WO2013190543A1

WO2013190543A1 - Method and apparatus for device advancement within a lumen

Info

Publication number: WO2013190543A1
Application number: PCT/IL2013/050498
Authority: WO
Inventors: Ohad Shafran; Benjamin Spenser; Alon Cohen; Itzhak AVNERI
Original assignee: Gi Motions, Ltd.
Priority date: 2012-06-17
Filing date: 2013-06-10
Publication date: 2013-12-27

Abstract

An advancement mechanism for advancing a device within a lumen, the device exhibiting a longitudinal axis, the advancement mechanism constituted of: at least one translatable member secured to the device, each translatable member arranged to be translated along a translation axis generally parallel to the longitudinal axis of the device; and a proximal translation mechanism arranged to translate the at least one translatable member proximally along the translation axis, wherein each of the at least one translatable member exhibits a translatable member variable extension length from the longitudinal axis of the device, the translatable member variable extension length arranged to increase responsive to the proximal translation mechanism.

Description

METHOD AND APPARATUS FOR DEVICE ADVANCEMENT WITHIN A

LUMEN

BACKGROUND

[0001] Diagnosis and treatment of gastro-intestinal (GI) diseases is advantageously performed responsive to visual inspection and occasion in-situ intervention or sampling. As a result, the field of endoscopy has advanced over the years, resulting in current solutions such as deep tube intubation and capsule endoscopy. Capsule endoscopy avoids a need to provide a tube extending from external of the subject to the target tissue, however control of capsule endoscopy is limited, and furthermore the ability to perform in-situ intervention or sampling is not provided.

[0002] Unless stated otherwise, the following terms have the following definitions. The term distal is defined as being away from the entrance to a lumen and the term proximal is defined as being close to the entrance to the lumen. In particular, the term distal end of a device is defined as the end of the device which is further away from the lumen entrance and the term proximal end is defined as the end of the device closer to the lumen entrance, or external of the lumen entrance. The term distal direction is defined as the direction extending away from the entrance to the lumen and further into the lumen. The term proximal direction is defined as the direction extending towards the entrance to the lumen from inside the lumen. The term distal translation is defined as a translation in the distal direction and the term proximal translation is defined as a translation in the proximal direction.

[0003] An endoscope is typically provided with an articulation section near the distal tip of the endoscope tube, allowing the operator to articulate the distal tip in relation to a central axis of the endoscope tube by actuation of an articulation mechanism at the proximal end thereof. The articulation mechanism typically allows for articulation in any of 4 orthogonal directions, conventionally known as up, down left and right, typically defined in relation to the operator view from the camera at the endoscope tip. In reality each of the 4 orthogonal directions of articulation reflects bending of the articulation section from the center line axis of the elongated endoscope. One non-limiting example of an articulation mechanism is described in U.S. Patent 5,704,898 issued January 6, 1998 to Kokish, the entire contents of which is incorporated herein by reference. [0004] One difficulty in tube based endoscopy is the need to control the advance of the distal tip of the endoscope through the tortuous area of the small intestine. One solution is the use of a balloon in cooperation with an overtube, wherein inflating the overtube balloon provides localized traction so that the endoscope disposed axially within the overtube may be advanced in relation thereto. Another solution is double balloon endoscopy, wherein inflatable balloons are provided at the distal tip of both the endoscope and the overtube. In addition to the ability to secure the overtube to the lumen wall, the endoscope may be fixed to the lumen wall by inflation of the endoscope tip balloon, thus allowing for advancing of the overtube. Upon completion of endoscopy, the endoscope is withdrawn from the patient by the operator.

[0005] Other methods include threaded catheters as described in U.S. Patent

Application Publication US 2002/0045855 published April 18, 2002 to Frassica, and a self propelled endoscope micro-robot as described in U.S. Patent S/N 6,702,734 issued March 9, 2004 to Kim et al, the entire contents of each of which is incorporated herein by reference. Unfortunately each of these solutions adds complexity and some of the solutions are not completely compatible with commercially available endoscopes, or cannot overcome the above mentioned difficulties in advancement and retrieval.

[0006] U.S. Patent US 8,142,348 granted March 27, 2012 to Miyoshi, the entire contents of which are incorporated herein by reference, describes an endoscope advancement device comprising an outer side unit exhibiting outer side arms uniformly arranged in a circumferential direction and comprising an inner side unit exhibiting inner side arms uniformly arranged in the circumferential direction between the outer side arms. In one described embodiment, during advancement of an endoscope through an intestine the inner side unit is advanced distally, the friction between the inner side arms and the inner walls of the intestine and the friction between the outer side arms and the inner walls of the intestine preventing movement of the endoscope in the proximal direction. After advancement of the inner side unit, the outer side unit is advanced over the inner side unit. The inner and outer side units are advanced responsive to an external device. Disadvantageously, during advancement of both the inner and outer side units the friction between the inner walls of the intestine and the external device causes buckling of the external device, thereby the advancement of the device is impeded. [0007] In another described embodiment, during advancement of an endoscope through the intestine the inner side unit is translated proximally from a distal position to a proximal position, with the inner arms in an expanded diameter state, the friction between the inner side arms and the inner walls of the intestine causing the intestine to be moved proximally over the endoscope. The endoscope is thus advanced through the intestine. The inner side arms are then contracted into a reduced diameter state and advanced distally to the distal position by an external device, where they are returned to the expanded diameter state and again translated proximally to the proximal position. Disadvantageously, the described shape of the inner arms do not allow for an effective advancement of the endoscope through the intestine. Additionally, as described above, the distal advancement of the inner side unit is impeded by buckling of the external advancement device.

[0008] The above disadvantages also apply to endoscope advancement, or other device advancements within other lumens, such as through pipes. It would thus be desirable to have a system which can effectively advance a device, such as an endoscope, through a lumen.

SUMMARY OF THE INVENTION

[0009] In view of the discussion provided above and other considerations, the present disclosure provides methods and apparatus to overcome some or all of the disadvantages of prior and present methods of device advancement and retrieval.

[00010] In one exemplary embodiment, an advancement mechanism for advancing a device through a lumen is provided, the device exhibiting a longitudinal axis, the advancement mechanism comprising: at least one translatable member secured to the device and arranged radially about the device, each translatable member arranged to be translated along a translation axis, the translation axis generally parallel to the longitudinal axis of the device; a proximal translation mechanism arranged to translate the at least one translatable member proximally along the translation axis; and an internal distal translation mechanism arranged to translate the at least one translatable member distally along the translation axis.

[00011] In one embodiment, each of the at least one translatable member exhibits a translatable member variable extension length from the longitudinal axis of the device, the translatable member variable extension length arranged to increase responsive to the proximal translation mechanism translating the at least one translatable member proximally along the translation axis. In one further embodiment, each of the at least one translatable member further comprises a pair of fixed connecting members arranged to connect the translatable member to the translation mechanism, each of the connecting members exhibiting a variable connection angle in relation to a second surface of the translatable member such that the fixed member, the pair of fixed connecting members and the longitudinal axis of the device form a generally parallelogram shape, wherein the variable connection angle is arranged to change responsive to the proximal translation mechanism, and wherein the increase of the translatable member variable extension length is responsive to the change in the variable connection angle.

[00012] In one yet further embodiment, the advancement mechanism further comprises at least one expandable retrieval preparation member, the at least one expandable retrieval preparation member is arranged in a deployed position of the device to not expand beyond a plane defined by the at least one translatable member, and wherein the at least one expandable retrieval preparation member is arranged in a retrieval position of the device to: expand beyond the plane defined by the at least one translatable member such that the walls of the lumen are not in contact with the at least one translatable member; and for each of the at least one translating members, apply proximal pressure to a first of the pair of translating connecting members such that the translatable member variable extension length is reduced. In another yet further embodiment, the advancement mechanism further comprises an extension and retraction member, the extension and retraction member arranged to be translated proximally and distally along the translation axis, wherein each of the pair of translatable connecting members are hingeably coupled to the extension and retraction member, wherein the translatable member variable extension length is arranged to increase responsive to the distal translation of the extension and retraction member, and wherein the translatable member variable extension length is arranged to decrease responsive to the proximal translation of the extension and retraction member.

[00013] In another further embodiment, the translatable member variable extension length is arranged to decrease responsive to the internal distal translation mechanism translating the translatable member along the translation axis. In one further embodiment, the at least one translatable member comprises expandable material, the translatable member variable extension length exhibiting an expanded length when the expandable material is expanded and the translatable member variable extension length exhibiting a contracted length, the expanded length greater than the contracted length when the expandable material is contracted, and wherein when the expandable material is contracted, the at least one translatable member protrusion is covered by one of: a covering; and the expandable material.

[00014] In another embodiment, the advancement mechanism further comprises at least one fixed member secured to the device and arranged radially about the device. In one further embodiment, each translatable member comprises at least one translatable member protrusion extending from a first surface of the respective translatable member, each translatable member protrusion exhibiting an acute translatable member protrusion angle in relation to the first surface of the respective translatable member, the acute translatable member protrusion angle determined from the proximal end of the device, and wherein each fixed member comprises at least one fixed member protrusion extending from a surface of the respective fixed member, each fixed member protrusion exhibiting an acute fixed member protrusion angle in relation to the surface of the respective fixed member, the acute fixed member protrusion angle determined from a proximal end of the device.

[00015] In another further embodiment, the advancement mechanism further comprises: a covering sheath arranged, in a retrieval position of the device, to cover the at least one fixed member and the at least one translatable member, and arranged, in a deployed position of the device, to be contracted such that the covering sheath does not cover either the at least one fixed member or the at least one translatable member. In one further embodiment, the at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device, wherein the at least one translatable member exhibits a translatable member variable extension length from the longitudinal axis of the device, and wherein the fixed member variable extension length and the translatable member variable extension length conform to the inner diameter of the body lumen.

[00016] In one yet further embodiment the advancement mechanism further comprises: at least one translatable connecting member, exhibiting elastic properties and arranged to secure the at least one translatable member to the device; and at least one fixed connecting member, exhibiting elastic properties arranged to secure the at least one fixed member to the device, wherein the conforming to the inner diameter of the body lumen is responsive to: an inner wall of the lumen applying pressure to the at least one translatable connecting member and the at least one fixed connecting member; and the elastic properties of the at least one translatable connecting member and the at least one fixed connecting member. In another further embodiment, the translation mechanism is arranged to translate the at least one translatable member along the translation axis in a proximal direction, and wherein the proximal translation is arranged such that the proximal maximus translatable member protrusion of the at least one translatable member is not substantially translated proximal of the proximal maximus fixed member protrusion of the at least one fixed member.

[00017] In one further embodiment, the advancement mechanism further comprises a proximal retraction member, the proximal retraction member coupled to the device and positioned distal of the at least one translatable member, wherein the proximal retraction member is arranged in a compressed mode to: be contracted, such that the diameter of the proximal retraction member is less than the diameter of the lumen; and be translated proximally and distally along the device, and wherein the proximal retraction member is arranged in an expanded mode to: be expanded, such that the diameter of the proximal retraction member is at least the diameter of the lumen; and be translated proximally along the device such that the lumen is retracted. In one yet further embodiment, the proximal retraction member comprises a balloon catheter.

[00018] In another further embodiment, the at least one fixed member comprises an expandable member exhibiting a plurality of fixed member protrusions, wherein the at least one translatable member comprises a plurality of translatable members, each of the translatable members extending over the expandable member, and wherein the plurality of fixed member protrusions are positioned in between adjacent translatable members. In one further embodiment, the at least one translatable member protrusion comprises a plurality of rows of the translatable member protrusions, the plurality of rows positioned along the particular translatable member.

[00019] In another further embodiment, the at least one translatable member comprises a plurality of expandable translatable members, and wherein the at least one fixed member comprises a plurality of expandable fixed members, each expandable translatable member positioned in between adjacent fixed expandable members. In one further embodiment, the advancement mechanism further comprises at least one fixed member extender coupled to each of the at least one translatable member, wherein the at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device, the fixed member extender arranged to extend towards the fixed member and apply radial force to the fixed member responsive to the proximal translation of the at least one translatable member.

[00020] In another further embodiment, the at least one fixed member comprises a plurality of fixed members, the plurality of fixed members evenly arrayed about the device, and wherein the at least one translatable member comprises a plurality of translatable members, the plurality of translatable members evenly arrayed about the device. In another embodiment, the advancement mechanism further comprises a plurality of separation members, a first end of each separation member coupled to the device and a second end of each separation member, opposing the first end of the separation member, extending away from the device, wherein the at least one translatable member comprises a plurality of translatable members, each separation member coupled to a particular translatable member, wherein in a deployed state, the separation members are arranged to not radially extend past the respective translatable members, and wherein in a retrieval state, the separation members are arranged to radially extend past the respective translatable members.

[00021] Independently, an advancement mechanism for advancing a device within a lumen is provided, the device exhibiting a longitudinal axis, the advancement mechanism comprising: at least one translatable member secured to the device and arranged radially about the device, each translatable member arranged to be translated along a translation axis, the translation axis generally parallel to the longitudinal axis of the device; and a proximal translation mechanism arranged to translate the at least one translatable member proximally along the translation axis, wherein each of the at least one translatable member exhibits a translatable member variable extension length from the longitudinal axis of the device, the translatable member variable extension length arranged to increase responsive to the proximal translation mechanism translating the at least one translatable member proximally along the translation axis.

