Multifunctional intra-cavity access device

Abstract

The present disclosure describes a device that allows a surgical scope to have varying degrees of flexibility during surgery by allowing active adjustment of a flexible portion of the scope during surgery. The disclosed device enables surgical procedures to be performed in body cavities such as the chest, abdomen, and pelvis with dynamic variable flexibility / rigidity of a scope used therewith. The device facilitates surgical access to body cavities to enable surgeons to perform surgical interventions or inspect visceral organs using a minimum number of access ports.

Description

PATENT APPLICATION GK.001PCTMULTIFUNCTIONAL INTRA-CAVITY ACCESS DEVICE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U. S. Provisional Patent Application Serial No. 63 / 759,767, filed on February 18, 2025, the disclosure of which is hereby incorporated herein in its entirety by reference.BACKGROUND

[0002] Various video-based surgical devices facilitate access to body cavities to facilitate surgical interventions. Examples of such devices include video-assisted thoracoscopes and laparoscopes. The human body is highly complex, with visceral organs in the body cavities arranged in compact clusters and with various vital organs and blood vessels positioned in a manner that requires multiple views and angulations of surgical devices to facilitate less invasive surgeries such as video-assisted thoracic surgery (VATS) and laparoscopy. These surgical devices are almost invariably rigid, and none have the potential for varying flexible and rigid parts thereof in real-time during surgery to facilitate improved access to visceral organs. Therefore a surgeon must use three to four ports to access the body cavity to perform surgery and cauterize bleeding vessels. Each of these ports require an incision to insert the port, thereby allowing surgical instruments, cameras, and cauterizing devices to pass through to effectively perform surgeries.

[0003] There remains a need for a surgical device that allows access to difficult to reach organs while simultaneously minimizing the number of incisions and ports required to perform surgery.SUMMARY

[0004] The present disclosure describes a device that allows a surgical scope to have varying degrees of flexibility during surgery by allowing active adjustment of a flexible portion of the scope during surgery. The disclosed device enables surgical procedures to be performed in body cavities such as the chest, abdomen, and pelvis with dynamic variable flexibility / rigidity of a scope used therewith. The device facilitates surgical access to bodyPATENT APPLICATION GK.001PCTcavities to enable surgeons to perform surgical interventions or inspect visceral organs using a minimum number of access ports.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] FIG. 1 shows a cut-out view of an embodiment of the device and a scope.

[0006] FIG. 2 shows a side view of the embodiment shown in FIG. 1 and a scope.

[0007] FIG. 3 shows a side cross-sectional view of the embodiment shown in FIG. 1 and a scope.

[0008] FIG. 4 shows a top cross-sectional view of the embodiment shown in FIG. 1 and a scope, illustrating how the Poisson effect causes inward compression of the sheath.

[0009] FIG. 5 shows an embodiment of the device that is a vacuum-activated sheath.

[0010] FIG. 6 shows an embodiment of the device that has interlocking links.DETAILED DESCRIPTION

[0011] The present disclosure describes a device that allows a surgical scope to have varying degrees of flexibility during surgery by allowing active adjustment of a flexible portion of the scope during surgery. The device facilitates surgical access to body cavities such as the thoracic cavity, abdominal cavity, and pelvic cavity to enable surgeons to perform surgical interventions or inspect visceral organs using a minimum number of access ports.

[0012] A scope is typically composed of a mesh spring element encased in a polymer that is designed to bend freely. If any external sheath is forcefully and frictionally applied to its outer diameter, then the overall stiffness of the scope will be driven by the elasticity of the sheath material and its distance from the neutral bending axis of the scope, which is its center axis. This principle is illustrated by the implementations described below. It should be understood that the invention is not limited to these implementations, but rather other approaches that are consistent with the claims may alternately be employed.

[0013] In some preferred implementations, the device is composed of a rigidification element that causes a portion of a scope to be reversibly rigidified during use. This reversible rigidity may be achieved using the Poisson effect, vacuum, compression or constriction elements, any combination thereof, or any other element that allows a portion of a scope to be reversibly rigidified.PATENT APPLICATION GK.001PCTCircumferential Shape Memory Alloy Wire Sheath Configurations

[0014] In some implementations, the disclosed device is a polymer sheath composed of at least two layers and having a plurality of pre-trained shape memory alloy (SMA) wires layered circumferentially between two layers or encapsulated circumferentially within one or more layers, as shown in FIG. 1.

