A medical apparatus and a method for carrying out an endoscopic gastric remodelling procedure
The present invention relates to a medical apparatus and a method for carrying out an endoscopic gastric remodelling procedure according to the independent claims .
Obesity is associated with a wide variety of diseases and comorbidities posing signi ficant health risks and may result in severe medical conditions such as Type 2 diabetes , high blood pressure , apnea, dyslipidemia and certain types of cancer .
Minimally invasive bariatric surgery, in particular by gastric volume restriction/reduction, has been shown to provide a most ef fective way for achieving improved long-term sustained weightloss outcomes while minimi zing surgical complications .
Nonetheless , bariatric surgery may be subj ect of health risks such as bleeding and/or leakage into the abdominal cavity which may in severe cases lead to infections , e . g . peritonitis , or even death . Therefore , it is of paramount importance to enable precise and ef ficient connection of stomach tissue which reduces surgical complications , provides post-surgery infection risk mitigation, and in particular may be tailored to the speci fic anatomy/needs of a patient .
US 2022 / 079577 Al discloses a bougie capsule section which is configured for shaping gastric tissue and suturing the tissue via an arcuate needle which may be driven by a rotatable drive by friction between a shaft and the needle .
EP 4 005 503 Al discloses a needle assembly with a suturing device which is adapted for placing tubular needle bodies with a suture extending through the needle bodies and the needle bodies are adapted to be longitudinally displaceable along a length of the suture .
The prior art lacks a medical apparatus which allows to connect stomach tissue in a simple and reliable manner such that tissue bulges are connected at spatially optimi zed locations and have ideal dimensions .
Moreover, the prior art lacks an optimi zed positioning of the optimi zed locations which is not dependent on the skills of a clinician . In particular, the prior art fails to disclose a medical apparatus which is configured for providing a more uni form and predictable suturing surface of the tissue bulges of the gastric tissue .
It is the obj ective of the present invention to overcome these and other disadvantages of the prior art and provide a medical apparatus and method for carrying out an endoscopic gastric remodelling procedure . The medical apparatus should further facilitate the surgical procedure , minimi ze surgical complications , and postoperative morbidity . These obj ectives are solved by the medical apparatus and method according to the independent claims . Further embodiments result from the dependent claims .
The medical apparatus for carrying out an endoscopic gastric remodelling procedure comprises a si zing tube which has an inner lumen, at least one vacuum port for applying suction to stomach tissue and forming at least two tissue bulges of the stomach tissue . The si zing tube has at least one tissue receiving opening extending in a longitudinal direction of the si zing tube for receiving the tissue bulges based on the applied suction . The medical apparatus further comprises a puncturing connection unit , which is adapted for connecting the at least two tissue bulges with each other by puncturing the tissue bulges . The medical apparatus preferably comprises an expansion unit for spreading the stomach . The expansion unit has a collapsed configuration and an expanded configuration . The expansion unit in the expanded configuration is configured for engaging the greater curvature of the stomach and for displacing the greater curvature away from the si zing tube .
The puncturing connection unit may be configured to connect the tissue bulges by deploying fastening devices , such as fasteners , staples , barbs , clips and/or sutures . In a preferred embodiment , the fasteners are staples formed by a puncturing element . The puncturing connection unit may also be adapted to deploy biocompatible adhesives for enhancing the connection of the tissue bulges .
In comparison with minimally invasive surgical procedures
( sleeve gastroplasty, Roux-en-Y gastric bypass , single-anastomosis gastric bypass , gastric banding) , endoscopic gastric remodelling is a less invasive surgical procedure , in which the stomach si ze / ef fective volume is reduced by connecting, e . g . ventral and dorsal , parts of the stomach to create a tubular sleeve formed by the native tissue of a patient . This enables to segment the stomach and precisely adj ust a portion of the stomach to receive incoming food . The medical apparatus may be adapted for carrying out an endoscopic peroral endosleeve surgery .
The expansion unit allows to flatten the stomach tissue and increase a tissue spread of the stomach such that unintended folding of stomach tissue , in particular transverse to the tube , can be prevented . These tissue folds may otherwise result in une- ven/non-uni form connection of tissue bulges . In addition, the expansion unit may enable a reliable placement of the si zing tube along the lesser curvature of the stomach by pushing the greater curvature of the stomach away from the si zing tube .
The expansion unit may comprise an inflatable structure which has a collapsed configuration and an expanded configuration . In the expanded configuration, the inflatable structure is adapted for displacing the greater curvature away from the si zing tube .
The expansion unit may be designed to allow the receiving opening ( s ) to be at least partially unobstructed, such that the expansion unit in the expanded configuration allows the tissue bulges to be received in the receiving opening ( s ) .
The expansion unit may be connected to a proximal and/or a distal end of the si zing tube . The expansion unit in the collapsed configuration may extend along a longitudinal direction of the si zing tube in a parallel or in an arcuate manner, in particular may longitudinally extend along the entire tissue receiving opening ( s ) .
The expansion unit may comprise an elongated element , in particular a hyperelastic elongated element , which has a collapsed configuration and an expanded configuration . The elongated element in the expanded configuration is adapted for displacing the greater curvature away from the si zing tube , in particular by the elongated element interfacing at least partially tangentially with the greater curvature . The elongated element may have an arcuate shape with a smaller radius in the expanded configuration than in the collapsed configuration . The elongated element may be a wire . The expansion unit may comprise or consist of a hyperelastic material , preferably a shape memory material , in particular nitinol .
The expansion unit may be reversibly convertible between the collapsed and expanded configuration by longitudinally advanc- ing/retracting the elongated element , in particular to progressively adapt an arcuate curvature of the expansion unit , in particular of the elongated element . This design of the expansion unit enables a simple and reliable deployment which evenly distributes the pressure along the greater curvature of the stomach to remove gastric folds .
The design of the expansion unit may further be configured to apply lateral tension to the dorsal and ventral stomach wall which facilitates formation of the tissue bulges and simpli fies the endoscopic gastric remodelling of the stomach .
The expansion unit may be configured have an expanded configuration in which the expansion unit laterally extends a distance between 4 cm to 18 cm, in particular a distance between 5 cm to
14 cm, preferably a distance between 7 cm to 10 cm, away from the si zing tube .
The expansion unit may extend a distance between 3 cm to 24 cm, in particular between 5 cm to 20 cm, preferably between 7 cm and
15 cm, along the longitudinal direction of the si zing tube in the collapsed and/or expanded configuration .
The medical apparatus may comprise a control unit which is configured for operating a fluid flow into/out of the stomach, e . g . through the at least one vacuum port . The control unit may be adapted for controlling a fluid inflow into the stomach and/or a fluid outflow from the stomach to facilitate a simultaneous or synchroni zed deployment of the expansion unit . The control unit may be adapted for providing cyclic inflow and outflow of fluid through the vacuum port in a synchroni zed manner with moving the expansion unit from the collapsed to the expanded configuration . The control unit may be adapted for converting the expansion unit completely to the expanded configuration, in particular while continuously increasing an applied fluid inflow, prior to applying suction for forming the tissue bulges .
The puncturing connection unit may longitudinally extend along the at least one longitudinal tissue receiving opening, in particular along the entire at least one tissue receiving opening . The puncturing connection unit may be configured to be transla- tionally immovable along the longitudinal direction, in particular fixedly connected to the si zing tube . The puncturing connection unit may be configured to be rotationally movable , in particular in unison with the si zing tube .
The medical apparatus may comprise an actuator for rotating the puncturing connection unit , in particular together with the si zing tube or relative to the si zing tube .
The medical apparatus may have at least two tissue receiving openings which are connected to the inner lumen of the si zing tube and are at least partially separated by an elongated parti- tioner of the si zing tube . The two tissue receiving openings may be arranged parallel to each other and/or may have a same longitudinal length . The first tissue receiving opening is adapted for receiving the first tissue bulge and the second tissue receiving opening is adapted for receiving the second tissue bulge when the suction is applied . The elongated partitioner may further be adapted such that the first tissue opening receives a first tissue bulge of the ventral stomach tissue and the second tissue opening receives a second tissue bulge of the dorsal stomach wall . This allows for reliably performing an endoscopic gastric remodelling procedure by connecting the tissue bulges of the stomach tissue .
This elongated partitioner allows for a reliable separate formation of the tissue bulges which are received in the receiving openings based on the applicable suction and preferably enables formation of uni formly si zed tissue bulges .
The elongated partitioner may be adapted such that the at least one tissue receiving opening, in particular both tissue receiving openings , are arrangeable on the lateral side of the si zing tube in the stomach that faces the greater curvature of the stomach rather than the lesser curvature of the stomach . This allows a simpler connection of the ventral and dorsal tissue bulges and optimi zed shape and si zing of the resulting endoscopic gastric remodelling .
The medical apparatus may have pairs of tissue receiving openings which are spaced apart from each other in a circumferential direction of the si zing tube . A plurality of pairs of tissue receiving openings may be arranged distanced from each other along the longitudinal direction of the si zing tube , in particular in an equidistant manner . This provides predefined puncturing connection positions at which the puncturing connection unit can connect the tissue bulges received by the pairs of tissue receiving openings . The tissue receiving openings may have a rectangular, polygonal , circular or elliptical shape . The elongated partitioner may be attached on both ends to the si zing tube and immovable with respect to the si zing tube . The puncturing connection unit may be arranged laterally outwardly with respect to the elongated partitioner . The puncturing connection unit may be adapted to connect the at least two tissue bulges at a location laterally outwardly with respect to the elongated partitioner and the si zing tube . This allows the puncturing connection unit to connect the tissue bulges in a manner that the elongated partitioner is not enclosed amidst the tissue bulges and deployed sutures/ fasteners such that a lateral removal of the elongated partitioner from between the tissue bulges can be achieved .
The elongated partitioner of the si zing tube may have one free end which is not connected to the si zing tube and one j oined end which is connected to the si zing tube . Alternatively, the elongated partitioner may have two j oined ends which are connected to the si zing tube with at least one of the j oined ends being separable from the si zing tube . The elongated partitioner may have a non- flexible state , in particular a non- flexible state having a bent shape , which can be converted into a more flexible state by actuation of a conversion element , in particular by retraction of the conversion element from the elongated partitioner . In the flexible state , a plurality of separated longitudinal subsections of the elongated partitioner are preferably freely movably connected to each other by at least one flexible connecting element , in particular a cable . The elongated partitioner may comprise or be formed by a sel f-dissolving, soluble and/or bioresorbable material .
Alternatively, the elongated partitioner may be movable with respect to the si zing tube , in particular retractable in a proximal direction with respect to the si zing tube . This provides for a simple removal of the elongated partitioner such that the two tissue receiving openings form a single tissue receiving opening, e . g . after deploying suture / fasteners through the tissue bulges .
This enables a simple removal of the elongated partitioner from between the connected tissue bulges once the tissue bulges were connected by the puncturing connection unit and provides a space-ef ficient design of the medical apparatus .
The elongated partitioner may be monolithically formed with the si zing tube . The elongated partitioner may be longitudinally retractable in a proximal direction from an advanced position at least partially separating the two tissue receiving openings to a retracted position in which the two tissue receiving openings are merged to one tissue receiving opening . This allows for a simple removal of the elongated partitioner from amidst the connected tissue bulges .
The elongated partitioner and/or the at least one receiving opening may extend over the maj ority of the si zing tube , in particular more than 80% , in particular more than 90% , of the length of the si zing tube . This allows a reliable formation of tissue bulges along most of a longitudinal length of the si zing tube .
The inner lumen of the si zing tube may have a first terminal opening and a second terminal opening on an opposing side from the first terminal opening, such that the si zing tube may be advanced over a medical instrument , in particular a guidewire , a balloon catheter, an endoscope , and/or an ultrasound device . The medical apparatus may comprise the medical instrument . The terminal openings enable a simple and facilitated position- ing/alignment of the medical instrument within the stomach, e . g . by prior advancing a more intricate medical instrument perorally through the oesophagus into the pylorus .
The medical apparatus may have at least one sealing unit for sealing an outlet from the stomach and/or an inlet into the stomach . The sealing unit may comprise a first sealing element and a second sealing element , preferably formed by a balloon . The first sealing element is adapted for sealing the outlet and the second sealing element is adapted for sealing the inlet .
This allows to seal the inlet and outlet of the stomach, such that locali zed suction can be applied only to the stomach via the vacuum port . Thus , the required pressure for forming the tissue bulges and the necessary suction to move the tissue bulges into the receiving opening ( s ) can be minimi zed . The vacuum port may comprise a perforated barrier which may be adapted to prevent clogging of the vacuum port and/or uni formly distributing a negative pressure of the vacuum port , e . g . along the tissue receiving opening .
The at least one sealing element , in particular the first sealing element for sealing the outlet , may further provide a reference position for the subsequent endoscopic gastric remodelling procedure once deployed to at a sealing position .
Additionally or alternatively, the medical instrument , e . g . a guidewire , catheter, or endoscope , may comprise the sealing unit , in particular the first and second sealing elements . At least one sealing element may be movable along the medical instrument or si zing tube such that the longitudinal position can be adj usted according to the stomach si ze . The sizing tube may be at least partially radially expandable, in particular inflatable, preferably along an entire longitudinal length of the sizing tube. The sizing tube may be sized and shaped to be radially expandable from a first cross-sectional dimension of the sizing tube having a value between 1 mm to 20 mm, in particular 2 mm to 16 mm, preferably 4 mm to 12 mm, to a second cross-sectional dimension having a value between 10 mm - 35 mm, in particular 15 mm - 25 mm, preferably 18 mm - 25 mm.
This enables a facilitated insertion of the sizing tube through the oesophagus and at the same time enables to adjust the cross- sectional dimension of the endoscopic gastric remodelling, such as a diameter of the endosleeve, can be adjusted, e.g. in accordance with the specifics of the surgical intervention, individual characteristics of patients, and/or the indication and clinician's decisions during the intervention.
The sizing tube may be sized and shaped to be uniformly radially expandable, preferably without radially expanding specific sections of the sizing tube to a larger degree.
The sizing tube may further be adapted such that a collapsed configuration is more flexible to facilitate insertion into the stomach and an expanded configuration, in particular radially expanded configuration, is more rigid, and in particular has a bent shape, for facilitating the surgical intervention in the stomach .
The sizing tube may comprise an inflatable section which renders the sizing tube radially expandable, in particular comprising a balloon. A mantle surface of the sizing tube circumferentially around the sizing tube without covering the receiving opening (s) may be expanded, in particular by inflating a flexible membrane of the inflatable section. The flexible membrane of the sizing tube may be adapted to expand in a uniform manner, such that the mantle surface of the sizing tube radially increases to the same extend. Alternatively, the flexible membrane may have an expanded state in which a radial dimension of the mantle surface varies along the length of the sizing tube. A proximal end of the flexible membrane in the expanded state may have a different radial dimension than a distal end. In the expanded state, the mantle surface may define an at least partially conical shape.
This may allow for adapting the stomach remodelling to the specific anatomy / indication of the patient and improve patient outcomes .
A movable puncturing connection unit may at least be partially arranged enclosed and/or neighbouring an inflatable section of the sizing tube. This enables reduced friction, e.g. with stomach tissue, when translationally/rotationally moving the puncturing connection unit, if the inflatable section is inflated to radially expand the sizing tube.
A volume of the sizing tube, or at least the section of the sizing tube adapted for insertion into the stomach may be between 50 ml - 350 ml, in particular 75 ml - 250 ml, preferably 100 ml - 200 ml in a target position.
This allows to perform the endoscopic gastric remodelling procedure on patients to constrain nutrition uptake while enabling safe digestion and assimilation of food.
If the sizing tube is radially expandable, the values of the volume of the sizing tube relates to the sizing tube in the previously described radially expanded state. The puncturing connection unit may be configured to translation- ally move in the longitudinal direction with respect to the si zing tube . This allows a more customi zable connection of the tissue bulges tailored to the indication of the patient .
The puncturing connection unit may comprise at least one puncturing element , an actuation unit for driving the puncturing element , and in particular a translation unit for translationally moving the actuation unit in the longitudinal direction/rota- tional direction . The translation unit may be adapted to interact with a guiding feature for translationally/rotationally moving the puncturing connection unit .
The translational/rotational movement of the puncturing connection unit allows for an optimi zed connection of the tissue bulges according to the anatomy of the patient , in particular in a sequential manner . The actuation unit may be configured for piercing the tissue bulges at pre-defined or user-defined positions which increases the reliability/versatility of the apparatus .
The puncturing connection unit may comprise a plurality of puncturing elements which may be driven by the at least one actuation unit , in particular in a synchroni zed manner, preferably in unison . The puncturing elements may be spaced apart from each other in the longitudinal direction of the si zing tube . The puncturing elements may be circumferentially arranged with respect to the si zing tube and in particular advanceable along a circumferential direction of the si zing tube , optionally without being movable in the longitudinal direction . The puncturing connection unit may be arranged (i) partially or completely within an inner lumen of the sizing tube, in particular partially within the at least one tissue receiving opening, (ii) around a surgical instrument within the sizing tube, (iii) around the sizing tube and/or (iv) around an elongated parti- tioner of the sizing tube formed between to openings, in particular formed between two tissue receiving openings, of the sizing tube .
Arranging the puncturing connection unit according to (i) or (ii) allows for a more compact design of the medical apparatus.
The puncturing connection unit may be longitudinally movably arranged or arrangeable with respect to the sizing tube, in particular slidable along a guiding feature of the sizing tube.
This allows for a simple translational movability of the puncturing connection unit to connect the tissue bulges while suction pressure is applied.
The puncturing connection unit which is arranged within the inner lumen of the sizing tube may be slidable along a guiding feature in the inner lumen, in particular a guiding feature extending in a longitudinal or helical direction along the inner lumen. A helical movement of the puncturing connection unit, in particular of the puncturing element, e.g. a helical needle, may allow for connecting, in particular suturing or deploying fasteners, at predetermined, preferably equidistant, longitudinal distances of the sizing tube through the tissue bulges. The guiding feature may be formed by a helical groove extending along the inner lumen for guiding the helical puncturing element . The puncturing connection unit may be actuatable along the guiding track via a push/pull rod which is configured to be moved longitudinally and/or rotationally .
The medical apparatus , in particular a proximal end of the puncturing connection unit , may comprise a moveable sealing structure which can be moved / changed for partially sealing the receiving opening ( s ) . Thereby, a location and length of the at least one vacuum port may be changed along the longitudinal direction of the si zing tube . The sealing structure may be configured for spatially confining the at least one vacuum port to a customi zable subsection of the receiving opening ( s ) . Additionally or alternatively, a spatial position of a proximal end of the vacuum port may be defined by the sealing structure independently from a distal end of the vacuum port . This allows a vacuum to be applied in a more targeted manner so that a larger suction can be applied at a speci fic confined location, e . g . only at a speci fic connection region for connecting the two tissue bulges .
Arranging the puncturing connection unit according to ( iii ) or ( iv) is particularly desirable , in particular for a design having two-receiving openings separated by the elongated parti- tioner, because the puncturing connection unit can be arranged at a radial more outwards position with respect to the si zing tube . This enables the puncturing connection unit to engage an ideal shape and si ze of tissue bulges at the radially outward position for an optimi zed connection, in particular with a minimum application of suction pressure .
