Systems and methods for closing incisions formed in fragile tissue
10945720 ยท 2021-03-16
Assignee
Inventors
- Julian Quintero (Flemington, NJ, US)
- Leo B. Kriksunov (Ithaca, NY)
- Shane A. Lacy (Bound Brook, NJ, US)
- Ibraheem T. Badejo (Natick, MA, US)
Cpc classification
A61B17/04
HUMAN NECESSITIES
International classification
A61B17/04
HUMAN NECESSITIES
Abstract
A method of reinforcing subcutaneous fragile tissue includes obtaining an absorbable surgical mesh having top and bottom major surfaces, the absorbable surgical mesh including a stitching zone and first and second reinforcing zones that bound opposite sides of the stitching zone. The method includes making an incision in a patient's skin for exposing subcutaneous fragile tissue, using one or more absorbable adhesives for adhering the bottom major surface of the absorbable surgical mesh to the subcutaneous fragile tissue, creating an incision through the stitching zone of the absorbable surgical mesh and into the subcutaneous fragile tissue, performing a surgical procedure through the incision, and passing an absorbable suture through the stitching zone of the absorbable surgical mesh and the fragile tissue for closing the incision.
Claims
1. A method of reinforcing subcutaneous fragile tissue comprising: obtaining a reinforcing incision drape having top and bottom major faces; using an adhesive for directly adhering said bottom major face of said reinforcing incision drape to subcutaneous fragile tissue; creating an incision through said reinforcing incision drape and into said subcutaneous fragile tissue; performing a surgical procedure through said incision; passing a surgical closing component through said reinforcing incision drape and said subcutaneous fragile tissue for closing said incision.
2. The method as claimed in claim 1, wherein said reinforcing incision drape, said adhesive and said surgical closing component are absorbable.
3. The method as claimed in claim 1, wherein said reinforcing incision drape comprises an absorbable surgical mesh, said adhesive comprises absorbable adhesive, and said surgical closing component comprises an absorbable suture.
4. The method as claimed in claim 1, wherein said reinforcing incision drape comprises: a centrally located stitching zone; first and second reinforcing zones that extend along opposite sides of said centrally located stitching zone, wherein said centrally located stitching zone has different structural properties than said first and second reinforcing zones.
5. The method as claimed in claim 4, wherein said first and second reinforcing zones are more porous than said centrally located stitching zone.
6. The method as claimed in claim 5, wherein the using an adhesive step comprises: using a weaker adhesive for securing said centrally located stitching zone to said subcutaneous fragile tissue; and using a stronger adhesive for securing said first and second reinforcing zones to said subcutaneous fragile tissue.
7. The method as claimed in claim 6, wherein said stronger adhesive comprises an absorbable adhesive containing a cross-linking initiator.
8. The method as claimed in claim 7, wherein said stronger adhesive comprises cyanoacrylate.
9. The method as claimed in claim 6, further comprising after the using a weaker adhesive step, applying said stronger adhesive over said top surface of said reinforcing incision drape and within said first and second reinforcing zones of said reinforcing incision drape.
10. The method as claimed in claim 9, further comprising: obtaining a releasable liner over said top surface of said reinforcing incision drape within said stitching zone of said reinforcing incision drape, wherein said releasable liner covers said stitching zone during the applying said stronger adhesive step; after the applying said stronger adhesive step, removing said releasable liner from said top surface of said reinforcing incision drape for exposing said stitching zone at said top surface of said reinforcing incision drape.
11. The method as claimed in claim 4, wherein said creating an incision step comprises forming an incision in said stitching zone of said reinforcing incision drape and said subcutaneous fragile tissue underlying said stitching zone, and wherein said passing a surgical closure step comprises passing a surgical suture through said stitching zone of said reinforcing incision drape and said subcutaneous fragile tissue underlying said reinforcing incision drape.
12. The method as claimed in claim 1, wherein said surgical closing component is selected from the group consisting of sutures, barbed sutures, surgical staples and surgical adhesives.
13. The method as claimed in claim 1, wherein after the using an adhesive for directly adhering said bottom major face of said reinforcing incision drape to subcutaneous fragile tissue, said bottom major face of said reinforcing incision drape is in contact with said subcutaneous fragile tissue.
