Disclosure of Invention
The object of the present invention is to overcome the drawbacks of the prior art, in particular to provide an implant and a duodenal anchor for securing the implant in the patient's duodenum, which is easier to manufacture, easier to deploy, capable of providing a reliable anchoring and reducing side effects such as chyme transfer unreliability.
It is a further object of the present invention to provide an implant and a therapeutic device for placement in the gastric tract of a patient that is easy to manufacture, easy to deploy, capable of providing a reliable anchoring, and that does not produce side effects, especially due to unreliable transfer of chyme.
These and other objects are achieved by means of a device and a method according to the characterizing portions of the independent claims. Further embodiments are provided by the dependent claims.
According to the present invention, there is provided a duodenal anchor for securing an implant within a patient's duodenum. The duodenal anchor has an outer surface configured to conform to an inner wall of a patient's duodenum. The duodenal anchor includes an internal, preferably centrally located passageway for delivering chyme. The duodenal anchor further includes an inflatable portion disposed at least partially circumferentially about the internal channel. When the fillable section is filled with fluid, its circumference is greater than the inner circumference of the duodenum.
The inflatable portion may be an inflatable member, in particular a balloon. The inflatable member may generally include a fluid-tight and/or airtight interior volume so that fluid may be injected through, for example, a valve or closable opening and prevent fluid outflow.
Preferably, the fillable section may comprise or be formed by an outer sleeve. The outer cover may have a first end and a second end. The first end may be connected (in particular glued) to the inner channel, thereby forming an inner volume that may be filled with a fluid. The outer jacket layer is connected to the inner channel in a fluid-tight manner by a first end.
The outer jacket layer may at least partially enclose the internal channels.
The internal volume formed by the outer jacket layer and the internal channels need not be fluid tight.
Preferably, the second end of the outer casing is a free end adapted to move (e.g. slide) at least or preferably only along the surface of the inner channel. In other words, the outer jacket layer may be attached at one end and not at the other end, such that fluid filled in the interior volume may escape through the gap formed between the second end and the interior channel. Preferably, the free end is located distally of the duodenal anchor. Thus, the duodenal anchor may move away in a distal direction relative to the proximal member of the implant system in response to the force, and folding of the outer jacket may increase the anchoring force of the duodenal anchor.
The proximal-most surface of the outer jacket layer and/or the first end may coincide with the proximal end of the internal passageway.
It will be appreciated that such a device may be filled with fluid even though the fluid may freely escape the internal volume.
Preferably, at least one connector passes through the fillable section and is attached to the distal end of the fillable section. Preferably, three connectors pass through the fillable section. It is particularly preferred that the distal end to which the at least one connector is attached is the second end of the outer sleeve. It should be understood that the connectors described herein may be formed from extensions of the connectors connecting the duodenal anchors and the gastric anchors.
At least one connector may be connected to the second end, through the interior volume of the fillable section, and through the aperture in the proximal portion of the outer jacket. The aperture may be sealed in a fluid-tight manner and/or adapted for sliding a connector through the aperture.
The at least one connector passing through the fillable section may be the end of a connector as described below.
Thus, when a pulling force is applied to the connector (e.g., due to peristaltic movement), the second end may slide in the direction of the force, resulting in a reduction in volume. The outer cover layer can be folded into an accordion shape. Fluid used to fill the fillable section may escape from the interior volume due to the reduced volume caused by the collapse.
While the initial anchoring may require filling with liquid in order to better conform to the internal shape of the patient's duodenum, surprisingly, the anchoring force of the duodenal anchor may be stronger when the outer cover is folded over and allows liquid to flow out. Thus, an automatic feedback mechanism may be provided to enhance the anchoring force by folding the outer casing when the duodenal anchor is subjected to the force. In this way, the duodenal anchor is prevented from being accidentally pulled back/moved into the stomach.
The duodenal anchor may also preferably comprise a pulling device. The pulling device may be attached to the distal end of the outer sheath. The pulling device may interact with the patient's bowel (e.g., due to peristalsis), thereby pulling the outer sheath away from the duodenal anchor.
In some patients, a gastric anchor attached to a duodenal anchor may continue to exert some pulling force. Thus, when the duodenal anchor is configured to fold the outer surface (e.g., the outer jacket layer) due to the pulling force, there may be a bias that causes the outer surface to permanently fold. Although temporary folding is advantageous for the reasons described above, the folded structure may irritate the duodenum over time. Thus, it is desirable to restore the fold when there is no tension and/or the tension is small enough to adequately anchor without the need for a fold structure. In addition, irritation may generally be reduced when the folding structure is allowed to move back and forth to some extent to accommodate the patient's duodenum. Thus, the pulling device may reduce irritation by at least partially deploying the outer sheath based on a first pulling force acting on the pulling device and a second opposing pulling force acting on, for example, a gastric anchor.
The invention also relates to a pulling device for a duodenal anchor. The pulling device may be attached or connectable to the duodenal anchor, preferably directly, and preferably not attached to a cannula connected to the duodenal anchor.
Completely filled with fluid is understood to mean filling with a maximum amount of fluid and/or gas at a pressure inside the fillable section that is not substantially higher than the external pressure (e.g. atmospheric pressure). Preferably, the fillable section can contain at most 10 ml to 60 ml of fluid (or gas) in a fully inflated and/or filled state. More preferably, the fillable section can contain at most 25 milliliters to 45 milliliters of fluid (or gas) in a fully inflated and/or filled state. In a preferred embodiment, the fillable section can hold a volume of 34 milliliters in a fully inflated and/or filled state.
In particularly preferred embodiments, the fillable section is filled with air (and/or other medically acceptable gas) only for implantation, and no additional fluid is injected into the fillable section before, during, or after implantation.
This allows the fillable section to reach the size of the duodenum without being fully inflated and/or filled. Thus, the fillable section can adapt to the inner surface of the duodenum, in particular its shape.
The fillable portion may be filled with an incompressible fluid, such as a liquid (e.g., saline) and/or a gas (e.g., air). The use of an air-filled fillable section makes it particularly flexible in construction when partially inflated.