The puncturing connection unit may be arranged such that the puncturing connection unit at least partially circumferentially encloses the si zing tube and/or the elongated partitioner . The apparatus may comprise a plurality of nested tubular elements which are movable with respect to each other without changing the total longitudinal dimension of the tubular elements . The nested tubular elements may extend along the longitudinal direction of the si zing tube , and in particular circumferentially enclose the si zing tube at least partially . The puncturing connection unit may be attached to on one of the tubular elements such that resistive force when moving the puncturing connection unit along the receiving opening ( s ) is reduced .
The si zing tube may have a bent shape or may be deflectable to a bent shape . The bent shape may have an angle between 10 ° - 110 ° , in particular between 20 ° - 100 ° , over an entire or partial longitudinal extension of the si zing tube . The longitudinal extension of the si zing tube may be shaped or deflectable corresponding to the gastric course along the lesser curvature of the stomach .
The bent shape allows the si zing tube to be def lected/de- flectable to conform to the speci fic anatomy of the patient . The si zing tube may be deflected by actuating means of the medical apparatus such as at least one pull wire or push rod . Alternatively, the actuating means may be formed by at least one additional vacuum port which can be aligned with the lesser curvature of the stomach wall such that an applied suction enables the si zing tube to be deflected and/or that the lesser curvature of the stomach wall is suctioned and positionable adj acent to the si zing tube .
The puncturing connection unit may have at least one puncturing element , in particular a curved puncturing element , which is functionally connected or connectable to an implantable connecting structure or forms the connecting structure , in particular to a fastener or a suture . The puncturing connection unit may be adapted for deploying the connecting structure through the tissue bulges by advancing the puncturing element with the connecting structure through the tissue bulges and preferably retracting the puncturing element .
This allows an ef ficient connection between the tissue bulges . In particular, a curved puncturing element provides a curved penetration path and reduces the tension of the connecting structure once it was deployed and allows for a compact design, in particular i f the at least one curved puncturing element is essentially arranged circumferentially or helically to the si zing tube . The puncturing connection unit may be adapted to advance the curved puncturing element in the circumferential or helical direction of the si zing tube .
The puncturing connection unit may comprise at least a first puncturing element having a curved shape with a first diameter and a second puncturing element having a curved shape with a second diameter . The first diameter is di f ferent from the second diameter .
Alternatively or additionally, the puncturing connection unit may have one puncturing element which has two curved puncturing regions that have two di f ferent diameters .
The puncturing connection unit may comprise a plurality of puncturing elements having the same diameter which are arranged for puncturing the tissue in a zig- zag pattern .
This may prevent leakage to a greater extend by enabling punctures through the tissue bulges at di f ferent heights and thus dimensions of the tissue bulges . This allows the puncturing connection unit to connect the tissue bulges at two laterally spaced apart puncturing sites via the puncturing element ( s ) with respect to the si zing tube , e . g . by placing laterally separated sutures / fasteners .
Alternatively, the puncturing element may be arranged parallel to the longitudinal direction of the si zing tube and transla- tionally movable along the longitudinal direction, i f a plurality of bulges is arrangeable along the longitudinal direction of the si zing tube .
The puncturing element may be adapted to release the connecting structure once it was deployed . The connecting structure may be bioresorbable , sel f-dissolving, or soluble . The connecting structure may comprise anchors , such as barbed anchors or helical anchors and in particular a suture .
An ef fective length of the suture of the connecting structure can be increased or decreased, e . g . via a locking mechanism which allows slippage of the suture or loosening the suture .
In this manner the tension or compression of the tissue bulges can be adj ustable . This may allow the anchors to be laced together similar to a corset .
The medical apparatus may comprise at least one fastener, in particular a plurality of fasteners . The fastener, in particular formed by a staple , may be I-shaped or U-shaped and have a first fastening element and a second fastening element which are connected by a connecting element . At least one fastening element may be formed by the puncturing element . The at least one fastening element may be arranged or arrangeable at least partially circumferentially around the puncturing element or within the puncturing element .
The term fastener in this application may be formed by any kind of thread, suture , and/or staple .
These fasteners enable a quicker and more consistent and uni form connection of the tissue bulges and a facilitated ease of use . The puncturing connection unit may be adapted to deploy the I- shaped fasteners such that the deployed fastener has a straight shape . In the straight shape , the first and second fastening elements may be arranged on opposing sides of the two neighbouring tissue bulges .
The puncturing connection unit may be configured to deploy the U-shaped fasteners such that the first and second fastening elements or a plurality of first and second fastening elements are arranged only on one side of the two neighbouring tissue bulges .
The puncturing connection unit may be configured to deploy fasteners formed by staples , in particular essentially U-shaped fasteners , such that the connecting element of the staples is only arranged on one side of the two neighbouring tissue bulges while the fastening elements , e . g . puncturing sections , is at least partially arranged on an opposing side of the neighbouring tissue bulges .
The puncturing element forming the fastener, in particular the staple , may have at least one puncturing section, preferably two puncturing sections . The puncturing section ( s ) may be formed by the fastening element ( s ) . A first and a second puncturing section of a staple may have different longitudinal lengths. The first and/or second puncturing section may have a curved shape. The curved shape of the first and the second puncturing section may have essentially the same curvature and in particular different longitudinal lengths. The puncturing section (s) , and in particular the curvature of the puncturing section (s) , may be arranged and adapted such that the entire puncturing section is uniformly equidistant from a center of rotation of the puncturing connection unit, e.g. located within the vacuum port or within the tissue receiving opening .
The puncturing connection unit may be configured such that the longitudinally shorter puncturing section of the fastener more radially inward with respect to the sizing tube than the longitudinally longer puncturing section of the fastener. Thereby, the reduced thickness of the tissue bulges at a location more radially inward of the sizing tube, e.g. within the receiving opening can be accounted for.
In addition, the length and/or an elasticity of the connecting element between the fasteners may be configured to optimize the strain on the tissue of the stomach wall to provide a sufficiently secure connection without damaging the tissue.
The first fastening element, the second fastening element, and/or the connecting element may be formed monolithically, in particular by a I-shaped or U-shaped wire. This may provide enhanced structural integrity and/or shape retention of the fastener .
The fastening elements may be adapted such that an effective length of the connecting element can be increased or decreased by changing a spacing between the fastening elements, e.g. by moving one fastening element along the connecting element which connects the fastener element and locking the anchor via a locking mechanism . The ef fective length may relate to the length of the connecting element which extends through the tissue bulges .
In a preferred embodiment , the fastening element is arranged/ar- rangeable within an inner lumen of the puncturing element . The puncturing element may have a longitudinal slit extending longitudinally along the puncturing element . The slit may be arranged on a radially outward tangential surface with respect to a curvature of the curved puncturing element . Alternatively, the slit may be arranged on a curvilinear radial flank of the curved puncturing element . The slit may be shaped and si zed such that the connecting element of the fastener can longitudinally move along a longitudinal direction of the slit . The slit may be connected to an inner lumen of the puncturing element and in particular extend up to a terminal end of the puncturing element forming an opening . The inner lumen may be adapted to receive the fastening element which is shaped and si zed to be confined within the inner lumen and cannot cross the slit but may be deployed from the opening at the terminal end .
The puncturing connection unit may have at least one pair of puncturing elements . The puncturing element of a pair may be arranged adj acent each other . In particular, the puncturing elements may extend along the circumferential direction of the si zing tube , preferably parallel to each other . The pair of puncturing elements may have slits which are arranged facing towards each other . The puncturing elements may be arranged distanced from each other such that the connecting element may extend between the puncturing elements when the fastening elements are arranged on or within the puncturing elements . This allows to place I-shaped or U-shaped fasteners with the connecting element having a U-shape in a fast and ef ficient manner .
The puncturing element ( s ) may comprise a fastener deploying member which is adapted to be longitudinally advanced within the inner lumen of the puncturing element ( s ) for pushing/deploying the fastening element ( s ) from the inner lumen once the tissue bulges were pierced and in particular, when the puncturing element is retracted from the tissue bulges . The fastener deploying member may be formed by an actuatable arcuate piston inside the inner lumen .
The puncturing connection unit may have a hydraulic, pneumatic, magnetic, or mechanic actuation unit for actuating the puncturing element , in particular for advancing and retracting the puncturing element through the tissue bulges .
This enables a simple actuation of the puncturing element . In particular a hydraulic actuation unit can be implemented in a simple manner for advancing and in particular retracting the puncturing element by applying a positive and negative pressure .
A mechanic actuation unit may comprise a bi-stable spring toggle which has two resting positions and which is configured to advance and/or retract the puncturing element when changing between the resting positions . The spring toggle may be actuated by a trigger element such as a pull wire and configured such that a force can be applied to a spring mechanism of the spring toggle .
The medical apparatus may comprise a gripping means , in particular formed by the puncturing connection unit , which is config- ured to adj oin the two tissue bulges together prior to connecting the tissue bulges , in particular by engaging the tissue bulges from opposing sides , so that they can be connected by the puncturing connection unit .
This allows to adj oin the tissue bulges with a suf ficient force via the gripping means to facilitate connecting the tissue bulges together . The gripping means may be actuatable by a hydraulic, pneumatic, magnetic, or mechanic actuation unit . In particular, the actuation unit which drives the puncturing element may also drive the gripping means .
The gripping means may comprise two movable parts or a movable part and a non-movable part for gripping the tissue . The movable part may be adapted to be advanced towards and retracted, in particular in a synchroni zed manner with the puncturing element , from the non-movable part of the gripping unit to grip and release the tissue . The gripping means may be synchroni zed to grip the tissue bulges and compress the tissue bulges prior to advancing the puncturing element to facilitate suturing / deployment of fasteners .
The gripping means may comprise a radially collapsible structure which has two arcuate elements which are preferably j oined at their ends or at one of their ends . The radially collapsible structure is collapsible by moving both or one of the ends away from each other or relative to the other end . This allows to apply a radially inwardly directed pressure . The pressure may be uni form on the tissue bulges . The radially collapsible structure may be arranged in a longitudinal direction and/or circumferential direction of the si zing tube and adapted such that the radially collapsible structure may radially engage the tissue bulge ( s ) when it is converted to the collapsed configuration . The gripping means may comprise at least two rollers , in particular cylindrical rollers which are adapted for contacting the tissue bulges and are actuatable to advance the tissue bulges further into the receiving opening ( s ) . The rollers are preferably arranged parallel to the longitudinal axis and/or adapted to radially engage the tissue bulges . This facilitates positioning an ideal thickness of the tissue bulges within the receiving opening ( s ) .
The puncturing connection unit may comprise the gripping means and/or the puncturing element and the gripping means may be actuatable in a synchroni zed manner which allows for a more reliable suturing, e . g . by compressing the tissue bulges prior to piercing them with the puncturing element . This may be achieved by a mechanical coupling element which coupled movement of the gripping means and the puncturing element or a control unit which is configured for controlling the gripping means and puncturing element in a synchroni zed manner .
The gripping means may be configured such that the puncturing element is arranged/arrangeable within the movable/non-movable part of the gripping means , in particular circumferentially enclosed by the movable/non-movable part of the gripping means . This ensures that the puncturing element punctures the tissue bulges at a location which is securely gripped via the movable/non-movable part of the gripping means .
Alternatively, the puncturing connection unit and the gripping means may be actuatable independently from each other .
The medical apparatus may comprise an implantable layer which is pre-loaded or loadable within the inner lumen of the si zing tube . The implantable layer is attachable to the tissue bulges when connecting the two tissue bulges via the puncturing connection unit . The implantable layer may be adapted for confining the two tissue bulges within a partial cross-sectional volume of the inner lumen when suction is applied by the at least one vacuum port , in particular by the implantable layer being connected to two lateral opposing sections of the si zing tube .
The implantable layer may reliably confine the tissue bulges within the partial cross-sectional region of the inner lumen, in particular along the entire length of the receiving opening ( s ) . This arrangement ensures that the tissue bulges cannot be pulled into the at least one vacuum port and potentially clog it . The implantable layer may be adapted such that the tissue bulges are sucked into the receiving opening ( s ) only up to a pre-determined depth . This may allow controlling the thickness of the tissue bulges at which the suture or the fastener is deployed, resulting in better patient outcomes . In addition, the increased shielding of the implantable layer and/or properties of the implantable layer of fer enhanced protection and improved healing, which reduces the criticality of suturing or deploying fasteners through a speci fic tissue bulge thickness .
The implantable layer may comprise or consist of ( i ) a haemostatic component for reducing bleeding, ( ii ) a drug delivery layer which is adapted for enhancing haemostasis and/or reducing scarring, and/or ( iii ) a waterproof layer for rendering a connection region of the two tissue bulges less permeable to fluids . The waterproof layer may be formed by a synthetic and/or a biological material . This implantable layer according to ( i ) - ( iii ) may prevent leakage or wound infection and improve wound healing and protection from contaminants . In addition, the implantable layer allows for di f ferent thicknesses of tissue bulges to be punctured without exhibiting high sensitivity to excessive penetration depth, thus avoiding adverse ef fects of less precise suturing and/or fastener deployment .
In particular, the locali zed drug delivery ( ii ) by the implantable layer may provide a sustained local release of therapeutic agents directly to a puncture site . The implantable layer may further comprise di f f erent/additional of therapeutic agents such as antibiotics , antiseptics , local anaesthetics , anti-inflammatory drugs , or growth factors to improve healing/prevent infection . The implantable layer may comprise or consist of synthetic polymers , such as polyurethanes or polyurethane derivatives , or biological or xenogeneic tissue , such as bovine pericardium, for decreasing fluid permeability of the implantable layer .
An implantable part , in particular the implantable layer and/or at least one implantable staple , of the medical apparatus may be adapted for release of a drug for treating diabetes and/or obesity, and/or enhancing weight management and/or cardiovascular health, in particular Glucagon-like Peptide- 1 ( GLP- 1 ) . The release of the drug may be slow and sustained, such that the drug is released from the medical apparatus for at least the first month, in particular for the first three months , preferably for the first six months after implantation of the implantable part .
This may be achieved by speciali zed surface treatment such as a biodegradable coating, a long-acting hydrogel coating, and/or a drug delivery device adapted for sustained drug release . GLP- 1 may improve the ef ficacy in terms of weight loss and the metabolic profile by enhancing glucose-dependent insulin secretion and suppressing glucagon release .
The medical apparatus for carrying out the endoscopic gastric remodelling may also be used in combination with administration of GLP- 1 prior or subsequent the gastric remodelling procedure to optimi ze long-term sustained weight-loss . In this context , in another aspect of the invention, a system or kit comprising the medical apparatus and GLP- 1 and a method of supplying GLP- 1 prior or subsequent to the use of the medical apparatus is suggested .
The implantable layer may be configured to form a separation member adapted for separating the two tissue bulges from each other along the longitudinal direction of the si zing tube when suction is applied via the suction port . The implantable layer may be detachable from the si zing tube , such that it can remain within the stomach post operatively . This may allow reliable formation of tissue bulges while simultaneously avoiding the problem of removal of the separation member from between the tissue bulges after suturing .
As an alternative to the elongated partitioner, the medical apparatus may have a separation member, in particular having a flexible separation fabric, which is deployable laterally outwardly with respect to the si zing tube extending through one tissue receiving opening of the si zing tube for separating the two tissue bulges from each other along the longitudinal direction when applying suction .
The expansion unit may comprise the separation member for separating the tissue bulges . The expansion unit may be adapted for collapsing and deploying the separation member when being converted between the collapsed and expanded configuration .
The separation member may comprise or consist of a flexible separation fabric . This separation fabric may support the formation of two adj acent tissue bulges .
The separation member of the expansion unit may be attached to the expansion unit in a manner to extend along the receiving opening ( s ) , in particular the entire receiving opening ( s ) , in the longitudinal direction . The separation member may have a proximal and distal end which is attached to the elongated element or the inflatable structure of the expansion unit .
The separation member may be movable in the longitudinal direction along the tissue receiving opening . This may allow for sequentially connecting the tissue bulges at the location of the separation member via the puncturing connection unit .
This allows to locally create the two tissue bulges which are separated by the separation member, e . g . instead of being separated via the elongated partitioner . The separation member which is movable in the longitudinal direction can be easily removed from amidst the two tissue bulges , e . g . from a locali zed sutur- ing/ fastening region, once the tissue bulges were connected with each other . In addition, the separation member may be laterally outwardly deployable at a plurality of longitudinal positions of the tissue receiving opening ( s ) and/or to di f ferent degrees of lateral deployment , such that the position/ thickness of the tissue bulges can be adj usted by a longitudinal position and/or a lateral outward extension of the separation member . This enables reliable separation of the tissue bulges to ensure that at least two tissue bulges are received within the receiving opening ( s ) , in particular that the dorsal tissue wall and the ventral tissue wall are received in one receiving opening, respectively . This may also allow tailored treatments according to speci fic indication or a patient-speci fic anatomy .
The medical apparatus may have an elongated deployment member which is connected or connectable to the separation member and adapted to reversibly deploy the separation member by pivoting the elongated deployment member laterally outwardly . Alternatively, the elongated deployment member may be connected or connectable to the separation member and adapted for reversibly deploying the separation member by longitudinally advancing the elongated deployment member such that a section of the elongated deployment member which is connected to the separation member moves laterally outwardly with respect to the si zing tube .
This allows to easily deploy the separation member while permitting a longitudinal displacement along the receiving opening . In addition, this enables the separation member to prevent entrapment amidst the tissue bulges by being collapsed after deployment .
The separation member may be arranged parallel to the longitudinal direction of the si zing tube . This allows for a simple design of the medical apparatus and deployment within the receiving opening .
The separation member, in particular the flexible separation fabric, may have an essentially triangular shape in a deployed configuration .
The separation member may be connected to the puncturing connection unit such that the separation member and the puncturing connection unit are longitudinally movable in unison or at least in a synchroni zed manner . Alternatively, the separation member may be movable independently from the puncturing connection unit .
The medical apparatus may comprise a robotic system for carrying out the endoscopic gastric remodelling procedure in a partially autonomous manner, in particular in a fully autonomous manner .
This allows a high level of precision and consistency, improved workflow ef ficiency, and reduces the required expertise of a clinician .
The puncturing connection unit may comprise a counter surface . The puncturing connection unit and the counter surface may be adapted for plastically deforming at least one puncturing section, in particular a terminal tip of the puncturing section, of the first and/or second fastening elements of the fastener, in particular the staple . The puncturing connection unit and the counter surface may further be adapted to deform the puncturing section after the puncturing section of the first and/or second fastening element was advanced through the tissue bulges .
Thereby, retraction of the fastening elements can be prevented while simultaneously enabling a reliable deployment through the tissue bulges in combination with a robust connection of the tissue bulges .
The counter surface may have a contour for deforming the puncturing section ( s ) in a pre-defined manner . The counter surface may also be called an anvil element . The counter surface / anvil element may be arranged on a movable or non-movable part of the gripping means which is formed by the puncturing connection unit .
The fastening elements and the connecting element of the fastener, in particular the staple , may be integrally formed . The fastener may comprise or consist of a metal , in particular stainless steel or titanium and/or an absorbable/bioresorbable or dissolvable material .
The puncturing connection unit may comprise a plurality of fasteners formed by staples . The fasteners may be arranged at predefined positions of the puncturing connection unit which are spaced apart from each other essentially equidistantly . The puncturing connection unit may be a single use puncturing connection unit with a plurality of equidistantly prepositioned fasteners .
