Implantable medical device comprising surround

Abstract

Various embodiments of an implantable medical device are disclosed. The apparatus includes a housing having a first major surface and a second major surface; the electronic component is arranged in the shell; and an electrode disposed on the first main surface of the case and electrically connected to the electronic component. The device also includes a surround having a body including a first major surface, a second major surface, and an opening disposed in the first major surface of the body. The enclosure is adapted to receive at least a portion of the housing within the body. Further, the enclosure includes a fixation member disposed on or through the body of the enclosure and adapted to attach the enclosure to tissue of a patient. The electrode extends through the opening of the body of the enclosure and is adapted to contact the tissue of the patient.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 359,192, filed on July 7, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates generally to implantable medical devices and, more particularly, to implantable medical devices including a surround. Background Art

[0003] An implantable medical device such as an implantable pacemaker can transmit pacing pulses to a patient's heart and monitor the condition of the patient's heart. In some examples, an implantable pacemaker includes a pulse generator and one or more electrical leads. The pulse generator can be implanted, for example, in a small bag on the patient's chest. The electrical leads can be coupled to the pulse generator, which can include a circuit system that generates pacing pulses and / or senses cardiac electrical activity. The electrical leads can extend from the pulse generator to a target site (e.g., atria and / or ventricles) so that electrodes at the distal ends of the electrical leads are positioned at the target site. The pulse generator can provide electrical stimulation to the target site via the electrodes and / or monitor cardiac electrical activity at the target site.

[0004] Other implantable pacemakers are adapted to be implanted completely within a chamber of the heart. Such pacemakers may be referred to as intracardiac pacemakers or leadless pacemakers, and may include one or more electrodes on their external housings to transmit therapeutic electrical signals and / or sense intrinsic depolarization of the heart. Such pacemakers may be positioned inside or outside the heart, and in some examples, may be anchored to the heart wall (e.g., epicardium) via a fixation component. Pacemakers may also be placed on the surface of the heart and fixed to tissue using a fixation component. Summary of the invention

[0005] The technology disclosed herein generally relates to an implantable medical device (IMD) comprising a housing and a surround adapted to receive the housing. At least a portion of the IMD is disposed within the surround. The surround may include a body and one or more fixing components disposed on or through the body. The one or more fixing components may be adapted to attach the surround to tissue of a patient such that an electrode of the IMD contacts the tissue and may send one or more electrical signals to the tissue or receive the one or more electrical signals from the tissue.

[0006] This disclosure includes but is not limited to the following terms:

[0007] Clause 1: An implantable medical device, comprising: a housing having a first major surface and a second major surface; an electronic component disposed within the housing; and an electrode disposed on the first major surface of the housing and electrically connected to the electronic component. The device further comprises a surround, the surround comprising a body having a first major surface, a second major surface, and an opening disposed in the first major surface of the body. The surround is adapted to receive at least a portion of the housing within the body. In addition, the surround further comprises a fixing component disposed on or through the body of the surround and adapted to attach the surround to tissue of a patient. The electrode extends through the opening of the body of the surround and is adapted to contact the tissue of the patient.

[0008] Clause 2: The device of clause 1, wherein the securing member comprises tines.

[0009] Clause 3: The device of clause 1, wherein the fixation feature comprises a suture hole.

[0010] Clause 4: The device of any one of clauses 1 to 3, wherein the body of the enclosure comprises a biocompatible material.

[0011] Clause 5: The device of clause 4, wherein the biocompatible material of the body of the surround comprises PEEK.

[0012] Clause 6: The device of any of clauses 1 to 5, wherein the opening of the body of the enclosure is adapted to receive the housing such that at least one side surface of the housing is disposed within the enclosure.

[0013] Clause 7: The device of clause 6, wherein each side surface of the housing is disposed within the body of the enclosure.

[0014] Clause 8: A device according to any one of clauses 1 to 7, wherein the enclosure further comprises a second opening, the second opening being arranged in the second major surface of the body of the enclosure, wherein the periphery of the second opening overlaps with the shell in a direction orthogonal to the second major surface of the body so as to prevent the shell from being removed from the enclosure through the second opening.

[0015] Clause 9: A device according to any one of clauses 1 to 8, wherein the body of the surround further comprises a lip, the lip being arranged on the first major surface of the body of the surround defining the opening, wherein the lip is adapted to be arranged on the front side of the first major surface of the shell passing through the periphery of the opening so that at least a portion of the periphery of the first major surface of the shell is covered by the lip.

[0016] Clause 10: The device of any of clauses 1 to 9, wherein the enclosure is adapted such that the housing is press-fit into the body of the enclosure.

[0017] Clause 11: The device of any of clauses 1 to 9, wherein the housing is adhered to the body of the enclosure.

[0018] Clause 12: The device of any of clauses 1 to 9, wherein the body of the enclosure comprises a first portion and a second portion, the second portion being connected to the first portion.

