Medical device housing defining lead hole and device compartment

Abstract

A medical device includes a housing that defines both a lead bore and a compartment. A separate housing can be inserted into the compartment, where the separate housing can include the circuitry of the medical device, such as circuitry to provide stimulation and / or sensing. Electrical conductors interconnect terminals of the separate housing with electrical connectors within the lead bore. The two housings can have different shapes and can be constructed of different materials. The shape and size of the housing that defines the lead bore and the compartment can be sized for a particular implant site, while providing a compartment sized for the separate housing.

Description

TECHNICAL FIELD

[0001] The present application relates to medical devices. More particularly, the present application relates to medical devices that define lead holes and device compartments. BACKGROUND

[0002] Medical devices that provide electrical stimulation and / or physiological sensing require an implant site within a patient's body that can accommodate the size and shape of the device while minimizing the intrusion on the patient. Typically, a pocket is created within a soft tissue region of the patient that is closest to the stimulation site while also being a convenient location for implantation and long-term use, such as below the clavicle for an upper body stimulation site. However, the closest implant site within the soft tissue region can be remote from the stimulation therapy site where stimulation and / or sensing occurs within the patient's body.

[0003] To address this distance and to provide a smaller object at the therapy site, an implant medical lead is implanted to carry stimulation and / or sensing signals between the medical device and the therapy site. The distal end of the lead with electrodes is routed to the therapy site within the body while the proximal end is routed to the medical device to establish an electrical connection of the therapy site to the medical device. Electrical conductors within the lead body carry the signals.

[0004] In some cases, the routing distance between the implant site of the medical device and the therapy site exceeds the length of the medical lead, and in such cases, a lead extension is also implanted. The lead extension has a proximal end that is connected to the medical device to establish an electrical connection, and a distal end that connects the proximal end of the lead to the lead extension to further establish the electrical connection. While the lead extension in some cases eliminates the distance problem, the lead extension adds complexity to the medical system and the implant procedure. SUMMARY

[0005] Embodiments address such issues and others by providing a medical device that includes two housings. A first device housing includes electrical circuitry for providing stimulation and / or sensing functionality. A second device housing includes a compartment that can be inserted into the first device housing, and the second device housing provides a lead hole that can be inserted into the proximal end of a lead. The second device housing can be adapted for one or more locations within a patient's body that can not be suitable for the first device housing, such as a location that is more convenient and / or closer to the therapy site than would otherwise be possible.

[0006] Embodiments provide an implantable medical device including a first device housing and circuitry within the first device housing. The circuitry includes electrical terminals present outside the first device housing. The implantable medical device also includes a second device housing having a lead bore and a device housing compartment. The first device housing is present within the device housing compartment and electrical connectors are present within the lead bore. Electrical conductors electrically connect the electrical terminals to the electrical connectors.

[0007] Embodiments provide an implantable medical system including an implantable medical device and an implantable medical lead. The implantable medical device includes a first device housing and circuitry within the first device housing. The circuitry includes electrical terminals present outside the first device housing. The implantable medical device includes a second device housing having a lead bore and a device housing compartment. The first device housing is present within the device housing compartment and electrical connectors are present within the lead bore. Electrical conductors electrically connect the electrical terminals to the electrical connectors. The implantable medical lead has a proximal end and a distal end and the proximal end is present within the lead bore.

[0008] Embodiments provide a method of providing stimulation therapy involving implanting an implantable medical device and implanting an implantable medical lead. The implanted implantable medical device includes a first device housing and circuitry within the first device housing. The circuitry includes electrical terminals present outside the first device housing. The implanted implantable medical device also includes a second device housing including a lead bore and a device housing compartment and the first device housing is present within the device housing compartment. Electrical connectors are present within the lead bore and electrical conductors electrically connect the electrical terminals to the electrical connectors. The implanted implantable medical lead includes a proximal end and a distal end and the distal end is positioned at a stimulation site while the proximal end is inserted into the lead bore. BRIEF DESCRIPTION OF DRAWINGS

[0009] Figure 1 An example of an implant site for embodiments of a medical system is shown.

[0010] Figure 2 A top view of an example of a medical system is shown in which a lead is being inserted into an embodiment of a medical device including a first device housing and a second device housing.

