BIOMEDICAL DEVICE FOR WATERTIGHT SEALING OF AN OPENING

Abstract

Disclosed is a biomedical device being introduced by a hollow tube having a longitudinal axis in a subject in a minimally invasive surgery procedure for watertight sealing of an opening including at least two assemblies, each assembly including one flap connected to one arm, the arm having an longitudinal axis; the assemblies including a delivery configuration, a deployed configuration, and a sealed configuration and outwards deployment unit for switching from the delivery configuration to the deployed configuration and inwards deployment unit for switching from the deployed configuration to the sealed configuration. Also disclosed is a kit of parts including an outer hollow tube, an inner hollow tube, and a related biomedical device.

Claims

1-16. (canceled)

17. A biomedical device being introduced by an outer hollow tube having a longitudinal axis in a subject in a minimally invasive surgery procedure for watertight sealing of an opening, the said biomedical device comprising: at least two assemblies, each assembly comprising a proximal end and a distal end and one flap connected to one arm, said arm having a longitudinal axis; and assembling means connected to the at least two assemblies, said assembling means being configured such that the proximal end of each assembly is located on a same plane transverse to the longitudinal axis; the assemblies comprising a delivery configuration, a deployed configuration, and a sealed configuration and outwards deployment means for switching from the delivery configuration to the deployed configuration and inwards deployment means for switching from the deployed configuration to the sealed configuration; wherein in the delivery configuration, the flap and the arm of each assembly are aligned in the longitudinal axis, each assembly extends along a direction substantially parallel to the longitudinal axis and the at least two assemblies together form a hollow cylinder for receiving an inner hollow tube therethrough; the axis of the hollow cylinder being the longitudinal axis; in the deployed configuration, the flap of each assembly remains in the delivery configuration and the arm of each assembly is deployed outwardly relative to the longitudinal axis and positioned at substantially 90° relative to its position in the delivery configuration; and in the sealed configuration, the flap of each assembly is deployed inwardly relative to the longitudinal axis and positioned at substantially 90° relative to its position in the delivery configuration, and the arm of each assembly remains in the deployed configuration.

18. The biomedical device according to claim 17, further comprising a membrane, connecting the arm of each assembly, which is stretched out upon deployment of the arms from the delivery configuration to the deployed configuration.

19. The biomedical device according to claim 17 wherein at least one flap comprises a first passage extending through the flap from an opening in the outer surface of the flap to an opening in the inner surface of the flap; and wherein at least one arm comprises a first passage extending through the arm from an opening in the proximal outer surface of the arm to an opening in the distal outer surface of the arm.

20. The biomedical device according to claim 19 wherein the outwards deployment means comprises at least one thread fixed at the opening in the proximal outer surface of at least one arm, passing through the first passage of the arm from the opening in the proximal outer surface of the arm to the opening in the distal outer surface of the arm, passing through the first passage of the flap of the corresponding assembly from the opening in the outer surface of the flap to the opening in the inner surface of the flap and extending out.

21. The biomedical device according to claim 17 wherein the flap of each assembly comprises a connecting passage extending across a part of the flap.

22. The biomedical device according to claim 17, wherein the flap of each assembly comprises a connecting passage extending across the distal part of the flap.

23. The biomedical device according to claim 17 wherein at least one flap comprises a second passage extending through the flap from the connecting passage to an opening in the inner surface of the flap.

24. The biomedical device according to claim 23 wherein the inwards deployment means comprises a thread connecting the flap of each assembly together through the connecting passage of each flap, passing through the second passage of one flap from the connecting passage to the opening in the inner surface of said flap and extending out.

25. The biomedical device according to claim 17 wherein the flap of each assembly comprises a connecting portion and the arm of each assembly comprises a connecting portion connected to the connecting portion of the flap.

26. The biomedical device according to claim 17 comprising 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 assemblies.

27. The biomedical device according to claim 17, wherein each assembly is made from a bioabsorbable material.

28. The biomedical device according to claim 18, wherein the membrane, the outwards and/or the inwards deployment means are made from a bioabsorbable material.

29. The biomedical device according to claim 17 further comprising a means for maintaining the outwards deployment means deployed.

30. The biomedical device according to claim 29, wherein the outwards deployment means is at least a clip or at least a surgical forceps or at least a V-shaped notch configured for keeping at least one thread under tension.

31. The biomedical device according to claim 17 further comprising a means for maintaining the inwards deployment means deployed.

32. The biomedical device according to claim 31, wherein the inwards deployment means are at least a clip or at least a surgical forceps or at least a V-shaped notch configured for keeping at least one thread under tension.

33. The biomedical device according to claim 31, further comprising an anchoring ring having an outer diameter substantially equal to the length of one assembly in the delivery configuration along the longitudinal axis; said anchoring ring comprising the means for maintaining the outwards and inwards deployment means deployed.

34. The biomedical device according to claim 17, wherein the assembling means is selected among at least one membrane, at least one elastic band, at least one thread or at least one ribbon.

