Patent Publication Number: US-2017348533-A1

Title: Telemetry Port for Implanted Medical Device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is a divisional application of co-pending and allowed U.S. patent application Ser. No. 14/837,135 filed on Aug. 27, 2015 and claims the benefit thereof. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates generally to electronic medical devices implanted within an animal or human body, and in particular the invention relates to fully implanted electronic medical devices including a telemetry communication mechanism. 
     2. Description of Related Art 
     Implantable electronic medical devices (IMD) often need to communicate with other devices, such as another IMD or an external device, such as for example, a monitoring system or programming console. 
     A telemetry communication system sends and receives information in a bidirectional mode. The system sends or receives commands to a separate device that might cause the separate device to alter its electronic or electro-mechanical performance, thereby controlling the device. The system may consist of hardware and software, sensors, a transmission protocol, and normally some form of a display, and possibly hardware and software capable of recording such interactions. 
     Telemetry systems can be implemented to acquire and transmit data from a remote implanted source to provide information about the implanted device and a user&#39;s activities. 
     It is desirable for physicians to exercise control over an IMD or to otherwise obtain information regarding the operational status of an IMD. 
     IMD&#39;s perform certain tasks to render treatment for various medical conditions. IMD&#39;s that are designed to include a remote control telemetry mechanism require that the device send and/or receive remote control telemetry commands. It is critical that the main electronic parts and power supply of the IMD are hermetically sealed within the shell of the IMD, in order to guard the subject&#39;s internal tissue from possible leakage of, or contact with, toxic components within the IMD and also prevent the incursion of internal bodily fluids into the shell of the IMD. The main electronic parts and power supply of IMD&#39;s are hermetically sealed in a hard-shell case, usually made of some form of metallic material, such as for example titanium. It is appreciated that the shell casing of the IMD may be formed of another suitable material. 
     Metallic compounds are effective materials for comprising the shell of an IMD because they are non porous, inert and highly durable. They are disadvantageous however because metals interfere or block remote telemetry signals going to and from the electronic receivers. 
     The medical device industry, as a whole, has been utilizing materials, such as titanium in the construction of shells for IMD&#39;s for their durability, inertness and air and fluid tightness for not only the protection of the various electronic parts that are being encased from a subject&#39;s bodily fluids, but also for the protection of the implant subject&#39;s tissue from being exposed to potentially toxic or otherwise harmful elements that may be associated with the implanted components within the IMD. 
     In such instances however, problems arise, since remote control commands are unable to be received or sent on a uniform basis to or from the electronic components encased within the metallic shell or case of the IMD. 
     Short and long term implant tests of prospective materials for IMD&#39;s have identified problems associated with using plastic especially when the implanted device includes an on-board power supply. The problems include, but are not limited to, porosity that may allow for the incursion of internal bodily fluids into the case, as well as, possible off-gassing issues that could alter the plastic shell&#39;s structural integrity. 
     The prior art includes various attempts to reduce or overcome interference in sending/receiving telemetry signals from implanted electronic medical devices. For example, U.S. Pat. No. 6,868,288 B2 (to Thomson) is a telemetry receiver for an implantable medical device (IMD) with an RF antenna coupled to a telemetry circuit that includes an out-of-band rejection filter comprising a thin film bulk acoustic resonator filter. 
     U.S. Pat. No. 8,160,705 B2 (to Stevenson et al.) provides for an EMI filter terminal assembly for an AIMD including a radio frequency (RF) telemetry pin antenna extending therethrough, including a conductive shield extending over a portion of the RF telemetry pin antenna in non-conductive relation with the telemetry pin, and conductively connected to a ground associated with the AIMD. 
     U.S. Pat. No. 8,527,060 B2 (to Amely-Velez et al.) teaches a shield that is configured to preserve telemetry communications between an AIMD in a patient and a telemetry wand when in an environment having high power electromagnetical interferers. The shield may include a plastic composition, include a shell including a wall that defines a volume and an opening in the shell. The volume may be configured to receive therein the telemetry wand such that the second and lateral sides of the telemetry wand face respective portions of the wall and the first side faces the opening in the shell. 