The puncturing connection unit for deploying the at least one staple may comprise an elongated actuation element , in particular a pull wire or a pushrod, which may be actuatable for deploying the at least one fastener .
The puncturing connection unit may comprise a deployment structure which is configured to be actuatable via the elongated actuation element , in particular the pull wire or the pushrod, for deploying the fastener, in particular a plurality of fasteners , preferably formed by the staple or staples .
The elongated actuation element may be extracorporeally actuatable by a clinician providing a simple actuation mechanism and may thereby provide facilitated force transmission for gastric suturing .
The deployment structure may be at least partially connected or connectable to the elongated actuation element . The deployment structure or parts thereof may be movable via the elongated actuation element to engage at least one fastener, in particular at least one staple , during deployment of the fastener through the tissue bulges .
The deployment structure may comprise a sledge which movable with respect to the at least one fastener, in particular in the longitudinal direction of the si zing tube and/or parallel to the tissue receiving opening . The sledge of the deployment structure may comprise a deployment surface which is configured to deploy the fastener .
The sledge may enhance the deployment of fasteners through the tissue bulges in an ef ficient manner . Furthermore , this design of a sledge is easily scalable , e . g . by moving the sledge such that a plurality of fasteners can be deployed across the tissue receiving opening via the same sledge .
The engagement surface may be adapted to ( i ) engage a proximal section of the fastener, in particular the proximal-most section of the fastener, or ( ii ) a fastener ej ector for deploying the staple through the tissue bulges .
The fastener ej ector may have a receiving section for releasably receiving at least one fastener, in particular at least one staple . The engagement surface may be configured for deploying the at least one fastener in a lateral direction with respect to a direction of movement of the sledge .
The deployment structure may be arranged on the movable and/or non-movable part of the gripping unit , in particular on an opposing side from the contoured surface for plastically deforming the staples .
The deployment structure may be arranged on the gripping means which is formed by the puncturing connection unit . Both the deployment structure and the counter surface / anvil element may be arranged on separate opposing movable and non-movable parts of the gripping means .
A deployment surface of the sledge may a flat , curved, contoured, concave , convex, or profiled in a predefined shape . The deployment surface may be at least partially arranged at an angle between 1 ° and 89 ° with respect to the direction of movement of the sledge , in particular at an angle between 15 ° and 75 ° , preferably between 30 ° and 60 ° .
The sledge may be configured to be converted between a non-con- tact state , a locali zed deployment state , and an alternate locali zed deployment state via the elongated actuation element .
In the non-contact state , the deployment surface of the sledge may not contact the fastener .
In the locali zed deployment state , a first location of the deployment surface of the sledge may contact the fastener and/or the fastener ej ector . In the alternate locali zed deployment state , a second location di f ferent than the first location of the deployment surface of the sledge may contact the fastener and/or the fastener ej ector . The deployment structure and fastener may be arranged and configured such that the fastener and/or the fastener ej ector moves along the first and second location of the deployment surface of the sledge during deployment while contacting the deployment surface .
Alternatively, the deployment surface may be formed by the fastener or fastener ej ector instead of on the sledge . The sledge may contact the fastener or fastener ej ector at a first location of the deployment surface in a first locali zed deployment state and at a second di f ferent location in the second locali zed deployment state .
The deployment structure may comprise a guide channel for guiding the movement of the sledge to the at least one fastener and/or fastener ej ector, in particular to a plurality of fasteners and/or fastener ej ectors , for the deployment of the fasteners .
The puncturing connection unit may comprise a plurality of fasteners which are arranged in at least one row, in particular in at least two or three rows which are parallel to each other . The row ( s ) of fasteners may be arranged or arrangeable along the tissue receiving opening adj acent the tissue bulges .
The fasteners of di f ferent rows may be arranged of fset with respect to each other, preferably in an alternating zig- zag pattern, in particular an alternating zig- zag pattern along the direction of movement of the sledge . The guide channel may have slits extending at an angle , in particular at least partially laterally away from a longitudinal direction of the guide channel , in particular towards the tissue receiving opening . The fastener ej ectors may be arranged at least partially within the slits in a movable manner . The deployment structure may be adapted such that moving the sledge along the guide channel moves the fastener ej ectors along the slits to deploy the fasteners . The slits may not terminate prior to the tissue receiving opening such that the fastener ej ectors may be maintained within the si zing tube after success ful radial deployment of the fastener ( s ) . To securely arrange the fasteners within the guide channel the fastener ej ectors may have an at least partially T-shaped cross-section which has a larger dimension than the slit .
An ej ection section of the fastener ej ector, in particular of a plurality of fasteners , may be partially or completely arranged within the direction of movement of the sledge , e . g . within a guide channel of the sledge . A fastener engagement section of the fastener ej ector which is connected to the ej ection section may be partially or completely arranged radially extending from the direction of movement of the sledge , e . g . from the guide channel . The fastener engagement section radially extending from the direction of movement may be essentially parallel to an engagement surface for engaging the tissue bulge . The fastener engagement sections of the fastener ej ectors may be alternatingly arranged extending in at least two di f ferent radial directions , in particular opposing radial directions , with respect to the direction of movement of the sledge .
A first longitudinal subsection of the si zing tube is configured to be arranged partially overlapping, in particular parallel , to a second longitudinal subsection of the si zing tube within the stomach by forming a loop, e . g . by having a pivotable or deflectable section connecting the longitudinal subsections . The first and second subsection may be connectable with each other, e . g . by magnetic connecting elements of the si zing tube , by the vacuum port applying suction, or by deflecting the pivotable or deflectable longitudinal subsection in predefined manner .
These longitudinal subsections provide a compact si zing tube for insertion through the esophagus into the stomach of a patient but simultaneously enable that a larger ef fective cross-sectional area can be achieved by arranging the longitudinal subsections next to each other in the stomach, e . g . in a parallel manner .
The puncturing connection unit may be arranged within the first and/or the second longitudinal subsection of the si zing tube , preferably such that the counter surface / anvil element is located within one longitudinal subsection, and the deployment structure is located within the other longitudinal subsection . The tissue receiving opening for receiving the tissue bulges upon application of suction may be arranged in the first and/or the second longitudinal subsection of the si zing tube , preferably only the second longitudinal subsection . One of the longitudinal subsections may comprise a plurality of tissue receiving opening, in particular arranged on opposing sides of the longitudinal subsection of the si zing tube .
The puncturing connection unit and the longitudinal subsections of the si zing tube may be si zed and shaped such that the puncturing connection unit at least partially arranged in one longitudinal subsection is adapted for deploying fasteners through the tissue bulges in the other longitudinal subsection . The si zing tube may comprise a plurality of articulated segments which are spaced apart from each other in the longitudinal direction of the si zing tube and connected via hinges between the rigid articulated segments . The si zing tube may be reversibly adaptable between a flexible state and a sti f f state . In the flexible state , neighboring rigid articulated segments are rotatably movable in at least in two-dimensions with respect to each other . In the sti f f state , the neighboring rigid articulated segments are non-movable with respect to each other, and in particular have a predefined shape .
This may simpli fy insertion of the si zing tube into the stomach perorally through the esophagus while enabling reliable sti f f state of the si zing tube in the stomach .
The rigid articulated segments may have at least one chamfered surface on at least one of their ends which enable the rotatable movement of the rigid articulated segments with respect to each other and/or facilitate forming the predefined shape .
The si zing tube may be changeable between the flexible and sti f f state by actuating an elongated actuation element of the si zing tube such as a pull wire . The elongated actuation element may be guided through the rigid articulated segments and connected to a distal-most rigid articulated segment such that a compressional tensioning force may be applied which longitudinally presses the rigid articulated segments together, in particular to assume the predefined shape . For this purpose , the elongated actuation element may be arranged in a low friction channel of the si zing tube leading through the rigid articulated segments . The predefined shape may be a straight shape or a curved shape , in particular a curved shape conforming to the lower curvature of the stomach . The predefined shape may be defined via a plurality of correspondingly formed neighboring contacting surfaces of the rigid articulated segments .
The predefined shape may be a previously described loop forming shape between two longitudinal subsections of the si zing tube .
Another aspect of the invention relates to a method for carrying out an endoscopic gastric remodelling procedure using a medical apparatus , in particular a previously describe medical apparatus . The method comprises the steps of ( i ) inserting a si zing tube of the medical apparatus perorally across the oesophagus into the stomach of a patient . The method optionally comprises ( ii ) sealing an outlet and/or an inlet of the stomach using a sealing unit of the medical apparatus and/or ( iii ) laterally outwardly deploying a separation member through a tissue receiving opening of the si zing tube by pivoting or longitudinally advancing an elongated deployment member . Additionally or alternatively, the method may comprise converting the expansion unit of the medical apparatus for spreading the stomach from a collapsed configuration to an expanded configuration . The method further comprises applying suction via at least one vacuum port of the si zing tube to form two tissue bulges of the stomach tissue . The method optionally comprises moving a puncturing connection unit of the medical apparatus in the longitudinal direction with respect to the si zing tube . The method comprises connecting the two tissue bulges with each other by puncturing the tissue bulges . When inserting the si zing tube , the si zing tube may be guided by a medical instrument , in particular an endoscope or a balloon catheter .
Sealing the outlet and/or the inlet of the stomach using the sealing unit may be carried out by arranging the sealing unit at least partially in the outlet and/or the inlet and at least partially inflating the sealing unit .
The si zing tube may be radially expanded after the insertion, in particular by inflating the si zing tube , to increase a cross- sectional dimension of the si zing tube .
A position and/or orientation of the si zing tube in the stomach may be adj usted using articulated segments which form a longitudinal subsection of the medical apparatus , e . g . a medical delivery device , and are connected to the si zing tube . The position and/or orientation of the si zing tube may be adj ustable towards the greater curvature of the stomach with respect to a position and/or orientation of residual components of the medical apparatus .
Another aspect of the invention relates to a puncturing connection unit for connecting two tissue bulges , in particular two tissue bulges of stomach tissue . The puncturing connection unit comprises a pusher element and a pusher path, in particular a circular or elliptical pusher path, along which the pusher element is movable and which includes a tissue receiving gap for receiving the tissue bulges . The puncturing connection unit comprises a puncturing element coupled to the pusher element and a deployment unit which is adapted to deploy a suture and/or a fastener from the puncturing element , and at least one actuating element , in particular a pull wire , which is functionally connected to the pusher element and/or the puncturing element . The at least one actuating element is actuatable to move the pusher element along the pusher path at least partially through the tissue bulges for deploying the suture and/or the fastener and retract the pusher element from the tissue bulges in an opposing direction .
This enables a simpli fied actuation of the puncturing connection unit to advance and retract the puncturing element across the tissue bulges in a reliable manner .
The pusher element and the puncturing element may be immovably connected with respect to each other . The pusher element and the puncturing element may be monolithically formed .
This allows the pusher element and the puncturing element to be advanced/retracted along the pusher path in unison . The at least one actuating element may be attached to the pusher element , in particular in such a manner that the at least one actuating element can move the pusher element and the puncturing element in opposing directions .
The actuating element , in particular a pull wire , may be crimped/connected to the pusher element in such a manner that retracting di f ferent ends of the pull wire moves the pusher element and the puncturing element in opposing directions along the pusher path . Alternatively, a plurality of pull wires may be crimped/connected to the pusher element such that retraction of a first pull wire moves the pusher element and the puncturing element in an opposite direction than the retraction of a second pull wire . The at least one actuating element may be adapted such that , irrespective of a position of the pusher element in the pusher path, the same longitudinal length of the at least one actuating element extends along the pusher path other than the tissue receiving gap . The puncturing element and/or the pusher element may be formed complementary to each other, in particular in a non-rotatable manner around a longitudinal axis of the puncturing element/pusher element , such that the pusher element and puncture element can be reliably guided along the pusher path .
The pusher element and the puncturing element may have dimensions which are suf ficient such that the puncturing element can be longitudinally advanced across the tissue receiving gap, in particular completely across the tissue receiving gap, while the pusher element remains at least partially within a part of the pusher path other than the tissue receiving gap .
This enables to reliably guide the puncturing element across the tissue receiving gap for connecting the two tissue bulges while the pusher element increases positioning stability by interacting with a housing of the puncturing connection unit . The housing may define the pusher path other than the tissue receiving gap .
The housing may have a ring-like shape which is preferably only interrupted by the tissue receiving gap .
The puncturing connection unit may be adapted such that the pusher element remains at least to 90% , in particular 75% , preferably 65% , of its longitudinal length within the housing during a regular operation mode of the puncturing connection unit . At least one connection position of the pusher element for connecting the at least one actuating element may always remain within the housing . The connection position may be arranged on an end of the puncturing element facing the pusher element or on an end of the pusher element facing the puncturing element . This enables reliable actuation and minimi zes the risk that puncturing the tissue bulges af fects the actuation of the at least one actuating element .
The puncturing connection unit , in particular the housing, may have at least one opening which is arranged adj acent to the tissue receiving gap for receiving the at least one actuating element . The at least one opening may be arranged perpendicular with respect to the pusher path, preferably perpendicular with respect to a plane of the pusher path .
The opening for receiving the actuating element enables reliable actuation of the actuating element to advance/retract the pusher element to a puncturing position, e . g . by a pull wire being pulled . The connection position of the pull wire to the pusher element may be arrangeable adj acent to the opening adj acent the tissue receiving gap . This enables advancing the puncturing element through the tissue bulges in a simple manner in a suturing position of the puncturing element .
Arranging the at least one opening perpendicular to the pusher path enables reliable actuation of the puncturing connection unit . In particular, a plurality of puncturing connection units of a medical apparatus may be arranged in series longitudinally spaced apart from each other and may be actuated by a linear actuator array formed by a plurality of actuating elements . The puncturing connection unit may comprise at least two openings for receiving separate actuating elements of the at least one actuating element or di f ferent ends of only one of the at least one actuating element . The openings may both be arranged adj acent to the tissue receiving gap within the housing, in particular parallel to the pusher path .
The deployment unit may comprise a deployment element which is adapted to deploy the fastener from the puncturing element once the puncturing element was advanced across the tissue receiving gap . The deployment unit may comprise a biasing element which is coupled to the deployment element and adapted to be biased when deploying the fastener .
This provides a simple and robust mechanism of deploying the fastener once the puncturing element has punctured the tissue bulges in the puncturing position . The biasing element may provide a resetting force once the fastener was deployed such that the deployment element may be automatically reset once the fastener was deployed .
The biasing element may be functionally connected to the pusher element , in particular an end of the pusher element facing the deployment element , and the deployment element , in particular an end of the deployment element facing the pusher element . The biasing element may be adapted to be biased in a deployment position in which the pusher element and the deployment element are closer together than in a resetting position in which the pusher element and the deployment element are further apart and the biasing element is in an unloaded state . The biasing element may be formed by a spring . The deployment unit , in particular the deployment element , may be adapted to be inserted into a lumen of the hollow puncturing element and the pusher element to deploy the fastener . The deployment element may be actuatable via a deployment actuating element , in particular while overcoming a resetting biasing force of the biasing element .
This enables a precise deployment of the fastener, which may be placed within the puncturing element , in particular a cannula, once the tissue bulges were pierced .
The deployment unit may be adapted to be movable along the pusher path via the deployment actuating element . The biasing element may be at least partially arranged around the deployment element . The deployment unit may comprise a counter surface for receiving the biasing element in such a manner that the biasing element is biased when deploying the fastener and inserting the deployment element into the puncturing element and the pusher element .
In an alternative embodiment , the actuating element for moving the pusher element may be also adapted to move the deployment element in such a manner that the resetting biasing force of the biasing element is only overcome once the puncturing element was advanced across the tissue bulges . This may provide a simpler actuation mechanism of the puncturing connection unit without requiring a separate deployment actuating element . Instead, the actuating element for driving the movement of the puncturing element and pusher element may drive the deployment element . For this reason, this actuation element may be connected to the deployment element . Another aspect of the invention relates to a medical system comprising the previously described medical apparatus and the previously described puncturing connection unit .
Another aspect of the invention relates to a medical system comprising a plurality of the previously described puncturing connection units arranged along a si zing tube in series . The si zing tube of the medical system may have a tissue receiving opening arranged in such a manner, that the tissue receiving gaps of the puncturing connection units are aligned with the tissue receiving opening such that tissue bulges received within the tissue receiving opening may be sutured at a plurality of longitudinally spaced apart positions by actuation of a plurality of actuating elements .
Another aspect of the invention relates to a puncturing connection unit for connecting two tissue bulges , in particular two tissue bulges of stomach tissue . The puncturing connection unit comprises at least one puncturing connection module which has a body and a first and a second elastically biased appendage which extend away from the body in a radial direction . The puncturing connection unit has a puncturing element which is arranged on the first biased appendage and directed towards a puncture section of the second biased appendage . The puncturing connection unit has an actuating mechanism, in particular comprising a pull wire . The puncturing connection unit is convertible between an open state and a closed state via the actuating mechanism . In the open state the first and second appendage are spaced apart from each other such that the tissue bulges may be received between the biased appendages . In the closed state the biased appendages are closed by an elastic deformation such that the bi- ased appendages engage the tissue bulges and the puncturing element is advanced across the tissue bulges towards the puncture section for deploying a suture and/or a fastener .
This puncturing connection unit enhances reliability and patient safety by providing accurate punctures with a reduced risk of component misalignment . In particular, the puncturing connection unit provides optimi zed positioning and reliability by reducing the movable parts , such as a separate actuation of a movable puncturing element or pivotable arms .
The body, the biased appendages and/or the puncturing element may be monolithically formed . This further reduced the complexity of the puncturing connection unit and risk of technical defects .
The biased appendage , in particular both biased appendages , may be biased towards the open state by a biasing section of the biased appendage , in particular formed by a resilient member, preferably integrally formed by a longitudinal subsection of the biased appendage .
This provides increased material strength and durability while avoiding j oints or seams and thereby rendering the puncturing connection unit more robust . The biased section may be adapted to achieve the elastic deformation when converting the puncturing connection unit to the closed state .
The puncture section of the second biased appendage may be formed by a puncture recess or a puncture opening .
This enables the puncturing element to be advanced across the puncture section such that deploying the suture/the fastener on a perforation ori fice of the tissue bulges once the tissue bulges were punctured .
The actuating mechanism may comprise the pull wire and a pulley assembly . The pulley assembly comprises at least one wire redirector wheel , in particular two wire redirector wheels . A first wire redirector wheel in the body may be adapted for redirecting the pull wire towards one of the biased appendages and a second redirector wheel may be adapted for redirecting the pull wire towards the other biased appendage to which the pull wire is connected .
The pulley assembly may provide an optimi zed force transmission and force distribution in the pull wire while redirecting the pull wire for converting the biased appendages between the open and closed state .
The puncturing connection unit may comprise a plurality of puncturing connection modules which are connected to each other along a longitudinal direction of the puncturing connection unit , in particular by pivotable connectors .
