Expandable implant deployment

Abstract

A method for deployment of an implant inside a body cavity, including: expanding a sac within a body cavity of a subject body; inducing expansion of an implant positioned within the expanded sac; retracting the sac from said subject body following said inducing.

Description

[0001] EXPANDABLE IMPLANT DEPLOYMENT

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of International Patent Application No. PCT / IL2023 / 051337, filed December 28, 2023 and of U.S. Provisional Patent Application No. 63 / 666,750 filed July 02, 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to deployment of an expandable implant within a body cavity, and, more particularly, but not exclusively, to deployment of an expandable fluid extraction chamber within a body cavity.

[0006] SUMMARY OF THE INVENTION

[0007] Some examples of some embodiments of the invention are listed below (it should be noted that one or more features of an example may be used in combination with one or more features of another example):

[0008] Example 1. A method for deployment of an implant inside a body cavity, comprising: expanding a sac within a body cavity of a subject body; inducing expansion of an implant positioned within the expanded sac; retracting the sac from the subject body following the inducing.

[0009] Example 2. A method according to example 1, wherein the inducing comprises inducing the expansion after the expanding of the sac.

[0010] Example 3. A method according to any one of examples 1 or 2, wherein the implant is a self- expandable implant comprising at least one skeleton coupled to the implant, and wherein the inducing expansion comprises allowing the self-expandable implant to expand within the expanded sac.

[0011] Example 4. A method according to any one of examples 1 or 2, wherein the implant comprises at least one skeleton is partly inserted within the implant when the implant is positioned within the expanded sac, and wherein the inducing expansion comprises advancing the at least one skeleton into the implant.

[0012] Example 5. A method according to any one of examples 3 or 4, wherein the at least one skeleton comprises an expandable frame or an expandable stylet, configured to expand and stretch the implant to acquire an expanded state. Example 6. A method according to any one of examples 3 to 5 comprising locking the at least one skeleton in an expanded following the inducing expansion.

[0013] Example 7. A method according to any one of the previous examples, comprising: activating at least one lubrication coating on an external surface of the sac prior to the expanding.

[0014] Example 8. A method according to any one of examples 1 to 6, comprising: lubricating an external surface of the sac prior to the expanding with at least one lubricant material.

[0015] Example 9. A method according to example 8, comprising: inserting the sac packed inside an external sleeve from outside the body via a body opening into the body cavity, and wherein the lubricating comprises injecting the at least one lubricant to a space between the sac and the external sleeve prior to the expanding.

[0016] Example 10. A method according to any one of examples 1 to 8, comprising: packing the sac within an external sleeve; introducing the external sleeve with the sac into the body cavity via a body opening formed in the subject body.

[0017] Example 11. A method according to example 10, wherein the body opening has a maximal width of between 3 mm and 50 mm.

[0018] Example 12. A method according to any one of the previous examples, comprising: introducing the sac already containing the implant into the body cavity.

[0019] Example 13. A method according to any one of examples 1 to 11, comprising: introducing the sac without the implant into the body cavity; inserting the implant into the sac after the expanding, when the sac is expanded.

[0020] Example 14. A method according to any one of the previous examples, wherein the expanding comprises actuating from outside the subject body a sac expander mechanically coupled to the sac, and wherein the retracting comprises retracting the sac expander from the subject body.

[0021] Example 15. A method according to any one of the previous examples, wherein the expanding comprises inflating at least one balloon mechanically coupled to the sac, and wherein the retracting comprises retracting the at least one balloon from the subject body.

[0022] Example 16. A method according to example 14, wherein the sac expander comprises at least one rod coupled to a first side of the sac and at least one second rod coupled to an opposite side of the sac, and wherein the expanding comprises moving the at least one first rod and the at least one second rod at opposite directions and away from each other, thereby expanding the sac. Example 17. A method according to any one of the previous examples comprising, removing the expanded implant from the expanded sac into the body cavity, following the inducing and prior or during the retracting.

[0023] Example 18. A method according to example 17, wherein the removing comprises removing the expanded implant from an inner volume of the sac through at least one existing opening in the sac.

[0024] Example 19. A method according to example 17, comprising tearing the sac to form at least one opening in the sac, and wherein the removing comprises removing the expanded implant through the at least one opening.

[0025] Example 20. A method according to any one of examples 17 to 19, wherein the removing comprises applying a force on the sac and / or on the implant suitable for removing the expanded implant from the expanded sac into the body cavity.

[0026] Example 21. A method according to any one of the previous examples, comprising collapsing the sac to a maximal width smaller than a minimal width of a body opening prior to the retracting, and wherein the retracting comprises retracting the collapsed sac through the body opening out from the subject body.

[0027] Example 22. A method according to any one of the previous examples, wherein the retracting comprises retracting the sac from the subject while maintaining the implant inside the body cavity.

[0028] Example 23. A method according to any one of the previous examples, wherein the body cavity comprises, a peritoneal cavity, a pleural space, a preperitoneal space, a pericardiac space, or a cerebrospinal space.

[0029] Example 24. A method according to any one of the previous examples, wherein the implant comprises a fluid extraction chamber configured to extract fluids out from the body cavity.

[0030] Example 25. A method according to example 24, wherein the fluid extraction chamber comprises a membrane on an outer surface of the fluid extraction chamber.

[0031] Example 26. A system for deployment of an implant within a body cavity, comprising: an implant deployment device having an elongated body, a long axis, a proximal portion and a distal portion configured to be introducible into a body cavity, wherein the device comprising: a sac positioned at the distal portion, wherein the sac comprises an inner volume and is configured to move between a folded state and an unfolded state, and wherein the inner volume is shaped and sized to receive an implant; a sac expander mechanically coupled to the sac and extending between the distal portion and the proximal portion, wherein the sac expander is configured to move the sac between the folded state and the unfolded state.

[0032] Example 27. A system according to example 26, wherein the distal portion comprising the sac is configured to move between a collapsed state in which the distal portion is introduced into a body cavity while the proximal portion remains outside a subject body, and an expanded state within the body cavity.

[0033] Example 28. A system according to any one of examples 26 or 27, wherein the sac expander is configured to unfold the sac substantially laterally relative to the long axis.

[0034] Example 29. A system according to any one of examples 26 to 28, wherein the sac expander comprises at least one balloon coupled to the sac, and wherein inflation of the balloon expands the sac to acquire the expanded unfolded state.

[0035] Example 30. A system according to example 29, wherein the at least one balloon is coupled to an external surface of the sac or is positioned inside the sac.

[0036] Example 31. A system according to any one of examples 29 or 30, wherein the at least one balloon comprises a plurality of spaced-apart inflatable chambers coupled to the sac, wherein when the at least one balloon is deflated adjacent inflatable chambers of the plurality of spaced- apart inflatable chambers are closely packed and contact each other, and wherein when the at least one balloon is inflated, the adjacent inflatable chambers are moved apart.

[0037] Example 32. A system according to example 31, wherein at least some of the plurality of spaced-apart inflatable chambers are axially oriented according to the long axis, and at least some of the plurality of spaced-apart inflatable chambers are oriented at angle relative to the axially oriented inflatable chambers and positioned there between.

[0038] Example 33. A system according to any one of examples 26 to 28, wherein the sac expander comprises at least one first rod and at least one second rod extending between the distal portion and the proximal portion of the elongated body, wherein the at least one first rod is coupled to a first side of the sac and the at least one second rod is coupled to a second opposite side of the sac, and wherein movement of the at least one first rod and the at least one second rod away from each other unfolds the sac.

[0039] Example 34. A system according to example 33, wherein the at least one first rod and the at least one second rod cross are pivotally coupled to each other at an intersection pivot location proximally to the sac and have each a proximal end at the proximal portion of the implant deployment device configured to be positioned outside a subject body and a distal end coupled to the sac, and wherein movement of the proximal end of the at least one first rod and the proximal end of the at least one second rod, away from each other unfolds the sac.

[0040] Example 35. A system according to example 34, wherein the sac expander comprises a movement frame having an aperture and located between the intersection pivot location and the proximal end of each of the rods, and wherein the at least one first rod and the at least one second rod are oriented to pass within the aperture, and wherein the movement frame is configured to limit a lateral movement of the at least one first rod and of the at least one second rod to a length of the aperture.

[0041] Example 36. A system according to any one of examples 33 to 35, wherein the at least one first rod and the at least one second rod are rigid in an axial direction and flexible in a lateral direction.

[0042] Example 37. A system according to any one of examples 33 to 35, wherein the at least one first rod and the at least one second rod are straight or have an angled distal portion.

[0043] Example 38. A system according to any one of examples 26 to 37, wherein the sac is formed from a single layer or a multi-layer of sheet material comprising at least one of, fabric, knitted material, mesh or solid material.

[0044] Example 39. A system according to any one of examples 26 to 38, wherein the sac comprises at least one preformed distal front opening.

[0045] Example 40. A system according to any one of examples 26 to 39, wherein the sac comprises at least one proximal opening facing the proximal portion of the device elongated body.

[0046] Example 41. A system according to any one of examples 26 to 40, wherein the implant deployment device comprises an implant remover extending between the proximal portion and the distal portion of the elongated body, wherein the implant remover is configured to apply force on the sac and / or on an implant within the sac that is suitable to remove the implant out form the sac.

[0047] Example 42. A system according to example 41, wherein the implant remover comprises at least one elongated rod having a distal end configured to contact the sac and / or the implant, and a proximal end at the device elongated body proximal portion.

[0048] Example 43. A system according to example 42, wherein the elongated rod is configured to contact at least one skeleton of an implant positioned within the sac.

[0049] Example 44. A system according to any one of examples 26 to 43, wherein the system comprises at least one lubricator device functionally coupled to the deployment device, comprising at least one lubricating channel fluidically connecting a source of a lubricant material and at least one opening in the at least one lubricating channel located at the deployment device distal portion, and wherein the at least one lubricating channel is configured to release the lubricant material via the at least one opening at the deployment device distal portion.

[0050] Example 45. A system according to example 44, wherein the at least one opening of the at least one lubricating channel is positioned outside the sac or inside the sac.

[0051] Example 46. A system according to any one of examples 26 to 45, wherein the sac comprises at least one channel fluidically connected to an inner volume of the sac and extending between the elongated body proximal portion and the sac, wherein the channel is shaped and sized to receive an implant in a collapsed state and to guide the implant into the inner volume of the sac.

[0052] Example 47. A system according to any one of examples 26 to 45, comprising the implant, wherein the implant comprises at least one skeleton configured to move the implant from a collapsed state to an expanded state.

[0053] Example 48. A system according to example 47, wherein the at least one skeleton is integrated in the implant, or the at least one skeleton is insertable into the implant.

[0054] Example 49. A system according to any one of examples 48 or 49, wherein the implant comprises a fluid extraction chamber having a wall defining an inner volume of the fluid extraction chamber, wherein the wall comprises a semi-permeable membrane configured to allow passage of fluid from outside the fluid extraction chamber into the fluid extraction chamber inner volume.

[0055] Example 50. A kit, comprising: a fluid extraction device, comprising: a fluid extraction chamber having a wall defining an inner volume, and at least one opening to the inner volume, wherein the fluid extraction chamber is configured to move between a folded state and an unfolded state, and wherein the fluid extraction chamber wall comprises a semi-permeable membrane configured to allow passage of fluid from outside the fluid extraction chamber into the inner volume; at least one skeleton; at least one channel coupled to the at least one opening configured to deliver the at least one skeleton into the fluid extraction chamber; an implant deployment device, comprising: a sac configured to move between a collapsed folded state when the sac is introduced into a body cavity in a subject body, and an expanded unfolded state, when the sac is unfolded within the body cavity, wherein the sac comprises an inner volume which includes the fluid extraction chamber; a sac expander mechanically coupled to the sac and configured to move the sac between the collapsed folded state and the expanded unfolded state.

[0056] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0057] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0058] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0059] In the drawings:

[0060] Fig. 1 is a flow chart of a general process for deployment of an expandable implant within a body cavity, according to some exemplary embodiments of the invention;

[0061] Fig. 2A is a schematic illustration showing direct contact between a folded implant and tissue in a body cavity during implant unfolding, according to some exemplary embodiments of the invention;

[0062] Figs. 2B-2E are schematic illustrations unfolding of an implant within a body cavity using an expandable, optionally removable, sac, according to some exemplary embodiments of the invention;

[0063] Figs. 3A and 3B are block diagrams of an implant deployment device when a sac of the deployment device is in a collapsed state (FIG. 3A), and when the sac is in an expanded state (FIG. 3B), according to some exemplary embodiments of the invention;

[0064] Fig. 3C is a schematic illustration showing folding and unfolding of a sac, according to some exemplary embodiments of the invention;

[0065] Fig. 4A is a flow chart of a process for deployment of an implant in a body cavity using a kit which includes an implant already within a sac of the deployment device, according to some exemplary embodiments of the invention; Fig. 4B is a flow chart of a process for deployment of an implant in a body cavity, where the implant is introduced into a sac of a deployment device already expanded in a body cavity, according to some exemplary embodiments of the invention;

[0066] Fig. 4C is a flow chart of a process for deployment of a self-expandable implant located within a sac, according to some exemplary embodiments of the invention;

[0067] Fig. 4D is a flow chart of a process for deployment of an implant located within a sac by advancing a skeleton into the implant following sac expansion, according to some exemplary embodiments of the invention;

[0068] Fig. 5A is a schematic illustration of a fan-shaped sac with elongated members coupled to the sac to allow expansion of the sac, according to some exemplary embodiments of the invention;

[0069] Fig. 5B is a schematic illustration of a fluid extraction chamber shaped as a fan with a draining tube coupled to the chamber, according to some exemplary embodiments of the invention;

[0070] Fig. 5C is a schematic illustration of the chamber shown in FIG. 5B within the sac shown in FIG. 5A, according to some exemplary embodiments of the invention;

[0071] Figs. 6A-6C are schematic illustrations of a deployment device having a rods-based sac expansion mechanism, according to some exemplary embodiments of the invention;