     U.S. Pat. Publ. No. 2012/0326886 A1 (to Herman et al.) discloses a telemetry head for communication with an implantable medical device comprises a telemetry antenna and a shield substantially surrounding at least a portion of the antenna, the shield having a coating comprising a ferromagnetic material applied to at least a portion of the shield, wherein the coating is configured to shield at least the portion of the telemetry antenna from electromagnetic interference fields while permitting telemetry signals to pass through the coating. 
     Thus, it is desirable to expose an antenna in an IMD to remotely broadcasted signals without subjecting the antenna to interference from the metallic shell of an IMB. 
     SUMMARY OF THE INVENTION 
     The present invention allows remote telemetry antennae to gain unfettered access to remotely broadcasted signals without interference by using a telemetry port in which to house the antennae. The telemetry port is formed of a non metallic, preferably plastic compound that is capable of securely bonding with the metallic shell of the IMB. The material for the telemetry port should be durable and capable of protecting human tissue and internal bodily fluids from contact with any of the mechanical, electronic or power supply components within the IMD, as well as allowing for unfettered bidirectional telemetry signals. 
     The present invention is described as an extension cover or a port, protruding out of a telemetry box or monitor, wherein the telemetry box may include a titanium or other metallic shell enclosure. It is noted herein that a telemetry box is one form of an IMD. A bottom portion of the telemetry port is hermetically sealed to the titanium or other metallic shell enclosure. In a preferred embodiment the telemetry port includes a flexible transparent plastic material. The telemetry port provides an interference free transmission zone for internal telemetry antennae that extend up from the telemetry box into the void space within the protruding telemetry port, beyond the metallic shell enclosure of the telemetry box or monitor. The internal telemetry antennae are thereby able to transmit and receive signals free from interference from the metallic or titanium shell of the telemetry box. It is to be appreciated that there may be one or more than one antenna within a telemetry port at any given time. 
     The antennae are positioned within the telemetry port but are not solidly encased within the telemetry port. Thus, the antenna or antennas within the telemetry port are completely unrestricted. The telemetry port provides the antennae with sufficient room to move around within the port without contacting the telemetry port, thereby avoiding a possible disruption of connection with a transmitter or receiver that may occur if the antenna contacted the housing/shell of the telemetry port, such as may occur if the antenna was solidly encased. 
     Accordingly, one aspect of the present invention is to provide a “free zone” wherein remote telemetry commands can be sent or received without interference from the titanium, or other metallic shell of the telemetry box. 
     Another aspect of the present invention is that it includes a material that is capable of binding with the metallic shell material of the telemetry box in such a way as to be able to continue to ensure that the bond is of a nature that the entire shell component of the IMD remains completely hermetically sealed without creating the possibility of bodily fluid incursion. 
     In a preferred embodiment, the telemetry port of the present invention is fabricated of a very durable flexible plastic material suitable for allowing the unimpeded transmission and reception of remote telemetry commands. 
     At least a portion of the material of the telemetry port must also be capable of tightly bonding with the material of the shell of the telemetry box, so as to form a hermetic seal with the telemetry box. 
     The telemetry port of the present invention can be made in a broad range of dimensions and/or shapes. The telemetry port can be made of a broad range of materials, as long as the material allows for the free flow of telemetry signals and is capable of hermetically bonding with the shell of the main body of the telemetry box or IMD. 
     In a preferred embodiment, a clear flexible plastic material is used to form the telemetry port. Plastic is used to prevent the signal from bouncing back off of a titanium shell of the main body of the telemetry box. 
     The telemetry port of the present invention provides a means of allowing the remote telemetry receiving antennae to gain unfettered access to the reception and transmission of signals. The main body of the telemetry box or IMD houses mechanical, electronic and power supply components. 
     An advantage of the present invention is that the protruding telemetry port is hermetically sealed to the main body of the IMD. 
     An objective of the present invention is for the telemetry port to provide a “free transmission” zone for the leads of the telemetry antennae in order to prevent signal interference and to improve signal transmission and reception. 
     Another advantage of the telemetry port of the present invention is that it is capable of both continuing to protect human tissue and internal bodily fluids from contact with any of the mechanical, electronic or power supply components inside the main body of the IMD and vice versa, as well as, allow for unfettered bidirectional telemetry signal transmission and reception. 