The human duodenum typically has an inner diameter of 25 mm and an inner circumference of 75 mm. Thus, when the fillable section is fully inflated and/or filled with fluid and/or gas, its circumference may be greater than 75 millimeters and/or its inner diameter may be greater than 25 millimeters.
Preferably, the outer diameter of the fillable section when fully inflated and/or filled is in the range of 30 to 70 mm, more preferably in the range of 35 to 55 mm, most preferably in the range of 35 to 45 mm. In a preferred embodiment, the outer diameter of the fillable section when fully inflated is 40 millimeters.
Preferably, the fillable section is arranged circumferentially with respect to the inner channel, whereas the inner channel may be arranged centrally.
The outer surface of the duodenal anchor is configured to conform to the inner wall of the patient's duodenum. For this purpose, the fillable section, in particular the outer wall, may be composed of a mechanically soft material, such as a soft polymer. Additionally or alternatively, the fillable portion may be sized such that at least one outer wall is mechanically flexible. The mechanical flexibility of the fillable section, and in particular the outer wall thereof, is sufficient to accommodate the inner wall of the patient's duodenum. The fillable section, in particular the outer wall thereof, may be made of a silicone, for example a silicone having a shore a hardness of 30-60. The tensile strain of the outer wall material of the fillable section and/or the tube/inner channel material may be 100-300%.
The diameter of the internal passageway ranges from 10mm to 25mm, preferably from 15mm to 21 mm, most preferably from 17 mm to 19 mm. In a preferred embodiment, the diameter of the internal passageway is 18 millimeters.
The duodenal anchors according to the present invention are particularly suited for delivery to and partial inflation at an implantation site. Thus, the anchor may have a compressed shape that is compact and easy to deliver safely. Particularly preferably, the fillable portion may be crimped under vacuum for delivery.
When the anchor is placed substantially to the final implantation position, a partial inflation may be performed, i.e. filling the fillable section with a quantity of fluid, but the quantity of fluid does not reach a fully filled state. To this end, an inflation port may be provided and in fluid communication with the interior volume of the fillable section. The inflatable portion may be inflated using a static syringe. When the fillable portion is vacuum corrugated, the fluid can penetrate the fillable portion due to the pressure gradient without applying additional pressure on the syringe.
Since the surrounding mucosa may impose constraints on the fillable section before it reaches its nominal shape (i.e. before it is completely filled), the fillable section may reach an under inflated equilibrium state. At this point, the inflation port may be closed and the inflation tube may be disconnected from the valve. Thus, the fillable section will attain a shape conforming to the anatomy of the implantation site, i.e., the anchor can be shaped in situ according to the specific shape of the patient.
This patient-specificity is achievable with anchors having a circumference that is greater than the inner circumference of a typical human duodenum, as it allows for the firm implantation of an underinflated anchor.
In general, the terms "distal" and "proximal" refer to directions relative to the gastrointestinal tract. Stomach of human body the intestine is located at the proximal end. The intestine is located distally relative to the stomach. Thus, the distal and proximal portions of any element herein refer to their respective positions under the implantation site (i.e., toward the stomach or intestine as described above).
In a preferred embodiment, the duodenal anchor is cylindrical over at least a portion of its length. Preferably, the cylindrical shape extends over 40% of its length. The length of the implant is understood to be an extension in a direction substantially parallel to the longitudinal axis of the duodenal anchor.
The cylindrical shape may in particular allow for a convenient connection to other implants, such as a duodenal tube.
In a preferred embodiment, the duodenal anchor includes a valve mechanism connected or connectable to the fillable section for filling the fillable section.
A valve mechanism may be connected to the inflation port. The valve mechanism is adapted to receive an inflation tube that can open the valve mechanism when inserted therein. The valve mechanism may also be adapted to close after removal of the inflation tube.
In general, when the valve mechanism is in an open state, fluid may flow into the fillable portion from an external source connected or connectable to the inflation port and/or the valve mechanism. When the valve mechanism is closed, fluid does not flow out of the fillable section through the valve mechanism.
In a preferred embodiment, the duodenal anchor is attached to the proximal end of a cannula having a distal end for placement within the small intestine.
In a preferred embodiment, the internal passageway of the duodenal anchor is substantially tubular.
The internal passageway of the duodenal anchor may be substantially tubular over at least 60%, more preferably 80%, and most preferably 90% of its length in a direction substantially parallel to the longitudinal axis of the implant body.
In a preferred embodiment, the fillable portion of the duodenal anchor comprises a mechanically flexible outer wall.
The fillable section is only partially filled when the duodenal anchor with the fillable section is placed into the patient's duodenum. The mechanically flexible outer wall of the fillable section may take on an amorphous shape as it is only partially filled.
Mechanically flexible outer walls may provide a number of advantages. First, in the radial direction, it may yield to peristaltic movements of the intestinal tract attempting to push the outer wall of the fillable section back and forth. Second, in the axial direction, the mechanically flexible outer wall may take on an amorphous shape due to the partial expansion of the fillable section. Thus, only the fluid within the fillable section, and not the entire duodenal anchor, will move back and forth as a result of the peristaltic movement of the intestinal tract.
In a preferred embodiment, the duodenal anchor (preferably the fillable portion) is crimped together by a release mechanism (preferably a crimping membrane and a release wire) to reduce the radial dimension of the duodenal anchor, thereby facilitating delivery. Particularly preferably, the crimp film comprises or is made of silica gel.
In order to facilitate delivery of the duodenal anchor into the duodenum of a patient, it is advantageous to reduce the size of the duodenal anchor, particularly the radial size thereof.
The fillable sections may be placed in a vacuum environment and crimped together by a release mechanism. The release mechanism may include a silicone crimp membrane bound together by a release wire that releases pressure applied to the duodenal anchor by pulling on one end of the release wire.
