Disclosed herein are implantable fistula treatment devices and related methods. In some embodiments, an anorectal fistula treatment device may comprise a disc-shaped distal anchor comprising a concave side and a convex side, an outer edge region, an inner sealing region protruding from the concave s
Disclosed herein are implantable fistula treatment devices and related methods. In some embodiments, an anorectal fistula treatment device may comprise a disc-shaped distal anchor comprising a concave side and a convex side, an outer edge region, an inner sealing region protruding from the concave side, and an attachment region configured for attachment to a connecting member. The inner sealing region may have a greater thickness than at least a portion of the attachment region and the outer edge region may be oriented at an acute angle to the inner sealing region. The distal anchor may have a tapered edge and the outer edge region and inner sealing region may be configured to form separate seals against tissue about a distal opening of an anorectal fistula.
대표청구항▼
1. An anorectal fistula treatment device, comprising: a disc-shaped distal anchor, comprising:a concave side;a convex side;an outer edge region, comprising a first ring along an outer edge of the distal anchor; an inner sealing region protruding from the concave side and comprising a second ring con
1. An anorectal fistula treatment device, comprising: a disc-shaped distal anchor, comprising:a concave side;a convex side;an outer edge region, comprising a first ring along an outer edge of the distal anchor; an inner sealing region protruding from the concave side and comprising a second ring concentrically disposed within the first ring;a concave transition formed by the outer edge region and extending from the inner sealing region toward the outer edge of the distal anchor;an attachment region protruding from a center of the concave side of the distal anchor and configured for attachment to a connecting member; andan intermediate region between the inner sealing region and the attachment region, wherein the attachment region has a greater average thickness than the intermediate region;wherein the inner sealing region has a greater thickness than at least a portion of the attachment region. 2. The anorectal fistula treatment device of claim 1, wherein the distal anchor has a tapered edge and wherein the outer edge region and inner sealing region are configured to form separate seals against tissue about a distal opening. 3. The anorectal fistula treatment device of claim 2, wherein the diameter of the distal anchor is in a range of about 0.6″ to 0.9″. 4. The anorectal fistula treatment device of claim 1, wherein the outer edge region comprises an average thickness that is less than 10% of an outer diameter of the distal anchor. 5. The anorectal fistula treatment device of claim 1, wherein the outer edge region comprises an average thickness that is in a range of about 3% and 5% of an outer diameter of the distal anchor. 6. The anorectal fistula treatment device of claim 1, wherein the outer edge region comprises an average thickness that is in a range of about 0.005″ and 0.03″. 7. The anorectal fistula treatment device of claim 1, wherein the outer edge region comprises a width that is in a range of about 5% and 60% of an outer diameter of the distal anchor. 8. The anorectal fistula treatment device of claim 1, wherein the outer edge region comprises a width that is in a range of about 15% and 30% of an outer diameter of the distal anchor. 9. The anorectal fistula treatment device of claim 1, wherein the outer edge region comprises a width that is in a range of about 0.01″ and 0.45″. 10. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises an average thickness that is less than 25% of an outer diameter of the distal anchor. 11. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises an average thickness that is in a range of about 5% and 10% of an outer diameter of the distal anchor. 12. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises an average thickness that is in a range of about 0.03″ and 0.09″. 13. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises a width that is in a range of about 5% and 45% of an outer diameter of the distal anchor. 14. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises a width that is in a range of about 5% and 25% of an outer diameter of the distal anchor. 15. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises a width that is in a range of about 0.05″ and 0.35″. 16. The anorectal fistula treatment device of claim 1, wherein the attachment region comprises an average thickness that is in a range of about 5% and 25% of an outer diameter of the distal anchor. 17. The anorectal fistula treatment device of claim 1, wherein the attachment region comprises an average thickness that is at least 30% of an outer diameter of the distal anchor. 18. The anorectal fistula treatment device of claim 1, wherein the attachment region comprises an average thickness that is in a range of about 0.08″ and 0.15″. 19. The anorectal fistula treatment device of claim 1, wherein the attachment region comprises a width that is in a range of about 15% and 60% of an outer diameter of the distal anchor. 20. The anorectal fistula treatment device of claim 1, wherein the attachment region comprises a width that is in a range of about 25% and 40% of an outer diameter of the distal anchor. 21. The anorectal fistula treatment device of claim 1, wherein the attachment region comprises a width that is in a range of about 0.15″ and 0.35″. 22. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises concentric outer and inner edges, and wherein the distal anchor further comprises a radius of curvature, measured radially between the inner edges of the inner sealing region, that is in a range of about 20% and 85% of an outer diameter of the distal anchor. 23. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises concentric outer and inner edges, and wherein the distal anchor further comprises a radius of curvature, measured radially between the inner edges of the inner sealing region, that is in a range of about 35% and 55% of an outer diameter of the distal anchor. 24. The anorectal fistula treatment device of claim 1, wherein the inner sealing region comprises concentric outer and inner edges, and wherein the distal anchor further comprises a radius of curvature, measured radially between the inner edges of the inner sealing region, that is in a range of about 0.12″ and 0.75″. 25. A disc-shaped distal anchor of an anorectal fistula treatment device, the disc-shaped distal anchor comprising: a concave side;a convex side;an outer edge region disposed along an outer edge of the distal anchor;an inner sealing region protruding from the concave side and disposed within the outer edge region;an attachment region disposed within the inner sealing region and configured for attachment to a connecting member; andat least one layer member coupled with the attachment region;wherein the at least one layer member comprises a middle layer member embedded within the attachment region; andwherein the middle layer member comprises a disc made of a first material that has at least one of a greater strength or a greater rigidity than that of a second material of which the disc-shaped distal anchor is made. 26. The disc-shaped distal anchor of claim 25, wherein the disc comprises a mesh material. 27. The disc-shaped distal anchor of claim 25, wherein the disc comprises a solid material. 28. The disc-shaped distal anchor of claim 25, wherein the middle layer member is sandwiched between two additional layer members formed from upper and lower surfaces of the disc-shaped distal anchor.
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