TUNNELING TOOL FOR DELIBERATE PLACEMENT OF AN ILR

• US 20160038181A1
• Filed: 10/19/2015
• Published: 02/11/2016
• Est. Priority Date: 05/08/2012
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Gratbatch Limited
• Inventors: Katra, Rodolphe, Dobrovolny, Walter J., Kimmel, Scott
• Granted Patent: US 9,474,547 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

A tunneling tool for implanting a medical device into body tissue is described. The tunneling tool comprises a first leg and a second leg. An intermediate portion of the second leg is shaped to nest a medical device therein. A hub connects the first and second distal leg ends together. A sheath providing a lumen extends from the hub to an open end distal of the first and second legs. The first and second legs are manipulatable to separate the hub and the sheath into two portions, a first split portion connected to the first leg and a second split portion connected to the second leg. When a medical device is nested in the tunneling tool, breaking the tunneling tool apart enables the first and second split portions to be removed from body tissue, leaving the implanted medical device behind.

Claims

1. A tunneling tool for implanting a medical device in a body tissue, the tunneling tool comprising:

a) a shaft extending axially from a proximal handle to a distal piercing tip, wherein the shaft comprises;

i) a tab extending from the shaft spaced proximally from the piercing tip and distally from the handle, wherein the tab has a first slot; and

ii) a second slot in the handle, wherein the second slot is spaced laterally from the shaft and is aligned axially with the first slot; and

b) a rip cord extending from a distal cord end that is releasably secured to the shaft to a movable relationship received in the first and second slots,

c) wherein an implantable medical device is contactable to the shaft with the rip cord extending around the medical device, opposite the shaft, and then through the first and second slots to thereby releasably secure the medical device to the shaft, and

d) wherein with the medical device secured to the shaft, the tunneling tool is movable into a body tissue to a desired implant location, and then a proximal end of the rip cord is manipulatable in a proximal direction to release the rip cord from the shaft to slide along the medical device until the rip cord reaches the tab, and wherein the tunneling tool in then manipulatable to be removed from the tissue, leaving the medical device implanted therein.

2. The tunneling tool of claim 1 wherein the handle comprises a plate and the second slot extends through the plate.

3. The tunneling tool of claim 1 wherein the first and second slots are of generally rectangular cross-sections with their respective long axes aligned generally parallel to the axial extent of the shaft.

4. The tunneling tool of claim 1 wherein the shaft comprises a planar wall section with an imaginary plane of the planar wall aligned generally perpendicular to an extending axis of the tab.

5. The tunneling tool of claim 1 wherein the shaft comprises an inverted U-shaped channel portion having a channel proximal end extending to a channel distal end, the channel proximal end being closer to the handle than the channel distal end connected to the piercing tip, and wherein the channel is sized and shaped for an antenna of a medical device to nest therein.

6. The tunneling tool of claim 5 wherein the shaft comprises a planar wall section with an imaginary plane of the planar wall aligned generally perpendicular to an extending axis of the tab, and wherein the planar wall section is intermediate the inverted U-shaped channel and the tab.

7. The tunneling tool of claim 5 wherein the shaft has a circular cross-section extending to and meeting with the inverted U-shaped channel.

8. The tunneling tool of claim 1 wherein the shaft comprises a polyethylene material.

9. The tunneling tool of claim 1 wherein the inverted U-shaped channel portion of the shaft is sufficiently flexible to deflect upon the tip contacting a muscle tissue.

10. A tunneling tool for implanting a medical device in a body tissue, the tunneling tool comprising:

a) a shaft extending axially from a proximal handle to a distal piercing tip, wherein the shaft comprises;

i) an inverted U-shaped channel extending from a channel proximal end to a first channel distal end;

ii) a tab extending from the shaft spaced distally from the handle, the tab having a first slot, wherein the channel proximal end is closer to the handle than the channel distal end connected to the piercing tip, and wherein the channel is sized and shaped for an antenna of a medical device to nest therein; and

iii) a second slot in the handle, wherein the second slot is spaced laterally from the shaft and is aligned axially with the first slot; and

b) a rip cord extending from a distal cord end that is releasably secured to the shaft to a movable relationship received in the first and second slots,

c) wherein an implantable medical device is contactable to the shaft with an antenna for the medical device nested in the inverted U-shaped channel and with the rip cord extending over the antenna and around the medical device, opposite the shaft, and then through the first and second slots to thereby releasably secure the medical device to the shaft, and

d) wherein with the medical device secured to the shaft, the tunneling tool is movable into a body tissue to a desired implant location, and then a proximal end of the rip cord is manipulatable in a proximal direction to release the rip cord from the shaft to slide along the medical device until the rip cord reaches the tab, and wherein the tunneling tool in then manipulatable to be removed from the tissue, leaving the medical device implanted therein.

11. The tunneling tool of claim 10 wherein the inverted U-shaped channel comprises a first inverted U-shaped channel extending from a first channel proximal end to a first channel distal end, and a second invented U-shaped channel having a second channel proximal end extending to a second channel distal end, and wherein the second channel proximal end is connected to the first channel distal end and the second channel distal end is connected to the piercing tip.

12. The tunneling tool of claim 11 wherein the first channel is sized and shaped to nest a portion of a medical device antenna immediately adjacent to a header for the device.

13. A method for implanting a medical device in a body tissue, comprising the steps of:

a) providing a tunneling tool comprising;

i) a shaft extending axially from a proximal handle to a distal piercing tip, wherein the shaft comprises;

A) a tab extending from the shaft spaced proximally from the piercing tip and distally from the handle, wherein the tab has a first slot; and

B) a second slot in the handle, wherein the second slot is spaced laterally from the shaft and is aligned axially with the first slot; and

ii) a rip cord extending from a distal cord end that is releasably secured to the shaft to a movable relationship received in the first and second slots, and

b) contacting an implantable medical device to the shaft with the rip cord extending around the medical device, opposite the shaft, and then through the first and second slots to thereby releasably secure the medical device to the shaft, and

c) moving the tunneling tool with the medical device secured to the shaft into a body tissue to a desired implant location, then

d) manipulating a proximal end of the rip cord in a proximal direction to release the rip cord from the shaft to slide along the medical device until the rip cord reaches the tab, and

e) removing the tunneling tool from the tissue, leaving the medical device implanted therein.

14. The method of claim 13 including providing the inverted U-shaped channel portion of the shaft being sufficiently flexible to deflect upon the tip contacting a muscle tissue.