In a preferred embodiment, the duodenal anchor comprises an elongate member having a free distal end extending in a direction generally parallel to the longitudinal axis of the duodenal anchor. Such an elongate element may provide for higher mechanical flexibility while preventing the sleeve therearound from collapsing (e.g., due to folding).
When implanted in a patient's duodenum, the distal end of the duodenal anchor may face the small intestine.
The elongate member may be made of the same or different material as the duodenal anchor. The elongate element preferably comprises or is constructed of a soft material and is additionally or alternatively dimensioned to be mechanically flexible (i.e. to elastically deform under typical forces applied in an implanted state). The elongate member may provide stability to, for example, a cannula placed around the elongate member. It will be appreciated that the function of the elongate element is substantially the same as the elongate element of the preferred embodiment of the implant according to the present invention. When the elongate element is connected to the duodenal anchor, particularly simple treatment may be provided as no separate implant need be provided.
Preferably, the elongate member is disposed about the distal end of the internal passageway of the distal end of the duodenal anchor. When extending in a direction parallel to the longitudinal axis of the duodenal anchor, the elongate member preferably forms a tubular structure having a straight longitudinal incision. Preferably, the width of each slit is the same as the width of each elongate element.
In a preferred embodiment, the proximal end of the duodenal anchor is connectable to a connector or stent, preferably by a plurality of connecting elements arranged in circumferential positions relative to the central channel.
Preferably, the duodenal anchor includes at least one passage extending through the wall adapted to receive a connector.
After implantation of the duodenal anchor into the patient's duodenum, its proximal end faces the stomach. The distal end of the duodenal anchor is opposite the proximal end.
When treating a patient with a gastric anchor in balloon form, the duodenal anchor may also be or can be connected to the gastric balloon.
According to another aspect of the present invention, an implant for placement in the duodenum of a patient is provided. The implant has a generally tubular implant body having a proximal end and a distal end. The proximal end of the implant body may be secured or secured to a duodenal anchor, preferably a duodenal anchor as described above. The implant body comprises a plurality of elongate elements having free distal ends extending in a direction substantially parallel to the longitudinal axis of the implant body. The free end of the elongate member forms the distal-most portion of the implant body.
Preferably, the proximal end of the implant body is securable or secured to the duodenal anchor, more preferably to the distal end of the duodenal anchor. When implanted in the patient's duodenum, the distal end of the duodenal anchor may face the small intestine.
The implant body may be generally tubular in length along a direction substantially parallel to its longitudinal axis, at least 60%, more preferably 80%, and most preferably 90%.
The generally tubular implant body, along with the elongate member, may be castellated.
As the elongate elements will bend and kink with the anatomy of the patient, the circumferential space between two adjacent elongate elements may form a chyme channel. The circumferential space between the elongated elements ensures a reliable delivery of chyme even if the elongated elements are bent and/or kinked, e.g. due to the anatomy of the patient. Thus, chyme channels formed from the tubular structure are less prone to blockage by, for example, kinking.
Preferably, the width of each circumferential space between the longitudinal elements is equal to the width of each elongated element.
The circumferential space may be a gap.
The length of each elongate element may be between 5mm and 30mm, preferably between 10mm and 15 mm.
Preferably, each elongate element is in the shape of a cuboid. Preferably, the elongate element has a width greater than its thickness. Preferably, the length of the elongate element is greater than its width and thickness.
Preferably, the elongate element comprises or consists of the same material as the body of the implant. Additionally or alternatively, the elongate element comprises or is constructed of a material that is mechanically more flexible than the implant body.
Preferably, the elongate element comprises or consists of a durable thermoplastic material, such as Thermoplastic Polyurethane (TPU) and/or silicone. The shore a hardness of the material may be 60.
Preferably, the elongate elements are arranged around the same circumference as the diameter of the internal passage, thereby forming a tubular shaped extension.
The width of each elongated element may be between 2 and 15 mm, preferably between 4 and 8 mm, particularly preferably between 5 and 6 mm.
In an advantageous embodiment, the implant further comprises a (preferably intestinal) sleeve arranged around the tubular implant body and attached to the proximal end of the implant body, wherein the distal end of the sleeve is configured for placement in the small intestine. The sleeve may be suitable for delivering chyme and may reduce or prevent contact of chyme with the intestinal wall.
The sleeve may be placed 60 to 100 cm from the proximal intestine, i.e. the sleeve may cover the duodenum and part of the jejunum. The diameter of the sleeve may be between 15 and 30 mm, preferably between 20 and 25 mm.
In an advantageous embodiment, the implant body comprises 3 to 20 elongated elements, preferably 6 to 12.
In an advantageous embodiment, the implant body comprises or consists of a soft material, preferably an elastic soft material.
Preferably, the elongate element and the implant body comprise or consist of the same material.
Particularly preferably, the elongate element is constructed of a soft material, preferably a resilient soft material, such as medical grade silicone.
The material may be a material having a Shore A hardness of less than 55-65.
In an advantageous embodiment, the outer dimension of the implant in a direction perpendicular to the longitudinal axis is between 1 and 10 cm, preferably between 10 and 30 mm.
In an advantageous embodiment, the elongated element has a closing surface, in particular in a direction perpendicular to the longitudinal axis.
The closing surfaces are understood to be solid elements, since they are filled with material, i.e. for example, they have no holes through them.
For example, an elongated element having a cuboid shape, wherein the elongated element is filled with material (i.e. is non-porous), presents four closed surfaces in a direction perpendicular to the longitudinal axis.
Preferably, the elongate element of the implant presents a closing surface in a direction perpendicular to the longitudinal axis, which closing surface is the largest surface of the elongate element.
In an advantageous embodiment, the width of at least one circumferential space (preferably all circumferential spaces) between the elongate elements of the implant body corresponds to the width of the elongate elements. When not all elongated elements have the same width, the width of the space may correspond to the width of at least one elongated element.
In an advantageous embodiment, the elongate element of the implant body is impermeable to liquid and gas.
Liquid and gas impermeable means that it does not allow liquid and gas to pass through, or at least reduces the rate of liquid or gas passage.
