JPWO2021048409A5

JPWO2021048409A5 -

Info

Publication number: JPWO2021048409A5
Application number: JP2022516214A
Authority: JP
Publication date: 2023-08-18

Description

好ましくは、リザーバは、接着剤が医療用インプラントの片側でのみ放出されるように適合される。特に、それは、パッチの遠位側またはパッチの近位側でのみ放出されてもよい。しかしながら、接着剤が医療用インプラントの側壁側でのみ放出されることも想定される。これにより、組織に面する接着剤の適切な配置が保証され、医療用インプラントが組織と動作可能に接触せず、そのように設計されていない場合、接着剤の放出が防止される。その結果、接着剤組成物の必要量も低減される。これは、患者にとってより経済的で安全である。医療用インプラントは、各側で異なる材料を選択することによって、各側で材料の厚さおよび／もしくは密度を変化させることによって、発泡体の孔径および／もしくは構造を変化させることによって、または、接着剤組成物のインプラント材料の透過性を変化させ得る任意の他の特性を変化させることによって、片側でのみ接着剤を放出するように適合され得る。 Preferably, the reservoir is adapted so that the adhesive is released only on one side of the medical implant. In particular, it may be released only on the distal side of the patch or on the proximal side of the patch. However, it is also envisioned that the adhesive is released only on the sidewall side of the medical implant. This ensures proper placement of the tissue-facing adhesive and prevents release of the adhesive if the medical implant is not in operable contact with the tissue and is not designed to do so. As a result, the required amount of adhesive composition is also reduced. This is more economical and safer for patients. Medical implants can be made by choosing different materials on each side, by varying the thickness and/or density of the material on each side, by varying the pore size and/or structure of the foam, or by bonding It can be adapted to release adhesive only on one side by altering any other property of the agent composition that can alter the permeability of the implant material.

好ましくは、接着剤組成物は、液体、特に有機溶媒、生理食塩水、および血液のうちの１つに暴露されると少なくとも部分的に溶解し、ゲル、特にヒドロゲルを形成するように適合される。 Preferably , the adhesive composition is adapted to at least partially dissolve upon exposure to one of a liquid, particularly an organic solvent, saline, and blood, forming a gel, particularly a hydrogel. be done.

好ましくは、繊維は生分解性材料から作製される。
好ましくは、生分解性材料は、ポリ（乳酸－ｃｏ－グリコール酸）、ポリ（Ｌ－乳酸）、ポリ（Ｄ－乳酸）、ポリ（グリコール酸）、ポリ（カプロラクトン）、これらの材料の任意のコポリマーおよび／またはブレンドからなる群から選択される。これらの材料は、非毒性であり、周知であり、医療用途に承認されており、市場で容易に入手可能であるという点で特に有利である。 Preferably, the fibers are made from biodegradable materials.
Preferably, the biodegradable material is poly(lactic-co-glycolic acid), poly(L-lactic acid ) , poly(D-lactic acid), poly(glycolic acid), poly(caprolactone), any of these materials. selected from the group consisting of copolymers and/or blends; These materials are particularly advantageous in that they are non-toxic, well known, approved for medical use, and readily available commercially.

Claims

A patch (5) adapted to repair or close a medical implant (1), preferably a defect (D), preferably an opening in a ventricular or atrial wall or vessel wall (W),
The medical implant (1) comprises an adhesive composition (6),
Said medical implant (1) comprises two states, in a first state said medical implant (1) is deployed at an implantation site while said adhesive composition (6) is inert. and placed in a second state, preferably at said implantation site, by an activation mechanism;
A medical implant (1), wherein said adhesive composition (6) is curable in said second state by a curing mechanism.

In said first state said medical implant (1) is adapted to contain said adhesive composition (6) and in said second state to release said adhesive composition (6) 2. Medical implant (1) according to claim 1, comprising at least one cavity (24).

3. The medical implant according to claim 2, wherein said cavity has at least two interfaces and at least one property, preferably at least one of permeability and solubility, differs between said two interfaces.

3. Medical implant according to claim 1 or 2, comprising a radiopaque element (106, 107, 108, 109).

A support structure (31, 107, 109) is provided, and said radiopaque elements (106, 107, 108, 109) are preferably disposed within or by said support structure (31). 5. The medical implant of claim 4 formed.