This enables the puncturing connection unit to connect the tissue bulges at a plurality of longitudinally spaced apart positions of the puncturing connection unit . Pivotable connectors for connecting the puncturing connection modules further enable suf ficient deformability of the puncturing connection modules with respect to each other such that a peroral insertion of the puncturing connection unit into the stomach is facilitated . Another aspect of the invention relates to a gripping unit for gripping two tissue bulges of the stomach in a gastric remodelling procedure . The gripping unit comprises a substantially ring-shaped body at least partially surrounding a lumen and two gripping elements for gripping the tissue bulges . The gripping unit is reversibly convertible between a contracted state and an expanded state . The gripping elements of the gripping unit in the contracted state are essentially aligned with the ring-like shaped body . The gripping unit in the expanded state is adapted to grip the tissue bulges from two opposing sides with gripping sections of the gripping elements at a gripping site positioned radially outside the ring-shaped body .
This expandable gripping unit enables a reduced radial dimension of the gripping unit which allows a simpler, less painful , and safer navigation though the anatomy of the patient , in particular through the oesophagus . At the same time the expanded state enables to increase the radial dimension of the gripping unit in the stomach such that a greater volume of stomach can be displaced which may enhance ef ficacy of the gastric remodelling procedure or enable clinicians to carry out optimi zed gastric remodelling procedures . This gripping unit may further ensure that the sutures/ fasteners are placed within the gastric tissue bulges at a suf ficient depth to pass through the serosa . The gripping unit may be adapted to such that the gripping unit in the expanded state has a maximum dimension of at least 10 mm such that stomach tissue enclosing the gripping unit , e . g . by applying suction via a suction port of a previously described si zing tube , forms a gastric sleeve with a correspondingly diameter of at least 10 mm around the gripping unit .
The gripping unit may comprise a mechanical linkage system for each gripping element which comprises at least two articulated arms respectively, which are connected to the ring-shaped body and the gripping elements via hinges at di f ferent connecting positions , in particular comprising connecting positions at oppo- site ends of the gripping element . The hinges and the articulated arms are adapted to successively pivot gripping sections of the gripping elements away from each other and towards each other while converting the gripping unit from the contracted state to the expanded state .
This enables that the tissue bulges are gripped only at the gripping site and that the gripping elements are not blocked by the tissue bulges when converting from the contracted state to the expanded state . This mechanical linkage system further enables a tuneable distance between the gripping sections of the gripping elements and/or a tuneable opening angle formed by the gripping sections . The tunability of the opening angle may be particularly advantageous prior to applying suction to capture both a ventral tissue bulge and a dorsal tissue bulge in the receiving opening of a si zing tube in a more controlled and reliable manner .
The mechanical linkage systems may form two symmetrical antiparallelogram 4-bar linkages via the four articulated arms and hinges .
The articulated arms and/or the gripping elements may have an at least partially circular shape . This may enhance the alignment of the articulated arms and/or the gripping elements with the ring-shaped body .
The articulated arms may have a longitudinal length of less than 50% , in particular less than 40% , of the radial cross-sectional dimension of the gripping unit in the contracted state . This may allow for a suf ficient radial increase in radial dimension of the gripping unit in the expanded state while not traversing too much of the lumen during conversion to the expanded state .
The gripping unit may be si zed and shaped such that the lumen of the gripping unit is not or only partially obstructed by the gripping elements when converting the gripping unit between the contracted and the expanded state .
Not obstructing the lumen enables to supply suf ficient suction via a suction port to receive tissue bulges , e . g . by using a previously described si zing tube . Not obstructing the lumen may further allow using the gripping unit in combination with a medical instrument within the lumen, such as an endoscope . Furthermore , gripped tissue bulges can be received within the lumen without obstructing/preventing the conversion of the gripping unit between the contracted and the expanded state .
The gripping unit may comprise at least one actuating element , in particular a pull wire , which is actuatable to convert the gripping unit between the contracted and the expanded state .
This may allow for a facilitated conversion of the gripping unit between the contracted and the expanded state . The actuating elements may be configured to be extracorporeally actuatable , in particular manually by a clinician .
The gripping unit may comprise at least two actuating elements , in particular four actuating elements , which are coupled to the articulated arms and/or the gripping elements , respectively . A first actuating element or an end of the actuating element may be adapted to convert the mechanical linkage system to the expanded state upon actuation . A second actuating element or another end of the actuating element may be adapted to convert the mechanical linkage system to the contracted state .
The gripping unit may have a maximum radial dimension of less than 12 mm, in particular less than 10 mm, preferably less than 9 mm, in the contracted state and more than 17 . 4 mm, in particular more than 14 . 5 mm, preferably more than 13 mm, in the expanded state .
This enables simple peroral insertion of the gripping unit into the stomach through the oesophagus which typically has a diameter of approximately 2 cm . The increased maximum radial dimension in the expanded state further enables to ensure that the gripping unit can grip larger tissue bulges to ensure that sutures/ fasteners in the tissue bulges can be placed at a suf ficient depth, e . g . though the serosa .
The gripping unit may be adapted to have a maximum radial dimension in the expanded state of at least 130% , in particular at least 140% , preferably at least 150% of the maximum radial dimension of the gripping unit in the contracted state .
The gripping unit may be configured such that the maximum radial dimension in the expanded state extends at in a direction from its longitudinal axis to the gripping site . This ensures that larger tissue bulges can be gripped, e . g . for placing sutures/ fasteners at suf ficient depths .
The gripping unit may comprise a puncturing connection unit for connecting the tissue bulges which is coupled to the at least one gripping element such that a suture and/or a fastener is deployable via the puncturing connection unit through the tissue bulges at or adj acent to the gripping site .
This enables connecting the tissue bulges in proximity to the gripping site such that the suture/ fastener can be placed radially outside the ring-shaped body of the gripping unit at a sufficient depth .
The puncturing connection unit may at least partially extend through the at least one gripping element such that the suture/ fastener is deployable across the tissue bulges at the gripping site between the gripping sections .
The puncturing connection unit may have at least one puncturing element which is adapted to be advanced across the tissue bulges by translationally, in particular extracorporeally, moving the puncturing element or an actuating element , in particular a push-rod, coupled to the puncturing element to advance the puncturing element across the tissue bulges at the gripping site .
This provides a simple and reliable mechanism to deploy the suture/ fastener through the tissue bulges . The puncturing element or the actuating element may be designed to be elastically deformable to adapt its shape for peroral navigation through the oesophagus into the stomach . The puncturing connection unit may comprise a sheath, in particular forming a low friction channel , for guiding the puncturing element or actuating element through the oesophagus to the gripping elements in the stomach . The puncturing connection unit may be manually operable by a clinician . The puncturing connection unit may be adapted to deploy a previously described fastener, in particular a previously described I-shaped or U-shaped fastener, e . g . arranged around or within the puncturing element .
Another aspect of the invention relates to a system comprising the si zing tube , in particular a previously described si zing tube and a previously described gripping unit . The ring-shaped body, and in particular the gripping elements and/or the articulated arms , may at least partially form an outer mantle surface of the si zing tube in the contracted state .
In addition, to previously described advantages , this provides a smaller and compact design of the system comprising the gripping unit which is less invasive and safer for traversing the anatomy of the patient .
A maj ority of the puncturing connection unit , in particular the sheath for guiding the puncturing element or actuating element , may be partially, in particular completely, arranged within the si zing tube and/or a delivery device for delivering the si zing tube .
Further embodiments of the invention and improvement of the described embodiments will become apparent with the following nonlimiting description of the embodiments .
The invention is now described with reference to certain embodiments and figures which show :
Figures 1A - IE : a longitudinal cross-sectional view of a medical apparatus being inserted into the stomach, sealing the stomach, suturing the stomach, and being removed from the stomach,
Figures 2A and 2B : a perspective view of a medical apparatus which is inserted into a gastric model and applying suction to form two tissue bulges which are received in two tissue receiving openings of a si zing tube ,
Figures 3A and 3B : a longitudinal cross-sectional view of a si zing tube which is inserted in a collapsed configuration through the oesophagus into the stomach and transitioning to an expanded configuration,
Figures 4A and 4B : a perspective side view of two embodiments of the si zing tube of the medical apparatus which have an elongated partitioner with two j oined ends and one j oined end and one free end, respectively,
Figures 5A and 5B : a perspective view of an embodiment of the si zing tube which has an elongated partitioner which has a plurality of separated longitudinal subsections and a separable j oined end,
Figures 6A to 6D : a cross-sectional and perspective view of an embodiment of the si zing tube which has an implantable layer which is arranged within an inner lumen of the si zing tube which is connectable to tissue bulges in parallel with connecting the tissue bulges ,
Figures 6E and 6F : a perspective view of the connected tissue bulges and the stomach having a connected dorsal and ventral wall after carrying out the steps described in Figs . 6C and 6D,
Figures 7A - 7D : a perspective side view of a first embodiment of a separation member of the medical apparatus which is laterally outwardly deployed by advancing an elongated deployment member in a longitudinal direction of the medical apparatus , Figures 7E - 7H : a perspective side view of a second embodiment of a separation member of the medical apparatus which is laterally outwardly deployed by advancing an elongated deployment member in a longitudinal direction of the medical apparatus ,
Figures 71 - 7K : a perspective side view of a third embodiment of a separation member and a si zing tube of the medical apparatus which is laterally outwardly deployed by pivoting a deployment member laterally outwardly,
Figures 7L and 7M : a perspective side view of a fourth embodiment of a separation member which is laterally outwardly deployable by a deployment member,
Figures 8A to 8D : a perspective view and a cross-sectional view of two embodiments of a si zing tube and a puncturing connection unit of the medical apparatus ,
Figures 9A and 9B : a perspective view of a puncturing element and a fastener of the medical apparatus ,
Figures 9C and 9D : a partially cut away perspective view of a puncturing connection unit having a gripping means and a fastener arranged around the puncturing element and within the puncturing element , respectively,
Figure 9E : a perspective view of an alternative embodiment of the puncturing element which has a predetermined fracture or deployment section,
Figure 9F : an exploded perspective side view of a puncturing connection unit ,
Figures 10A and 10B : a perspective view of a puncturing element having an inner lumen for receiving a fastener element , a longitudinal slit extending along the inner lumen, and a fastener deployment member,
Figures I OC and 10D : a perspective view and cross-sectional view of the deployed fastener through the tissue bulges without and with an implantable layer of Figs . 6A - 6F, Figure 10E : a perspective side view of a medical apparatus which has a puncturing connection unit which is translationally movable along a longitudinal direction of a si zing tube , Figures 11A - 11 F : a cross-sectional view and a perspective view of a di f ferent embodiment of the si zing tube having a guiding feature in an inner lumen,
Figures 12A - 12D : a perspective view of an embodiment of a puncturing connection unit which has longitudinally movable articulated segments which are movable relative to each other in a longitudinal direction of the si zing tube ,
Figures 12E and 12 F : a schematic view of a si zing tube which is adapted to alternatingly arrange the dorsal and ventral tissue bulges along a longitudinal direction and a puncturing connection unit comprising helical articulated segments ,
Figures 12G - 12 J : a schematic representation of di f ferent mechanic actuation units for actuating the puncturing connection unit ,
Figure 13A: a perspective side view of a si zing tube of the medical apparatus which was inserted into stomach tissue and which applies suction to form dorsal and ventral tissue bulges ,
Figures 13B and 13C : a perspective side view of a si zing tube of the medical apparatus which has an expansion unit for spreading the stomach in a collapsed and expanded configuration, respectively,
Figures 13D - 13G : a perspective side view of a si zing tube of the medical apparatus which has an expansion unit which was inserted into the stomach and is controlled in a synchroni zed manner with a fluid supply and/or suction via a vacuum port ,
Figures 14A and 14B : a perspective top and side view of a si zing tube of the medical apparatus which has a perforated bar- rier , Figure 14C: a perspective side view of a sizing tube of the medical apparatus comprising an expansion unit which has a separation fabric,
Figures 15A - 15D: a cross-sectional view of different embodiments of the sizing tube having circumferentially differently positioned and dimensioned longitudinal tissue receiving openings,
Figures 16A and 16B: a perspective view of a plurality of pairs and a pair of puncturing elements with longitudinal slits facing towards each other, respectively,
Figures 16C and 16D: a schematic representation of an alternative embodiment of a fastener,
Figures 16E and 16F: perspective views of two tissue bulges which were connected by a plurality of fasteners deployed via puncturing elements of Figs. 16A and 16B,
Figure 16G: a perspective view of a plurality of puncturing elements with different diameters puncturing two tissue bulges, Figure 16H: a perspective view of two tissue bulges which were connected by a plurality of fasteners deployed via the puncturing elements of Fig. 16G in a zig-zag pattern,
Figures 17A and 17B: a schematic view of an embodiment of a gripping means for gripping the tissue bulges via a radially collapsible structure,
Figure 17C: a schematic view of a different embodiment of a gripping means for gripping the tissue bulges via two actuatable rollers,
Figures 18A and 18B: a perspective side view of an embodiment of the sizing tube of the medical apparatus,
Figures 19A - 19C: a side view and two perspective views of different embodiments of a perforated barrier of a sizing tube, Figures 20A - 20D: a schematic representation of different embodiments of a medical apparatus which comprises a sizing tube that is movable by an articulated segment ( s ) of the medical apparatus ,
Figures 21A and 21B : a semi-opaque perspective view of two embodiments of the medical apparatus having a si zing tube with a helical guiding feature and a longitudinal guiding feature , respectively,
Figures 22A and 22B : a semi-opaque perspective view of an embodiment of a puncturing connection unit comprising a ringshaped housing, a puncturing element , and a pusher element ,
Figures 23A and 23B : a semi-opaque perspective view of a di f ferent embodiment of a puncturing connection unit comprising a ring-shaped housing, a puncturing element , and a pusher element ,
Figures 24A and 24B : a perspective view of a deployment unit without and with the puncturing element and the pusher element adapted to deploy a suture/a fastener from the puncturing element ,
Figures 25 : a semi-opaque top view of a puncturing element , a biasing element , and a deployment element of the puncturing connection unit ,
Figures 26A to 26C : perspective views and a longitudinal axial view of a di f ferent embodiment of a puncturing connection unit ,
Figures 27A to 27D : a longitudinal axial view of an exemplary embodiment of a gripping unit being converted from a contracted state to an expanded state ,
Figures 28A to 28D : a longitudinal axial view of an embodiment of the gripping unit being converted from a contracted to an expanded state ,
Figures 29A and 29B : a longitudinal axial view of the embodiment of the gripping unit of Figs . 28A - 28D in the expanded state gripping and connecting two tissue bulges , Figures 30A and 30B : a perspective view of an embodiment of the gripping unit with a puncturing connection unit ,
Figure 31A: a schematic cross-sectional view of an embodiment of the puncturing connection unit for deploying a straight staple through the tissue bulges ,
Figure 31B : a schematic cross-sectional view of an embodiment of the puncturing connection unit for deploying curved staples through the tissue bulges ,
Figures 31C and 31D : a top view of a surface for deploying staples of two embodiments of the puncturing connection unit arranged on a movable / non-movable part of the gripping unit which are arranged in two and three rows in an alternating zig- zag pattern, respectively,
Figures 31E and 31 F : a schematic side view of an embodiment of a staple having two curved puncturing sections which are plastically deformed by a counter surface of the puncturing connection unit ,
Figures 32A, 32B and 32C : two embodiments of a deployment structure of the puncturing connection unit having a sledge which is movable for deploying a plurality of fasteners formed by staples ,
Figures 33A and 33B : a cross-sectional and perspective view of an embodiment of the si zing tube having two actuated rings driving the puncturing connection unit ,
Figures 34A and 34B : a schematic perspective view and cross-sectional view of an embodiment of the si zing tube having overlapping longitudinal subsections ,
Figures 35A - 35C : an exemplary embodiment of the si zing tube having a plurality of rigid articulated segments connected via hinges being inserted through the esophagus in a flexible state and converted into a sti f f state . The figures 1A - IE show a longitudinal cross-sectional view of a medical apparatus 101 being inserted into the stomach of a patient , sealing the stomach, suturing the stomach, and being removed from the stomach .
Figure 1A shows that a medical instrument 201 comprising an endoscope 202 or guidewire is introduced through the oesophagus sphincter which forms an inlet 194 of the stomach along a lesser curvature 195 of the stomach tissue 19 up to the pyloric sphincter which forms an outlet 193 of the stomach . The medical instrument 201 has a sealing unit 5 which comprises a first sealing element 51 formed by an expandable balloon which is used for sealing the outlet 193 of the stomach by inflating the first sealing element 51 .
Figure IB shows that a si zing tube 2 of the medical apparatus 101 is advanced over the medical instrument 201 into the stomach such that the si zing tube 2 extends along the lesser curvature 195 of the stomach tissue 19 between the pylorus and duodenum . The si zing tube 2 has a proximal and distal terminal opening 26 , 25 such that it is advanceable over the medical instrument 201 .
Figure 1C shows that a second sealing element 52 of the sealing unit 5 formed by a balloon is advanced over the medical instrument 201 and inflated for sealing the inlet 194 of the stomach . Subsequently, a suction is applied by at least one vacuum port (not shown in Figs . 1A - IE ) of the si zing tube 2 indicated by the arrows in Fig . 1C . Based on the sealing of the stomach by the sealing unit 5 , the suction is confined to the stomach volume . The applied suction enables a formation of tissue bulges of the dorsal stomach wall and the ventral stomach wall of the stomach tissue 19 which enter the si zing tube 2 through at least one receiving opening . Figure ID shows that a puncturing connection unit (not shown in Fig . ID) of the medical apparatus 101 is used for suturing the two tissue bulges together by deploying a plurality of sutures 33 or fasteners . The sutures create a tube formed by native stomach tissue 19 along the lesser curvature 195 of the stomach which decreases the stomach ' s volume to a value between 100 - 200 ml , i . e . reducing the stomach ' s volume to about 15 - 20% in comparison to its original volume .
Figure IE shows that the medical apparatus 101 was removed from the stomach without leaving any implants other than the sutures 33 or fasteners such that an endosleeve of essentially circular cross-section is formed extending between the oesophagus and the pylorus .
Figures 2A and 2B show a perspective view of a medical apparatus 101 which is inserted into a gastric model 203 of a stomach and applying suction to form two tissue bulges which are received in two tissue receiving openings 23 , 24 of a si zing tube 2 . A vacuum port of the si zing tube 2 for applying suction is connected to an extracorporeally arrangeable def lation/ inf lation pump via a supply line 221 . The gastric model 203 has a lesser curvature 195 along which the si zing tube 2 is positioned in Fig . 2B and a greater curvature 196 . Figure 2B shows that the dorsal and ventral wall of the gastric model 203 are received in two separate receiving openings such that they can connected via a puncture connection unit .
Figures 3A and 3B show a longitudinal cross-sectional view of a si zing tube 2 of a medical apparatus 101 which is inserted in a collapsed configuration through the oesophagus into the stomach adj acent a lesser curvature 195 of the stomach and transitioning to an expanded configuration . The si zing tube 2 is radially expandable along its entire length in an uni form manner by being at least partially inflatable . In this manner, the cross-sectional dimension of the si zing tube 2 can be radially expanded from a value between 6 mm - 16 mm to 20 mm - 27 mm such that the insertion is simpli fied and the si ze of the endosleeve can be adj usted to the speci fic needs of the patient by adj usting the cross-sectional dimension according to the speci fic anatomy or indication .