In an advantageous embodiment, the substantially tubular implant body has a wall without openings and/or has a substantially continuous surface.
The elongated element may in particular have a rectilinear shape, without a curve along the longitudinal axis. The elongate element may be made of a soft material and/or the same material as the implant body.
The solid cuboid may form a wall without openings.
According to another aspect of the present invention, a connector for connecting a duodenal anchor and a gastric anchor is provided. Preferably, the duodenal anchor is a duodenal anchor as previously described. The connector has a central portion and a plurality of first and second ends disposed at opposite ends of the central portion. The central portion has a generally elongated shape along a longitudinal axis. The plurality of first ends are configured to be secured or securable to the duodenal anchors at the free ends of the first ends. The plurality of second ends are configured to be secured or securable to the gastric anchor at the free ends of the second ends. The first plurality of free ends and the second plurality of free ends extend radially away from the longitudinal axis. Preferably, the plurality of first free ends and the plurality of second free ends have connection means for connection to a duodenal anchor and a gastric anchor, respectively.
The connector according to the present invention allows for the connection of two elements, such as a gastric anchor and a duodenal anchor, through the pylorus while still allowing chyme to pass through the pylorus.
The connector may comprise or be made of medical grade silicone, which is biocompatible and atraumatic.
The gastric anchor may be a stent or an inflatable gastric anchor, such as a balloon. The inflatable stomach anchor may be fully inflated.
When the gastric anchor is inflatable, the nominal volume of the inflatable member may be 30 to 80 milliliters, preferably 50 to 60 milliliters.
When the gastric anchor is a stent, the stent length may be in the range of 15 to 50 mm, preferably 20 to 30 mm. The diameter of the stent may be in the range of 30 to 80 mm, preferably 50 to 60mm. The rack may comprise 9 to 18 rack units, preferably 12 to 15.
The filaments of the stent may extend within the pylorus for a length of 5 to 50 mm, preferably 20 to 30 mm. The number of filaments may be 2 to 6, preferably 3 to 4.
The filaments have a tensile modulus of elasticity of up to 300%, whereas the assembled filaments (which usually comprise three filaments and may also be bonded or lashed to the duodenal and/or gastric anchors) preferably have a tensile modulus of elasticity of 20% to 100%, particularly preferably 60% to 80%.
The aspect ratio of the gastric anchor may be 1:5 to 1:1, preferably 1:2 to 1:1, particularly preferably 8:11. In some embodiments, the aspect ratio may also be 1:2.
The duodenal anchor may be an inflatable duodenal anchor or a non-inflatable duodenal anchor. The duodenal anchor may also include an inflatable member and a non-inflatable member.
Preferably, the central portion is generally elongate in shape and extends in a direction parallel to the longitudinal axis of the connector.
Preferably, the plurality of first ends are configured to extend into the interior of the duodenal anchor, but they may also be configured into the interior of the duodenal anchor.
Preferably, the plurality of second ends are configured to extend into the interior of the gastric anchor, but they may also be configured into the interior of the gastric anchor.
In a particularly preferred embodiment, at least one of the plurality of first ends and the plurality of second ends of the connector is constituted by a rod, preferably exactly three rods.
Preferably, the rods of the first plurality of ends extend through the central portion and are connected to or form the second plurality of ends.
Preferably, the plurality of first and/or second ends consists of 2 to 6 bars, more preferably 3 to 4 bars.
Preferably, the bars of the plurality of first ends and the plurality of second ends have a stretch elasticity of 20% to 100%, more preferably 60% to 80%.
In a particularly preferred embodiment, at least one of the plurality of first free ends and the plurality of second free ends of the connector are arranged at a substantially constant angle and/or radial distance with respect to the longitudinal axis.
The plurality of first and/or second free ends may all terminate on a virtual circle centered on and perpendicular to the longitudinal axis.
In a particularly preferred embodiment, the central portion of the connector extends in the longitudinal direction for a length of between 3 and 50mm, preferably between 20 and 30 mm. Typically, the length of the central portion is at least equal to the length of a typical pyloric sphincter, and preferably less than twice the length of a typical pyloric valve.
In a particularly preferred embodiment, the length of the plurality of first ends and/or the plurality of second ends of the connector is between 10 and 50mm, preferably between 20 and 30 mm.
These lengths allow the connector portion to extend beyond the pyloric valve, thereby reducing or avoiding wear of the pylorus by the anchor.
In some embodiments, the distance between the first end and the second end along the longitudinal axis is 20 to 30 millimeters.
In a particularly preferred embodiment, the plurality of first ends and/or the plurality of second ends and/or the central portion of the connector comprise or are composed of a soft material.
Soft materials refer to materials with low hardness and high flexibility. For example, silicone and/or polyurethane may be suitable materials. Preferably, the stretch elasticity of the soft material is 20% to 100%, more preferably 60% to 80%. Preferably, the soft material has a shore a hardness of between 40 and 70, more preferably between 55 and 65.
It is particularly preferred that the first ends and/or the second ends and/or the central portion of the connector (which may correspond to the pyloric soft segment) comprise or consist of an elastic filament which is elastically stretchable to a tensile strain of 500-600% upon breaking. For cyclic loading of such components (cyclic fatigue of the elastic filaments) up to a strain of 150-200% without failure is conceivable.
In a particularly preferred embodiment, the central portion of the connector is constituted by a plurality of central extensions and circumferentially arranged tubular elements. The central portion may be formed of a plurality of central extensions and tubular elements (350) circumferentially arranged around the central extensions. The length of the tubular element is at least the same as its diameter. The tubular element may be configured to reduce the lateral diameter of the central portion and/or to bring the central extensions into physical contact with each other.
The length of the tubular element may be measured in a direction parallel to its longitudinal axis and may be the same as the length of the central portion. Preferably, the length of the tubular element is between 3 and 50 mm, more preferably between 5 and 30mm, particularly preferably between 5 and 15 mm, even more preferably between 6 and 8 mm.
Preferably, the wall thickness of the tubular element is between 0.2 and 4 mm, more preferably between 0.5 and 2 mm.
