figure 2A and Figure 2B It shows that the element is inserted ( Figure 2A ) and partially removed ( Figure 2BThis is a schematic diagram of an example embodiment of an implantable device 200. Device 200 includes a low-profile housing 210 housing several components including an induction coil 270 and electronic circuitry 280 (within the housing). The electronic circuitry, as described herein, may also be referred to as one or more “electronic modules.” Leads 290 are connected to the sensor 280. The housing includes a cranial attachment feature 219 for securing the housing to the skull of a subject. In this embodiment, the cranial attachment feature 219 is a hole for screwing the device onto the skull. In other embodiments, alternatively, other types of attachment features may be provided for attachment to different bones or for securing the device to other subcutaneous locations.

[0037] In some embodiments, electronic circuitry 280 may include a processor, such as a microprocessor, that receives and processes information received from one or more pluggable and removable elements. In some embodiments, electronic circuitry 280 may include a processor that transmits information or instructions to one or more pluggable and removable elements. Instructions may include actuating one or more elements to perform a function. In some embodiments, electronic circuitry 280 includes a communication interface configured to transmit information to a receiver outside the housing, device, and object. In some embodiments, electronic circuitry 280 includes a communication interface configured to receive information, commands, or other instructions from a transmitter outside the housing, device, and object.

[0038] The housing 210 also includes insertable and removable elements 220A and 220B. Specifically, elements 220A and 220B are magnets encapsulated in titanium housings, and these housings are adapted to snap into corresponding cavities in the housing 210 along a direction parallel to the surgical plane of the housing for insertion and removal. The surgical plane of the housing 210 is parallel to... Figure 2A The XY plane is shown in the figure.

[0039] The housing 210 may be made of biocompatible materials such as silicone and / or titanium.

[0040] Figure 3 A diagram of the skull of subject 311 with a subcutaneous implant is shown, the subcutaneous implant comprising... Figure 2A and Figure 2BThe implantable device 200 and the cochlear implant device 315 are described. The surgical plane of device 200 (i.e., the XY plane shown) is generally parallel to the skull at the implantation site. The illustration shows relatively small and straight corresponding incisions (S1 307 and S2 309, blue straight lines) near and adjacent to the implantation site for inserting and / or removing the element, in contrast to the more invasive and relatively large curved incision (C 313, blue) required for the cochlear implant with skin retraction and lifting. In one example of the device implementation, each S (meaning "straight") incision 307, 309 is approximately 10 mm long, while the C 313 ("C-shaped" incision) is approximately 55 mm long. However, in various embodiments, the element can be insertedly removed relative to the housing via a cut through the skin of the object, wherein the length of the cut is less than or equal to 20 mm, 10 mm or 5 mm, or wherein the length of the cut is in the range of 5 mm to 20 mm, and preferably in the range of 5 mm to 15 mm or 7 mm to 13 mm.

[0041] Generally, the smaller the incision, the fewer problems it causes; therefore, two short, straight incisions S are preferred over a larger, curved incision C. Furthermore, straight, vertical incisions are superior to C-shaped incisions because the blood vessels lining the scalp originate at the base of the skull and are deployed themselves towards the top of the head in a generally vertical pattern. Therefore, by forming straight, vertical incisions for inserting and removing elements of the implementation device, the possibility of cutting across blood vessels can be reduced. Cutting across blood vessels would result in reduced blood supply to the scalp distal to the incision. Therefore, the implementation devices are not only easier to maintain, but they are also significantly safer than existing cochlear implants.

[0042] Figure 4 This is a flowchart illustrating a process 400 for maintaining an implantable device. At 431, at an incision near the implantation site of the implantable device, the element is inserted and removably accessed in a direction substantially parallel to the surgical plane of the implantable device. The implantable device includes a low-profile housing and an element having a cavity defined in its sides. The low-profile housing has a first portion adapted to be received in the housing cavity and a second portion adapted to protrude from the housing. In one process within the scope of the embodiment, where only one element of the implantable device needs maintenance, only 431 is performed. Nevertheless, process 400 includes maintaining additional elements of the embodiment device, as shown at 433.

[0043] At 433, the cavity is considered a first cavity, the side is considered a first side, the element is considered a first element, and the incision is considered a first incision. The method also includes approach at one or more corresponding second incisions near the implantation site of the implantable device. The low-profile housing may have one or more corresponding second cavities defined on its first side or one or more corresponding second sides. The implantable device may include one or more second elements having corresponding first portions adapted to be received in the housing cavity. Approach is particularly insertable and removable approach to one or more second elements in one or more corresponding second directions substantially parallel to the surgical plane, as will be understood from the description of other embodiments herein.

[0044] In some embodiments of the method, the second portion includes at least one surface adapted to engage with a surgical instrument for inserting and removing elements relative to the housing. The method can also be modified to utilize, employ, or operate any of the features of the embodiments described above.