[00022] In one embodiment, the advancement mechanism further comprises at least one fixed member secured to the device and arranged radially about the device. In one further embodiment, each translatable member comprises at least one translatable member protrusion extending from a first surface of the respective translatable member, each translatable member protrusion exhibiting an acute translatable member protrusion angle in relation to the first surface of the respective translatable member, the acute translatable member protrusion angle determined from the proximal end of the device, and wherein each fixed member comprises at least one fixed member protrusion extending from a surface of the respective fixed member, each fixed member protrusion exhibiting an acute fixed member protrusion angle in relation to the surface of the respective fixed member, the acute fixed member protrusion angle determined from a proximal end of the device.

[00023] In another further embodiment, the advancement mechanism further comprises: a covering sheath arranged, in a retrieval position of the device, to cover the at least one fixed member and the at least one translatable member, and arranged, in a deployed position of the device, to be contracted such that the covering sheath does not cover either the at least one fixed member or the at least one translatable member. In one further embodiment, the at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device, and wherein the fixed member variable extension length and the translatable member variable extension length conform to the inner diameter of the lumen.

[00024] In one yet further embodiment, the advancement mechanism comprises: at least one translatable connecting member, exhibiting elastic properties and arranged to secure the at least one translatable member to the device; and at least one fixed connecting member, exhibiting elastic properties arranged to secure the at least one fixed member to the device, wherein the conforming to the inner diameter of the body lumen is responsive to: an inner wall of the lumen applying pressure to the at least one translatable connecting member and the at least one fixed connecting member; and the elastic properties of the at least one translatable connecting member and the at least one fixed connecting member. In another further embodiment, the translation mechanism is arranged to translate the at least one translatable member along the translation axis in a proximal direction, and wherein the proximal translation is arranged such that the proximal maximus translatable member protrusion of the at least one translatable member is not substantially translated proximal of the proximal maximus fixed member protrusion of the at least one fixed member.

[00025] In one further embodiment, the advancement mechanism further comprises a proximal retraction member, the proximal retraction member coupled to the device and positioned distal of the at least one translatable member, wherein the proximal retraction member is arranged in a contracted mode to: be contracted, such that the diameter of the proximal retraction member is less than the diameter of the lumen; and be translated proximally and distally along the device, and wherein the proximal retraction member is arranged in an expanded mode to: be expanded, such that the diameter of the proximal retraction member is at least the diameter of the lumen; and be translated proximally along the device such that the lumen is retracted. In one yet further embodiment, the proximal retraction member comprises a balloon catheter.

[00026] In another further embodiment, the at least one fixed member comprises an expandable member exhibiting a plurality of fixed member protrusions, wherein the at least one translatable member comprises a plurality of translatable members, each of the translatable members extending over the expandable member, and wherein the plurality of fixed member protrusions are positioned in between adjacent translatable members. In one further embodiment, the at least one translatable member comprises expandable material, the translatable member variable extension length exhibiting an expanded length when the expandable material is expanded and the translatable member variable extension length exhibiting a contracted length, the expanded length greater than the contracted length when the expandable material is contracted, and wherein when the expandable material is contracted, the at least one translatable member protrusion is covered by one of: a covering; and the expandable material.

[00027] In another further embodiment, the at least one translatable member protrusion comprises a plurality of rows of the translatable member protrusions, the plurality of rows positioned along the particular translatable member. In one further embodiment, the at least one translatable member comprises a plurality of expandable translatable members, and wherein the at least one fixed member comprises a plurality of expandable fixed members, each expandable translatable member positioned in between adjacent fixed expandable members.

[00028] In one further embodiment, each of the at least one fixed member further comprises a pair of fixed connecting members arranged to connect the fixed member to the device, each of the fixed connecting members exhibiting a variable connection angle in relation to a second surface of the fixed member such that the fixed member, the pair of fixed connecting members and the longitudinal axis of the device form a generally parallelogram shape, wherein the at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device, wherein the variable connection angle is arranged to change responsive to the a proximal force applied to the fixed member, and wherein the fixed member variable extension length is arranged to increase responsive to the change in the variable connection angle. In another further embodiment, the advancement mechanism further comprises at least one fixed member extender coupled to each of the at least one translatable member, wherein the at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device, the fixed member extender arranged to extend towards the fixed member and apply radial force to the fixed member responsive to the proximal translation of the at least one translatable member.

[00029] In one further embodiment, the at least one fixed member comprises a plurality of fixed members, the plurality of fixed members evenly arrayed about the device, and wherein the at least one translatable member comprises a plurality of translatable members, the plurality of translatable members evenly arrayed about the device. In another embodiment, the advancement mechanism further comprises: an internal distal translation mechanism arranged to translate the at least one translatable member distally along the translation axis, wherein the translatable member variable extension length of each translatable member is arranged to decrease responsive to the internal distal translation mechanism translating the translatable member along the translation axis.

[00030] In one embodiment, each of the at least one translatable member forms a generally parallelogram shape further comprises: a pair of translatable connecting members arranged to connect the translatable member to the translation mechanism, each of the translatable connecting members exhibiting a variable connection angle in relation to a second surface of the translatable member such that the translatable member, the pair of translatable connecting members and the longitudinal axis of the device form a generally parallelogram shape, wherein the variable connection angle is arranged to change responsive to the proximal translation of the proximal translation mechanism, and wherein the increase of the translatable member variable extension length is responsive to the change in the variable connection angle. In one yet further embodiment, the advancement mechanism further comprises at least one expandable retrieval preparation member, wherein the at least one expandable retrieval preparation member is arranged in a deployed position of the device to not expand beyond a plane defined by the at least one translatable member, and wherein the at least one expandable retrieval preparation member is arranged in a retrieval position of the device to: expand beyond the plane defined by the at least one translatable member such that the walls of the lumen are not in contact with the at least one translatable member; and for each of the at least one translating members, apply proximal pressure to a first of the pair of translating connecting members such that the translatable member variable extension length is reduced.

[00031] In another yet further embodiment, the advancement mechanism further comprises an extension and retraction member, the extension and retraction member arranged to be translated proximally and distally along the translation axis, wherein each of the pair of translatable connecting members are hingeably coupled to the extension and retraction member, wherein the translatable member variable extension length is arranged to increase responsive to the distal translation of the extension and retraction member, and wherein the translatable member variable extension length is arranged to decrease responsive to the proximal translation of the extension and retraction member. In another embodiment, the advancement mechanism further comprises a plurality of separation members, a first end of each separation member coupled to the device and a second end of each separation member, opposing the first end of the separation member, extending away from the device, wherein the at least one translatable member comprises a plurality of translatable members, each separation member coupled to a particular translatable member, wherein in a deployed state, the separation members are arranged to not radially extend past the respective translatable members, and wherein in a retrieval state, the separation members are arranged to radially extend past the respective translatable members.

[00032] Independently, a method of advancing a device within a lumen is provided, the device exhibiting a longitudinal axis, the method comprising: translating a translatable member secured to the device, the translating being along a translation axis in a proximal direction, the translation axis generally parallel to the longitudinal axis of the device; responsive to the translating, applying a first proximal force to an inner wall of the lumen, the first proximal force being applied in the proximal direction; responsive to the translating, applying a first orthogonal force to the inner wall of the lumen, the first orthogonal force being applied in a direction generally orthogonal to the direction of the first proximal force; and preventing the movement of the device in the proximal direction responsive to a first distal force applied between the inner wall of the lumen and the translatable member, the first distal force being applied in the distal direction.

[00033] In one embodiment, the method further comprises: preventing the movement of the device in the proximal direction responsive to a second distal force applied between the inner wall of the lumen and a fixed member secured to the device, the second distal force applied in the distal direction; and responsive to a second proximal force applied to the fixed member in a proximal direction, applying a second orthogonal force to the inner wall of the lumen, the second orthogonal force being applied in a direction generally orthogonal to the direction of the second proximal force. In another embodiment, the method further comprises: translating the secured fixed member along the translation axis in a distal direction responsive to an internal distal translation mechanism; and responsive to the distal translation, reducing the applied first orthogonal force.

[00034] In one embodiment, the method further comprises: rolling up a covering sheath, the covering sheath secured to the device; inserting the device within the body lumen; advancing the device within the body lumen by performing the preventing, translating, applying proximal force and applying orthogonal force; covering the secured fixed member with the covering sheath; and retrieving the device from the body lumen. In another embodiment, the translation along the translation axis in a proximal direction is arranged such that a protrusion extending from the secured fixed member is not substantially translated proximal of a proximal maximus protrusion of the secured translatable member.

[00035] Additional features and advantages of the invention will become apparent from the following drawings and description.

BRIEF DESCRIPTION OF DRAWINGS

[00036] For a better understanding of the invention and to show how the same may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings in which like numerals designate corresponding elements or sections throughout.

[00037] 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 the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the accompanying drawings:

[00038] FIG. 1A illustrates a high level perspective view of an advancement mechanism secured to a device and comprising a plurality of fixed members and a plurality of translatable members;

[00039] FIG. IB illustrates a high level perspective view of the advancement mechanism of FIG. 1 A with the translatable members in a distal position;

[00040] FIG. 1C illustrates a high level perspective view of the advancement mechanism of FIG. 1 A with the translatable members in a proximal position;

[00041] FIG. ID illustrates a high level side view of the advancement mechanism of FIG. 1A showing a single fixed member and a single translatable member;

[00042] FIG. IE illustrates a high level side view of a translatable member of

FIGs. 1A - ID in an expanded state;

[00043] FIG. IF illustrates a high level side view of a translatable member protrusion of a translatable member of FIGs. 1A - ID;

[00044] FIG. 1G illustrates a high level side view of the translatable member of

FIG. IE in a partially contracted state;

[00045] FIG. 1H illustrates a high level side view of a fixed member of FIGs.

1A - ID in an expanded state;

[00046] FIG. II illustrates a high level side view of a translatable member protrusion of a translatable member of FIGs. 1A - ID;

[00047] FIG. 1J illustrates a high level side view of the fixed member of FIG.

1H in a partially contracted state;

[00048] FIG. IK illustrates a high level side view of the fixed member of FIG.

1H in a fully contracted state;

[00049] FIG. 1L illustrates a high level perspective view of the advancement mechanism of FIG. 1A, further comprising securing mechanisms for securing a device to the advancement mechanism; [00050] FIG. 1M illustrates a high level perspective of a translatable member of

FIGs. 1A - ID comprising a plurality of sets of translatable member protrusions;

[00051] FIG. 2A illustrates a high level perspective partially cut a way view of the advancement mechanism of FIGs. 1A - IF within a lumen;

[00052] FIG. 2B illustrates a high level side view of the advancement mechanism of FIGs. 1A - IF within the lumen of FIG. 2A, showing a single fixed member and a single translatable member, the translatable member being in a distal position, the advancement mechanism further comprising a first embodiment of an internal distal translation mechanism;

[00053] FIG. 2C illustrates a high level side view of the advancement mechanism of FIG. 2A, the translatable member being in a proximal position;

[00054] FIG. 2D illustrates a high level side view of the advancement mechanism of FIGs. 1A - IF within the lumen of FIG. 2A, the translatable member being in a proximal position, the advancement mechanism further comprising a second embodiment of an internal distal translation mechanism;

[00055] FIGs. 3 A - 3B illustrate various views of the advancement mechanism of FIGs. 1A - IF, further comprising a covering sheath in a rolled up state;

[00056] FIGs. 3C - 3D illustrate various views of the advancement mechanism of FIG. 3A, with the covering sheath in a partially deployed state;

[00057] FIG. 3E illustrates a high level perspective view of the advancement mechanism of FIG. 3A, with the covering sheath in a full covering state;

[00058] FIG. 4 illustrates a high level flow chart of a first embodiment of a method of advancing a device within a lumen;

[00059] FIG. 5 illustrates a high level flow chart of a second embodiment of a method of advancing a device within a lumen;

[00060] FIGs. 6 A - 6G illustrate a high level side view of an advancement mechanism secured to a device and comprising a proximal retraction member;

[00061] FIGs. 7 A - 7D illustrate a high level side view of an advancement mechanism secured to a device and comprising a proximal retraction member, the proximal retraction member comprising a balloon catheter;

[00062] FIG. 8 illustrates a high level perspective view of an advancement secured to a device and incorporating the proximal retraction member of FIGs. 6 A - 6G; [00063] FIG. 9A illustrates a high level side view of an advancement mechanism secured to a device and comprising a translatable spiked balloon;

[00064] FIGs. 9B - 9C illustrate a high level side view of an advancement mechanism secured to a device and comprising a fixed spiked balloon;

[00065] FIGs. 10A - 10B illustrate various setups of translatable and fixed members;

[00066] FIGs. 11 A - 11H illustrate various high level views of an advancement mechanism secured to a device and comprising a plurality of short and long balloons;

[00067] FIGs. 12A - 12D illustrate various side views of an advancement mechanism comprising fixed member extenders;

[00068] FIGs. 13A - 13D illustrate various positions of an advancement mechanism comprising an extension and retraction member;

[00069] FIG. 14A illustrates a high level side view of a device arranged to advance within a body lumen without an endoscope;

[00070] FIG. 14B illustrates an illustration of forces applied to a bent device;

[00071] FIGs. 15A - 15D illustrate various high level views of a spiked element and an associated separation member;

[00072] FIGs. 16A - 16C illustrate a high level side view of various states of an advancement mechanism secured to a device and comprising a plurality of balloons;

