Tunneling tool for deliberate placement of an ILR

• US 9,474,547 B2
• Filed: 10/19/2015
• Issued: 10/25/2016
• Est. Priority Date: 05/08/2012
• Status: Expired due to Fees

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Katra, Rodolphe, Dobrovolny, Walter J., Kimmel, Scott
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US14/886,444
• Publication Number:
  US 20160038181A1
• Time in Patent Office: 372 Days
• Field of Search: 606/170, 606/167, 606/108, 606/129, 606/185, 600/423, 600/424, 600/365, 607115-116, 607/4, 607/9, 623/1.11, 623/1.12
• 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 an implantable medical device (IMD) in a body tissue, the tunneling tool comprising:

a) a shaft extending along a longitudinal axis from a proximal handle to a distal piercing tip, the shaft comprising;

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

ii) a second slot in the handle, wherein the second slot is spaced laterally from the longitudinal axis of the shaft,

iii) wherein the shaft comprises an inverted U-shaped channel portion that is sized and shaped for an antenna of the IMD to nest therein; and

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

c) wherein with the IMD contacting the shaft, the distal rip cord end is releasably secured to the shaft at a position distal to the IMD with the rip cord extending around and contacting a portion of the IMD, opposite the shaft, and then passing through the first and second slots to thereby releasably secure the IMD to the shaft, and

d) wherein with the IMD secured to the shaft, the tunneling tool is movable into a body tissue and to a desired implant location, and then the proximal rip cord end is manipulatable in a proximal direction to release the distal rip cord end from the shaft so that the rip cord slides along the first and second slots and out of contact with the IMD, and

e) wherein the tunneling tool is then manipulatably removable from the tissue, thereby leaving the IMD 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 longitudinal axis aligned generally parallel to the longitudinal axis of the shaft.

4. The tunneling tool of claim 1 wherein the shaft comprises a planar wall section, and wherein a first imaginary plane of the planar wall is aligned generally perpendicular to a second imaginary plane aligned along the tab extending from the shaft.

5. The tunneling tool of claim 1 wherein the shaft comprises a planar wall section, and wherein a first imaginary plane of the planar wall is aligned generally perpendicular to a second imaginary plane aligned along the tab extending from the shaft, and wherein the planar wall section of the shaft is intermediate to the inverted U-shaped channel portion of the shaft and the tab.

6. The tunneling tool of claim 1 wherein the shaft has a circular cross-section extending from the handle to the tab.

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

8. 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.

9. The tunneling tool of claim 1 wherein the first slot is aligned axially with the second slot.

10. The tunneling tool of claim 1 wherein with the IMD contacting the shaft, the first and the second slots are proximal to the IMD.

11. A tunneling tool for implanting an implantable medical device (IMD) in a body tissue, the tunneling tool comprising:

a) a shaft extending along a longitudinal axis from a proximal handle to a distal piercing tip, the shaft comprising;

i) an inverted U-shaped channel portion that is sized and shaped for an antenna of the IMD to nest therein;

ii) a tab extending from the shaft and being spaced distally from the handle, wherein the tab has a first slot spaced from the longitudinal axis and the inverted U-shaped channel is disposed between the distal piercing tip and the tab; and

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

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

c) wherein with the IMD contacting the shaft, the antenna of the IMD nests in the inverted U-shaped channel with the distal rip cord end releasably secured to the shaft at a position distal to the IMD and with the rip cord extending over the antenna and around and contacting a portion of the IMD, opposite the shaft, and then passing through the first and second slots to thereby releasably secure the IMD to the shaft, and

d) wherein with the IMD secured to the shaft, the tunneling tool is movable into a body tissue and to a desired implant location, and then the proximal rip cord end is manipulatable in a proximal direction to release the distal rip cord end from the shaft so that the rip cord slides along the first and second slots and out of contact with the IMD, and

e) wherein the tunneling tool is then manipulatably removable from the tissue, thereby leaving the IMD implanted therein.

12. The tunneling tool of claim 11 wherein the shaft comprises a planar wall section extending from the tab to the inverted U-shaped channel portion, the inverted U-shaped channel portion extending distally to the piercing tip, and wherein the inverted U-shaped channel is sized and shaped to nest the antenna of the IMD with the IMD contacting the planar wall section of the shaft.

13. The tunneling tool of claim 12 wherein a first imaginary plane of the planar wall section is aligned generally perpendicular to a second imaginary plane aligned along the tab extending from the shaft.

14. The tunneling tool of claim 11 wherein with the IMD contacting the shaft, the first and the second slots are proximal to the IMD.

15. A tunneling tool for implanting an implantable medical device (IMD) in a body tissue, the tunneling tool comprising:

a) a shaft extending along a longitudinal axis from a proximal handle to a distal piercing tip, the shaft comprising;

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

ii) a second slot in the handle, wherein the second slot is spaced laterally from the longitudinal axis of the shaft,

iii) wherein the first and second slots are of generally rectangular cross-sections with their respective longitudinal axis aligned generally parallel to the longitudinal axis of the shaft; and

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

c) wherein with the IMD contacting the shaft, the distal rip cord end is releasably secured to the shaft at a position distal to the IMD with the rip cord extending around and contacting a portion of the IMD, opposite the shaft, and then passing through the first and second slots to thereby releasably secure the IMD to the shaft, and

d) wherein with the IMD secured to the shaft, the tunneling tool is movable into a body tissue and to a desired implant location, and then the proximal rip cord end is manipulatable in a proximal direction to release the distal rip cord end from the shaft so that the rip cord slides along the first and second slots and out of contact with the IMD, and

e) wherein the tunneling tool is then manipulatably removable from the tissue, thereby leaving the IMD implanted therein.

16. The tunneling tool of claim 15 wherein the handle comprises a plate and the second slot extends through the plate.

17. The tunneling tool of claim 15 wherein the shaft comprises a planar wall section, and wherein a first imaginary plane of the planar wall is aligned generally perpendicular to a second imaginary plane aligned along the tab extending from the shaft.

18. The tunneling tool of claim 15 wherein the shaft comprises an inverted U-shaped channel portion that is sized and shaped for an antenna of the IMD to nest therein.

19. The tunneling tool of claim 18 wherein the inverted U-shaped channel portion of the shaft is sufficiently flexible to deflect upon the tip contacting a muscle tissue.

20. The tunneling tool of claim 18 wherein the shaft comprises a planar wall section, and wherein a first imaginary plane of the planar wall is aligned generally perpendicular to a second imaginary plane aligned along the tab extending from the shaft, and wherein the planar wall section of the shaft is intermediate to the inverted U-shaped channel portion of the shaft and the tab.