Interlaced compositions and methods of production

• US 20050080453A1
• Filed: 10/10/2003
• Published: 04/14/2005
• Est. Priority Date: 10/10/2003
• Status: Active Grant

• Current Assignee: Clozex Medical LLC (3M Company)
• Original Assignee: Clozex Medical LLC (3M Company)
• Inventors: Barbuto, Raymond, Lebner, Michael
• Granted Patent: US 7,332,641 B2
• Time in Patent Office: Days
• US Class Current: 606/216
• CPC Class Codes: A61B 17/0466 Suture bridges
• CPC Class Codes: A61B 17/085 with adhesive layer
• CPC Class Codes: A61B 2017/086 having flexible threads, filaments, laces or wires, e.g. parallel threads, extending laterally from a strip, e.g. for tying to opposing threads extending from a similar strip
• CPC Class Codes: B21L 3/00 Making chains or chain links by bending the chain links or link parts and subsequently welding or soldering the abutting ends B21L7/00 takes precedence
• CPC Class Codes: F21V 21/104 Pendants

Abstract

Disclosed are methods for producing an interlaced device or composition which includes at least a first and a second interlaced element. Each interlaced element includes a mated first and second part, the first part having two termini and the second part having two termini, and a defined central void through which the other interlaced element passes. The method includes the processing and mating of a first and a second substrate layer, each including a top surface, a bottom surface and a mating zone. The first substrate layer includes a portion corresponding to a first part of a first interlaced element and a first part of a second interlaced element. The second substrate layer includes a portion corresponding to a second part of a first interlaced element and a second part of a second interlaced element. Also disclosed are interlaced devices or compositions.

Claims

1. A method for producing an interlaced device, the device comprising a first and a second interlaced element, each interlaced element comprising a mated first and second part, the first part having two termini and the second part having two termini, and a defined central void through which the other interlaced element passes, the method comprising:

a) providing a first and a second substrate layer, the first and second substrate layers each comprising a top surface, a bottom surface and a mating zone, the first substrate layer to having a portion corresponding to a first part of a first interlaced element and a first part of a second interlaced element and the second substrate layer having a portion corresponding to a second part of a first interlaced element and a second part of a second interlaced element;

b) introducing terminal end cuts in the first substrate layer for the first part of the first interlaced element and the first part of the second interlaced element;

c) introducing cross-over point cuts in the first substrate layer for the first part of the first interlaced element first part of the second interlaced element;

d) introducing terminal end cuts in the second substrate layer for the second part of the first interlaced element and the second part of the second interlaced element;

e) introducing cross-over point cuts in the second substrate layer to define a cross-over point of the second part of the first interlaced element and a cross-over point of the second part of the second interlaced element;

f) mating the top surface of the first substrate layer to the bottom surface of the second substrate layers by aligning the mating zones and interlaced element parts;

g) bonding the top and bottom substrate layers along the mating zones; and

h) completing, any cuts necessary to fully define the first and second interlaced elements.

2. The method of claim 1 wherein the first and second substrate layers are produced from a material selected from the group consisting of polymer, sheet metal, foil, textile and hide.

3. The method of claim 1 wherein the substrate layers are cut by a die cut process.

4. The method of claim 1 wherein the substrate layers are cut by a laser cutting device.

5. The method of claim 1 wherein the bonding of step g) is carried out using an adhesive.

6. The method of claim 1 wherein the bonding of step g) is carried out using an ultrasonic welding technique.

7. The method of claim 1 wherein step h) includes cutting away portions of the bonded mating zone which, in a preferred embodiment, do not directly link the first portion of a first interlaced element to the second portion of an interlaced element.

8. A method for producing an interlaced device, the device comprising at least two interlaced elements, each of the interlaced element comprising at least two parts with each part having at least two termini that are mated during production, and a defined central void through which at least one other interlaced element passes, the method comprising:

a) providing at least a first and a second substrate layer, each substrate layer comprising a top surface, a bottom surface and a mating zone, the substrate layers to be processed to form at least four interlacing parts, each of the interlacing parts processed from a single substrate layer being mated with one part from another substrate layer to create an interlaced element;

b) introducing terminal end cuts in each substrate layers for each interlacing part;

c) introducing cross-over point cuts in each substrate layers to define cross-over points, with at least one cross-over point on each interlacing part;

d) mating the substrate layers by aligning mating zones;

e) bonding the substrate layers along the mating zones; and

f) completing any cuts necessary to fully define the interlaced elements.