[00073] FIGs. 17 A - 17B illustrate various high level views of an accordion shaped inflatable spiked element;

[00074] FIGs. 18A - 18B illustrate various high level views of a pair of balloons arranged to lift a lumen wall off of a spiked element;

[00075] FIGs. 19A - 19B illustrate various high level views of an inflatable spiked element arranged to cover its spikes;

[00076] FIGs. 20 A - 20B illustrate various high level views of an inflatable spiked element in relation to a covering; and

[00077] FIG. 21 illustrates a high level front view of and advancement mechanism comprising a plurality of spiked balloons and a plurality of smooth balloons. DESCRIPTION OF EMBODIMENTS

[00078] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is applicable to other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[00079] FIG. 1A illustrates a high level perspective view of an advancement mechanism 10, advancement mechanism 10 comprising a plurality of fixed members 20 and a plurality of translatable members 30, translatable members 30 being in a distal position; FIG. IB illustrates a high level partial perspective view of advancement mechanism 10 with translatable members 30 in the distal position; FIG. 1C illustrates a high level partial perspective view of advancement mechanism 10 with translatable members 30 in the proximal position; FIG. ID illustrates a high level partial side view of advancement mechanism 10 showing a single fixed member 20 and a single translatable member 30; FIG. IE illustrates a high level side view of a translatable member 30 in an expanded state; FIG. IF illustrates a high level side view of a translatable member protrusion 140 extending from a translatable member 30; FIG. 1G illustrates a high level side view of a translatable member 30 in a partially contracted state; FIG. 1H illustrates a high level side view of fixed member 20 in an expanded state; FIG. II illustrates a high level side view of a translatable member protrusion 140 extending from a translatable member 30; FIG. 1J illustrates a high level side view of fixed member 20 in a partially contracted state; FIG. IK illustrates a high level side view of fixed member 30 in a fully contracted state; FIG. 1L illustrates a high level perspective view of advancement mechanism 10, further comprising securing mechanisms for securing a device 2 to advancement mechanism 10; and FIG. 1M illustrates a high level perspective of a translatable member 30 comprising a plurality of sets of translatable member protrusions 140; FIGs. 1A - 1L being described together.

[00080] Advancement mechanism 10 comprises: plurality of fixed members

20, each exhibiting a proximal end 22 and a distal end 24; plurality of translatable members 30, each exhibiting a proximal end 32 and a distal end 34; a proximal translation mechanism 40 comprising a support member 45; and a guide member 50, exhibiting a proximal end 52 and a distal end 54.

[00081] Each fixed member 20 exhibits a first surface 60 and a second surface

70 opposing first surface 60. In one embodiment first surface 60 exhibits a plurality of fixed member protrusions 80 each extending from first surface 60, fixed member protrusions 80 arrayed along first surface 60 from proximal end 22 to distal end 24. Each fixed member protrusion 80 comprises a distal portion 82 and a proximal portion 84 meeting at a joint 86. Proximal portion 84 defines an acute fixed member protrusion angle al in relation to first surface 60, fixed member protrusion angle al determined between proximal portion 84 of fixed member protrusion 80 and proximal end 22 of fixed member 20, and defined from the perspective of proximal end 22. In another embodiment (not shown), fixed member protrusions 80 are not provided and first surface 60 exhibits a predetermined friction coefficient with an inner wall of a lumen, as will be described below. In one further embodiment, first surface 60 is covered with a fabric exhibiting capillary capabilities, i.e. the fabric transfers liquids and moisture through itself. Optionally, the fabric comprises one or more of: cotton; polyester; and COOLMAX fabric, commercially available from Invista of Wichita, KS.

[00082] Each fixed member 20 further exhibits a fixed member extension length 100 from longitudinal axis 4 of device 2, fixed member extension length 100 defined by the distance between first surface 60 of fixed member 20 and longitudinal axis 4. In one embodiment, as will be described below, fixed member extension length 100 is variable. In one embodiment, first surface 60 exhibits a curved shaped and fixed member extension length 100 is defined by the distance between the apex of curved first surface 60 and longitudinal axis 4.

[00083] Each fixed member 20 further comprises at least one connecting member 110. A first end of each connecting member 110 is connected to a base member 115 and base member 115 is attached to guide member 50. In one embodiment, where guide member 50 is generally tubular shaped, each base member 115 is generally ring shaped and surrounds guide member 50. A second end of each connecting member 110 connected to second surface 70 of the particular fixed member 20. In one embodiment, a pair of connecting members 110 are provided, a first connecting member 110 is connected towards proximal end 22 of fixed member 20 and a second connecting member 110 is connected towards distal end 24 of fixed member 20. There is no requirement that first and second connecting members 110 each meet one of the proximal end 22 and distal end 24, and an extension distal of the connection between first connecting member 110 and distal end 24 and/or an extension proximal of the connection between second connecting member 110 and proximal end 22 is specifically contemplated. In particular, FIG. IE shows such an extension proximal of the connection between second connecting member 110 and proximal end 22. A pair of connecting members 110 are illustrated, however this is not meant to be limiting in any way and any number of connecting members 110 may be provided without exceeding the scope. In one embodiment, each connecting member 110 is arranged to be compressed responsive to a force applied thereto, with variability of fixed member extension length 100 responsive to the compression of connecting member 110 and each connecting member 110 urges to expand in a compressed state. In one embodiment, connecting members 110 are configured such that when fully compressed, as illustrated in FIG. 1J, the pressure applied by first surface 60, responsive to the urge to expand, is about 600 millibars, and when compressed 1/3 from the open position, as illustrated in FIG. IK, the pressure applied is about 200 millibars. In one embodiment, advancement mechanism 10 is configured such that connecting members 110 are at least 1/3 compressed from the open position when situated within a particular lumen. In one embodiment, the resistance of connecting member 110 to a force Fl, applied in a direction generally orthogonal to first surface 60 in the direction of guide member 50, is given as:

Fl = P1*T1*L1

where PI is the pressure applied by first surface 60, as described above, Tl is the width of each fixed member protrusion 80 and LI is the length of the section of each fixed member 20 comprising fixed member protrusions 80.

[00084] In one embodiment, each connecting member 110 exhibits a connection angle βΐ in relation to second surface 70 of the particular fixed member 20, connection angle βΐ defined from the perspective of proximal end 22. In one embodiment, as will be described below, each connection angle βΐ is greater than 90°. In one embodiment, each connection angle βΐ is 125 - 135 degrees and in one further embodiment is about 135 degrees. In one non-limiting further embodiment, each connecting member 110 is generally rectangular shaped however this is not meant to be limiting in any way and one or more connecting members 110 of various shapes may be provided, without exceeding the scope. In one embodiment, each fixed member 20 comprises metal, such as steel, and in another embodiment each fixed member 20 comprises plastic.

[00085] In one embodiment (not shown), each connecting member 110 is hingeably connected to one, or both of, the associated base member 115 and the associated fixed member 20.

[00086] Each translatable member 30 exhibits a first surface 120 and a second surface 130 opposing first surface 120. In one embodiment first surface 120 exhibits a plurality of translatable member protrusions 140 each extending from first surface 120, translatable member protrusions 140 arrayed along first surface 120 from proximal end 32 to distal end 34. Each translatable member protrusion 140 comprises a distal portion 142 and a proximal portion 144 meeting at a joint 146. Proximal portion 144 defines an acute translatable member protrusion angle a2 in relation to first surface 120, translatable member protrusion angle a2 determined between proximal portion 144 of translatable member protrusion 140 and proximal end 32 of translatable member 30, and defined from the perspective of proximal end 32. In another embodiment, translatable member protrusions 140 are not provided and each first surface 120 exhibits a predetermined friction coefficient with an inner wall of a lumen, as will be described below. In one further embodiment, first surface 60 is covered with a fabric exhibiting capillary capabilities, i.e. the fabric transfers liquids and moisture through itself. Optionally, the fabric comprises one or more of: cotton; polyester; and COOLMAX fabric, commercially available from Invista of Wichita, KS.

[00087] Each translatable member 30 further exhibits a translatable member extension length 150 from longitudinal axis 4 of device 2, translatable member extension length 150 defined by the distance between first surface 120 of translatable member 30 and longitudinal axis 4. In one embodiment, as will be described below, translatable member extension length 150 is variable. In one embodiment, first surface 120 exhibits a curved shaped and second member extension length 150 is defined by the distance between the apex of curved first surface 120 and longitudinal axis 4.

[00088] Each translatable member 30 further comprises at least one connecting member 160, a first end of each connecting member 160 connected to a base member 165 and a second end of each connecting member 160 connected to second surface 130 of the particular translatable member 30. Base member 165 is secured to support member 45 of proximal translation mechanism 40. In one embodiment, a pair of connecting members 160 are provided, a first connecting member 160 connected towards a proximal end 32 of translatable member 30 and a second connecting member 160 connected towards distal end 34 of translatable member 30. There is no requirement that first and second connecting members 160 each meet one of the proximal end 32 and distal end 34, and an extension distal of the connection between first connecting member 160 and distal end 34 and/or an extension proximal of the connection between second connecting member 160 and proximal end 32 is specifically contemplate. In particular, FIG. IB shows such an extension proximal of the connection between second connecting member 160 and proximal end 32. A pair of connecting members 160 are illustrated, however this is not meant to be limiting in any way and any number of connecting members 160 may be provided without exceeding the scope. In one embodiment, each connecting member 160 is arranged to be compressed responsive to a force applied thereto, with variability of translatable member extension length 150 responsive to the compressing of connecting member 160 and each connecting member 160 urges to expand in a compressed state. In one embodiment, connecting members 160 are configured such that when fully compressed the pressure applied by first surface 120, responsive to the urge to expand, is about 600 millibars, and when compressed 1/3 from the open position, as illustrated in FIG. 1G, the pressure applied is about 200 millibars. In one embodiment, advancement mechanism 10 is configured such that connecting members 160 are at least 1/3 from the open position compressed when situated within a particular lumen. In one embodiment, the resistance of connecting member 160 to a force F2, applied in a direction generally orthogonal to first surface 120 in the direction of guide member 50, is given as:

F2 = P2*T2*L2

where P is the pressure applied by first surface 120, as described above, T2 is the width of each translatable member protrusion 140 and L2 is the length of the section of each translatable member 30 comprising fixed member protrusions 140.

[00089] In one embodiment, each connecting member 160 exhibits a connection angle β2 in relation to second surface 130 of the particular translatable member 30, connection angle β2 defined from the perspective of proximal end 32. In one embodiment, as will be described below, each connection angle β2 is greater than 90°. In one embodiment, each connection angle β2 is 125 - 135 degrees and in one further embodiment is about 135 degrees. In one non-limiting illustrated further embodiment, each connecting member 160 is generally rectangular shaped however this is not meant to be limiting in any way and one or more connecting members 160 of various shapes may be provided, without exceeding the scope.

[00090] In one embodiment (not shown), each connecting member 160 is hingeably connected to one, or both of, the associated base member 165 and the associated translatable member 30.

[00091] In one embodiment (not shown), each translatable member 30 further comprises an extender arranged to increase and decrease translatable member extension length 150. In one non-limiting further embodiment, the extender comprises a motor arranged to translate at least a portion of connecting member 160 in a direction generally orthogonal to longitudinal axis 4 of device 2. In one embodiment, each translatable member 30 comprises metal, such as steel, and in another embodiment each translatable member 30 comprises plastic.

[00092] In one embodiment, each fixed member 20 comprises a plurality of sets of fixed member protrusions 80, each extending from a plane defined by surface 60 as described above. Each fixed member protrusion 80 of each set is arranged to be in line with, and associated with a particular fixed member protrusion 80 of the other set, or sets. The associated fixed member protrusions 80 generally align along a member protrusion axis 90, each of the various member protrusion axes 90 being parallel with each other along a fixed member 20 and generally orthogonal to longitudinal axis 4. In another embodiment, each translatable member 30 comprises a plurality of sets of translatable member protrusions 140, each extending from a plane defined by surface 60 as described above. Each translatable member protrusion 140 of each set is arranged to be in line with, and associated with a particular translatable member protrusion 140 of the other set, or sets. The associated translatable member protrusions 140 generally align along a member protrusion axis 90, each of the various member protrusion axes being parallel with each other along a translatable member 30 and generally orthogonal to longitudinal axis 4 and translation axis 170.