     Yet another advantage of the present invention is that it allows the antenna within the telemetry port to move freely without contacting the housing of the telemetry port. 
     The above mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings. 
     It is noted that references made herein to the present invention or aspects of the invention thereof should be understood to mean certain embodiments of the present invention and should not necessarily be construed as limiting all embodiments to a particular description. The present invention is set forth in various levels of detail in the Summary of the Invention as well as in the attached drawings and the Detailed Description of the Invention and no limitation as to the scope of the present invention is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary of the Invention. Additional aspects of the present invention will become more readily apparent from the Detail Description, particularly when taken together with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is an exploded view of the telemetry port of the present invention in conjunction with an implantable electric device. 
         FIG. 2  is a side view of the telemetry port of the present invention. 
         FIG. 3  is a front view of the telemetry port of the present invention. 
         FIG. 4  is a bottom view of the telemetry port of the present invention. 
         FIG. 5  is a cross sectional side view of the telemetry port of the present invention. 
         FIG. 6  is a side perspective view of the bottom of the telemetry port of the present invention. 
         FIG. 7  is a side view of an alternative embodiment of the present invention. 
         FIG. 8  is a front view of an alternative embodiment of the present invention shown in  FIG. 8 . 
         FIG. 9  is a close-up view of the telemetry port of the present invention as shown in  FIG. 8 . 
     
    
    
     DETAILED DESCRIPTION OF THE DRAWINGS: 
     The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limited, but merely as the basis for the claims and as a basis for teaching on skilled in the art how to make and/or use the invention. 
     Referring now to  FIGS. 1-9  the subject invention is a telemetry port  10  for providing an open space in which an antenna  20  may transmit and receive signals free from interference from a metal shell  32  of an IMD  30 . It is appreciated that the shell  32  may include one or more segments. In one embodiments, the shell includes segments  38  and  38 ′. The telemetry port  10  comprises a material that is permeable to sending and receiving telemetry signals and allows free and clear ingress and egress of telemetry signals. In a preferred embodiment, the material of the telemetry port  10  is a clear flexible plastic. It is to be appreciated that the material of the telemetry port  10  may also comprise a hard plastic, a non-clear plastic, or another material, so long as the material is permeable to telemetry signals and at least a portion of the telemetry port  10  is capable of forming a hermetic seal with the metal shell  32 . 
     The telemetry port  10  includes a housing  12  defining a void space  16  therein for receiving an antenna  20  within the void space  16 . The void space  16  is of sufficient size to allow the antenna  20  therein to engage in the free flow of telemetry signals within the telemetry port  10 . 
     The void space  16  is configured to provide the antenna  20  positioned therein with sufficient space such that the antenna  20  does not contact the housing  12  of the telemetry port  10 . There is a gap  22  that is defined between the antenna  20  and the housing  12 . The gap  22  is of sufficient size relative to the antenna  20 , to allow for freedom of movement of the antenna  20  within the housing  12 , such that the antenna  20  can move freely in any direction within the housing  12  as a result of vibrational movement without contacting the housing  12 . Movement of the antenna  20  within the telemetry port  10  may result from vibrational movement or other mechanical movement, such as, for example, if the antenna  20  is retracted or otherwise retractable. 
     The housing  12  of the telemetry port  10  includes a periphery  40 . The periphery  40  is positioned along a bottom edge of the housing  12  of the telemetry port  10 . The periphery  40  is configured to integrally mate with the IMD  30 . In a preferred embodiment, the periphery  40  mates with a rim  34  of the IMD  30  when the telemetry port  10  is in integral communication with the IMD  30 . The periphery  40  further includes a durable material that is capable of forming a hermetic seal with the shell  32  of the IMD  30 . 
     A hermetic seal between the telemetry port  10  and the IMD  30  is needed to prevent the incursion of bodily fluid into the IMD  30  or telemetry port  10  or leakage of, or contact with, potentially toxic material from components within the IMD  30  and the subject&#39;s internal tissue. A hermetic seal between the periphery  40  of the telemetry port  10  and the shell  32  of the IMD  30  at the rim  34  may be achieved using a laser or sonic, or another welding process. It is noted that the telemetry port  10  may be hermetically sealed to the shell  32  the IMD  30  using other methods as will be appreciated by one reasonably skilled in the art. 