[0011] Figure 3 A side view of an embodiment of a medical device is shown.

[0012] Figure 4A A bottom view of an embodiment of a medical device is shown.

[0013] Figure 4BA bottom perspective view of an embodiment of a medical device is shown prior to insertion of a first device housing into a second device housing.

[0014] Figure 5 A bottom view of a second device housing is shown.

[0015] Figure 6 A perspective view of a first device housing is shown.

[0016] Figure 7 A perspective view of an embodiment of a medical device is shown with a first device housing being inserted into a second device housing.

[0017] Figure 8 A set of manufacturing operations to produce an embodiment of a medical device is shown. DETAILED DESCRIPTION

[0018] Embodiments include a medical device having two housings, where a first device housing includes circuitry for providing stimulation and / or sensing, and a second device housing includes a compartment for the first device housing. The second device housing also includes a lead bore that receives a proximal end of a medical lead, and the lead bore includes electrical connectors for establishing electrical connections with the proximal end of the lead. Electrical conductors are present within the second device housing and electrically interconnect electrical terminals of the first device housing with the electrical connectors within the lead bore.

[0019] Figure 1 An example of a medical system 100 that has been implanted within a patient 110 is shown. In this example, the patient is receiving deep brain stimulation therapy that provides electrical stimulation and / or sensing at a treatment site within the brain. It will be appreciated that embodiments of the medical system 100 can be used for other purposes and located at other locations within the patient 110. For example, the medical system can be used for other forms of neural stimulation and / or sensing, such as spinal cord sensing and / or stimulation, peripheral nerve sensing and / or stimulation, and cardiac sensing and / or stimulation, among others.

[0020] The medical system 100 includes a medical device 102 and a medical lead 104 coupled to the medical device 102. In this example, the medical device 100 is implanted directly onto the skull of the patient 110. A region 108 can be prepared on the skull to create a depression for subcutaneously positioning the medical device 102 in the region 108. This allows the medical device 102 to be positioned closer to the hole in the skull into which the lead 104 is inserted compared to a typical implant site near the collarbone, such that a lead extension is not needed in this example.

[0021] As Figure 1As shown, the medical lead 104 extends from the medical device 102 to an insertion hole in the skull. The medical lead 104 extends through the brain to a location of the distal end 106 of the lead 104 having the electrodes 105 to the treatment site. The medical device 102 located on the skull can then exchange stimulation and / or sensing signals with the electrodes 105 that have established an electrical interface to the brain tissue. It should be appreciated that the medical device 102 can be implanted in other locations on the skull or other parts of the body of the patient 110 as Figure 1 The implantation site of the medical device 102 as shown is merely an example, and the medical device 102 can be implanted in various other locations on the skull or other parts of the body of the patient 110.

[0022] While Figure 1 This example of the medical system 100 shows a percutaneous lead 104 implanted in the brain of the patient 110, it should be appreciated that the medical system 100 including the medical device 102 can be implanted in many other areas of the body of the patient 110 while utilizing aspects of the embodiments disclosed herein. It should also be appreciated that other variations can exist in the medical system 100, such as utilizing other types of leads, including paddle leads, etc.

[0023] Figure 2 And Figure 3 A more detailed view of the medical device 102 is provided. Here, it can be seen that the medical device 102 includes a first device housing 204 that is positioned within a compartment 206 formed by a second device housing 202. As discussed in further detail below, the first device housing 204 encloses circuitry, such as a stimulation engine, sensing circuitry, a controller, a battery, etc. Thus, the first device housing 204 can be assembled as a complete unit that is then subsequently inserted into the compartment 206 of the second device housing 202, which can then be completed therein with the medical device 102. A medical adhesive or similar biocompatible material can be applied to fill any voids that exist between the first device housing 204 and the second device housing 202. The first device housing 204 of this example includes a main housing portion 205 as well as a top cover 214, as Figure 4A And Figure 6 As shown, the main housing portion and the top cover are discussed in further detail below. While the first device housing 204 is shown as being rectangular in shape with a top cover 214, it should be appreciated that other shapes and configurations can also allow the first device housing 204 to be inserted into a suitably shaped and sized compartment 206 of the second device housing 202.

