FIBROTIC BAND INTERRUPTER AND IMPLANT INTRODUCING DEVICE

• US 20130190783A1
• Filed: 12/15/2011
• Published: 07/25/2013
• Est. Priority Date: 03/15/2007
• Status: Abandoned Application

• Current Assignee: Giuseppe Amato
• Original Assignee: Insightra Medical, Inc.
• Inventors: Noda, Wayne A., Adzich, Vaso, Bell, Stephen Graham, Amato, Giuseppe
• Application Number:
  US13/326,696
• Publication Number:
  US 20130190783A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61M 2005/31508 provided on the piston-rod

Abstract

A space in a muscle wall such as the inguinal canal is dilated by a plunger-based mechanism to break up fibrotic bands by divulsion. While the space is dilated a dynamic plug is advanced into it, with the plug expanding and contracting with the space.

Claims

1. Assembly, comprising:

a housing including a hollow proximal barrel and a hollow distal bulb, the bulb and barrel being coaxial and being engaged with each other to define a continuous channel from a proximal end of the barrel to a distal opening of the bulb, the bulb having a larger outside diameter than the barrel and having a rounded distal segment tapering down to the distal opening, an interior stop being formed in the barrel and extending into the channel;

a closure element covering the proximal end of the barrel and defining a round opening and a keyway contiguous to the round opening; and

a plunger including a stem slidably disposed in the channel from the proximal end of the barrel into the channel and terminating at a distal disc, a proximal disc being formed on the stem, a key being formed on the stem, the plunger being movable relative to the housing between a distal position, in which the distal disc is closely juxtaposed with the distal opening of the bulb, an unlocked proximal position, in which the proximal disc abuts the interior stop to prevent proximal motion of the plunger relative to the housing and the key of the plunger aligns with the keyway of the closure element to permit distal motion of the plunger toward the distal position, and a locked proximal position, in which the plunger is at a different angular location relative to the barrel from an angular position of the plunger in the unlocked proximal position such that the key of the plunger is not aligned with the keyway of the closure element and instead the key abuts the closure element to prevent distal motion of the plunger relative to the housing.

2. The assembly of claim 1, wherein the channel has a first diameter in the barrel and a second diameter in the bulb, and the second diameter is larger than the first diameter.

3. The assembly of claim 1, wherein the interior stop is an annular ring circumscribing the barrel.

4. The assembly of claim 1, wherein the barrel is cylindrical.

5. The assembly of claim 1, wherein the keyway includes a first rectilinear opening extending radially from the round opening of the closure element and a second rectilinear opening extending radially from the round opening of the closure element and radially opposed to the first rectilinear opening, and the key of the plunger includes radially opposed first and second ribs on the stem of the plunger slidably disposed in respective rectilinear openings of the keyway.

6. The assembly of claim 1, wherein the closure element includes radially opposed flat wings extending radially away from the barrel.

7. The assembly of claim 1, further comprising a stop flange circumscribing a proximal end of the bulb and extending radially outwardly therefrom, the stop flange defining a circular periphery except for a notch formed in the periphery.

8. The assembly of claim 1, further comprising an implant including a central core and plural resilient lamellae extending radially from the core to define an implant body, the implant body being biased to an extend configuration, in which the lamellae establish a radially uniform configuration having an enlarged diameter, the implant body being foldable to a deploy configuration, in which some of the lamellae are folded around the central core to establish a loop space on one side of the implant body and to configure the body to have a deploy diameter smaller than the enlarged diameter to facilitate advancing the implant into the bulb for deployment thereof.

9. The assembly of claim 8, further comprising a stop flange circumscribing a proximal end of the bulb and extending radially outwardly therefrom, the stop flange defining a circular periphery except for a notch formed in the periphery, the notch being aligned with the loop space of the implant body when the implant is in the deploy configuration in the bulb to facilitate juxtaposing the loop space with a spermatic cord of a patient during deployment of the implant from the bulb.

