Methods for delivering surgical grafts to a resected tonsil

Patent metadata

Field	Value
Publication number	US-9839721-B2
Application number	US-201313865298-A
Country	US
Kind code	B2
Filing date	Apr 18, 2013
Priority date	Apr 18, 2012
Publication date	Dec 12, 2017
Grant date	Dec 12, 2017

Abstract

Described are graft devices useful for treating surgical defects, delivery implements for delivery of the graft devices, combinations thereof, and methods for the preparation and use thereof. In certain aspects a tonsillectomy graft can include convexly curved outer edges, where the graft is sized and configured such that these outer edges reside proximate and along tonsillar pillars bounding a surgical tonsillectomy defect. The graft can include one or more pull tethers laced to the graft and functional to draw these outer edges toward one another when tensioned. The graft can be combined with a delivery implement having a delivery head and attached handle, where the delivery head is sized for receipt onto the tonsillectomy defect to deliver the graft. Additional product features, as well as associated methods, are also described.

First claim

What is claimed is:

1. A surgical tonsillectomy method, comprising:
removing tissue from a patient, the tissue including at least one tonsil, so as to create a surgical defect between a posterior tonsillar pillar and an anterior tonsillar pillar of the patient;
applying to the surgical defect a graft including a sheet-form decellularized animal tissue layer comprising extracellular matrix tissue said graft positioned such that a first lateral edge of the graft is adjacent the anterior tonsillar pillar and a second lateral edge of the graft opposite said first lateral edge is adjacent the posterior tonsillar pillar, wherein said graft includes a first plurality of buttress segments extending from said first lateral edge and sized to extend over the anterior tonsillar pillar, a second plurality of buttress segments extending from said second lateral edge and sized to extend over the posterior tonsillar pillar, and wherein said first plurality of buttress segments and said second plurality of buttress segments comprise portions of said sheet-form decellularized animal tissue layer comprising extracellular matrix tissue, each of said buttress segments having a first sheet face between a first buttress edge and a second buttress edge and a second sheet face opposite said first sheet face and between said first buttress edge and said second buttress edge, wherein said buttress segments are configured to fold over and cover segments of the anterior or posterior tonsillar pillars and receive a stitch through the buttress segment and underlying pillar segment;
closing the surgical defect by bringing together said first lateral edge and said second lateral edge so as to draw the posterior tonsillar pillar and the anterior tonsillar pillar toward one another; and
securing the closed surgical defect by passing a stitch through one or more of the buttress segments and the underlying pillar segments.

2. The method of claim 1 , wherein the graft comprises a multilaminate construct including a plurality of layers of said decellularized animal tissue layer.

3. The method of claim 2 , wherein the decellularized animal tissue layers are dehydrothermally bonded to one another.

4. The method of claim 1 , wherein the decellularized animal tissue layer retains at least one native growth factor of the tissue layer.

5. The method of claim 1 , wherein the graft comprises a graft body and one or more tethers connected to the graft body and operable upon tensioning to move said first lateral edge and said second lateral edge of the graft body toward one another.

6. The method of claim 5 , wherein said one or more tethers includes a plurality of pull tethers.

7. The method of claim 6 , wherein said plurality of pull tethers includes tethers laced between multiple positions proximate to the first lateral edge and multiple positions proximal to the second lateral edge.

8. The method of claim 1 , also comprising:
securing the graft to the surgical defect; and
tensioning a tether connected to the graft so as to fold the graft and thereby fold the defect.

9. The method of claim 1 , wherein said first lateral edge is convexly curved and said second lateral edge is convexly curved.

10. The method of claim 1 , wherein said first lateral edge and said second lateral edge are convexly curved.

11. The method of claim 1 , wherein said applying step further comprises introducing the graft while in contact with a graft delivery implement, the graft delivery implement comprising:
a handle;
a delivery head connected to the handle and sized and configured for receipt onto a tonsillectomy defect between the anterior tonsillar pillar and the posterior tonsillar pillar; and
the delivery head including:
a forward face for receiving the graft;
a first lateral delivery head region including a first plurality of open-sided suturing slots extending inward from an outer edge of the first lateral delivery head region; and
a second lateral delivery head region opposite the first lateral delivery head region, the second lateral delivery head region including a second plurality of open-sided suturing slots extending inward from an outer edge of the second lateral delivery head region.

12. The method of claim 11 , wherein the forward face of the delivery head has a convexly curved surface.

13. The method of claim 11 , wherein said delivery head also comprises a barb member for engaging the graft.

14. The method of claim 11 , wherein the graft delivery implement also comprises a tether retention slot defined in the handle.

15. The method of claim 11 , wherein said first plurality of open-sided suturing slots and said second plurality of open-sided suturing slots terminate inwardly at rounded inner slot walls.

16. The method of claim 11 , wherein the outer edge of the first lateral delivery head region and the outer edge of the second lateral delivery head region are each convexly curved.

17. A surgical tonsillectomy method, comprising:
removing tissue from a patient, the tissue including at least one tonsil, so as to create a surgical defect between a posterior tonsillar pillar and an anterior tonsillar pillar of the patient;
applying to the surgical defect a graft including a sheet-form decellularized animal tissue layer comprising extracellular matrix tissue, said graft positioned such that a first lateral edge of the graft is adjacent the anterior tonsillar pillar and a second lateral edge of the graft opposite said first lateral edge is adjacent the posterior tonsillar pillar, wherein said graft includes a first plurality of buttress segments extending from said first lateral edge and sized to extend over the anterior tonsillar pillar, a second plurality of buttress segments extending from said second lateral edge and sized to extend over the posterior tonsillar pillar, and wherein said first plurality of buttress segments and said second plurality of buttress segments comprise portions of said sheet-form decellularized animal tissue layer comprising extracellular matrix tissue, wherein each of said buttress segments having a first sheet face extending between a first buttress edge and a second buttress edge and a second sheet face opposite said first sheet face and between said first buttress edge and said second buttress edge, and wherein said buttress segments are configured to receive a stitch passing through the buttress segments and the underlying tonsillar pillars;
wherein said applying is conducted with the graft in contact with a graft delivery implement, the graft delivery implement comprising:
a handle;
a delivery head connected to the handle and sized and configured for receipt onto a tonsillectomy defect between the anterior tonsillar pillar and the posterior tonsillar pillar; and
the delivery head including:
a forward face for receiving the graft;
a first lateral delivery head region on a first side of said forward face including a first plurality of open-sided suturing slots extending inward from an outer edge of the first lateral delivery head region;
a second lateral delivery head region on a second side of said forward face and opposite the first lateral delivery head region, the second lateral delivery head region including a second plurality of open-sided suturing slots extending inward from an outer edge of the second lateral delivery head region; and
an intermediate delivery head region occurring laterally between the first lateral delivery head region and the second lateral delivery head region, the intermediate delivery head region defining a convexly curved surface; and

attaching the gra

Assignees

• Cook Biotech Inc
• Cook Medical Technologies Llc

Inventors

• Mohan P Arun
• Melder Patrick
• Schaeffer Darin G
• Kaucher Andrew J

Classifications

• A61B17/0469

  Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery · CPC title

• A61B17/0482

  Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403) · CPC title

• A61L27/3604 Primary

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title

• A61F13/00012

  Human Necessities · mapped topic

• A61B2017/00969

  used for transplantation · CPC title