Said radiopaque element (106, 107, 108, 109) is disposed within or formed by said adhesive composition (6, 104, 117', 117''). 6. The medical implant according to claim 4 or 5, wherein the medical implant is

The medical implant according to any one of claims 4-6, wherein said radiopaque element (106, 107, 108, 109) comprises at least one of barium sulfate and iodine.

Medical implant according to any one of the preceding claims , wherein the implant (1) comprises at least one discrete marker (110).

9. The medical implant of claim 8, wherein the marker (110) is at least one of radiopaque and echogenic.

10. Medical implant according to claim 8 or 9, wherein the implant comprises at least two discrete markers (110) arranged at a predetermined distance and/or orientation from each other.

Said medical implant (1) has a generally flat shape with a first surface (101′, 103′) and a second surface (101′, 103″), said first surface (101 ', 103') and said second surface (102, 103'') have substantially opposite orientations, and at least one property of said first surface (101', 103') is characterized in that said Medical implant according to any one of the preceding claims, which differs from the corresponding properties of the second surface (102, 103'').

12. The medical implant of claim 11, wherein said first surface (101', 103') is adapted to enhance cell ingrowth.

Said second surface (102, 103'') is so as to provide adhesion to biological tissue, preferably human tissue, most preferably one of endocardial tissue, pericardial tissue and septal tissue. 13. Medical implant according to claim 11 or 12, adapted.

Medical implant according to any one of the preceding claims, wherein at least one surface of said implant comprises a velor-like surface (101'').

The medical implant according to any one of the preceding claims , wherein the adhesive composition is arranged on the medical implant, preferably in a non-uniform pattern.

Medical implant according to any one of the preceding claims , wherein the adhesive composition comprises GelMA, preferably Animal-derived GelMA, particularly preferably Fish GelMA or Porcine GelMA.

17. Medical implant according to claim 16, wherein said GelMA is formed by a mixture of at least two GelMAs of animal origin, preferably a mixture of fish GelMA and porcine GelMA.

18. The medical implant of claim 16 or 17, wherein said adhesive composition further comprises a photoinitiator.

The medical implant according to any one of claims 16-18, wherein said GelMA is crosslinkable by X-ray radiation.

Medical implant according to any one of the preceding claims, comprising at least one rivet ( 130 ), preferably a blind rivet, for attaching said implant to tissue.

1-, comprising at least a retaining element (123, 124) for retaining a suture (125) around the circumference of said implant; and a suture (123, 124) disposed within said loop (124). 21. The medical implant according to any one of 20 .

22. Medical implant according to claim 21, wherein said at least one retaining element (123, 124) is formed from the same material as said medical implant (1).

23. Medical implant according to claim 21 or 22, wherein said at least one retaining element (123, 124) is made of polyurethane with a thickness of 35-65 μm, preferably 45-55 μm.

The medical implant according to any one of claims 21 to 23, wherein said at least one retaining element (123, 124) is configured as a separate element arranged on said medical implant (1).

Medical implant according to any one of claims 21 to 24, wherein said at least one retaining element (123, 124) comprises a predetermined breaking point, in particular an indentation (122, 127).

Medical implant according to any one of the preceding claims , wherein said adhesive composition comprises, preferably consists of, a dry adhesive composition (111', 112').

27. The medical implant of claim 26, wherein said dry adhesive composition is activatable by exposure to liquid.

A method for deploying a medical implant (1) with an adhesive, preferably a medical implant (1) with an adhesive according to claim 1, comprising:
deploying the medical implant (1) in a first state at a first site;
and placing said medical implant (1) in a second state by an activation mechanism, wherein said adhesive is cured by a curing mechanism.

29. Method according to claim 28, comprising increasing the temperature to bring the medical implant (1) into the second state.

30. A method according to claim 29, wherein said temperature increase is provided at least partially by an external heat source, preferably by said external heat source only.

31. A method according to any one of claims 29 or 30, wherein the temperature increase is provided at least partially by the patient's body heat, preferably solely by the patient's body heat.

A method according to any one of claims 29 to 31, wherein said temperature increase is provided at least partially by electromagnetic radiation, preferably by said electromagnetic radiation alone.

A method according to any one of claims 28 to 32, comprising applying an increased pressure to bring the implant into said second condition.