The figures 4A and 4B show a perspective side view of two embodiments of the si zing tube 2 of the medical apparatus which have an elongated partitioner 4 with two j oined ends 42 , 43 and one j oined end 42 and a free end 41 , respectively . The si zing tube 2 has a bent shape 28 or is deformable to a bent shape to better conform to a traj ectory of the lesser curvature of the stomach . The elongated partitioner 4 is adapted for separating two tissue receiving openings 23 , 24 of the si zing tube 2 such that a formation of two tissue bulges by applying suction is possible .
Figure 4A shows that the elongated partitioner 4 has two ends 42a, 43 . The distal end 43 is separable from the si zing tube by retracting the entire elongated partitioner 4 with respect to the si zing tube 2 in a proximal direction P .
Figure 4B shows that the free end 41 of the elongated partitioner 4 is arranged at a distal end of the elongated partitioner 4 . The proximal end 42b in Fig . 4B forms a monolithically j oined end with the si zing tube 2 .
This retractable end 43 or free end 41 of the elongated partitioner 4 in Figs . 4A and 4B enable the elongated partitioner 4 to be removed from amidst the tissue bulges within the receiving openings 23 , 24 after connecting the tissue bulges has been achieved, in particular by suturing or deploying fasteners . The design of Fig . 4A allows that the elongated partitioner 4 can be retracted in the proximal direction from between the tissue bulges such that the si zing tube 2 can then be removed in a simple manner . The design of Fig . 4B enables removal of the elongated partitioner 4 in conj unction with retraction of the si zing tube 2 such that the elongated partitioner 4 slides of f from a region amidst the connected tissue bulges .
Figures 5A and 5B show a perspective view of an embodiment of the si zing tube 2 which has an elongated partitioner 4 which has a plurality of separated longitudinal subsections formed by tubular elements 44 and a separable distal end 43 . The elongated partitioner 4 is positioned to separate two tissue receiving openings 22 , 23 of the si zing tube 2 from each other . The elongated partitioner 4 is convertible between a non- flexible state having a bent shape shown in Fig . 5A and a more flexible state shown in Fig . 5B by pulling a conversion element formed by a pull wire 46 in a distal direction D such that the tubular elements 44 are freely movably connected to each other . The tubular elements 44 are still connected via a connecting wire 47 which is connected to the si zing tube 2 such that the tubular elements 44 are retrievable from the stomach together with the si zing tube 43 . Even though Figs . 5A and 5B show removing the pull wire 46 in a distal direction, the pull wire 46 may alternatively be removable in a proximal direction to release the end 43 .
Figures 6A - 6D show a cross-sectional and perspective view of an embodiment of the si zing tube 2 which has an implantable layer 7 within an inner lumen 21 of the si zing tube 2 which is connectable to tissue bulges 191 , 192 at the same time as with connecting the tissue bulges 191 , 192 with each other . The implantable layer 7 is arranged between a vacuum port 22 of the si zing tube 2 and two receiving openings 23 , 24 for receiving the tissue bulges 191 , 192 . The receiving openings 23 , 24 are separated from each other by an elongated partitioner 4 . The cross-section of the si zing tube 2 and the elongated partitioner 4 form a wedge shape with the elongated partitioner 4 forming the tapered end to facilitate the formation of the ventral and dorsal bulges 23 , 24 . The elongated partitioner 4 and/or the implantable layer 7 may be si zed and arranged in such a manner that the serosa of the tissue bulges 191 , 192 may be punctured by a puncturing connection unit (not shown in Figs . 6A - 6D) . The receiving openings 191 , 192 are further arranged such that the first receiving opening 23 receives a part of the ventral tissue wall and the second receiving opening 24 receives a part of the dorsal tissue wall . The elongated partitioner 4 , the vacuum port 22 and the receiving openings 23 , 24 may extend over the maj ority of a longitudinal length of the si zing tube 2 or even the entire longitudinal length .
The implantable layer 7 may be at least partially permeable to applied suction such that the tissue bulges 191 , 192 can be sucked into the receiving openings 23 , 24 . The implantable layer 7 may comprise holes , a mesh structure , or cut-outs , in particular in regions of the implantable layer 7 which are not to be punctured by a puncturing element ( similar to Figs . 18A - 18C ) . The implantable layer 7 may be formed by a woven or microporous fabric or comprise a speci fic cutout pattern to enable permeability to applied suction . The implantable layer 7 may comprise expanded polytetrafluoroethylene and/or polyurethane . Figure 6C shows that the tissue bulges 191 , 192 are sucked through the receiving openings 23 , 24 in such a manner that they contact the implantable layer 7 and deform it .
Figure 6D shows deployment of a suture or fastener 32 through the implantable layer 7 and the tissue bulges 191 , 192 for fastening them together . Subsequently, the elongated partitioner 4 may be removed from between the tissue bulges 191 , 192 as previously described or e . g . by being sel f-dissolving, soluble , or bioresorbable .
Figures 6E and 6F show a perspective view of the connected tissue bulges 191 , 192 and the stomach having a connected dorsal and ventral wall covered by the implantable layer 7 after carrying out the steps described in Figs . 6C and 6D . The implantable layer 7 is connected via a plurality of fasteners 32 which have an I-shape and comprise a connecting element 323 which is provided on both sides with a fastening element 321 , 321 which extends essentially perpendicularly to the connecting element 323 . The implantable layer 7 is impermeable/ less permeable to fluids , at least at puncture sites at which fasteners 32 were deployed such that the risk of infection can be reduced . The implanted implantable layer 7 in Figs . 6E and 6F isolates the punctured sections of the tissue bulges from fluid, thus eliminating the necessity of the tissue bulges to independently establish a fluid impermeable bond . The implantable layer 7 further or alternatively has a haemostatic fabric which reduces bleeding from the puncture wounds . Figure 6F shows that the final endosleeve is formed by a tubular section between a lesser curvature 195 of the stomach and the connected dorsal and ventral wall .
Figures 7A - 7D show a perspective side view of a first embodiment of a separation member 8 for separation of the tissue bulges as an alternative to the previously described elongated partitioner which is laterally outwardly deployed by advancing an elongated deployment member 9 . A distal tip 91 of the deployment member 9 which is formed by a flexible push rod is attached to the separation member 8 such that advancing the distal tip 91 in a distal direction is redirected in a laterally outward direction L . Based on the laterally outward movement a triangular flexible separation fabric which forms the separation member 8 can be deployed .
Figures 7E - 7H show a perspective side view of a second embodiment of a separation member 8 which is laterally outwardly deployable by advancing an elongated deployment member 9 in a longitudinal direction of the medical apparatus . A distal tip 91 of the deployment member 9 is connected to the si zing tube such that advancing a proximal end of the deployment member 9 in a distal direction D bends the deployment member 9 to an arcuate shape which deploys the separation member 8 which is formed by a flexible separation fabric . The separation member 8 is radially attached or connected to the deployment member 9 along an entire longitudinal dimension of the separation member 8 .
Figures 71 - 7K show a perspective side view of a third embodiment of a separation member 8 and a si zing tube 2 of the medical apparatus which is laterally outwardly deployed by pivoting a deployment member 9 laterally outwardly in a direction R away from a longitudinal axis of the si zing tube 2 . Figures 71 - 7K show that the separation member 8 is deployed within the tissue receiving opening 23 to separate the tissue receiving opening 23 into two separated sections on either side of the separation member 8 such that the formation of two tissue bulges can be facilitated . The deployment member 8 of Figs . 7A - 7H may also be arranged and configured to separate sections of the receiving opening or the entire receiving openings .
The separation member 8 and deployment member 9 in the embodiments of Figs . 7A - 7K may be movable in unison together along the tissue receiving opening 23 of the si zing tube 2 such that the spatial position of tissue bulge formation is adj ustable . This allows to move the separation member 8 away from sections of tissue bulges which have already been connected until the endosleeve surgery is completed . Subsequently, the separation member 8 can be moved to a collapsed configuration by pivoting the deployment member 9 or retracting the deployment member 9 in a proximal direction .
Figures 7L and 7M show a perspective side view of a fourth embodiment of a separation member 7 which is laterally outwardly deployable by a deployment member 9 . The deployment member 9 is arranged within a flexible guide sleeve 92 which confines the movement of the deployment member 9 in a lateral and longitudinal direction . By advancing the deployment member in a distal direction, the deployment member 9 is deformed within the guide sleeve 92 to a curvature to deploy the separation member 8 which is formed by a flexible separation fabric which is connected along its longitudinal direction to the guide sleeve 92 .
Figures 8A to 8D show a perspective view and a cross-sectional view of two embodiments of a si zing tube 2 and a puncturing connection unit 3 of the medical apparatus . The puncturing connection unit 3 has an annular shape and has a gripping means 6 . The gripping means 6 are formed by a movable part formed by a hammer 61 which is adapted to be advanced back and forth in a circumferential direction towards/away from a second part formed by an anvil 62 to deploy a suture or a fastener through tissue bulges . The puncturing connection unit 3 may be configured such that the hammer 61 is moved in the circumferential direction, while the anvil 62 is rotated in the opposite direction, such that the hammer 61 and anvil 62 meet in the middle of a receiving opening . This may be achieved by the puncturing connection unit 3 , or at least the anvil 62 , being rotatably arranged with respect to the si zing tube 2 .
The puncturing connection unit 3 is configured to be moved in the longitudinal direction of the si zing tube 2 , in particular by an actuator of the medical apparatus , such that the tissue bulges can be sequentially connected .
In Figs . 8A and 8C the puncturing connection unit is arranged circumferentially around an outer mantle surface of the si zing tube 2 . The si zing tube 2 and the puncturing connection unit 3 is enclosed by a cover along a part of the circumference of the si zing tube . The cover extends along the si zing tube 2 such that the puncturing connection unit 3 is movable underneath the cover . The cover may optionally form an inflatable balloon, e . g . to radially expand the si zing tube 2 .
In Figs . 8B and 8D, the puncturing connection unit is arranged within longitudinal openings of the si zing tube 2 such that the puncturing connection unit 3 is partially arranged within an inner lumen 21 of the si zing tube 2 in Figs . 8B and 8D .
Figures 9A and 9B show a perspective view of a puncturing element 31 and a fastener 32 of the puncturing connection unit 3 ( see Figs . 9C and 9D) . The fastener 32 has a first fastening element 321 which has a cylindrical lumen and is arrangeable circumferentially around the puncturing element 31 such that it can be advanced through the tissue bulges together with the puncturing element 31 . The first fastening element 321 is connected via a flexible connecting element 323 to a second fastening element 322 of the fastener 32 such that the second fastening element 322 can be arranged adj acent the puncturing element 31 by the connecting element 323 being deformed to a curvature . This allows the fastener 32 to be easily mounted on the puncturing element 31 and to be arranged in a longitudinal guide 34 together with the puncturing element 31 .
Figures 9C and 9D show a partially cut away perspective view of a puncturing connection unit 3 having a gripping means 6 for gripping the tissue bulges and a fastener 32 arranged around the puncturing element 31 and within the puncturing element 31 , respectively . The puncturing element 31 is formed by an arcuate needle which is operable by hydraulicly operated pistons . The gripping means 6 are formed by two arcuate parts 61 , 62 which may be movable towards each other .
In a preferred embodiment , the first part 61 of the gripping means 6 is movable with respect to the second part 62 , in particular in unison with the puncturing element 31 , while the second part 62 is non-movable . The puncturing element 31 is arranged within the first part 61 which facilitates reliably gripping the tissue bulges and advancing the puncturing element 31 through the section gripped by the gripping means 6 . The puncturing element 31 is circumferentially surrounded by the first part 61 of the gripping means 6 during/prior to puncturing the tissue bulges . Alternatively, the arcuate parts 61 , 62 may be configured to be movable towards and apart from each other, in particular by a spring mechanism . Figures 9C and 9D show that the fastener 32 has a first and second fastening element 321 , 322 which are arranged perpendicular to a connecting element 323 of the fastener 32 to form an I- shape . The first fastening element 321 in Fig . 9C is arranged circumferentially surrounding the puncturing element 31 . The first fastening element 321 in Fig . 9D is arranged within an inner lumen of the puncturing element 31 . Both embodiments allow the fastener 32 to be advanced through the tissue bulges via the puncturing element 31 . This enables placement of the first fastening element 321 on an entry side of the tissue bulges and a second fastening element 322 on an exit side of the tissue bulges while a connecting element 323 of the fastening elements 321 , 321 extends through the tissue bulges .
Figure 9E shows a perspective view of an alternative embodiment of the puncturing element 31 which has a predetermined fracture or deployment section 35 . This allows a distal tip 36 of the puncturing element 31 to be deployed in a similar manner to the previously described first fastening element 321 ( see Figs . 9A - 9D) . The distal tip 36 may also be connected via a connecting element to a second fastening element which is arranged within the puncturing element 31 to be deployed in a similar manner to the fastener 32 .
The puncturing connection unit 3 for deploying the fasteners 32 or distal tips 36 of puncturing elements 31 may comprise a reloading or replenishing reservoir/magazine of fasteners 32 or distal tips 36 such that the puncturing element 31 can be re- loaded/replenished for deploying further fasteners 32 or distal tips 36 .
Figure 9F shows an exploded perspective view of a puncturing connection unit 3 which has a puncturing element 31 formed by an arcuate needle which is guided along a circular longitudinal guide 34 which is arranged within a gripping means 6 formed by two parts 61 , 62 . A spring mechanism, in particular comprising a helical spring 311 and a radial protrusion 312 on the puncturing element 31 , is adapted to move the two parts 61 , 62 in a circumferential direction away from each other . This allows the two parts 61 , 62 to be actuated simultaneously for gripping the tissue bulges and advancing the puncturing element 31 through the tissue bulges . The spring mechanism is further actuatable such that the helical spring 311 is collapsed and the two parts 61 , 62 move towards each other, e . g . via actuatable tendons . The guide 34 allows to drive the puncturing element and prevents out of plane movement of the puncturing element and the spring mechanism . This simpli fies the actuation of the gripping means 6 and the puncturing element 31 and allows for a synchroni zed movement .
Figures 10A and 10B show a perspective view of a puncturing element 31 which has an inner lumen 37 for receiving a fastener element 321 , a longitudinal slit 38 extending along the inner lumen 37 , and a fastener deployment member 39 . The puncturing element is formed by an arcuate hollow needle . The longitudinal slit 38 is arranged on a lateral surface of the puncturing element 31 . Alternatively, the longitudinal slit 38 may be arranged perpendicular to the curvature of the puncturing element 31 . The fastener deployment member 39 comprises actuatable piston which may be actuated by tensioning a spring mechanism for deploying the fastener 32 (not shown in Figs . 10A and 10B ) . The fastener 32 comprises the first fastening element 321 , a second fastening element 322 , and a connecting element 323 which form an I-shape or a U-shape . This allows to deploy the fastener 32 once the puncturing element 31 was advanced through the tissue bulges such that a connecting element 323 of the fastener 32 is deployed through the tissue bulges with the fastening elements 321 , 322 deployed on both sides of the tissue bulges . When deploying the fastener 32 , the connecting element 323 moves along the slit 38 driven by the fastener deployment member 39 while the first fastening element 321 remains within the puncturing element 31 . The fastener 32 can be deployed by the fastening element 321 being released from a terminal end of the puncturing element 31 .
The figures I OC and 10D show a perspective view and cross-sectional view of the deployed fastener 32 through the tissue bulges 191 , 192 without and with an implantable layer 7 of Figs . 6A - 6F . This allows to place a first fastening element 321 on an entry side 197 of the tissue bulge 191 and a second fastening element 322 on an exit side 198 of the tissue bulge 192 while a connecting element 323 of the fastening elements 321 , 321 extends through the tissue bulges 191 , 192 .
Figure 10D shows that the entry side 197 and the exit side 198 are covered by the implantable layer 7 such that leakage can be reduced, and haemostasis at a puncture site can be promoted .
Figure 10E shows a perspective side view of a medical apparatus 101 which has a puncturing connection unit 3 which is transla- tionally movable along a longitudinal direction of a si zing tube 2 . When suction is applied by a vacuum port of the si zing tube 2 the stomach tissue 19 forms a dorsal and ventral tissue bulge which are received within two tissue receiving openings 23 , 24 of the si zing tube 2 which are separated by an elongated parti- tioner 4 . This allows the puncturing connection unit 3 to deploy previously described fasteners or sutures successively through dorsal and ventral tissue bulges of the stomach tissue 19 successively by moving along the tissue receiving openings 23, 24. Figures 11A - 11F show a cross-sectional view and a perspective view of a different embodiment of the sizing tube 2 having a guiding feature 29 for guiding a movement of a puncturing connection unit (see Fig. 11F) in a longitudinal direction in an inner lumen 21 of the sizing tube 2. The guiding feature 29 is formed by a guide rail which has two undercuts which extends along a longitudinal direction of the sizing tube 2. Figure 11B shows that a negative pressure via a vacuum port 22 can be applied within the inner lumen 21 such that two tissue bulges 191, 192 from the dorsal and ventral stomach wall may be received within a tissue receiving opening 23 which extends along the longitudinal direction. The sizing tube 2 may separate the receiving opening 23 into two openings/sections by an elongated partitioner 4 (see e.g. Figs. 4A and 4B) , a separation member 8 (see Figs. 7A - 7M) , or a an expansion unit 11 (see Fig. 14C) indicated by the dashed line in Figs. 11B, 11D and 11F. This may facilitate the formation of the two tissue bulges 191, 192.
Figures 11D and HE show that a puncturing connection unit 3 may be arranged within the inner lumen 21 which has a gripping unit and a puncturing element 31 for connecting the tissue bulges 191, 192 by deploying a suture or a fastener.
The puncturing connection unit 3 in Fig HF has a longitudinal translation unit formed by two cylindrical rollers 301 which are adapted for translationally moving the puncturing connection unit 3 along the longitudinal direction. The puncturing connection unit 3 in Fig. HF further has an actuation mechanism 303 for advancing the puncturing element 31 and the gripping unit for deploying the suture/fastener through the tissue bulges 191, 192 formed within the receiving opening 23 . The actuation mechanism 303 is preferably hydraulically actuated .
Figures 12A to 12D show a perspective view of an embodiment of the puncturing connection unit 3 which has a plurality of segments 302 which are movable relative to each other in a longitudinal direction of the si zing tube . The si zing tube may have a plurality of receiving openings which are adapted for receiving several longitudinally separated tissue bulges of the dorsal and ventral wall sections . This allows the segments 302 to deploy a fastener 32 to connect the tissue bulges by being moved towards each other . An elongated partitioner or a separation member may extend longitudinally through the segments 302 to facilitate the formation of the two tissue bulges within the tissue receiving opening ( s ) .
Figures 12B - 12D show that the segments 302 may be configured such that the segments 302 are movable toward each other by compressing the segments 302 in the longitudinal direction such that the tips of the fasteners 32 are bent and the fasteners 32 can be deployed to connect the tissue bulges . Subsequently, the segments 302 may be moved apart from each other to release the tissue bulges and fasteners 32 as shown in Fig . 12D .
