JP2023505759A - Implantable anchor device and method of use - Google Patents

Abstract

A method of using an implantable device provides an implantable device that includes a plurality of arcuate portions. Each arc includes multiple links. The implantable device further includes a device closure pin, a lock-in unit mounted and positioned between the three arcs, and a quick release unit mounted and positioned between the three arcs. A plurality of arcuate portions, a lock-in unit and a release unit form a closed contour. The closed contour in the rigid state of the implantable device is a three-dimensional shape.

Description

The present disclosure relates generally to devices that are inserted into body cavities using intraoral procedures and positioned within body cavities by deformation of the shape and stiffness of the device.

Some medical procedures require placement of a medical device into a lumen of the human or animal body, particularly the stomach. Once inserted, movement of the inserted medical device must be restrained, and this is done using anchors. Chamorro, U.S. Patent No. 6,200,100, includes a proximal element configured to reside in the stomach and a distal element configured to reside in the intestine, the proximal element being configured to resist migration over time. A configured gastrointestinal device is described. Albrecht, US Pat. No. 6,200,302, describes an alternative proximal element for placement in hollow body organs. The proximal element includes a member having a first shape for delivery to the hollow body and a second shape for embedding in the hollow body. In its second configuration, the member has sufficient rigidity to apply an outward force against the interior of the hollow body to bring two substantially opposing surfaces of the hollow body together. Domingues, US Pat. No. 5,301,323, describes a gastric balloon that is introduced into the stomach. The balloon takes up space in the stomach, thereby leaving less space for food and making the patient feel full. Ganoe, US Pat. No. 5,300,301 discloses an expandable, space-occupying device that can be inserted into a patient's stomach and maintained in the stomach by tethering or otherwise securing the device to the stomach wall. ing. Haller, US Pat. No. 5,300,303, describes a gastrointestinal device that is a pouch filled with digestion-resistant or indigestible material. The pouch is placed in the gastric lumen in a compact form. The pouch is then manipulated into or assumes a second expanded configuration large enough to maintain the pouch in the stomach and not enter the intestine through the pylorus. becomes possible. The examples of implants described in the aforementioned patents have several drawbacks when inserted into a body lumen and do not provide the long-term implant stability needed.

U.S. Pat. No. 9,636,245 U.S. Patent Application No. 2008/0058840 U.S. Patent Application No. 2012/0095385 U.S. Pat. No. 6,994,715 International Publication No. 2007/076021

The present disclosure describes an implantable device that includes at least three(s) of arcs, each arc including a plurality of links. Implantable devices are configured to be in one of two states: a flexible state in at least one plane of the device or a rigid state in all other planes of the device. In the rigid state, the device has a three-dimensional curved shape. The implantable device includes, but is not limited to, at least a device closure pin, a lock-in unit, a quick release unit, and a plurality of arcs, each arc extending on one side. and a plurality of links connected to two other links or one link and on the opposite side to either a lock-in unit or a release unit. Implantable devices are inserted into body cavities using intraoral procedures. During insertion, the device closure pin is attached to only one side, in one embodiment attached to a quick release unit, and the implantable device is in a flexible state. The flexibility of the implantable device gives it the ability to follow the contours of the body opening, facilitating insertion of the device with minimal discomfort to the patient. The implantable device is removably connected to the intraoral insertion device with a lock-in unit. After inserting the implantable device into the body and placing the implantable device in the desired body cavity, the device closure pin is drawn into the lock-in unit and locked in place. A device closure pin is then attached to each end of the pin, transforming the implantable device into a rigid state. In a rigid state, the implantable device has a three-dimensional curved shape, such as a sphere or ellipsoid, that provides an anchoring function and impedes mobility of the implantable device within the body cavity.
In one embodiment, functional units providing body-related functions are attached to the release unit. One example of a functional unit is an intragastric sleeve configured to reduce food intake in the intestine.

Fig. 10 is an embodiment of an implantable device composed of two arcuate portions and a plurality of links and configured to be flexible in at least one plane;

Fig. 10 is an example of an implantable device composed of two arcuate sections and multiple links just prior to being configured to be rigid and inflexible in all planes.

