SE1430158A1 - Device and Method for Placement in Hollow Body Organs - Google Patents

Abstract

A device and method for placement in hollow organs, comprising a stable, formed and. relaxed configuration at the time of deployment, with or without fenestrations in the structure and having nonpenetrating contact with the wall of the hollow organ, with or without additional penetrating features. The device comprises a plurality of forms, is generally spring shaped or tubular, with central axial opening and provides placement for other devices and substances in the hollow organ. In an embodiment has functional coating\covering. In embodiments, nonpenetrating contact is enhanced with adhesion enhancing features like patterns and\or microfibrillar structures, and\or adhesion enhancing covering or coating on the surface of the device in entirety or partially.

Description

PATENT APPLICATION Anørdning och Metødför Placering i Ihåliga Description Vasantha Martin 2014/11/07 DESCRIPTION FIELD OF THE INVENTION This invention relates generally to medical apparatuses and methods and morespecifically, to a device and method for placement in a hollow body organ to helpretain and provide placement for other devices or substances in the lumen orcavity of a hollow organ, for example, in a part of gastrointestinal tract (e.g., esophagus) to enable retention and assess.

BACKGROUND OF THE INVENTION AND PRIOR ARTTransluminal assess to the interior of the organ is made easy and safe by theintroduction and advances in fibre-optic endoscopy. This makes the interior of the hollow organ easily assessable for various purposes.

Lumen or cavity of a hollow organ provides an excellent opportunity to assessthe interior of the organ, and also nearby organs for various purposes. Theretention of the devices or substances in required position of the lumen or cavityof a hollow organ, for required length of time safely without adverse effects due to placement is often desirable.

The retention of the devices or substances in hollow organs, for required lengthof time has problems like difficulty of optimum positioning, premature migrationand complications like ulcerations, necrosis, strictures, fistulas, etc. in theseorgans. The presence of peristalsis, required open transit through the lumen forthe passage of substances like food, secretions, air, urine, reflux, etc., make theretention of devices in hollow organ difficult.

The prior art makes reference to the endoluminal implantation devices like stentsfor hollow organs like blood vessel, esophagus, etc., to maintain or restore thepatency of the passageway. One example of a prior art is a percutaneousendovascular stent delivery system in U.S. Patent No. 4,580,568 to Gianturco. 2 A self-expanding esophageal stent is disclosed in US 5876448. A capsule devicefor in vivo imaging and pH measuring of the esophagus is described in EP2596748 A1. Currently there are devices used for diagnostic purposes (e.g.:Bravo PH monitoring system), where the devices stay in the lumen of the holloworgan for a limited time. An invention, which includes an endoluminal sleeve fortreating obesity, is described in WO 2011062833 A3 and an anchored duodenalsleeve for the same is described in EP 2629716 A2.

A device, which can remain in the required position of a hollow organ safely, canhelp retain other devices and carrier devices, in the hollow organs like a platform,helps assess, ambulatory medicine and e-medicine. Towards this goal this invention is described.

DESCRIPTION OF THE INVENTION This invention discloses a device and method for placement in hollow organs in ahuman or animal body, to help retain and provide placement for other devices orsubstances in the lumen or cavity of a hollow organ, for example, in a part ofgastrointestinal tract (e.g.: esophagus). The device 100 has a stable, formed andrelaxed configuration at the time of deployment, with or without fenestrations 106in the structure and nonpenetrating contact with the wall of the hollow organ, withor without additional penetrating features, with or without coating\covering 105.

The device 100 has a stable, formed and relaxed configuration at the time ofdeployment does not require expanding like a self-expanding stent afterdeployment. The device 100 comprises a plurality of forms, is disposed betweenthe lumen or cavity of the hollow organ and its wall. lt has generally a springshape 120 or tubular shape, with central axial opening, reference fig.1. Examplesof other shapes are arc shape 123, reference fig.4, branching or bifurcating 122,reference fig.3. An example of hollow organs, requiring these shapes is tracheo-bronchial tree 700. 3 ln one of the embodiment of this invention, the device 100 provides placementfor other devices or substances 1000, in the lumen or cavity of a hollow organ,with or without one or more placement or mounting features 101 on it. ln anembodiment, the device 100 has one or more eyeiets 102 configured to receive a suture, preferably on the end convolutions.