[0019] Clause 13: The device of any one of clauses 1 to 12, further comprising an airtight component, the airtight component forming a portion of the housing. The airtight component comprises: a dielectric substrate having a first major surface and a second major surface, wherein the first major surface of the dielectric substrate defines at least a portion of the first major surface of the housing; and a ferrule hermetically sealed to the dielectric substrate. The ferrule is connected to an edge of the second portion of the housing.

[0020] Clause 14: The device of clause 13, wherein the ferrule is laser bonded to the dielectric substrate.

[0021] Clause 15: The device of any of clauses 13-14, wherein at least a portion of the collar is disposed within the body of the enclosure.

[0022] Clause 16: The device of any of clauses 13 to 15, wherein the dielectric substrate comprises sapphire.

[0023] Clause 17: The device of any of clauses 13 to 16, wherein the ferrule is adapted to provide a return path for electrical energy directed to the tissue via the electrode.

[0024] Clause 18: The device of any of clauses 13 to 17, wherein the ferrule comprises titanium.

[0025] Clause 19: The device of any one of clauses 1 to 18, wherein the housing of the implantable medical device comprises a ceramic material.

[0026] Clause 20: The device of any of clauses 1 to 19, wherein the electronic component comprises a power source and a charging coil, the charging coil being electrically connected to the power source.

[0027] Item 21: A surround comprising a body comprising a first major surface and a second major surface; an opening disposed in the first major surface of the body, wherein the surround is adapted to receive at least a portion of a housing of an implantable medical device within the body; and a fixing member disposed on or through the body of the surround and adapted to attach the surround to tissue of a patient.

[0028] Clause 22: The enclosure of clause 21, wherein the securing members comprise tines.

[0029] Clause 23: The surround of clause 21, wherein the securing features comprise suture holes.

[0030] Clause 24: The enclosure of any one of clauses 21 to 23, wherein the body of the enclosure comprises a biocompatible material.

[0031] Clause 25: The surround of clause 24, wherein the biocompatible material of the surround comprises PEEK.

[0032] Clause 26: The enclosure of any one of clauses 21 to 25, wherein the opening of the body of the enclosure is adapted to receive the housing such that at least one side surface of the housing is disposed within the enclosure.

[0033] Clause 27: The enclosure of clause 26, wherein each side surface of the shell is disposed within the body of the enclosure.

[0034] Clause 28: A surround according to any one of clauses 21 to 27, wherein the surround further comprises a second opening, the second opening being arranged in the second major surface of the body of the surround, wherein the periphery of the second opening is adapted to overlap with the shell in a direction orthogonal to the second major surface of the body so as to prevent the shell from being removed from the surround through the second opening.

[0035] Clause 29: A surround according to any one of clauses 21 to 28, wherein the body of the surround further comprises a lip, the lip being arranged on the first major surface of the surround defining the opening, wherein the lip is adapted to be arranged on the front side of the first major surface of the shell passing through the periphery of the opening so that at least a portion of the periphery of the first major surface of the shell is covered by the lip.

[0036] Clause 30: The surround of any one of clauses 21 to 29, wherein the surround is adapted to enable the housing to be press-fit into the body of the surround.

[0037] Clause 31: A method comprising: providing an opening in a first major surface of a body of a surround; providing a fixation member on or through the body of the surround; and connecting the surround to a housing of an implantable medical device. At least a portion of the housing is provided within the body of the surround. The housing comprises a first major surface and a second major surface, wherein an electrode provided on the first major surface of the housing extends through the opening of the body of the surround.

[0038] Clause 32: The method of clause 31, wherein the securing member comprises tines.

[0039] Clause 33: The method of clause 32, wherein the tines extend through the body of the enclosure.

[0040] Clause 34: The method of clause 31, wherein the securing feature comprises a suture hole.

[0041] Clause 35: The method of any of clauses 31 to 34, wherein the body of the enclosure comprises a first portion and a second portion, the second portion being connected to the first portion.

[0042] Clause 36: The method of any one of clauses 31 to 35, wherein connecting the surround to the implantable medical device comprises molding the surround onto the housing of the implantable medical device.

[0043] Clause 37: The method of any one of clauses 31 to 35, wherein connecting the enclosure to the implantable medical device comprises press-fitting the implantable medical device into the body of the enclosure.

[0044] Clause 38: The method of any one of clauses 31 to 35, wherein connecting the surround to the implantable medical device comprises adhering the surround to the implantable medical device.

[0045] Clause 39: A method according to any one of clauses 31 to 38, further comprising: providing a second opening in the second major surface of the body of the enclosure, wherein the periphery of the second opening overlaps with the shell of the implantable medical device in a direction orthogonal to the second major surface of the body, so as to prevent the implantable medical device from being removed from the enclosure through the second opening.

[0046] The details of one or more aspects of the present disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the techniques described in the present disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 is a schematic illustration of one embodiment of an implantable medical device disposed within a patient.

[0048] Figure 2 yes Figure 1 Schematic perspective view of an implantable medical device.