[00093] In one embodiment, fixed members 20 are evenly radially arrayed about guide member 50 and translatable members 30 are evenly radially arrayed about guide member 50, with equal radial angles defined between each of the various fixed members 20 and translatable members 30, a translatable member 30 deployed between each two fixed members 20. In another embodiment, fixed members 20 and translatable members 30 are sequentially interspersed about guide member 50, with each fixed member 20 flanked on either side by a particular translatable member 30, and each translatable member 30 flanked on either side by a particular fixed member 20. In one embodiment, fixed members 20 each exhibit substantially the same length from proximal end 22 to distal end 24. In another embodiment, translatable members 30 each exhibit substantially the same length from proximal end 32 to distal end 34. In one embodiment, length LI of the section of each fixed member 20 comprising fixed member protrusions 80 is greater than length L2 of the section of each translatable member 30 comprising translatable member protrusions 140. In one embodiment, length LI is greater than 1.5*L2. In another embodiment, the difference between length LI and length L2 is at least 10 millimeters. In another embodiment, length L2 is at least 20 millimeters. In one embodiment, length LI is at least 5 times the diameter of guide member 50, denoted D. In another embodiment, a circular plane 165 is defined which touches the apex of each fixed member protrusion 80 and the apex of each translatable member protrusion 140. The distance between the outer surface of guide member 50 and circular plane 165 is denoted H and is arranged to be larger than the radius of the lumen where device 2 is to be inserted therein. Therefore, when advancement mechanism 10 is situated within a lumen, pressure is applied between fixed members 20 and the wall of the lumen and pressure is applied between translatable members 30 and the wall of the lumen. In explanation, the pressure is applied responsive to the resistance of the wall of the lumen to bending, the bending caused by fixed members 20 and translatable members 30 which are larger than the lumen diameter. In one embodiment, distance H is given as:

H = A/(2*K) - D/2

where A is the diameter of the lumen where device 2 is to be inserted therein, K is a constant which is less than one and D is the diameter of guide member 50. Constant K ensures that distance H is greater than the radius of the lumen, i.e. that advancement mechanism 10 is larger than the diameter of the lumen. Empirical data shows that when the lumen is an intestine, constant K should preferably be about 0.8 - 0.9.

[00094] In one embodiment, proximal translation mechanism 40 comprises: support member 45; a connection member 185; and a user device 190 comprising a proximal force application member 195. A first end of connection member 185 is connected to proximal force application member 195 and a second end of connection member 185 is connected to support member 45. In one non-limiting embodiment, connection member 185 comprises a steel string, in one embodiment coated with Teflon and situated within a spring. In one embodiment, a plurality of connection members 185 are provided. In one further embodiment, 2 connection members 185 are provided, each on opposing sides of guide member 50. When proximal force application member 195 is pulled back, tension is formed in the string of connection member 185 which applies a proximal force to support member 45. When proximal force application member 195 is pushed forward, the tension in the string of connection member 185 is released. In another embodiment (not shown), proximal translation mechanism 40 comprises a motor in communication with support member 45, the motor arranged to translate support member 45 along longitudinal axis 4 of device 2.

[00095] In one embodiment, guide member 50 is a generally tubular member and is arranged to encase at least a portion of device 2. In one further embodiment, support member 45 of proximal translation mechanism 40 is generally ring shaped, surrounding guide member 50. In one embodiment, guide member 50 comprises a plurality of slits 55 arranged to provide flexibility to guide member 50 and allowing guide member 50 to bend, as will be described below. In one embodiment, guide member 50 comprises steel and in another embodiment guide member 50 comprises plastic. In one embodiment, as illustrated in FIG. 1L device 2 is attached to proximal end 52 of guide member 50 by a first retaining ring 56 and to distal end 54 of guide member 50 by a second retaining ring 56. In one embodiment, proximal end 52 and distal end 54 each comprise a thread and retaining rings 56 are each arranged to be secured by a covering member 58 screwed on to the particular thread.

[00096] In one embodiment, device 2 is an endoscope exhibiting an articulating section near distal end 54 of guide member 50 and is in communication with an articulation mechanism 3 which is arranged to control the movement of device 2, and especially of the articulating section thereof, while inside a lumen. As will be described below, proximal translation mechanism 40 is arranged to translate each translatable member 30 along an associated translation axis 170, translation axis 170 generally parallel to longitudinal axis 4 of device 2. In one embodiment, translation axis 170 proceeds along a line defined by first surface 120 of translatable member 30.

[00097] In one embodiment, as will be described below in relation to FIG. 4, fixed members 20 are not provided and only translatable members 30 are secured to guide member 50. [00098] FIG. 2A illustrates a high level perspective, partially cut away view of advancement mechanism 10 and device 2 within a lumen 250; FIG. 2B illustrates a high level side view of advancement mechanism 10 and device 2 within lumen 250, further comprising a first embodiment of an internal distal translation mechanism 200 and showing a single fixed member 20 and a single translatable member 30 in contact with an inner wall 260 of lumen 250, translatable member 30 being in a distal position; FIG. 2C illustrates a high level side view of advancement mechanism 10 and device 2 within lumen 250, comprising the first embodiment of internal distal translation mechanism 200 and showing a single fixed member 20 and a single translatable member 30 in contact with inner wall 260, translatable member 30 being in a proximal position; and FIG. 2D illustrates a high level side view of advancement mechanism 10 and device 2 within lumen 250, comprising a second embodiment of internal distal translation mechanism 200 and showing a single fixed member 20 and a single translatable member 30 in contact with inner wall 260, translatable member 30 being in a proximal position, FIGs. 2A - 2D being described together.

[00099] In one embodiment, as illustrated in FIGs. 2B - 2C, internal distal translation mechanism 200, which in one embodiment comprises an elastic member 220, and in another embodiment comprises spring member 230, as illustrated in FIG. 2D. In one embodiment, spring member 230 is a compression spring. In the embodiment where internal distal translation mechanism comprises an elastic member 220, a first end of each elastic member 220 is connected to a particular translatable member 30 and a second end of each elastic member 220 is connected to distal end 54 of guide member 50. In the embodiment where internal distal translation mechanism 200 comprises a spring member 230, a first end of spring member 230 is connected to support member 45 of proximal translation mechanism 40 and a second end of spring member 230 is connected in one embodiment to proximal end 52 of guide member 50. In one embodiment, the second end of spring member 230 is connected to the base member 115 closest to proximal end 52.

[000100] In another embodiment (not shown), internal distal translation member 200 comprises both an elastic member 220 and a spring member 230. In another embodiment (not shown), advancement mechanism 10 comprises an internal distal translation mechanism comprising a motor in communication with support member 45 of proximal translation mechanism 40. Advantageously, the internal distal translation member does not need to be pushed from external of guide member 50, thereby avoiding buckling of any connecting member attached thereto during the distal translation.

[000101] As will be described below in relation to FIG. 4, in operation guide member 50 is secured to device 2. Distal end 54 of guide member 50 is the inserted into lumen 250 such that when guide member 50 is fully within lumen 250 proximal end 52 of guide member 50 is in closer proximity to the entrance of lumen 250 than distal end 54. In order to advance device 2 within lumen 250, translatable members 30 are proximally translated in the direction of proximal end 52 of guide member 50. Responsive to the proximal translation, a proximal force 280 is applied by translatable members 30 to inner wall 260, as described below. Responsive to proximal force 280, guide member 50 advances through lumen 250, as described below, and device 2 advances responsive to the advancement of guide member 50. As will be described below, a proximal force 270 is applied by fixed member protrusions 80 and translatable member protrusions 140 to inner wall 260, thereby preventing proximal movement of guide member 50. As will further be described below, translatable members 30 are then distally translated towards distal end 54 of guide member 50, in one embodiment responsive to internal distal translation mechanism 200.

[000102] FIG. 3A illustrates a high level perspective view of advancement mechanism 10, further comprising a covering sheath 300 in a rolled up position; FIG. 3B illustrates a high level side view of advancement mechanism 10 with covering sheath 300 in the rolled up position; FIG. 3C illustrates a high level perspective view of advancement mechanism 10 with covering sheath 300 in a partially deployed state; FIG. 3D illustrates a high level side cut view of advancement mechanism 10 with covering sheath 300 in the partially deployed state; and FIG. 3E illustrates a high level perspective view of advancement mechanism 10 with covering sheath 300 in a fully deployed state, FIGs. 3 A - 3E being described together.

[000103] Covering sheath 300 comprises: a membrane 310; and a plurality of deploying members 320, which in one embodiment are implemented as strings. In one embodiment, an end portion of each of deploying members 320 are rolled up together with membrane 310 such that when deploying members 320 are pulled from the opposing end portion membrane 310 unrolls in coordination with the rolled up end portions of deploying members 320. In one embodiment, membrane 310 comprises latex. In another embodiment, membrane 310 comprises silicon. In one embodiment, each deploying member 320 comprises Nitinol. In one embodiment, each deploying member 320 exhibits a diameter of about 0.2 milimeters. In one non-limiting embodiment, 4 strings 320 are provided. A first end of each deploying member 320 is connected to membrane 310. In one embodiment (not shown) a second end of each deploying member 320 is connected to a user device. In another embodiment, a second end of each deploying member 320 extends past proximal end 52 of guide member 50. In one embodiment, the length of membrane 310, when unrolled, is 1.5 times the length of the section of each fixed member 20 comprising fixed member protrusions 80, i.e. 1.5*L1.

[000104] In operation, during a deployed position of device 2, i.e. when device 2 is inserted within lumen 250, membrane 310 is provided in a rolled up state distal of first and translatable members 20, 30. In particular, in the rolled up state, membrane 310 exhibits a diameter less than the lengths 100, 150 of FIG. ID when connecting members 110 and connecting members 160 are in a fully compressed position. Thus, membrane 310 does not extend towards surfaces 60, 120, and particularly does not interpose itself between the inner walls of lumen 250 and surfaces 60, 120.

[000105] In a retrieval position of device 2, i.e. when device is to be retrieved from lumen 250, covering sheath 300 is deployed thereby disengaging advancement mechanism 10 from inner walls 260. In particular, force in a proximal direction is applied via deploying members 320 thereby unrolling rolled up membrane 310. As membrane 310 is unrolled, membrane 310 extends proximally from its initial location, and covers surfaces 60, 120 and particularly first protrusions 80 and second protrusions 140. As described above, membrane 310 in one embodiment comprises a smooth material, such as latex or silicon, and thus when deployed ensures that advancement mechanism 10 does not resist a proximal withdrawal force applied to device 2 in order to withdraw device 2 from lumen 250.

[000106] FIG. 4 illustrates a high level flow chart of a method of advancement of device 2 within lumen 250. The method is described in the context of the operation of advancement mechanism 10 of FIGs. 1A - 3E, however this is not meant to be limiting in any way and other mechanisms capable of performing the below method may be provided, without exceeding the scope. Device 2 is inserted into guide member 50, secured in relation to guide member 50 and the combination of device 20 and guide member 50 is inserted into lumen 250. In one embodiment, device 2 is an endoscope and in one non-limiting embodiment, lumen 250 is a body lumen. In another non-limiting embodiment, lumen 250 is a pipe. As described above, the distal direction is the direction into lumen 250 and the proximal direction is towards the direction of the entrance of lumen 250, i.e. the direction out of lumen 250.

[000107] In stage 3000, movement of device 2 in the proximal direction is prevented responsive to a force 270 applied by at least one translatable member 30 to inner wall 260 of lumen 250. In the embodiment where lumen 250 is a body lumen, inner wall 260 comprises a plurality of indentations and creases, and in the embodiment where each translatable member 30 comprises a plurality of translatable member protrusions 140, joints 146 of translatable member protrusions 140 protrude into the indentations and creases. Proximal portion 144 of each translatable member protrusion 140, in cooperation with acute translatable member protrusion angle a2 is arranged to meet inner wall 260 within the particular indent, or crease. In the event a force is applied to guide member 50 in the proximal direction, as will be described below, a force 270 is applied to proximal portion 144 by inner wall 260, force 270 being the resistant force to the applied proximal force. As described above, advancement mechanism 10 is configured such that translatable members 30 extend at an at rest state to a distance greater than the inner diameter of lumen 250, the pressure applied by translatable members 30 to inner wall 260 of lumen 250 increasing the resistance to movement between proximal portion 144 of each translatable member protrusion 140 and the particular indent or crease of inner wall 260, since a maximal section of proximal portion 144 is arranged to meet the particular indent or crease responsive to the applied pressure. As further described above, in one embodiment connecting members 110 are arranged to be compressed while situated within lumen 250, the urge to expand further increasing force 270, as described above.

[000108] In the embodiment where each first surface 120 of each second member 30 exhibits a predetermined friction coefficient with inner wall 260, force 270 is the friction between inner wall 260 of lumen 250 and first surface 120. As described above, pressure is applied by translatable members 30 to inner wall 260 of lumen 250, the applied pressure generating the friction. In one embodiment, first surface 120 of each translatable member 30 is configured such that the friction between first surface 120 and inner wall 260, generated responsive to the applied pressure of translatable members 30, is sufficient to prevent proximal movement of guide member 250 regardless of any expected proximal force applied to guide member 50. [000109] In an embodiment where translatable members 30 exhibit translatable member protrusions 30 and inner wall 260 of lumen 250 doesn't exhibit creases or indents sufficiently large enough for translatable member protrusions 30 to substantially protrude therein, force 270 is the friction between inner wall 260 of lumen 250 and joints 146 of translatable member protrusions 140. As described above, pressure is applied by translatable members 30 to inner wall 260 of lumen 250, the applied pressure generating the friction. In one embodiment, translatable member protrusions 140 of each translatable member 30 are configured such that the friction between joints 146 and inner wall 260, generated responsive to the applied pressure of translatable members 30, is sufficient to prevent proximal movement of guide member 250 regardless of any expected proximal force applied to guide member 50.

[000110] In one embodiment, as described above, a plurality of fixed members 20 are provided and are similarly arranged to prevent proximal movement of device 2. In one particular embodiment, as described above in relation to translatable members 30, proximal portion 84 of each fixed member protrusion 80, in cooperation with the associated acute fixed member protrusion angle al, is arranged to meet inner wall 260 at a particular crease or indentation. As described above in relation to force 270, inner wall 260 applies a force 275 in the distal direction responsive to a proximal force applied to fixed member protrusions 80.

