Medical device system and apparatus for guiding the placement of a subcutaneous device

A medical device system for advancing a subcutaneous device to a desired implant site, the apparatus comprising:

• a strap having a major length extending from a proximal end to a distal end;
• a first flange comprising a first sidewall portion and a second flange comprising a second sidewall portion, the first flange and the second flange extending along the major length of the strap from the proximal end to the distal end;
• a base portion extending along the major length of the strap from the proximal end to the distal end, the base portion comprising a bottom wall extending from the first sidewall portion of the first flange to the second sidewall portion of the second flange;
• and
• an indentation extending from the proximal end to the distal end along the major length of the strap, the indentation formed by the first sidewall portion, the second sidewall portion, and the base portion, wherein the first flange and the second flange include bottom portions that make contact with and compress a tissue layer to position the tissue layer towards the base portion within the indentation as the subcutaneous device further advances the tissue layer to be positioned against one or more of the first sidewall portion, the second sidewall portion and the base portion of the indentation during placement of the subcutaneous device;
• a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue as the tunneling tool is inserted into an incision in a patient's body;
• and a channel extending though the strap from the proximal end to the distal end along the major length of the strap;
• and wherein the strap is configured as a mechanical guide for guiding the placement of the tunneling tool as the tunneling tool is inserted along the indentation and into the space between the first plane of tissue and the second plane of tissue of the patient's body;
• and means for attaching the bottom portions to a patient's skin that comprises bands attached to the strap.

A medical device system for advancing a subcutaneous device to a desired implant site, the apparatus comprising:

• a strap having a major length extending from a proximal end to a distal end;
• a first flange comprising a first sidewall portion and a second flange comprising a second sidewall portion, the first flange and the second flange extending along the major length of the strap from the proximal end to the distal end;
• a base portion extending along the major length of the strap from the proximal end to the distal end, the base portion comprising a bottom wall extending from the first sidewall portion of the first flange to the second sidewall portion of the second flange;
• and
• an indentation extending from the proximal end to the distal end along the major length of the strap, the indentation formed by the first sidewall portion, the second sidewall portion, and the base portion, wherein the first flange and the second flange include bottom portions that make contact with and compress a tissue layer to position the tissue layer towards the base portion within the indentation as the subcutaneous device further advances the tissue layer to be positioned against one or more of the first sidewall portion, the second sidewall portion and the base portion of the indentation during placement of the subcutaneous device;
• a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue as the tunneling tool is inserted into an incision in a patient's body;
• and a channel extending though the strap from the proximal end to the distal end along the major length of the strap;
• and wherein the strap is configured as a mechanical guide for guiding the placement of the tunneling tool as the tunneling tool is inserted along the indentation and into the space between the first plane of tissue and the second plane of tissue of the patient's body;
• and a vacuum system coupled to the strap for pulling the patient's skin upward to be positioned within the indentation.

A medical device system for advancing a subcutaneous device to a desired implant site, the system comprising:

• a strap having a major length extending from a proximal end to a distal end and comprising a material from the proximal end to the distal end of the strap, and that conforms to a patient's body when the strap is attached to the patient's body;
• a hollow channel extending through the material a tunneling tool, the strap configured as a mechanical guide for guiding the placement of the tunneling tool as the tunneling tool is inserted into the patient's body prior to inserting the tunneling tool into the patient's body;
• a first flange comprising a first sidewall portion and a second flange comprising a second sidewall portion, the first flange and the second flange extending along the major length of the strap from the proximal end to the distal end;
• a base portion extending along the major length of the strap from the proximal end to the distal end, the base portion comprising a bottom wall extending from the first sidewall portion of the first flange to the second sidewall portion of the second flange;
• an indentation extending from the proximal end to the distal end of the major length of the strap, the indentation formed by the first sidewall portion, the second sidewall portion, and the base portion, wherein the first flange and the second flange include bottom portions that make contact with and compress a tissue layer to position the tissue layer towards the base portion within the indentation as the subcutaneous device further advances the tissue layer to be positioned against one or more of the first sidewall portion, the second sidewall portion and the base portion of the indentation during placement of the subcutaneous device in a space created by the tunneling tool between a first plane of tissue and a second plane of tissue after the tunneling tool has been advanced into the patient's body through an incision and along the indentation of the strap;
• and means for attaching the bottom portions to a patient's skin that comprises an adhesive.