The Iongitudinai axis of the device 100 is generally designed to correspond with the Iongitudinai axis of the hollow organ. ln one of the embodiment of this invention, the device 100 has a coating\covering105 for providing required surface characters like compatibility with wide range ofpH, compatibility with organ of placement, flexibility, required spring rate,durability, etc... ln one of the embodiment of this invention, the device 100 has enhancednonpenetrating contact with the wall of the hollow organ, with adhesion en hancing features 107 like patterns and\or microfibrillar structures, and\oradhesion enhancing covering or coating 105 on its surface in entirety or partially. ln one of the embodiment, the device has a coating\covering 105 containingfunctional substances like substances to provide, alter or maintain one or more ofthe following in the hollow organ: pH, peristalsis, status of muscles (contractionor relaxation), local tissue health, local defenses, production of mucus or itscharacters, enzymes, coenzymes, vitamins, trace elements, or nutrients.Medications can also be carried on the device in the form of a covering or coating. ln another embodiment, another device 1000, containing medications orfunctional substances like substances to provide, alter or maintain one or more ofthe following in the hollow organ: pH, peristalsis, status of muscles( contractionor relaxation), local tissue health, local defenses, production of mucus or itscharacters, enzymes, coenzymes, vitamins, trace elements, or nutrients, is 4 placed thereon while the said device 100 is in the lumen or cavity of a hollow organ. ln one of the embodiment, the structure of the device 100 has fenestrations 106throughout its length or in a portion, to reduce the weight of the device or toobtain required spring rate.

The shape of the coi| of spring device 100, in cross-section can be rectangular,round, oval, square, etc. to suit the intended part of the hollow organ, itscharacters and local pathology. For example, as shown in fig.2b, a flat ribbon likecoi| gives better contact to the wall of the hollow organ by increasing the contactsurface area and is preferred. The shape of the coi| in cross-section 104 is eitherkept constant or varying along the length of the device, depending on the location requirements.

The distance between convolutions along with angle of slope of the rings in therelaxed status of the device, is kept either constant as in fig.5 or varying as infig.1, depending on the pitch requirement along the length of the device 100, tosuit the intended part of the hollow organ. The flexibility or rigidity along thelength of the device 100 is adjusted to suit the intended part of the hollow organ,so that the device 100 does not cause structural or functional damage to theorgans. The shape, materials used and the thickness of the coi| contributetowards the required flexibility in the device 100. The flexibility can be either constant or varying along the length of the device 100.

The device 100 is made from one or more of the biocompatible materials, isflexible, elastic and with optimal strength. Examples of such materials, withoutlimitation, include nitinol, stainless steel, tantalum, titanium, elgiloy, silicone,CNT, PTFE, PEEK, polyurethane, etc... These properties are known to the artand these materials are being used for medical devices. The choice of thematerial depends on the characters of the intended hollow organ like requirement of: 5a. compatibility with wide range of pH,b. corrosion resistance,c. degree and variability of flexibility and elasticity,d. degree and variability of tensile strength, e. compatibility with lVlRl & other investigational or therapeutic modalities likeRF, Electrical, magnetic, ultrasound, etc...

The device 100, in accordance with the present invention can take on variouscombinations of parameters. The spring rate, length of the device, number ofturns of the coil, diameter of the convolutions of the coil, thickness of the coil,distance and angle of slope between the turns are chosen to get required degreeof elasticity, flexibility and contact with the wall of the organ along the length ofthe device 100, so as to suit the organ of placement and local pathology, whenpresent.

The spring or elastic tubular shape of the device 100 with central axial openingallows unobstructed passage of matter like food, secretions, air, etc. through thedevice 100. The presence of matter like food in the lumen also applies radialpressure on the device, increasing its contact with the wall of the organ. Thespring shape 120 of the device 100 also avoids applying 360 degreecircumferential pressure on the wall of the organ constantly, so avoiding pressurecomplications like ulcerations, necrosis, strictures, fistulas, etc. in these organs.

The ends 103 of the device 100 are pliable, smooth and atraumatic. ln a springshaped device the ends are open or closed and ground or not ground. lnpreferred embodiment, reference fig.1 and 2, ends 103 are atraumatic, open, notground, flat, wider, bigger, contains a visual marker and is either radiopaque orhas a radiopaque marker. The device 100 has markers 108, visual and alsoradiopaque, if not made of sufficiently radiopaque material. The markers 108 are 6 located on end turns and at set points along the device 100 including themounting features 101 for carrier devices 1000.