35. A kit of parts comprising: an outer hollow tube; an inner hollow tube; wherein said inner hollow tube has a smaller diameter than the outer hollow tube; and a biomedical device; being introduced by an outer hollow tube having a longitudinal axis in a subject in a minimally invasive surgery procedure for watertight sealing of an opening, the said biomedical device comprising: at least two assemblies, each assembly comprising a proximal end and a distal end and one flap connected to one arm, said arm having a longitudinal axis; and assembling means connected to the at least two assemblies, said assembling means being configured such that the proximal end of each assembly is located on a same plane transverse to the longitudinal axis; the assemblies comprising a delivery configuration, a deployed configuration, and a sealed configuration and outwards deployment means for switching from the delivery configuration to the deployed configuration and inwards deployment means for switching from the deployed configuration to the sealed configuration; wherein in the delivery configuration, the flap and the arm of each assembly are aligned in the longitudinal axis, each assembly extends along a direction substantially parallel to the longitudinal axis and the at least two assemblies together form a hollow cylinder for receiving an inner hollow tube therethrough; the axis of the hollow cylinder being the longitudinal axis; in the deployed configuration, the flap of each assembly remains in the delivery configuration and the arm of each assembly is deployed outwardly relative to the longitudinal axis and positioned at substantially 90° relative to its position in the delivery configuration; and in the sealed configuration, the flap of each assembly is deployed inwardly relative to the longitudinal axis and positioned at substantially 90° relative to its position in the delivery configuration, and the arm of each assembly remains in the deployed configuration; wherein said biomedical device is configured: for being positioned between said inner and outer hollow tubes in a delivery configuration; the inner hollow tube, the outer hollow tube and the biomedical device having the same longitudinal axis in said delivery configuration; and for being axially moveable along said longitudinal axis.

36. The kit of parts according to claim 35, wherein the kit of parts further comprises an anchoring ring.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0185] The foregoing summary and detailed description of the invention will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings, certain embodiment(s) which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

[0186] FIG. 1 is showing a perspective view of the biomedical device in the deployed configuration.

[0187] FIG. 2A shows a perspective view of a flap.

[0188] FIG. 2B shows a projection view of a flap along the width.

[0189] FIG. 2C shows a longitudinal cross section of a flap.

[0190] FIG. 2D shows a longitudinal cross section of a flap.

[0191] FIG. 3A shows a perspective view of an arm.

[0192] FIG. 3B shows a top view of an arm.

[0193] FIG. 3C shows a projection view of an arm along the width.

[0194] FIG. 3D shows a side view of an arm along the length.

[0195] FIG. 3E shows a longitudinal cross section of an arm.

[0196] FIG. 4 shows a perspective view of the biomedical device in the delivery configuration.

[0197] FIG. 5A shows a perspective view of the biomedical device in the deployed configuration.

[0198] FIG. 5B shows the biomedical device in the deployed configuration, view from the body cavity.

[0199] FIG. 6 shows the biomedical device in an intermediary step between the deployed configuration and the sealed configuration, view from the body cavity.

[0200] FIG. 7 shows the biomedical device in the sealed configuration, view from the body cavity.

[0201] FIG. 8 shows a view of the biomedical device comprising a cylindrical anchoring ring.

[0202] FIGS. 9A and 9B shows a view of an anchoring ring in the deployed (9A) and sealed configuration (9B).

REFERENCES

[0203] A Longitudinal axis of the hollow tube

[0204] B Longitudinal axis of the arms

[0205] 1 Flap

[0206] 1.1 Occluding portion of the flap

[0207] 1.11 First free edge of the occluding portion

[0208] 1.12 Second free edge of the occluding portion

[0209] 1.2 Connecting portion of the flap

[0210] 1.21 Inner surface of the connecting portion

[0211] 1.22 First lateral edge of the connecting portion

[0212] 1.23 Second lateral edge of the connecting portion

[0213] 1.24 First groove of the connecting portion

[0214] 1.25 Inclined plan of the connecting portion

[0215] 1.26 Second grove of the connecting portion

[0216] 2 Arm

[0217] 2.1 Connecting portion of the arm

[0218] 2.11 Tongue of the connecting portion

[0219] 2.12 Inclined plan of the connecting portion

[0220] 2.2 Pressing portion

[0221] 2.21 Inner surface of the pressing portion

[0222] 3 Outwards deployment means

[0223] 4 Inwards deployment means

[0224] 5 Watertight membrane

[0225] 6.1 First passage of the flap

[0226] 6.2 First passage of the arm

[0227] 7 Connecting passage of the flap

[0228] 8 Second passage of the flap

[0229] 9 Anchoring ring

[0230] 9.1 First part of the anchoring ring

[0231] 9.2 Second part of the anchoring ring

[0232] 10 Outer hollow tube

[0233] 11 Inner hollow tube

[0234] 12 Thread of the inwards deployment means

[0235] 13 Body wall opening

[0236] 14 Connecting means of the anchoring ring

[0237] 14.1 Tongue

[0238] 14.2 Blocking means