[000111] In another particular embodiment, as described above in relation to translatable members 30, force 275 is the friction between inner wall 260 and first surface 60 of fixed members 20 or joints 86 of fixed member protrusions 80, the friction generated by the applied pressure of fixed members 20. As described above in relation to first surfaces 120 of translatable members 30, in one embodiment first surface 60 of each fixed member 20 is configured such that the friction between first surface 60 and inner wall 260, generated responsive to the applied pressure of fixed members 20, is sufficient to prevent proximal movement of guide member 250 regardless of any expected proximal force applied to guide member 50. As described above in relation to translatable member protrusions 140 of translatable members 30, in one embodiment fixed member protrusions 80 are configured such that the friction between joints 86 and inner wall 260, generated responsive to the applied pressure of fixed members 20, is sufficient to prevent proximal movement of guide member 250 regardless of any expected proximal force applied to guide member 50. [000112] Thus, proximal movement of device 2 is prevented regardless of the presence of proximal forces within lumen 250. Additionally, if device 2 is inadvertently pulled in the proximal direction, forces 270 and optionally 275 prevent proximal movement thereof. Furthermore, as will be described below in stage 3010, in one embodiment a proximal force is applied to support member 45 of proximal translation mechanism 40 by connection members 185. Forces 270 and 275 thus prevent proximal movement of device 2 regardless of the proximal force applied by connection members 185. Optionally, as described above, the plurality of translatable members 30 arrayed radially, evenly about device 2, cooperate to ensure that proximal motion is fully prevented. Further optionally, as described above, the plurality of fixed members 20 arrayed radially, evenly about device 2, cooperate to ensure that proximal motion is fully prevented.

[000113] In stage 3010, proximal translation mechanism 40 is arranged to translate each translatable member 30 along the respective translation axis 170, in a proximal direction. As indicated above, translation axis 170 is generally parallel to longitudinal axis 4. In one embodiment, as described above, a user operates proximal force application member 195 to apply a proximal force to connecting members 185, thereby tension forms in the string of each connection member 185. As described above, in one embodiment the proximal force is applied by pulling back on proximal force application member 195. The tension in the strings of connection members 185 applies a proximal force to support members 45 thereby proximally translating translatable members 30. In another embodiment, as described above, the proximal force is applied to support member 45 responsive to the action of a motor.

[000114] In stage 3020, responsive to the translation of stage 3010, a proximal force 280 is applied to inner wall 260 of lumen 250, as illustrated in FIG. 2C, proximal force 280 applied in the proximal direction between inner wall 260 and the translated translatable members 30. In the embodiment where each translatable member 30 comprises a plurality of translatable member protrusions 140 and lumen 250 is a body lumen, as described above in relation to stage 3000, proximal portion 144 of each translatable member protrusion 140 is arranged to meet inner wall 260 within a respective crease or indentation in cooperation with acute translatable member protrusion angle a2. Responsive to the proximal translation, proximal force 280 is applied by proximal portion 144 to the respective portion of inner wall 260. As described above, advancement mechanism 10 is configured such that translatable members 30 extend at an at rest state to a distance greater than the inner diameter of lumen 250, the pressure applied by translatable members 30 to inner wall 260 of lumen 250 prevents proximal movement of translatable members 30 along inner wall 260, as the pressure maintains translatable protrusion members 140 within the respective indents or creases. As further described above, in one embodiment connecting members 160 are arranged to be compressed while situated within lumen 250 and the urge to expand maintains translatable protrusion members 140 within the respective indents or creases.

[000115] In one embodiment, proximal force 280 causes advancement mechanism 10 to advance distally through lumen 250. In another embodiment, proximal force 280 causes lumen 250 to be pulled proximally over advancement mechanism 10. In another embodiment, proximal force 280 causes lumen 250 to be pulled proximally over advancement mechanism 10 and additionally causes advancement mechanism 10 to advance distally through lumen 250. As described above in stage 3000, proximal movement of advancement mechanism 10 is prevented responsive to force 275 applied between translatable members 30 and inner wall 260 and optionally responsive to force 270 applied between fixed members 20 and inner wall 260. In the embodiment where a plurality of slits 55 are provided in guide member 50, the advancement of guide member 50 is aided by slits 55 in that guide member 50 is flexible and can therefore bend according to the shape of lumen 250. As described above, in one embodiment fixed member extension length 100 and translatable member extension length 150 are variable, the lengths varied to allow smooth advancement of guide member 50 through lumen 250 regardless of the dimensions and shape of lumen 250. As described above, in one embodiment connecting members 110 and connecting members 160 are arranged to compress responsive to a force applied thereon, the shape of each connecting member 110 and 160 arranged to adapt to the changing diameter of lumen 250, as illustrated in FIG. 1G. In another embodiment, as described above, each connecting member 110 is hingeably connected to the respective base member 115 and each connecting member 160 is hingeably connected to the respective base member 165, the hingeable connections allowing fixed member extension length 100 and translatable member extension length 150 to vary responsive to the force applied by the changing diameter of lumen 250 to connecting members 110 and connecting members 160. [000116] In the embodiment where each first surface 120 of each translatable member 30 exhibits a predetermined friction coefficient with inner wall 260 of lumen 250, proximal force 280 is the friction between inner wall 260 of lumen 250 and first surface 120 of each translatable member 30 responsive to the pressure applied by translatable member 30. In such an embodiment, first surface 120 of each translatable member 30 is designed so that the friction coefficient between first surface 120 and inner wall 260 is such that force 280 is sufficient to resist movement of the respective translatable member 30 along inner wall 260 in a proximal direction, regardless of the proximal force applied by translation mechanism 40.

[000117] In stage 3030, responsive to the translation of stage 3010, an orthogonal force 290 is applied to inner wall 260 of lumen 250, orthogonal force 290 being applied in a direction generally orthogonal to the direction of proximal force 280. Orthogonal force 290 is applied between each translated translatable member 30 and inner wall 260. In one embodiment, orthogonal force 290 is formed by increasing translatable member extension length 150 of each translatable member 30. In one further embodiment, where connecting member 160 of each translatable member 30 exhibits an acute connection angle β2, translatable member extension length 150 is increased as a result of the translation of stage 3010. In explanation, as described above in relation to stage 3000, when translatable member 30 is proximally translated force 275 prevents the proximal movement of translatable member 30. In the embodiment where connecting members 160 are arranged to be compressed responsive to a force applied thereto, when translatable member 30 is proximally translated connection angle β2 of the respective connecting member 160 decreases responsive to the inherent elasticity thereof. As connection angle β2 decreases, translatable member extension length 150 increases, thereby applying orthogonal force 290 to inner wall 260 of lumen 250. In the embodiment where translatable member protrusions 140 are arranged to protrude into portions of inner wall 260, orthogonal force 290 increases the protrusion depth within inner wall 260, thereby significantly decreasing the chance that translatable member 30 will move along inner wall 260 in the proximal direction. In the embodiment where proximal movement of translatable members 30 is prevented responsive to the friction between first surface 120 and inner wall 260 or between joints 146 of translatable member protrusions 140 and inner wall 260, orthogonal force 290 increases the friction. Thus, translatable member extension length 150 increases responsive to proximal translation mechanism 40 proximally translating translatable members 30, however translatable member extension length 150 in fact increases responsive only to force 275, i.e. the friction with inner wall 260, without the aid of any unnecessary devices.

[000118] In the embodiment where connecting members 160 are arranged to be hingeably connected to the respective base members 165, connection angle β2 of the respective connecting member 160 decreases responsive to the radial movement of connecting member 160 along the respective hinge. In another embodiment, where an extender is provided, as described above, orthogonal force 290 is applied to inner wall 260 by extending the respective connecting member 160 towards inner wall 260.

[000119] In optional stage 3040, in the event a proximal force is applied to advancement mechanism 10, as described above, an orthogonal force 295 is applied to inner wall 260 of lumen 250, orthogonal force 295 being applied in a direction generally parallel to the direction of orthogonal force 290. Orthogonal force 295 is applied between each fixed member 20 and inner wall 260. In one embodiment, orthogonal force 295 is formed by increasing fixed member extension length 100 of each fixed member 30. In one further embodiment, where connecting member 110 of each fixed member 30 exhibits an acute connection angle βΐ, fixed member extension length 100 is increased as a result of the proximal force applied to advancement mechanism 10. In explanation, as described in relation to stage 3000, force 270 prevents the proximal movement of translatable member 20. In the embodiment where connecting members 110 are arranged to be compressed responsive to a force applied thereto, when a proximal force is applied to a fixed member 20 connection angle βΐ of the respective connecting member 160 decreases responsive to the inherent elasticity thereof. As connection angle βΐ decreases, fixed member extension length 100 increases, thereby applying orthogonal force 295 to inner wall 260 of lumen 250. In the embodiment where fixed member protrusions 80 are arranged to protrude into portions of inner wall 260, orthogonal force 290 increases the protrusion depth within inner wall 260, thereby significantly decreasing the chance that fixed member 20 will move along inner wall 260 in the proximal direction. In the embodiment where proximal movement of fixed members 20 is prevented responsive to the friction between first surface 600 and inner wall 260 or between joints 86 of fixed member protrusions 80 and inner wall 260, orthogonal force 295 increases the friction. [000120] In the embodiment where connecting members 110 are arranged to be hingeably connected to the respective base members 115, connection angle βΐ of the respective connecting member 110 decreases responsive to the radial movement of connecting member 110 along the respective hinge.

[000121] In optional stage 3050, proximal translation mechanism 40 is arranged such that during the proximal translation of stage 3010 the proximal maximus translatable member protrusion 140, i.e. the translatable member protrusion 140 closest to proximal end 32 of translatable member 30, is not substantially translated proximal of the proximal maximus fixed member protrusion 80, i.e. the fixed member protrusion 80 closest to proximal end 22 of fixed member 20. Thus, the proximal maximus translatable member protrusion 140 is at all times distal of the proximal maximus fixed member protrusion 80. As a result, any part of inner wall 260 which is proximally translated by translatable members 30 is supported by fixed member protrusions 80 of fixed members 20, as will be described below.

[000122] In optional stage 3060, after the proximal translation of stage 3010 each translatable member 30 is distally translated responsive to an internal distal translation mechanism, such as the first embodiment of internal distal translation mechanism 200 of FIGs. 2B - 2C, the second embodiment of internal distal translation mechanism 200 of FIG. 2D, or an internal distal translation mechanism comprising a motor, as described above. In the embodiment where elastic members 220 are provided, during the translation of stage 3010 each elastic member 220 is stretched. After the proximal translation ceases, translatable members 30 return to the distal position responsive to the elasticity of elastic members 220. In the embodiment where spring member 230 is provided, during the translation of stage 3010 spring member 230 is extended. After the proximal translation ceases, translatable members 30 return to the distal position responsive to the spring restoring force of spring member 230. In the embodiment where an internal distal translation mechanism comprising a motor is provided, after the proximal translation ceases the motor is arranged to actively distally translate support member 45 of proximal translation mechanism 40 such that translatable members 30 return to the distal position. When translatable members 30 are translated distally, any portion of inner wall 260 proximally translated during stage 3020 urge to return to their original position. Advantageously, fixed members 20 prevent distal translation of inner wall 260 responsive to the force opposing force 270, as described above. [000123] In the event further advancement of device 2 is desired, stage 3010 as described above is again performed. In the event advancement of device 2 is no longer desired guide member 50 and device 2 are removed from lumen 250. In one embodiment, as described in optional stage 3070, covering sheath 300 is unrolled thereby covering fixed members 20 and translatable members 30. In particular, in one embodiment, force in a proximal direction is applied to membrane 310 via deploying members 320. As described above, in one embodiment deploying members 320 are rolled up together with membrane 310 thereby a proximal force applied to deploying members 320 causes membrane 310 to unroll over fixed members 20 and translatable members 30. Advantageously, when advancement device 10 is retrieved from lumen 250, fixed members 20 and translatable members 30 don't interact with inner wall 260 of lumen 250 as membrane 310 intercedes between fixed members 20 and inner wall 260 and between translatable members 30 and inner wall 260. Thus, withdrawal of guide member 50 from lumen 250 is enabled. Additionally, in one embodiment, as membrane 310 is pulled over fixed members 20 and translatable members 30 pressure is applied by membrane 310 thereby reducing fixed member extension lengths 100 and translatable member extension lengths 150. Advantageously, this allows retrieval of guide member 50 with minimal contact with inner wall 260 of lumen 250.

[000124] FIG. 5 illustrates a high level flow chart of a second embodiment of a method of advancement of a device 2 within a lumen 250. The flow chart of FIG. 5 is in all respects similar to the flow chart of FIG. 4 with the exception that stage 3030 is optional and is denoted stage 3035. In particular, in one embodiment an orthogonal force is not provided responsive to the translation of stage 3030 and only a proximal force is applied between translatable members 30 and inner wall 260 of lumen 250. Additionally, stage 3060 is provided as not optional and is denoted 3065. In particular, as described above, after the translation of stage 3030 translatable members 30 are distally translated by an internal distal translation mechanism.