[0045] It will be understood that, when used herein, the words “comprise” (and any form of inclusion, such as “comprise” and “comprises”), “have” (and any form of having, such as “have” and “has”), “include” (and any form of inclusion, such as “includes” and “include”), or “contains” (and any form of containing, such as “contains” and “contain”) specify the presence of the said feature, integer, step, operation, element, and / or component, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0046] It should also be understood that although the terms first, second, third, etc., may be used herein to describe various restrictions, elements, components, regions, layers, and / or sections, these restrictions, elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only to distinguish one restriction, element, component, region, layer, or section from another. Therefore, without departing from the teachings of this application, the first restriction, element, component, region, layer, or section discussed below may be referred to as the second restriction, element, component, region, layer, or section.

[0047] It should also be understood that when an element is described as "on another element," "attached," "connected," or "linked" to another element, it can be directly on or above the other element, or directly connected to or linked to the other element, or there may be one or more intermediate elements. Conversely, when an element is described as "directly on another element," "directly attached," "directly connected," or "directly linked" to another element, there are no intermediate elements. Other terms used to describe the relationship between elements should be interpreted in a similar manner (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0048] It should also be understood that when the first element is referred to as “in,” “on,” and / or “within” the second element, the first element may be positioned: within the internal space of the second element; within a portion of the second element (e.g., within the wall of the second element); positioned on the outer and / or inner surface of the second element; and one or more combinations thereof.

[0049] As used herein, the term "proximity" when used to describe a first component or location proximity to a second component or location will be considered to include one or more locations near the second component or location, as well as locations within, above, and / or within the second component or location. For example, a component positioned proximity to an anatomical site (e.g., a target tissue location) should include components positioned near the anatomical site, as well as components positioned within, above, and / or within the anatomical site.

[0050] Spatial relative terms, such as “below,” “under,” “above,” “over,” etc., may be used to describe the relationship of an element and / or feature to another element(s) and / or one or more elements(s), as shown, for example, in the figures. It should also be understood that spatial relative terms are intended to include different orientations of the device in use and / or operation other than those shown in the figures. For example, if the device in the figures is flipped, an element described as “below” and / or “under” other elements or features would be oriented as “above” other elements or features. The device may be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein shall be interpreted accordingly.

[0051] The term “and / or” as used herein should be understood to mean that each of the two specified features or components is or is not specifically disclosed with the other feature or component. For example, “A and / or B” should be understood to mean that each of (i) A, (ii) B, and (iii) A and B is specifically disclosed as if each were stated separately herein.

[0052] As used herein, the term "functional element" is considered to include one or more elements configured and arranged to perform a function. A functional element may include sensors and / or transducers. In some embodiments, a functional element is configured to deliver energy and / or otherwise process tissue (e.g., a functional element configured as a processing element). Alternatively or additionally, a functional element (e.g., a functional element including sensors) may be configured to record one or more parameters, such as object physiological parameters; object anatomical parameters (e.g., tissue geometry parameters); object environmental parameters; and / or system parameters. In some embodiments, sensors or other functional elements are configured to perform diagnostic functions (e.g., collecting data for performing diagnostics). In some embodiments, a functional element is configured to perform therapeutic functions (e.g., delivering therapeutic energy and / or therapeutic agents). In some embodiments, a functional element includes one or more elements configured and arranged to perform a function selected from the group consisting of: delivering energy; extracting energy (e.g., a cooling component); delivering drugs or other agents; manipulating system components or object tissue; recording or otherwise sensing parameters such as object physiological parameters or system parameters; and combinations of one or more of these.

[0053] As used herein, the term "transducer" is considered to include any component or combination of components that receives energy or any input and produces an output. For example, a transducer may include electrodes that receive electrical energy and distribute it to tissue (e.g., based on electrode size). In some configurations, a transducer converts an electrical signal into any output, such as light (e.g., a transducer including a light-emitting diode or light bulb), sound (e.g., a transducer including a piezoelectric crystal configured to deliver ultrasonic energy), pressure, heat, cryogenic energy, chemical energy; mechanical energy (e.g., a transducer including a motor or solenoid), magnetic energy, and / or various electrical signals (e.g., Bluetooth or other wireless communication elements). Alternatively or additionally, a transducer may convert a physical quantity (e.g., a change in a physical quantity) into an electrical signal. A transducer may include any component that delivers energy and / or agents to tissue, such as a transducer configured to deliver one or more of the following: delivering electrical energy to tissue (e.g., a transducer including one or more electrodes); delivering optical energy to tissue (e.g., a transducer including a laser, a light-emitting diode, and / or an optical component such as a lens or prism); delivering mechanical energy to tissue (e.g., a transducer including a tissue manipulation element); delivering acoustic energy to tissue (e.g., a transducer including a piezoelectric crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0054] As used herein, the term "fluid" may refer to a liquid, gas, gel, or any flowable material, such as a material that can be propelled through a cavity and / or opening.