[0049] Figure 3 yes Figure 1 Schematic top plan view of an implantable medical device.

[0050] Figure 4 yes Figure 1 Schematic bottom plan view of an implantable medical device.

[0051] Figure 5 yes Figure 1 Schematic cross-sectional view of an implantable medical device.

[0052] Figure 6 yes Figure 1 Schematic perspective view of a fixation component of an implantable medical device.

[0053] Figure 7 For assembly Figure 1 A flow chart of one embodiment of a technology for an implantable medical device.

[0054] Figure 8 is a schematic perspective view of another embodiment of a surround.

[0055] Fig. 9 is a schematic perspective view of an insertion tool that can be used to insert Figure 1 An implantable medical device is placed in a patient's body.

[0056] Fig.10 yes Fig. 9 Schematic cross-sectional view of an insertion tool.

[0057] Fig.11 yes Fig. 9 A schematic cross-sectional view of a portion of an insertion tool, wherein Figure 1 The tines of the implantable medical device are retracted within the tool.

[0058] Fig.12 yes Fig.11 A schematic cross-sectional view of a portion of an insertion tool in which the tines of an implantable medical device extend beyond the body of the surrounding implantable medical device.

[0059] Fig.13 is a schematic cross-sectional view of another embodiment of an implantable medical device. DETAILED DESCRIPTION

[0060] In general, the present disclosure provides various embodiments of an implantable medical device (IMD) comprising a housing and a surround adapted to receive the housing. At least a portion of the IMD is disposed within the surround. The surround may include a body and one or more fixing components disposed on or through the body. The one or more fixing components may be adapted to attach the surround to the patient's tissue so that an electrode of the IMD contacts the tissue and may send one or more electrical signals to the tissue or receive the one or more electrical signals from the tissue.

[0061] An IMD typically includes a housing that includes a biocompatible material. Some IMDs include a metal housing that may provide one or more electrodes for sending or receiving electrical signals. However, such metal housings are expensive to manufacture. Recently, some IMDs include ceramic housings or other non-conductive housings that are less expensive to manufacture than metal housings. However, these ceramic housings may be challenging to manufacture, such that they include one or more fixing components that are suitable for attaching the IMD to the patient's tissue, because such components increase design complexity and may also increase manufacturing costs.

[0062] One or more embodiments of the IMD described herein may provide various advantages over currently available devices. For example, one or more embodiments of the IMD may include a surround adapted to receive at least a portion of the housing of the IMD. In one or more embodiments, the IMD may be press-fitted into or attached to the surround using any suitable technique. The surround may include one or more fixing components disposed on or through the body of the surround. The fixing components may be connected to the surround using any suitable technique and are adapted to attach the surround to the patient's tissue. When compared with arranging such components on the housing, arranging the fixing components on or through the surround may reduce the cost of manufacturing the device. In addition, the surround may extend over one or more edges of the housing of the device to prevent such edges from engaging the patient's tissue. In one or more embodiments, the surround may also include a charging coil for receiving electromagnetic energy from an external charging device and providing such energy to one or more power sources (e.g., one or more batteries) disposed within the IMD. The surround may also include a shape or contour that may better match the anatomical structure of the organ to which the surround is attached.

[0063] Figure 1 is a schematic view of one embodiment of an implantable medical device 12 disposed in a patient 2. The device 12 may include any suitable one or more medical devices (e.g., a pacing device, a pressure sensing device, a cardiac monitor, other physiological sensors, etc.). The device 12 may include, for example, an implantable leadless pacing device that is adapted to be implanted completely within a chamber of the heart 4 or on or within a wall of the heart (e.g., the epicardium), and that provides electrical signals to the heart below the sternum 3 via one or more electrodes carried on the device. The device 12 may also include a surround as further described herein.

[0064] The device 12 is generally described as being attached as an intracardiac pacing device within a chamber of the heart 4. In one or more embodiments, the device 12 may be attached to the epicardium of the heart 4. In one or more embodiments, the device 12 is attached to the outer surface of the heart 4, and one or more components of the device, such as electrodes, may be in contact with the epicardium of the heart. Figure 1 The schematically shown device 12 is attached to the ventricular wall of the heart 4 via one or more fixation components (e.g., tines, spirals, etc.) that pierce the tissue. These fixation components can fix the device 12 to the cardiac tissue and maintain contact of the electrode (e.g., cathode or anode) with the cardiac tissue. The device 12 can be implanted at or near the apex of the heart. In one or more embodiments, the pacing device can be implanted at other ventricular locations, such as on the free wall or septum, at an atrial location, or anywhere on or in the heart 4.