[0024] The medical device 102, comprising both a first device housing 204 and a second device housing 202, offers several advantages. Regardless of the shape of the second device housing 202, the shape and size of the first device housing 204 can be configured to house the necessary circuitry, batteries, etc. The first device housing 204 can also be constructed from a different material than the second device housing 202, such as by utilizing biocompatible metals or other conductive materials that provide better electromagnetic interference shielding. This allows the first device housing to have more versatile applications.

[0025] The second device housing 202 can be produced using shapes and materials more specific to the specific implantation site. For example, the second device housing 202 can be configured in a disc-shaped form as shown in the figure to better fit within a circular recess created in the skull. Furthermore, the second device housing 202 can be constructed from materials such as biocompatible polymers that provide protection for the first device housing 204 while also providing a suitable interface to the bone and subcutaneous tissue at the specific implantation site.

[0026] The second device housing 202 also provides a lead hole 208 where an electrical connector is located, and the lead hole 208 includes an external opening 209. For example... Figure 2 As shown, the proximal end 103 of the medical lead 104 is passing through the opening 209 and inserted into the lead hole 208. The proximal end 103 of the lead 104 includes a plurality of proximal contacts 107 attached to the lead body 212, which establish an electrical connection within a connector in the lead hole 208. The proximal contacts 107 are connected to the internal conductor of the lead 104 via... Figure 1 The distal electrode 105 shown is electrically connected. Once the proximal end 103 is fully inserted, the lead 103 can be secured in place by fastening the proximal end 103, such as by a retaining screw 210 that fastens one of the contacts in the proximal contact 107.

[0027] While the example shown has a disc-shaped form, it should be understood that in other examples the second device housing 202 can have many other shapes while providing both the lead hole 208 and the compartment 206 of the first device housing 204. Furthermore, the orientation of the compartment 206 and the lead hole 208 can differ from the parallel configuration shown, such as where the longitudinal dimension of each of the compartments and the lead hole forms an angle with respect to each other, including a vertical orientation. Therefore, a disc-shaped form is shown only for illustrative purposes. Additionally, while the second device housing in this example can be constructed from polymers such as polysulfone or polyetheretherketone (PEEK), it should be understood that other biocompatible materials, such as biocompatible metals, can be used alternatively. However, for conductive materials such as metals, the channels and compartments should be coated with a non-conductive material such as polysulfone to electrically isolate the second housing from the conductors and connectors.

[0028] While the first housing 204 is located in the compartment 206, it can be seen in the illustrated example that a portion of the end of the first housing 204 is not covered by the second housing 202. Further, this exposed portion of the first housing 204 can remain uncovered by medical adhesive such that, if the first housing 204 is constructed of a conductive material such as metal, the first housing 204 can act as a node for the stimulation and sensing circuitry, such as for monopolar stimulation. Additionally, for embodiments in which the second housing 202 is constructed of a conductive material such as metal, the second housing 202 can make electrical contact with the conductive portion of the first housing 204 such that the second housing 202 also forms an electrical node for the stimulation and sensing circuitry.

[0029] Figure 4A The bottom of this example of the complete medical device 102 is shown. Figure 4B The bottom of the first device housing 204 is shown in perspective view, uninserted. Figure 5 Only the bottom of the second device housing 202 is shown. For this medical device 102, the second device housing 202 can be molded or otherwise constructed to have features that allow for the inclusion of the first device housing 204 within the compartment 206, as well as features that allow for the necessary electrical connections between the first device housing 204 and the electrical connectors 226 within the lead bore 208 of the second device housing 202.

[0030] As Figure 5 shown, a first pocket 234 and a second pocket 238 are formed in the bottom of the second device housing that are open to the exterior. The second device housing 202 provides a passageway 236 that extends from the first pocket 234 to the second pocket 238. In Figure 4B perspective view, the depth of the pockets 234, 238 and the passageway 236 in this example can be seen. Also as Figure 5 shown, an aperture 232 is present in the wall of the first pocket 234 to provide a location for the set screw block and Figure 2 corresponding set screw 210 within the lead bore 208. In this example, the second device housing 202 also forms a notch 203 in the otherwise circular perimeter of the second device housing 202, in which the opening 209 to the lead bore 208 is located. This notch 203 allows the lead 104 to begin to arc as it extends away from the opening 209, so as to subsequently wrap around the second device housing 202 one or more times before extending into a hole in the skull to provide strain relief.