Figures 12E and 12 F show a schematic view of a si zing tube 2 which is adapted to alternatingly arrange the dorsal and ventral tissue bulges along a longitudinal direction L and a puncturing connection unit 3 comprising helical segments 302 . The helical segments 302 form only one helical turn which is correspondingly formed for receiving the dorsal or ventral wall tissue bulge in an upper section and the other of the dorsal or ventral wall tissue bulge in the lower section . Alternatingly arranging the dorsal and ventral tissue bulges may be achieved by arranging the tissue receiving openings in a zigzag pattern or alternatively arranging the elongated partitioner or separation member in a zig- zag pattern . This allows to arrange a dorsal tissue bulge and a ventral tissue bulge adj acent each other between the segments 302 . Each segment 302 has a first fastener 32 at its bottom surface of the upper section and a second fastener 303 at its bottom surface of a lower section . This allows to place more fasteners for connecting the dorsal and ventral tissue bulges by each fastener 32 being deployable through separate dorsal and ventral tissue bulges in an alternating manner . Tips of the fasteners 32 , 303 can be bent and deployed by moving the single helix segments 302 towards each other, in particular by longitudinal compression in a similar manner as described in Figs . 12A - 12D .
Figures 12G to 12 J show schematic representation of di f ferent mechanical actuation units 12 of the puncturing connection unit 3 by advancing and/or retracting a puncturing element 31 . The mechanical actuation units 12 may be arranged within a si zing tube of the medical apparatus and be adapted to be movable with respect to the si zing tube .
Figure 12G shows a longitudinally translationally movable actuation rod 121 of the mechanical actuation unit 12 which is adapted for frictionally engaging a plurality of puncturing elements 31a of a puncturing connection unit 3 which are formed by arcuate needles . When the actuation rod 121 is advanced within an inner lumen of the si zing tube to the puncturing connection unit 3 , the actuation rod 121 can be rotated to frictionally drive a rotational movement of the circumferentially movable puncturing elements 31a in a circumferential direction of the si zing tube to connect two tissue bulges within a receiving opening .
Figure 12H shows a cylindrical mechanical actuation unit 12 which comprises a radially inwardly extending protrusion 122 which extends longitudinally along an inner surface of the cylindrical mechanical actuation unit 12 . The protrusion 122 is configured for engaging a plurality of puncturing elements 31a of a puncturing connection unit 3 , in particular only at a proximal end of the puncturing elements 31a and for providing a motive force to the puncturing elements to simultaneously drive the puncturing elements 31a in a circumferential direction with respect to the si zing tube .
Figure 121 shows an actuation unit 12 which has an actuation rod 121 which is movable in the longitudinal direction for axially actuating a puncturing elements 31b, e . g . to drive a deployment of fasteners as described in Figs . 12A - 12 F . The puncturing connection unit 3 in Fig . 121 comprises a plurality of articulated segments 302 which are adapted for deploying the fasteners by puncturing dorsal and ventral tissue bulges together which are arrangeable between the articulated segments 302 . Each articulated segment 302 is connected via a first and second tendon 123 , 124 to the actuation rod 121 . The tendons 123 , 124 are coupled to the actuation rod 121 in such a manner that a unidirectional movement of the actuation rod 121 , e . g . in a distal or proximal direction, pulls the antagonistic first tendons 123 while releasing the negative second tendons 124 such that the articulated segments 302 move towards each other for suturing . Moving the actuation rod 121 in an opposing unidirectional movement , e . g . the other distal or proximal direction, pulls the second tendons 124 and releases the first tendons to move the articulated segments 302 apart from each other . Figure 12 J shows a mechanical actuation unit 12 which has a longitudinal slider 125 or a push rod . The puncturing connection unit 3 has two articulated segments 302 which are connected to the longitudinal slider 125 via a first and a second tendon 123 , 124 , respectively .
The antagonistic first tendons 123 and the negative second tendons 124 of the articulated segments 302 are each guided around a proximal and distal tendon guide 126 , 127 which may be formed by pulleys , respectively . The slider 125 is adapted such that a unidirectional displacement of the longitudinal slider 125 , e . g . by sliding along a guide rail in a proximal or distal direction, pulls the antagonistic first tendons 123 and releases the negative second tendons 124 . This moves the articulated segments 302 towards each other to actuate a puncturing element 31b of the puncturing connection unit 3 through the tissue bulges and deploy a suture or a fastener . An opposing unidirectional displacement of the slider 125 instead pulls the negative second tendons 124 and releases the antagonistic first tendons 123 via the pulleys to move the articulated segments 302 apart from each other .
Figure 13A shows a perspective side view of a si zing tube 2 of the medical apparatus 101 which was inserted into stomach tissue 19 and which applies suction to form dorsal and ventral tissue bulges . A vacuum port of the si zing tube supplies the suction along the entire receiving opening ( s ) of the si zing tube , such that the tissue bulges are received in the si zing tube and can be connected via a puncturing connection unit . Figure 13A shows that the applied suction may result in gastric folds 199 of the stomach tissue 19 , in particular in a region in proximity of the oesophageal sphincter, e . g . in the cardia, cardial notch, or fundus region of the stomach . These gastric folds 199 may result in clogging of the si zing tube 2 and/or improper capture of the tissue bulges which may negatively impact the suturing of the tissue bulges . Most importantly, the formation of gastric folds 199 may impair suturing or fastener deployment . In particular, the gastric folds 199 may result in sutures or fasteners being improperly placed, in insuf ficient numbers per section of stomach tissue 19 , or in placement at an insuf ficient depth . The gastric folds 199 may even result in suture/ fastener failure due to tissue apposition . This may further result in adverse surgical outcomes such as gastric leakage , infection, and/or delayed healing . Most importantly, this reduces leakage between sections of the stomach that are separated by the sutures/ fasteners which would negatively impact the surgical outcome , in particular regarding weight loss .
Figures 13B and 13C show a perspective side view of a si zing tube 2 of the medical apparatus 101 which has an expansion unit
I I for spreading the stomach assuming a collapsed configuration
I I I and an expanded configuration 112 , respectively . The expansion unit 11 comprises a nitinol wire which has a distal end which is fixedly connected to a distal end of the si zing tube 2 . The expansion unit 11 is convertible between the collapsed configuration 111 and the expanded configuration 112 by advanc- ing/retracting a proximal end of the nitinol wire . In the collapsed configuration 111 , the nitinol wire longitudinally extends along two tissue receiving openings 23 , 24 of the si zing tube 2 which are separated by an elongated partitioner 4 . In the collapsed configuration 111 , the nitinol wire of the expansion unit 11 has a first curvature which is lower than a second curvature in the expanded configuration 112 once the nitinol wire was advanced . In the expanded configuration 112 , the nitinol wire engages a greater curvature 196 of the stomach tissue and thereby stretches the stomach tissue and urges the si zing tube 2 towards a lesser curvature 195 of the stomach tissue . This enables the formation of gastric folds 199 ( see Figs . 13A and 13D - 13G) can be reduced/prevented . This embodiment further provides a uni form pressure distribution for stretching the stomach tissue further along the greater curvature 196 via the nitinol wire such that uni form ventral and dorsal tissue bulges may be formed and received within the tissue receiving openings 23 , 24 .
Figures 13D - 13G show a perspective side view of a si zing tube 2 of the medical apparatus 101 which comprises the expansion unit 11 which was inserted into the stomach and is controlled in a synchroni zed manner with a fluid supply and/or suction via a vacuum port . Figures 13D and 13E show that the stomach tissue forms a plurality of gastric folds 199 which complicates suf ficiently connecting dorsal and ventral tissue bulges . Figures 13E - 13G show that the expansion unit 11 is successively converted to an expanded configuration 112 to stretch the stomach tissue by engaging a greater curvature 196 of the stomach and remove the gastric folds 199 . In conj unction, fluid is supplied to expand a volume of the stomach to facilitate deployment of the expansion unit 11 and reliably remove the gastric folds 199 . The fluid supply via a vacuum port may be configured for continuously supplying fluid when converting the expansion unit 11 from the collapsed configuration to the expanded configuration 112 . The fluid may be supplied in a synchroni zed manner with the conversion of the expansion unit 11 such that the volume of the stomach receives fluid inflow which facilitates successive deployment of the expansion unit 11 . After completely deploying the expansion unit , in particular without fully inflating the stomach, a suction pressure may be applied to the stomach to remove the fluid again . Once the gastric folds 199 have been removed in this manner, the surgical procedure for connecting the dorsal and ventral tissue bulges can be carried out in a more reliable manner . Figure 13G shows that the tissue bulges which are formed by the stomach tissue and received within the tissue receiving opening ( s ) are more uni form without the gastric folds 199 once suction is applied .
In a preferred embodiment , the medical apparatus 101 comprises a control unit which is adapted for operating the expansion unit 11 in a synchroni zed manner with a fluid supply and/or suction of a vacuum port of the si zing tube 2 .
Figures 14A and 14B show a perspective top and side view of a si zing tube 2 of the medical apparatus 101 which has a perforated barrier 13 . The perforated barrier 13 extends along a vacuum port 22 which is connected to a longitudinal tissue receiving opening 23 . The perforated barrier 13 has perforations for uni formly distributing the fluid supply and/or the applied suction . The perforated barrier 13 extends over the entire longitudinal tissue receiving opening 23 of the si zing tube 2 and is arranged to prevent tissue bulges from obstructing the vacuum port 22 . The perforated barrier 13 is further arranged to form an abutment surface such that the tissue bulges can be punctured through the serosa . This enables to precisely control the tissue thickness of the received tissue bulges .
Figure 14C shows a perspective side view of a si zing tube 2 of the medical apparatus 101 having an expansion unit 11 which has a separation member 8 . The expansion unit 11 is in an expanded configuration 112 for engaging the greater curvature of the stomach tissue ( see Figs . 13D - 13G) . The separation member 8 is formed by a meshed separation fabric which extends along a longitudinal receiving opening of the si zing tube 2 for separating a dorsal and ventral tissue bulge . A proximal end of the separation member is operatively connected to a proximal end of a ni- tinol wire of the expansion unit 11 and a distal end of the separation member 8 is connected to a distal end of the nitinol wire . The separation member 8 is deployable in unison with the expansion unit 11 being converted from a collapsed configuration to the expanded configuration 112 . Simultaneous/ synchroni zed deployment of the expansion unit 11 and the separation member 8 within the longitudinal tissue receiving opening allows for a more intuitive operation of the medical apparatus and a simpler design .
Figures 15A to 15D show a cross-sectional view of di f ferent embodiments of the si zing tube 2 having circumferentially di f ferently positioned and dimensioned longitudinal tissue receiving openings 23 , 24 . The longitudinal tissue receiving openings 23 , 24 are separated by an elongated partitioner 4 and have a uniform cross-sectional profile along a longitudinal direction of the si zing tube 2 .
The two longitudinal tissue receiving openings 23 , 24 are arranged within a circumferential section of the si zing tube 2 having an angle A of 120 ° or less in Fig . 15A, 140 ° or less in Fig . 15B, and 160 ° or less in Figs . 15C and 15D . Arranging the tissue receiving openings 23 , 24 within this angular range and aligned towards a greater curvature of the stomach allows to reliably engage the dorsal and ventral gastric wall to form and receive the tissue bulges and carry out an endosleeve surgery . Simultaneously, an opposing side of the si zing tube 2 facing away from the tissue receiving openings 23 , 24 is aligned to face the lesser curvature of the stomach . Figure 15D further shows that an average width W of the longitudinal tissue receiving openings 23 , 24 may be larger than shown in Figs . 15A - 15C . In a preferred embodiment , the width W may have a value between 4 mm - 6 mm .
Figures 15A - 15D further show that a cross-sectional geometric center of an inner lumen 21 is of fset from a cross-sectional geometric center of the si zing tube 2 . In this manner, the side of the si zing tube for engaging the lesser curvature of the stomach can have a thinner wall thickness , while the side for receiving the tissue bulges through the longitudinal tissue receiving openings 23 , 24 can have a thicker wall thickness . This allows a miniaturi zation of the si zing tube 2 which facilitates insertion and at the same time allows for receiving desirably dimensioned tissue bulges due to a larger depth of the tissue receiving openings 23 , 24 . In addition, this may reduce the buckling of the elongated partitioner 4 and/or the si zing tube 2 when applying suction .
Figures 16A and 16B show a perspective view of a plurality of pairs 313 of puncturing elements 31 and a pair 313 of puncturing elements 31 with longitudinal slits 38 . The slits face towards each other, respectively . The puncturing elements 31 are arranged in a puncturing connection unit which is not shown in Figs . 16A and 16B for better visibility of the puncturing elements 31 . Figures 16A and 16B further show a fastener 32 that comprises a first and second fastening element 321 , 322 which are connected by a connecting element 323 and which are arranged within inner lumen of each pair 313 of puncturing elements 31 . The connecting elements 323 extend through the slits 38 . Fastener deployment members 39 which are formed by actuatable pistons are arranged within the inner lumen of the puncturing elements 31 . The pairs 313 of puncturing elements and corresponding deployment members 39 are actuatable together such that the first and second fastening elements 321 , 322 can be advanced through adj acently arranged dorsal and ventral tissue bulges 191 , 192 to connect the tissue bulges 191 , 192 . In one embodiment , the plurality of pairs 313 of puncturing elements 31 and fastener deployment members 39 in Fig . 16A are actuatable simultaneously, in particular by an actuation unit operated by a control unit of the medical apparatus .
Deploying both the first and second fastening elements 321 , 322 from the inner lumen of the pairs 313 of puncturing elements 31 allows for a more reliable positioning of the fasteners 32 and enables each fastener 32 to connect the tissue bulges 191 , 192 at two separate puncture sites . In addition, a puncture resistance of advancing the fastener elements 321 , 322 can be minimi zed since both fastener elements 321 , 322 are deployed after success fully puncturing the tissue bulges 191 , 192 such that surface interactions and/or frictional resistance for deployment is reduced .
Figures 16C and 16D show a schematic representation of an alternative embodiment of a fastener 32 . The fastener 32 has a connecting element 323 which connects a first pair of fastening elements 3211 , 3212 and a second pair of fastening elements 3221 , 3222 which is formed by a u-shaped wire . This u-shape allows for reducing the strain on the gastric tissue when the fastener 32 of Figs . 16C and 16D is deployed through tissue bulges as previously described in Figs . 16A and 16B . The pairs of fastening elements 3211 , 3212 ; 3221 , 3222 are adapted to be deformed when being deployed through the tissue bulges . This may be achieved by a counter surface , e . g . formed by the puncturing connection unit , for receiving the pairs of fastening elements 3211 , 3212 ; 3221 , 3222 in such a manner that the fastening elements 3211 , 3212 ; 3221 , 3222 are bent laterally outwardly as shown in Fig .
16D . Thereby, detachment of the deployed fastener 32 through the tissue can be prevented since the laterally outwardly bent fastening elements 3211 , 3212 ; 3221 , 3222 form an anchoring surface against the tissue bulges .
Figures 16E and 16F show perspective views of two tissue bulges 191 , 192 which were connected by a plurality of fasteners 32 deployed via puncturing elements of Figs . 16A and 16B . The fastening elements 321 , 322 of the fasteners 32 are arranged only on an exit side of the tissue bulges 191 , 192 . The connecting elements 323 of the fasteners 32 are U-shaped and extend through the tissue bulges 191 , 192 longitudinally along an entry side of the tissue bulges 191 , 192 . This deployment of fasteners 32 enables each fastener 32 to securely connect the tissue bulges 191 , 192 at two puncturing sites which are longitudinally spaced apart from each other along a longitudinal length of the tissue bulges 191 , 192 .
Figure 16G shows a perspective view of a plurality of puncturing elements 314 , 315 with di f ferent diameters puncturing two tissue bulges 191 , 192 . The puncturing elements 314 , 315 may be actuatable in a previously described manner in unison or separately from each other . The puncturing elements 314 , 315 in Fig . 16G are arranged concentrically to a common axis corresponding to a longitudinal axis of a si zing tube to which the puncturing connection units of the puncturing elements 314 , 315 are mounted (not shown in Fig . 16G) . The first puncturing elements 314 having the smaller diameter are adapted for deploying a fastener 32 ( see Fig . 16H) to connect the tissue bulges 191 , 192 at a higher position with respect to the gastric wall where the tissue bulge dimension is smaller . The second puncturing elements 315 having the larger diameter are adapted for deploying the fastener 32 to connect the tissue bulges 191 , 192 at a lower position with respect to the gastric wall where the tissue bulge dimension is larger . This allows placement of fasteners 32 in a zig- zag pattern .
Figure 16H shows a perspective view of two tissue bulges 191 , 192 which were connected by a plurality of fasteners 32 deployed via the puncturing elements 314 , 315 of Fig . 16G . The fasteners 32 are arranged in a zig- zag pattern which facilitates positioning a greater number of fasteners along the longitudinal extend of the tissue bulges 191 , 192 , ensuring a more robust linkage of the tissue bulges 191 , 192 . The fasteners 32 comprise fastening elements 321 which secure the fasteners 32 on either side of the tissue bulges 191 , 192 in a previously described manner .
Figures 17A and 17B show a schematic view of an embodiment of a gripping means 6 for gripping tissue bulges 191 , 192 via a radially collapsible structure . The tissue bulges 191 , 192 in Figs . 17A and 17B are schematically separated by a dashed line . Alternatively, the medical apparatus may have two gripping means 6 of Figs . 17A and 17B which are configured for separately gripping one of the tissue bulges 191 , 192 independently from each other, e . g . by being arranged within respective receiving openings of a si zing tube .
The collapsible structure of the gripping means 6 comprises two arcuate elements 65 , 66 which are not connected at a first end 63 and j oined at a second end 64 . In a preferred embodiment , the arcuate elements may be connected to each other at the first and second ends . Figure 17A shows that the collapsible structure has a radially expanded configuration for receiving the tissue bulges 191 , 192 . Figure 17B shows that the collapsible structure can be moved to a radially collapsed configuration by moving at least one of the ends 63, 64 relative to the other of the ends 63, 64. This allows to apply a radially inwardly directed pressure in a uniform manner onto the tissue bulges 191, 192 by engaging the tissue bulges 191, 192 via the arcuate elements 65, 66 which are deformed to a lesser curvature. The collapsible structure may comprise more than two or three arcuate elements 165, 166 which are adapted for engaging the tissue bulges 191, 192, in particular similar to a Dormia device by Coloplast.
Figure 17C shows a schematic view of a different embodiment of a gripping means 6 for gripping the tissue bulges 191, 192 via two actuatable rollers 67, 68. The actuatable rollers 67, 68 of the gripping means 6 are formed by cylindrical rollers and are configured to be rotatable and in particular operable via a control unit of the medical apparatus. The actuatable rollers 67, 68 in Fig. 17C are arranged at least partially along a tissue receiving opening or tissue receiving openings. This allows that dimensions of the tissue bulges 191, 192 received within the tissue receiving opening (s) can be controlled in a more reliable manner. The dimensions of the tissue bulges 191, 192 can be adjusted via the actuatable rollers 67, 68 to optimize a position of a puncturing site via the puncturing element, e.g. through the serosa.
Figures 18A and 18B show a perspective side view of an embodiment of the sizing tube 2 of the medical apparatus. The sizing tube 2 has a puncturing connection unit 3 which is formed by a plurality of puncturing connection sub-units which each comprise four puncturing elements 31. The puncturing connection unit 3 extends over the entire longitudinal length of a tissue receiving opening 23 of the sizing tube 2. The puncturing connection unit 3 has an annular shape and is positioned circumferentially on a mantle or outer surface of the sizing tube 2. Each of the puncturing connection sub-units are actuatable in unison with a corresponding gripping means 6 . The gripping means 6 have a movable part 61 . The movable part 61 is configured for gripping the tissue bulges and advancing the puncturing elements 31 formed by arcuate needles . A second non-movable part 62 of the gripping means 6 is adapted to interact with the first part 61 to grip the tissue bulges . The separate puncturing connection sub-units and corresponding gripping means 6 are configured to be actuatable independently from each other . This allows for sequential suturing of the tissue bulges along the tissue receiving opening ( s ) 23 . This may provide facilitated application of suction to speci fic regions of the tissue receiving opening ( s ) 23 by partially closing the tissue opening ( s ) 23 by moving the subunits sequentially to a closed configuration .