[0072] Figs. 7A-7C are schematic illustrations showing deployment of an implant using a deployment device having a sac and a rods-based sac expansion mechanism, according to some exemplary embodiments of the invention;

[0073] Fig. 7D is a schematic illustration showing layers of a sleeve, a sack and implant passing through layers of the body, according to some exemplary embodiments of the invention;

[0074] Figs. 7E-7K are schematic illustrations showing deployment of an implant which includes an embedded skeleton using a deployment device having a sac and a rods-based sac expansion mechanism, according to some exemplary embodiments of the invention;

[0075] Figs. 7L and 7M are images showing manipulation of a skeleton inside an implant under x-ray imaging, according to some exemplary embodiments of the invention;

[0076] Figs. 8A-8D are schematic illustrations showing deployment of an implant within a sac using a catheter system, according to some exemplary embodiments of the invention;

[0077] Figs. 9A and 9B are schematic illustrations showing a cross section through a sleeve which includes a sac with an inner implant, when the sac is in a collapsed state (9A), and when the sleeve is removed and the sac and implant are expanded (9B), according to some exemplary embodiments of the invention; Figs. 10A-10G are schematic illustrations showing different lubrication and / or washing setups, according to some exemplary embodiments of the invention;

[0078] Figs. 11A and 11B are schematic illustrations showing expansion of an implant by advancing at least one skeleton, for example a stylet, from outside the body into the implant following expansion of a sac, according to some exemplary embodiments of the invention;

[0079] Figs. 12A and 12B are schematic illustrations showing expansion of an implant, optionally self-expansion, having an integrated skeleton, according to some exemplary embodiments of the invention;

[0080] Figs. 13A-13F are schematic illustrations showing deployment of an implant in a body cavity after the implant is inserted to an already expanded empty sac, according to some exemplary embodiments of the invention;

[0081] Fig. 14A is an image of a fluid extraction chamber positioned within a sac of a deployment device, according to some exemplary embodiments of the invention;

[0082] Figs. 14B-14C are schematic illustrations of a system or kit which include an implant deployment device and a fluid extraction chamber device, according to some exemplary embodiments of the invention;

[0083] Figs. 14D-14E are schematic illustrations showing a system, for example a delivery system in a collapsed state (14D) and in expanded state (14E), according to some exemplary embodiments of the invention;

[0084] Fig. 14F is a schematic illustration of a delivery system having an implant and a skeleton advancer, according to some exemplary embodiments of the invention;

[0085] Figs. 14G-14O are schematic illustrations showing implant deployment inside a subject body using a delivery system having an insertable skeleton, according to some exemplary embodiments of the invention;

[0086] Figs. 15A-15E are schematic illustrations showing expansion of a sac using at least one balloon, according to some exemplary embodiments of the invention;

[0087] Figs. 16A-16G are schematic illustrations showing balloons with different arrangements of inflatable chambers, according to some exemplary embodiments of the invention;

[0088] Figs. 17A-17C are schematic illustrations showing a mechanism for increasing a volume of a sac by rotating elongated members within the sac, according to some exemplary embodiments of the invention; and

[0089] Figs. 18A-18B are schematic illustrations showing different types of rods, according to some exemplary embodiments of the invention. DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0090] The present invention, in some embodiments thereof, relates to deployment of an expandable implant within a body cavity, and, more particularly, but not exclusively, to deployment of an expandable fluid extraction chamber within a body cavity.

[0091] Overview

[0092] An aspect of some embodiments relates to expanding, for example unfolding a sac within a body cavity, and then allowing an implant positioned within the sac to expand within the expanded sac. In some embodiments, the expanded implant is then released from the sac into the body cavity, and the sac is optionally removed from the body cavity. Optionally, when releasing the expanded implant from the sac, the expanded implant remains static relative to tissue within the body cavity. Alternatively, during releasing the expanded implant from the sac the expanded implant is moved, optionally forward, while retracting the sac surrounding the implant.

[0093] According to some embodiments, the sac unfolds within the body cavity until reaching a target unfolded state which is required to have an inner volume within the sac that allows expansion of the implant. In some embodiments, if the sac cannot unfold to reach the target unfolded state, then the sac with the implant is either re positioned within the body cavity or is removed from the body cavity.

[0094] According to some embodiments, the sac is unfolded within the body cavity by pulling sideways two opposite sides of the sac at opposite directions. In some embodiments, the two opposite sides are moved at opposite directions using at least two intersecting elongated members that pivotally move relative to each other, each having a distal portion coupled to a different side of the opposite sides and a proximal portion. In some embodiments, moving the two portions of the elongated members laterally away from each other results with lateral sideways movement of the distal portions of the elongated members and unfolding of the sac.

[0095] According to some embodiments, the sac is unfolded using at least one inflatable member, for example a balloon, coupled to the sac. In some embodiments, the at least one inflatable member is coupled to an external surface of the sac, and is optionally configured to allow lateral unfolding of the sac. Alternatively of additionally, the at least one inflatable member is coupled to an inner surface of the sac, between the sac and the implant, and optionally surrounding at least partly the implant.

[0096] According to some embodiments, the implant comprises at least one integrated skeleton, configured to allow self-expansion of the implant within the expanded sac. Optionally, following implant expansion, for example unfolding, the skeleton is secured in an expanded state and / or to the implant body, optionally to prevent collapse of the implant when exiting the sac into the body cavity and / or movement of the at least one skeleton within the implant. Alternatively or additionally, following expansion of the sac, at least one skeleton already partially positioned within the implant is advanced into implant. Optionally, following advancement of the skeleton into the implant, the skeleton is secured in an expanded state and / or to the implant body, optionally to prevent collapse of the implant when removing the implant from the sac into the body cavity and / or to prevent movement of the at least one skeleton within the implant.

[0097] According to some embodiments, the sac is introduced into the body cavity via a small incision, optionally formed in a mini-laparotomy approach, in the body, or via puncturing forming a body access site having a maximal width between about 3 mm and about 50 mm, for example between about 3 mm and about 10 mm, between about 5 mm and about 20 mm, between about 8 mm and about 50 mm or any intermediate, smaller or larger with of the body access site.

[0098] According to some embodiments, the implant comprises an external surface which is sensitive to friction surface. In some embodiments, the implant external surface comprises a membrane, for example a semi-permeable membrane, having pores. In some embodiments, the implant comprises a fluid extraction chamber and the porous membrane allows penetration of fluid from the body cavity or from tissue in the body cavity into an inner volume of the chamber.

[0099] According to some embodiments, the external surface of the sac is pre-coated prior to insertion of the sac into the body cavity and / or is lubricated prior and / or following the insertion, for example to allow easier unfolding of the sac by optionally minimizing friction forces between the external surface of the sac and tissue within the body cavity.

[0100] A potential advantage of using a sac may be that the sac is suitable for various friction reduction solutions, while protecting the implantable device from the friction modifying agent. For example, such sac is highly relevant for expansion of implantable devices which comprise semi-permeable membranes, intended to infiltrate fluids. In some embodiments, the sac allows, for example, to avoid applying coating materials directly onto a long term implant, thus alleviating challenges (for example particulate matter release risks, permeability impairment, and / or regulatory burden) related to keeping the coating material for a long term period.

[0101] An additional potential advantage of using a sac, as described herein in this patent application may be that it allows changing an introduction method of a given standalone implant from laparoscopic approach to a percutaneous approach or a mini-laparotomy approach by providing a way for introducing a folded implant via a small incision into a body cavity and then unfolding the implant within the body cavity into a clinically functional, efficient and safe unfolded conformation. An additional potential advantage of using a sac, as described herein in this patent application may be that it allows introduction of expandable implants into a preperitoneal space or other cavities that are not naturally open, or accessible via gas insufflation, require a certain tissue layer separation for facilitating surgical access and volume. Deployment of a medical device implant in such cavities is associated with high resistance and friction by the collapsed tissues. Thus, deploying an intermediate expandable sac in such cavities allows, for example to introduce into these cavities implants that are sensitive to high friction and surface modifying agents.

[0102] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0103] Exemplary general deployment process

[0104] Reference is now made to fig. 1, depicting a general process for deployment of an implant in a target body cavity, according to some exemplary embodiments of the invention.

[0105] According to some exemplary embodiments, a sac of a deployment device is inserted into a body cavity, at block 102. In some embodiments, the sac is already preloaded with an implant. Optionally, the implant is a self-expandable implant.

[0106] According to some exemplary embodiments, the sac is expanded, at block 104. In some embodiments, the sac is expanded, for example unfolded laterally, optionally in a direction of the sac plane. Additionally or optionally, the sac is expanded in a z-axis to the sac expansion plane, for example to increase sac thickness, thereby to increase sac inner volume.

[0107] According to some exemplary embodiments, an implant is induced to expand within the expanded sac at block 106. In some embodiments, in case of a self-expandable implant, expansion of the sac at block 104 induces expansion of a self-expandable implant positioned within the sac. In some embodiments, in case of an implant with a partially embedded skeleton or with no skeleton, a skeleton is introduced into the implant following sac expansion, causing the implant to expand. In some embodiments, in case of an empty sac during introducing at block 102, a folded implant is introduced into the expanded sack, and self-expands within the expanded sac. Alternatively, a skeleton is advanced into the folded implant to expand the implant.

[0108] According to some exemplary embodiments, the expanded implant is removed from the sac at block 108. In some embodiments, the expanded implant is moved, for example pushed out from the sack through an already existing opening, for example a distal front opening in the sac, optionally by retrieving the sac backwards. Alternatively, movement of the implant within the sac tears the sac structure. Alternatively, an opening, for example a distal front opening is formed in the sac by pealing or tearing a portion of the sack.

[0109] According to some exemplary embodiments, the deployment device is removed from the subject body, at block 110. In some embodiments, the deployment device is removed from the subject body while leaving the expanded implant deployed in the target body cavity.

[0110] Exemplary expansion of an implant within a body cavity

[0111] Application of expandable implant devices into body cavities may carry inherent challenge of interaction, optionally friction, with opposing tissue inside the body cavity. For example, interaction with surrounding tissue can lead to incomplete or improper unfolding of the implant within the body cavity, resulting with a non-functional implant, this challenge is often solved by insufflation or retraction of the tissue. However, such solutions limit the procedure setting and usually require deep sedation and anesthesia. A different solution approach is surface modification, for example using friction reduction coating or lubrication. However, some long term or temporary implantable devices may not be suitable for coating or lubricants application.

[0112] Reference is now made to fig. 2 A depicting unfolding of a folded implant within a body cavity, according to some exemplary embodiments of the invention.

[0113] According to some exemplary embodiments, in order to introduce an implant 202 in a body cavity 204 via an access site formed by a small incision or puncturing, the implant is collapsed, for example folded, to acquire the maximal width of the formed access site in the body. In some embodiments, for example as shown in fig. 2A, during unfolding implant 202 interacts with tissue 206, at least partly surrounding implant 202. In some embodiments, the interaction between implant 202 and tissue 206 interferes with proper unfolding of implant 202, and may lead to incomplete unfolding or improper unfolding of implant 202. Incomplete unfolding or improper unfolding of implant 202 can result with a non-functional implant that should be removed from the body cavity of the subject.

[0114] Reference is now made to figs. 2B-2E, depicting implantation of an implant using a sac in a body cavity, according to some exemplary embodiments of the invention.

[0115] According to some exemplary embodiments, for example as shown in fig. 2 A in order to prevent direct interaction between the implant 202, and the tissue 206, implant 202 is introduced into body cavity 204 within a sac, for example sac 208. In some embodiments, both the sac 208 and the implant 202 are collapsed, for example folded, during the insertion into the body cavity 204 in order to be able to pass through a narrow access site formed in a body of a subject. In some embodiments, for example as shown in fig. 2B, the tissue 206 surrounds the sac 208.

[0116] According to some exemplary embodiments, for example as shown in fig. 2C, the sac 208 expands within the body cavity 204. Optionally, during expansion the sack 208 interacts with the tissue 206. In some embodiments, expansion, for example unfolding of the sac 208 increases an inner volume 210 of the sac 208 in which the implant 202 is positioned. In some embodiments, the inner volume 210 has a size and / or shape that allows proper unfolding of the implant 202, for example as shown in fig. 2D. Optionally, the sac is preshaped to unfold and generate an inner volume that allows a proper unfolding of the implant 202.

[0117] According to some exemplary embodiments, for example as shown in fig. 2E, once the implant 202 is unfolded, the implant 202 is removed from the sac 208 and the sac is removed from the bod of the subject.

[0118] Exemplary deployment device

[0119] According to some exemplary embodiments, a deployment device is used to introduce a folded implant into a body cavity in a subject body. In some embodiments, the deployment device is configured to navigate a sac into a target location within a body cavity, to control the unfolding of the sac to a target dimension, for example to a target width and / or to a target volume. In some embodiments, the deployment device is configured to control unfolding of an implant positioned within the sac inner volume and / or stabilization of a folded implant in a folded state. Optionally, in some embodiments the deployment device comprises a channel that is shaped and sized to guide a folded implant from outside the body into a sac of the deployment device already positioned within the body cavity, optionally into an unfolded sac.

[0120] According to some exemplary embodiments, the deployment device is configured to allow implantation of an implant, re-positioning of a sac with the implant within the body cavity and / or retrieval of the sac with the implant, by manipulations of a portion of the implantation device located outside a subject body and proximally to a user operating the deployment device.

[0121] Reference is now made to figs. 3A and 3B, depicting block diagrams of a deployment device, when a sac of the deployment device is in a collapsed folded state (3A), and when the sac is in an expanded state (3B), according to some exemplary embodiments of the invention.

[0122] According to some exemplary embodiments, a deployment device, for example device 302 comprises an elongated body 304 having a long axis 305, a distal portion 306 shaped and sized to be introduced through an opening formed in a body of a subject, for example a human subject, into a body cavity, and a proximal portion 308 configured to be positioned outside the subject body. As used herein, the term proximal portion refers to a portion of the device 302 located closer to a user operating and / or manipulating the device 302, and the term distal portion refers to a portion of the device 302 located at a distance and away from the user, when the device is in use and under the control of the user.