[0015] As used herein, the term “embedded” may refer to a position between two layers of the sheath or may alternately refer to a position encapsulated within a single layer of the sheath.

[0016] The outer layer of the polymer sheath is composed of one or more biocompatible polymers. The one or more biocompatible polymers must have a high range of temperature and pH stability, must be malleable and transparent, and must provide insulation from heat and electricity such that electricity conducted through the wires does not conduct through the remainder of the sheath. Suitable polymers include polyimides, polysulfones, polyether ether ketone (PEEK), and polyethylene terephthalate (PET).

[0017] The outer layer may, for example, be composed of a polyimide having the following structure:which is known commercially as Kapton®; a polyimide / polysulfone co-polymer or blend; a polyamide-imide such as a copolymer of trimellitic anhydride chloride (TMAC), m-phenylenediamine (m-PDA), and 4,4’ -oxy dianiline (ODA) which is known commercially as Torlon®; a polyetherimide or another suitable polyimide; polyether ether ketone (PEEK); or polyethylene terephthalate (PET).

[0018] The inner layer of the sheath may be silicone or another suitable polymer that exhibits the Poisson effect.

[0019] The shape memory alloy (SMA) wires may preferably be Nitinol wires. Alternately, the SMA wires may be other biocompatible SMA wires. In some implementations, the SMA wires may be 0.001”-0.20” Nitinol wires.

[0020] In some preferred implementations, the sheath has between four (4) and twenty-four (24) SMA wires embedded circumferentially therein. In some highly preferredPATENT APPLICATION GK.001PCTimplementations, the sheath has sixteen (16) SMA wires embedded circumferentially therein. When the sheath has more wires embedded therein, there is an increased Poisson effect, as described below.

[0021] The diameter of the sheath may be altered to fit scopes of various diameters by decreasing or increasing the number of SMA wires, thereby increasing or decreasing motion authority to achieve the desired effect. Motion authority refers to the amount of change of the diameter of the sheath when electricity is conducted through the SMA wires due to the Poisson effect, as described below.

[0022] In some implementations, the wires are connected to an insulated feedback loop flex tension amplifier, as shown in FIG. 2. The flex tension amplifier is composed of a polymer that is stable across a broad range of temperatures and that turns on and off at a preset narrow temperature range, thereby activating the SMA wires to exert a Poisson effect on the sheath. The flex tension amplifier functions within a predetermined narrow temperature range and with low hysteresis (short lag time). The Poisson effect is the deformation (expansion or contraction) of a material in directions perpendicular to the specific direction of loading, as shown in FIG. 4.

[0023] In some implementations, relatively constant temperature is maintained by passing electric current generated by a rechargeable battery incorporated into the flex tension amplifier, shown in FIG. 2, or housed externally. The SMA wires run along the longitudinal axis of the sheath and are activated when subjected to the predetermined temperature range. This reduces the diameter of the sheath via the Poisson effect. A Poisson ratio of up to 0.5 is achievable, thereby achieving a decrease the diameter of the sheath by up to 50%. The transition temperature may range between about 0.5 °C - 5 °C, depending on the SMA electric system configuration that is appropriate for the specific application. To prevent bulging of the sheath during contraction, high strength composite fiber wires such as graphite, carbon, Kevlar, etc. are run at intervals along the transverse axis of the sheath, as shown in FIG. 2. Electric current is passed through the SMA wires embedded in the insulated sheath, and a feedback loop through the detachable flex tension amplifier maintains the predetermined temperature range. This activates the SMA wires to exert the Poisson effect on the inner layer. The electric current used is at a low voltage, and the insulation prevents any direct contact with tissue duringPATENT APPLICATION GK.001PCTsurgery. In some implementations, a grounding pad is applied to the patient as a measure of added precaution. Grounding pads are used in all surgeries that use electrocautery.

[0024] In some implementations, the sheath is composed of a series of axially conjoined sheath assemblies with SMA wires embedded therein, as described above. The use of a series of sheath assemblies to form the sheath will reduce the likelihood of Euler buckling and increase the likelihood that the Poisson effect will lead to the desired compression.

[0025] In some preferred implementations, the sheath is then applied to a flexible scope, as shown in FIGS. 1-4. The flexible scope may preferably have a working channel and a suction port. The sheath may be applied to any desired length on the shaft of the scope, thereby making that length rigid and the rest of the scope flexible.