Fig. 10 is an embodiment of an implantable device composed of two arcuate sections and multiple links configured to be rigid and inflexible in all planes.

Fig. 3 is an example of an implantable device consisting of three arcs and multiple links;

Fig. 3 is an example of an implantable device composed of three arcuate segments and multiple links and shown in a rigid state;

FIG. 2A is an example of an implantable device link.

FIG. 2B is an example of a top view of the links of the implantable device.

FIG. 2C is an example of a side cross-sectional view of the links of the implantable device at section line NN of FIG. 2B.

FIG. 3A is an example of a device closure pin attached to a release unit.

FIG. 3B is an example of a side view of a device closure pin attached to a release unit.

FIG. 3C is an example rear view of a device closure pin attached to a release unit.

FIG. 4A is an example of a device closure pin attached to a receptacle.

FIG. 4B is an example of a side view of a device closure pin attached to a receptacle.

FIG. 4C is an example of a top view of a device closure pin attached to a receptacle.

FIG. 10 is an example of a method of using an implantable device consisting of two arcuate segments and a plurality of links that are rigid to constrain movement of the device within a body cavity. FIG.

Fig. 10 is an example of a method of use of an implantable device composed of three arcuate segments and a plurality of links that are rigid to constrain movement of the device within a body cavity.

FIG. 6A is an example of a wavy anchor in a folded configuration.

FIG. 6B is an example of a wavy anchor in a spread configuration.

The following detailed description refers to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized and other changes may be made without departing from the spirit or scope of the subject matter presented herein. The aspects of the disclosure generally described herein and shown in the figures can be arranged, permuted, combined and designed in a variety of different forms, all of which are expressly intended to , will be readily understood to form part of this disclosure. The present disclosure is directed, inter alia, to devices that are inserted into the human or animal body using intraoral procedures and positioned within the body cavity by changing the shape and stiffness of the device.

In the implantable device examples/patents mentioned above, the proximal element is in contact with the pylorus. The proximal element has a rounded shape and as a result exerts a dilating force on the pylorus, which widens the pyloric opening over time and expels the proximal element. Such implants suffer from migration within the lumen of the human or animal body and do not provide the long-term required implant stability. It can have a proximal element that has a three-dimensional curved shape that can make contact with the stomach wall, is large enough in shape, does not slide into the pylorus, and provides the long-term needed implantation stability. desirable.

FIG. 1A is an embodiment of an implantable device made up of two arcuate portions and a plurality of links and configured to be flexible in at least one plane. Implantable devices include, but are not limited to, at least a lock-in unit 103, a quick release unit 105, and a plurality of links 101, 113, 115, 117, 119 (collectively 101-19 or 101), each link 101 being connected on one side to two other links 101 or to one link 101, 113, 115, 117, 119 and to the lock-in unit 103 or release unit 105 on the opposite side. A plurality of links 101, 113, 115, 117, 119 connected to any one. Implantable devices are inserted into body cavities using intraoral procedures. During insertion, the flexibility of the implantable device gives the device the ability to follow the contours of the body opening, facilitating insertion with minimal discomfort to the patient. The implantable device connects to the delivery or insertion device at lock-in unit 103 . In one embodiment, functional units that provide body-related functions are attached to quick release unit 105 . One example of a functional unit is an intragastric sleeve configured to reduce food intake in the intestine.

FIG. 1B is an example of an implantable device including two arcs and a plurality of links just prior to being configured to be rigid and inflexible in all planes. The implantable device moves from the flexible state described in FIG. 1A to the rigid state described in FIG. converted to state. Device closure pin 111 follows cord 121 into lock-in unit 103 where a locking mechanism holds device closure pin 111 in place. Confined device closure pin 111 exerts a force on implantable device links 101-119, limiting relative movement of the links and transitioning the implantable device into a rigid state. Transitioning the implantable device from a rigid state to a flexible state facilitates removal of the implantable device from the body cavity. Removing the release pin 123 from the device closure pin 111 releases the device closure pin 111 from the release unit 105 and transitions or converts the implantable device to a flexible state. After transitioning the implantable device to the flexible state, the implantable device is removed from the body cavity by an intraoral procedure. Examples of materials for manufacturing link 101 include, but are not limited to, titanium, stainless steel, cobalt, chromium, nitinol alloys, thermoset plastics and similar materials, or mixtures of the foregoing materials. .