[0123] According to some exemplary embodiments, the device 304 comprises a sac 310 having an inner volume 312, at the distal portion 306. In some embodiments, the sac 310 is configured to move, optionally controllably move, between a folded state and an unfolded state. In some embodiments, the sac is formed from a single layer or a multi-layer sheet material, for example from fabric, knitted material, mesh, or solid material.

[0124] According to some exemplary embodiments, the sheet material is pre-coated to provide lubrication-like behavior, for example with at least one of, hydrophilic coating such as Polyvinylpyrolidone (PVP), Polyurethanes, Polyacrylic acid (PAA), Polyethylene oxide (PEO), Polysaccharide or hydrogel surfactant-based gels or antibacterial-agent including gel, or antithrombotic or thrombolytic agents including gels.

[0125] According to some exemplary embodiments, an outer surface of the sac 310 facing outwardly from the inner volume 312 and configured to face tissue in a body cavity, is precoated, for example to reduce friction between the sac and tissue. Additionally or optionally, an inner surface of the sac 310 facing the inner volume is pre-coated, for example to reduce friction between an implant within the inner volume 312 and the inner surface of the sac.

[0126] According to some exemplary embodiments, the device 302 further comprises a sac expander 314 mechanically coupled to the sac 310, and configured to controllably control from outside the subject body, movement of the sac 310 within a body cavity between a collapsed folded state and an expanded folded state. In some embodiments, the sac expander 314 is configured to allow adjustment of an expansion degree of the sac 310, for example the sac expander 314 allows to adjust an expansion degree of the sac 310 between 0% expansion when the sac 310 is in a fully collapsed or folded state, and a 100% expansion when the sac 310 is in a fully expanded or unfolded state.

[0127] According to some exemplary embodiments, for example as shown in fig. 3B, the sac expander 314 expands the sac 310 in a direction 316 substantially perpendicular, for example + / - 15 degrees, relative to the long axis 305. In some embodiments, the sac expander 314 expands the sac 310 in a direction 316 oriented at an angle 318 of between 45 degrees and 135 degrees, for example at an angle between 45 degrees and 100 degrees, at an angle between 60 degrees and 120 degrees, or any intermediate, smaller or larger angle relative to the long axis 305. According to some exemplary embodiments, the sac expander 314 is configured to expand the sac 310 length in an expansion direction, for example an axial direction (in a direction of the long axis 305), in direction 316, or in any other direction, in at least 2 times, at least 3 times, at least 5 times, at least 10 times, at least 20 times or any intermediate, smaller or larger value, relative to a length of the sac 310 length in the expansion direction, when the sac 310 is in a collapsed state.

[0128] According to some exemplary embodiments, the sac expander 314 comprises at least one balloon mechanically coupled to an external surface and / or to an internal surface of the sac 310. In some embodiments, the sac expander comprises at least one channel fluidically connecting at least one opening of the balloon and a fluid source located outside the subject body. In some embodiments, inflation of the balloon via the at least one channel expands the balloon and unfolds the sac 310. In some embodiments, the inflation of the balloon expands the balloon in a direction substantially perpendicular, for example + / - 15 degrees, relative to the long axis 305. In some embodiments, the inflation of the balloon expands the balloon in a direction oriented at an angle between 45 degrees and 135 degrees, for example at an angle between of 45 degrees and 100 degrees, at an angle between 60 degrees and 120 degrees, or any intermediate, smaller or larger angle relative to the long axis 305.

[0129] According to some exemplary embodiments, the sac expander 314 comprises at least two elongated members, each is coupled to an opposite side of the sac. In some embodiments, when moving the elongated members away from each other the sac 310 expands in direction 316. In some embodiments, the at least two elongated members comprise elongated bars, for example straight or angled bars. In some embodiments, the bars are rigid. Alternatively, the bars are flexible. Optionally, the bars are rigid in a first direction, for example an axial direction parallel to the axis 305, and flexible in a second direction lateral to the axis 305.

[0130] According to some exemplary embodiments, the sac 310 is shaped and sized to receive an implant, for example implant 318 within the inner volume 312. In some embodiments, the implant 318 comprises a chamber formed from a single layer or a multi-layer sheet material, having an inner volume. Additionally, the chamber comprises at least one opening to the inner volume. In some embodiments, the implant 318 comprises a fluid extraction chamber configured to extract fluid from a body cavity into the chamber inner volume and then through the at least one chamber opening, out from the subject body.

[0131] According to some exemplary embodiments, the implant 318 comprises a self-expandable implant, configured to self-expand when the sac 310 moves from a collapsed state to an expanded state. In some embodiments, the self-expandable implant comprises at least one integrated self- expandable scaffold. In some embodiments, the at least one integrated self-expandable scaffold is configured to expand the chamber when a force applied on the chamber in an inward direction is smaller than a force applied by the at least one integrated self-expandable scaffold in an outward direction on the chamber, for example when the sac 310 expands.

[0132] Alternatively or additionally, at least one scaffold is advanced into an inner volume of the implant 318 after the sac 310 is introduced into the body cavity. Optionally, the at least one scaffold is already partially positioned within the implant 318 when the sac is introduced into the body cavity.

[0133] According to some exemplary embodiments, the at least one scaffold comprises a frame, a flexible wire or a flexible stylet. In some embodiments, the at least one scaffold is formed from a metallic material, an alloy and / or from a polymeric material. According to some exemplary embodiments, the device 302 comprises a removable sleeve 320 surrounding the distal portion 306 and / or the sac 310. In some embodiments, the sleeve 320 is optionally a non-expandable, and / or a non-stretchable sleeve, or has a limited expansion and / or stretching capacity. In some embodiments, the sleeve 320 is configured to restrict expansion of the sac 310, when the sac 310 is introduced into the body cavity. In some embodiments, the sleeve 320 is configured to maintain an overall maximal outer width of the distal portion 306 that is introducible through an access site in the body, to be smaller than a minimal width of the access site, for example to allow easy passage through an opening in the access site into the subject body.

[0134] According to some exemplary embodiments, the sleeve 320 is configured to be removed from the subject body after the insertion of the device distal portion 308 into the body cavity. In some embodiments, the sleeve 320 is removed from the distal portion 306 and / or the sac 310 by tearing part of the sleeve 320 and / or by retracting the sleeve 320 towards the proximal portion 308 of body 304, and out from the subject body. In some embodiments, the sleeve 320 is formed from at least one layer of fabric material. In some embodiments, optionally the sleeve 320 is also precoated with same or similar friction reduction coating as the sac 310, for example to improve initial introduction into body and later retraction of sleeve 320.

[0135] According to some exemplary embodiments, the device 302 comprises at least one lubrication channel, for example channel 322, having at least one lubrication opening 324 at the distal portion 306 between the sleeve 320 and the sac 310. In some embodiments, the channel 322 interconnects a source 326 of lubrication material located outside the subject body and the opening 324. In some embodiments, the channel is configured to allow flow of lubricant material from the opening 324 to a space between the sac 310 and the sleeve, optionally prior to removal of the sleeve 320, for example to allow lubrication of an external surface of the sac 310. In some embodiments, lubrication of the external surface of the sac 310 allows, for example, to reduce friction or other forces between tissue in the body cavity and the sac 310 when the sac 310 unfolds.

[0136] According to some exemplary embodiments, the device comprises at least one different channel, for example channel 328 having at least one opening 328 at the distal portion 306 within the sac 310 and optionally between the sac 310 and an implant 318, for example to allow flow of lubricant material into the sack to reduce friction or other forces between the sac 310 and the implant 318 during unfolding of the sac 310 and / or unfolding of the implant 318. Alternatively, channel 322 has both openings 324 and 328. In some embodiments, the source 326 of lubricant material is coupled to a proximal openings of channels 322 and 326, and optionally comprises at least one syringe for pushing the lubricant material into at least one or both of channels 322 and 326.

[0137] According to some exemplary embodiments, the sack 310 is configured to allow release of the implant 318 after the sack 310 unfolds. In some embodiments, the sack comprises at least one opening, for example opening 330, that is shaped and size to allow release of the implant 318 from the inner volume 312 and into a body cavity. In some embodiments, the opening 330 is a distal front opening configured to allow release the implant 318 from the inner volume 312 in a distal direction and distally to the device 302. Alternatively, the sack 310 comprises a tear-away portion configured to generate an opening, for example a distal and / or a front facing opening, to optionally allow release of the implant 318 out from the sac 310. In some embodiments, the tearaway portion of the sac 310 is more sensitive to application of force relative to other portions of the sac 310, for example by having a thinner sac wall at the tear-away portion.

[0138] Optionally, the sac 310 further comprises at least one proximal opening 332, facing the proximal portion 308.

[0139] Exemplary folding lines

[0140] Reference is now made to fig. 3C, depicting a sac preformed with folding lines, according to some exemplary embodiments of the invention.

[0141] According to some exemplary embodiments, the sac, for example sac 310 is preformed to include one or more folding lines, for example folding lines 350, 352, 354, 356, 358 and 360. In some embodiments, the preformed folding lines are formed in the sac 310, for example to allow directional folding and unfolding of the sac, optionally in a lateral direction 362 relative to a long axis of the device, for example axis 305. In some embodiments, the preformed folding lines are used to allow accordion folding of the sac, and / or formation of a series of valley folds and mountain folds.

[0142] According to some exemplary embodiments, similarly, the implant 318 is also preformed to include one or more folding lines, for example to allow directional folding and unfolding of the sac, optionally in a lateral direction relative to a long axis of the device.

[0143] According to other embodiments, the sac 310 and implant 318 are folded together in other folding pattern lines, or by rolling.

[0144] Exemplary detailed deployment process of an implant

[0145] According to some exemplary embodiments, a deployment device comprising a sac is used to deliver and induce expansion of an implant, for example an expandable implant, within one or more body cavities, for example a peritoneal cavity and an intermuscular cavity.

[0146] Reference is now made to fig. 4A depicting delivery and implantation of an implant already found within a sac of the deployment device when a distal portion of the device is introduced into the body cavity, according to some exemplary embodiments of the invention.

[0147] According to some exemplary embodiments, a target body cavity for insertion of an implant is optionally determined, at block 402. In some embodiments, the target body cavity is optionally determined based on a clinical and / or a physiological state of the subject. In some embodiments, the target body cavity is determined by an expert, for example a health care provider or a physician examining the subject.

[0148] According to some exemplary embodiments, a clinical application in which the implant is used is optionally determined at block 404. In some embodiments, the clinical application or the implant comprises at least one of, removal of fluids from the body cavity, drug delivery apparatus, serum sampling and / or monitoring apparatus, cell / organ capsulation device, and mechanical spacer device.

[0149] According to some exemplary embodiments, an implant is optionally selected at block 406. In some embodiments, the implant is selected according to the determined target body cavity and / or according to the determined clinical application. In some embodiments, the selected implant have structural and / or functional parameters that will allow its implantation at the determined target body cavity for performing the target clinical application.

[0150] According to some exemplary embodiments, a deployment device, for example a sac device, is optionally selected at block 408. In some embodiments, the sac device is selected according to the selected implant and / or the determined target body cavity. In some embodiments, selecting a sac device comprises selecting a kit, for example a sterilized kit package that includes a sac device already loaded with the selected implant within the sac, where the sac device and the implant are in a collapsed folded state ready to be introduced into a body cavity.

[0151] According to some exemplary embodiments, a sac device loaded with an implant is provided at block 410.

[0152] According to some exemplary embodiments, the sac device is optionally prepared, at block 412. In some embodiments, preparing the sac device comprises activating a surface coating, for example by exposing a hydrophilic coating to water-based biocompatible solution, for example water, prior to use. Optionally, immersing a coated device in water before the actual use preconditions the surface by reacting to its polarized / functional groups of the coating which absorbs water for instance, thus allowing exploitation of its functional potential.

[0153] According to some exemplary embodiments, a body opening at a determined access site, is formed at block 414. In some embodiments, the body opening is formed by making an incision through skin tissue and body wall. Alternatively, the body opening is formed by puncturing. In some embodiments, the formed body opening has a minimal width between 5 mm and 50 mm, for example a minimal width of between 5 mm and 30 mm, a minimal width between 10 mm and 20 mm, a minimal width between 10 mm and 40 mm, a minimal width between 20 mm and 50 mm, or any intermediate, smaller or larger range of values.

[0154] According to some exemplary embodiments, the formed body opening is expanded at block 416. In some embodiments, the formed body opening is expanded using at least one of dilator, retractor, spatula or a port device, optionally configured to form a rigid channel into the target body cavity from outside the subject body.

[0155] According to some exemplary embodiments, the sac device preloaded with the implant is introduced through the body opening into the body cavity, at block 418. In some embodiments, a distal portion of the sac device covered with an external sleeve is introduced into the body cavity, while a proximal portion of the sac device remains outside the subject body.

[0156] According to some exemplary embodiments, before removal of the sleeve, lubricant is optionally applied on the external surface of the sac, for example by injection of lubricant through a channel and at least one distal opening, for example channel 322 and opening 324 shown in fig. 3A. In some embodiments, the lubricant is injected through one or more openings to a space between the inner surface of the sleeve and an outer surface of the sac.

[0157] According to some exemplary embodiments, the external sleeve covering the sac is removed from the body cavity, at block 420. In some embodiments, the external sleeve is removed by pulling a string or a wire from outside the body cavity, and the sleeve is retracted via the body opening, out from the subject body.

[0158] According to some exemplary embodiments, the sac is expanded at block 422. In some embodiments, the sac is expanded using sac expanding means, for example the sac expander 314 shown in figs. 3 A and 3B. In some embodiments, the sac expander is activated from outside the body, for example using a portion of the sac expander located at a proximal portion of the sac device outside the body.

[0159] According to some exemplary embodiments, the implant is optionally expanded at block 424. In some embodiments, the implant is expanded following expansion of the sac, by activating an implant expander of the deployment device from outside the body. In some embodiments, the implant expander applies force on an integrated skeleton coupled to the implant or positioned within the implant, optionally to move the skeleton to an expanded state such that the skeleton stretches and expands, for example unfolds the implant body. Alternatively, the implant is expanded by introducing a skeleton into the implant or further advancing a skeleton already partly positioned within the implant.