9. The method of claim 8 wherein the first and second substrate layers are produced from a material selected from the group consisting of polymer, sheet metal, foil, textile and hide.

10. The method of claim 8 wherein the substrate layers are cut by a die cut process.

11. The method of claim 8 wherein the substrate layers are cut by a laser cutting device.

12. The method of claim 8 wherein the bonding of step e) is carried out using an adhesive.

13. The method of claim 8 wherein the bonding of step e) is carried out using an ultrasonic welding technique.

14. The method of claim 8 wherein step f) includes cutting away portions of the bonded mating zone which do not directly link the first portion of a first interlaced element to the second portion of an interlaced element.

15. A method for manufacturing an interlaced two-component device useful for altering the spatial relationship between two surfaces, or two portions of a single surface, the two-component closure device comprising:

a) a first component, the first component comprising;

i) a first anchoring element for attachment to the surface of an article, the first anchoring element having an inner edge and an outer edge;

ii) a plurality of first connecting elements extending from the inner edge of the first anchoring element, at least a portion of the plurality of first connecting elements having a two layer thickness;

iii) a first pulling element having an outer edge, and an inner edge, the inner edge being joined to the plurality of first connecting elements;

b) a second component, the second component comprising;

i) a second anchoring element for attachment to the surface of an article, the second anchoring element having an inner edge and an outer edge;

ii) a plurality of second connecting elements extending from the inner edge of the second anchoring element, at least a portion of the plurality of second connecting elements having a two layer thickness;

iii) a second pulling element having an outer edge, and an inner edge, the inner edge being joined to the plurality of second connecting elements;

c) means for attaching the first connecting elements to the second anchoring element and means for attaching the second connecting elements to the first anchoring element, the method for manufacturing comprising;

i) providing a bottom substrate layer having a top surface, a bottom surface, a left edge, a right edge, and a mating zone and processing the bottom substrate layer according to the following steps;

(1) cutting two parallel series of cut-outs, the first parallel cut-out series extending from the left edge of the mating zone toward the left edge of the bottom substrate layer, the second parallel cut-out series extending from the right edge of the mating zone toward the right edge of the bottom substrate layer, the portion of the bottom substrate layer remaining left of the mating zone between individual cut-outs in the first series of parallel cut-outs defining the connecting elements of a series of first components, the inner edge of the series of first pulling elements, and an edge to be further processed to define the inner edge of the first anchoring element, the portion of the bottom substrate layer remaining right of the mating zone between individual cot-outs in the second series of parallel cut-outs defining the connecting elements of a series of second components, the inner edge of the series of second pulling elements, and an edge to be further processed to define the inner edge of the second anchoring element;

ii) providing a top substrate layer having a top surface, a bottom surface and a mating zone and processing the top substrate layer according to the following steps;

(1) cutting a first and second series of slits at the two boundaries of the mating zone, the first and second series of slits forming the inner edges of the to-be-formed first and second anchoring elements;

(2) cutting a third series of slits through the top substrate layer, the third series of slits defining the outer edge of the first anchoring element opposite its associated inner edge in the to-be-completed first anchoring element;

(3) cutting a fourth series of slits through the top substrate layer, the fourth series of slits defining the outer edge of the second anchoring element opposite its associated inner edge in the to-be-completed second anchoring element;

iii) aligning the bottom substrate layer and the top substrate layer in two dimensions and mating the top surface of the bottom substrate layer with the bottom surface of the top substrate layer;

iv) bonding the mated top surface and bottom surface along the length of the mating zone;

v) introducing a series of cross-mating zone cuts through both layers of the mated substrates thereby extending connecting elements from one side of the mating zone to the opposite side of the mating zone, each of the cross-mating zone cuts intersecting with a pre-existing cut on both sides of the mating zone;

vi) completing the formation of the first and second pulling tabs; and

vii) introducing a series of cuts through the first and second substrate layers, the series of cuts intersecting with the second, third and fourth series of slits formed in step c)1), c)2) and c)3), thereby releasing individual, interlaced two-component closure devices.

16. The method of claim 15 wherein the first and second substrate layers are produced from a material selected from the group consisting of polymer, sheet metal, foil, textile and hide.