Double element

[000125] FIGS. 6 A - 6E illustrate a high level schematic diagram of an advancement mechanism 1000 comprising a proximal retraction member 1011, according to certain embodiments. Advancement mechanism 1000 comprises: a device 2, such as an endoscope; a proximal member 1010; and proximal retraction member 1011. In one embodiment, proximal member 101010 comprises fixed members 20 and translatable members 30, as described above. In one embodiment, proximal retraction member 1011 comprises translatable members 30, as described above, without fixed members 20. Proximal retraction member 1011 can be expanded and contracted. In one embodiment, in its expanded state proximal retraction member 1011 exhibits a diameter greater than the inner diameter of lumen 250 and in its contracted state proximal retraction member 1011 exhibits a diameter less than the inner diameter of lumen 250. Proximal retraction member 1011 is coupled to device 2 and positioned distally of proximal member 1010. Proximal retraction member 1011 provides traction on inner wall 260 of lumen 250 without the "ratchet" mechanism, i.e. the proximal and distal translation of translatable members 30 in relation to fixed members 20. This configuration improves the ability to pass sharp curves, as the proximal retraction member 1011 can advance over the flexible yet relatively rigid endoscope shaft, pleat the bowel and allow proximal member 1010 to easily advance distally, as it becomes lax.

[000126] More particularly, FIG. 6A illustrates advancement mechanism 1000 where proximal retraction member 1011 is contracted. In FIG. 6B, proximal retraction member 1011 is advanced over device 2 into a curve of lumen 250. In FIG. 6C, proximal retraction member 1011 is expanded to contact inner wall 260. In FIG. 6D, proximal retraction member 1011 is pulled proximally over device 2 thereby retracting lumen 250. In the event lumen 250 is a bowel, as illustrated in FIG. 6D, the bowel is pleated between proximal member 1010 and proximal retraction member 1011. In FIG. 6E, the retracted lumen 250 is further retracted over proximal member 1010 and device 2 is advanced, as described above. Proximal retraction member is then contracted and translated distally to its distal position described in FIG. 6A.

[000127] In one embodiment, proximal retraction member 1011 is translated distally by the action of a spring 1012, as shown in FIGs. 6F - 6G, where proximal retraction member 1011 is shown in its expanded state in FIG. 6F and in its contracted state in FIG. 6G. As described above, in one embodiment, proximal retraction member 1011 comprises a radially expandable member similar in structure to translatable members 30 of FIG. 1A. Alternatively, in another embodiment, proximal retraction member 1011 comprises a balloon exhibiting protruding members, such as described in relation to translatable member protrusions 140. Alternatively, in another embodiment, proximal retraction member 1011 comprises a combination of a rigid or semi rigid structure that is expanded radially using an inflatable balloon. The term "balloon" as used throughout this disclosure is not meant to be limited to an air inflated balloon and any expandable device may be provided without exceeding the scope.

[000128] An alternative embodiment is shown in FIGs. 7 A - 7D, which illustrate a high level schematic diagram of an advancement mechanism 1100. Advancement mechanism 1100 is in all respects similar to advancement mechanism 1000 with the exception that proximal retraction member 1011 and spring 1012 are replaced with a balloon catheter 1110 which is passed through a channel of device 2, balloon catheter 1110 comprising a balloon section 1111 and a catheter section 1112. Balloon catheter 1110 extends out distal end 1101 of device 2. In FIG. 7 A, advancement mechanism 1100 is illustrated with balloon catheter 1110 concealed within device 2. In FIG. 7B, advancement mechanism 1100 is illustrated with balloon catheter 1110 extended distally through device 2, balloon section 1111 in a deflated position. In FIG. 7C, balloon section 1111 is inflated to meet the lumen walls and in FIG. 7D balloon catheter 1110 is proximally translated, as described above in relation to FIG. 6D. In one embodiment, balloon catheter 1110 is pulled by an operator to perform the proximal translation.

[000129] Proximal retraction member 1011 may be moved back and forth over the endoscope in several ways. In one embodiment, as illustrated in FIG. 8, a spring or other flexible component to push proximal retraction member 1011 distally and cables for pulling it proximally. More specifically, FIG. 8 illustrates a spring 1410 coupled between proximal member 1010 and proximal retraction member 1011. Spring 1410 comprises coils 1420, at least some of coils 1420 optionally having at least two rings 1430. Cables 1440 are attached to proximal retraction member 1011 are arranged to proximally pull proximal retraction member 1011, passing through rings 1430.

[000130] Alternative ways to proximally and distally translate proximal retraction member 1011 include, for example, a hydraulic or pneumatic mechanism. In one embodiment, proximal retraction member 1011 will move distally up to the base of the articular section of device 2.

[000131] In one embodiment, where lumen 250 is the large intestine and device 2 is an endoscope, the following specifications may be observed. The range of movement of proximal retraction member 1011 is in one embodiment 10mm - 200mm from proximal member 1010, preferably 25mm - 140mm. In another embodiment, the spring force of spring 1410 does not exceed 45N, thereby preventing buckling of the endoscope within the intestine which may occur if larger forces are used, as well as to prevent injury to the intestine.

[000132] In another embodiment, wherein lumen 250 is the small intestine and device 2 is an endoscope, the following specifications may be observed. The range of movement of proximal retraction member 1011 is in one embodiment 5mm- 150mm from proximal member 1010, preferably 8mm - 100mm. In another embodiment, the spring force of spring 1410 would not exceed 35N.

Inflatable embodiments

[000133] Other embodiments are demonstrated in FIGs. 9A - 9C. These embodiments utilize inflatable balloons to expand spiked elements towards the intestinal wall. Advantages of such embodiments include the ability to inflate and deflate the device thus enabling easy insertion and removal into and out of the body, increased flexibility thereby improving performance in curved areas of the bowel, and increased softness preventing injury to the mucosa. The term "spiked elements" as used in the present disclosure is meant as elements with a surface providing a desired friction. In one embodiment, the spiked elements comprise unidirectional protrusions as described above in relation to FIGs. 1A - 1M. In another embodiment, the spiked elements comprise multidirectional protrusions. In yet another embodiment, the spiked elements comprise radially extending protrusions. In one embodiment, as described above, the spiked elements are shaped and configured to provide a desired friction coefficient with the intestinal wall.

[000134] The spiked elements of these embodiments may either be rigid as those previously described, or alternatively they may be soft. Soft and relatively blunt spikes do not create high traction with the bowel wall, however they increase the friction forces created by pressure of the balloon towards the bowel wall, and at the same time do not injure the mucosa when slipping over it. An additional important advantage of these embodiments therefore includes the ability to remove the device by deflating the balloon and pulling the endoscope out, without the need to cover it with a flexible sleeve as previously described in FIGs. 3 A - 3E.

[000135] More specifically, FIG. 9A illustrates an advancement mechanism 1445 comprising a balloon 1450 exhibiting spiked elements 1455 on the outer surface thereof, spiked elements 1455 arranged generally longitudinally parallel to a longitudinal axis 4 of a device 2. Radially expandable "wings" 1460 are located proximal to balloon 1450 and extend distally and radially from device 2. Wings 1460 each exhibit a plurality of spikes 1465, and the distal edges of wings 1460 lay over balloon 1450, such that when inflated balloon 1450 supports wings 1460 and radially expands wings 1460. Balloon 1450 is in one embodiment longitudinally translatable along device 2, such that when balloon 1450 is translated proximally and distally relative to wings 1460, each wing 1460 remains in contact with the smooth surface of balloon 1450 between its spiked areas.

[000136] In operation, as balloon 1450 moves proximally over device 2, it proximally pulls the lumen (not shown) with it, and due to the overlap between spiked elements 1465 of wings 1460 and spiked elements 1455 of balloon 1450, the pleated lumen is engaged by spiked elements 1465 of wings 1460 and distal movement of the lumen is prevented. Thus the proximal and distal movement of balloon 1450 creates advancement of device 2 relative to the lumen.

[000137] Alternatively to actually moving balloon 1450, a stretchable "skin" (not shown) having spiked elements can be placed over inflatable balloon 1450. Pulling the stretchable skin proximally over balloon 1450 creates proximal movement of the spiked element of the skin relative to the static spiked elements on wings 1460. A biocompatible lubrication fluid may be used between the skin and balloon 145- to reduce friction.

[000138] FIGs. 9B - 9C show another embodiment of an advancement mechanism 1465 comprising: an inflatable balloon 1470 exhibiting spiked strips 1475 along the surface thereof; and spiked strips 1480 each exhibiting a plurality of spikes 1485. Balloon 1470 is fixed to device 2. Spiked strips 1480 extend over balloon 1470, as described above in relation to FIG. 9A, are coupled to device 2 distal to balloon 1470 and coupled to a pulling mechanism at a proximal edge of the pulling mechanism (not shown). Spiked strips 1480 may be completely flexible, or alternatively they may have a non-stretchable area, with only a distal stretchable area. In either case, proximal pulling of strips 1480 by a pulling mechanism causes proximal movement of spikes 1485 on strips 1480. The effect is similar to that described in FIG. 9A.

[000139] In yet another embodiment, the spiked strips are flexible and they are pulled distally, optionally with a pulley mechanism. During stretching of the strips, the distance between spikes increases, which causes loss of traction with the lumen wall, facilitating slippage of the spikes in this direction. After passing a distance along the bowel, the strips are pulled proximally, pulling the lumen wall proximally with them.

[000140] In one embodiment described above, the translatable and fixed spiked elements are interlaced (i.e. each translatable element is between two fixed elements and vice versa). If for some reason, one of the sets of spiked elements (i.e. either fixed or translatable) protrudes radially more than the other set, it might hold the lumen wall away from the other set of spiked elements, and cause an ineffective movement whereby only one set is in contact with the lumen. The risk for this increases with the number of individual elements. For example, with only two fixed elements 1490 and two translatable elements 1495, there is no risk of this phenomenon, as shown in FIG. 10A which illustrates a front view of two fixed elements 1490 and two translatable elements 1495. In contrast, with 10 of each element, for example, the risk is very high because the difference in radial expansion between the sets sufficient to cause lack of contact of one set with the lumen, becomes very small, as shown in FIG. 10B which illustrates a front view of ten fixed elements 1490 and ten translatable elements 1495. On the other hand, use of a small number of individual elements in each set has a detrimental effect as it increases the friction over the fixed elements in the undesired direction, allows for excessive stretching of the bowel between the sets, and creates a less aerodynamic "attacking" edge for the device. In one embodiment, an optimal number of individual elements or groups of elements from each set would therefore be 3 - 6.

[000141] The previously described embodiments employ only a proximal and distal movement of the spiked elements, in an attempt to simplify the device. However it may be desirable to employ a more complex motion, which increases friction at certain stages of the movement cycle to prevent proximal slippage of the device, decreases friction when moving device parts distally along the lumen, or a combination of the above. The following embodiments describe such mechanisms. Clover

[000142] The embodiment depicted in FIGs. 11A - 11H uses balloons to move overlapping spiked elements and also change the degree of friction of each set of spiked elements at different stages of operation.

[000143] More specifically, FIG. 11A illustrates a three dimensional depiction of an advancement mechanism 1700 device placed on an endoscope. Advancement mechanism 1700 comprises two sets of inflatable balloons with unidirectional spikes 1705 on them. All balloons are oriented with their longitudinal axes generally parallel to the endoscope's longitudinal axis. A set of short balloons 1710 is statically coupled to the endoscope while another set of longer balloons 1720 is slideably coupled to the endoscope. Each of long balloons 1720 are separated from each other by gaps 1730 such that short balloons 1710 are located in gaps 1730. In one embodiment, each short balloon 1710 and long balloon 1720 are shaped such that the surface area of all of the balloons are equal to each other.

[000144] Figs. 11B - 11H depict the stages of operation of device 1700. Long balloons 1720 are inflated, as shown in FIG. 11C and pulled proximally, as shown in FIG. 11D, moving the bowel proximally with them. Short balloons 1710 are then inflated and "hold" the bowel that was moved proximally, preventing it from returning forward, as shown in FIG. HE. Long balloons 1720 are then deflated, as shown in FIG. 11F, and can then be moved forward without creating friction with the bowel, as shown in FIG. 11G. As shown in FIG. 11H, long balloons 1720 are then inflated and short balloons 1710 deflated to allow pulling backwards of long balloons 1720, and so on. In one embodiment, short balloons 1710 and long balloons 1720 are inflated and deflated via tubes (not shown) extending external of the bowel. In one further embodiment, the inflating tubes are elastic, being stretched when long balloons 1720 are proximally translated as shown in FIG. 11D. When long balloons 1720 are deflated, as shown in FIG. 11F, the stretched elastic tubes cause the distal translation of long balloons 1720 shown in FIG. 11G.

[000145] This structure enables creation of overlap between fixed and translatable balloons, as well as a "changer" action, i.e. alternating contact with the bowel between different elements.

[000146] While one of the two sets of balloons are in an inflated state, fixed or translatable, it is preferably that they do not interfere with the movements of the other set of balloons. One way of avoiding interference between balloons is by using an accordion shaped balloon 2011, as shown below in FIG. 17A. When balloon 2011 is inflated, it expands only in the radial direction, i.e. the direction of the bowel wall as shown in fig. 17B, until the spiked element 2010 contacts the bowel wall. Since balloon 2011 doesn't expand in all directions, it won't come in contact with an adjacent balloon.