[0160] According to some exemplary embodiments, for example in a case of a self-expandable implant, expansion of the sac at block 422, expands the implant.

[0161] According to some exemplary embodiments, the expanded implant is removed from the sac into the body cavity at block 430. In some embodiments, the expanded implant is removed from the sac through at least one opening, for example a distal opening or a front opening of the sac. In some embodiments, the opening is preformed in the sac. Alternatively a tear in the sac structure is formed and the implant is removed from the sac through the tear site.

[0162] According to some exemplary embodiments, the sac device is retrieved out from the body cavity at block 432. In some embodiments, in order to remove the sac device, the sac is folded to a collapsed state, for example to allow passage of the sac through the body opening.

[0163] According to some exemplary embodiments, the implant is ready for use, at block 434.

[0164] According to some exemplary embodiments, the sac device is provided and introduced into the body cavity without an implant within the sac. In these embodiments, after expansion of the sac at block 422, an implant is introduced into the expanded sac via a channel terminating with an opening to the sac inner volume. In some embodiments, a proximal opening of the channel is positioned outside the subject body. In some embodiments, the implant in a folded state, optionally positioned within a sleeve, is introduced through the channel into the sac inner volume. In some embodiments, after removal of the sleeve, the implant self-expands. Alternatively, after removal of the sleeve the implant is expanded by activating an integrated scaffold or by advancing a scaffold into the implant inner volume.

[0165] Reference is now made to figs. 4B, depicting a process for implant deployment using a deployment device as a general platform for deployment of different implants, according to some exemplary embodiments of the invention.

[0166] According to some exemplary embodiments, an opening is facilitated or formed in a body of a subject using puncturing and / or incision, at block 440.

[0167] According to some exemplary embodiments, the formed opening is dilated, at block 442, optionally using a dedicated dilator or a port.

[0168] According to some exemplary embodiments, a surface coating of a sac of a deployment device is optionally activated, for instance by saline immersion, at block 444.

[0169] According to some exemplary embodiments, a deployment device having the sac is at least partly introduced into a body cavity through the formed opening, at block 446. In some embodiments, a distal portion of the sac device which includes the sac is inserted into the body cavity.

[0170] According to some exemplary embodiments, lubricant is optionally applied on an external surface of the sac, at block 448. In some embodiments, the lubricant comprises at least one of, hypromellose, propylene glycol, Polyethylene Glycol (PEG), PEG 400, Carbomer, Methylparaben, Propylparaben, Sodium Hydroxide, Silver chloride, and silver sulfadiazine. In some embodiments, the lubricant is applied onto the surface of the sac by injecting the lubricant through one or more holes into a space between the external surface of the sac and a sleeve placed around the sac.

[0171] According to some exemplary embodiments, the sleeve, for example a dilator sleeve or a folded sac introducer, is retrieved from the body cavity, at block 450.

[0172] According to some exemplary embodiments, the sac device is used to expand or deploy the sac to a final expanded state, at block 452. In some embodiments, the sac is expanded, for example unfolded, to an expanded state using a sac expander mechanically coupled to the sac.

[0173] According to some exemplary embodiments, a folded implant delivery system is inserted into a sac access channel, at block 454.

[0174] According to some exemplary embodiments, the folded implant delivery system is inserted into an inner volume of the sac, at block 456. According to some exemplary embodiments, optionally, if needed, the sac is further expanded in order to create more space within the sac inner lumen to allow receiving of the folded implant delivery system, at block 458.

[0175] According to some exemplary embodiments, the folded implant delivery system is manipulated to deploy a standalone folded implant within the inner volume of the expanded sac, at block 460. In some embodiments, the manipulation comprises pulling at least one wire of the folded implant delivery system from outside the body, for example to remove a sheet surrounding the folded implant and / or to unfold the folded implant.

[0176] According to some exemplary embodiments, the sac and the sac device are retrieved from the body cavity, while leaving the unfolded implant within the body cavity, at block 462.

[0177] According to some exemplary embodiments, a procedure required to use the unfolded implant as part of a clinical procedure is completed at block 464. For example, in case the unfolded implant is a fluid extraction chamber, completion of a procedure comprises connecting an outlet port of the chamber to a first end of a draining tube and connecting a second end of the draining tube optionally to a reservoir.

[0178] Reference is now made to figs. 4C, depicting a process for deployment of a selfexpandable implant already preloaded into the sac, according to some exemplary embodiments of the invention.

[0179] According to some exemplary embodiments, a sac including a pe-loaded implant is deployed at block 466. In some embodiments, the sac is deployed using a sac expander or other expansion means.

[0180] According to some exemplary embodiments, deployment of the sac at block 466 results with self-expansion and deployment of the implant within the expanded sac, at block 468.

[0181] According to some exemplary embodiments, imaging, for example x-ray, fluoroscopy or ultrasound imaging, is used to ensure that the implant is properly deployed, unfolded, expanded, positioned or oriented within the sac, at block 470.

[0182] Reference is now made to figs. 4D, depicting a process for deployment of an implant already preloaded into the sac, according to some exemplary embodiments of the invention.

[0183] According to some exemplary embodiments, following deployment and expansion of a sac at block 466, a pre-formed skeleton is inserted into an inner volume of the implant, for example to expand the implant, at block 472.

[0184] According to some exemplary embodiments, once the skeleton is inserted, the skeleton is secured to the implant body, at block 474. In some embodiments, in case the implant is a chamber, for example a fluid extraction chamber, the skeleton is secured to a port positioned at an opening to the inner volume of the chamber.

[0185] Exemplary sac and implant assembly

[0186] Reference is now made to figs. 5A-5C depicting assembly between fan-shaped sac and an implant comprising a chamber, according to some exemplary embodiments of the invention.

[0187] According to some exemplary embodiments, for example as shown in fig. 5A, a sac 502 comprises a distal end 504 and a proximal end 508. In some embodiments, the sac is formed from at least one layer or a plurality of layers of fabric material. Optionally, in some embodiments, the sac 502 comprises at least one distal opening at the distal end 504. Optionally or additionally, the sac 502 comprises at least one proximal opening at the proximal end 506. In some embodiments, in an expanded unfolded state, for example as shown in fig. 5A, the sac is shaped as a fan.

[0188] According to some exemplary embodiments, the sac 502 is mechanically coupled to a sac expander comprising two elongated members 508 and 510. In some embodiments, each of the two elongated members 508 and 510 comprise a distal portion 512 coupled to the sac 502, and a proximal portion 514. In some embodiments, the elongated members 508 and 510 are oriented such that they cross each other path at an intersection point 516. In some embodiments, having intersection point 516 allows the elongated members to be pulled out from the subject body through a narrow opening in the body wall.

[0189] According to some exemplary embodiments, the elongated members, shaped as elongated rods, are coupled to opposite sides of the sac 502 via loops, for example loops 518, 520, 522 and 524, at least one loop on each side of the sac. Alternatively, the sac comprises two channels, one at each side of the sac, into which a distal portion of each elongated member is inserted.

[0190] According to some exemplary embodiments, for example as shown in fig. 5B, a chamber device, for example device 526 is shaped to fit inside sac 502. In some embodiments, the device comprises a chamber 528, optionally formed from a sheet material. In some embodiments, the chamber 528 comprises an inner volume, at least one opening 530 to the inner volume, for example to allow removal of fluids from the chamber inner volume. Optionally, the chamber device comprises a port at the opening 530, and a channel 532 connected to the port or passing through the opening 530 into the inner volume. In some embodiments, the channel comprises a draining tube.

[0191] According to some exemplary embodiments, for example as shown in fig. 5C, an assembly 534 comprises the chamber device 526 within the sac 502. In some embodiments, the at least one proximal opening 506 of the sac 502 is shaped and sized to allow passage of the channel 532 out from the sac 502.

[0192] According to some exemplary embodiments, the sac 526 is deployed, for example expanded and / or unfolded using a delivery system comprising the elongated members 508 and 510, which allow, for example to determine a target optimal fan shape of the sac in an expanded state, for example as shown in figs. 5 A and 5C.

[0193] According to some exemplary embodiments, the sac 526 is formed from a mesh, and the chamber 5B is positioned within the sac. In some embodiments, expansion of the sac 502 allows self-expansion of the chamber 528.

[0194] According to some exemplary embodiments, the sac 502 is expanded by moving a proximal portion 514 of each of the elongated members outwardly at opposite directions to move the elongated members away from each other, for example at opposing antero-lateral and anteromedial directions or at opposing antero- superior and antero-inferior directions. In some embodiments, after expansion of the sac, the elongated members are extracted, and the sac is extracted as well, leaving the chamber implant in site within the body cavity.

[0195] According to some exemplary embodiments, the sac 502, for example the fan-shaped mesh sac is made from fabric, for example knitted material or solid sheets. In some embodiments, the fabric is pre-coated, for example to provide pre-coated lubrication behavior. Optionally, the sac coating comprises hydrogel.

[0196] According to some exemplary embodiments, an area size of the sac 502 is between 100 to 1000 square centimeters, for example between 100 and 800 square centimeters, between 100 and 400 square centimeters, between 200 and 800 square centimeters, between 400 and 1000 square centimeters, or any intermediate, smaller or larger value or range of values. In some embodiments, a length of a long arch 544 of the sac 502 is between 100 and 400 mm, for example between 100 mm and 200 mm, between 150 mm and 300 mm , between 200 mm and 400 mm or any intermediate, smaller or large value or range of values. In some embodiments, a length of a short arch 544 of the sac 502 is between 20 and 170 mm, for example between 20 mm and 80 mm, between 50 mm and 120 mm , between 80 mm and 170 mm or any intermediate, smaller or large value or range of values.

[0197] According to some exemplary embodiments, an incision in the body, or puncturing formed to allow passage of a sac, for example the sac 502, has a width between 5 mm and 60 mm, for example between 8 mm and 30 mm, between 10 mm and 25 mm, between 12 mm and 50 mm, or any intermediate, smaller or larger value or range of values. According to some exemplary embodiments, the sac is configured to be introduced in a body cavity comprising peritoneal cavity, pleural space, preperitoneal space, pericardiac space, and cerebrospinal space.

[0198] Exemplary rods-based deployment device

[0199] According to some exemplary embodiments, a deployment device comprises a sac, and means for controlling sac expansion, for example a sac expander. In some embodiments, when the is introduced into a subject body, the sac is in a collapsed state and has a low profile, to allow the sac to pass through a narrow opening formed in the body. In some embodiments, the sac expander secures the sac is a collapsed folded state, for example to prevent the sac expansion during passage through the body opening. In some embodiments, when the sac is inside a target body cavity, the sac expander is configured to expand, for example to unfold, the sac to a desired expansion span.

[0200] Reference is now made to figs. 6A-6C, depicting a deployment device having a rods- based sac expander, according to some exemplary embodiments of the invention.

[0201] According to some exemplary embodiments, a deployment device 602 comprises an elongated body 604 having a long axis 605, a distal portion 606 configured to be introduced into a body cavity, and a proximal portion 608. In some embodiments, when the distal portion 606 is introduced at least partly into a body cavity, the proximal portion 608 remains outside the subject body.

[0202] According to some exemplary embodiments, the device 602 comprises a sac 610 at the distal portion 606, having in some embodiments an implant 612, for example a chamber, within the sac 610. In some embodiments, the device further comprises a rods-based sac expander mechanically coupled to the sac 610, and configured to control expansion and collapse of the sac. In some embodiments, the sac expander comprises at least two elongated members, for example rods 614 and 616. In some embodiments, a distal portion of each rod is coupled to a different opposite side of the sac 612. In some embodiments, the distal portion of the rods are coupled to an outer surface of the sac 612, are positioned within the sac 612 or are inserted within specific channels at opposite sides of the sac 612.

[0203] According to some exemplary embodiments, a proximal portion of each rod comprises a gripping member, for example gripping members 618 and 620. In some embodiments, each of the gripping members is configured to allow holding of the rod via the gripping member with a single hand. In some embodiments, the rods 614 and 616 are pivotally coupled to each other at a pivot site 622 located between a distal portion and a proximal portion of each rod. In some embodiments, pivotally coupling the rods 614 and 616 allows for example to move the distal portions of the rods away from each other, by moving the gripping members of the rods sideways at opposite directions, and away from each other.

[0204] According to some exemplary embodiments, the sac expander comprises a frame 615, for example an arc-shaped frame optionally defining an enclosed opening. In some embodiments, the rods 614 and 616 pass within the frame opening and / or are coupled to the frame. In some embodiments, the frame guides the rods movement and limits the maximal separation distance between proximal portions of the rods, optionally to reach a maximal target expansion of the sac 610. Optionally, an outer surface of the frame comprises visual distance indications configured to indicate an expansion length of the sac 610.

[0205] According to some exemplary embodiments, the device 602 comprises a handle 624 located proximally to the gripping members 618 and 620, at the proximal portion 608 or a proximal end of the body 604. In some embodiments, the handle 624 comprises a mandrel handle. In some embodiments, the handle 624 is coupled to an elongated shaft 626 extending towards and optionally into the sac 610. In some embodiments, shaft 626 is configured to axially move along axis 605, with respect to the sac 610. Alternatively the shaft 626 is static. Optionally, the shaft 626 is coupled to the frame 615 and / or to the pivot site 622.

[0206] According to some exemplary embodiments, the device 602 comprises at least one channel extending between the sac 610 and the handle 624. In some embodiments, the at least one channel comprises one or more openings within the sac and / or one or more openings outside the sac. Optionally, the channel passes within the shaft extending from the handle 624. In some embodiments, the handle 624 comprises at least one port or connector fluidically connected to the at least one channel, for example a Tuohy-Borst adapter, or any other type of connector, adapter or valve, for fluidically connecting a fluid source to the at least one channel. In some embodiments, the at least one channel allows, for example, flow or lubricant fluid and / or wash fluid into a volume within the sac 610 and / or into a space outside the sac, for example a space between the sac and an external sleeve wrapped around the sac.

