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EP-3574848-B1 - SURGICAL INCISION AND CLOSURE APPARATUS

EP3574848B1EP 3574848 B1EP3574848 B1EP 3574848B1EP-3574848-B1

Inventors

  • BELSON, AMIR
  • STORNE, ERIC
  • SCAHER, Alan
  • RATHI, PANKAJ
  • ICHIRYU, Keiichiro
  • D'AQUANNI, PETER
  • CLAUSON, LUKE

Dates

Publication Date
20260513
Application Date
20131030

Claims (15)

  1. An incision closure apparatus, comprising a first base panel (1402) having an axial direction, an upper layer (1406), and an adhesive lower layer (1408); a second base panel (1404) having an axial direction, an upper layer (1410), and an adhesive lower layer (1412), wherein the second base panel (1404) is discrete from the first base panel (1402); and a plurality of lateral tie assemblies (1422) coupling the first and second base panels to one another, wherein the first base panel (1402) and the second base panel (1404) each comprise perforations or other fenestrations made near outer edges of the first base panel (1402) and the second base panel (1404) parallel to the axial direction.
  2. The incision closure apparatus according to claim 1, further comprising one or more axially aligned perforations (1418, 1420) disposed along a lateral line across the first base panel (1402) and the second base panel (1404).
  3. The incision closure apparatus according to claim 1, wherein the first and second base panels (1402, 1404) further comprise a middle layer which is coupled to and covers at least a portion of the adhesive lower layer (1408, 1412), and is coupled to and at least a portion of which is covered by the upper layer (1606, 1410), and wherein the adhesive lower layer (1408, 1412) is flexible.
  4. The incision closure apparatus according to claim 3, wherein the flexible adhesive lower layer (1408, 1412) has a first elasticity, the middle layer has a second elasticity less than the first elasticity, and the upper layer (1406, 1410) has a third elasticity less than the second elasticity.
  5. The incision closure apparatus according to claim 1, wherein the apparatus further comprises: a first sacrificial cover adhered over the first base panel (1402) and extending laterally from the outer lateral edge of the first base panel (1402) when adhered thereto, a second sacrificial cover adhered over the second base panel (1404) and laterally extending beyond the outer lateral edge of the second base panel (1404) when adhered thereto, wherein the first and second sacrificial covers each have an adherent lower surface for adhering to the first and second base panels (1402, 1404), respectively, and an upper surface configured to adhere to a surgical drape placed thereover.
  6. The incision closure apparatus according to claim 1, further comprising a first skirt coupled to an upper surface of the first base panel (1402) and a second skirt coupled to an upper surface of the second base panel (1404), the first skirt and the second skirt having a tissue adherent lower surface, wherein the first skirt and the second skirt extend laterally beyond the outer lateral edge of each of the first base panel (1402) and the second base panel (1404).
  7. The incision closure apparatus according to claim 1, further comprising: a first plurality of axially spaced-apart supports coupled to the upper surface of the first base panel (1402); and a second plurality of axially spaced-apart supports coupled to the upper surface of the second base panel (1404); wherein the lateral ties (1422) each have a first end permanently fixed relative to a support of the first base panel (1402) and a second end reversibly and adjustably attached to a laterally opposed support of the second base panel (1404), thereby allowing the lateral ties to draw the first and second base panels laterally together.
  8. The incision closure apparatus according to claim 7, wherein the first end of each lateral tie assembly (1422) is integrally formed with its respective support on the first base panel (1402).
  9. The incision closure apparatus according to claim 7, wherein the second end comprises a ratchet mechanism, and optionally wherein the lateral tie assemblies are independently adjustable such that the lateral spacing between the first and second base panels is variable along the axial direction of the first and second base panels.
  10. The incision closure apparatus according to claim 7, wherein the first base panel (1402) and the second base panel (1404) each comprise a plurality of second perforations (1418, 1420) extending in a lateral direction, wherein the plurality of second perforations on the first base panel (1402) are axially offset relative to the plurality of second perforations on the second base panel (1404).
  11. The incision closure apparatus according to claim 7, wherein the first plurality of axially spaced-apart supports and the second plurality of axially spaced-apart supports each comprise: (i) an axial spine disposed parallel to the axial direction of the first base panel (1402) and the axial direction of the second base panel (1404) and (ii) two lateral support portions coupled to the axial spine.
  12. The incision closure apparatus according to claim 7, wherein areas not covered by supports on the first base panel (1402) are offset relative to areas not covered by supports on the second base panel (1404), and wherein the tie assemblies (1422) are configured to pivot axially from their respective first ends in response to axial stretching of the first and second base panels; and optionally, wherein axial pivoting of the tie assemblies causes the first and second base panels to draw closer together.
  13. The incision closure apparatus according to claim 1, wherein the one or more perforations (1418, 1420) are formed in the upper layer (1406) of the first base panel (1402) and the upper layer (1410) of the second base panel (1404).
  14. The incision closure apparatus according to claim 12, wherein the one or more perforations (1418, 1420) are further formed in the adhesive lower layer (1408) of the first base panel (1402) and the adhesive lower layer (1412) of the second base panel (1404).
  15. The incision closure apparatus according to claim 12, wherein the one or more perforations (1418, 1420) are formed only in the upper layer of the first base panel (1402) and the upper surface of the second base panel (1404) such that the adhesive lower layer (1408) of the first base panel (1402) and the adhesive lower layer (1412) of the second base panel (1404) are intact.