14. A method of reinforcing subcutaneous fragile tissue comprising: obtaining an absorbable surgical mesh having top and bottom major surfaces, said absorbable surgical mesh including a stitching zone and first and second reinforcing zones that bound opposite sides of said stitching zone; making an incision in a patient's skin for exposing subcutaneous fragile tissue; using one or more absorbable adhesives for directly adhering said bottom major surface of said absorbable surgical mesh to said subcutaneous fragile tissue; creating an incision through said stitching zone of said absorbable surgical mesh that is directly adhered to said subcutaneous fragile tissue and into said subcutaneous fragile tissue; performing a surgical procedure through said incision; passing an absorbable suture through said stitching zone of said absorbable surgical mesh that is directly adhered to said subcutaneous fragile tissue and said subcutaneous fragile tissue for closing said incision.
15. The method as claimed in claim 14, wherein the using one or more absorbable adhesives step comprises: using a weaker absorbable adhesive for adhering said stitching zone of said absorbable surgical mesh to said subcutaneous fragile tissue; using a stronger absorbable adhesive for adhering said first and second reinforcing zones of said absorbable surgical mesh to said subcutaneous fragile tissue.
16. The method as claimed in claim 15, wherein the using a stronger absorbable adhesive step comprises: after placing a bottom surface of said absorbable surgical mesh in contact with said subcutaneous fragile tissue, applying said stronger absorbable adhesive over said top major surface of said absorbable surgical mesh and within said first and second reinforcing zones of said absorbable surgical mesh.
17. The method as claimed in claim 16, further comprising: obtaining a releasable liner that covers said top major surface of said absorbable surgical mesh within said stitching zone; after the applying said stronger absorbable adhesive over said top major surface of said absorbable surgical mesh step, removing said releasable liner for uncovering said stitching zone at said top major surface of said absorbable surgical mesh.
18. The method as claimed in claim 14, wherein said stitching zone of said absorbable surgical mesh is less porous than said first and second reinforcing zones of said absorbable surgical mesh.
19. The method as claimed in claim 14, wherein after the using one or more absorbable adhesives for directly adhering said bottom major surface of said absorbable surgical mesh to said subcutaneous fragile tissue, said bottom major surface of said absorbable surgical mesh is in contact with said subcutaneous fragile tissue.
20. A method of reinforcing subcutaneous fragile tissue comprising: obtaining an absorbable surgical mesh having top and bottom major surfaces, said absorbable surgical mesh including a stitching zone and first and second reinforcing zones that bound opposite sides of said stitching zone, wherein said stitching zone of said absorbable surgical mesh is less porous than said first and second reinforcing zones of said absorbable surgical mesh; making an incision in a patient's skin for exposing subcutaneous fragile tissue; using one or more absorbable adhesives for adhering said bottom major surface of said absorbable surgical mesh to said subcutaneous fragile tissue; creating an incision through said stitching zone of said absorbable surgical mesh and into said subcutaneous fragile tissue; performing a surgical procedure through said incision; passing an absorbable suture through said stitching zone of said absorbable surgical mesh and said fragile tissue for closing said incision.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
(15) Referring to
(16) Referring to
(17) Referring to
(18) Referring to
(19) Referring to
(20) In one embodiment, the surgical closure element may be a suture, an absorbable or non-absorbable suture, a barbed suture, surgical staples, and/or surgical adhesives.
(21) Referring to
(22) Referring to
(23) In one embodiment, an incision 214 may be created through the reinforcing incision drape 202 and into the fragile tissue 200. After a surgical procedure has been completed through the incision 214, surgical sutures 216 may be applied directly through the reinforcing incision drape 202 that remains attached to the fragile tissue 200. The surgical sutures 216 preferably approximate and/or draw the opposing edges of the cut fragile tissue 200 together, and also desirably draw the opposing cut edges of the reinforcing incision drape 202 together for closing the wound formed by the incision 214. In one embodiment, the reinforcing incision drape 202 is absorbable and is absorbed by a patient's body during and/or after healing of the incision 214. In one embodiment, the suture material 216 is also absorbable. In one embodiment, the pressure sensitive adhesive and the second, stronger adhesive used to more reliably secure the reinforcing incision drape 202 to the fragile tissue 200 is also absorbable.