Figures 19A to 19C show a side view and two perspective views of di f ferent embodiments of a perforated barrier 13 of a si zing tube 2 .
The perforated barrier 13 in Fig . 19A is formed by a wire which is wound around a si zing tube 2 below an elongated partitioner 4 such that tissue receiving openings 23 , 24 of the si zing tube 2 are partially covered .
The perforated barrier 13 of the embodiments in Figs . 19B and 19C is formed by a perforated cylindrical segment which has as plurality of circular perforations which may have a diameter of 0 . 1 - 2 mm, preferably 0 . 5 - 1 mm .
The perforated barrier 13 in Figs . 19A to 19C allows a passage of fluid while preventing excess tissue of the tissue bulges to be sucked into a vacuum port of the si zing tube . In addition, the perforated barrier 13 is preferably oriented and positioned for controlling the dimensions of the tissue bulges which are formed within the receiving opening ( s ) .
Figures 20A to 20D show a schematic representation of di f ferent embodiments of a medical apparatus 101 which comprises a si zing tube 2 that is movable by an articulated segment ( s ) 14 , 15 of the medical apparatus 101 .
The articulated segment 14 of the medical apparatus 101 in Figs . 20A and 20B is formed by a longitudinal section which has a proximal end connected to a delivery catheter and a distal end which is connected to a proximal end of the si zing tube 2 . The articulated segment 14 may be actuatable via at least one deflection element , in particular at least one actuatable tendon .
The at least one deflection element and routing of at least one deflection element may be configured for deflecting the articulated segments 14 , 15 of the medical apparatus 101 along two distinct curvatures as shown in Fig . 20A or along a single curvature as shown in Fig . 20B .
A first articulated segment 14 of the medical apparatus 101 in Figs . 20C and 20D is connected to a proximal end of the si zing tube 2 and a second articulated segment 15 is connected to a distal end of the si zing tube 2 . The articulated segments 14 , 15 are formed by rigid links which are pivotable and allow positioning and/or orienting of the si zing tube 2 in a multi-bar linkage fashion known to a person skilled in the art .
The articulated segment ( s ) 14 , 15 of Figs . 20A - 20D may comprise a manual actuation, a spring actuation, a pneumatic/hy- draulic actuation, or an electric actuation such that the posi- tion/orientation of the si zing tube may be controlled, in particular via a control unit of the medical apparatus 101 . This allows positioning the si zing tube 2 in a speci fic section of the stomach to adj ust the dimensions of an endosleeve when performing an endosleeve stomach surgery by adj usting an angular orientation and position of the si zing tube 2 .
Figures 21A and 21B show a semi-opaque perspective view of two embodiments of the medical apparatus 101 having a si zing tube 2 with a helical guiding feature 29a and a longitudinal guiding feature 29b, respectively . A puncturing connection unit 3 of the medical apparatus 101 has an engagement section to engage the guiding feature 29a, 29b .
The guiding feature 29a in Fig . 21A has a helical shape which extends in a longitudinal direction within an inner lumen 21 of the si zing tube . The guiding feature 29a is configured for guiding the puncturing connection unit 3 along a helical path within the inner lumen 21 . The puncturing connection unit 3 is driven along the guiding feature 29a by rotation and translation of a push rod which is connected to a proximal end of the puncturing connection unit 3 .
The guiding feature 29b in Fig . 21B has a longitudinal guide rail which extends parallel to a longitudinal direction of the si zing tube 2 . This allows the puncturing connection unit 3 to be translationally movable along a linear path in the inner lumen 21 along the si zing tube 2 by being driven by translation- ally advancing a push rod connected to a proximal end of the puncturing connection unit 3 . The puncturing connection unit 3 may comprise an electronic control unit for operating a puncturing element and deploy sutures/ fastener which are pre-loaded within the puncturing connection unit 3 , in particular in a replenishing reservoir/maga- zine .
The guiding feature 29a, 29b may extend longitudinally along a tissue receiving opening ( s ) of the si zing tube 2 such that the puncturing connection unit 3 may be guided along the tissue receiving opening ( s ) to connect the dorsal and ventral tissue bulges within the tissue receiving opening ( s ) . In particular, the helical shape of a guiding feature 29a may allow for deploying sutures/ fasteners at speci fic predetermined positions corresponding to the windings of the helical shape . The helical guiding feature 29a may be partially discontinuous , in particular in the region of the tissue receiving opening ( s ) .
Figures 22A and 22B show a semi-opaque view of an embodiment of a puncturing connection unit 401 comprising a ring-shaped housing 411 , a puncturing element 402 , and a pusher element 403 . The ring-shaped housing 411 encloses a circular pusher path 404 for guiding the pusher element 403 . The ring-shaped housing 411 further has two openings 408 , 409 which are arranged adj acent to a tissue receiving gap 405 formed between two ends of the ringshaped housing 411 . The openings 408 , 409 are arranged perpendicular to a plane defined by the pusher path 404 and are adapted to receive a pull wire 407 . The pull wire 407 is crimped/connected to the pusher element 403 in such a manner that one end of the pull wire 407 exits the ring-shaped housing 411 from a first opening 408 and another end of the pull wire 407 exits on the other end of the housing 411 at a second opening 409 as shown in Fig . 22B . Figs . 22A and 22B show that the openings 408 , 409 are arranged adj acent to the tissue receiving gap 405 .
This arrangement of the pull wire 407 and at least one opening 408 , 409 adj acent the tissue receiving gap 405 enables a simple advancement/retraction of the pusher element 403 and the puncturing element 402 along the pusher path 404 . By pulling on one end of the pull wire 407 of the first opening 408 , the puncturing element 402 can be advanced across the tissue receiving gap 405 such that tissue bulges which can be received in the tissue receiving gap 405 can be punctured and connected by deploying a suture/ fastener . I f the other end of the pull wire 407 is actuated, the pusher element 403 and the puncturing element 402 can be retracted along the pusher path 404 such that the puncturing element 402 is partially or completely arranged within the ringshaped housing 411 . The second end of the pull wire 407 leading to the second opening 409 may be guided in parallel to the pusher path 404 . The ring-shaped housing 411 may provide a guide path for receiving the pull wire 407 . The openings 408 , 409 may comprise a bevelled surface adj acent on an inner side shown in Fig . 22A and 22B to allow for a seamless actuation of the pull wire 407 and reduces a frictional resistance .
Alternatively, multiple pull wires 407 may be used for actuating the pusher element and puncturing element in a similar manner .
Figures 23A and 23 B show a semi-opaque perspective view of a di f ferent embodiment of a puncturing connection unit 401 comprising a ring-shaped housing 411 , a puncturing element 402 , and a pusher element 403 . The puncturing connection unit 401 of Figs . 23A and 23B is designed similar to Figs . 22A and 22B but an opening 409 is arranged tangentially to a pusher path 404 such that the frictional resistance of a actuating element for retracting the pusher element 403 after advancing the puncturing element 402 across a tissue receiving gap 405 is reduced . Optionally or in conj unction, the opening 409 can be adapted for receiving a deployment element ( see Fig . 25 ) .
Figures 24A and 24B show a perspective view of a deployment unit 406 without and with the puncturing element 402 and pusher element 403 adapted to deploy a suture/a fastener from the puncturing element 402 . The deployment unit 406 comprises a deployment element 412 and a biasing element 410 formed by a spring . The deployment element 412 has a curved shape and is si zed to be inserted through the pusher element 403 and the puncturing element 402 to deploy a suture/a fastener which is placed within the puncturing element 402 ( see Fig . 24 ) .
The biasing element 410 is arranged around the deployment element 412 and contacts a counter surface of the deployment unit 406 on one end and is adapted to contact the pusher element 403 on the other end ( see Fig . 24B ) . The deployment unit 406 may be advanceable along the pusher path within a ring-shaped housing as previously described ( see Figs . 22A - 23B ) by an actuating element such as a pull wire . The pull wire may be arranged within an opening of the housing and guided along the pusher path in a previously described manner to advance the deployment unit 406 towards the pusher element 403 . Figure 24A shows the biasing element 410 in a relaxed state and Figure 24B shows the biasing element 410 in a tensioned state .
The deployment unit 406 is preferably actuated once the puncturing element 402 was advanced across the tissue bulges such that the suture/the fastener can be deployed . The fastener may be an T-shaped fastener ( see Fig . 25 ) . I f the deployment unit 406 is advanced with respect to the pusher element 402 along the pusher path indicated by the dashed arrow in Fig . 24B, the deployment element 412 is inserted through the pusher element 403 and the puncturing element 402 . Advancing the deployment unit 406 with respect to the pusher element 403 overcomes a resetting force of the biasing element 410 interacting with the counter surface and the pusher element 403 . After the suture/the fastener was deployed, the actuating element may be released . Subsequently, the resetting force of the biasing element 410 pushes apart the pusher element 403 and the counter surface such that the deployment unit 406 is moved apart from the pusher element 403 along the pusher path . This enables the deployment element 412 to be retracted from a lumen of the pusher element 403 in a reliable auto-resetting manner .
Figure 25 shows a semi-opaque top view of a puncturing element 402 , a biasing element 410 , and a deployment element 412 of the puncturing connection unit . Figure 25 schematically shows that the deployment element 412 is insertable into a lumen of the puncturing element 402 to deploy a previously described I-shaped fastener 32 ( see e . g . Fig . 10D) . The fastener 32 in Fig . 25 is completely arranged within the lumen such that the fastener 32 can be deployed when inserting the deployment element 412 indicated by the dashed arrow . The deployment element 412 pushes the fastener 32 such that one end of the fastener 32 protrudes from the puncturing element 402 . Upon retracting the puncturing element 402 , the I-shaped fastener 32 is ej ected and the other end is deployed on the other side of the tissue bulges . For this reason, a connecting element of the fastener 32 may be adapted to be elastically deformable as described in Fig . 9A. Similarly to Figs . 23A and 23B, the biasing element 410 formed by a mechanical spring is contracted between the puncturing element 402 and a counter surface of the deployment unit while the deployment element 412 is advanced, e . g . via a pull wire . Subsequently, puncturing element 402 and the deployment element 412 are pushed apart by a resetting force of the biasing element 410 .
Figure 25 further shows that the deployment element 412 may be elastically deformable to conform to a traj ectory of the lumen, e . g . from a straight shape to a curved shape . This may be advantageous , i f the deployment element 412 is not guided along a pusher path of the puncturing connection unit but e . g . introduc- ible into the pusher path via an opening of the ring-shaped housing ( see Figs . 23A and 23B ) .
Figures 26A to 26C shows perspective views and a longitudinal axial view of a di f ferent embodiment of a puncturing connection unit 501 . The puncturing connection unit 501 comprises a plurality of puncturing connection modules 511 which are connected to each other by pivotable connectors 514 formed by hinges such that the puncturing connection modules 511 are movable with respect to each other to facilitate peroral access . Each puncturing connection module 511 has two biased appendages 504 , 505 which radially extend from a body 503 of the puncturing connection unit 501 . Figures 26A to 26C show a puncturing element 502 which is arranged on a first biased appendage 504 and a puncture section 506 formed by a puncture opening arranged on a second biased appendage 505 . The biased appendages 504 , 505 have a longitudinal subsection in close proximity to the body 503 which form a biasing section 512 , 513 which allows the biased appendages 504 , 505 to be elastically movable with respect to each other . Each puncturing connection module 511 has an actuating mechanism
507 which comprises a pull wire 508 and a first and second redirector wheel 509 , 510 ( only shown exemplary in Fig . 26A) . The body 503 has a plurality of lumens for receiving the pull wires
508 of the di f ferent puncturing connection modules 511 as shown in Fig . 26C . The first redirector wheel 509 is configured for redirecting the pull wire 508 radially towards the second biased appendage 505 . The second redirector wheel 510 is configured for redirecting the pull wire 508 to the first biased appendage 504 . The pull wire 508 is attached to the first appendage 504 such that a tensile force is applicable to the pull wire 508 by retracting the pull wire 508 , e . g . by manually extracorporeally pulling the pull wire 508 by a clinician . The redirector wheels 509 , 510 allow for optimi zed force transmission via the pull wire 508 . This enables the pull wire 508 to be actuated to pull the biased appendages 504 , 505 towards each other such that the puncturing element 502 can be advanced through the puncture opening 506 . Thereby, the puncturing element 502 can be advanced through tissue bulges which may be placed in between the biased appendages 504 , 505 . The puncturing element 502 is adapted to deploy a previously described fastener or suture through the tissue bulges once it was advanced through the puncture opening 506 . The biasing sections 512 , 513 of the biased appendages 504 , 505 are elastically deformed during conversion to the closed state . Based on a restoring force of the biasing sections 512 , 513 which are shown in Figs . 26A - 26C as mechanical springs , the biased appendages 504 , 505 return to their original positions in the open state without tensioning the pull wire 508 .
The embodiments illustrated in Figs . 22A to 26C are readily combinable with the previously described medical apparatus comprising a si zing tube . Figures 27A to 27D show a longitudinal axial view of an exemplary embodiment of the gripping unit 601 being converted from a contracting state 606 to an expanded state 607 . In the figures 27A to 27D, for enhanced visibility, solely a single gripping element 604 and mechanical linkage system associated with it is depicted . The gripping unit 601 has a ring-shaped body 602 which encloses a circular lumen 603 . The ring-shaped body 602 may longitudinally extend to a tubular shape or form a si zing tube ( see Figs . 30A and 30B ) . Two articulated arms 610 , 611 are connected on one end to the ring-shaped body 602 by hinges 612 which enable a pivoting movement of the articulated arms 610 , 611 radially outward with respect to the ring-shaped body 602 . Another end of the articulated arms 610 , 611 is attached via hinges 612 to the gripping element 604 . The gripping element 604 comprises a gripping section 613 which is adapted to laterally engage tissue bulges at a position radially outside of the ring-shaped body 602 at a gripping site . The gripping site is spaced apart more than 50% of the radial dimension of the ring-shaped body from the ring-shaped body 602 . This increase from a small cross- sectional dimension in the contracted state 606 to the expanded state 607 enables safe and reliable peroral insertion into the stomach in the contracted state and simultaneously enhanced manipulation of the tissue bulges in the stomach .
Figures 27A shows the gripping unit 601 in the contracted state 606 . Figures 27B and 27C show the conversion of the gripping unit 601 by pivoting the articulated arms 610 , 611 radially outward in a clockwise direction . The first articulated arms 610 , 611 have an arcuate shape correspondingly formed to the ringshaped body 602 such that they may form a seamless surface in the contracted state 606 . The first articulated arm 610 traverses the inner lumen 603 during the pivoting movement and has a larger longitudinal length than the second articulated arm 611 . The pivoting movement may be operated via one or more actuating element such as pull wires . The first articulated arm 610 in Figs . 27 A - 27B has a longitudinal length corresponding to 90% of the cross-sectional dimension of the ring-shaped body 602 and the second cross-sectional arm 611 to 50% of the cross-sectional dimension of the ring-shaped body 602 . Figure 27D shows the gripping unit 601 in the expanded state 607 . For gripping the tissue bulges from either side at a gripping site via the gripping section 613 of the gripping elements 604 , a mirrored mechanical linkage system and a second gripping element 605 may be provided to engage the tissue bulges from the other side ( see Figs . 28A - 29B ) .
Figures 28A -28D show a longitudinal axial view of an embodiment of the gripping unit 601 being converted from a contracted state 606 to an expanded state 607 . The gripping unit 601 has a ringshaped body 602 enclosing an inner lumen 603 . For each gripping element 604 , 605 , two articulated arms 610 , 611 are attached to the ring-shaped body 602 . The articulated arms 610 , 611 are connected to the ring-shaped body 602 via hinges which are spaced apart from each other and connected to either ends of the gripping elements 604 , 605 . The gripping unit 601 is convertible between the contracted state 606 and the expanded state 607 in a similar manner as previously described in Figs . 27A to 27D .
The articulated arms 610 , 611 attached to the respective gripping elements 604 , 605 in Figs . 28A to 28D have a curved shape corresponding to the ring-shaped body 602 in the contracted state 606 . Both articulated arms 610 , 611 have a longitudinal length of less than 50% of a radial cross-sectional dimension of the ring-shaped body 602 . The first and second articulated arms 610 , 611 of the respective gripping elements 604 , 605 are adapted to be pivoted with respect to the ring-shaped body 602 in opposing clockwise and counterclockwise directions in contrast to the gripping unit 601 in Figs . 27A to 27D . This reduces the space required for an actuation of the mechanical linkage system .
Figures 28A to 28D show that an actuating element formed by a pull wire 614 may be guided through a channel 615 of the ringshaped body 602 . The pull wire 614 may further be connected to the first articulated arm 610 , e . g . at a hinge connecting the articulated arm 610 and one end of the gripping element 605 . The pull wire 614 may be attached to the articulated arm 610 and/or the gripping element 605 in such a manner that the channel 615 for receiving the pull wire 614 is furthest away from the attachment point in the contracted state 606 and closest in the expanded state 607 . Figures 28A to 28D further show that the pull wire 614 has a second end which is actuatable for converting the gripping unit 601 in the expanded state 607 back to the contracted state 606 .
Figure 28A show the gripping unit 601 in the contracted state 606 for peroral insertion through the oesophagus .
Figures 28B and 28C show the conversion of the gripping unit 601 from the contracted state 606 to the expanded state 607 by pivoting the articulated arms 610 , 611 in opposing directions radially outwardly . The pivoting movement is driven by actuating an end of the pull wire 614 which is led through the channel 615 on either side of the gripping unit 601 for the mechanical linkage system . Alternatively, the movement of the gripping elements 604 , 605 or articulated arms 610 , 611 may be coupled to each other such that a single actuating element may be used for converting the gripping unit 601 to the expanded state . During the conversion of the gripping unit 601 the lumen 603 is not blocked/obstructed due to the short longitudinal lengths of the articulated arms 610 , 611 of the gripping unit in Figs . 28A - 28D .
Figure 28D shows that the gripping unit was converted to the expanded state 607 in which the gripping elements 604 , 605 enclose a gripping site 608 from two opposing directions such that tissue bulges may be gripped and connected, e . g . via puncturing connection unit ( see Fig . 29A - 30B ) . In the expanded state 607 , flat gripping sections 613 of the gripping elements 604 , 605 are adapted to compress the gripped tissue bulges .
The movement of the gripping elements 604 , 605 in 28A to 28B shows that the gripping section 613 is pivoted radially outwardly away from each other in a first stage of the conversion . The movement of the gripping elements 604 , 605 in Figs . 28C to 28D shows that the gripping sections are pivoted radially inwardly again towards each other . This enables reliable engagement of the tissue bulges from opposing sides precisely at the gripping site 608 without obstructing the lumen 603 or being obstructed by received tissue bulges . At the same time , an opening angle by the gripping elements may be adj usted such that di f ferently si zed tissue bulges can be reliably engaged and connected, rendering the gripping unit 601 more versatile .