Preferably, the tubular element comprises or consists of the same material as the plurality of first and/or second ends and/or central portions of the connector. The tubular element may comprise or consist of medical grade silicone.
The plurality of central extensions may be 2 to 6 rods connected or connectable to the first and second pluralities of ends.
The plurality of central extensions may include a number of central extensions that is less than a number of ends included in the plurality of first and/or second ends.
Each of the plurality of central extensions may be connected or connectable to more than one of the plurality of first ends.
Each of the plurality of central extensions may be connected or connectable to more than one of the plurality of second ends.
Preferably, the tubular element is configured to enclose all elements of the central portion. More preferably, the tubular element is configured to enclose a plurality of central extensions.
According to yet another aspect of the present invention, an implant system for implantation in a patient's gastric tract is provided. The implant system includes a gastric anchor, preferably one of a stent or balloon, adapted to be placed within the patient's stomach. The implant system further comprises a duodenal anchor, preferably a duodenal anchor as described above. The implant system further comprises a connector, preferably a connector as described above. The connector has a first end, a second end, and a central portion. The connector is connected or connectable at a first end to a duodenal anchor and at a second end to a gastric anchor. The first and second ends of the connector are connected by a central portion. The connector is adapted to connect the gastric anchor and the duodenal anchor across the patient's pylorus when the system is implanted.
It will be appreciated that in some embodiments, the use of a non-inflatable duodenal anchor is envisioned.
Preferably, the connector is adapted to connect a stomach anchor and a duodenal anchor. The connectors may be connected to the stomach and duodenal anchors already prior to implantation of the system, or they may be connected during surgery (e.g., in the patient).
The length of the duodenal anchor may be 20 to 80 millimeters, preferably 30 to 50 millimeters or 50 to 60 millimeters, in the direction of chyme through the duodenal anchor/system. The length may include an elongate member as part of the duodenal anchor and/or an implant body with an elongate member attached to the duodenal anchor.
The stomach anchors, whether in the form of stents or balloons, may have a length in the range of 15 to 50 mm, preferably 30-50 mm or 20-30 mm. The diameter of the gastric anchor may be in the range of 30 to 80 mm, preferably 50 to 60 mm. When the gastric anchor is formed from a balloon, the nominal volume of the gastric anchor may be 40 milliliters in some embodiments, or generally in the range of 50 to 80 milliliters, with 70 milliliters being particularly preferred.
The length of the connector (adapted to extend through the pylorus) may be between 5 and 50 mm, preferably 20 to 30 mm.
In a preferred embodiment, the implant system further comprises an implant, preferably an implant as described above. The implant includes an implant body. The implant body may be tubular. The implant body may be connected proximally to a duodenal anchor. Preferably, the implant body includes an elongate element extending in a direction away from the duodenal anchor.
The system may provide first and second channels formed by the duodenal and gastric anchors separated by a connector. Thus, chyme may pass through the gastric anchor, and as the connector does not substantially obstruct chyme passage, chyme may pass substantially naturally through the pylorus and then into the duodenal anchor.
In a preferred embodiment, the implant system further comprises a sleeve arranged around the tubular implant body. The cannula is connected to the proximal end of the implant body, and the distal end of the cannula is configured for placement within the small intestine.
According to another aspect of the present invention there is provided a method of treating a patient comprising implanting an implant system as provided previously.
The method of treating a patient may comprise any of the following steps:
-inserting a guidewire into the proximal duodenum through the endoscope working channel;
-inserting a concentric delivery system loaded with the aforementioned implant onto the inserted guide wire, the distal end of the delivery system being provided with an atraumatic ball;
pushing the delivery system into the throat and esophagus of the patient until the stomach is reached, the portion of the delivery system loaded with the docking station such that the ball and a portion of the cannula are distal to the pylorus;
-inserting an endoscope into the stomach for imaging;
-advancing the docking station under visual guidance of the endoscope, passing the duodenal component through the pylorus;
-advancing the cannula distally through an internal catheter at the rear end of the delivery system until the cannula is fully placed into the small intestine;
-releasing the distal atraumatic ball;
-injecting a pressurized fluid through the inner catheter into the cannula while retracting the catheter. The sleeve is completely unobstructed and can be confirmed by X-ray imaging;
-releasing the duodenal anchor crimp sleeve and partially inflating to a desired volume;
Removing the gastric stent sheath in the antrum (distal stomach) if the system comprises a gastric anchor formed by a stent, inflating the gastric anchor to its nominal volume if the gastric anchor is formed by a balloon;
-disconnecting the balloon once the anchoring position and deployment is visually confirmed by the endoscope;
-removing the endoscope;
-removing the delivery system.
In accordance with yet another aspect of the present invention, a method of treating a patient is disclosed. The method of treating a patient includes the step of placing a duodenal anchor comprising a fillable section, preferably a duodenal anchor as previously described, into the patient's duodenum. The method of treating a patient further comprises the step of filling a predetermined amount of fluid into the fillable section. The predetermined amount of fluid is 10% to 80% of the volume of the fully inflated portion. The volume which can be accommodated when the fillable portion is fully inflated is 10 ml to 60 ml, preferably 25 ml to 45 ml, particularly preferably 34 ml.
In a preferred embodiment, the predetermined amount of fluid used in the method of treating a patient is between 5 and 10 milliliters. However, it should be understood that any amount of liquid less than 50 milliliters (preferably less than 20 milliliters, and particularly preferably less than 10 milliliters) may be suitable, depending on the size of the duodenal anchor used, and may result in only partial inflation. In some embodiments, 1 to 5 milliliters is used.
The duodenal anchor may be removed from the patient's duodenum after implantation. The removability of the duodenal anchor enables it to be removed from the patient's duodenum, for example, after successful treatment of the patient.