[0207] According to some exemplary embodiments, a deployment system comprises the device 602, for example a sac device, and an implant 612, positioned within the sac 610. In some embodiments, the implant comprises an inner and optionally at least partly integrated, skeleton 628. In some embodiments, for example as shown in fig. 6C, when the device 602 is ready to introduced into a subject body, the sac 610 is covered with an external sleeve, for example sleeve 630, while the sac 610 and an implant 612 inside the sac 610 are collapsed, optionally folded. According to some exemplary embodiments, the folded device 602 and the rods 614 and 616, for example distending rods, are held by the sleeve 630. In some embodiments, the sleeve 630 is peelable, or tearable and / or retrievable distal sleeve.

[0208] According to some exemplary embodiments, after introduction of the distal portion of the device 602 into the subject body cavity, the sleeve 630 is removed and the sac deployment is made by releasing of safety latch and maneuvering of gripping members 618 and 620, acting for example as deployment handles. In some embodiments, the safety latch is positioned between the gripping members 618 and 620, for example to secure them in a closed conformation close to each and other and to prevent accidently movement of the members 618 during device introduction into the body cavity. Alternatively, the safety latch is located at the distal handle 624.

[0209] According to some exemplary embodiments, during deployment or expansion of the sac, for example as shown in fig. 6B, a deployment curve is determined by the deployment frame 615 which is adjusted to the designated arc of the fan-shaped sac 610. In some embodiments, the coincident point, for example pivot point 622 of the rods 614 and 616 is also set by the shape of the deployment frame.

[0210] According to some exemplary embodiments, the proximal comprises a piston coupled to an elongated shaft or rod 632 which mechanically supports the introduction, distension and locking of the implant’s inner skeleton 628, for example an inner frame or an inner stylet, against a resistance force applied by tissue in the body cavity against the sac. Additionally, the proximal piston is configured to provide a counter-force to hold implant intact while retrieving backwards the sac 610.

[0211] According to some exemplary embodiments, the washing port 634 in the handle 624, allows, for example fluid injection and optionally activation of the sac 610 friction reducing coating, optionally to enhance activation coverage, in respect to passive immersion of the distal sleeve.

[0212] Optionally, in case there is a difference in size and / or shape between the implant and the sac in an expanded state, the device further comprises one or more grippers configured to increase a retention force between the sac and the implant. Optionally the grippers are made by magnetic clips that hold the implant, for exmaple implant membrane or embedded skeleton to at least one layer of the sac. Alternatively, the grippers are made from mechanical clips that apply horizontal force (in direction of device long axis) but not in an orthogonal, for example lateral direction or a direction of the expansion of the sac and / or the implant thus optionally allowing release and separation of the sac from implant. Optionally, the clips comprise an adjustment mechanism or can be structured to adjust and control the gripping force.

[0213] According to some exemplary embodiments, a deployment device comprises a mechanism for adjusting the coincident or pivot point between the rods, according to a target implantation depth. In some embodiments, the frame 615 comprises a rail, a slot or an opening, determining a range of opening of the rods and / or an expansion degree of the sac. Optionally, the angle of the arc- shaped frame 615, and the travelling distance of the rods restricted by the frame, are adjusted according to a length of the rods and / or according to a size, shape and / or length of the sac.

[0214] Exemplary implant expansion

[0215] Reference is now made to figs. 7A-7C insertion and expansion of an implant using a rods- based deployment device, according to some exemplary embodiments of the invention.

[0216] According to some exemplary embodiments, a distal portion of a deployment device 702 is introduced through an incision 704, into a subject body, and a body cavity in the subject body. In some embodiments, a sac of the device covered with a sleeve 706 is positioned within the body cavity. In some embodiments, during the introduction phase, a safety latch secures gripping members 708 and 710 of the rods-base sac expander, in a closed collapsed configuration, such that they close to each other, within the frame 712.

[0217] According to some exemplary embodiments, for example as shown in fig. 7B, the device 702 is at least partly inserted into the body through the incision 704, that forms an access site, or a body opening through the skin 714 and the peritoneal wall 716. In some embodiments, the distal portion of the device 701 which comprises the sac, is placed in a close proximity or in contact with the intestines 718.

[0218] According to some exemplary embodiments, for example as shown in fig. 7C, after removal of the sleeve, the sac expander expands the sac 720, by moving the gripping members 708 and 710 of the rods, away from each other to a maximal distance determined by the frame 712. In some embodiments, the implant 722 positioned within the sac 720 self-expands, as the sac 720 expands.

[0219] Reference is now made to fig. 7D, depicting different layers of the deployment device and an implant, according to some exemplary embodiments of the device.

[0220] According to some exemplary embodiments, the deployment device sac is positioned within a sleeve during the insertion of the sac into the body. In some embodiments, the sac and the implant are folded within the sleeve in a cylindrical shape. In some embodiments, the cylindrical shaped distal portion of the deployment device is introduce via layers of skin, fat and muscle into a target body cavity. In some embodiments, the outermost layer of the cylinder comprises a mesh layer of the sleeve, having a mesh layer of the sac underneath the sleeve layer.

[0221] In some embodiments, the implant comprises a fluid extraction chamber having an outer membrane positioned on a membrane support layer, and inner skeleton mesh underneath the membrane support and a central implant frame or skeleton.

[0222] Exemplary introduction of an implant having an inner skeleton into a body

[0223] According to some exemplary embodiments, an implant which already has an inner skeleton, optionally a partially embedded skeleton, for example a scaffold, is introduced into the body. In some embodiments, the implant is introduced through a small incision made through the skin and body tissue to generate a passage through the body wall towards a body cavity.

[0224] Reference is now made to figs. 7E-7N depicting a process for introducing an implant having an inner, optionally embedded, skeleton, into a body, according to some exemplary embodiments of the invention. In some embodiments, an embedded skeleton is a skeleton which is integrated at least partly or completely with an implant, prior to insertion of the implant into a subject body.

[0225] According to some exemplary embodiments, for example as shown in fig. 7E, an implant model 730 is used to predict a location of the implant within the body. Alternatively or additionally, the implant model 730 is used to determine whether an implant having a similar shape and size of the model implant can be positioned inside the body. Alternatively or additionally, the model implant 730 is used to determine an incision location in the skin and through the body wall, for example incision 732. In some embodiments, the incision has a length of between about 10 mm and about 80 mm, for example between about 10 mm and about 15 mm, between about 10 mm and about 30 mm, between about 15 mm and about 30 mm, between about 30 mm and about 50 mm, between about 40 mm and about 60 mm, between about 50 mm and about 70 mm, or any intermediate, smaller or larger incision length.

[0226] According to some exemplary embodiments, prior to performing an incision, the subject is locally anesthetized or regionally anesthetized, and is optionally sedated.

[0227] According to some exemplary embodiments, for example as shown in fig. 7F, once an incision is formed and a passage towards the body cavity, optionally an abdominal cavity, is formed, a deployment device, for example deployment device 602 shown in fig. 6C, is partially inserted into the body cavity. In some embodiments, a distal portion of the deployment device is introduced through the incision into the body cavity, while a proximal portion 734 of the deployment device comprising a handle and a sac expander remain outside the body. In some embodiments, a proximal end of a sleeve, for example sleeve 630 shown in figs. 6B and 6C remains outside the body, optionally to allow manipulation of the sleeve positioned inside the body from outside the body.

[0228] According to some exemplary embodiments, the incision is made to form a body opening between an umbilicus 731 and a neck 733 of a subject, optionally at a distance of up to 50 cm, up to 40 cm, up to 30 cm, up to 20 cm, up to 10 cm, up to 5 cm, or any intermediate, smaller or larger value from the umbilicus.

[0229] According to some exemplary embodiments, for example as shown in fig. 7G, once the sac of the deployment device is positioned in a target location within the body, the sleeve 736 is pulled out from the body through the incision site 732. In some embodiments, pulling the sleeve 736 out form the body exposes an external surface of a sac to the body lumen, for example to body lumen tissue and / or body lumen fluids. In some embodiments, the sleeve is removed while the sac, for exmaple sac 612 shown in fig. 6C, is in a folded, for example collapsed state.

[0230] According to some exemplary embodiments, for example as shown in fig. 7H, an expert activates the sac expander from outside the body, to expand the sac inside the body lumen. In some embodiments, the sac expander is activated to expand, for example to unfold the sac within the body lumen, manually or using at least one motor, for example an electric motor functionally coupled to the sac expander. In some embodiments, the expert activates the motor and / or controls the expansion of the sac using at least one user interface located outside the patient body.

[0231] According to some exemplary embodiments, for example as shown in fig. 71, the expert moves expands and / or monitors the expansion of the implant within the sac. Additionally or optionally, once the implant has expanded, the expert moves the implant out form the sac, for example through a distal or a forward opening of the sac. Optionally, unfolding of the sac expands the implant, for example by allowing a self-expandable skeleton coupled to the implant to expand.

[0232] According to some exemplary embodiments, once the implant is expanded the device is retracted out from the subject body, while leaving an access tube 738 to the implant inner lumen, outside the body.

[0233] According to some exemplary embodiments, for example as shown in fig. 7J, an introduction sleeve holding the sac is removed out from the body.

[0234] According to some exemplary embodiments, for example as shown in fig. 7K, an outlet tube connected to the implant is tunneled, either to an organ or to at least one second implant, for example a control unit, or alternatively, an end of the outlet tube is removed out from the body, for example to allow connecting the implant to an external control unit.

[0235] Exemplary implant deployment verification

[0236] According to some exemplary embodiments, at least part of the implant deployment process is performed under imaging, for example to verify fully expansion of the implant. In some embodiments, one or more components of the implant are predesigned to be visible under imaging. In some embodiments, at least part of the implant for example a frame and / or a scaffold of the implant are formed from a radiopaque material. Alternatively or additionally. One or more radiopaque tags are coupled to the implant body.

[0237] Optionally, one or more portions of a deployment device or deployment system that is configured to be introduced into a body, for example a sac or a sleeve is formed from a radiopaque material and / or comprises at least one radiopaque tag.

[0238] Reference is now made to figs. 7L and 7M, depicting visualization of implant deployment, according to some exemplary embodiments of the invention.

[0239] According to some exemplary embodiments, at least part of a deployment process of an implant is performed under imaging, for example under fluoroscopy. In some embodiments, a frame or an expandable skeleton of an implant, for example skeleton 750 is visible under x-ray imaging, for example under fluoroscopy. In some embodiments, for example as shown in fig. 7L, the deployment of the expansion of the implant is not complete, optionally due a force applied on the implant by tissue inside the body lumen. In some embodiments, a skeleton manipulator, for example a mandrel 752 coupled to the skeleton 750 is used to expand and / or shape the skeleton 750. In some embodiments, for example as shown in figs. 7L and 7M, the mandrel is visible under fluoroscopy.

[0240] According to some exemplary embodiments, the mandrel extends form the skeleton, out form the body. In some embodiments, moving the mandrel 752 from outside the body, for example pulling, pushing or rotating the mandrel, applies force on the skeleton 750 within the body. In some embodiments, the applied force is sufficient to allow fully expansion of the skeleton and the implant, for example as shown in fig. 7M.

[0241] According to some exemplary embodiments, other imaging techniques can be used, for example ultrasound, to monitor deployment of the implant and / or to verify that the implant is expanded to a target or a desired state within the body lumen. Exemplary introduction of a sac via a catheter

[0242] According to some exemplary embodiments, a sac is introduced into the body via a catheter. In some embodiments, the sac is introduced into the body while loaded with an implant. Alternatively, the sac is introduced into the body without an implant, and following sac expansion, the implant is inserted into the expanded sac.

[0243] Reference is now made to figs. 8A-8D depicting deployment of an implant within a body cavity using a catheter, according to some exemplary embodiments of the invention.

[0244] According to some exemplary embodiments, the sac 712 and the implant are folded into a small profile catheter 714. The size of the distal end of the catheter or the catheter used for delivery is between 6-30 in French scale, for example between 6 French and 10 French, between 8 French and 20 French, between 10 French and 20 French, or any intermediate, smaller or larger value or range of values. In some embodiments, the catheter is introduced to the body using an introducer sheath or dilator and can be guided into the cavity using a prepositioned guidewire 716.

[0245] According to some exemplary embodiments, the sac 712 is folded into a protective sheath sleeve 718. In some embodiments, the implant device is partially integrated in the sac, where the implant’s external membrane is folded inside the sac and the implant’s skeleton (for example a stylet) is mostly located in a proximal position, optionally outside the device’s membrane.

[0246] According to some exemplary embodiments, after introduction of the catheter 714 into the body, for example as shown in fig. 8 A, and optionally over a preposition guidewire, the protecting sheath 718 is retrieved, for example as shown in fig. 8B, allowing partial expansion, for example distention of the sac 712 and an internal implant.

[0247] According to some exemplary embodiments, for example as shown in figs. 8C and 8D, a skeleton 720 is introduced into the implant, causing both device and sac 712 to expand. In some embodiments, a role of the sac in this application is to reduce a friction of between the expanded implant and the tissues, without jeopardizing the surface properties of the implant. In some embodiments, after reaching full deployment, the sac is retrieved and the guiding system is detached from the implant.

[0248] Exemplary sac and implant folds

[0249] According to some exemplary embodiments, a sleeve, for example an external or an outer sleeve is used to maintain a sac and an inner implant within the sac folded, to allow passage through a narrow opening into the body. In some embodiments, the sleeve surrounds the sac with the inner implant, and constrict the overall width of the sac and inner implant. Optionally, in some embodiments, the sac is positioned within the sleeve and does not contain an inner implant.

[0250] According to some exemplary embodiments, reference is now made to figs. 9A and 9B, depicting a sac and an inner implant in a folded state (9A), and in an expanded state (9B), according to some exemplary embodiments of the invention.

[0251] According to some exemplary embodiments, for example as shown in fig. 9A, a sac 902 and an implant 904 are folded within an outer sleeve 906. In some embodiments, the implant 904 and the sac 902 are folded to have valley folds and mountain folds. In some embodiments, the inner implant 904 and the sac 902 are folded and closely packed such that valley and mountain folds of the implant 904 are positioned within respective valley and mountain folds of the sac 902. Optionally, the folds of the sac 902 and the implant 904 are accordion folds.