Figures 29A and 29B show a longitudinal axial view of the embodiment of the gripping unit 601 of Figs . 28A to 28D in the expanded state 607 gripping and connecting two tissue bulges 191 , 192 . The gripping unit 601 was converted to the expanded state 607 in a previously described manner such that the gripping sections 613 of the gripping elements 604 , 605 grip the tissue bulges 191 , 192 of the stomach tissue from two opposing sides at the gripping site 608 .
The dashed line indicates that the tissue bulges 191 , 192 between the gripping elements 604 , 605 may be separated from each other via a previously described separation member . The gripping unit 601 may form a longitudinal section of the si zing tube such that the ring-shaped body 602 forms a mantle surface of a si zing tube . The tissue bulges may be sucked into the opening defined by the space between the gripping elements 604 , 605 and/or the si zing tube by applying a pressure via a suction port .
Once the tissue bulges 191 , 192 were securely gripped via the gripping sections 613 , a puncturing connection unit 701 shown in Fig . 29B is used for puncturing the tissue bulges 191 , 192 and placing an T-shaped fastener through the tissue bulges to connect them . The puncturing connection unit 701 in Fig . 29B has a low friction channel which guides a flexible puncturing element 702 through a lumen within the gripping element 605 to the gripping section 613 of the gripping element 605 . By advancing the puncturing element 702 , in particular manually by a clinician, the puncturing element 702 can be advanced across the tissue bulges 191 , 192 between the gripping sections 613 of the gripping elements 604 , 605 . The other gripping element 604 may comprise a receiving section for the puncturing element , in particular a puncture opening which facilitates deployment of the fastener ( see Figs . 30A and 30B ) . Subsequently, to the deployment of the fastener, the puncturing element 702 may be retracted through the low friction channel . The low- friction channel may be arranged within the ring-si zed body 602 or a si zing tube of a medical apparatus . After the tissue bulges 191 , 192 were connected, the gripping unit 601 may be converted from the expanded state 607 back to the contracted state , e . g . via actuation of the pull wire 614 , such that the gripping unit 601 can be retracted through the oesophagus . The pull wire 614 for converting the gripping unit 601 to the contracted state may also be arranged within a channel enclosed or within the ring-shaped body 602 (not shown in Figs . 29A and 29B ) .
Figures 30A and 30B show a perspective view of an embodiment of the gripping unit 601 with a puncturing connection unit 701 similarly to Fig . 29B . The gripping unit 601 in Figs . 30A and 30B may form a longitudinal subsection of a previously described medical apparatus . The gripping unit 601 may comprise or consist of polyurethane , silicone rubber, thermoplastic elastomers , and/or medical-grade polyvinyl chloride . On the one hand, these materials may provide suf ficient flexibility for atraumatic insertion but suf ficient rigidity to perform the gastric remodelling and conversion of the gripping unit 601 between the contracted and expanded state 607 .
Figs . 30A and 30B further show that two low- friction channels of the puncturing connection unit 701 for guiding a puncturing element 702 through one gripping element 604 . The low friction channels are guided to the gripping section of the gripping element 604 , such that the tissue bulges can be pierced at a gripping site . The other gripping element 605 has puncture openings for receiving the puncturing element 702 and facilitate deploying a fastener through tissue bulges . The low friction channels are arranged parallel relative to each other . The low- friction channels are further arranged to puncture the tissue bulges at di f ferent longitudinally spaced apart positions such that the gripped stomach tissue bulges may be punctured at a plurality of longitudinal positions for performing a gastric remodelling procedure , in particular a gastric sleeve procedure . Figure 31A shows a schematic cross-sectional view of an embodiment of the puncturing connection unit 801 for deploying a fastener formed by a straight staple 802 through the tissue bulges . The tissue bulges may be received in a tissue receiving opening 23 shown in Fig . 31A or a plurality of tissue receiving openings of the si zing tube in a previously described manner . The puncturing connection unit 801 has a movable part 804 and a non-mov- able part 805 forming a gripping unit . Figure 31A shows that a deployment structure for deploying the staple 802 is arranged within the movable part 804 . The staple 802 may be deployed similarly to a previously described manner, e . g . via moving the movable part 804 having an arcuate shape towards a counter surface 806 of the non-movable part 805 . The staple 802 may be deployed by moving a deployment element 412 ( see Figs . 24A and 24B ) in a circumferential direction to deploy the staple 802 through the tissue bulges towards the counter surface 806 . The puncturing connection unit 801 may comprise a biasing element as previously described to retract the deployment element 412 again via a resetting force (not shown in Fig . 31A) . The counter surface 806 or anvil element has a concave contour for plastically deforming the staple 802 once it was advanced through the tissue bulges such that the staple 802 cannot be retracted through the tissue bulges . Thereby, the staple 802 securely connects the tissue bulges together after deployment .
Figure 31B shows a schematic cross-sectional view of an embodiment of the puncturing connection unit 801 for deploying curved staples 803 through the tissue bulges . The puncturing connection unit is similar to the embodiment of Fig . 31A, but the deployment structure of the staples is instead arranged on a non-movable part 805 of the gripping unit of the puncturing connection unit 801 . Figure 31B shows instead that a movable part 804 which has a counter surface 806 for plastically deforming the staple 803 is movable in a circumferential direction towards the deployment structure for deploying the curved staples 803 through the tissue bulges . The deployment structure for deploying the curved staples may be a previously described deployment structure , see e . g . Fig . 9F, Figs . 18A and 18B, Figs . 22A - 24B, or Figs . 30A and 30B, or a deployment structure of Figs . 31A and 31B .
Figures 31C and 31D show a top view of a surface for deploying staples 803 of two embodiments of the puncturing connection unit ( see Figs . 31A or 31B ) arranged on a movable / non-movable part of the gripping unit . The staples 803 are arranged in two and three rows in an alternating zig- zag pattern, respectively .
Figs . 31C and 31D show that the surface for deploying may be arranged along a longitudinal direction of the si zing tube . The surface may be adapted to laterally contact the tissue bulges received within a tissue receiving opening, e . g . by moving the parts of the gripping unit towards each other . The gripping unit may have two movable parts or one movable and one non-movable part as previously described .
The staples 803 of the alternating zig- zag pattern in Figs . 31C and 31D are arranged such that the staples 803 are spaced apart equidistantly from each other . Deploying the staples 803 in this manner enables to establish a uni form connection of the tissue bulges along the tissue receiving opening .
Figures 31E and 31 F show a schematic side view of an embodiment of a staple 803 having two curved puncturing sections which are plastically deformed by a counter surface 806 of the puncturing connection unit . The staples 803 have two fastening elements formed by puncturing sections 807 which are connected via a con- necting element and form a U-shape . The staples 803 are mono- lithically formed and made of stainless steel or titanium . The counter surface 806 has two contoured sections which are adapted for plastically deforming, i . e . non-elastically deforming, the puncturing sections 807 of the staples 803 in a predefined manner .
When the staple 803 is deployed in a circumferential direction of the si zing tube across the tissue receiving opening through the tissue bulges as indicated by the dashed arrows in Figs . 31E and 31 F, the puncturing sections 807 engage the contoured section of the counter surface 806 and are deformed in the predefined manner . The staples 803 and the counter surface and its contoured sections may be adapted to deform in such a manner that a distal tip of the puncturing sections 807 is deflected by more than 90 ° , in particular more than 120 ° , preferably more than 150 ° . This enables to provide an atraumatic distal tip of the puncturing sections 807 after deployment through the tissue bulges .
Figures 32A and 32B and 32C show two embodiments of a deployment structure of the puncturing connection unit having a sledge 808 which is movable for deploying a plurality of fasteners formed by staples 803 .
Figures 32A and 32B show the first embodiment of the deployment structure 901 . The sledge 808 is movably arranged within a guide channel of the deployment structure 901 indicated by the rectangular shape . The sledge 808 is movable by an elongated actuation element such as a pull wire along the guide channel as indicated by the arrow in Figs . 32A and 32B . The staples 803 are spaced apart equidistantly in the direction of movement of the sledge 808 such that the staples 803 form a row in the guide channel . The sledge 808 has a deployment surface 809 which is chamfered such that a proximal end of the staples 803 can be engaged by the deployment surface 809 , i f the sledge 808 is pulled along the guide channel . When the sledge 808 is pulled along the guide channel even further, the proximal end of the staples 803 slides along the deployment surface 809 and is pushed radially outwards with respect to the direction of movement of the sledge 808 such that the tissue bulges may be connected . Thereby, the fasteners 803 can be deployed radially outwardly by the sledge 808 by continuously contacting sledge 808 at the deployment surface 809 in locali zed deployment states of the sledge 808 .
Figure 32A shows that the sledge 808 is in a non-contact state in which the sledge 808 does not contact the staples 803 . Figure 32A shows that the sledge 808 has deployed four fasteners 803 radially outwardly . This enables that the deployment structure 901 only necessitates a single actuation of the sledge 808 to sequentially deploy a plurality of the fasteners 803 along the tissue receiving opening to connect the tissue bulges reliably . On a radially opposing side of the deployment structure 901 of Figs . 32A a previously described counter surface may be arranged to plastically deform the puncturing sections of the staples 803 once they were advanced through the tissue bulges .
Figure 32C shows the second embodiment of the deployment structure 901 . The deployment structure 901 is similar to Figs . 32A and 32B but instead of engaging the fasteners 803 directly, a sledge 808 is adapted for engaging the fastener, e . g . staples 803 , indirectly . The sledge 808 of Fig . 32C is instead adapted for engaging fastener ej ectors 810 via its chamfered deployment surface 809 to deploy the staples 803 . Figure 32C shows that the sledge 80 is movable in a direction of movement along a guide channel in which the fastener ej ectors 810 are arranged .
The guide channel has a plurality of slits which extend from the guide channel in a direction orthogonally away from the direction of movement of the sledge . These slits may be directed towards the tissue receiving opening .
The fastener ej ectors 810 comprise an ej ection section 811 which is arranged within the guide channel . As shown in Fig . 32C, the fastener ej ectors 810 have a T shaped cross-section such that the ej ection section is securely held within the guide channel and the slit of the deployment structure 901 . The fastener ej ectors 810 extends radially through the slits formed in the guide channel to a fastener engagement section 812 of the fastener ej ector 810 .
The fastener engagement section 812 is adapted for engaging and radially deploying the staple 803 . Once the deployment section 809 is moved along the guide channel , the deployment section 809 engages the ej ection section 811 and slides it in a radially outwardly direction . Thereby, the fastener ej ector 810 is moved along the radially extending slit such that the ej ection section
811 radially ej ects and deploys the fasteners 803 .
Fig . 32C shows that the slits and fastener engagement sections
812 may be alternatingly arranged on two radially outward sides of a longitudinal direction of the guide channel , i . e . the direction of movement of the sledge . This enables a deployment of the fasteners 803 in a zig- zag pattern through the tissue bulges , e . g . along the longitudinal direction of the tissue receiving opening . In a preferred embodiment , the sledge 808 is movable in parallel to the tissue receiving opening such that the plurality of fasteners 803 can be deployed radially across the tissue receiving opening in a reliable manner .
Figures 33A and 33B show a cross-sectional a perspective view of an embodiment of the medical apparatus 101 comprising a si zing tube 2 having two actuated rings 821 , 822 driving the puncturing connection unit 801 . In alternative , the si zing tube 2 may merely have one actuated ring 821 . The puncturing connection unit 801 is a previously described puncturing connection unit 801 with a deployment structure 901 described in Figs . 31A - 32C . The deployment structure 901 is adapted to deploy straight fasteners 802 through the tissue bulges 191 , 192 for connecting them, in particular via a sledge and fastener ej ector . The tissue bulges 191 , 192 shown in Fig . 33A are received within a tissue receiving opening 21 of the si zing tube as previously described . In particular, the embodiment may comprise a separation member and a suction port as previously described to enable a formation of the two tissue bulges , preferably formed by a posterior and anterior wall of the stomach . The puncturing connection unit 801 further comprises a counter surface 806 formed by an anvil element . Figures 33A and 33B show that the counter source 806 is arranged on a movable part 61 of a gripping unit 6 . The deployment structure 901 is instead arranged on a nonmovable part 62 of the gripping unit . Alternatively, the deployment structure 901 may instead of the counter surface 806 be arranged on the movable part . In a preferred embodiment , both the counter surface 806 and the deployment structure 901 are arranged on a movable part 61 of the gripping unit (not shown in the figures ) . As indicated by the dashed arrow in Fig . 33A, the movable part 61 comprising the counter surface 806 is either rotatable or elastically deformable towards the non-movable part 62 and thus the deployment structure 901 . Subsequently, the staples 802 are deployed through the tissue bulges 191 , 192 and are plastically deformed to reliably connect the tissue bulges 191 , 192 .
Figures 33A and 33B further show that the gripping unit 6 which is adapted for bringing the counter surface 806 and the deployment structure 901 together has two pull wires 823 , 824 . The actuation elements , e . g . the pull wires 823 , 824 , of the gripping unit 6 may be longitudinally spaced apart from the tissue receiving opening . Figure 33B shows that the movable and non-mova- ble part 61 , 62 are inserted into a hollow spacing of the first and second ring 821 , 822 . The pull wires 823 , 824 are further attached to a proximal-most end of the counter surface 806 of the movable part 61 on either side . The pull wires 823 , 824 extend at least partially in a circumferential direction, e . g . in a low- friction channel or slit adj acent to the proximal end of the movable/non-movable part 61 , 62 such that they are actuatable to def orm/rotate the movable part 61 . Figure 33A shows that the si zing tube 2 comprises a partially deformable material such as silicone which is chemically inert and can be elastically deformable . However, in a preferred embodiment , a movable part 61 of the gripping unit 6 is rotatably movable in a circumferential direction of the si zing tube 2 . Thereby, the movable part 61 can be def ormed/rotated towards the deployment structure 901 by manipulating the first pull wire 823 and def ormed/rotated back via manipulation of the second pull wire 824 . The second distal ring 822 may be coupled to this def ormation/rotation such that the movable part 61 can be actuated via a uni form force distribution via the proximal and the distal ring 821 , 822 .
A person skilled in the art would further recogni ze , that alternatively or additionally the non-movable part 62 comprising may be movable . The pull wires in the second ring 822 may e . g . be adapted for driving this movement similarly as described for the movable part 61 shown in Fig. 33B.
Figure 33B further shows that the deployment structure 901 comprises a plurality of staples 802 which are arranged in one row extending in a longitudinal direction of the sizing tube 2 adjacent the tissue receiving opening 21. However, the deployment structure 901 may comprise more rows, in particular at least two or three, and/or the staples 802 may preferably be arranged in the previously described zig-zag pattern. Once the tissue bulges 191, 192 were received in the tissue receiving opening 21, the pull wire 823 may be actuated such that the tissue bulges 191, 192 are gripped by def orming/rotating the movable part 61 towards the non-movable part 62 and the deployment structure 901. Subsequently, the deployment structure 901 may be actuated, e.g. by pulling a sledge which is arranged in a guide channel at the distal end of the sizing tube 2, e.g. in the second ring 822 towards the proximal end via a pull wire (not shown in Figs. 33A and 33B) . Thereby, a deployment surface of the sledge may deploy the plurality of staples 802 to connect the tissue bulges 191, 192 as previously described (see Figs. 32A - 32C) .
Figures 34A and 34B show a schematic perspective view and cross- sectional view of an embodiment of the medical apparatus 101 comprising a sizing tube 2 having overlapping longitudinal subsections 902, 903. The sizing tube 2 has a deflectable section, e.g. via a pull wire, which is actuatable such that the sizing tube 2 forms a loop within the stomach. This can be achieved by pivoting the second longitudinal subsection 903 via deflecting the deflectable section such that the second longitudinal subsection 903 is arranged essentially parallel to a first longitudinal subsection 902. As indicated by the arrows in Fig. 34A and shown in further detail in Fig . 34B, a puncturing connection unit of the si zing tube 2 is adapted for deploying fasteners through an opening between the two longitudinal subsections 902 , 903 .
Figure 34B shows the cross-sectional view of the two longitudinal subsection 902 , 903 . The second longitudinal subsection 903 has two tissue receiving openings 22 , 23 on opposite sides such that the tissue bulges 191 , 192 can be received within the second longitudinal subsection 903 in a partially overlapping manner . This can be achieved by applying suction via a suction port in a previously described manner .
At least one fastener 903 and a deployment structure (not shown in Fig . 34B ) of the puncturing connection unit are arranged within the first longitudinal subsection 902 . A counter surface 806 / an anvil element is arranged on an opposing side within the second longitudinal subsection 903 of the puncturing connection unit . Thereby, the at least one fastener, formed by a saple 803 in Fig . 34B can be advanced through the opening between the longitudinal subsections 902 , 903 . After success fully deploying the staple 803 through the tissue bulges 191 , 192 , the puncturing section of the staple 803 are deformed by the counter surface 806 in the second longitudinal subsection 903 . Figure 34B further shows an endoscope 905 which is arranged within a lumen of the si zing tube to monitor the stapling procedure .
Figures 35A - 35C show an exemplary embodiment of a medical apparatus 101 comprising a si zing tube 2 having a plurality of rigid articulated segments 813 connected via hinges 814 being inserted through the esophagus in a flexible state 816 and converted into a sti f f state 817 . The plurality of articulated segments 813 can be advanced perorally through the esophagus in a Ill flexible state 816. In the flexible state, the hinges 814 enable at least a two-dimensional movement, in particular a three-dimensional movement, of the rigid articulated segments 813 with respect to each other. This enables to advance the sizing tube 2 in a simple manner along the curvature of the esophagus. The rigid articulated segments 813 may have chamfered articulated neighboring surfaces 818 (see Fig. 35C) such that they can be deflected in the flexible state 186 in a predefined manner.
Once the sizing tube 2 was advanced into the stomach as exemplary shown in Fig. 35A, the sizing tube 2 may be converted to a stiff state 817. The sizing tube 2 is convertible via an elongated actuation element 815 formed by a pull wire which can be pulled in a proximal direction to create a compression stress between the rigid articulated segments 813 of the sizing tube 2. The pull wire is arranged within a low-friction channel leading through the rigid articulated segments 813 and is connected to a distal most articulated segment 813. Simultaneously, to pulling the pull wire, a placement catheter 820 remains in place, such that the compression force is only exerted on the rigid longitudinal subsections 813. In the stiff state 817, the sizing tube may assume a specific predefined shape. Figure 35C exemplary shows that neighboring contacting surfaces 819 of the rigid longitudinal subsections 813 through which the pull wire 815 is guided have an essentially flat surface orthogonally with respect to a longitudinal direction of the sizing tube, such that the predefined shape is a straight shape. After successfully connecting the tissue bulges, the sizing tube 2 may be converted from the stiff state 817 to the flexible state 816 again to be retracted through the esophagus. Figures 35A - 35C do not explicitly show the receiving opening, puncturing connection unit , suction port , in particular a gripping unit . However, a skilled person would recogni ze that each rigid articulated segment 813 may have these features and be adapted for connecting the at least two tissue bulges in a previously described manner .
In a preferred embodiment , the si zing tube 2 may be adapted to deploy fasteners through the tissue bulges in one of the previously describe manners in Figs . 31A - 34B .