[0026] The position of the device in relation to the scope may be adjusted manually or may alternately be adjusted using an optional positioner. This allows adjustment of the respective lengths of the rigid and flexible portions of the scope in real-time during surgery.

[0027] In some implementations, the sheath is calibrated so that the precise length of the flexible portion of the scope may be determined by the surgeon. The surgeon can vary this length during surgery by deactivation and reactivation of the Poisson effect exerted by the SMA wires. This generates a dynamic semi-rigid scope, enabling the surgeon to alter the length of the flexible tip depending on the desired access to organs through a port for any given surgical procedure in the thoracic, abdominal, and pelvic cavities. By altering the length of the flexible portion, the surgeon may perform visual inspection, cauterize bleeding vessels in difficult to access spots, or perform biopsies or removal of diseased organs with fewer incisions and ports than is currently possible.

[0028] FIG. 1 shows a cut-out view of an embodiment 100 of the device having a polymer sheath 102 with shape memory alloy wires 104 that run along the longitudinal axis of the sheath embedded therein. The device is placed over a flexible scope 200.

[0029] FIG. 2 shows another view of the embodiment 100 of the device, where the polymer sheath 102 has high strength composite fiber wires 106 encircling the sheath at intervals along its tranverse axis. The removable flex tension amplifier 108 is used to apply current to the shape memory alloy wires that run along the longitudinal axis of the sheath (not shown). The device is placed over the flexible scope 200.PATENT APPLICATION GK.001PCT

[0030] FIG. 3 shows a cross-sectional side view of the embodiment 100 of the device, showing the sheath 102 and shape memory alloy wires 104 around the flexible scope 200.

[0031] FIG. 4 shows a cross-sectional top view of the embodiment 100 of the device, showing the sheath 102 and shape memory alloy wires 104 around the flexible scope 200 and showing the inward compression 300 caused by the Poisson effect.Helical Shape Memory Alloy Wire Sheath Configurations

[0032] In some alternate implementations, the disclosed device is a polymer sheath having one or more pre-trained shape memory alloy (SMA) wires layered helically between two layers or encapsulated helically within one or more layers.

[0033] As used herein, the term “embedded” may refer to a position between two layers of the sheath or may alternately refer to a position encapsulated within a single layer of the sheath.

[0034] As described above for implementations having circumferential SMA wire configurations, the outer layer of the polymer sheath is composed of one or more biocompatible polymers, where the one or more biocompatible polymers have a high range of temperature and pH stability, are malleable and transparent, and provide insulation from heat and electricity such that electricity conducted through the embedded wire(s) does not conduct through the remainder of the sheath. As described above for implementations having circumferential SMA wire configurations, suitable polymers include polyimides, polysulfones, polyether ether ketone (PEEK), and polyethylene terephthalate (PET).

[0035] The outer layer may, for example, be composed of a polyimide having the following structure:T o o "1. 'FX I J N. ();)•. ». \L o o. Uwhich is known commercially as Kapton®; a polyimide / polysulfone co-polymer or blend; a polyamide-imide such as a copolymer of trimellitic anhydride chloride (TMAC), m-phenylenediamine (m-PDA), and 4,4’ -oxydianiline (ODA) which is known commercially as Torlon®; a polyetherimide or another suitable polyimide; polyether ether ketone (PEEK); or polyethylene terephthalate (PET).PATENT APPLICATION GK.001PCT

[0036] The inner layer of the sheath may be silicone or another suitable polymer that exhibits the Poisson effect.

[0037] The shape memory alloy (SMA) wires may preferably be Nitinol wires. Alternately, the SMA wires may be other biocompatible SMA wires. In some implementations, the SMA wires may be 0.001”-0.20” Nitinol wires.

[0038] Use of a helical configuration of one or more SMA wires may decrease complexity, where one or more elements contract to provide both elongate strain to achieve the Poisson effect and also provide radial constriction. The balance between elongate strain and radial constriction is determined at least in part by the number of turns of the helix per unit length.

[0039] Another advantage of a helix is that, where a single SMA wire is used, Euler buckling is significantly reduced or avoided entirely, and only one constant current source is required.

[0040] If a helix of SMA wire is embedded circumferentially in a thin-walled sheath that is free to slide along the body of a scope and the ends of the sheath are constrained, when the SMA wire contracts the sheath is radially compressed onto the body of the scope. The SMA wire simultaneously exhibits longitudinal and radial strain. The ratio of these strain vector components is a product of the helix angle.