10. Apparatus comprising:

a housing including a hollow proximal barrel and a hollow distal bulb, the distal bulb being curved from an open distal end such that a distal diameter of the bulb is smaller than a proximal diameter of the bulb so that the bulb can be advanced into an opening in tissue distal diameter first and then advanced further until the proximal diameter is in the opening so as to gently stretch the tissue during advancement of the bulb, thereby interrupting fibrotic bands in the tissue;

a plunger slidably disposed in the channel and terminating at a distal disc, the plunger being movable relative to the housing between a distal position, in which the distal disc is closely juxtaposed with the open end of the bulb, and a proximal position, in which the distal disc is distanced from the open end of the bulb such that a tissue repair implant is disposable in the open end of the bulb, wherein moving the plunger from the proximal position to the distal position urges the implant out of the bulb into tissue.

11. The apparatus of claim 10, comprising:

an interior stop formed in the barrel and extending into a channel defined at least in part by the barrel;

a closure element covering a proximal end of the barrel and defining a round opening and a keyway contiguous to the round opening; and

wherein the plunger includes a stem slidably disposed in the channel from the proximal end of the barrel into the channel and terminating at the distal disc, a proximal disc being formed on the stem, a key being formed on the stem, the plunger being movable to an unlocked proximal position, in which the proximal disc abuts the interior stop to prevent proximal motion of the plunger relative to the housing and the key of the plunger aligns with the keyway of the closure element to permit distal motion of the plunger toward the distal position, the plunger being further movable to a locked proximal position, in which the plunger is at a different angular location relative to the barrel from an angular position of the plunger in the unlocked proximal position such that the key of the plunger is not aligned with the keyway of the closure element and instead the key abuts the closure element to prevent distal motion of the plunger relative to the housing.

12. The apparatus of claim 11, wherein the channel has a first diameter in the barrel and a second diameter in the bulb, and the second diameter is larger than the first diameter.

13. The apparatus of claim 11, wherein the interior stop is an annular ring circumscribing the barrel.

14. The apparatus of claim 11, wherein the barrel is cylindrical.

15. The apparatus of claim 11, wherein the keyway includes a first rectilinear opening extending radially from the round opening of the closure element and a second rectilinear opening extending radially from the round opening of the closure element and radially opposed to the first rectilinear opening, and the key of the plunger includes radially opposed first and second ribs on the stem of the plunger slidably disposed in respective rectilinear openings of the keyway.

16. The apparatus of claim 11, wherein the closure element includes radially opposed flat wings extending radially away from the barrel.

17. The apparatus of claim 11, further comprising a stop flange circumscribing a proximal end of the bulb and extending radially outwardly therefrom, the stop flange defining a circular periphery except for a notch formed in the periphery.

18. The apparatus of claim 11, further comprising an implant including a central core and plural resilient lamellae extending radially from the core to define an implant body, the implant body being biased to an extend configuration, in which the lamellae establish a radially uniform configuration having an enlarged diameter, and implant body being foldable to a deploy configuration, in which some of the lamellae are folded around the central core to establish a loop space on one side of the implant body and to configure the body to have a deploy diameter smaller than the enlarged diameter to facilitate advancing the implant into the bulb for deployment thereof.

19. The assembly of claim 18, further comprising a stop flange circumscribing a proximal end of the bulb and extending radially outwardly therefrom, the stop flange defining a circular periphery except for a notch formed in the periphery, the notch being aligned with the loop space of the implant body when the implant is in the deploy configuration in the bulb to facilitate juxtaposing the loop space with a spermatic cord of a patient during deployment of the implant from the bulb.

20. Method comprising:

retracting a plunger in a hollow barrel and rotating the plunger to a locked proximal position such that the plunger cannot be advanced back distally into the barrel;

advancing an implant into an open distal end of a bulb extending proximally from the barrel;

advancing the bulb into a tissue defect until a depth stop flange formed between the bulb and barrel rests against a muscular wall in which the tissue defect is formed;

rendering the plunger into an unlocked proximal position;

advancing the plunger distally relative to the barrel to release the implant out of the open distal end onto the defect.