[0065] Figures 2 to 5yes Figure 1 Various views of an implantable medical device 12. The device 12 includes a housing 14 having a first major surface 16 ( Figure 3 ) and the second major surface 18 ( Figure 4 ); electronic component 20( Figure 5 ), the electronic component is disposed within the housing; and an electrode 22, the electrode being disposed on the first major surface of the housing and being electrically connected to the electronic component. The device 12 also includes: a surround 24 having a body 26, the body including a first major surface 28 ( Figure 3 )、the second main surface 30( Figure 4 ) and an opening 32 disposed in the first major surface of the body. Surrounding 24 is adapted to receive at least a portion of housing 14 of IMD 12 within body 26. Surrounding 24 also includes one or more fixing members 34 disposed on or through body 26 of the surrounding, the one or more fixing members being adapted to attach the surrounding to tissue of patient 2, such as heart 4 ( Figure 1 ). In one or more embodiments, electrodes 22 of IMD 12 extend through opening 32 of body 26 of enclosure 24 and are adapted to contact tissue of patient 2.

[0066] Device 12 may include any suitable one or more medical devices. Representative examples of such IMDs include: hearing implants, such as cochlear implants; sensing or monitoring devices; signal generators, such as cardiac pacemakers or defibrillators, neurostimulators (such as spinal cord stimulators, brain or deep brain stimulators, peripheral nerve stimulators, vagus nerve stimulators, occipital nerve stimulators, subcutaneous stimulators, etc.) or gastric stimulators; etc. In one or more embodiments, device 12 may include a leadless pacemaker.

[0067] The housing 14 of the device 12 can take any suitable shape or shapes and have any suitable size. In addition, the housing 14 can include any suitable material or materials, such as a polymeric material or an inorganic material (such as a metallic material or a ceramic material). Suitable materials for the housing 14 can include at least one of titanium (e.g., any suitable grade of titanium, such as grade 1 to grade 4 titanium, grade 5 titanium, etc.), stainless steel, polymers, ceramics, glass, or combinations thereof (such as laminates, composites, or compatible blends or mixtures). In one or more embodiments, the housing 14 can include any suitable polymeric material or materials, such as at least one of epoxy resins, polyurethanes, silicones, polyolefins, acrylic polymers, polyesters, polyetheretherketones, polysulfones, polymethylene oxides, or polyethylene materials, or combinations thereof.

[0068] The housing 14 can be a unitary body. In one or more embodiments, the housing 14 can include two or more parts that are connected together using any suitable technique, such as welding, mechanical fastening, adhesive bonding, thermal bonding, diffusion bonding, laser-assisted diffusion bonding, solvent bonding, etc. See, for example Fig.13 Surrounding 424. In addition, the housing 14 can be formed using any suitable technique, such as molding, thermoforming, lamination, overmolding, casting, insert molding, etc.

[0069] In one or more embodiments, the device 12 may include a hermetic assembly 36 that forms a portion or part of the housing 14. The hermetic assembly 36 includes: a dielectric substrate 38 ( Figure 5 ), the dielectric substrate having a first major surface 40 and a second major surface 44, wherein the first major surface defines at least a portion of the first major surface 16 of the housing 14. Although not shown, the hermetic assembly 36 may also include a patterned layer disposed on at least one of the first major surface 40 or the second major surface 44 of the dielectric substrate 38. The patterned layer may be disposed on the dielectric substrate 38 using any suitable technique (e.g., laser bonding, brazing, diffusion bonding, etc.). In one or more embodiments, an interposer (not shown) may be disposed on one or more portions of the patterned layer. The electrode 22 may be disposed on the interposer or the patterned layer using any suitable technique.

[0070] The hermetic assembly 36 may also include a ferrule 50 that is hermetically sealed to the dielectric substrate 38 using any suitable technique. The ferrule 50 is connected to the edge 15 of the second portion 17 of the housing 14 using any suitable technique. Any suitable hermetic assembly 36 may be used with the device 12, such as one or more embodiments of the hermetic assembly described in U.S. Patent Publication No. 2021 / 0178518 entitled “HERMETIC ASSEMBLY AND DEVICE INCLUDING SAME” to Ruben et al. At least a portion of the ferrule 50 may be disposed within the body 26 of the surround 24. In one or more embodiments, the ferrule 50 may be adapted to provide a return path for electrical energy directed to the tissue through the electrode 22.

[0071] The dielectric substrate 38 may include any suitable material. In one or more embodiments, the substrate 38 may include a dielectric material, such as at least one of glass, quartz, silicon dioxide, sapphire, silicon carbide, diamond, or gallium nitride. In addition, the substrate 38 may include at least one of a biocompatible material or one or more coatings or layers that may provide biocompatibility. The substrate 38 may also take any suitable shape and have any suitable size. The second portion 17 of the housing 14 may also include any suitable material, such as the same material as described herein with respect to the dielectric substrate 38. The dielectric substrate 38 and the second portion 17 of the housing may include the same material or different materials.

[0072] Furthermore, the ferrule 50 may include any suitable material, such as at least one of titanium, niobium, or stainless steel. In one or more embodiments, the ferrule 50 may include a conductive material. The ferrule 50 may take any suitable shape or shapes and have any suitable size.