[0041] An increased number of rotations of the helix around the length of the sheath will increase the conversion of the contraction strain from the SMA wire into radial force that directly compresses the sheath.Vacuum- Activated Sheath Configurations

[0042] In some alternate implementations, the disclosed device is a polymer sheath that includes seals at its distal and proximal ends, and is configured to be activated by application of vacuum, as shown in FIG. 5. The sheath is preferably sized to have a slightly larger inner diameter than the outer diameter of a body of a scope for which it is designed.

[0043] The sheath may be composed of any biocompatible polymer that exhibits very high modulus in tension in all directions but is disposed to buckle under compression. Suitable polymers include polyethylene, polyimides, polysulfones, polyether ether ketone (PEEK), and polyethylene terephthalate (PET).PATENT APPLICATION GK.001PCT

[0044] The polymer may, for example, be polyethylene; a polyimide having the following structure:r: <;..• P? i •■4- 4 y 4 «•••• 4 / >-■ 4-4-I * b,4which is known commercially as Kapton®; a polyimide / polysulfone co-polymer or blend; a polyamide-imide such as a copolymer of trimellitic anhydride chloride (TMAC), m-phenylenediamine (m-PDA), and 4,4’ -oxy dianiline (ODA) which is known commercially as Tori on®; a poly etherimide or another suitable polyimide; poly ether ether ketone (PEEK); polyethylene terephthalate (PET); or another suitable biocompatible polymer.

[0045] The sheath may include a port at the proximal end that is configured for connection to a vacuum system. For example, the port may be configured to allow attachment to vacuum tubing and include a valve that toggles a connection to an operating room vacuum system. Alternately, an external valve attached to vacuum tubing may be used.

[0046] FIG. 5 shows an embodiment 600 of the device, showing the proximal end seal 601 and distal end seal 602 positioned over a scope, where the device is connected to an external valve 611 via vacuum tubing 612.

[0047] When the sheath is positioned over a scope at ambient pressure, the small radial gap between the inner surface of the sheath and the outer surface of the scope allows the scope to bend freely. When vacuum is applied, the sheath comes into high force frictional contact with the scope. The friction interface provides resistance to bending that is proportional to the distance of the interface from the neutral axis of the scope. This is achieved through an increase in local shear stress at the interface, which provides resistance against bending. Each friction interface provides local resistance to bending, and the combination of friction interfaces along the length of the scope that is in contact with the sheath stiffens the entire length of the scope that is in contact with the sheath.

[0048] In some implementations, to compensate for any decrease in overall length of the sheath as radial and axial buckling occur, the sheath may be slightly longer than the targeted length of the scope intended to be reversibly rigidified.PATENT APPLICATION GK.001PCTInterlocking Link Configurations

[0049] In some alternate implementations, the disclosed device is composed of a plurality of coaxially interlocking polymer segments. The interlocking segments may be composed of segments that may be positioned coaxially along the body of a scope. In some implementations, the interlocking segments may preferably be molded polymer segments. In other implementations, the interlocking segments may be metal segments.

[0050] In some preferred implementations, the polymer segments may be held loosely in place using an outer sheath. The outer sheath may be a biocompatible polymer tube, such as a polyethylene terephthalate (PET) tube. The outer sheath is preferably thin and strong.

[0051] The outer sheath may be composed of any biocompatible polymer. Suitable polymers include polyimides, polysulfones, polyether ether ketone (PEEK), and polyethylene terephthalate (PET).

[0052] The outer sheath may, for example, be composed of a polyimide having the following structure:which is known commercially as Kapton®; a polyimide / polysulfone co-polymer or blend; a polyamide-imide such as a copolymer of trimellitic anhydride chloride (TMAC), m-phenylenediamine (w-PDA), and 4,4’ -oxydianiline (ODA) which is known commercially as Torlon®; a polyetherimide or another suitable polyimide; polyether ether ketone (PEEK); polyethylene terephthalate (PET); or another suitable biocompatible polymer.

[0053] The outer sheath may be affixed at its distal end onto an end ring and may be affixed at its proximal end to a pull flange. Force is applied to the first proximal segment when it is actuated by an end flange, and the end flange and pull flange are displaced forcefully together manually or by an actuator. Because it is both thin and strong, the outer sheath is loaded in tension and applies no radial forces to the assembly.