34. The method of claim 33, wherein said pressure increase is caused at least in part by osmotic pressure.

35. Method according to claim 33 or 34, wherein said pressure increase is at least partially caused by applying a mechanical deformation, preferably a mechanical pressure, to said medical implant (1).

36. The method of any one of claims 28-35, comprising exposing the implant to humidity to place the implant in the second state.

37. The method of any one of claims 28-36, comprising exposing the implant to electromagnetic radiation to place the implant in the second state.

A method according to any one of claims 28 to 37, comprising spontaneously mixing the two components in said second state causing curing of said adhesive.

39. The method of any one of claims 28-38, comprising exposing the implant to electromagnetic radiation in the second state to cause curing of the adhesive.

A method according to any one of claims 28 to 39, comprising inflating a separate inflation reservoir (27) to bring said medical implant (1) into said second state.

Claims 28-40, comprising placing a liquid, preferably an organic solvent, even more preferably an organic solvent miscible with human blood, to place said medical implant (1) in said second state. A method according to any one of

A medical implant (1) adapted to repair or close a defect (D), preferably an opening in a ventricular or atrial wall or vessel wall (W), preferably according to any one of claims 1 to 25 A medical implant (1) according to
said medical implant (1) comprises at least one tear line (3) located close to the periphery of said medical implant (1);
adapted to be able to attach said medical implant (1) to a tissue wall and tear along said tear line (3) upon deployment to an implantation site, preferably a septal defect site (D). A medical implant (1).

43. Any of claims 1-25 or 42, comprising a biodegradable material adapted to lose mechanical strength within the human body within 6-36 months, preferably within 12 months, even more preferably within 6 months. Medical implant (1) according to claim 1.

said medical implant (1) between said outer edge (OC) and said tear line (3) by means of a non-adhesive coating (2), preferably at least one of silicone and poly(tetrafluoroethylene) 44. Medical implant (1) according to claim 42 or 43, which is coated.

Said medical implant (1) preferably comprises a cross-shaped notch (4), said notch adapted to allow the delivery device to extend partially through said notch (4). A medical implant (1) according to any one of claims 42-44.

46. Medical implant (1) according to any one of claims 42 to 45, wherein said medical implant (1) comprises fibers (26), preferably woven, spun or knitted fibers (26).

47. Medical implant (1) according to claim 46, wherein said fibers (26) are made of biodegradable material.

Said biodegradable materials include poly(lactic-co-glycolic acid), poly(L-lactic acid), poly(D-lactic acid), poly(glycolic acid), poly(caprolactone), any copolymers of these materials and 48. Medical implant (1) according to claim 47, selected from the group consisting of/or blends.

49. Any one of claims 1 to 27 or 42 to 48 , comprising a spine structure (31), preferably a spine structure (31) having different mechanical properties than the rest of the medical implant (1). A medical implant (1) according to .

50. Medical implant according to claim 49, wherein the spine structure (31) comprises, preferably consists of polyurethane.

50. The medical implant (1) according to claim 49, wherein said spine structure extends beyond said medical implant (1) to provide inelastic tear arms.

52. Claims 20 to 25 and 51, wherein the retaining element (123, 124) is formed by or on the inelastic tearing arm (120, 126). medical implants.

Claims 42-48, wherein said medical implant (1) comprises an adhesive composition (6), in particular an adhesive composition (6) adapted to attach said medical implant (1) to human tissue. A medical implant (1) according to any one of Claims 1 to 3.

54. The medical implant (1) according to any one of claims 42-53, wherein said tear line (3) comprises a laser cut tear line (3).

55. The medical implant (1) according to any one of claims 42 to 54, comprising at least one extension (13) extending radially beyond the periphery of the medical implant (1).

56. The medical implant (1) according to claim 55, wherein said at least one extension (13) comprises one of a string and a suture.

57. Medical implant (1) according to claim 55 or 56, wherein said at least one extension (13) comprises a strip of the same material as said medical implant (1).

58. According to any one of claims 20-25 and 55-57, wherein said retaining element (123, 124) is formed by said at least one extension (120, 126) medical implants.

4. The at least one tear line (3) is adapted, particularly arranged and dimensioned, to undergo tearing and separate the at least one extension (13) from the medical implant (1). 58. Medical implant (1) according to any one of claims 55-57.