The duodenal anchors and/or gastric anchors may be adapted for filling, unfilling, inflating or deflating after implantation. To this end, the invention further relates to a method of treating a patient comprising the step of placing a duodenal anchor (such as the duodenal anchors described herein) and/or an inflatable gastric anchor, respectively, in the duodenum and/or stomach tract of the patient, wherein at least one of the duodenal anchor and the gastric anchor comprises an inflatable member. The method further comprises the step of inflating or deflating the inflatable member.
The implant system according to the present invention and/or any element of the implant system (e.g. stomach anchors, duodenal anchors, cannulas, connectors) may be placed by an autonomous robot. To this end, the invention also relates to a method of treating a patient comprising the step of placing an implant system (e.g., an implant system as described herein, preferably a duodenal anchor, such as a duodenal anchor as described herein) and/or a gastric anchor, respectively, in the duodenum and/or gastric tract of the patient. The method comprises the step of positioning the duodenal and/or gastric anchors within the duodenum of the patient by a robot, which is preferably at least partially autonomous. The robot may be adapted to inflate and/or deflate the stomach anchor and/or the duodenal anchor. The robot may also place a cannula attached to the duodenal anchor.
The implant system may comprise at least one sensor, in particular a biosensor, adapted to collect information, for example information related to the content of nutrients (e.g. glucose and/or lipids) in chyme flowing through the implant system. Additionally or alternatively, the sensor may sense the shape and/or size of any portion of the implant system (e.g., the duodenal or gastric anchors), for example, to determine if the implant system is placed correctly at any point in time after implantation. Such information may be used in a closed loop feedback manner within the duodenal anchor, and/or may be transmitted to the outside by wireless communication or the like for subsequent use by the caregiver. In particular, the size and shape of the duodenal anchor may be selectively varied based on the measured nutrient content in the stomach and/or intestinal tract.
Detailed Description
Fig. 1 shows a first embodiment of a duodenal anchor 100. The duodenal anchor 100 includes an internal passageway 20 for delivering chyme, which is shown in two dashed lines. The internal passageway 20 is tubular and is centered about the longitudinal axis L of the duodenal anchor 100. An inflatable member 30 is disposed about the interior passageway 20. The inflatable member 30 has a mechanically flexible outer wall 31 configured to conform to the inner wall of the patient's duodenum. Inflatable member 30 is connected to valve mechanism 41. Proximal end 101 of duodenal anchor 100 carries connecting member 82 adapted for connection to, for example, a connector and/or a gastric anchor (not shown). The duodenal anchors shown here are made of silica gel.
Fig. 2 shows another embodiment of a duodenal anchor 100. The duodenal anchor 100 is similar to the embodiment shown in fig. 1. For clarity, the same features will not be described here alone. Here, the duodenal anchor 100 is made of polyurethane and further includes an elongated member 70 having a plurality of free ends 72 separated by gaps 71. Alternatively, the duodenal anchor 100 may be made of silicone. The duodenal anchor 100 has a mechanically flexible outer wall 10 configured to conform to the inner wall of the patient's duodenum.
Fig. 3 shows a schematic view of the implant 200 shown in fig. 1 connected to the duodenal anchor 100. Implant 200 has a tubular implant body 210 with a proximal end 211 and a distal end 212. Proximal end 211 is connected to duodenal anchor 100. The plurality of elongate members 270 have free distal ends 272 that extend generally in a direction parallel to the longitudinal axis L. A plurality of elongate elements 270 form the distal-most portion 213 of the implant body 210. Between the elongated elements 270, in the circumferential direction of the implant body 210, there is a circumferential space 271. The duodenal anchor 100 has a mechanically flexible outer wall 10 configured to conform to the inner wall of the patient's duodenum.
Fig. 4 schematically shows an implant 200 according to the invention, which essentially consists of an implant body 210. At the proximal end 211, the implant body is formed substantially tubular with closed sides. A plurality of elongate members 270 having free distal ends 272 are formed from the proximal end 211 in a generally distal direction along the longitudinal axis L (left to right as viewed in fig. 4), and the elongate members 270 are separated by gaps 271. These elongated elements 270 substantially constitute the distal end 212 of the implant body 210. The implant is made of medical grade silicone. The implant body 210 is shown here as having an outer dimension D of 5cm in a direction perpendicular to the longitudinal axis L. Here, the elongated element 270 has a closed surface and is free of any holes or discontinuities. The elongate member is a substantially solid and integrally formed extension.
It will be appreciated that the implant of fig. 4 in combination with the duodenal anchor of fig. 1 may produce an integrally formed device that functions similarly to the embodiment of fig. 2.
Fig. 5 shows a schematic diagram of an embodiment of a connector 300. The connector 300 has a central portion 310, a plurality of first ends 320, and a plurality of second ends 330. Preferably, the plurality of first ends 320 and the plurality of second ends 330 are comprised of rods. The plurality of first ends 320 and the plurality of second ends 330 terminate at first free ends 321 and second free ends 331, respectively. The plurality of first ends 320 and the plurality of second ends 330 are connected by a plurality of central extensions 340, which in this example are integrally formed, extending the entire central portion 310. The tubular element 350 is circumferentially arranged around a central extension 340 in the central portion 310. The tubular member 350 extends across the entire length of the central portion 310, the length of which is considered to be along the longitudinal axis L of the connector 300. Additionally or alternatively, a plurality of central extensions 340 may be bonded together in a central portion.
Fig. 6 shows a schematic view of an embodiment of a connector 300 connected to the duodenal anchor 100. There is shown a view along the longitudinal axis of the connector (see figure 5). The plurality of first ends 320 of the connector 300 extend from a central portion (not shown) surrounded by the tubular member 350. The free end 321 of the first end is connected to the duodenal anchor 100 at a location circumferentially of the internal channel 20 proximal to the duodenal anchor 100. The plurality of first ends 320 are disposed at a generally constant angle and radial distance relative to the longitudinal axis of the connector.