17. The method of claim 15 wherein the substrate layers are cut by a die cut process.

18. The method of claim 15 wherein the substrate layers are cut by a laser cutting device.

19. The method of claim 15 wherein the bonding of step c)iv) is carried out using an adhesive.

20. The method of claim 15 wherein the bonding of step c)iv) is carried out using an ultrasonic welding technique.

21. A method for manufacturing an interlaced wound closure device comprising two interlaced elements, each interlaced element being produced from two or more substrate layers, each interlaced element having a plurality of overlapping and bonded portions at which at least two substrate layers are joined to form an interlaced element, each interlaced element further comprising:

a) an adhesive-backed anchoring element having a substantially linear wound edge;

b) a plurality of connecting elements having removable and non-removable portions, the plurality of connecting elements extending from the wound edge in a first direction, at least a portion of the lower surface of the connecting elements being adhesive-backed; and

c) a pulling element attached to the connecting members, the method of manufacturing comprising;

i) providing a bottom substrate layer having a top surface, a bottom surface, a left edge, a right edge and a center line bisecting a mating zone and processing the bottom substrate layer according to the following steps;

(1) applying to the top surface of the bottom substrate layer, a first adhesive layer suitable for securing a connecting element to an anchoring element when the device is in use;

(2) applying an adhesive-kill layer to the portions of the first, adhesive layer which will comprise the to-be-formed pulling elements, and removable portions of connecting elements;

(3) applying a first release liner along the left edges of the bottom substrate layer, the first release liner extending from the left edge of the bottom substrate layer toward the center line of the bottom substrate layer and terminating at the left edge of the mating zone;

(4) applying a second release liner along the right edge of the bottom substrate layer, the second release liner extending from the right edge of the bottom substrate layer toward the center line of the bottom substrate layer and terminating at a point near the center line which defines the right edge of the mating zone;

(5) applying a third release liner covering adhesive previously applied over the mating zone;

(6) cutting two parallel series of cut-outs through the bottom substrate layer and associated release liners, the first parallel cut-out series extending from the left edge of the mating zone toward the left edge of the bottom substrate layer, the second parallel cut-out series extending from the right edge of the mating zone toward the right edge of the bottom substrate layer, the portion of the bottom substrate layer remaining left of the mating zone between individual cut-outs in the first series of parallel cut-outs defining the connecting elements of a series of first interlaced elements, the portion of the bottom substrate layer remaining right of the mating zone between individual cut-outs in the second series of parallel cut-outs defining connecting elements of a series of second interlaced elements;

ii) providing a top substrate layer having a top surface, a bottom surface and a center line bisecting a mating zone and processing the top substrate layer according to the following steps;

(1) applying a second adhesive layer to the top surface of the top substrate layer, the second adhesive layer comprising an adhesive suitable for securing an anchoring element to the skin of an individual when the device is in use;

(2) applying an adhesive-kill layer to a portion of the second adhesive layer comprising the mating zone;

(3) applying a fourth release liner to the portion of the second adhesive layer exposed to the left side of the mating zone following the adhesive-kill step;

(4) optionally applying a first longitudinal crease in the fourth release liner, the first longitudinal crease being substantially parallel to the margin of the mating zone, the position of the first longitudinal crease in the X-dimension of the fourth release liner falling within the boundary of the to-be-formed second adhesive-backed anchoring element;

(5) applying a fifth release liner to the portion of the second adhesive layer exposed to the right side of the mating zone following the adhesive-kill step,

(6) optionally applying a second longitudinal crease, the second longitudinal crease being applied to the fifth release liner, the second longitudinal crease being substantially parallel to the margin of the mating zone, the position of the second longitudinal crease in the X-dimension of the fifth release liner falling within the boundary of the to-be-formed first adhesive-backed anchoring element;

(7) applying a third adhesive layer and a protective release liner to the portion of the fourth release liner bounded in the X-dimension by the adhesive-killed portion, and the first longitudinal crease, if present, or by an imaginary line drawn to meet the positioning requirements of the first longitudinal crease;

(8) applying a fourth adhesive layer and a protective release liner to the portion of the fifth release liner bounded in the X-dimension by the adhesive-killed portion, and the second longitudinal crease, if present, or by an imaginary line drawn to meet the positioning requirements of the second longitudinal crease;

(9) cutting a first and second series of slits at the two boundaries of the mating zone, the first and second series of slits forming the wound edges of the to-be-formed first and second adhesive-backed anchoring elements;

(10) cutting a third series of slits through the fourth release liner and the attached top substrate layer, the third series of slits defining an edge of the first adhesive-backed anchoring element opposite its associated wound edge in the to-be-completed first adhesive-backed anchoring element;