[0054] A scope is typically inserted through a cannula. The sheath may be partially external to the cannula and the actuation may be proximal to the cannula. Manual actuation may employ a simple locking mechanism that is effective over a range of actuation forces.PATENT APPLICATION GK.001PCT

[0055] The interlocking segments may preferably be configured to allow mating of a tapered conical socket and a protrusion having identical or similar taper angles. The taper angle may be within the known range for locking angles. When compressed together, the segments preferably seat firmly, similar to a machine tool collet taper. The taper angle may be between about 0.01 to 30 degrees.

[0056] The male taper may incorporate one or more bayonet protrusions and the female taper may incorporate a helical socket having the same number of paths as the bayonet protrusions.

[0057] As the segments are forced together, the mated bayonet protrusions and helical sockets hold the segments together approximately as a function of the tangent of the helix angle.

[0058] The segments may further include one or more finger spring beams with camshaped contact surfaces incorporated into the molding. The finger spring beams resist the joining of mating segments and effectively eject each pair of mated segments when the external compression between the segments is removed. When the proximal flanges are released, the sheath relaxes without delay.

[0059] FIG. 6 shows an embodiment 800 of the device, showing a plurality of segments. The segments are mated together to form a segment pair 801 using bayonet protrusions (not shown) and corresponding female tapers (not shown). The segments are inserted into an outer sheath 806 which is affixed to an end ring 808 and pull flange 809. An end flange 810 is used to insert segments 801 into the outer sheath 806. Finger spring beams 812 facilitate the release of segments from one another.

[0060] The inside bore of the segments may preferably slide with a small clearance over the body of the scope and may be tapered internally such that the contact point for each segment is a circle around the circumference of the scope at the distal end of the segment rather than providing a cylindrical contact area. This increases overall flexibility when the scope is used in its flexible state. As the tapers unlock, the rotation angle between nested segments increases and this internal link taper allows for greater inter-segment flexibility.

[0061] Performance tests conducted using exemplary interlocking links exhibited a stiffness ratio of 2.8:1, where a flexible length of scope would achieve a stiffness approximately equal to the stiffness of a pencil when actuated. The stiffness is approximatelyPATENT APPLICATION GK.001PCTlinearly proportional to actuation force. It is therefore possible to continuously select a variable stiffness as desired.

[0062] The interlocking segments may be scaled for a range of scope body diameters and overall scope lengths.Methods of Use

[0063] A method of reversibly rigidifying a scope during surgery is disclosed herein. In some implementations, the method entails using a sheath to reversibly rigidify a portion of the scope using the Poisson effect and / or radial constriction. In some other implementations, the method entails using vacuum to reversibly rigidify a portion of the scope. In some other implementations, the method entails using interlocking segments to reversibly rigidify a portion of the scope.Advantages of Rigid / Flexible Scope Adjustment

[0064] The disclosed device enables a surgeon to alter the rigid / flexible portion of a scope in real time, thereby allowing a variable range of motion for the surgeon. This enables a surgeon to adjust the range of motion of the scope based on the anatomy encountered during surgery and allows surgery to be performed with fewer ports and increased access. In addition, revisiting surgical cavities may be accomplished with minimal effort, in contrast to what is currently possible. The device may also be converted into a rigid bronchoscope after a flexible insertion of the scope through the airway for airway procedures, making it a truly multifunctional device.

[0065] In some preferred implementations, the device is sterilizable and reusable for at least a minimum number of times and is not a single use device. Thus, the device is an economically desirable option for the above-mentioned uses.

[0066] The disclosed device is a multi-functional, sterilizable, and reusable device that enables surgical procedures to be performed in body cavities such as the chest, abdomen, and pelvis with dynamic variable flexibility / rigidity of a scope used therewith. This facilitates access to complex anatomical structures to perform surgical interventions in a less invasive fashion than what is currently possible. The device is sterilizable and reusable, and may be available in multiple sizes to suit any specific surgical need.PATENT APPLICATION GK.001PCT

[0067] Conditional language used herein, such as, among others, “can,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments or implementations include, while other embodiments or implementations do not include, certain features, elements, and / or states. Thus, such conditional language is not generally intended to imply that features, elements, and / or states are in any way required for one or more embodiments or implementations. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied.

[0068] If and as used herein, “substantially” may mean to a considerable degree or extent, or approximately, while still achieving the intended purpose, function, or result. The term may allow for minor deviations that do not materially affect the operation or performance of the invention as described and claimed. For example, the term “substantially the same” may refer to materials, compositions, or compounds that exhibit essentially equivalent chemical identity, structure, and functional performance, notwithstanding minor variations or impurities that do not materially affect the intended properties or performance. For example, “substantially” may mean within 5.0%, 1.0%, 0.5%, 0.1%, or 0.01% of a reference that does not include the term “substantially.”