The device 100 has one or more of the following features in its design towithstand the displacing forces, like longitudinal axial pressure from food,peristalsis, gravity, etc.: a. By having spring or tubular shape with central axial opening, device 100allows the unobstructed passage through, remains in contact with the wall ofthe organ, which offers structural support and surface adhesion. The radialforces applied by wall of the organ, food, etc. help the contact between the device 100 and wall of the organ. b. ln one of the embodiment of this invention, the device 100 has enhancedadhesion or friction between the device 100 and wall of organ in its entirety orpartially, such as adhesion enhancing covering or coating 105, patterns, and microfibrillar structures 107 on the surface. c. ln one of the embodiment of this invention, the cross section 104 of the coilof the device has a flat ribbon shape for increased surface area for contact. d. ln one of the embodiment of this invention, the structure of the device 100has fenestrations 106, to reduce the weight and adjust the spring rate of different segments. e. Displacement of the device 100 is opposed by the deflection characteristicsof the elastic spring or tubular shape of this invention. The desired spring rate,which is either constant or varying along the length of the device 100, isachieved through specifically designing the convolutions and the selection ofan appropriate material for the device 100, to suit the organ of placement andlocal pathology, when present. ln one of the embodiment, the convolutions ofthe device 100 react progressively to longitudinal axial pressure on them to give initial attenuation and resistance gradually builds up in the device 100 7 commensurate with higher force levels compressing the device 100 toprevent its displacement. The device 100, according to an embodiment of thepresent invention, has an elastic body with plurality of segments with differingdegree of compressibility, relatively rigid segments supporting more mobilesegments and hindering excessive deflection of the more mobile segments inthe direction of the deflecting force. Because of the interspersed rigidsegments, the stability of the mobile segments is increased in thisembodiment. This design allows the smaller convolutions to roll onto thewider convolutions or the wider convolutions to roll onto smaller convolutionsduring deflection, depending on their corresponding spring rate withoutsubstantial expansion of the diameter of the device. When, in a portion of thedevice, the convolutions touch each other on deflection, the resistance to further deflection increases rapidly, because of the increase in the spring rate Displacement of an endoluminal device usually happens along the longitudinalaxis of the lumen. This device 100 resists such displacement. The elastic or spring action is provided by whole or portion of the device 100.

These and other features, objects and advantages of this invention will be more apparent from the following drawings in which: Fig.1 is a diagram illustrating the front view of the device 100 in a spring shape 120, according to an embodiment of the invention.Fig.2a shows a sectional view of device 100 along lines 2-2”.

Fig.2b shows detailed view of the cross section of the coil 104 of the device in an embodiment.

Fig.3 shows the device 100 with branching type configuration 122, as in an embodiment in trachea-bronchial 700 placement. 8 Fig.4 shows the device 100 with arc shape 123, as in an embodiment in trachea-bronchial 700 placement.

Fig.5 shows the device 100, as in an embodiment, with convoiutions of constant diameters 130, along its length.

Fig.6-10 show steps of a method of deployment of the device 100 of an embodiment in esophagus 500.

Fig.6 shows endoscopic placement of guide wire 301 in to the stomach 600.Fig.7 shows overtube 302 placement over the bougie 202 and a guide wire 301.Fig.8 shows overtube 302 after removal of bougie and guide wire.

Fig.9 shows placement of device 100 carried to esophagus 500 over theendoscope 201.

Fig.10 shows device 100 mounted in esophagus 500.

Fig.11 shows removal of the device 100 from esophagus 500, using anendoscope 201, an overtube 302 and an endoscopic grasping forceps 205.

Figs.12, 13, and 14 show examples of the carrier device 1000.

DETAILED DESCRIPTION OF THE INVENTION This invention discloses a device 100 and method for placement in ho||ow organs, toprovide placement for structures 1000 like other devices or substances in the lumenor cavity of a ho||ow organ, for example, in a part of gastrointestinal tract (e.g.:esophagus 500). The device 100 has a stable, relaxed configuration at the time ofdeployment, does not require expanding like a self-expanding stent afterdeployment. lt has generally a spring shape 120 as shown in fig.1 or tubular, withcentral axial opening, but also can have other shapes. Examples of such shapes are 9 arc shape 123 as in fig 4 or branching 122 as in fig 3, for tracheo-bronchial 700 placement.

The device 100 according to an embodiment of the present invention has springshape, with central axiai opening, with convoiutions or rings constituting the bodywith constant or varying parameters such as diameters, thicknesses, cross-sections,pitches along the length of the device 100, achieved through specificaiiy designingthe convoiutions in the device 100, in order to achieve required spring rate along thelength of the device 100. The device 100 has 2 ends 103, proximal and distal whichare atraumatic, open, not ground, flat, wider, bigger, contain visual marker and radiopaque in the preferred embodiment, as shown in Fig 1 and 2.