[0252] According to some exemplary embodiments, closely packing the folds of the implant 904 within the folds of the sac 902 allows to fit the sac 902 and the implant 904 into a sleeve 906 having a maximal outer width 906, or outer diameter of between 5 mm and 60 mm, for example an outer width 906 between 5 mm and 30 mm, between 10 mm and 40 mm, between 7 mm and 20 mm, or any intermediate, smaller o rlarger value or range of values.

[0253] According to some exemplary embodiments, for example as shown in fig. 9B, removal of the sleeve allows expansion of the sac 902 and optionally self-expansion of the implant 904. In some embodiments, removal of the sleeve allows to expand the sac 902 to a maximal outer width of up to 400 mm, for example, up to 300 mm, up to 200 mm, up to 100 mm, or any intermediate, smaller or larger value or range of values.

[0254] Exemplary lubrication

[0255] According to some exemplary embodiments, lubricant is added during or prior to unfolding of the sac and / or the implant, for example to reduce friction and / or to assist in proper unfolding. In some embodiments, the deployment device is configured to allow application of lubricant material, for example gel, on one or more external surfaces of the sac. Optionally, the sac is permeable and lubricant material penetrates into the sac.

[0256] According to some exemplary embodiments, lubrication is applied directly to the interior of the sleeve. Optionally, the sac material is impermeable to gel thereby allowing the gel to protect the implant membrane.

[0257] According to some exemplary embodiments, the lubricant material is applied directly to the interior and optionally exterior of the sac. Optionally, the sac is permeable to lubricant, for example to allow homogeneous application of gel / lubricant prior to procedure. According to some exemplary embodiments, the deployment device comprises at least one channel, for example a tube, and optionally pumping means, for example using a syringe, to deliver the lubricant material to a space between the sac and the sleeve and / or into the sac.

[0258] According to some exemplary embodiments, in case there is a need to avoid an interaction between a lubricant and with the applied gel, the use of a sac protects the implant and the implant membrane from application of gel, while still providing the lubrication features needed for deployment. In some embodiments, additional tubing system that positioned in the sac allows, for example, outward flushing to washout the lubricant material.

[0259] Reference is now made to fig. 10A, depicting a deployment device with one or more lubrication and / or washing channels, according to some exemplary embodiments of the invention.

[0260] According to some exemplary embodiments, a deployment device 1002 comprises at least one channel, for example tubes 1004 and 1006, having one or more openings 1010, 1012 and 1014 between a sleeve 1016 and a sac 1018 positioned within the sleeve 1016. In some embodiments, the tubes 1004 and 1006 are coupled to at least one lubricant reservoir and / or pump, for example syringes 1020 and 1022. In some embodiments, each of the tubes 1004 and 1006 is fluidically coupled to a different syringe. Optionally, the at least two tubes 1004 and 1006 are coupled to the same syringe. In some embodiments, a syringe is used to controllably introduce lubricant material stored in the syringe into the sleeve 1016 via openings 1010, 1012, and 1014.

[0261] According to some exemplary embodiments, the deployment device 1002 optionally further comprises at least one washing channel, for example channel 1024, having one or more openings within the sleeve 1016 and / or within the sac 1018. In some embodiments, the channel 1024 is configured to deliver washing fluid into the sleeve 1016 and / or into the sac 1018, for example to was residual lubricant material. Optionally, the washing channel 1024, and / or one or both of the channels 1004 and 1006 is used as an outflow channel for removing fluids out from the sleeve 1016 and / or out from the sac 1018. In some embodiments, the at least one washing channel 1024 is fluidcally coupled to a reservoir of washing fluid, for example syringe 1026, located at a proximal portion of the device 1002. In some embodiments, as used herein, a syringe is used as a reservoir and as means for injecting fluid through a channel coupled t the syringe. Alternatively, the channel is coupled to a reservoir of the fluid, and pumping means or injection means, other than a syringe are positioned on the channel or fluidically coupled to the channel, for injecting the fluid in or out from the channel. Reference is now made to figs. 10B-10G, depicting delivery of washing and / or lubricant material into a sleeve and / or a sac, according to some exemplary embodiments of the invention.

[0262] According to some exemplary embodiments, for example as shown in figs. 10B and IOC, fluid, for example lubricant or wash is delivered via channel 1030 from a reservoir, for example syringe 1032, into sac 1034. In some embodiments, the fluid is delivered when the sac 1034 is folded as in fig. 10B and / or when the sac 1034 is unfolded, as in fig. 10C. In some embodiments, lubricant is delivered into the sac 1034, for example to reduce friction between an inner surface of the sac and an outer surface of an implant positioned within the sac. In some embodiments, washing fluid is delivered into the sac 1034, for example to wash residual lubricant from the sac 1034.

[0263] According to some exemplary embodiments, for example as shown in figs. 10E and 10F, lubricant is delivered via at least one channel 1030 into the sac 1034, for example to a space between the sac 1034 and the implant 1035, and via at least one different channel 1038, to a space between the sac 1034 and the sleeve 1042, for two different reservoirs 1032 and 1040, each is coupled to a different channel. In some embodiments, the lubricant is delivered via the at least two channels when the sac is folded, for example as shown in fig. 10D, and when the sac is unfolded, for example as shown in fig.lOE.

[0264] According to some exemplary embodiments, for example as shown in figs. 10F and 10G, the deployment device comprises at least one channel 1030 for delivery of lubricant into the sac 1034, from reservoir 1032, and at least one different channel 1042 for delivery of washing fluid from a different reservoir 1044 into the implant 1035, for example to wash residual lubricant entered into the implant 1035, when the sac is folded as shown for example in fig. 10F, and when the sac is unfolded, for example as shown in fig. 10G.

[0265] Exemplary implant expansion

[0266] According to some exemplary embodiments, the implant positioned within the sac is configured to expand within the expanded sac. In some embodiments, the implant already includes an integrated expandable skeleton, for example a stylet, and self-expands when the sac expands. Alternatively, a skeleton, for example an expandable skeleton is introduced into the implant after the implant is within the sac, and optionally after sac expansion.

[0267] Reference is now made to figs. 11A-11B, depicting expansion of an implant with a partially loaded skeleton, according to some exemplary embodiments of the invention.

[0268] According to some exemplary embodiments, a deployment device 1102 is introducing via a body opening formed in the body wall 1104 into a body cavity, in a collapsed folded state. In some embodiments, in the collapsed folded state, a sac 1106 of the device comprises an implant 1108 within the sac 1106, and both the sac 1106 and the implant 1108 are in a collapsed folded state, and are positioned within an outer sleeve 1110. In some embodiments, the sac 1106 extends proximally towards a proximal portion 1112 of the device 1102 located outside the body, forming a passage way or a channel 1114 from outside the body and into the sac 1106 inner volume. In some embodiments, the implant comprises a partially introduced skeleton 1116, for example a stylet, partially positioned within the implant 1108 and extends through the channel 1114 out from the body.

[0269] According to some exemplary embodiments, for example as shown in fig. 11B, once the sleeve 1110 is removed and the sac 1106 is expanded, the skeleton 1116 is further advanced into the implant 1108 to expand the implant.

[0270] Reference is now made to figs. 12A-12B, depicting expansion of an implant with an integrated skeleton, according to some exemplary embodiments of the invention.

[0271] According to some exemplary embodiments, a deployment device 1202 having a sac 1204 and an inner implant 1205 with an integrated skeleton 1206 is positioned within a sleeve 1208 is introduced into a body cavity through an opening in the body wall. As used herein, the term integrated skeleton means a scaffold already entirely positioned within an implant during the insertion of the implant into a body.

[0272] According to some exemplary embodiments, for example as shown in fig. 12B, removal of the sleeve, and further expansion of the sac 1204 induce expansion of the skeleton 1206 leading to self-expansion of the implant 1205.

[0273] Exemplary use of a deployment device with empty sac

[0274] According to some exemplary embodiments, a deployment device is used to introduce an implant from outside the body into a sac already expanded within a body cavity.

[0275] Reference is now made to figs. 13A-13F depicting a process for introducing an implant into an expanded sac, according to some exemplary embodiments.

[0276] According to some exemplary embodiments, for example as shown in fig. 13A, a deployment device 1302 having a distal sac 1304, and a sac access channel 1306 is used to introduce the sac 1304 in a collapsed state within a sleeve 1308 into a body cavity. In some embodiments, the sleeve 1308 comprising the sac 1304 is introduced via an opening in the body wall 1310. In some embodiments, the deployment device 1302 holds the sac 1304 such that the access channel 1306 extends via the opening in the body, out from the subject body. In some embodiments, the access channel 1306 is shaped and sized to allow passage of at least one implant into the inner volume of the sac 1304.

[0277] According to some exemplary embodiments, for example as shown in fig. 13B, following insertion of the sac 1304 into the body cavity, the sleeve 1308 is removed and the sac 1304 is expanded, for example using a sac expander, for example an expanding mechanism, or a rods- based expander, by moving rods coupled to the sac 1304 at opposite directions away from each other.

[0278] According to some exemplary embodiments, for example as shown in fig. 13C, following expansion of the sac 1304, a folded implant 1314 optionally coupled to an introducing flexible shaft 1316, is advanced into the access channel 1306. In some embodiments, the implant 1314 comprises an outlet tubing 1318 coupled to the implant body and a skeleton 1320 partially introduced into the implant.

[0279] According to some exemplary embodiments, for example as shown in fig. 13D, the implant 1314 is introduced into the expanded sac 1304 in a folded or a semi-folded state. In some embodiments, for example as shown in fig. 13E, the skeleton 1320 is advanced and inserted into the implant 1314, causing the implant to expand, while the outlet tubing passes through the access channel 1306 and out from the subject body.

[0280] According to some exemplary embodiments, for example as shown in fig. 13F, after expansion of the implant 1314, the deployment device including the sac 1304 is removed from the subject body, while leaving the implant 1314 deployed and the outlet tubing 1318 extends from the implant 1314 and out from the body, for example to allow draining of fluids from the implant inner volume to a reservoir outside the body.

[0281] Exemplary deployment system which includes a fluid extraction chamber

[0282] According to some exemplary embodiments, the deployment device is used to deploy a fluid extraction chamber within a body cavity.

[0283] Reference is now made to fig. 14A, depicting a system for deployment of a fluid extraction chamber, according to some exemplary embodiments of the invention.

[0284] According to some exemplary embodiments, a deployment device 1400 comprises a sac 1402 having an inner volume pre-loaded with a fluid extraction chamber 1404. In some embodiments, the chamber 1404 is mechanically coupled to a shaft 1406 of an applicator 1408.

[0285] According to some exemplary embodiments, the sac 1402 comprises at least one proximal opening 1410, through which the shaft 1406 coupld to the chamber 1404 exits from the sac 1402. Optionally, the sac 1402 comprises a front distal opening 1412, shaped and sized to allow removal of the chamber 1404 out from the sac 1402 into the body cavity after chamber expansion.

[0286] According to some exemplary embodiments, the deployment device 1400 further comprises a rods based sac expander comprising rods 1414 and 1416. In some embodiments, the rods are coupled to opposite sides of the sac 1402, such that when proximal portions of the rods located outside the sac are moved away from each other, the distal portions of the rods coupled to sac stretch the sac at opposite directions and unfold the sac.

[0287] Reference is now made to figs. 14B and 14C depicting a deployment system comprising an implant deployment device and a fluid extraction device (FIG. 14C is an enlarged view of section AA shown in fig. 14B, according to some exemplary embodiments of the invention.

[0288] According to some exemplary embodiments, an implant deployment system, for example system 1, optionally a kit, comprises an implant deployment device 1422 and an implant device, for example fluid extraction device 1424.

[0289] According to some exemplary embodiments, the device 1422 has an elongated body a distal portion 1426 having an outer smooth surface configured to be positioned inside a subject body, and a proximal portion 1428 configured to be positioned outside the subject body. In some embodiments, the device 1422 comprises a sac 1430 having an inner volume shaped and sized to receive an implant, and configured to move between a collapsed folded state, for example when the distal portion 1426 is inserted into a body cavity through an opening in the body wall, and an expanded unfolded state, for example when the sac 1430 is positioned inside a body cavity.

[0290] According to some exemplary embodiments, the device 1422 further comprises a sac expander comprising at least two elongated rods, for example at least one first rod 1431 and at least one second rod 1432, each having a distal end positioned within the sac 1430, for example with the sac inner volume or within dedicated channels in the sac 1430, and a proximal end configured to be positioned outside a subject body. In some embodiments, the at least two elongated rods 1431 and 1432 cross each other in an intersection location 1434. In some embodiments, the at least two elongated rods 1431 and 1432 are pivotally coupled to each other at location 1434, for example by a mechanical joint, optionally a hinge.

[0291] According to some exemplary embodiments, the sac expander of the device 1422 further comprises a movement frame 1436 having an aperture through which the rods 1431 and 1432 pass. In some embodiments, the movement frame 1436 is configured to limit the lateral movement of the rods 1431 and 1432 within the frame aperture to a maximal length of the aperture. According to some exemplary embodiments, the fluid extraction device 1424 comprises a chamber 1436 having a wall defining an inner volume and at least one opening 1442 to the inner volume. In some embodiments, the at least one opening comprises a port connector configured to connect the chamber 1438 to at least one draining tube. In some embodiments, the wall of the chamber comprises a membrane, for example a semi-permeable membrane. In some embodiments, the membrane is configured to allow passage of fluids from a body cavity in which the chamber is deployed into the inner volume of the chamber via the chamber wall. In some embodiments, the membrane comprises one or more of, Polytetrafluoroethylene (PTFE), Polyethersulfone (PES), Polyvinylidene fluoride or polyvinylidene difluoride (PVDF), Polypropylene (PP), Nylon, Polyester (PET), Collagen, Hydrogels or others, either in a single layer or in multilayer. In some embodiments, the fluid extraction device comprises an elongated hollow rigid tube 1440 coupled to the opening 1442. In some embodiments, the rigid tube 1440 forms a channel configured to allow advancement of at least one skeleton, for example a stylet, into the chamber 1438. Optionally, the tube 1440 is coupled to a skeleton storage 1443 which stores the at least one skeleton prior to advancement of the at least one skeleton into the chamber 1438.