Fig. 7 shows a schematic diagram of an embodiment of an implant system 500. Implant system 500 includes a gastric anchor 400, a duodenal anchor 100 (similar to that shown in fig. 1) having an inflatable member 30, a connector 300 similar to that shown in fig. 5, and an implant 200 similar to that shown in fig. 4. Implant 200 includes an elongate member 70 with a free distal end 72. The elongated element 70 has a closing surface 73, i.e. the elongated element 70 has material distributed throughout. Implant 200 is attached to the distal end of duodenal anchor 100. The distal end of the duodenal anchor is located on the opposite side of the proximal end 101 of the duodenal anchor 100. The duodenal anchor 100 has an outer surface 10 configured to conform to the inner wall of the patient's duodenum. At the proximal end 101 of the duodenal anchor 100, a plurality of first ends 320 of the connectors 300 are connected to the duodenal anchor 100. From the proximal end 101 of the duodenal anchor 100 to the central portion 310, the plurality of first ends 320 are pulled together under the pulling of the tubular member 350. The tubular element 350 covers a portion of 7 mm in length. The plurality of second ends 330 of the connector 300 are connected to the gastric anchor 400. The gastric anchor 400 shown here is an inflatable balloon, but may be replaced with a stent in some embodiments.
Fig. 8 illustrates another embodiment of an implant system 500. The duodenal anchor 100 is connected by a connector 300 to a gastric anchor 400 formed of a stent. Other components of the system are substantially identical to the embodiment shown in fig. 7, and for clarity, the same components are not repeated.
Fig. 9 shows a schematic view of another embodiment of an implant system 500. The gastric anchor 400 is formed in a balloon shape and is connected to the duodenal anchor 100 comprising the elongated member 70 by the connector 300. The elongate member is disposed within the sleeve 50. Gastric balloon 400 includes a valve mechanism 40 for inflation. The duodenal anchor may be inflated by a separate valve mechanism (not shown, see fig. 2 and 3). Additionally or alternatively, the valve mechanism 40 may also be connected to an inflatable member of the duodenal anchor for inflating the inflatable member. Cannula 50 has a distal end 52 and a proximal end 51. The proximal end 51 of the cannula 50 is connected to the duodenal anchor 100 such that the elongate member 70 is located inside the cannula 50 at the proximal end 51 of the cannula 50.
Fig. 10 shows a rolled state of the duodenal anchor 100 according to the present invention. The duodenal anchor 100 is crimped by a release mechanism 60, the release mechanism 60 comprising a silicone crimp membrane 61 and a release wire 62. The silicone crimp membrane 61 of the release mechanism 60 is placed around the duodenal anchor 100 and is pulled so that it exerts concentric force on the duodenal anchor 100 and is maintained in that state by the release wire 62. The release wire may be selectively released by the operator without inflation, for example, for inflating the duodenal anchor 100.
Fig. 11 shows the duodenal anchor 100 of fig. 10 after release of the release wire and removal of the silicone sheath (neither shown, see fig. 10). The inflatable member 30 of the duodenal anchor 100 is in a deflated state, i.e., there is no or little liquid and/or gas within the inflatable member 30 of the duodenal anchor 100.
Fig. 12a shows an implant system 500 having a gastric anchor 400, a duodenal anchor 100, and a cannula 50. A connector (see fig. 12 c) connects the stomach anchor and the duodenal anchor 100. The cannula 50 and its connection to the duodenal anchor 100 are substantially the same as those shown in figures 7 and 9 and will not be described in detail for clarity. Here, the duodenal anchor 100 is composed of an inner channel 20 having a wall 21 and an outer jacket layer 110 disposed around the inner channel 20. The arrangement of the outer jacket 110 relative to the inner channels 20 will be described in more detail in fig. 12C and 13. As shown herein, the extension 130 of the connector extends through the interior volume 120 formed between the outer jacket 110 and the inner wall 21. When implanted, the gastric anchor 400 is positioned in the patient's stomach and allows chyme to pass therethrough, substantially in the configuration shown. The duodenal anchor 100 is positioned within the patient's duodenum and is adapted to receive chyme which exits the implant assembly 500 through the gastric anchor 400 and through the sleeve 50 after the patient's pylorus. Chyme generally passes through the implant assembly 500 along the longitudinal axis L. Here, the distal end of the jacket layer 110 is not connected to the wall 21, so that a gap 102 is formed, allowing the jacket layer 110 to slide along the outer wall 21. The distal end of the cannula 50 is provided with two radio-opaque markers 55 to facilitate placement of the implant and/or to check the position of the implant.
Fig. 12b shows a perspective view of the duodenal anchor 100 in a direction parallel to the longitudinal axis L (see fig. 12 a), from distal to proximal (i.e., opposite to the chyme delivery direction when implanted and used as intended). The distal end 132 of the connector extension 130 is located on the outer surface of the sheath 110 and is configured to be connected because it has a diameter greater than the hole through which the connector extension 130 passes. The extension 130 is an elastic wire made of silicone.
Fig. 12c shows a cross-sectional view of the implant assembly 500 of fig. 12a along plane a of fig. 12 b. The gastric anchor 400 is an inflatable anchor that may be inflated with gas and/or fluid through a valve mechanism 40 embedded within the shaft of the gastric anchor 400. Extension 131 of connector 300 extends through gastric anchor 400 at the inner wall of the gastric anchor. The connector 300 is substantially identical to the connector shown in fig. 7 and 8, and consists of extensions 131, 130 that pass through the gastric anchor 400 and the duodenal anchor 100 and are joined in a single wire at an intermediate portion. The cannula 50 connected to the duodenal anchor 100 corresponds substantially to the configuration shown in fig. 9, for example. To this end, the duodenal anchor 100 includes a so-called castellation having an elongated portion 70 formed in the wall 21 of the interior channel 20 and a gap 71 therebetween. The duodenal anchor further includes an outer jacket 110 bonded to the wall 21 at a proximal anchor point 101 that is generally disposed on a proximal side 111 of the duodenal anchor 100 and forms a fluid-tight seal. The thickness of the overcoat layer 110 is 0.6 mm. The extension 130 of the connector passes through the outer sheath 110, through a passage hole near the anchor point 101 and generally on the proximal side of the duodenal anchor. Extension 130 is slidably disposed in passage bore 104 and is substantially fluid-tight therein, although it will be appreciated that fluid passage through the passage is also acceptable. Distal side 112 of duodenal anchor 100, extension 130 passes through a second distal access hole in outer layer 110 and is secured by distal bulb 132 of extension 130. Additionally or alternatively, an adhesive may be used to secure the extension 130 to the outer cover 110. The mantle 110 is not fixed to the wall 21 of the distal side 112, thereby forming a gap 102, which gap 102 extends around the circumference of the wall 21 and allows the mantle 110 to slide along the wall 21. Thus, as will be shown in more detail in fig. 14b, the outer sheath 110 may move proximally and reduce the internal volume 120.