(11) cutting a fourth series of slits through the fifth release liner and the attached top substrate layer, the fourth series of slits defining an edge of the second adhesive-backed anchoring element opposite its associated wound edge in the to-be-completed second adhesive-backed anchoring element;

iii) removing the third release liner from the top surface of the bottom substrate layer;

iv) aligning the top and bottom substrate layers in two dimensions and mating the top surface of the bottom substrate layer with the bottom surface of the top substrate layer using the adhesive layer exposed by the removal of the third release liner;

v) introducing cross-mating zone cuts to extend connecting elements, portions of which are pre-existing in the bottom substrate layer, across the mating zone, each cross-mating zone cut intersecting with a pre-existing cut in both the top and bottom substrate layers on both sides of the mating zone;

vi) removing the release liner from the third and fourth adhesive layers;

vii) applying to the adhesive layers exposed in the preceding step, a strip of semi-rigid material to be further processed to form a series of first and second members of a series of flip tab pairs, the left edge of the strip being aligned with the outer edge of the third adhesive layer, the right edge of the strip being aligned with the outer edge of the fourth adhesive, the strip being incompletely cut to form a frangible line in the area applied over the mating zone of the mated top and bottom substrate layers;

viii) completing the formation of the first and second pulling tabs by introducing any necessary cuts; and

ix) introducing a series of cuts through all layers of the mated assembly, the series of cuts intersecting with the second, third and fourth series of slits, thereby releasing individual, interlaced two-component wound closure devices.

22. An interlaced wound closure device comprising two interlaced elements, each interlaced element being produced from two or more substrate layers, each interlaced element having a plurality of overlapping and bonded portions at which the at least two substrate layers are joined to form an interlaced element, each interlaced element further comprising:

i) an adhesive-backed anchoring element having a substantially linear wound edge;

ii) a plurality of connecting elements extending from the wound edge in a first direction, at least a portion of the lower surface of the connecting elements being adhesive-backed; and

iii) a pulling element attached to the connecting elements.

23. The device of claim 22 wherein the connecting elements comprise removable and non-removable portions and the pulling element is attached to the removable portion.

24. The device of claim 23 wherein the removable and non-removable portions of the connecting elements are separated by a perforation in the connecting elements.

25. The device of claim 22 wherein the adhesive-backed portions of the device are protected by release liners.

26. The device of claim 22 wherein the overlapping and bonded portions of each interlaced element comprise portions of connecting elements.

27. The device of claim 26 wherein the portions of connecting elements comprise those portions which span the area over a laceration or incision, between two attached anchoring elements, in an applied device.

28. The device of claim 27 further comprising an applied strip preserving an as manufactured relationship of the two interlaced elements.

29. The device of claim 28 wherein the applied strip is produced from a semi-rigid polymer.

30. The device of claim 28 wherein the as-manufactured relationship of the two interlaced elements comprises parallel, spaced-apart relation between wound edges of the two interlaced elements.

31. The device of claim 30 wherein the applied strip produced from a semi-rigid polymer spans the spaced-apart portion between parallel wound edges and is adhered to portions of release liners protecting adhesive-backed surfaces of anchoring elements.

32. The device of claim 31 wherein the applied strip produced from a semi-rigid polymer is incompletely cut to form a frangible line.

33. A method for producing an interlaced device, the device comprising at least two interlaced elements, at least one of every two of the interlaced elements comprising at least two parts with each part having at least two termini ends that are mated during production, and a defined central void through which at least one other interlaced element passes, the method comprising:

a) providing at least a first and a second substrate layer, each substrate layer comprising a top surface, a bottom surface and a mating zone, the substrate layers to be processed to form at least two interlacing parts, each of the interlacing parts processed from a single substrate layer being mated with one part from another substrate layer to create an interlaced element;

b) introducing terminal end cuts in each substrate layers for each of its interlacing parts;

c) introducing cross-over point cuts in each substrate layer to define cross-over points for each interlacing parts;

d) mating the substrate layers by aligning mating zones;

e) bonding the substrate layers along the mating zones; and

f) completing any cuts necessary to fully define the interlaced elements.

34. The method of claim 33 wherein the first and second substrate layers are produced from a material selected from the group consisting of polymer, sheet metal, foil, textile and hide.

35. The method of claim 33 wherein the substrate layers are cut by a die cut process.

36. The method of claim 33 wherein the substrate layers are cut by a laser cutting device.

37. The method of claim 33 wherein the bonding of step g) is carried out using an adhesive.

38. The method of claim 33 wherein the bonding of step g) is carried out using an ultrasonic welding technique.

39. The method of claim 33 wherein step h) includes cutting away portions of the bonded mating zone which, in a preferred embodiment, do not directly link the first portion of a first interlaced element to the second portion of an interlaced element.