60. According to claim 55 or 59, wherein said extension (13) is adapted to hold said medical implant (1), preferably patch (5), against a delivery device, preferably a balloon (B). Medical implant (1) as described.

Medical implant (1) according to any one of claims 42 to 60, wherein said medical implant (1) is formed by part of the surface of an inflatable balloon (B) of a delivery device.

A delivery device for delivering a medical implant (1) according to any one of claims 42 to 61, preferably comprising an adhesive (6), comprising:
A shaft (S) having an implant holder (21) for holding said implant (1), said implant holder (H) preferably holding said implant (1) at least partially along its circumference. comprising a shaft (S) adapted to
Said delivery device comprises an actuation mechanism for increasing the distance between at least two predetermined points of said implant such that said tear line (3) is at least partially broken upon actuation of said actuation mechanism. A delivery device, further comprising:

63. The delivery device of claim 62, wherein said actuation mechanism comprises an inflatable balloon (B).

Said delivery device (C), preferably said implant holder, is a suture (125) adapted to hold at least one suture (125) connected or connectable to said medical implant (1) 64. A delivery device according to claim 62 or 63, having a retaining element (129) of .

65. The method of claims 62-64, further comprising a gauge (114', 114'') preferably arranged on the handle (113) for indicating the adhesive force between the medical implant (1) and tissue. 10. The delivery device of any one of clauses.

A medical implant (1), preferably a patch, preferably adapted to close an opening in a defect (D), preferably a heart wall or a vessel wall (W), preferably any of claims 1-25 or 42-61 1. A medical implant (1) according to claim 1,
at least one connecting element (9, 22), preferably a bead (9), arranged at the outer edge (OC) of the implant,
such that said connecting elements (9, 22) are adapted to engage a delivery device (C) having suitable mating elements (10, 11, 12, 21) for connection with said connecting elements; , a medical implant (1), wherein said connecting element has a size, in particular a thickness (T), of said implant (1).

67. Medical implant (1) according to claim 66, wherein said connecting elements (9, 22) comprise polymeric or metallic material.

A delivery device for delivering a medical implant (1), preferably a medical implant (1) according to claim 66, comprising:
at least one tube (10) comprising an actuation element (11), preferably a wire arranged in said tube;
at least one holder (12a, 12b), preferably at least two holders, preferably at least two holders, operably connected to said actuating element (11) and preferably attached to said wire, said tube (10) and said at least one Two holders (12a, 12b), preferably said at least two holders, are arranged such that said at least one holder (12a, 12b), preferably said at least two holders ( 12a, 12b),
Delivery device, wherein said medical implant (1), preferably a medical implant (1) according to claim 66, can be released by actuation of said actuating element (11).

A method for manufacturing a medical implant, preferably a medical implant (1) according to any one of claims 1-27 or 42-67 , wherein the adhesive composition is at least partially liquid, The method further comprising the step of drying the adhesive composition disposed on at least one surface of the medical implant.

A method for manufacturing a medical implant, preferably a medical implant according to any one of claims 21 to 25, preferably a method according to claim 69, characterized in that a Placing and in particular said stretching, placing at least one stretching element (120, 126), said stretching element (120, 126) preferably comprising a predetermined breaking point (122, 127) Said at least one extension element ( 120, 126) to form retaining elements (123, 124); and arranging said extension elements (120, 126) to comprise retention elements (123, 124), preferably placing a suture (125) within said retention elements (123, 124), preferably The method further comprising placing within said substantially closed loop.

71. A method according to claim 69 or 70 , wherein said adhesive composition is placed on said medical implant (1) via inkjet printing.

71. A method according to claim 69 or 70 , wherein said adhesive composition is arranged in a predetermined pattern on said medical implant (1).

A method of treating a defect (D), preferably an opening in the ventricular or atrial wall or vessel wall (W), comprising a medical implant, preferably according to claims 1 to 25, or 42 to 61, or 66, or 67, wherein the medical implant comprises an adhesive composition, the method further comprising hydrating the adhesive composition in situ. Prepare, how.

Method for treating a defect (D), preferably an opening in the ventricular wall or atrium or vessel wall (W), comprising a medical implant (1), preferably according to any one of claims 21-25. and pulling at least one suture (125), said medical implant (1) being released by pulling said suture (125).