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US-12623084-B2 - Insertion tool for pouches for IPGs

US12623084B2US 12623084 B2US12623084 B2US 12623084B2US-12623084-B2

Abstract

An insertion tool having a wall of tubular or funneled shape, with, on a front portion thereof, a front side opening so that an opening of an empty pouch for an implantable pulse generator, and corresponding wiring, can be shifted onto the front portion and over the front side opening, and with, on a back portion of the insertion tool, a backside opening so that an implantable pulse generator, and corresponding wiring, can be inserted through that backside opening, through a passageway opening to the front side opening and into the pouch, while manually holding the insertion tool using the back portion The wall has an axial slot between the front side opening and the backside opening.

Inventors

  • Benjamin JOSI
  • Francesco ROBOTTI
  • Simone BOTTAN
  • Aldo Ferrari

Assignees

  • HYLOMORPH AG

Dates

Publication Date
20260512
Application Date
20210525
Priority Date
20200605

Claims (20)

  1. 1 . An insertion tool having a wall, comprising, on a front portion of the insertion tool, a front side opening configured so that an opening of an empty pouch for an implantable pulse generator can be shifted onto said front portion and over said front side opening, and comprising, on a back portion of the insertion tool, a backside opening configured so that an implantable pulse generator can be inserted through that backside opening, through a passageway opening to the front side opening and into said pouch, while manually holding the insertion tool using said back portion, wherein said wall comprises an axial slot between the front side opening and the backside opening; and wherein the wall has a funnel shape, widening the passage opening from the front side opening to the backside opening.
  2. 2 . The insertion tool according to claim 1 , wherein at said front side opening there is provided a latch axially protruding beyond a front edge of the front side opening.
  3. 3 . The insertion tool according to claim 2 , wherein there is provided one single latch.
  4. 4 . The insertion tool according to claim 2 , wherein the latch has a circumferential length in the range of 5-90 mm.
  5. 5 . The insertion tool according to claim 2 , wherein there is provided one single latch, on a side of the front side opening opposite to said axial slot, and wherein the rest of the front edge is shaped as an essentially straight edge.
  6. 6 . The insertion tool according to claim 2 , wherein the latch has a circumferential length in the range of 10-20 mm.
  7. 7 . The insertion tool according to claim 1 , wherein the front side opening has an elongated or oval shape, having a long width and a short width.
  8. 8 . The insertion tool according to claim 1 , wherein the wall has an elongated or oval shape viewed along an axial direction of the insertion tool, and wherein the axial slot, at the narrowest point, has a circumferential width of at least 2 mm.
  9. 9 . The insertion tool according to claim 1 , wherein the wall has an elongated or oval shape viewed along an axial direction of the insertion tool, and wherein the axial slot is located on a long side of said wall, and wherein on the opposite long side of said wall there is provided an axial cut-out from the backside opening.
  10. 10 . The insertion tool according to claim 1 , wherein the insertion tool is made of a metal or plastic material, and/or wherein the wall is a contiguous or perforated wall.
  11. 11 . The insertion tool according to claim 1 , wherein the wall thickness is in the range of 0.5-4 mm.
  12. 12 . The insertion tool according to claim 1 , wherein the wall has an elongated or oval shape viewed along an axial direction of the insertion tool, and wherein the axial slot is located on a long side of said wall, and wherein on the opposite long side of said wall there is provided an axial cut-out from the backside opening, separating the insertion tool into a latch portion and a wing portion, wherein the latch portion carries a latch axially protruding beyond a front edge of the front side opening, and wherein the wing portion, on the back portion comprises at least one wide wing portions, joined by a saddle portion, extending beyond the rest of the backside edge of the backside opening and widening the funneled wall.
  13. 13 . The insertion tool according to claim 1 , wherein the outer surface of said wall at least in a front portion is structured or provided with a coating or made of a material providing static friction when interacting with the pouch.
  14. 14 . The insertion tool according to claim 1 , wherein at said front side opening there is provided a latch axially protruding beyond a front edge of the front side opening, with rounded shape, wherein this latch is formed as a protruding portion of said wall.
  15. 15 . The insertion tool according to claim 14 , wherein the latch protrudes by at least 2 mm beyond the rest of the front edge.
  16. 16 . The insertion tool according to claim 14 , wherein the latch protrudes in the range of 5-30 mm beyond the rest of the front edge.
  17. 17 . The insertion tool according to claim 1 , wherein the front side opening has an elongated or oval shape, having a long width (b) and a short width (c), with rounded edges, or wherein said shape is elliptical, rectangular with rounded edges, or super elliptic with n>2.