Additionally, a Teflon (polytetrafluoroethylene) coating or overcoat enhances the atraumatic properties of the links 101-119 surfaces. (These surfaces are considered "atraumatic" because they do not cause trauma to the body.) Examples of materials for device closure pin 111 and release pin 123 include, but are not limited to, stainless steel. Including steel, titanium, cobalt, chromium, nitinol alloys, thermoset plastics and similar materials, or mixtures of the foregoing materials. In one example, the implantable device link 101 is manufactured using an additive manufacturing process, such as 3D printing. Link 101, lock-in unit 103, quick release unit 105, and interconnecting pins are arranged such that the additive manufacturing cycle results in a connected closed profile of links 101-119, lock-in unit 103, and quick release unit 105. Manufactured in a simultaneous and connected manner.

Thus, in one embodiment, a plurality of links 101-119, a device closure pin 111, a lock-in unit 103 attached and positioned between the two links 117,119, and a device between the two links 113,115. An implantable device is described that includes a release unit 105 attached to and positioned on. A plurality of links 101 - 119 , lock-in unit 103 and release unit 105 form a closed profile, and the implantable device is closed when device closure pin 111 is coupled to lock-in unit 103 or quick release unit 105 . is flexible and rigid when the device closure pin 111 is attached to both the lock-in unit 103 and the quick release unit 105 .

FIG. 1C is an example of a side view of a rigid implantable device 135 with closed contour and device closure pins 111 forming a figure eight. In an alternative embodiment, the implantable device comprises multiple links 101-119 forming a closed loop in which one link 101, 113, 115, 117 is connected to two other links 101-119, and the device closure. The implantable device including pin 111 is flexible when only one side of device closure pin 111 is attached to links 101-119 and both sides of device closure pin 111 are attached to links 101-119. rigid and inflexible when attached to the In a further embodiment, the closed contour of the rigid implantable device 135 is elliptical and is configured to follow the shape of the two arcuate portions 125, 127 and the two interconnecting portions 131, 133, and the two The absolute radius of arcuate portions 125,127 is at least five times greater than the absolute radius of interconnecting portions 131,133. The radius of each arcuate portion 125, 127 is of opposite sign. In a further embodiment, the closed contour of the rigid implantable device is elliptical and consists of two arcuate portions 125, 127 and two interconnecting portions 131, 133, two interconnecting portions 131, 133; 133 is substantially straight. In a further embodiment, the closed contour of the rigid implantable device has a figure eight shape consisting of two arcuate portions and two connected interconnecting portions. The resulting shape of the rigid implantable device in contact with the pylorus is substantially straight, thus exerting no dilating force on the pylorus, ensuring long-term stability of the implanted device.

FIG. 1D is an example of an implantable device consisting of three arcs and multiple links. FIG. 1D shows implantable device 140 in a first or flexible state. Implantable device 140 is comprised of three arcuate sections 142, 144 and 146, each arcuate section including multiple links 101-119. Arcuate portions 142, 144 and 146 having a plurality of links 101-119 are configured to be sufficiently flexible for intra-oral introduction into the body of the recipient. Implantable device 140 includes, but is not limited to, at least lock-in unit 148, quick release unit 155, and plurality of links 101-119. Each link 101-119 is connected on one side to two other links 101-119 or to one link 101-119 and on the opposite side to either a lock-in unit 153 or a quick release unit 155. . Implantable device 140 in the first or flexible state is inserted into the body cavity using intra-oral procedures. During insertion, the flexibility of the implantable device gives the implantable device 140 the ability to follow the contours of the body opening. This flexibility facilitates insertion with minimal discomfort to the patient. Implantable device 140 is connected to the delivery or insertion device at lock-in unit 153 . In one embodiment, functional units that provide body-related functions are attached to quick release unit 155 . One example of a functional unit is an intragastric sleeve configured to reduce food intake in the intestine.