     The periphery  40  of the telemetry port  10  includes a first band  42 , a second band  44  and a ring  43 , positioned intermediate to the first band  42  and second band  44 , the ring  43  further having a circumference that is generally smaller than the circumference of each of the first band  42  and the second band  44  such that the ring  43  forms a groove and is indented relative to each of the first band  42  and second band  44 . 
     In one embodiment, the housing  12  of the telemetry port  10  comprises a first side wall  50  a second side wall  52  the second side wall  52  being generally opposite to the first side wall  50 , a first lateral side  54  and a second lateral side  56 , the second lateral side  56  being generally opposite to the first lateral side  54  and contiguous to the first side wall  50  and second side wall  52 , a top face  58  positioned along a topmost edge of each of the first side wall  50 , second side wall  52 , first lateral side  54  and second lateral side  56 , the top face  58  positioned intermediate to the first side wall  50  and second side wall  52  and further extending therebetween, from the first side wall  50  to the second side wall  52 , and from the first lateral side  54  to the second lateral side  56 . 
     The first band  42  of the periphery  40  is configured to mate with the IMD  30 , at an aperture  36  above the rim  34  and the second band  44  is configured to mate with the IMD  30  below the rim  34 , when the periphery  40  of the telemetry port  10  is in integral communication with the IMD  30  such that the periphery  40  and the rim  34  of the IMD  30  are in sealing engagement. When the periphery  40  of the telemetry port  10  and the rim  34  of the IMD  30  are in sealing engagement, the ring  43  is generally level with the rim  34  of the IMD  30 . 
     The aperture  36  provides a point of ingress and egress to the antenna  20  from within the shell  32  of the IMD  30  and the telemetry port  10 . 
     In a preferred embodiment, the void space  16  of the telemetry port  10  is of a sufficient size to allow for ingress or egress of the antenna  20 . It is noted that the antenna  20  may be retractable. 
     In another embodiment, the void space  16  of the telemetry port  10  is of sufficient size to allow for ingress or egress of an antenna  20  with an on board or integrated PC board  24 . 
     In yet another embodiment, a portion of the antenna  20  sufficient to freely receive and transmit signals is projected within the void space  16  of the telemetry port  10 . 
     In another embodiment of the invention, the telemetry port  10  is affixed to the shell  32  of the IMD  30 . 
     The telemetry port  10  allows portions of the antenna  20  that are within the telemetry port  10  to move freely within the telemetry port  10  without contacting the housing  12  of the telemetry port  10  to allow space for movement of the antenna  20  within the telemetry port  10  that may arise under various circumstances. For example, movement of the antenna  20  may arise as a result of vibration or when the antenna  20  are being moved in and out of the telemetry port  10 . 
     The telemetry antenna  20  allow for signal transmission and reception and may include an on board PC-board  24 . It is appreciated that the antenna  20  may comprise various sizes, shapes and configurations. In a preferred embodiment, the antenna  20  comprises a solid projection affixed to an on-board PC-board  24 . 
     In yet another preferred embodiment, a module having an internal lattice placement structure is used to slide the antenna and on board PC-board  24  into the IMD  30  and the telemetry port  10 . It is appreciated that many different types and sizes of antenna  20  may be used without departing from the spirit and scope of the invention. It is further understood that there are many possible sizes and configurations for the telemetry port  10  without departing from the spirit and scope of the invention. 
     Referring now in particular to  FIG. 1  there is shown an exploded view of the telemetry port  10  of the present invention in conjunction with an IMD  30 . The telemetry port includes the housing  12  defining the void space  16  within the telemetry port  10 . In this embodiment, the shell  32  of the IMD  30  includes segments  38  and  38 ′. The antenna  20  enters the shell  32  through segment  38  and projects upwards through the aperture  36  at the rim  34  of the shell  32  of the IMD  30 , beyond the shell  32  of the IMD  30  and into the void space  16  of the telemetry port  10 . There is shown the periphery  40  of the telemetry port  10 . The periphery  40  mates with the IMD  30  at the aperture  36  of the rim  34  and forms a sealing engagement therewith. 