Description

BACKGROUND OF THE INVENTION 1. Field of the invention. The present invention relates generally to medical apparatus and methods. More particularly, present invention relates to apparatus and methods for forming and closing surgical incisions. Surgical closure devices including an adhesive based patch with right and left panels are known. Of particular interest of the present invention, such devices are described in co-pending, commonly owned PCT application US 2010/000430. As described in the PCT application, an adhesive patch is placed over a patient's skin at a site where it is desired to form a surgical incision. After the patch is placed, an incision is formed along an axial line extending through the middle of the patch. After it is formed, the incision can be opened to perform a desired procedure, and after the procedure is completed the incision may be closed by drawing the inner edges of the panels together with a clip, zipper, or other closure member. The principal objective of such surgical closure devices is to improve healing and reduce scarring from the incision. This objective, however, has been inhibited by certain characteristics of the presently available devices. For example, the tissue edges are not always brought together along a line evenly, which can increase the eventual scarring. Many such closure devices do not have the ability to adjust the closure force or distance on the tissue edges, limiting the ability to slightly "pucker" tissue which has been found to reduce scarring. Other shortcomings of the available incision and wound closure devices include difficulty of use and inability to conform to tissue manipulation during subsequent surgical protocols, i.e. those devices which are sufficiently rigid to securely close the tissue are often unable to conform to the tissue movement during the surgical procedure. A particular problem arises with self-adhesive wound closure patches when they're used beneath an adherent surgical incision drape. Such drapes are used to help maintain the sterility of a tissue surface during a surgical procedure, and the drapes may be placed over a previously positioned tissue closure patch. As the surgical incision drape has an adhesive lower surface which adheres to the tissue, the drape will adhere to an upper surface of an underlying tissue closure patch. Removal of the surgical incision drape will thus often remove or at least displace a previously placed tissue closure patch. If any significant portion of the tissue closure patch is removed or displaced, the patch will no longer be useful for closing a surgical wound. For these reasons, it would be desirable to provide improved surgical incision closure devices and methods for their use. It would be particularly desirable to provide incision closure devices which are able to adhere to the tissue, allow formation of the incision, conform to the deformation of the tissue during a subsequent surgical procedure, and provide controlled closure of the adjacent tissue edges subsequent to the procedure. In particular, it would be desirable if the incision closure devices were able to provide for the control and the uniform distribution of closure forces on the tissue edges while causing minimum restraint or stretching of the tissue during the surgical procedure. It would be still further desirable to provide improved surgical incision closure devices and methods for their use where the devices will resist removal and dislocation when used beneath a surgical incision drape. At least some of these objectives will be met by the inventions described below. 2. Description of the Background Art. Surgical closure devices are described in U.S. Patents Nos. 2,012,755; 3,516,409; 3,863,640; 3,933,158; 4,114,624; 3,926,193; 4,535,772; 4,676,245; 4,881,546; 4,905,694; 5,377,695; and 7,455,681; and U.S. Patent Publication Nos. 2005/0020956 and 2008/0114396. Further surgical closure devices are described in commonly owned U.S. Patents Nos. 8,313,508, 8,323,313, and 8,439,945; U.S. Patent Publication No. 2013/0066365; and PCT Publication nos. WO 2011/139912, WO 2011/159623, WO 2011/043786, and WO 2013/067024. Commercial incision closure devices available from Ethicon, a division of Johnson & Johnson, under the trade name Ethizip™ temporary abdominal wound closure device. US 3971384 A discloses a surgical closure device. The device comprises two pieces of surgical tape each having an adhesive face. These pieces are secured to the skin on opposite sides of the incision. An anchor for one end of a tie strip is carried by the exposed face of one tape. A slide is secured to the exposed face of the other tape. A tie strip having ratchet teeth on its upper or exposed face has one end secured to the anchor with its other end being taken up in the slide. The slide includes a locking tab which secures the tie strip by cooperating with the ratchet teeth thereon after the tie strip has been drawn to a desired degree of tautness. The t