Apparatus and method for implanting an implantable device

• US 10,052,489 B2
• Filed: 03/23/2015
• Issued: 08/21/2018
• Est. Priority Date: 03/23/2015
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Katra, Rodolphe, Kimmel, Scott, Kane, Lawrence, Chase, Daniel
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US14/665,309
• Publication Number:
  US 20160279397A1
• Time in Patent Office: 1,247 Days
• 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 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Claims

1. An apparatus for subcutaneously inserting an implantable device within a patient, the implantable device including a housing and an antenna extending outwardly from the housing, the antenna including an antenna length, the apparatus comprising:

a dilator portion including a dilator including a dilator length, the dilator portion being configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate the implantable device within the subcutaneous pocket; and

a sheath portion including;

a sheath sized and shaped to accommodate the dilator within a sheath lumen, the sheath configured to accommodate the antenna of the implantable device with the dilator removed from within the sheath; and

a sheath housing at a proximal sheath end, the sheath housing including a passage substantially aligned with the sheath lumen, wherein the sheath includes a sheath length that is at least substantially as long as the antenna length, the sheath including a substantially longitudinal split extending from the proximal sheath end to a distal sheath end, the substantially longitudinal split being formed between a first edge and a second edge, the first edge overlapping but not interlocking with the second edge to form a substantially tubular shape for the sheath, wherein the sheath is configured to spread apart along the substantially longitudinal split to allow removal of the sheath past the housing of the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient, the sheath housing including an opening along a side of the sheath housing to allow access to the passage from the side of the sheath housing, the opening and the passage being configured to allow the housing of the implantable device to pass through the sheath housing without splitting the sheath housing, and wherein the sheath portion includes an intermediate sheath opening disposed between a proximal end of the sheath housing and the substantially longitudinal split of the sheath, wherein, with the dilator portion removed from the sheath portion, the passage permits movement of the implantable device into the sheath portion to a position residing in the intermediate sheath opening with the antenna residing in the sheath lumen.

2. The apparatus of claim 1, wherein the dilator portion includes a handle configured to separate tissue to create the subcutaneous pocket, such that:

the dilator portion is configured to create a portion of the subcutaneous pocket configured to accommodate the antenna of the device; and

the handle is configured to create a portion of the subcutaneous pocket configured to accommodate the housing of the device.

3. The apparatus of claim 1, wherein the passage of the sheath housing is fluidly coupled with the sheath lumen.

4. The apparatus of claim 1, wherein the dilator portion includes a handle, the handle having a portion complementary to the passage of the sheath housing to fit within the passage with the dilator disposed within the sheath.

5. The apparatus of claim 1, wherein the passage of the sheath housing includes a funnel shape configured to facilitate insertion of the antenna within the sheath lumen.

6. The apparatus of claim 1, wherein the sheath housing includes a first material and the sheath includes a second material, the first material being different than the second material.

7. The apparatus of claim 1, wherein the dilator includes a distal dilator end including an atraumatic shape, the dilator length being longer than the sheath length to allow the distal dilator end to extend distally from the sheath.

8. The apparatus of claim 1, comprising at least two electrodes configured to electrically couple to a test device, the electrodes being configured to verify a signal at a location within the patient prior to implantation of the implantable device.

9. The apparatus of claim 8, wherein the at least two electrodes are disposed on the sheath portion.

10. The apparatus of claim 1, wherein the sheath is formed from fluorinated ethylene propylene (FEP).

11. The apparatus of claim 1, wherein the opening is substantially aligned with the substantially longitudinal split to allow the housing of the implantable device to pass through the opening and the substantially longitudinal split with removal of the sheath portion from the implantable device.

12. The apparatus of claim 1, wherein the passage and the opening of the sheath housing form a channel-like configuration of the sheath housing.

13. The apparatus of claim 1, wherein the sheath housing is substantially U-shaped when viewed from a proximal end of the sheath housing.

14. An apparatus for subcutaneously inserting an implantable device within a patient, the implantable device including a housing and an antenna extending outwardly from the housing, the antenna including an antenna length, the apparatus comprising:

a dilator portion including a dilator including a dilator length, the dilator portion being configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate the implantable device within the subcutaneous pocket; and

a sheath portion including;

a sheath sized and shaped to accommodate the dilator within a sheath lumen, the sheath configured to accommodate the antenna of the implantable device with the dilator removed from within the sheath, wherein the sheath includes a sheath length that is at least substantially as long as the antenna length, the sheath including a substantially longitudinal split extending from a proximal sheath end to a distal sheath end, the substantially longitudinal split being formed between a first edge and a second edge, the first edge overlapping but not interlocking with the second edge to form a substantially tubular shape for the sheath; and

a sheath housing disposed at the proximal sheath end, the sheath housing including a passage fluidly coupled with the sheath lumen at a sheath housing distal end and extending through the sheath housing to a sheath housing proximal end, the sheath housing including an opening in a sidewall of the sheath housing to allow access to the passage from the side of the sheath housing, the opening and the passage being configured to allow the housing of the implantable device to pass through the sheath housing without splitting the sheath housing, wherein the sheath is configured to spread apart along the substantially longitudinal split along a separation line substantially aligning with the opening in the sidewall of the sheath housing, the separation line and the opening cooperating to allow the housing to pass through the opening and the separated sheath with removal of the sheath from the implantable device to leave the implantable device within the subcutaneous pocket within the patient, and wherein the sheath portion includes an intermediate sheath opening disposed between the sheath housing proximal end and the substantially longitudinal split of the sheath, wherein, with the dilator portion removed from the sheath portion, the passage permits movement of the implantable device into the sheath portion to a position residing in the intermediate sheath opening with the antenna residing in the sheath lumen.

15. The apparatus of claim 14, wherein the dilator portion includes a handle configured to separate tissue to create the subcutaneous pocket, such that:

the dilator portion is configured to create a portion of the subcutaneous pocket configured to accommodate the antenna of the device; and

the handle is configured to create a portion of the subcutaneous pocket configured to accommodate the housing of the device.

16. The apparatus of claim 14, comprising at least two electrodes disposed on the sheath portion configured to electrically couple to a test device, the electrodes being configured to verify a signal at a location within the patient prior to implantation of the implantable device.

17. The apparatus of claim 14, wherein the sheath is formed from fluorinated ethylene propylene (FEP).

18. The apparatus of claim 14, wherein the passage and the opening of the sheath housing form a channel-like configuration of the sheath housing, such that the sheath housing is substantially U-shaped when viewed from a proximal end of the sheath housing.