[0073] Disposed within the housing 14 are electronic components 20. Components 20 may include any discrete electronic circuit components and / or integrated electronic circuit components that implement analog circuits and / or digital circuits that are capable of producing the functions attributed to the device 12 described herein. In one or more embodiments, components 20 may also include components for sensing other physiological parameters (such as acceleration, pressure, sound, and / or impedance). Components 20 may include any suitable electronic components, such as at least one of a capacitor, a transistor, an integrated circuit (including a controller or multiplexer), a sensor, an accelerometer, an inductive charging coil, an optical component (such as a transmitter and a detector), etc. The device 12 may include any suitable number of electronic components 20. In addition, the device 12 may include one or more additional electronic components or elements disposed on the exterior of the housing 14 or on or within the enclosure 24.

[0074] The electronic components 20 may also include a power source (e.g., a battery) 48 disposed within the housing 14. The power source 48 may include any suitable power source. In one or more embodiments, the power source 48 is a rechargeable battery that can be recharged using any suitable technique using a charging coil 49 electrically connected to the battery. In addition, the power source 48 can be electrically connected to one or more additional electronic components 20 using any suitable technique.

[0075] Disposed on the first major surface 16 of the housing 14 is an electrode 22. Although depicted as being disposed on the first major surface 16, the electrode 22 may be disposed on any suitable portion of the device 12. The electrode 22 may be electrically connected to the electronic component 20 using any suitable technology. The electrode 22 may include any suitable electrode suitable for directing electrical energy from the electronic component 20 to the patient's tissue. In addition, the electrode 22 may include any suitable electrode suitable for receiving electrical energy from the tissue (e.g., one or more electrical signals from the heart 4). Although depicted as including a single electrode 22, the device 12 may include any suitable number of electrodes disposed on any suitable portion of the device. In one or more embodiments, the electrode 22 extends through the opening 32 of the body 26 of the surround 24 so that the electrode can contact the patient's tissue.

[0076] Disposed on one or more portions of the housing 14 of the device 12 is a surround 24 that includes a body 26 having a first major surface 28 and a second major surface 30. An opening 32 of the surround is disposed in the first major surface 28 of the body 26. The surround 24 is adapted to receive at least a portion of the housing 14 of the device 12 within the body 26. The surround 24 may take any suitable shape and have any suitable size.

[0077] The body 26 may include any suitable material, such as at least one of a polymer material or an inorganic material (such as a metal material or a ceramic material). In one or more embodiments, the body 26 includes a biocompatible material such as PEEK, PVC, polyethylene, polypropylene, PTFE, PMMA, trimethyl carbonate, medical grade silicone, etc. The body 26 may be a monolithic body, for example, the body may be manufactured as a single piece. In one or more embodiments, the body 26 may include a biocompatible material such as PEEK, PVC, polyethylene, polypropylene, PTFE, PMMA, trimethyl carbonate, medical grade silicone, etc. Fig.13 The surrounding object 424 is further described as two or more parts connected together by any suitable technology. In addition, the main body 26 can be manufactured using any suitable technology, such as molding, casting molding, 3D printing, machining, etc.

[0078] The opening 32 of the body 26 may be disposed in any suitable portion or portions of the body. Figure 3 As shown, the opening 32 is disposed in the first major surface 28 of the body 26. The opening 32 can take any suitable shape and have any suitable size so that at least a portion of the shell 14 can be received by the surround 24. In one or more embodiments, the opening 32 of the body 26 is adapted to receive the shell 14 so that at least one side surface 78 of the shell is disposed within the surround, such as Figure 5In one or more embodiments, each side surface 78 of the housing 14 can be completely disposed within the body 26. In one or more embodiments, one or more portions of one or more side surfaces 78 of the housing can be disposed within the body 26.

[0079] The opening 32 may include a sidewall 33 extending between the first major surface 28 and the second major surface 30 of the body 26. Figure 5 ). The sidewall 33 can have any suitable shape. The sidewall 33 is adapted to engage at least a portion of the side surface 78 of the housing 14. In one or more embodiments, the sidewall 33 can include a texture that can help retain the housing 14 at least partially within the surround 24.

[0080] In one or more embodiments, the surround 24 also includes a second opening 58 ( Figure 4 ), the second opening is disposed in the second main surface 30 of the body 26. Figure 5 As can be seen in FIG. 1 , the perimeter 60 of the second opening 58 overlaps the shell 14 in a direction 6 orthogonal to the second major surface 30 of the body 26, so that the shell is prevented from being removed from the surround 24 through the second opening. In one or more embodiments, the surround 24 may include one or more tabs 76 ( Figure 4 ), the second opening is adapted to engage the second major surface 18 of the housing 14 to prevent the housing from being guided through the second opening. The tab 76 may be disposed in any suitable portion or portions of the perimeter 60. In addition, the tab 76 may take any suitable shape and have any suitable size. Although depicted as including two openings 32, 58, the surround 24 may include any suitable number of openings, such as one, two, three, four, five, or more openings, disposed in any suitable portion or portions of the body 26.