Fig. 13 schematically illustrates the configuration of the outer casing 110 and the internal passageway 20 of the duodenal anchor 100 of fig. 12a-12 c. The connector 300 and the internal passage 20 correspond to the previous embodiments and are not described again for clarity. Here, the outer jacket layer 110 forms an interior volume 120 with the wall 21 of the interior channel 20 and is attached proximally to the wall 21 by a first adhesive layer 101. It will be appreciated that the adhesive layer 101 (here visible in cross-section) extends around the entire circumference of the wall 21 and forms a fluid-tight seal at the proximal end of the duodenal anchor 100. The extension 130 of the anchor 300 extends through the interior volume 120. It will be appreciated that two extensions 130 are visible here according to plane a of fig. 12b, but in this embodiment there are three extensions 130 which are equiangularly distributed about the longitudinal axis of the duodenal anchor 100. The extension 130 passes proximally through the aperture 104 of the outer jacket 110 and is slidably disposed therein. At the distal end of the duodenal anchor 100, an extension 130 passes through the outer layer 110, wherein a bulb 132 is secured to the outer surface of the outer layer 110 by a second adhesive layer 103. At the distal end of the outer jacket 110, and generally in the region of the connection of the extension 130 to the outer jacket 110, the outer jacket 110 is not connected to the wall 21 of the internal channel 20 and forms the gap 102. Because the gap 102 extends circumferentially around the internal passage 20, the outer jacket 110 may slide in a proximal direction when traction is applied to the extension. Due to the connector 101, the proximal end of the outer sheath 110 is fixed to the internal passage 20 and the proximal end of the outer sheath 110 does not move relative to the wall 21 when the extension 130 is pulled back and the distal end of the outer sheath 110 moves in the proximal direction.
Fig. 14a schematically illustrates a duodenal anchor 100 similar to that of fig. 13, in an expanded configuration. Here, the extension 130 is connected to the outer jacket 110 only by the bulb 132, but the distal side does not require additional adhesive (see fig. 13). The proximal end is connected to the wall 21 by an adhesive layer 101. The gap 102 allows the outer jacket 110 to slide over the wall 21 of the tube 20. The extension 130 extends through the opening 104 on the proximal side of the outer jacket 110.
Fig. 14b shows a schematic view of the duodenal anchor 100 of fig. 14b as the extension 130 is pulled back. As described above, the gap 102 allows sliding such that the distal end of the outer sheath 110 moves along the wall 21 while the adhesive layer 101 secures the proximal end to the wall 21. Thus, when the extension 130 is pulled back through the opening 104 in the outer cover 110, the outer cover 110 is pulled back and forms a folded, accordion-like structure. Filling liquid (not shown) may escape through the gap 102. Due to the accordion-like structure, the anchoring force in the duodenum can be enhanced.
Fig. 15 shows an embodiment of an implant system 500 similar to the previous embodiments. The stomach anchor 400, duodenal anchor, connector 300, and cannula 50 are substantially identical to the embodiment of fig. 12c, but it is understood that any of these elements may be identical to any of the configurations previously described. Specifically, the duodenal anchor 100 need not have a gap, and thus corresponds to the embodiment of FIG. 9, for example. Here, the ring 170 is connected to the outer jacket 110 by three rods 160. The lever 160 may be made of the same material and the same thickness as the extension 130 of the connector 300. The rod is connected to the mantle 110 through a hole with balls 161 arranged on the inner surface of the mantle 110 between the ends of the extensions 130 connected to the mantle 110. It should be appreciated that the wand 160 may be attached by any means known in the art and is typically attached at any location distal to the outer layer 110. It is also conceivable to configure the extension 130 to extend beyond the end of the outer jacket layer 110 so as to integrally form the rod 160 and connect to the ring 170.
Fig. 16a and 16b schematically illustrate the function of the ring 170.
Fig. 16a shows the implant system 500 of fig. 15 in an expanded configuration corresponding to the configuration of fig. 14a when implanted.
Fig. 16b shows the implant system 500 of fig. 15 in a folded configuration corresponding to the configuration of fig. 14b when implanted. The intestinal tract I undergoes natural peristalsis, symbolically indicated by the arrow PM, which interacts with the ring 170 and exerts a traction force on the ring 170. The ring 170 is generally larger than the sleeve 50 so as to surround the sleeve 50. Thus, the loop 170 is pulled back into the outer jacket 110 by the stem 160 with the balls 161. Thus, the ring 170 and the rod 160 act as a pulling device. Although traction forces on the duodenal anchors are typically required in some circumstances, it is particularly advantageous to provide a traction device of this type, as described above, when the outer casing 110 is not connected to the distal end and is therefore folded up when traction forces are applied on the extension 130. The pulling device may then act as a reaction force to reopen and/or inhibit folding of the outer sheath 110, thereby allowing the duodenal anchor 100 to better conform to the patient's intestinal tract. The wand 160 is made of a non-elastic wire core wrapped with medical grade silicone. Thus, the wand 160 is atraumatic and biocompatible, while being suitable for transmitting traction forces. In addition, the enhanced stiffness provided by the inelastic wire core may prevent the ring 170 from bending, rotating, and/or tipping. The length of the shaft 160 is adjusted so that the loop 170 is distal to the duodenal anchor 100 even if the sheath 110 is fully folded.