  18. 18 . The insertion tool according to claim 17 , wherein the long width of the shape is at least twice as large as the short width, and/or wherein the short width (c) of the shape is in the range of 5-50 mm, and the long width (b) is in the range of 5-100 mm.
  19. 19 . The insertion tool according to claim 17 , wherein the long width of the shape is in the range of twice to 4 times as large as the short width, and/or wherein the short width (c) of the shape is in the range of 10-30 mm, and the long width (b) is in the range of 30-70 mm.
  20. 20 . The insertion tool according to claim 1 , wherein the wall has an elongated or oval shape viewed along an axial direction of the insertion tool, and wherein the axial slot, at the narrowest point, has a circumferential width (w) in the range of 10-30 mm.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a National Stage of International Application No. PCT/EP2021/063880 filed May 25, 2021, claiming priority based on European Patent Application No. 20 178 539.1 filed Jun. 5, 2020. TECHNICAL FIELD The present invention relates to insertion tool with which implantable pulse generators can be inserted into correspondingly adapted pouches or envelopes or sleeves prior to implantation, to uses of such insertion tools, as well as to methods how to insert implantable pulse generators into pouches, envelopes or sleeves using such insertion tools. PRIOR ART Implantable Pulse Generators (IPGs) provide electrical stimulation and are integral parts of devices such as pacemakers, implantable cardioverter defibrillators, or neurostimulators. IPGs remain implanted for several years before either being exchanged due to battery depletion, or upgrade to device providing additional functionality. Examples of medical devices incorporating implantable pulse generators are Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers, implantable cardioverter defibrillators, and devices for cardiac resynchronization therapy, but also implantable neurostimulators such as vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, etc. These implantable electronic devices exert their function upon deployment in the body, generally in contact with soft tissue. The implantation procedure requires the generation of a surgical pocket (i.e. a space in the tissue) to provide room to the implant. Despite the high level of development of these implants, some significant risks remain associated with their implantation, because the devices comprise synthetic materials at their interface with the surrounding tissue. The risks are related to complications mostly arising at the level of the surgical pocket, due to local infection and/or to the body fibrotic response to artificial materials. Altogether, these adverse events can cause pain and discomfort, but also more serious threats to the patient's life, leading in the worst cases to revision surgeries with additional costs and risks. To tackle these problems a number of solutions in the form of specific medical devices have been recently proposed for the management of surgical pocket health. These medical devices have generally the form of protective pouches, envelopes or sleeves, into which the casing and the proximal part of the leads of the implanted device (the CIED or neurostimulator) are inserted before deployment in the surgical pocket. The pouches can have purely stabilization purposes (i.e. to support the regeneration of the tissue surrounding the implant in the surgical pocket), or may also provide additional functions such as the delivery of active molecules (e.g. antibiotics) or the enforcement or stimulation of an antifibrotic barrier. US 2012059467 discloses a cover for receiving an implantable medical device with self-anchoring protrusions that engage tissue of a pocket where the device is implanted to resist movement including rotation and flipping. The implantable medical device is placed into the cover prior to being placed into the pocket so that once in the pocket, the device may reduce rotating, flipping, or otherwise moving. The self-anchoring protrusions may include barbs of various shapes to frictionally engage the tissue of the pocket. The cover may include features such as a strap and elastic construction to assist in holding the implantable medical device within the cover. Apertures may be included to enable the device. The cover may include additional features like suture tabs to allow additional fixation via suturing the cover to the surrounding tissue. WO 2019/113451 discloses a resorbable bioelectric device with multiple first reservoirs and multiple second reservoirs joined with a planar substrate. Selected ones of the multiple first reservoirs include a reducing agent, and first reservoir surfaces of selected ones of the multiple first reservoirs are proximate to a first substrate surface. Selected ones of the multiple second reservoirs include an oxidizing agent, and second reservoir surfaces of selected ones of the multiple second reservoirs are proximate to the first substrate surface. US 2005/267543 discloses an anti-infective covering for an implantable medical device which may be a polymeric boot that comprises an anti-infective agent in an amount effective to prevent an infection when implanted in a pocket of a patient. The boot is configured to snuggly engage at least a portion of the implantable medical device. The boot may contain a side hole that allows a housing of the implantable medical device to serve as a return electrode. The boot may be placed about the implantable medical device to render the device anti-infective. US 2019/351241 describes implantable pouch products having a segmental lamination structure that provides an interior poc