       FIG. 2  is a side view of a preferred embodiment of the telemetry port  10  of the present invention. As illustrated, the telemetry port  10  includes the top face  58  is positioned along a topmost edge of each of the first side wall  50 , first lateral side  54  and second lateral side  56 , the top face  58  extends from the first lateral side  54  to the second lateral side  56 . The second lateral side  56  as shown is generally opposite to the first lateral side  54  and contiguous to the first side wall  50 .  FIG. 2  further illustrates the periphery  40  of the telemetry port  10  including the first band  42 , the second band  44  and the ring  43 , positioned therebetween and intermediate to the first band  42  and second band  44 , the ring  43  further having a circumference that is generally smaller than the circumference of each of the first band  42  and the second band  44  such that the ring  43  forms a groove and is indented relative to each of the first band  42  and second band  44 . 
       FIG. 3  is a front view of the telemetry port of the present invention and further illustrates the embodiment shown in  FIG. 2 . 
       FIG. 4  is a bottom view of the telemetry port of the present invention illustrating the bottom of the telemetry port  10 . As shown, the second band  44  encompasses an opening for entry of the antenna  20  (not shown) into the void space  16 . 
       FIG. 5  is a cross sectional side view of the telemetry port  10  of the present invention. The void space  16  within the telemetry port  10  receives the antenna  20  (not shown) and allows the antenna  20  to transmit and receive telemetry signals without interference from the IMD  30  (not shown). 
       FIG. 6  is a side perspective view of the bottom of the telemetry port  10  of the present invention. There is shown the second side wall  52 , the first lateral side  54 , the top face  58  is positioned along a topmost edge of each of the second side wall  52  and the first lateral side  54 , the top face  58  is intermediate to the second side wall  52  and further extends therebetween, from the first side wall  50  (not shown) to the second side wall  52 , and from the first lateral side  54  to the second lateral side  56  (not shown). 
       FIG. 7  is a side view of an alternative embodiment of the present invention and illustrates the shell  32  of the IMD  30  having two segments  38  and  38 ′. 
       FIG. 8  is a front view of an alternative embodiment of the present invention shown in  FIG. 7  and illustrates the telemetry port  10  in conjunction with the IMD  30 . The periphery  40  of the telemetry port  30  is in sealed mating engagement with the IMD  30  and connects to the IMD  30  at the aperture  36  of the rim  34  of the IMD  30 . The antenna  20  is shown projecting within the void space  16  of the telemetry port  10 . 
       FIG. 9  is a close-up view of the telemetry port  10  of the present invention as shown in  FIG. 8 . The gap  22  defined between the antenna  20  and the housing  12  is shown. The gap  22  is of sufficient size relative to the antenna  20 , to allow for freedom of movement of the antenna  20  within the housing  12 . The housing  12  of the telemetry antenna  10  includes the first side wall  50 , the second side wall  52 , the second side wall  52  being generally opposite to the first side wall  50 , and the top face  58 . The periphery  40  is in sealed mating engagement with the rim  34  of the IMD  30 . As shown, when the periphery  40  of the telemetry port  10  and the rim  34  of the IMD  30  are in sealing engagement, the ring  43  is generally level with the rim  34  of the IMD  30 , while the second band  44  mates with the IMD  30  below the rim  34  and the first band  42  mates with the IMD  30  above the rim  34 . 
     In a preferred embodiment the dimensions of the telemetry port  10  are such that the first side wall  50 , second side wall  52 , first lateral side  54  and second lateral side  56  each have a thickness of generally 0.040 inches. In a preferred embodiment, the length measured from the top face  58  to the upper side of the second band  44  is generally 0.395 inches. In a preferred embodiment, the first lateral face  54  and second lateral face  56  each have a width of generally 0.310 inches. In a preferred embodiment, the side wall  50  and second side wall  52  each have a width of generally 0.520 inches. In a preferred embodiment, the ring  43  includes a thickness of generally 0.020 inches. In a preferred embodiment, the second band  44 , has a thickness of generally 0.040 inches. The second band  44  extends below the rim  34  and beyond the aperture  36  generally by 0.040 
     While this invention has been described as having a preferred design, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains and which fall within the limits of the appended claims.