[0292] According to some exemplary embodiments, optionally, the device 1424 comprises a skeleton advancement mechanism, for example skeleton advancer 1444 optionally interconnecting the storage 1443 and the tube 1440. In some embodiments, the advancement mechanism is configured to allow indirect holding and manual advancement of the at least one skeleton stored in the storage 1442 into the chamber 1438 via the tube 1440 and the opening 1442. In some embodiments, the advancement mechanism comprises a flexible tube having accordion folds, for example to allow axial manual advancement of the scaffold within the flexible tube. Alternatively, the skeleton advancer comprises at least one actuator, for example a spring or a motor, optionally an electric motor, for moving the skeleton. In some embodiments, the skeleton is moved between the storage 1443 and the sac, for example chamber 1438. In some embodiments, for example as shown in figs. 14B and 14C, the rod 1431 of the sac expander is mechanically coupled to the tube 1440 of the chamber device, for example to allow using the tube 1440 to move the rod 1431 with respect to the rod 1432.

[0293] Exemplary implant delivery system

[0294] Reference is now made to figs. 14D and 14E, depicting an implant delivery system, in a collapsed state (fig. 14D), and in an expanded state (fig. 14E), accoridng to some exemplary embodiments of the invention. According to some exemplary embodiments, an implant delivery system 1403, for example a deployment system, comprises an elongated body 1405 having a distal portion 1407 configured to be introduced through a body opening into a subject body, and a proximal portion 1409 configured to be positioned outside the subject body.

[0295] According to some exemplary embodiments, the distal portion 1407 comprises a sac 1411 coupled to a sac expander, optionally comprising two elongated rods extending between the distal portion 1407 and the proximal portion 1409, for example rods 1413 and 1415. In some embodiments, the sac expander expands the sac by moving the rods 1413 and 1415 away from each other, for example as shown in fig. 14E, showing the sac in an expanded state. In some embodiments, in a collapsed state, shown in fig. 14D, a maximal distance between the two rods 1413 and 1415, optionally a maximal distance of a distal portion of the rods configured to be positioned inside the subject body, is up to 20 cm, up to 15 cm, up to 10 cm, up to 5 cm, or any intermediate, smaller or larger value, for example to allow insertion of the distal portion 1407 through a small incision into the subject body.

[0296] According to some exemplary embodiments, the system 1403, optionally comprises a sleeve, for example sleeve 1417, configured to surround the sac 1411 during insertion of the distal portion 1407 into the subject body. In some embodiments, the sleeve keeps the distal portion 1407 is a collapsed state, for example by restricting movement, for example lateral movement of the rods 1413 and 1415.

[0297] According to some exemplary embodiments, the sac 1411 comprises an implant, for example chamber 1419. In some embodiments, for example as shown in fig. 14D, the chamber 1419, for example a fluid extraction chamber is in a collapsed, optionally folded state, when the sac 1411 is collapsed.

[0298] According to some exemplary embodiments, the proximal portion 1409 comprises a sac expander 1421 configured to controllably expand the sac 1411, for example by moving the rods 1413 and 1415 or a distal portion of the rods, away from each other. In some embodiments, the sac expander 1421 is a manual sac expander, configured to allow manual separation or distancing of the rods. Alternatively, the sac expander comprises at least one actuator, for example a motor, for moving the rods away from each other.

[0299] According to some exemplary embodiments, the body 1406 further comprises a skeleton mover, for example a skeleton advancer 1421 configured to advance at least one skeleton, for example a scaffold towards the implant 1419, optionally into an inner volume of the implant 1419. In some embodiments, the skeleton advancer 1421 is configured to move the at least one skeleton from outside the subject body into an inner volume of the implant, when the implant is positioned inside the subject body, optionally via a channel interconnecting the skeleton advancer 1423 and the implant 1419.

[0300] According to some exemplary embodiments, the body 1405 comprises a storage 1425 at the proximal portion 1409, for storing the at least one skeleton. In some embodiments, the storage 1425 is interconnected to the implant by at least one channel, and optionally via the skeleton advancer 1423. In some embodiments, the skeleton advancer 1423 is configured to advance the at least one skeleton stored in the storage 1425 towards and optionally into the implant 1419.

[0301] According to some exemplary embodiments, the chamber 1419 comprises at least one port to an internal volume of the chamber, for example port 1427. In some embodiments, at least one channel 1429, for example a tube, is functionally coupled to the port 1427, for forming a fluid flow path from, and to the chamber 1419. In some embodiments, the tube extends between the distal portion 1407 and the proximal portion 1403, for example to allow fluid flow from the chamber 1419, out from a subject body.

[0302] According to some exemplary embodiments, prior to expansion of the sac 1411, the sleeve 1417 is removed. In some embodiments, the rods 1413 and 1415 are pivotally coupled to each other, for example by a joint, optionally by a hinge. In some embodiments, the sac expander comprises the joint and the rods. In some embodiments, to expand the sac a proximal end of each rod, for example proximal ends 1431 and 1433 are moved away from each other, for example to allow distancing of distal ends of the rods at the distal portion 1407 that are coupled to the sac 1411. In some embodiments, when the rods distal ends move away from each other, the sac 1411 expands, for example as shown in fig. 14E.

[0303] Reference is now made to fig. 14F, depicting an additional embodiment of an implant delivery system, according to some exemplary embodiments of the invention.

[0304] According to some exemplary embodiments, in the delivery system 1433 rods 1413 and 1415 are coupled to a guide 1435, for exmaple to a guiding frame or a guiding rail, configured to allow a relative rotation of the rods 1413 and 1415 with respect to each other, optionally along a restricted movement path. In some embodiments, the rods 1413 and 1415 are pivotally coupled to each other by a joint, and the guide 1435 is used to restrict a relative movement of the rods with respect to each other, optionally along a predetermined arch length, for example an arc length defined by an aperture of the guide 1435 in which one or both of the rods move.

[0305] According to some exemplary embodiments, the system 1433 comprises a skeleton advancer 1437 unit, optionally comprising at least one actuator, or a manual user interface for manually advancing the skeleton, optionally form the storage 1425, towards the implant 1419. According to some exemplary embodiments, a delivery system comprises an implant within the sac and / or a sleeve. Alternatively, the implant and / or the sleeve are part of a kit comprising a delivery system, an implant and / or the sleeve.

[0306] Exemplary introduction of an implant into a body using an insertable skeleton

[0307] According to some exemplary embodiments, a deployment device or a deployment system, is used to introduce an implant into a body lumen using at least one insertable skeleton. In some embodiments, after the implant is positioned in a folded, collapsed state within the body lumen, at least one skeleton is inserted into the implant, optionally to an inner volume of the implant. In some embodiments, the at least one skeleton is inserted into the implant, for example to allow expansion and / or unfolding of the implant to a desired expansion state.

[0308] Reference is now made to figs. 14G-14O, depicting deployment of an implant by introduction of a skeleton from outside the body into the implant, according to some exemplary embodiments of the invention.

[0309] According to some exemplary embodiments, for example as shown in fig. 14G, a model implant 1450 is used to determine an incision site 1452. In some embodiments, the model implant 1450 is used, for example as described in fig. 7E. In some embodiments, the incision forms a body opening having a maximal length of up to 30 cm, up to 20 cm, up to 15 cm, up to 10 cm or any intermediate, smaller or larger length.

[0310] According to some exemplary embodiments, for example as shown in fig. 14H, a deployment device is at least partly introduced through the incision site 1452 into a body lumen. In some embodiments, a distal portion of the deployment device, for example distal portion 1426 of device 1422 shown in fig. 14B is inserted through the incision site into the body lumen. In some embodiments, the distal portion of the device is inserted in a collapsed state through the incision site to the body lumen. In some embodiments, a maximal width of the distal portion of the device is smaller than the body opening, for example smaller than the body opening width.

[0311] According to some exemplary embodiments, for example as shown in figs. 141 and 14J, the distal portion of the device is positioned inside the body lumen in a target location and / or in a target orientation.

[0312] According to some exemplary embodiments, for example as shown in fig. 14K, once the distal portion of the device comprising the sac , is positioned in a target location, a sleeve 1458 covering the sac, for example sac 1430 shown in figs. 14B and 14C is removed. In some embodiments, the sleeve protects the sac from interaction with tissue and / or fluid when inserting the distal portion of the deployment device into the body. Optionally, in case the sac is a self- expandable sac, when the sleeve surrounds the sac it maintains the sac in a collapsed state preventing sac expansion. In some embodiments, in case the sac is a self-expandable sac, removal of the sleeve expands the sac, and optionally an expansion mechanism of the device is used for fine tuning and / or adjustments of the sac expansion.

[0313] According to some exemplary embodiments, for example as shown in fig. 14L, a sac expander, for example sac expander 1454 is activated to expand the sac within the body. In some embodiments, the sac expanderl454 is activated manually by moving rods 1456 and 1458 located outside the patient body away from each other.

[0314] According to some exemplary embodiments, for example as shown in fig. 14M, once the sac 1460 is expanded and / or during the expansion of the sac, at least one skeleton, for example skeleton 1462 is advanced towards the implant, for example chamber 1463. In some embodiments, the skeleton 1462 is inserted into an inner lumen or an inner volume of the chamber 1463. In some embodiments, the inserted skeleton 1462 stabilizes the chamber in an expanded, deployed conformation.

[0315] According to some exemplary embodiments, the at least one skeleton 1462 is advanced by a skeleton advancer 1464 towards the chamber 1463, optionally from a storage portion 1466. In some embodiments, at least one skeleton is advanced manually, or using at least one actuator of the skeleton advancer. In some embodiments, the skeleton comprises an elastic elongated strip configured to bend or flex, optionally an elongated spring.

[0316] According to some exemplary embodiments, for example as shown in fig. 14N, once the chamber is expanded to acquire an expanded functional conformation, the introduction device is removed from the body, leaving the chamber 1463 inside the patient body. In some embodiments, the chamber 1463 is coupled to at least one tube 1468, fluidically coupled to at least one port of the chamber 1463, for example to allow outflow of fluids out form the chamber inner volume, and / or optionally inflow of fluids into the chamber inner volume. In some embodiments, a proximal end 1470 of the tube 1468 is functionally coupled to the chamber 1463, for example to at least one port of the chamber, and a distal end 1472 of the tube 1468 is located outside the patient body, optionally passing via the body opening formed by the incision.

[0317] According to some exemplary embodiments, for example as shown in fig. 140, a distal end of the tube 1468 can be coupled to an implanted reservoir and / or to an implanted control unit. Alternatively, the distal end of the tube 1468 can be fluidically coupled to a biological reservoir, for example to the bladder. Alternatively, the distal end 1472 of the tube 1468 can be functionally coupled to an external reservoir and / or to an external control unit located outside the patient body. Exemplary sac expansion using a balloon

[0318] According to some exemplary embodiments, the sac expander comprises an inflatable portion, for example a balloon coupled to the sac. In some embodiments, during insertion of the sac into a body cavity, the sac and the balloon are in a collapsed compact state, to maintain a low profile while moving through a narrow opening into the body. In some embodiments, inflation of the balloon through one or more inflation channels, expands the balloon and sac coupled to the balloon in a lateral direction and / or in an axial direction.

[0319] Reference is now made to figs. 15A-15C, depicting expansion of a sac using a balloon, according to some exemplary embodiments of the invention.

[0320] According to some exemplary embodiments, at least one inflatable portion, for example a balloon 1502 is mechanically coupled at one or more locations to an external surface of a sac 1504 comprising implant. In some embodiments, the balloon 1502 is coupled to a single side of the sac 1504. Alternatively, the balloon 1502 surrounds at least partly the sac 1504.

[0321] According to some exemplary embodiments, for example as shown in fig. 15B, the balloon 1508 comprises a plurality of elongated inflatable chambers for example chambers 1510, 1412, 1514, and 1516, separated by welding lines 1618 and 1520. In some embodiments, at least some the elongated inflatable chambers are oriented in parallel to each other, and are coupled to an external surface of the sac 1522. In some embodiments, the sac 1522 comprises an inner implant, for example chamber 1624 having an inner skeleton 1526.

[0322] In some embodiments, for example as shown in fig. 15B, when the inflatable chambers, for example chambers 1510 and 1512 are deflated, the chambers are closely packed and contact each other to form a compact formation, in which the sac 1522 coupled to the inflatable chambers is folded. In some embodiments, for example as shown in fig.l5C, expansion of the inflatable chambers 1510 and 1512, pushes the chambers away from each other to expand the sac 1522 in a lateral direction. Optionally, the balloon comprises one or more inflatable chambers interconnecting the chambers 1510 and 1512 and oriented at an angle relative to the chambers 1510 and 1512 axis. In some embodiments, inflation of the interconnecting chambers rigidize the balloon in the lateral direction causing the chambers 1510 and 1512 to move away from each other, and thereby to expand the sac 1522.

[0323] Reference is now made to figs. 15D and 15E, depicting a balloon positioned within a sac, according to some exemplary embodiments of the invention.

[0324] According to some exemplary embodiments, at least balloon 1540 is positioned within the sac 1542, between the sac 1542 and an implant 1544. In some embodiments, the at least one balloon 1542 is coupled to an external surface of the sac 1544. In some embodiments, the balloon 1542 comprises 2 or more spaced-apart inflatable chambers, where at least two inflatable chambers surround at least partly the implant 1544, for example chambers 1548 and 1552. In some embodiments, when the balloon is deflated, for example as shown in fig. 15D, the implant 1544 is collapsed. In some embodiments, inflation of the balloon, for example as shown in fig. 15E, expands the implant and increases the implant thickness, thereby increases the implant volume.

[0325] Figs. 16A-16F, depict different types of balloons with various arrangements of axial and geometric inflatable chambers. In some embodiments, having different arrangements of inflatable chambers, optionally aligned in in a similar or different directions allows, for example to control the expansion direction of a sac coupled to the balloon.