[0081] As mentioned herein, the body 26 may take any suitable shape. For example, Fig.13 is a schematic cross-sectional view of another embodiment of an implantable medical device 412. Figures 1 to 6 All design considerations and possibilities described for implantable medical devices 12 also apply Fig.13An implantable medical device 412. One difference between the device 412 and the device 12 is that the device 412 includes a surround 424 having a body 426, the body including a first portion 427 and a second portion 429, the second portion being connected to the first portion. In one or more embodiments, the first portion 427 of the body 426 may be integral with the second portion 429, i.e., manufactured as a single piece. In one or more embodiments, the first portion 427 may be manufactured separately from the second portion 429 and connected to the second portion using any suitable technique (e.g., press fit, mechanical fastening, adhesion, welding, bonding, etc.). The second portion 429 of the body 426 may be connected to the first portion 427 after the housing 414 of the device 412 has been at least partially disposed within the first portion or the second portion. In one or more embodiments, the first portion 427 may include a material different from the material of the second portion 429. In one or more embodiments, the first portion 427 includes the same material as the material of the second portion 429.

[0082] The second portion 429 of the body 426 can include a lip 462 that can be adapted to be disposed on a perimeter 464 of the first major surface 416 of the housing 414 of the IMD 412 that passes through the opening 432 of the surround 424, such that at least a portion of the perimeter of the first major surface of the housing is covered by the lip. The lip 462 can extend along any suitable portion of the perimeter 464 of the first major surface 416 of the housing 414. In one or more embodiments, the lip 462 extends over the entire perimeter 464 of the first major surface 416 of the housing 414. Once the housing has been at least partially disposed within the surround, the lip 462 can be adapted to retain the housing 414 within the surround 424. In one or more embodiments, the lip 462 can be adapted to reduce the profile of the ferrule 450 of the housing 414 in a plane parallel to the first major surface 416 of the device 412, such that an electrical return path through the ferrule is reduced, thereby regulating the flow of current from the electrode 422 of the device 412 to the ferrule via the patient's tissue.

[0083] Return to Figures 1 to 6, any suitable one or more portions of the housing 14 may be disposed within the surround 24 using any suitable technique. In one or more embodiments, the housing 14 may be press-fitted to the surround 24 using any suitable technique. In addition, the housing 14 may be retained within the surround 24 using any suitable technique. In one or more embodiments, the housing 14 is retained within the surround 24 by friction, i.e., the opening 32 of the body 26 of the surround may have a cross-sectional area in a plane parallel to the first major surface 28 of the body that is smaller than the cross-sectional area of ​​the housing 14 in the same plane, such that the body retains the housing by friction between the housing and the body. In one or more embodiments, the housing 14 may be adhered to the body 26 using any suitable adhesive. In addition, in one or more embodiments, the housing 14 may be mechanically fastened to the body 26 using any suitable technique. In one or more embodiments, the body 26 of the surround 24 may be molded or printed onto the housing 14 using any suitable technique.

[0084] The surround 24 also includes one or more fixing members 34, which can be disposed on or through the body 26 of the surround and can be suitable for attaching the surround to the patient's tissue. The fixing member 34 can include any suitable one or more members suitable for connecting the surround 24 to the tissue. In one or more embodiments, the fixing member 34 includes one or more tines 66. Any suitable number of tines 66 can be disposed on or through the body 26 of the surround 24. In one or more embodiments, the tines 66 can be connected to the body 26 using any suitable technology (e.g., adhesion, mechanical fastening, etc.). In one or more embodiments, one or more of the tines 66 can be disposed through the body 26. For example, the body 26 may include one or more tine openings 70 disposed through the body 26 so that one or more of the tines 66 can be inserted through the body and retained.

[0085] Each tine 66 can take any suitable shape and have any suitable size. In one or more embodiments, each tine 66 can be a separate tine connected to the body 26. In addition, in one or more embodiments, two or more tines 66 can be connected together by a tine body 72, such as Figure 6 The connected tine 66 can be inserted through the adjacent tine opening 70, and the tine body 72 can be inserted into the slot 74 provided in the body 26 of the surround 24, as shown. Figure 4 As shown, the tine body is recessed into the surrounding object.

[0086] The fixing member 34 may also include one or more suture holes 68 disposed through the body 26 using any suitable technique. The surround 24 may include any suitable number of suture holes 68. Figures 1 to 6As shown, the surround 24 includes two suture holes 68. In one or more embodiments, the surround 24 includes only the suture holes 68 and does not include other fixation components such as the tines 66. In one or more embodiments, the surround 24 includes the tines 66 and does not include the suture holes 68. Additionally, in one or more embodiments, the surround 24 includes one or more tines 66 and one or more suture holes 68. Each suture hole 68 may take any suitable shape and have any suitable size so that a clinician can suture the surround 24 to the patient's tissue using any suitable technique. The suture holes 68 may be disposed in any suitable one or more portions of the body 26 of the surround 24. In one or more embodiments, the body 26 may include one or more tabs 80 extending from the body 26, such as Figure 3 One or more suture holes 68 may be provided through tab 80. Tab 80 may be adapted to offset suture hole 68 from body 26 of surround 24 so that a clinician may pass sutures through the suture holes from first major surface 28 or second major surface 30 of the body.