Device 100 has a suitable modulus of elasticity as well as suitable dimensions.These figures are not fixed since they are highly dependent on the individual patient.The length, diameters of the rings, elasticity and spring rate are adapted to suit theorgan of placement, patient's size, age and local pathology, when present. ln an embodiment the construction of the present device 100 includes a series ofelements and arrangement of segments that helps the retention of the device 100 inthe hollow organ. Each segment can have different mechanical behaviors. The moremobile segments are responsible for most, if not all, of the deflection of the device,when a force large enough to compress reaches the rings.

There are several ways to manufacture a device 100 based upon these principle andit can be made from one or more biocompatible materials. ln an embodiment, thedevice has a variable spring rate along its length and plurality of zones having a differing degree of compressibility.

An alternative design to the design in Fig.1, is shown in Fig.3, 4, and 5. The device100 can have same diameter convoiutions along its length, but still have variablespring rate along the length of the device. By using different materials for different segments, the segments can have the same diameter convolutions 130 or thicknessof coil 130, but different spring rate, strengths or elasticity.

Another way of achieving this is to use the same material, like a metal, for all thesegments but selectively strengthen some. Heat treatment strengthens somematerials, but some for example, Nitinol, becomes more pliable as a result of heattreatment and this property can be used to make more pliable rings. Another waywould be to use fenestrations 106 in segments to reduce weight and change springrate in differing amount. Combination of these techniques can also be used.

One of the methods of manufacturing this device 100 includes selecting a corematerial, which in the preferred embodiment is a metal and a cover/ coating 105which is an elastomer. The metal has the spring constant needed and acts like askeleton to provide the mechanical stability to the device 100. The molding coversthe core with the liquid elastomer. During molding microfibrillar structures or patterns107 are created.

Finally the device is made by winding the coated/encapsulated coil around a mantel.Additional surface treatment using plasma or a coating can also be done, if needed to enhance the adhesion of the surface.

The examples of biocompatible elastomer materials for molding are biocompatibleSilicone and biocompatible polyurethane. The patterns or microfibrillar structures107 are created on the surface of the selected covering 105 using an availabletechnique, for example: nanomolding, photolithography, silicon micro-machining, or laser micromachining.

To date, a number of methods are used to fabricate and replicate microfibrillarstructures or patterns on surfaces e.g. photolithography, nanomolding, roll to rollimprint, stretching of a polymer film, replicating a nanoporous membrane withpolymer, carbon nanotubes technology, replica molding with an UV-curable polymerand angled etching of polySi substrate. 11 There are many ways in which the device 100 can be deployed, depending on theintended hollow organ. For description sake the method of placement of the device100 in to the esophagus 500 is described here as an example. For various otherhollow organs the placement is modified to suit the organ of placement. ln principle,the device is carried over a carrier instrument like an endoscope 201, bougie 202,balloon catheter, all purpose catheter, grasping forceps 205, and placed preferablyunder visual guidance. After deployment, the desired position of the device 100 isconfirmed using visual and /or radiological markerst 08. There are many ways of placing the device 100 in to the esophagus 500. A few are described here: The device 100 is carried to the place of deployment in the esophagus 500 over acarrier instrument like endoscope 201, bougie 202, catheter, endoscopic forceps205, balloon bougie, balloon catheter, etc... Choice of the carrier instrument dependson the availability and choice of the physician. ln one of the preferred method of placement, after preliminary examination with anendoscope 201, a guide wire 301 of suitable length is placed to extend beyond thearea of placement of the device 100, for placement in esophagus 500, the guide wire301 is extended in to the stomach 600 as shown in fig. 6.The endoscope 201 is removed leaving the guide wire 301 in place. lt is preferable to use an overtube 302 during deployment to allow easy passage tothe carrier instrument with the device 100 and protect the tissues along the route, asshown in fig.7. A suitable well lubricated bougie 202, (e.g. Savary or Maloneybougie) along with the suitable well lubricated overtube 302 is advanced over theguide wire 301 as shown in fig.7. Once the overtube 302 is in place, the bougie 202and the guide wire 301 are removed and the endoscope 201 with the device 100 onthe shaft of the endoscope is inserted through the overtube 302, as shown in fig.7.

To facilitate deployment, the device 100 can be temporarily held on to the distalportion of a carrier instrument by a thread 303 with a release knot (e.g., Highwayman's Hitch, falconer's knot, Slipped Buntline, etc.). The release end of the 12 thread 303 is long and brought out through the positioned overtube 302, as shown infig 9. For holding the device 100 on to the carrier instrument, instead of a thread witha release knot, a ring made out of soluble or other material, which can be released or cut easily also can be used.

Once the device 100 is in place, the release end of the release knot of therestraining thread 303 is pulled to release the tie, so loosening the device 100 from its carrier instrument.