FIG. 1E is an example of an implantable device composed of three arcs and multiple links, shown in a rigid state. Implantable device 140 in the first form is in a flexible state. In a second configuration or rigid state, implantable device 140 forms a closed contour, with three arcuate portions 142, 144 and 146, lock-in unit 153 and quick release unit 155 forming a closed three-dimensional curved shape. configure devices; The closed three-dimensional curved shape of implantable device 140 can be one of a family of shapes consisting of a sphere or an ellipsoid.

All links (101-119) have titanium atraumatic surfaces. Additionally, a Teflon (polytetrafluoroethylene) coating or overcoat enhances the atraumatic properties of the links 101-119 surfaces. The links (101, 113, 115, 117, 119) are typically manufactured using an additive manufacturing process.

FIG. 2A is an example of an implantable device link (101-119 in FIG. 1A). Links 101 - 119 include mounting shafts 203 and pin cavities 201 . The mounting shaft 203 is configured to connect to the pin cavity 201 in the second link to form a closed contour made up of a plurality of links 101-119, each link 101-119 in the closed contour. is connected on one side to two other links 101-119 or to one link 101 and on the opposite side to a lock-in unit (103 in FIG. 1B and 153 in FIG. 1E) or a release device (153 in FIG. 1B). 105 and 155) in FIG. 1E. FIG. 2B is an example of a top view of the link 101 of the implantable device. FIG. 2C is an example side cross-sectional view of the implantable device link at section line NN of FIG. 2B. Link 101 includes mounting shaft 203 and pin cavity 201 . The link further includes slanted sides 205 . In the flexible state of the implantable device, one link 101 connects to a second link 101 and the shaft 203 of one link 101 is inserted into the pin cavity 201 of the second link 101 . Links 101 are free to move about axes defined by their axes 203 . Relative movement about the axis of link 101 provides the necessary flexibility along one plane of the implantable device in the flexible state. In the restrained state, the slanted side surface 205 of one link 101 is pressed against the facing surface 211 of the adjacent connecting link 101 . The contour shape of the implantable device in the constrained state is determined by the relative angle between the slanted side 205 of one link 101 and the opposite side 211 of the adjacent link 101 that contacts said slanted side 205 . In a further embodiment, the above relative angles vary from link to link to configure a specific size shape of the closed contour of the rigid implantable device.

Support recesses 207 or 209 contact support recesses 209 or 207 of adjacent links at a preset maximum angle to provide a constraint on relative motion of links 101 in the flexed state. A link includes at least a base 220 ( FIG. 2A ), one or more connecting pins 203 and one or more vias 201 . All the links (101-119 in FIG. 1A and 101 in FIG. 2A) and pins 203 and pinholes 205 that make up the implantable device are such that the pin 203 of one link 101 is adjacent to the link 101 or lock-in unit (FIG. 1A). 103 and 153 in FIG. 1E) or in the pinhole 205 of the quick release unit (105 in FIG. 1A and 155 in FIG. 1E), link 101, lock-in unit (103 in FIG. 1A and 1E) and the quick release unit (105 in FIG. 1A and 155 in FIG. 1E) are manufactured simultaneously to provide a closed profile.

As shown in the embodiment, the link consists of at least a base 220 , one or more connecting shafts 203 and one or more holes 201 . The base 220 of one link and the connecting shaft 203 (101-119 in FIGS. 1B-1E) located within the pinhole 201 of the second link (101-119 in FIGS. 1B-1E) facilitate the additive manufacturing process. manufactured at the same time using