[0069] Further, any range of numbers recited above describing or claiming various implementations, embodiments, or aspects of the invention, such as ranges that represent a particular set of properties, units of measure, conditions, physical states, or percentages, is intended to literally incorporate any number falling within such range, including any subset of numbers or ranges subsumed within any range so recited. As used herein, the terms “about” and “approximately” when used as modifiers are intended to convey that the numbers and ranges disclosed herein may be flexible as understood by ordinarily skilled artisans and that practice of the disclosed invention by ordinarily skilled artisans using properties that arePATENT APPLICATION GK.001PCToutside of a literal range will achieve the desired result. The use of “about” or “approximately” as modifiers refers to known commercial and / or experimental measurement variations or tolerances for the referenced quantity. In some embodiments or implementations, such known commercial and / or experimental measurement tolerances are ±10% of the measured value, while in other embodiments or implementations such known commercial and / or experimental measurement tolerances are ±5% of the measured value, while in still other embodiments or implementations such known commercial and / or experimental measurement tolerances are ±2.5% of the measured value, and in still other embodiments or implementations, such known commercial and / or experimental measurement tolerances are ±1% of the measured value.

[0070] The previous description of the disclosed embodiments and implementations is provided to enable any person skilled in the art to make or use the invention disclosed herein. Although the various inventive aspects are disclosed in the context of certain illustrated embodiments, implementations, and examples, it should be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments and implementations to other alternative embodiments, implementations, and / or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of various inventive aspects have been shown and described in detail, other modifications that are within their scope will be readily apparent to those skilled in the art based upon reviewing this disclosure. It should be also understood that the scope of this disclosure includes the various combinations or sub-combinations of the specific features and aspects of the embodiments and implementations disclosed herein, such that the various features, modes of implementation, and aspects of the disclosed subject matter may be combined with or substituted for one another. The generic principles defined herein may be applied to other embodiments and implementations without departing from the spirit or scope of the disclosure. Thus, the present disclosure is not intended to be limited to the embodiments and implementations shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0071] Each of the foregoing and various aspects, together with those summarized above or otherwise disclosed herein, including the figures, may be combined without limitation to form claims for a device, apparatus, system, method of manufacture, and / or method of use.

[0072] All references cited herein are hereby expressly incorporated by reference.

Claims

PATENT APPLICATION GK.001PCTCLAIMSWhat is claimed is:

1. A multifunctional intra-cavity access device comprising a rigidification element configured to reversibly rigidify a portion of a scope to which it applied during a medical procedure.

2. The device of Claim 1, wherein the rigidification element comprises a plurality of interlocking segments.

3. The device of Claim 2, wherein the rigidification element further comprises an outer sheath for securing the interlocking segments4. The device of Claim 2 or 3, wherein the rigidification element further comprises an end flange.

5. The device of Claim 3 or 4, wherein the outer sheath is configured to be attached to an end ring at a first end of the outer sheath and is configured to be attached to a pull flange at a second end of the outer sheath.

6. The device of any of Claims 2-5, wherein each interlocking segment comprises a plurality of bayonet protrusions and a plurality of female tapers.

7. The device of any of Claims 2-6, wherein each interlocking segment comprises at least one finger spring beam.

8. The device of Claim 1, wherein the rigidification element comprises a sheath, wherein the sheath comprises at least two layers and a shape memory alloy embedded within the sheath, wherein the two layers include at least an outer layer and an inner layer.

9. The device of Claim 8, wherein the shape memory alloy is one or more wires.

10. The device of Claim 9, wherein the wires are arranged circumferentially within the sheath.

11. The device of Claim 9, wherein the wires are arranged helically within the sheath.

12. The device of Claim 10 or 11, wherein the device further comprises a flex tension amplifier to provide current to the shape memory alloy wires.

13. The device of Claim 1, wherein the rigidification element comprises a sheath having a distal end and a proximal end.PATENT APPLICATION GK.001PCT14. The device of Claim 13, wherein the distal end comprises a seal and the proximal end comprises a seal.

15. The device of Claim 13 or 14, wherein when a vacuum is applied to the sheath a portion of a scope is reversibly rigidified.

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