(24) Referring to
(25) In one embodiment, the reinforcing incision drape 302 preferably includes a plurality of pores extending through the reinforcing incision drape that desirably enable medical personnel to have visibility through the drape for observing an underlying incision and/or the tissue surrounding a planned incision. In one embodiment, the plurality of openings that extend through the reinforcing incision drape preferably enable an adhesive to be passed through the openings for forming a strong bond between the reinforcing incision drape and the underlying fragile tissue. In one embodiment, the porous openings are located within the first and second reinforcing zones 322A, 322B, and the stitching zone 320 may be less porous or non-porous. In one embodiment, the porous openings are located within the first and second reinforcing zones 322A, 322B and not within the stitching zone 320. In one embodiment, the porous openings within the first and second reinforcing zones 322A, 322B are larger than the porous openings in the stitching zone 320. In one embodiment, the openings or pores in the surgical mesh have a diameter of about 1 mm.
(26) In one embodiment, the reinforcing incision drape may be a surgical mesh. In one embodiment, the surgical mesh may be a polypropylene mesh. In one embodiment, the surgical mesh may include a substantially flat monofilament polypropylene mesh with reinforcement filaments. The length of the reinforcing incision drape may vary depending upon surgical needs.
(27) In one embodiment, prior to making an incision, the bottom surface of the reinforcing incision drape may be positioned against the fragile tissue of a patient. The bottom surface may have a slight or weak adhesive layer (e.g., a pressure sensitive adhesive) applied thereto for forming a non-permanent and/or repositionable frictional engagement between the reinforcing incision drape and the fragile tissue. Due to the slight or weak adhesive layer, if an initial positioning of the reinforcing incision drape on a patient's fragile tissue is not acceptable (e.g. misaligned), the reinforcing incision drape 302 may be lifted or peeled away from the patient's fragile tissue for re-positioning. Once medical personnel are satisfied that the reinforcing incision drape has been properly positioned and/or aligned atop the fragile tissue (e.g. properly aligned with a surgical site where an incision will be made), a stronger adhesive, such as a clear or translucent adhesive may be applied over the top surface of the reinforcing incision drape for passing through the plurality of openings (e.g., pores) to more permanently and/or more firmly affix the reinforcing incision drape to the fragile tissue. In one embodiment, the clear or translucent adhesive preferably includes tissue glue such as Cyanoacrylate.
(28) In one embodiment, a reinforcing incision drape may be wound into a roll for shipment and storage. In one embodiment, after a surgeon determines a length of an incision required for a surgical procedure, the surgeon may unwind the roll and cut a section of the roll to provide a section of reinforcing incision drape having a desired length. In one embodiment, medical personnel may unwind a section of the reinforcing incision guide onto a flat support surface. In one embodiment, when the reinforcing incision drape has been unwound, a cutting instrument may be used for cutting the reinforcing incision drape to a desired length. In one embodiment, a plurality of reinforcing incision drapes having different sizes, dimensions and/or lengths may be provided to medical personnel. In one embodiment, medical personnel may select one of the reinforcing incision drapes having the proper size, length and/or width that suit the particular surgical needs of a patient. In one embodiment, a plurality of reinforcing incision drapes having different sizes, lengths and/or widths may be provided, and a surgeon may cut or trim a selected one of the plurality of drapes to suit surgical requirements.
(29) In one embodiment, the pressure sensitive adhesive enables the reinforcing incision drape 302 to be initially positioned over a surface of fragile tissue. If a surgeon determines that the reinforcing incision drape 302 is not properly positioned over the fragile tissue, the pressure sensitive adhesive enables the reinforcing incision drape to be removed from the surface of the fragile tissue and re-positioned over the fragile tissue. In one embodiment, after a surgeon is satisfied that the reinforcing incision drape has been properly positioned over the fragile tissue, a stronger and/or more rugged second adhesive may be used to more permanently secure the reinforcing incision drape 302 to the fragile tissue. In one embodiment, the stronger adhesive is applied to the reinforcing zones 322A and 322B of the reinforcing incision drape 302 and is not applied to the stitching zone 320 of the reinforcing incision drape 302.
(30) Referring to
(31) In one embodiment, the stitching zone 320 is secured to the fragile tissue 300 using only a pressure sensitive adhesive provided on the tissue facing face of the reinforcing incision drape. In one embodiment, the reinforcing zones 322A, 322B also include a pressure sensitive adhesive for adhering the reinforcing incision drape 302 to the fragile tissue. In one embodiment, additional adhesive is applied over the reinforcing zones 322A, 322B of the reinforcing incision drape 302. In one embodiment, the additional adhesive preferably passes through pores provided in the reinforcing zones 322A, 322B for forming a stronger bond between the reinforcing zones 322A, 322B and the fragile tissue 300. In one embodiment, the stitching zone 320 portion of the reinforcing incision drape 302 is less porous than the reinforcing zones 322A, 322B of the reinforcing incision drape 302. In one embodiment, the stitching zone 320 does not include any of the stronger, second adhesive used to bond the reinforcing zones 322A, 322B to the fragile tissue 300.