[0031] As Figure 4A and Figure 4B shown, various items are present within the first pocket 234, and thus within the lead bore 208 further defined by this first pocket 234, including the set screw block 224 and the electrical connectors 226, which are separated by a non-conductive seal 228.Figure 4A It is shown as the first device housing 204 is being inserted into the compartment 206 (as Figure 7 It is shown that the top end of the first device housing 204 is positioned within the second bay 238 as the insertion is being completed. Figure 4B It is shown that a wall 239 in the bay 238 provides a hard stop for the insertion of the first device housing, as the top cover 214 abuts the wall 239 once the first device housing 204 is fully inserted.

[0032] Once the top cover 214 reaches the wall 239, the electrical terminals 216 in the form of feedthrough pins extend from the top cover 214 of the first device housing 204 to the corresponding passageway 238. Electrical conductors 218 are present within the passageway 236, with one end of the conductors 218 electrically connected to the corresponding electrical connectors 226, and the other end of the conductors 218 electrically connected to the corresponding electrical terminals 216. As Figure 4B As can be seen in the middle, in this example, the conductors 218 include a portion 219 that drops to a lower position within the bay 238, such that once the first device housing 204 is inserted, the pads 220 are positioned directly below the terminals 216. To facilitate the creation of contact, such as a weld or other conductive joint between the conductors 218 and the terminals 216, the end of the conductors 218 can form a conductive pad 220 with increased surface area. Alternatively, other forms of contact can occur between the conductors 218 and the terminals 216, such as a frictional engagement via a spring-loaded connector of the conductors 218 that frictionally contacts the terminals 216 in place of the conductive pads 220.

[0033] Figure 6 The top end of the first device housing 204 in relation to the stimulation and / or sensing circuit 240 is shown in greater detail. It can be seen that the main portion 205 of the first device housing encloses the circuit 240, while the top cover 214 provides the electrical terminals 216 to expose the exterior of the first device housing 204 for electrical connection to the conductors 218. The top cover 214 can establish a feedthrough that is hermetically sealed to further protect the circuit 240 from bodily fluids that surround the medical device 102. Alternatively, the top cover 214 can provide a filtered feedthrough to reduce the amount of electrical noise that can be present on the conductors 218 reaching the circuit 240.

[0034] Once the electrical connections have been established between the components, a medical adhesive or other similar filling material 223 (represented for illustrative purposes only as Figure 4AThe fill material 223 is applied to the bottom of the second device housing 202. The fill material 223 fills both the first and second compartments 234, 238 to encapsulate the components mounted within those compartments 234, 238. Alternatively, the fill material 223 is applied within the channel 236 to encapsulate the conductor 218. The fill material 223 can be applied to completely fill the compartments 234, 238 and channel 236 and produce a flush bottom surface for the second device housing 202. The fill material 223 thereby electrically isolates the components within the compartments 234, 238 and channel 236.

[0035] Other methods can be used instead of installing all components and making electrical connections prior to applying the fill material 223. For example, components can be installed in the compartments 234 and channel 236 and then the compartments 234 and channel 236 are filled, while the compartment 238 remains unfilled. Then, the first device housing 204 is inserted into the compartment 206 with the terminals 216 making engagement with the pads 220 and then the second compartment 238 is filled. As another possibility, the order can be reversed with the first device housing 204 being inserted with the terminals engaging the pads 220 and the compartment 238 being filled while the compartment 234 remains unfilled. Then, the components of the first compartment 234 are installed with the connectors 226 engaging the conductor 218 and then the compartment 238 is filled.

[0036] Figure 4A 、 Figure 4B and Figure 5 Another feature that some embodiments can have is also shown in FIGS. 1-3. A bridge channel 230 can be provided in the second device housing 202 for receiving a bridge conductor that bridges the multiple electrical connectors 226 in parallel to the same conductor 218 and thereby to the same terminals 216 of the first device housing 204. This can be used in cases where the first device housing 204 has fewer electrical terminals 216 than the lead 204 has proximal contacts 107 and distal electrodes 106. This allows all of the proximal contacts 107 and distal electrodes 106 to be active electrical nodes of the circuit 240 if desired. The fill material 223 is also applied to the bridge channel 230 to encapsulate the bridge conductor.