Lifter concept [000147] FIGs. 12A - 12D illustrate an embodiment of an advancement mechanism 1495. Advancement mechanism 1495 is in all respects similar to advancement mechanism 10 described above with the addition of a plurality of fixed member extenders 1500. In one embodiment, each fixed member extender 1500 comprises a flexible strip and is connected to a particular translatable member 30. As illustrated in FIG. 12A, each fixed member extender 1500 (shown as 1500A) is generally flat. As illustrated in FIG. 12B, as translatable member 30 is translated proximally, fixed member extender 1500 (shown as 1500B) bends outwardly. At the final part of the proximal movement of translatable member 30, fixed member extender 1500 applies radial force to the respective fixed member 20, which causes them to contact the lumen wall and lift it off translatable member 30. This creates a "transfer" of the lumen from the translatable members 30 to the fixed members 20 and prevents distal movement of the lumen when translatable members 30 are translated distally. FIGs. 12C - 12D illustrate the operation of advancement mechanism 1495, described in FIGs. 12A - 12B, with the addition of connecting members 110 of a plurality of fixed members 20 and connecting members 160 of a plurality of translatable members 30.

Changer concept

[000148] FIGs. 13 A - 13D illustrate a high level diagram of an advancement mechanism 1525, according to certain embodiments. Advancement mechanism 1525 comprises: a pair of translatable spiked elements 1540; a pair of fixed spiked element 1541; a pair of extenders 1542; an extension and retraction member 1543; and a translation mechanism 1544. Only one pair of fixed spiked elements 1541 and one pair of translatable spiked elements 1540 are illustrated, however this is not meant to be limiting in any way and any plurality of fixed spiked elements 1541 and translatable spiked elements 1540 are particularly contemplated, as described above. Extension and retraction member 1543 is arranged to be translated proximally and distally along device 2. Extender 1542 extends from extension and retraction member 1543 to translatable spiked element 1540 and is hingeably coupled to extension and retraction member 1543. Each translatable spiked element is coupled to translation mechanism 1544. In one embodiment, extension and retraction member 1543 is generally tubular shaped. In another embodiment, translation mechanism 1544 is generally tubular shaped. In operation, initially, as shown in FIG. 13 A, translation mechanism 1544 and extension and retraction member 1543 are removed from each other and translatable spiked elements 1540 are contracted. In FIG. 13B, extension and retraction member 1543 is translated distally. Each extender 1542 is thus raised, thereby applying radial force to the respective translatable spiked element 1540. The translatable spiked element 1540 is thus expanded above the height of the fixed set of spiked elements 1541. In one embodiment, extension and retraction member 1543 is distally translated until coming in contact with translation mechanism 1544. In particular, in one embodiment extension and retraction member 1543 is distally translated by pulling a string proximally through a pulley connected to translation mechanism 1544. Thus, when extension and retraction member 1543 is in contact with translation mechanism 1544, proximally pulling the string will cause both extension and retraction member 1543 and translation mechanism 1544 to move proximally thereby proximally translating translatable set of spiked elements 1540, as shown in FIG. 13C. This occurs independently of the degree of friction/force applied on it by the bowel wall. As a result, the motions of the spiked elements which are in physical contact with the bowel wall are always in the direction promoting distal advancement of the device. When translatable set of spiked elements 1540 are translated distally to the state shown in fig. 13D, responsive to a distal translation of translation mechanism 1544, the translatable set of spiked elements 1540 retracts radially beneath the height of the fixed set of spiked elements 1541, thus finishing a motion cycle. This motion forms a situation where there is always only one set of elements in contact with the bowel wall, at a given time.

Stand-alone

[000149] Traditional endoscopes are designed to advance using push forces and to resist creation of small diameter loops and kinks, and as a result they are relatively rigid and bulky. Advancing an endoscope in a body lumen therefore adds difficulty due to these characteristics of endoscopes, which create friction and stretching forces on the bowel wall along the endoscope, resisting advancement. It is therefore beneficial to provide means for advancing a probe within a body lumen which enables visualization and insertion of tools, without use of an endoscope. The following embodiments provide such means.

[000150] FIG. 14 is a schematic drawing of a "stand-alone" device which advances in a body lumen without an endoscope. Such devices may include advancement means similar to those described above, in addition to a steerable tip with optics and a working channel.

[000151] As shown in FIG. 14, the device 1600 comprises advancement means 1610 which may be any of the previously described advancement means, a steerable tip containing an optical unit 1630 including a light source and camera, and a working channel 1640 which has an opening at the distal end of steerable tip 1620.

[000152] Probe 1600 is connected to a control unit 1650 by: catheter 1660, which is in fluid communication with working channel 1640, i.e. fluids can be applied through catheter 1660 to working channel 1640; electrical wiring 1670 which connects to optical unit 1630; and mechanical wiring 1680 (not shown) connecting to steerable tip 1620.

[000153] Catheter 1660 is preferably a thin walled catheter, optionally having an ID of 2.8mm and an OD of 3.6mm. Such a catheter preferably has anti-kink properties, possibly aided by a metallic braiding within its wall. Guide-wires of various flexibilities may be inserted into catheter 1660 to increase its rigidity or resistance to looping as required.

[000154] Electrical wiring 1670 typically contains electrical wires supplying energy to optical unit 1630 and transferring optical data from optical unit 1630 to control unit 1650. Alternatively, such optical data may be wirelessly transmitted by optical unit 1630.

[000155] Mechanical wiring 1680 typically consists of 4 wires which connect to the distal end of steerable tip 1620 and enable control of its direction and degree of flexion by pulling on the wires. A minimum of 2 wires may be sufficient if rotation is used to aid in control of the tip direction. Alternatively, steerable tip 1620 may be controlled by electrical engines within body of probe 1600, and activated by control unit 1650 via electrical wiring 1670.

[000156] All above wires and cables pass from probe 1600 to control unit 1650 as a bundle or multi lumen catheter 1690, optionally have an OD of 7mm or less. The main difference between the mechanical properties of bundle 1690 and a traditional endoscope are that bundle 1690 has a much greater flexibility and is lighter in weight.

[000157] In greater detail, the flexibility and/or rigidity of a catheter may be characterized by the force (F) that is required to create a 180 degrees bend having a radius of 10 mm, as shown in FIG. 14B. [000158] For a typical endoscope, this force is usually greater than 25 (N). In contrast, for the bundle of wires 1690 or "tail" of the standalone device, this force (F) will typically be 0.3 - 5 (N), preferably 1 - 3 (N). Such properties may be achieved for example by covering the wires by a braided metal wire mesh, as commonly used in endovascular catheters.

[000159] The significance of the upper boundary of this range is that the "tail" of the device of the invention also has low column strength. The combined result of this low column strength, flexibility and low diameter is that the "tail" will not form large loops within the bowel, will not stretch the bowel wall and will not create increased friction over the wall as do the shafts of traditional endoscopes, which consequently impede advancement in the bowel.

[000160] The lower boundary of the above range is important in order to prevent excessive bending and formation of "kinks" in the "tail", i.e. twist or bends in the tail of the device. Such "kinks" could interfere with advancement and removal and might cause plastic deformation of the "tail" and damage it.

[000161] As the device advances in the bowel, it is sometimes temporarily exposed to higher forces which might create tight bends. In this regard, it is beneficial for the current embodiment that the "tail" also have elastic properties, such that it will have a certain tendency to assist in "opening" tight bends in the bowel, once the forces that created them decrease. In this way, the elastic tail tends to "untie" undesirable "knots" in the tail and bowel. Appropriate elastic properties may be achieved for example by embedding a nitinol wire or tube within the "tail". Alternatively, a device having a tail without elasticity may be inserted into the bowel, and a nitinol wire can be inserted through the working channel of the "tail" just before pulling the device out. In this way the device "tail" can pass small bends during insertion, and resists "knots" during removal.

[000162] In another embodiment, the wires are covered by a vacuumed, noncompliant, inflatable tube. Before retracting the device, the tube is inflated, optionally to a diameter of 10 - 20 mm. When the tube is inflated it stiffens the tail, "trying" to straighten it, making the retraction of the device easier.

[000163] In this particular example, during insertion the force F is in the lower boundary and the tail shapes itself as the bowel twists and turns.

Removal solutions [000164] While enabling effective advancement within the lumen, the spiked elements pose an obstacle to device removal. Therefore, solutions enabling complete coverage of the spikes or other ways of making them ineffective are valuable. The previously described rolled elastic tube of figs. 3 A - 3E is one such solution. Additional embodiments of such solutions are described in FIGs. 15 - 16.

Smooth element

[000165] FIG. 15 shows an embodiment in which a separation member is elastically coupled to each spiked element. The separation member does not have a spiked surface facing the lumen wall. The device has an "open" or deployed position, and a "closed" or retracted position, the transition between the positions is made by means of a cable that contracts the device centrally. When the device is at its "open" position, the elastic recoil of each separation member pushes it centrally such that the spikes of the spiked element protrude radially beyond the separation member. When the device is at its "retracted" position, each separation member contacts the central tube of the device and is pushed such that it protrudes radially beyond the spikes of the spiked elements, rendering them ineffective, and enabling removal of the device.

[000166] More specifically, FIG. 15A is a schematic side view of an apparatus 1800 at its "open" position; and FIG. 15B is an axial cross section of the same at line 1890. Shown is spiked element 1810 having protrusions 1840 at both its ends, a separation member 1820 having slots 830 at both its ends through which pass protrusions 1840 of spiked element 1810. Separation member 1820 exhibits elastic members 1850 which press against protrusions 1840 such that at the device's "open" state 1800A, spikes of spiked element 1810 protrude radially beyond separation member 1820.

[000167] FIGs. 15C and 15D are a side view and axial cross section respectively, of apparatus 1800 at its "closed" state 1800B. The figures show the same components as in FIGs. 15A - 15B, differing in that due to central closure of the spiked elements, separation member 1820 is pressed against the central tube of the device and is pushed radially relative to spiked element 1810, such that protrusions 1840 compress elastic member 1850B and enable protrusion of separation member 1820 radially beyond spikes of spiked element 1810.

[000168] Central closure of the device can be achieved in various ways, one of them is by passing a wire loop through all spiked elements 1810 of the fixed and translatable elements, for example through the frontal protrusions 1840. The edges of such wire pass along the endoscope out to the user. Pulling on this wire will contract the loop and pull all spiked elements towards the center of the device.

Inflatable coverage

[000169] FIGs. 16A - 16C show an advancement mechanism 1900 in which a balloon is located at each end of the device. Inflation of the balloons to a diameter larger than that of the device pushes inner wall 260 away from the spiked elements 1905 and enables pulling device 2 out. FIG. 16A shows advancement mechanism 1900 with deflated distal balloon 1910A and deflated proximal balloon 1920 A, with the spiked element 1905 in contact with inner wall 260.

[000170] FIG. 16B shows advancement mechanism 1900 with inflated anterior balloon 1910B and inflated posterior balloon 1920B. Inner wall 260 is pushed away from spiked elements 1905 and is not in contact with them.

[000171] As shown in FIG. 16C, the distal balloon may further be structured so that it will compress spiked elements 1905 centrally at least slightly, so that their diameter will decrease, decreasing the required diameter to which the balloons must be inflated. In one embodiment balloon 1910A is divided into two balloons having a common wall 1930, such that inflation of the balloon will be proximally over the spiked elements' base.

[000172] FIGs. 18A - 18B illustrate an embodiment which inflatable balloons

2100 are located on each side of a spiked element 2101. When balloons 2100 are inflated, as shown in FIG. 18 A, they push inner wall 260 away from spiked element

2101 thus enables pulling the device out. When balloons 2100 are deflated, as shown in FIG. 18B, spiked element 2101 can meet inner wall 260.

[000173] FIGs. 19A - 19B illustrate an embodiment comprising an inflatable spiked element 2200. When deflated, as shown in FIG. 19A the spikes 2202 are covered by the inflatable element walls 2201. When inflated, as shown in FIG. 19B, inflatable spiked element 2200 extends, inflatable element wall 2201 retracts and spikes 2202 are exposed.

[000174] FIGs. 20 A - 20B illustrate an embodiment in which elastic and smooth elements 2301 are positioned on each side of an inflatable spiked element 2300. When deflated, spikes 2302 of spiked element 2300 are covered by elements 2301. When inflated, spiked element 2300 extends, thereby pushing elements 2301 to the sides and spikes 2302 are exposed. [000175] FIG. 21 illustrates a portion of and advancement mechanism 2400, similar to advancement mechanism 1700 of FIG. 11 A. In this embodiment, the longer balloons 1720 are spike-less and smooth while the shorter balloons 1710 are spiked. When balloons 1710 and 1720 are both deflated, balloons 1720 cover spiked balloons 1710, thus allowing the smooth retrieval of the device.

[000176] 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 sub-combination.

[000177] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as are commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods are described herein.

[000178] All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the patent specification, including definitions, will prevail. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[000179] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined by the appended claims and includes both combinations and sub-combinations of the various features described hereinabove as well as variations and modifications thereof, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

What is claimed is:

1. An advancement mechanism for advancing a device through a lumen, the device exhibiting a longitudinal axis, the advancement mechanism comprising:

at least one translatable member secured to the device and arranged radially about the device, each translatable member arranged to be translated along a translation axis, said translation axis generally parallel to the longitudinal axis of the device;

a proximal translation mechanism arranged to translate said at least one translatable member proximally along said translation axis; and

an internal distal translation mechanism arranged to translate said at least one translatable member distally along said translation axis.

2. The advancement mechanism of claim 1, wherein each of said at least one translatable member exhibits a translatable member variable extension length from the longitudinal axis of the device, said translatable member variable extension length arranged to increase responsive to said proximal translation mechanism translating said at least one translatable member proximally along said translation axis.

