Minimally invasive implantable neurostimulation system

Patent metadata

Field	Value
Publication number	US-10258789-B2
Application number	US-201314098608-A
Country	US
Kind code	B2
Filing date	Dec 6, 2013
Priority date	Dec 7, 2012
Publication date	Apr 16, 2019
Grant date	Apr 16, 2019

Abstract

A medical device system for delivering a neuromodulation therapy includes a delivery tool for deploying an implantable medical device at a neuromodulation therapy site. The implantable medical device includes a housing, an electronic circuit within the housing, and an electrical lead comprising a lead body extending between a proximal end coupled to the housing and a distal end extending away from the housing and at least one electrode carried by the lead body. The delivery tool includes a first cavity for receiving the housing and a second cavity for receiving the lead. The first cavity and the second cavity are in direct communication for receiving and deploying the housing and the lead coupled to the housing concomitantly as a single unit.

First claim

The invention claimed is:

1. A medical device system for delivering a neuromodulation therapy, comprising:
an implantable medical device comprising:
an electronic circuitry comprising a pulse generator configured to generate neurostimulation pulses;
a sealed housing enclosing the electronic circuitry;
an electrical lead comprising a lead body extending between a proximal end coupled to the housing and a distal end extending away from the housing and at least one lead electrode carried by the lead body, the at least one lead electrode configured to deliver the neurostimulation pulses generated by the pulse generator to a targeted therapy delivery site of a patient;

a delivery tool for implanting the implantable medical device, the delivery tool comprising a first cavity for receiving the housing and a second cavity for receiving the lead, the first cavity and the second cavity in direct communication for receiving the housing and the lead coupled to the housing as a single unit, the first cavity having a cross-sectional dimension that is larger than a cross-sectional dimension of the second cavity; and
a delivery tool electrode positioned along a distal end of the delivery tool for testing stimulation sites to identify at least one neuromodulation therapy site,
wherein the delivery tool is configured so that the implantable medical device including the electrical lead is removable from the delivery tool as part of an implantation procedure comprising withdrawal of the delivery tool while leaving the implantable medical device at an implant site and the at least one lead electrode at the targeted therapy delivery site.

2. The system of claim 1 , wherein the lead body comprises a flattened side.

3. The system of claim 1 , further comprising a first fixation member along the distal end of the lead body.

4. The system of claim 3 , wherein the lead further comprises a second fixation member spaced apart proximally from the first fixation member along the lead body such that a tissue layer is captured between the first fixation member and the second fixation member when the lead distal end is advanced through a tissue layer.

5. The system of claim 1 , wherein the delivery tool comprises a distal tool end adapted to be inserted through a tissue layer to implant the lead distal end beneath the tissue layer, the housing remaining superficial to the tissue layer.

6. The system of claim 1 , further comprising a housing fixation member for anchoring the housing at an implant site.

7. The system of claim 6 , wherein the housing fixation member comprises one of a flanged post, a hook, a cross-beam with descending legs, a shroud, a serrated body and ratcheting collet, and a U-shaped clip.

8. The system of claim 6 , wherein the housing fixation member comprises a bioabsorbable material.

9. The system of claim 6 , wherein the housing fixation member comprises a shape memory alloy.

10. The system of claim 6 , wherein the housing fixation member comprises an electrode.

11. The system of claim 6 , wherein the housing comprises a major side and an electrode along the major side, the electrode electrically coupled to the electronic circuitry,
the housing fixation member being adapted to anchor the major side against a tissue layer.

12. The system of claim 1 , wherein the lead is non-removably coupled to the housing.

13. A medical device system for delivering a neuromodulation therapy, the medical device system comprising:
an implantable medical device comprising:
an electronic circuitry comprising a pulse generator configured to generate neurostimulation pulses;
a sealed housing enclosing the electronic circuitry;
an electrical lead comprising a lead body extending between a proximal end coupled to the housing and a distal end extending away from the housing and at least one lead electrode carried by the lead body, the at least one lead electrode configured to deliver the neurostimulation pulses generated by the pulse generator to a targeted therapy delivery site of a patient; and

a delivery tool for implanting the implantable medical device, the delivery tool comprising:
a first cavity for receiving the housing and a second cavity for receiving the lead, the first cavity and the second cavity in direct communication for receiving the housing and the lead coupled to the housing as a single unit, a handle portion,
a first shaft portion extending from the handle portion and comprising a side wall defining the first cavity for receiving the housing;
a second shaft portion comprising an open-sided lumen extending from the first shaft portion and defining the second cavity for receiving the lead; and
a distal tool end,
the first shaft portion comprising a distal opening in direct communication with the open-sided lumen of the second shaft portion for receiving the housing coupled to the lead as the single unit.

14. The system of claim 13 , wherein the delivery tool comprises a movable cover fitting over at least a portion of one of the first shaft portion and the second shaft portion to retain the housing and lead within the delivery tool.

15. A medical device system for delivering a neuromodulation therapy, the medical device system comprising:
an implantable medical device comprising:
an electronic circuitry comprising a pulse generator configured to generate neurostimulation pulses;
a sealed housing enclosing the electronic circuitry;
an electrical lead comprising a lead body extending between a proximal end coupled to the housing and a distal end extending away from the housing and at least one lead electrode carried by the lead body, the at least one lead electrode configured to deliver the neurostimulation pulses generated by the pulse generator to a targeted therapy delivery site of a patient; and

a delivery tool for implanting the implantable medical device, the delivery tool comprising:
a first cavity for receiving the housing and a second cavity for receiving the lead, the first cavity and the second cavity in direct communication for receiving the housing and the lead coupled to the housing as a single unit, a syringe body extending between a proximal syringe end and a distal syringe end and comprising:
a distal needle guiding portion extending proximally from the syringe distal end and comprising an open sided lumen, and
a proximal device guiding portion extending between the syringe proximal end and the distal needle guiding portion and defining the first cavity for receiving the housing; and
a plunger extending between a proximal plunger end and a distal plunger end and comprising:
a proximal shaft,
a mid-portion extending from the proximal shaft and through the device guiding portion, and
a distal hollow needle extending from the mid-portion and extending through the needle guiding portion, the distal hollow needle comprising an open-sided lumen defining the second cavity for receiving the lead,
the plunger configured to deploy the housing and the lead as the single unit at an implant site when the plunger is advanced through the syringe body.

16. The system of claim 15 , further comprising a fixation member extending from the lead body, wherein the needle guiding portion of the syringe body comprises an open groove, the fixation member coupled to the lead adapted to extend through the open-sided lumen and the groove as the plunger is advanced.

Assignees

• Medtronic Inc

Inventors

• Tischendorf Brad C
• Bonde Eric H
• Falkner Phillip C
• Kast John E
• Roles Randy S
• Scott Erik R
• Smith Todd V
• Wei Xuan K
• Chasensky Anthony M
• Ebert Michael J
• Kelley Shawn C
• Molnar Gabriela C
• Stone Richard T

Classifications

• A61N1/02 Primary

  Details · CPC title

• A61N1/37518

  Anchoring of the implants, e.g. fixation · CPC title

• A61N1/3756

  Casings with electrodes thereon, e.g. leadless stimulators · CPC title

• A61N1/3727

  characterised by the modulation technique · CPC title

• A61N1/37223

  Circuits for electromagnetic coupling · CPC title