FIG. 3A is an example of device closure pin 111 attached to release unit 105 (or 155). The top surface of device closure pin 111 is configured as a snap-in portion. The snap-in portion includes recess 305 and conical tip 309 . In a further embodiment, a cord (121 in FIG. 1B) is connected to the top of the conical tip 309 when the implantable device is in the flexible state. Pulling on the cord (121 in FIG. 1B) pulls the device closure pin 111 into the receptacle (401 in FIG. 4) where it is locked in place by recess 305. FIG. Device closure pin 111 further includes one or more quick release pinholes 307 . FIG. 3B is an example of a side view of a device closure pin attached to a release unit. Device closure pin 111 further includes mounting pin 315 and mounting pin cavity 311 corresponding to mounting pin (203 in FIG. 2C) and mounting pin cavity (201 in FIG. 2C) of link (101 in FIG. 2A). Pins are used to attach the links to either side of the device closure unit. Device closure unit 105 / 155 further includes quick release housing 301 and second pinhole 303 . A device mounting pin is inserted into the quick release housing 301 and held in place by inserting the quick release pin (123 in FIG. 1B) through the second pin hole 303 and the quick release pin hole 307 of the device closure pin 111. be done. Prior to insertion into the body, device closure pin 111 is attached to quick release unit 105/155. The effective length of the device closure pin 111 is adjusted by selecting which quick release pin hole 307 the quick release pin (123 in FIG. 1B) passes to lock the device pin 111 in place. The effective length of device closure pin 111 determines the contour shape of the implantable device when it is in its rigid state. In a further embodiment, the profile is configured to be substantially flat with respect to at least one link on either side of quick release unit 105 . Sleeve connection pin 321 is the anchor point for the cord that connects the implantable device to the intestinal sleeve. FIG. 3C is an example rear view of a device closure pin attached to a release unit.

FIG. 4A is an example of device closure pin 111 attached to receptacle 401 . 4B is an example side view of device closure pin 111 attached to receptacle 401, and FIG. 4C is an example top view of device closure pin 111 attached to receptacle 401. FIG. In one embodiment, the receptacle 401 includes an outer ring 403 a and a plurality of spokes 405 that terminate short of the center of the receptacle 401 such that the conical tip 309 of the device closure pin 111 passes through the receptacle 401 . It then allows the device closure pin 111 to be locked in place by extending into the device closure pin recess 305 . Examples of materials for manufacturing the receptacle include, but are not limited to, stainless steel titanium, stainless steel, cobalt, chromium, nitinol alloys, thermoset plastics and similar materials, or mixtures of the foregoing materials. include.

Closure pin 111 includes a conical tip 309 configured to be inserted and locked into a receptacle 401 having an outer ring 403 and one or more spokes 405, and in a further embodiment, receptacle 401 is slotted. Configured as a spring washer, it is configured to receive and retain the snap-in portion of the device closure pin 111 .

FIG. 5A is an example of a method of using an implantable device in a rigid state 135 to constrain movement of the implantable device within a body cavity. In one embodiment, the implantable device in rigid state 135 is secured to stomach 511 . An intestinal sleeve 505 is attached to the implantable device in rigid state 151 with a sleeve cord 501 and inserted into the intestine 513 . In a further embodiment, intestinal sleeve 505 includes undulating anchors 503 that position the intestinal sleeve in place.

FIG. 5B is an example of use of an implantable device composed of three arcuate segments and multiple links that are rigid to constrain movement of the implantable device within a body cavity. In the rigid state, the shape of implantable device 140 has the contour of a closed three-dimensional curved shape. Three arcuate portions 142 , 144 and 146 of device 140 open within stomach 511 to secure device 140 . Arcuate portions 142 , 144 and 146 of device 140 can contact the wall of stomach 511 . The three-dimensional curved contour of unit 140 supports a substantially constant position of unit 140 within the stomach.

FIG. 6A is an example of an undulating anchor 503 in a collapsed configuration and FIG. 6B is an example of an undulating anchor in an expanded configuration.

Several examples have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the method. Accordingly, other implementations are within the scope of the following claims.