[0326] Fig. 16G depicts a sac 1602 comprising an inner implant and at least one balloon. In some embodiments, the balloon comprises a plurality of finger- like inflatable chambers 1604, 1606, 1608 and 1610, axially aligned according to a long axis 1612 of the sac. In some embodiments, the finger- like chambers are interconnected by channels or chambers, for example channels 1614, 1616 and 1618, for example to allow expansion of the sac in a lateral sideways direction relative to axis 1612.

[0327] Exemplary expansion by rotation of rods

[0328] Reference is now made to figs. 17A-17C depicting expansion of a sac in a z axis perpendicular to the sac plane, according to some exemplary embodiments of the invention.

[0329] According to some exemplary embodiments, a deployment device comprises a rods-based sac expander having elongated rods inserted into the sac 1702, optionally to axial side channels oriented along the long axis of the sac. In some embodiments, at least a portion of the rods within the sac 1702, for example rods 1704 and 1706 have an elongated cross section, having a long axis and a short axis. In some embodiments, the rods are rotatable. In some embodiments, when the sac is in a collapsed state, the rods are oriented within the sac such that a long axis of the rods cross section is aligned with the sac plane 1708, for example as shown in fig. 17A.

[0330] According to some exemplary embodiments, for example as shown in fig. 17B, in order to increase a volume of the sac 1702, the rods 1704 and 1706 are rotated such that a long axis of the cross section of the rods is oriented substantially perpendicular to the sac plane 1708, for example to allow expansion of the sac inner volume in an axis 1710 substantially perpendicular to the sac plane. A potential advantage of rotating the rods to increase the volume of the sac may be to allow easier access to an implant lumen, for example during insertion or advancement of a skeleton into the implant. According to some exemplary embodiments, for example as shown in fig. 17C, the rods 1704 and 1706 are rotated by rotating or turning, for example in 90 degrees, proximal gripping members of the rods, for example gripping members 1714 and 1716 located outside the subject body.

[0331] According to some exemplary embodiments, the rods contain an actuation mechanism to distend the sac in the z axis, by using leaf springs that are exposed by pulling or rotating the proximal handles of the rods. In some other embodiments, the rods allow introduction of flexible preshaped wires loops that distend further sac in the z direction.

[0332] Exemplary elongated member

[0333] Reference is now made to figs. 18A and 18B, depicting types of elongated members, for example rods, used for expansion of a sac, according to some exemplary embodiments of the invention.

[0334] According to some exemplary embodiments, an elongated member assembly, for example rod 1802 comprises a distal portion 1804 configured to be introduced into a subject body, for example into a sac or channels within a sac. In some embodiments, the distal portion 1804 has a smooth outer surface and a rounded, blunt or soft material distal tip, for example to prevent puncturing of tissue or the sac. In some embodiments, the rod 1802 comprises a proximal portion 1806 terminating with a handle 1808 at a proximal end of the rod 1820. In some embodiments, the proximal portion 1806 of the rod 1802 is configured to remain outside the subject body, and to control the expansion of the sac by controlling movement of the rods. In some embodiments, a frame 1810 is configured to be coupled to the rod between the distal portion 1804 and the proximal portion 1806.

[0335] According to some exemplary embodiments, the rod is rigid. Alternatively, or optionally, the rod is rigid in an axial direction and is flexible in a direction substantially perpendicular to the axial direction. In some embodiments, for example as shown in fig. 18A, the rod is straight along the entire length of the rod. Optionally, for example as shown in fig. 18B, a distal portion 1812 of the rod 1804 is angled, and a proximal portion 1814 of the rod is angled or curved.

[0336] A potential advantage of having an angled distal portion may be to allow insertion of a sac to a body cavity closer to a body wall and at a distance from an opening.

[0337] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0338] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”. The term “consisting of’ means “including and limited to”.

[0339] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0340] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0341] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0342] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0343] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0344] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts. As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0345] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0346] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0347] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A method for deployment of an implant inside a body cavity, comprising: expanding a sac within a body cavity of a subject body; inducing expansion of an implant positioned within the expanded sac; retracting said sac from said subject body following said inducing.

2. A method according to claim 1, wherein said inducing comprises inducing said expansion after said expanding of said sac.

3. A method according to any one of claims 1 or 2, wherein said implant is a self- expandable implant comprising at least one skeleton coupled to the implant, and wherein said inducing expansion comprises allowing said self-expandable implant to expand within said expanded sac.

4. A method according to any one of claims 1 or 2, wherein said implant comprises at least one skeleton is partly inserted within the implant when the implant is positioned within the expanded sac, and wherein said inducing expansion comprises advancing said at least one skeleton into said implant.

5. A method according to any one of claims 3 or 4, wherein said at least one skeleton comprises an expandable frame or an expandable stylet, configured to expand and stretch said implant to acquire an expanded state.

6. A method according to any one of claims 3 to 5 comprising locking said at least one skeleton in an expanded following said inducing expansion.

7. A method according to any one of the previous claims, comprising: activating at least one lubrication coating on an external surface of said sac prior to said expanding.

8. A method according to any one of claims 1 to 6, comprising: lubricating an external surface of said sac prior to said expanding with at least one lubricant material.

9. A method according to claim 8, comprising: inserting said sac packed inside an external sleeve from outside the body via a body opening into said body cavity, and wherein said lubricating comprises injecting said at least one lubricant to a space between said sac and said external sleeve prior to said expanding.

10. A method according to any one of claims 1 to 8, comprising: packing said sac within an external sleeve; introducing said external sleeve with said sac into said body cavity via a body opening formed in the subject body.

11. A method according to claim 10, wherein said body opening has a maximal width of between 3 mm and 50 mm.

12. A method according to any one of the previous claims, comprising: introducing said sac already containing said implant into said body cavity.

13. A method according to any one of claims 1 to 11, comprising: introducing said sac without said implant into said body cavity; inserting said implant into said sac after said expanding, when the sac is expanded.

14. A method according to any one of the previous claims, wherein said expanding comprises actuating from outside said subject body a sac expander mechanically coupled to said sac, and wherein said retracting comprises retracting said sac expander from said subject body.

15. A method according to any one of the previous claims, wherein said expanding comprises inflating at least one balloon mechanically coupled to said sac, and wherein said retracting comprises retracting said at least one balloon from said subject body.

16. A method according to claim 14, wherein said sac expander comprises at least one rod coupled to a first side of said sac and at least one second rod coupled to an opposite side of said sac, and wherein said expanding comprises moving said at least one first rod and said at least one second rod at opposite directions and away from each other, thereby expanding said sac.

17. A method according to any one of the previous claims comprising, removing said expanded implant from said expanded sac into said body cavity, following said inducing and prior or during said retracting.

18. A method according to claim 17, wherein said removing comprises removing said expanded implant from an inner volume of said sac through at least one existing opening in said sac.

19. A method according to claim 17, comprising tearing said sac to form at least one opening in said sac, and wherein said removing comprises removing said expanded implant through said at least one opening.

20. A method according to any one of claims 17 to 19, wherein said removing comprises applying a force on said sac and / or on said implant suitable for removing said expanded implant from said expanded sac into said body cavity.

21. A method according to any one of the previous claims, comprising collapsing said sac to a maximal width smaller than a minimal width of a body opening prior to said retracting, and wherein said retracting comprises retracting said collapsed sac through said body opening out from said subject body.

22. A method according to any one of the previous claims, wherein said retracting comprises retracting said sac from said subject while maintaining said implant inside said body cavity.

23. A method according to any one of the previous claims, wherein said body cavity comprises, a peritoneal cavity, a pleural space, a preperitoneal space, a pericardiac space, or a cerebrospinal space.

24. A method according to any one of the previous claims, wherein said implant comprises a fluid extraction chamber configured to extract fluids out from the body cavity.

25. A method according to claim 24, wherein said fluid extraction chamber comprises a membrane on an outer surface of the fluid extraction chamber.

26. A system for deployment of an implant within a body cavity, comprising: an implant deployment device having an elongated body, a long axis, a proximal portion and a distal portion configured to be introducible into a body cavity, wherein said device comprising: a sac positioned at said distal portion, wherein said sac comprises an inner volume and is configured to move between a folded state and an unfolded state, and wherein said inner volume is shaped and sized to receive an implant; a sac expander mechanically coupled to said sac and extending between said distal portion and said proximal portion, wherein said sac expander is configured to move said sac between said folded state and said unfolded state.

27. A system according to claim 26, wherein said distal portion comprising said sac is configured to move between a collapsed state in which said distal portion is introduced into a body cavity while said proximal portion remains outside a subject body, and an expanded state within said body cavity.

28. A system according to any one of claims 26 or 27, wherein said sac expander is configured to unfold said sac substantially laterally relative to said long axis.

29. A system according to any one of claims 26 to 28, wherein said sac expander comprises at least one balloon coupled to said sac, and wherein inflation of said balloon expands said sac to acquire said expanded unfolded state.

30. A system according to claim 29, wherein said at least one balloon is coupled to an external surface of said sac or is positioned inside said sac.

31. A system according to any one of claims 29 or 30, wherein said at least one balloon comprises a plurality of spaced-apart inflatable chambers coupled to said sac, wherein when said at least one balloon is deflated adjacent inflatable chambers of said plurality of spaced- apart inflatable chambers are closely packed and contact each other, and wherein when said at least one balloon is inflated, said adjacent inflatable chambers are moved apart.

32. A system according to claim 31, wherein at least some of said plurality of spacedapart inflatable chambers are axially oriented according to said long axis, and at least some of said plurality of spaced-apart inflatable chambers are oriented at angle relative to said axially oriented inflatable chambers and positioned therbetween.

33. A system according to any one of claims 26 to 28, wherein said sac expander comprises at least one first rod and at least one second rod extending between said distal portion and said proximal portion of said elongated body, wherein said at least one first rod is coupled to a first side of said sac and said at least one second rod is coupled to a second opposite side of said sac, and wherein movement of said at least one first rod and said at least one second rod away from each other unfolds said sac.

34. A system according to claim 33, wherein said at least one first rod and said at least one second rod cross are pivotally coupled to each other at an intersection pivot location proximally to said sac and have each a proximal end at said proximal portion of said implant deployment device configured to be positioned outside a subject body and a distal end coupled to said sac, and wherein movement of said proximal end of said at least one first rod and said proximal end of said at least one second rod, away from each other unfolds said sac.

35. A system according to claim 34, wherein said sac expander comprises a movement frame having an aperture and located between said intersection pivot location and said proximal end of each of said rods, and wherein said at least one first rod and said at least one second rod are oriented to pass within said aperture, and wherein said movement frame is configured to limit a lateral movement of said at least one first rod and of said at least one second rod to a length of said aperture.

36. A system according to any one of claims 33 to 35, wherein said at least one first rod and said at least one second rod are rigid in an axial direction and flexible in a lateral direction.

37. A system according to any one of claims 33 to 35, wherein said at least one first rod and said at least one second rod are straight or have an angled distal portion.

38. A system according to any one of claims 26 to 37, wherein said sac is formed from a single layer or a multi-layer of sheet material comprising at least one of, fabric, knitted material, mesh or solid material.

39. A system according to any one of claims 26 to 38, wherein said sac comprises at least one preformed distal front opening.

40. A system according to any one of claims 26 to 39, wherein said sac comprises at least one proximal opening facing said proximal portion of said device elongated body.

41. A system according to any one of claims 26 to 40, wherein said implant deployment device comprises an implant remover extending between said proximal portion and said distal portion of said elongated body, wherein said implant remover is configured to apply force on said sac and / or on an implant within the sac that is suitable to remove said implant out form said sac.

42. A system according to claim 41, wherein said implant remover comprises at least one elongated rod having a distal end configured to contact said sac and / or said implant, and a proximal end at said device elongated body proximal portion.

43. A system according to claim 42, wherein said elongated rod is configured to contact at least one skeleton of an implant positioned within said sac.

44. A system according to any one of claims 26 to 43, wherein said system comprises at least one lubricator device functionally coupled to said deployment device, comprising at least one lubricating channel fluidically connecting a source of a lubricant material and at least one opening in said at least one lubricating channel located at said deployment device distal portion, and wherein said at least one lubricating channel is configured to release said lubricant material via said at least one opening at said deployment device distal portion.

45. A system according to claim 44, wherein said at least one opening of said at least one lubricating channel is positioned outside said sac or inside said sac.

46. A system according to any one of claims 26 to 45, wherein said sac comprises at least one channel fluidically connected to an inner volume of said sac and extending between said elongated body proximal portion and said sac, wherein said channel is shaped and sized to receive an implant in a collapsed state and to guide the implant into said inner volume of the sac.

47. A system according to any one of claims 26 to 45, comprising said implant, wherein said implant comprises at least one skeleton configured to move said implant from a collapsed state to an expanded state.

48. A system according to claim 47, wherein said at least one skeleton is integrated in said implant, or said at least one skeleton is insertable into said implant.

49. A system according to any one of claims 47 or 48, wherein said implant comprises a fluid extraction chamber having a wall defining an inner volume of said fluid extraction chamber, wherein said wall comprises a semi-permeable membrane configured to allow passage of fluid from outside said fluid extraction chamber into said fluid extraction chamber inner volume.

50. A kit, comprising: a fluid extraction device, comprising: a fluid extraction chamber having a wall defining an inner volume, and at least one opening to said inner volume, wherein said fluid extraction chamber is configured to move between a folded state and an unfolded state, and wherein said fluid extraction chamber wall comprises a semi-permeable membrane configured to allow passage of fluid from outside said fluid extraction chamber into said inner volume; at least one skeleton; at least one channel coupled to said at least one opening configured to deliver said at least one skeleton into said fluid extraction chamber; an implant deployment device, comprising: a sac configured to move between a collapsed folded state when the sac is introduced into a body cavity in a subject body, and an expanded unfolded state, when the sac is unfolded within the body cavity, wherein said sac comprises an inner volume which includes said fluid extraction chamber;a sac expander mechanically coupled to said sac and configured to move said sac between said collapsed folded state and said expanded unfolded state.

Images