3. The advancement mechanism of claim 2, wherein each of said at least one translatable member further comprises a pair of fixed connecting members arranged to connect said translatable member to said translation mechanism, each of said connecting members exhibiting a variable connection angle in relation to a second surface of said translatable member such that said fixed member, said pair of fixed connecting members and the longitudinal axis of the device form a generally parallelogram shape,

wherein said variable connection angle is arranged to change responsive to said proximal translation mechanism, and

wherein said increase of said translatable member variable extension length is responsive to said change in said variable connection angle.

4. The advancement mechanism of claim 3, further comprising at least one expandable retrieval preparation member, wherein said at least one expandable retrieval preparation member is arranged in a deployed position of the device to not expand beyond a plane defined by said at least one translatable member, and

wherein said at least one expandable retrieval preparation member is arranged in a retrieval position of the device to:

expand beyond the plane defined by said at least one translatable member such that the walls of the lumen are not in contact with said at least one translatable member; and

for each of said at least one translating members, apply proximal pressure to a first of said pair of translating connecting members such that said translatable member variable extension length is reduced.

5. The advancement mechanism of claim 3, further comprising an extension and retraction member, said extension and retraction member arranged to be translated proximally and distally along said translation axis,

wherein each of said pair of translatable connecting members are hingeably coupled to said extension and retraction member,

wherein said translatable member variable extension length is arranged to increase responsive to said distal translation of said extension and retraction member, and

wherein said translatable member variable extension length is arranged to decrease responsive to said proximal translation of said extension and retraction member.

6. The advancement mechanism of claim 2, wherein said translatable member variable extension length is arranged to decrease responsive to said internal distal translation mechanism translating said translatable member along said translation axis.

7. The advancement mechanism of claim 2, wherein said at least one translatable member comprises expandable material, said translatable member variable extension length exhibiting an expanded length when said expandable material is expanded and said translatable member variable extension length exhibiting a contracted length, said expanded length greater than said contracted length when said expandable material is contracted, and

wherein when said expandable material is contracted, said at least one translatable member protrusion is covered by one of:

a covering; and

said expandable material.

8. The advancement mechanism of claim 1, further comprising at least one fixed member secured to the device and arranged radially about the device.

9. The advancement mechanism of claim 8, wherein each translatable member comprises at least one translatable member protrusion extending from a first surface of the respective translatable member, each translatable member protrusion exhibiting an acute translatable member protrusion angle in relation to the first surface of the respective translatable member, the acute translatable member protrusion angle determined from the proximal end of the device, and

wherein each fixed member comprises at least one fixed member protrusion extending from a surface of the respective fixed member, each fixed member protrusion exhibiting an acute fixed member protrusion angle in relation to the surface of the respective fixed member, the acute fixed member protrusion angle determined from a proximal end of the device.

10. The advancement mechanism of claim 9, further comprising:

a covering sheath arranged, in a retrieval position of the device, to cover said at least one fixed member and said at least one translatable member, and arranged, in a deployed position of the device, to be contracted such that said covering sheath does not cover either said at least one fixed member or said at least one translatable member.

11. The advancement mechanism of claim 9, wherein said at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device,

wherein said at least one translatable member exhibits a translatable member variable extension length from the longitudinal axis of the device, and wherein said fixed member variable extension length and said translatable member variable extension length conform to the inner diameter of the body lumen.

12. The advancement mechanism of claim 11, further comprising:

at least one translatable connecting member, exhibiting elastic properties and arranged to secure said at least one translatable member to the device; and

at least one fixed connecting member, exhibiting elastic properties arranged to secure said at least one fixed member to the device,

wherein said conforming to the inner diameter of the body lumen is responsive to:

an inner wall of the lumen applying pressure to said at least one translatable connecting member and said at least one fixed connecting member; and the elastic properties of said at least one translatable connecting member and said at least one fixed connecting member.

13. The advancement mechanism of claim 9, wherein said translation mechanism is arranged to translate said at least one translatable member along said translation axis in a proximal direction, and

wherein said proximal translation is arranged such that the proximal maximus translatable member protrusion of said at least one translatable member is not substantially translated proximal of the proximal maximus fixed member protrusion of said at least one fixed member.

14. The advancement mechanism of claim 9, further comprising a proximal retraction member, said proximal retraction member coupled to the device and positioned distal of said at least one translatable member,

wherein said proximal retraction member is arranged in a compressed mode to:

be contracted, such that the diameter of said proximal retraction member is less than the diameter of the lumen; and

be translated proximally and distally along the device, and wherein said proximal retraction member is arranged in an expanded mode to: be expanded, such that the diameter of said proximal retraction member is at least the diameter of the lumen; and be translated proximally along the device such that the lumen is retracted.

15. The advancement mechanism of claim 14, wherein said proximal retraction member comprises a balloon catheter.

16. The advancement mechanism of claim 9, wherein said at least one fixed member comprises an expandable member exhibiting a plurality of fixed member protrusions, wherein said at least one translatable member comprises a plurality of translatable members, each of said translatable members extending over said expandable member, and

wherein said plurality of fixed member protrusions are positioned in between adjacent translatable members.

17. The advancement mechanism of claim 9, wherein said at least one translatable member protrusion comprises a plurality of rows of said translatable member protrusions, said plurality of rows positioned along said particular translatable member.

18. The advancement mechanism of claim 8, wherein said at least one translatable member comprises a plurality of expandable translatable members, and

wherein said at least one fixed member comprises a plurality of expandable fixed members, each expandable translatable member positioned in between adjacent fixed expandable members.

19. The advancement mechanism of claim 8, further comprising at least one fixed member extender coupled to each of said at least one translatable member,

wherein said at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device, said fixed member extender arranged to extend towards said fixed member and apply radial force to said fixed member responsive to said proximal translation of said at least one translatable member.

20. The advancement mechanism of claim 8, wherein said at least one fixed member comprises a plurality of fixed members, said plurality of fixed members evenly arrayed about the device, and

wherein said at least one translatable member comprises a plurality of translatable members, said plurality of translatable members evenly arrayed about the device.

21. The advancement mechanism of claim 1, further comprising a plurality of separation members, a first end of each separation member coupled to the device and a second end of each separation member, opposing said first end of said separation member, extending away from the device,

wherein said at least one translatable member comprises a plurality of translatable members, each separation member coupled to a particular translatable member,

wherein in a deployed state, said separation members are arranged to not radially extend past said respective translatable members, and

wherein in a retrieval state, said separation members are arranged to radially extend past said respective translatable members.

22. An advancement mechanism for advancing a device within a lumen, the device exhibiting a longitudinal axis, the advancement mechanism comprising:

at least one translatable member secured to the device and arranged radially about the device, each translatable member arranged to be translated along a translation axis, said translation axis generally parallel to the longitudinal axis of the device; and

a proximal translation mechanism arranged to translate said at least one translatable member proximally along said translation axis,

wherein each of said at least one translatable member exhibits a translatable member variable extension length from the longitudinal axis of the device, said translatable member variable extension length arranged to increase responsive to said proximal translation mechanism translating said at least one translatable member proximally along said translation axis.

23. The advancement mechanism of claim 22, further comprising at least one fixed member secured to the device and arranged radially about the device.

24. The advancement mechanism of claim 23, wherein each translatable member comprises at least one translatable member protrusion extending from a first surface of the respective translatable member, each translatable member protrusion exhibiting an acute translatable member protrusion angle in relation to the first surface of the respective translatable member, the acute translatable member protrusion angle determined from the proximal end of the device, and

25. The advancement mechanism of claim 24, further comprising:

26. The advancement mechanism of claim 24, wherein said at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device, and

wherein said fixed member variable extension length and said translatable member variable extension length conform to the inner diameter of the lumen.

27. The advancement mechanism of claim 26, further comprising:

at least one fixed connecting member, exhibiting elastic properties arranged to secure said at least one fixed member to the device, wherein said conforming to the inner diameter of the body lumen is responsive to:

28. The advancement mechanism of claim 24, wherein said translation mechanism is arranged to translate said at least one translatable member along said translation axis in a proximal direction, and

29. The advancement mechanism of claim 24, further comprising a proximal retraction member, said proximal retraction member coupled to the device and positioned distal of said at least one translatable member,

wherein said proximal retraction member is arranged in a contracted mode to: be contracted, such that the diameter of said proximal retraction member is less than the diameter of the lumen; and

be translated proximally and distally along the device, and wherein said proximal retraction member is arranged in an expanded mode to: be expanded, such that the diameter of said proximal retraction member is at least the diameter of the lumen; and

be translated proximally along the device such that the lumen is retracted.

30. The advancement mechanism of claim 29, wherein said proximal retraction member comprises a balloon catheter.

31. The advancement mechanism of claim 24, wherein said at least one fixed member comprises an expandable member exhibiting a plurality of fixed member protrusions, wherein said at least one translatable member comprises a plurality of translatable members, each of said translatable members extending over said expandable member, and

32. The advancement mechanism of claim 24, wherein said at least one translatable member comprises expandable material, said translatable member variable extension length exhibiting an expanded length when said expandable material is expanded and said translatable member variable extension length exhibiting a contracted length, said expanded length greater than said contracted length when said expandable material is contracted, and

a covering; and

said expandable material.

33. The advancement mechanism of claim 24, wherein said at least one translatable member protrusion comprises a plurality of rows of said translatable member protrusions, said plurality of rows positioned along said particular translatable member.

34. The advancement mechanism of claim 23, wherein said at least one translatable member comprises a plurality of expandable translatable members, and

35. The advancement mechanism of claim 23, wherein each of said at least one fixed member further comprises a pair of fixed connecting members arranged to connect said fixed member to the device, each of said fixed connecting members exhibiting a variable connection angle in relation to a second surface of said fixed member such that said fixed member, said pair of fixed connecting members and the longitudinal axis of the device form a generally parallelogram shape, wherein said at least one fixed member exhibits a fixed member variable extension length from the longitudinal axis of the device,

wherein said variable connection angle is arranged to change responsive to said a proximal force applied to said fixed member, and

wherein said fixed member variable extension length is arranged to increase responsive to said change in said variable connection angle.

36. The advancement mechanism of claim 23, further comprising at least one fixed member extender coupled to each of said at least one translatable member,

37. The advancement mechanism of claim 23, wherein said at least one fixed member comprises a plurality of fixed members, said plurality of fixed members evenly arrayed about the device, and

38. The advancement mechanism of claim 22, further comprising:

an internal distal translation mechanism arranged to translate said at least one translatable member distally along said translation axis,

wherein said translatable member variable extension length of each translatable member is arranged to decrease responsive to said internal distal translation mechanism translating said translatable member along said translation axis.

39. The advancement mechanism of claim 22, wherein each of said at least one translatable member forms a generally parallelogram shape further comprises:

a pair of translatable connecting members arranged to connect said translatable member to said translation mechanism, each of said translatable connecting members exhibiting a variable connection angle in relation to a second surface of said translatable member such that said translatable member, said pair of translatable connecting members and the longitudinal axis of the device form a generally parallelogram shape,

wherein said variable connection angle is arranged to change responsive to said proximal translation of said proximal translation mechanism, and

40. The advancement mechanism of claim 39, further comprising at least one expandable retrieval preparation member,

wherein said at least one expandable retrieval preparation member is arranged in a deployed position of the device to not expand beyond a plane defined by said at least one translatable member, and

41. The advancement mechanism of claim 39, further comprising an extension and retraction member, said extension and retraction member arranged to be translated proximally and distally along said translation axis,

42. The advancement mechanism of claim 22, further comprising a plurality of separation members, a first end of each separation member coupled to the device and a second end of each separation member, opposing said first end of said separation member, extending away from the device,

43. A method of advancing a device within a lumen, the device exhibiting a longitudinal axis, the method comprising:

translating a translatable member secured to the device, said translating being along a translation axis in a proximal direction, said translation axis generally parallel to the longitudinal axis of the device;

responsive to said translating, applying a first proximal force to an inner wall of the lumen, said first proximal force being applied in the proximal direction;

responsive to said translating, applying a first orthogonal force to the inner wall of the lumen, said first orthogonal force being applied in a direction generally orthogonal to the direction of said first proximal force; and

preventing the movement of the device in the proximal direction responsive to a first distal force applied between the inner wall of the lumen and said translatable member, said first distal force being applied in the distal direction.

44. The method of claim 43, further comprising:

preventing the movement of the device in the proximal direction responsive to a second distal force applied between the inner wall of the lumen and a fixed member secured to the device, said second distal force applied in the distal direction; and

responsive to a second proximal force applied to the fixed member in a proximal direction, applying a second orthogonal force to the inner wall of the lumen, said second orthogonal force being applied in a direction generally orthogonal to the direction of the second proximal force.

45. The method of claim 43, further comprising:

translating the secured fixed member along said translation axis in a distal direction responsive to an internal distal translation mechanism; and

responsive to said distal translation, reducing said applied first orthogonal force.

46. The method of claim 43, further comprising:

rolling up a covering sheath, the covering sheath secured to the device;

inserting the device within the body lumen;

advancing the device within the body lumen by performing said preventing, translating, applying proximal force and applying orthogonal force;

covering the secured fixed member with the covering sheath; and

retrieving the device from the body lumen.

47. The method of claim 43, wherein said translation along said translation axis in a proximal direction is arranged such that a protrusion extending from the secured fixed member is not substantially translated proximal of a proximal maximus protrusion of the secured translatable member.