[0087] As mentioned herein, one or more electronic components may be disposed on or at least partially within the enclosure 24. For example, Figure 8 is a schematic perspective view of another embodiment of the surround 224. Figures 1 to 6 All design considerations and possibilities described around 24 apply equally to Figure 8 For the purpose of description, the surrounding includes a body 226, which is Fig. 9 The enclosure 224 also includes a charging coil 249 disposed within the body 226. The charging coil 249 may include any suitable one or more charging coils. In addition, the charging coil 249 may be disposed within any suitable one or more portions of the body 226 of the enclosure 224 and electrically connected to one or more electronic components (e.g., Figure 5 The electronic components 20) are arranged in an implantable medical device (e.g., Figures 1 to 5 226) or at least partially disposed within the implantable medical device. For example, in one or more embodiments, one or more feedthroughs may be electrically connected to a charging coil 249 extending from a surface of the body 226 and electrically connect the charging coil to one or more electronic components of the implantable medical device. Although depicted as being disposed within the body 226, one or more portions of the charging coil 249 may be disposed on one or more external surfaces of the body 226. In one or more embodiments, the charging coil 249 may be completely disposed on one or more external surfaces of the body 226.

[0088] Any suitable technique may be used to manufacture the implantable medical device 12. For example, Figure 7 is a flow chart of one embodiment of a technique 100 for forming an assembly 12. Figures 1 to 6 Although the device 12 is described herein, the technology 100 may be utilized to provide any suitable implantable medical device.

[0089] At 102, technique 100 includes providing an opening 32 in a first major surface 28 of a body 26 of a surround 24 using any suitable technique. In one or more embodiments, the surround 24 is molded such that it includes the opening 32. One or more fixation members 34 may be provided on or through the body 26 of the surround 24 at 104 using any suitable technique. In one or more embodiments, the fixation members 34, such as suture holes 68, may be molded into the body 26. Additionally, in one or more embodiments, the fixation members 34, such as tines 66, may be inserted through the body 26.

[0090] At 106, the enclosure 24 can be connected to the housing 14 of the device 12 using any suitable technique. In one or more embodiments, at least a portion of the housing 14 is disposed within the body 26 of the enclosure 24. Additionally, in one or more embodiments, one or more side surfaces 78 of the housing 14 can be disposed within the body 26. The housing 14 is connected to the enclosure 24 such that the electrode 22 extends through the opening 32 of the body 26 of the enclosure. At 108, a second opening 58 can be optionally disposed in the second major surface 30 of the body 26 of the enclosure 24 using any suitable technique such that a perimeter 60 of the second opening overlaps the housing 14 of the device 12 in a direction 6 orthogonal to the second major surface 30 of the body 26. Thus, when the housing 14 is at least partially disposed within the enclosure, the device 12 can be prevented from being removed from the enclosure 24 through the second opening 58.

[0091] The device 12 may be positioned within the patient using any suitable technique such that the surround 24 is attached to the patient's tissue. Figures 9 to 12 300, which can be used to implant the device 12 at a desired location within the patient's body. Figures 1 to 6The device 12 of the present invention is described, but any suitable implantable medical device can be implanted using the insertion tool 300. The insertion tool 300 includes a body 302 having a first end 304 and a second end 306 and a plunger 308 at least partially disposed within a channel 310 of the body. The implantable medical device 12 can be at least partially disposed within a cavity 312 of the tool 300. The plunger 308 extending between the first end 314 and the second end 316 includes a hammer 318 that is connected to the second end of the plunger and is adapted to engage the device 12 and guide the device from the cavity 312 of the body 302 of the tool 300.

[0092] like Figure 11 to Figure 12 , body 302 also includes a tine channel 320 adapted to receive tines 66 of surround 24 of IMD 12. Tine channel 320 may be aligned with slots 74 and tine openings 70 provided in body 26 of the surround such that tines 66 may be guided from tine channel 320 into the slots and through the openings.

[0093] The tool 300 may also include one or more retention sutures 322 that may be connected to the plunger 308. The retention sutures 322 may also be connected to the tines 66 so that when the device 12 is disposed within the cavity 312 and the plunger 308 is pulled in a direction away from the first end 304 of the body 302 of the tool 300, the tines 66 are retracted into the tine channels 320. Fig.11 As can be seen in FIG. 1 , when retracted into channels 320, tines 66 are aligned. Thus, the aligned tines 66 are ready to be deployed into the patient's tissue. In one or more embodiments, tines 66 may be biased into a curved configuration for securing IMD 12 to tissue. Due to this bias, tines 66 may need to be positioned as shown. Fig.11 Shown aligned for deployment.