(32) In one embodiment, a cutting tool, such as a scalpel, may be used for forming an incision 314 in the stitching zone 320 of the reinforcing incision drape 302. The incision 314 preferably extends into the fragile tissue 300 for enabling a surgical procedure to be performed through the incision 314. In one embodiment, at the conclusion of a surgical procedure through the incision 314, a surgical suture 316 may be utilized for closing the incision 314 in the fragile tissue 100 and approximating the cut opposing edges of the reinforcing incision drape 302.
(33) Referring to
(34) In one embodiment, the reinforcing incision drape 402 preferably includes pressure sensitive adhesive applied over the wound-facing side of the reinforcing incision drape 402.
(35) In one embodiment, after the reinforcing incision drape 402 is positioned over the fragile tissue and with the removable liner 430 in place over the top surface of the stitching zone, a second, stronger liquid adhesive may be applied to the top surface of the reinforcing incision drape 402 that faces away from the fragile tissue. The stronger liquid adhesive preferably passes through the pores located in the reinforcing zones 422A, 422B of the reinforcing incision drape 402. The releasable liner 430 acts as a mask to prevent the stronger liquid adhesive from contacting the stitching zone 420 of the reinforcing incision drape 402. In one embodiment, after the stronger liquid adhesive applied to the reinforcing zones 422A, 422B has cured and/or hardened, the releasable liner 430 may be removed for exposing the top surface of the stitching zone 420. An incision may be formed in the stitching zone 420 of the reinforcing incision drape for making a surgical opening in the fragile tissue. At the conclusion of a surgical procedure, the incision may be closed using surgical closing components, such as surgical sutures.
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(37) In one embodiment, after the reinforcing incision drape 502 has been initially positioned over the fragile tissue, a liquid adhesive may be applied to the exposed surface areas of the reinforcing incision drape 502 that are not covered by the releasable liner 530. The liquid adhesive desirably passes through the pores in the first and second reinforcing zones 522A, 522B that are not covered by the respective laterally extending strips 535A, 535B. The stronger liquid adhesive that passes through the exposed pores is desirably cured for strongly adhering the first and second reinforcing zones 522A, 522B to the exposed surface of the fragile tissue. After the stronger adhesive has cured, the releasable liner 530 including the laterally extending strips 535A, 535B may be removed from the exposed top surface of the reinforcing incision drape 502.
(38) In one embodiment, an incision 514 may be made in the reinforcing incision drape 502. The incision 514 preferably extends along the length of the central stitching zone 520 of the reinforcing incision drape for providing access to a surgical site within the fragile tissue. The incision 514 preferably extends into the fragile tissue. After a surgical procedure has been completed, a closure element such as surgical sutures may be used for closing the incision 514 formed in the stitching zone 520 and the fragile tissue.
(39) Referring to
(40) In one embodiment, the reinforcing incision drape 602 desirably includes a central stitching zone 620 that is bounded by first and second reinforcing zones 622A, 622B. In one embodiment, the reinforcing incision drape 602 desirably includes a releasable liner 630 having a central section 633 that preferably overlies and extends along the length of the central stitching zone 620 and first and second laterally extending strips 635A, 635B that extend outwardly from opposite sides of the central section 633 of the releasable liner 630.
(41) In one embodiment, the reinforcing incision drape 602 desirably has relatively large openings 640 (i.e., larger than the pores) that are initially covered by the laterally extending strips 635A, 635B of the releasable liner 630. In one embodiment, the laterally extending strips 635A, 635B of the releasable liner 630 cover the relatively large openings 640. In one embodiment, the first laterally extending strips 635A of the releasable liner are spaced from one another so that at least some of the pores in the first reinforcing zone 622A of the reinforcing incision drape 602 are exposed between the first laterally extending strips 635A. In one embodiment, the second laterally extending strips 635B are spaced from one another so that at least some of the pores in the second reinforcing zone 622B of the reinforcing incision drape 602 are exposed between the second laterally extending strips 635B.
(42) In one embodiment, after the tissue-facing surface of the reinforcing incision drape 602 is positioned over fragile tissue, and with the releasable liner 630 in place over the top surface of the reinforcing incision drape 602, a liquid adhesive 625 (
(43) Referring to
(44) While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.