Claims (18)

an implantable device,
at least three arcuate portions convertible from a first flexible state to a second rigid state;
a device closure pin;
a lock-in unit mounted and arranged at one end of the three arcuate portions;
a quick release unit mounted and positioned at opposite ends of said three arcuate portions;
Coupling the device closure pin to one of the lock-in unit or the quick release unit places the device in the first flexible state and connects the device closure pin to both the lock-in unit and the quick release unit. An implantable device wherein attachment places said device in said second rigid state. 2. The implantable device of claim 1, wherein in the second rigid state the at least three arcuate portions, the lock-in unit and the release unit form a closed three-dimensional curved shape. 3. The implantable device of claim 2, wherein the closed three-dimensional curved shape is one of a family of shapes consisting of a sphere or an ellipsoid. 2. The implantable device of claim 1, wherein the surfaces of all links are atraumatic surfaces made of titanium, said atraumatic surfaces of said links further comprising a polytetrafluoroethylene coating or overcoat. 5. The implantable of claim 4, wherein each of said links is composed of at least one base, a mounting axis, and one or more pinholes, said links being manufactured using an additive manufacturing process. device. 6. The implantable device of claim 5, wherein the base of one link and the mounting axis located within the pinhole of the second link are manufactured simultaneously using an additive manufacturing process. 2. The implantable device of claim 1, wherein the device closure pin includes a conical tip configured to be inserted and locked into a receptacle. 2. The release unit of claim 1, wherein the release unit includes a retractable pin that attaches the device closure pin to the release unit, removal of the retractable pin releases the device closure pin from the release unit. implantable device. The closed contour of the implantable device in a rigid state is a three-dimensional curvilinear shape comprising three arcuate portions and two interconnecting portions, the two interconnecting portions being substantially straight. An implantable device according to clause 1. an implantable device,
a plurality of links forming three arcuate portions forming a closed three-dimensional curvilinear shape, each link being connected to two other links;
a device closure pin including a snap-in portion;
a lock-in unit mounted and positioned at one end of the three arcuate portions;
a quick release unit positioned attached to opposite ends of the three arcuate portions;
The implantable device is flexible when the device closure pin is attached to either the lock-in unit or the quick release unit, and both sides of the device closure pin are aligned with the lock-in unit and the quick release unit. Stiff and unbendable when attached to the quick release unit,
The implantable device, wherein the device closure pin includes a receptacle having a slotted spring washer configured to receive and retain a snap-in portion of the device closure pin. 11. The implantable device of claim 10, wherein the lock-in unit is configured as a slotted spring washer and includes a receptacle configured to receive and retain a snap-in portion of the device closure pin. 11. The implantable device of claim 10, wherein the device closure pin includes at least one quick release pin hole and a retractable pin that attaches the device closure pin to the lock-in unit or the release unit. 11. The implantable device of claim 10, wherein the closed three-dimensional curved state of the implantable device is sufficiently large to prevent the implantable device from passing through the pylorus. A method of using an implantable device, comprising:
at least three arcuate portions, a device closure pin, a lock-in unit attached and arranged at one end of said at least three arcuate portions, and an attached and arranged end at an opposite end of said at least three arcuate portions. providing an implantable device including a quick release unit;
configuring the at least three arcuate portions, the lock-in unit and the quick release unit in a closed rigid configuration;
the closed rigid form of the implantable device is a three-dimensional curved shape;
The method of claim 1, wherein the three-dimensional curved shape of the implantable device includes at least three arcuate portions and two interconnecting portions, each interconnecting portion connecting the at least three arcuate portions. 15. The method of claim 14, further comprising attaching the device closure pin to both the lock-in unit and the release unit to hold the implantable device rigid. providing at least three arcuate sections of a plurality of links, all link surfaces being titanium atraumatic surfaces, said link atraumatic surfaces further comprising a polytetrafluoroethylene coating or protective membrane; 15. The method of claim 14. The implantable device is flexible when the device closure pin is coupled to at least one of the lock-in unit or the quick release unit, and the device closure pin engages the lock-in unit and the quick release unit. 15. The method of claim 14, which is rigid when attached to both units. A method of using an implantable device, comprising:
A plurality of arcs, each arc being a flexible linear element, a device closing pin, a lock-in unit mounted and positioned between the three arcs, and an attachment between the three arcs. providing an implantable device comprising a quick release unit positioned at a position;
configuring the plurality of arcuate portions, the lock-in unit and the release unit in a closed state;
the rigid closed state of the implantable device is a three-dimensional curvilinear shape;
The method, wherein the implantable device shape is composed of at least three arcuate portions and two interconnecting portions.

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