Endoscope 201 is reintroduced to visually confirm or adjust the position of the device 100. Desired placement is confirmed visually and\or radiologically.

When the device 100 needs to be removed, using an endoscope 201, a guide wire301 of suitable length is placed to extend beyond the device 100, a well lubricatedovertube 302 with a well lubricated suitable bougie 202 is passed over a guide wire301. Once the overtube 302 is in place, bougie 202 and the guide wire 301 areremoved and an endoscope 201 is reintroduced through the overtube 302. Asuitable forceps 205 is passed down the instrument channel of the endoscope 201and the proximal end of the device 100 is grasped and the endoscope 201 alongwith the forceps 205 holding the device 100 are gently removed through theovertube 302, as shown in Fig.11. Lubricating jelly or liquids can be used to facilitate removal.

The carrier device 1000 to carry other devices or substances for mounting on thepositioned device 100 is made from biocompatible material and has a plurality offorms. The carrier device 1000, in embodiments has at least one of the following: a mesh envelop 1001, reference fig.12, a “C” shape, holding the structure to be mounted, between the limbs of reference fig.13, 13 walls, isolating the structure inside from lumen of the hollow organ, preferablycontaining nonporous, impermeable walls, a coating\covering 1003, for example a poiymer coating\covering,walls, allowing the structure inside exposure to lumen of the hollow organ, a harness that secures the structure to be mounted in position inside thecarrier device 1000.

Although some embodiments of this invention have been described to illustratethe invention, the scope of the claims is not limited to such particularembodiments, but to cover all modifications, alternative constructions andmethods falling within the scope of the invention.

Claims (12)

What is claimed is:

1. A device for providing placement in a hollow organ, comprising a stable, formed and relaxed configuration at the time of deployment, with or withoutfenestrations in the structure, and nonpenetrating contact with the wall of the hollow organ, with or without additionalpenetrating features, with or without coating\covering.

2. A device as in claim 1, further comprising a shape, position, size and dimensions to receive and support another device or carrier,placed thereon while the said device is in the lumen or cavity of a hollow organ, with orwithout one or more placement or mounting features on it.

3. A device as in claim 1, wherein the coating\covering contains functional substances like substances to provide, alter ormaintain one or more of the following in the hollow organ; pH, peristalsis, status of muscles( contraction or relaxation), local tissue health, localdefenses, production of mucus or its characters, enzymes, coenzymes, vitamins, traceelements, or nutrients.

4. A device as in claim 2, wherein another device or carrier contains medications or functional substances like substancesto provide, alter or maintain one or more ot the following in the hollow organ: pH, peristalsis, status of muscles (contraction or relaxation), local tissue health, localdefenses, production of mucus or its characters, enzymes, coenzymes, vitamins, traceelements, or nutrients.

5. A device as in claim 1, further comprising generally a spring or tubular configuration, with central axial opening or a variableconfiguration, like arc shape or branching, with constant or variable spring rate along thelength of the device, with or without covering\coating.

6. A device as in claim 5, further comprising more than one segments, wherein segments have differing spring rate and rigidity, withconstant or varying diameters or thickness of the rings.

7. A device as in claim 1, further comprising an enhanced nonpenetrating contact with the wall of the hollow organ with adhesionenhancing features like patterns and\or microfibrillar structures, and\or adhesionenhancing covering or coating on the surface of the device in entirety or partially.

8. A carrier device, comprising of biocompatible material and at least one of the following: a mesh envelop, shape holding the structure to be mounted between the limbs of walls, isolating the structure inside from lumen of the hollow organ, preferably containingnonporous, impermeable walls, a c0ating\covering, for example a polymer c0ating\covering, walls, allowing the structure inside, exposure or contact to lumen of the hollow organ, a harness that secures the structure to be mounted in position inside the carrier device.

9. A method comprising positioning a device in a hollow organ of the body, with a stable, formed and relaxedconfiguration at the time of deployment, with or without fenestrations in the structure, and configuring shape, position, size and dimensions of the device to form nonpenetrating contactwith the wall of the hollow organ, with or without additional penetrating features, with orwithout coating\covering.

10. A method as in claim 9, comprisingenhancing nonpenetrating contact of the device with the wall of the hollow organ withadhesion enhancing features like patterns and\or microfibrillar structures, and\or adhesionenhancing covering or coating on the surface of the device in entirety or partially.

11. A method as in claim 9, comprisingdesigning the convolutions along the length of the device to react progressively to longitudinalaxial pressure on them to give initial attenuation and building up of resistance gradually in thedevice.

12. A method as in claim 9, comprising receiving and supporting placement of another device or a carrier on the said device in thelumen or cavity of a hollow organ.