[0055] It should be understood that certain features of the invention described in the context of individual embodiments for clarity may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of individual embodiments may also be provided individually or in any suitable sub-combination. For example, it will be understood that all features set forth in any claim (whether independent or dependent) may be combined in any given manner.

[0056] It should be understood that at least some of the drawings and descriptions of this invention have been simplified to focus on elements relevant to a clear understanding of the invention, while other elements that would be understood by those skilled in the art to also constitute part of the invention have been removed for clarity. However, because these elements are well known in the art, and because they do not necessarily contribute to a better understanding of the invention, descriptions of these elements are not provided herein.

[0057] All teachings of the patents, published applications and references cited in this article are incorporated herein by reference in their entirety.

[0058] Although exemplary embodiments have been specifically shown and described, those skilled in the art will understand that various changes in form and detail may be made therein without departing from the scope of the embodiments as contained in the appended claims.

Claims

1. An implantable device, the implantable device comprising: A low-profile housing having a width and a length extending in the X and Y directions of the XY surgical plane of the implantable device, the width and the length being greater than the height of the low-profile housing, the low-profile housing having a cavity defined in its side surface; An implantable element capable of being insertably removed relative to the cavity in the side of the low-profile housing in a direction substantially parallel to the XY surgical plane of the implantable device, the implantable element having a first portion adapted to be received in the housing cavity; as well as The second portion, adapted to protrude from the low-profile housing after the implantable element is inserted into the housing cavity, is the distal end of the implantable element, the distal end including a pawl configured to engage with a surgical instrument for inserting and removing the implantable element relative to the low-profile housing, the pawl extending from a surface of the second portion in a direction perpendicular to the XY surgical plane into the second portion.

2. The apparatus according to claim 1, wherein, The implantable element includes a magnet.

3. The apparatus according to claim 1, wherein, The implantable component includes a battery.

4. The apparatus according to claim 1, wherein, The implantable element includes a sensor.

5. The apparatus according to claim 1, wherein, The implantable component includes an electronic module.

6. The apparatus of claim 1, further comprising electronic circuitry located within the housing.

7. The apparatus according to claim 6, wherein, The implantable element is configured to have electrical connections to the electronic circuitry.

8. The apparatus according to claim 1, wherein, The implantable element includes a radiopaque marker.

9. The apparatus according to claim 1, wherein, The implantable element includes an RFID tag.

10. The apparatus according to claim 1, wherein, The implantable element includes reabsorbable material.

11. The apparatus according to claim 1, wherein, The implantable element includes consumable materials.

12. The apparatus according to claim 1, wherein, The shell and the implantable element are made of biocompatible materials.

13. The apparatus according to claim 1, wherein, The first part is adapted to be frictionally fitted into the cavity of the housing.

14. The apparatus according to claim 1, wherein, The housing cavity includes a cavity wall, and the first portion and the cavity wall are bonded to each other for engagement and alignment.

15. The apparatus according to claim 1, wherein, The implantable element can be removed in an insertable manner relative to the housing via an incision through the skin of the object.

16. The apparatus according to claim 1, wherein, The cavity is a first cavity, the side is a first side, and the implantable element is a first element. The device also includes one or more second cavities defined in the first side or one or more corresponding second sides of the low-profile housing. The device also includes one or more corresponding second elements that are insertably removable relative to the housing in one or more corresponding second directions substantially parallel to the surgical plane of the implantable device. The one or more corresponding second elements have one or more corresponding first portions adapted to be received in the cavity of the housing.

17. A method for maintaining an implantable device, the implantable device comprising a low-profile housing and an implantable element having a first portion, the low-profile housing having a width and a length extending in the X and Y directions of the XY surgical plane of the implantable device, the width and the length being greater than the height of the low-profile housing, the low-profile housing having a cavity defined in its sides, the first portion being adapted to be received in the housing cavity, the method comprising approaching the implantable element in an insertable and removable manner in a direction substantially parallel to the XY surgical plane of the implantable device, and The implantable element further includes a second portion adapted to protrude from the low-profile housing after the implantable element is inserted into the housing cavity, the second portion being the distal end of the implantable element, the distal end including a pawl configured to engage with a surgical instrument for inserting and removing the implantable element relative to the low-profile housing, the pawl extending from a surface of the second portion in a direction perpendicular to the XY surgical plane into the second portion.

18. The method according to claim 17, wherein, Approaching includes removing the implantable element from the housing cavity.

19. The method of claim 17, wherein, Approaching includes inserting the implantable element into the cavity of the housing.

20. The method of claim 17, wherein, The cavity is a first cavity, the side is a first side, the implantable element is a first element, the low-profile housing has one or more corresponding second cavities defined in or in one or more corresponding second sides, and the implantable device includes one or more second elements having corresponding first portions adapted to be received in the housing cavity, the method further comprising approaching the one or more second elements in an insertable and removable manner in one or more corresponding second directions substantially parallel to the surgical plane.

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