[0094] Fig.10 and Fig.12 The tines 66 are shown after being deployed into tissue (not shown). Thus, the tines 66 return to their biased curved configuration to hold the device 12 on the tissue. The tines 66 and the device 12 can be deployed using any suitable technique. In one or more embodiments, the plunger 308 is directed toward the first end 304 of the body 302 of the tool 300 so that the hammer 318 forces the device 12 out of the cavity 312 and into contact with the patient's tissue. The retaining suture 322 is released using any suitable technique so that the clip can extend beyond the channel 320 into the slot 74 and the tines opening 70 of the surround 24, where they can extend through the opening of the surround.

[0095] To deploy the device 12 using the insertion tool 300, the tines 66 may be inserted into the slots 74 of the body 26 of the surround. The retention sutures 322 may be attached to the tines 66 using any suitable technique. The IMD 12 may then be disposed within the lumen 312 and the tines 66 retracted into the tine channels 320 such that they are positioned as shown. Fig.11 The straight configuration shown. Any suitable technique may be used to guide the insertion tool 300 to an implantation site (e.g., epicardium) within the patient's body. When the first end 304 of the body 302 of the tool 300 is positioned adjacent the implantation site and the device 12 is in contact with tissue at the site, the plunger 308 may be directed toward the first end 304 of the body 302 so that the tines 66 are directed through the channel 320 and the slots 74 of the surround 24 and engage the target tissue. Once the tines 66 extend from the tine openings 70 of the surround 24, they are presented as shown. Fig.10 and Fig.12 Their offset curved shape as shown enables the tines to secure the device 12 to the target tissue. The hammer 318 of the plunger 308 is adapted to guide the device 12 against the target tissue and beyond the lumen 312. The retaining suture 322 can be released from the tines 66 using any suitable technique so that the insertion tool 300 is no longer connected to the device 12. The tool 300 can be removed from the patient using any suitable technique.

[0096] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., not all described actions or events may be required to perform these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the techniques of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

Claims

1. An implantable medical device, comprising: a housing, the housing comprising a first major surface and a second major surface; an electronic component, wherein the electronic component is disposed in the housing; an electrode disposed on the first major surface of the housing and electrically connected to the electronic component; and a surround comprising a body including a first major surface, a second major surface, and an opening disposed in the first major surface of the body, wherein the surround is adapted to receive at least a portion of the housing within the body, wherein the surround further comprises a securing member disposed on or through the body of the surround and adapted to attach the surround to tissue of a patient; Wherein the electrode extends through the opening of the body of the enclosure and is adapted to contact the tissue of the patient.

2. The device of claim 1, wherein the fixing member comprises tines. The device according to claim 1 , wherein the fixing member comprises a suture hole.

4. The device according to any one of claims 1 to 3, wherein the body of the enclosure comprises a biocompatible material.

5. The device of claim 4, wherein the biocompatible material of the body of the surround comprises PEEK.

6. The device according to any one of claims 1 to 5, wherein the opening of the body of the enclosure is adapted to receive the housing such that at least one side surface of the housing is disposed within the enclosure.

7. The device of claim 6, wherein each side surface of the housing is disposed within the body of the enclosure.

8. A device according to any one of claims 1 to 7, wherein the enclosure further comprises a second opening, the second opening being arranged in the second major surface of the body of the enclosure, wherein a periphery of the second opening overlaps with the shell in a direction orthogonal to the second major surface of the body, so as to prevent the shell from being removed from the enclosure through the second opening.

9. A device according to any one of claims 1 to 8, wherein the main body of the surround further comprises a lip, the lip being arranged on the first major surface of the main body of the surround defining the opening, wherein the lip is suitable for being arranged on the front side of the first major surface of the shell passing through the periphery of the opening so that at least a portion of the periphery of the first major surface of the shell is covered by the lip.

10. A device according to any one of claims 1 to 9, wherein the enclosure is adapted such that the housing is press-fit into the body of the enclosure.

11. A device according to any one of claims 1 to 9, wherein the housing is adhered to the body of the enclosure.

12. The device according to any one of claims 1 to 9, wherein the body of the enclosure comprises a first portion and a second portion, the second portion being connected to the first portion.

13. The device according to any one of claims 1 to 12, further comprising an airtight component, the airtight component forming a part of the housing, wherein the airtight component comprises: a dielectric substrate comprising a first major surface and a second major surface, wherein the first major surface of the dielectric substrate defines at least a portion of the first major surface of the housing; and a ferrule hermetically sealed to the dielectric substrate; Wherein the collar is connected to an edge of the second portion of the housing.

14. The apparatus of claim 13, wherein the ferrule is laser bonded to the dielectric substrate.

15. A device according to any one of claims 13 to 14, wherein at least a portion of the collar is disposed within the body of the enclosure.

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