[0037] Figure 8 An example of manufacturing operations that can be performed to produce the medical device 102 is shown. Initially, at operation 302, the connectors 226 and seals 228 and the set screw block 224 can be installed in the first compartment 234. In addition, the conductor 218 is routed through the channel 236 and engaged to the corresponding connectors 226, such as by soldering. As noted above, in one example, the fill material can be added at this time, except for the second compartment 238. However, in this example, all of the fill material is added later. Figure 8

[0038] ​At operation 304, the first device housing is inserted into the compartment 206 of the second device housing 202. As described above with respect to this example Figure 4B As described, the second pocket 238 includes a wall 239 that acts as a stop when the first device housing 204 is inserted into the compartment 206, and at which the terminal 216 aligns with the pad 220 when the top cover 214 reaches the wall 239. At operation 306, the terminal 216 is placed in contact with the conductor, such as by being joined to the pad 220 via soldering or other conductive joining, or by other contact forms such as frictional engagement. Once all electrical connections are established, the previously unfilled pockets 234, 238 and passage 236 can be filled at operation 308 with medical adhesive or other biocompatible filling material. The medical device 102 is then ready for implantation.

[0039] While embodiments have been particularly shown and described, it will be understood by those skilled in the art that various other modifications in form and details can be made therein without departing from the essence and scope of the application.

Claims

1. An implantable medical device, the implantable medical device comprising: First device casing; A circuit located inside the housing of the first device, wherein the circuit includes electrical terminals present outside the housing of the first device; A second device housing, the second device housing including a lead hole and a device housing compartment, wherein the first device housing is located within the device housing compartment; An electrical connector, wherein the electrical connector is located within the lead hole; and An electrical conductor that electrically connects the electrical terminals to the electrical connector. The second device housing includes a channel, wherein an electrical conductor is present within the channel, and the implantable medical device further includes a filler material located within the channel and isolating the electrical conductor.

2. The implantable medical device of claim 1, wherein each of the electrical conductors includes an end, the end including a conductive pad.

3. The implantable medical device according to claim 2, wherein each of the electrical terminals includes a pin, and the pin contacts a corresponding conductive pad in the conductive pad.

4. The implantable medical device of claim 1, wherein the first device housing comprises metal, and wherein the second device housing comprises polymer.

5. The implantable medical device of claim 1, wherein the second device housing includes a capsule, wherein the end of the first device housing and the electrical terminal are located within the capsule, and the implantable medical device further includes a filler material located within the capsule and isolating the electrical terminal and the end of the first device housing.

6. The implantable medical device according to claim 1, wherein the implantable medical device further comprises a fixing screw block located within the lead hole.

7. An implantable medical system, the implantable medical system comprising: An implantable medical device, the implantable medical device comprising: First device casing; A circuit located inside the housing of the first device, wherein the circuit includes electrical terminals present outside the housing of the first device; A second device housing, the second device housing including a lead hole and a device housing compartment, wherein the first device housing is located within the device housing compartment; An electrical connector, wherein the electrical connector is located within the lead hole; An electrical conductor that electrically connects the electrical terminals to the electrical connector; and An implantable medical lead, the implantable medical lead having a proximal end and a distal end, the proximal end being located within the lead hole. The second device housing includes a channel, wherein an electrical conductor is present within the channel, and the implantable medical device further includes a filler material located within the channel and isolating the electrical conductor.

8. The implantable medical system of claim 7, wherein each of the electrical conductors includes an end, the end including a conductive pad.

9. The implantable medical system of claim 8, wherein each of the electrical terminals includes a pin, the pin contacting a corresponding conductive pad in the conductive pad.

10. The implantable medical system of claim 7, wherein the first device housing comprises metal, and wherein the second device housing comprises polymer.

11. The implantable medical system of claim 7, wherein the second device housing includes a capsule, wherein the end of the first device housing and the electrical terminal are located within the capsule, and the implantable medical device further includes a filler material located within the capsule and isolating the electrical terminal and the end of the first device housing.

12. The implantable medical system according to claim 7, wherein the implantable medical system further comprises a fixing screw block located within the lead hole.

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