Implantable device

Abstract

To provide a device to be inserted into a body cavity by using intraoral procedures and arranged in the body cavity by deformation of the shape and rigidity of the device.SOLUTION: A method of using an implantable device provides an implantable device 140 including a plurality of arcs. Each arc contains a multiplicity of links. The implantable device 140 further includes a device closure pin, a lock-in unit 153 attached and located between the three arcs, and a quick-release unit 155 attached and located between three arcs. The plurality of arcs, the lock-in unit 153, and the release unit 155 form a closed contour. The closed contour of the implantable device 140, in a rigid state is a three-dimensional shape.SELECTED DRAWING: Figure 1E

Description

Technical Field

[0001] The present disclosure relates generally to a device that is inserted into a body cavity using an oral procedure and is positioned within the body cavity by deformation of the shape and rigidity of the device.

Background Art

[0002] Some medical procedures require placement of a medical device within a body lumen of a human or animal body, particularly within the stomach. Once inserted, the movement of the inserted medical device must be restricted, which is done using an anchor. Chamorro Patent Document 1 describes a gastrointestinal device that includes a proximal element configured to be present in the stomach and a distal element configured to be present in the intestine, with the proximal element configured to resist movement over time. Albrecht Patent Document 2 describes an alternative proximal element for placement in a hollow body organ. 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. The member has sufficient rigidity in its second shape to apply an outward force against the interior of the hollow body to integrate two substantially opposing surfaces of the hollow body. Domingues Patent Document 3 describes a gastric balloon introduced into the stomach. The balloon takes up space in the stomach, thereby reducing the space for food and giving the patient a feeling of fullness. Ganoe Patent Document 4 discloses an expandable and space-occupying device that can be inserted into a patient's stomach and maintained within the stomach by attaching or otherwise securing the device to the stomach wall. Haller Patent Document 5 describes a gastrointestinal device that is a bag filled with a digestion-resistant or indigestible substance. The bag is placed in the lumen of the stomach in a compact form. The bag is then manipulated into a second expanded form that is large enough to maintain the bag within the stomach and prevent it from entering the intestine through the pylorus, or is capable of taking on the second expanded form. The examples of implants described in the above patents have several drawbacks when inserted into the body lumen of a human body and do not provide the long-term implant stability required.

Prior Art Documents

Patent Document

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Summary of the Invention

Means for Solving the Problems

[0004] The present disclosure describes an implantable device that includes at least three arcs, each arc including a plurality of links. The implantable device is configured to be in one of two states, namely, 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 surface 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 including a plurality of links that are connected to two other links or are connected to one link on one side and to either the lock-in unit or the release unit on the opposite side. The implantable device is inserted into a body cavity using an intraoral procedure. During insertion, the device closure pin is attached only on one side and, in one embodiment, is attached to the quick release unit, and the implantable device is in a flexible state. The flexibility of the implantable device gives the device the ability to conform to the contour of the body opening, facilitating the insertion of the device while minimizing patient discomfort. The implantable device is removably connected to an intraoral insertion device by the lock-in unit. After inserting the implantable device into the human body and placing the implantable device in the target body cavity, the device closure pin is pulled into the lock-in unit and locked in place. The device closure pin is then attached to both ends of the pin, converting the implantable device to a rigid state. In the rigid state, the implantable device has a three-dimensional curved surface shape, such as a sphere or an ellipsoid, that provides an anchoring function and prevents movement of the implantable device within the body cavity. In one embodiment, a functional unit that provides a body-related function is attached to the release unit. An example of a functional unit is a gastric sleeve configured to reduce food intake in the intestine.

Brief Description of the Drawings

[0005]

Fig. 1A

[0006]

Fig. 1B

[0007]

Fig. 1C

[0008]

Fig. 1D

[0009]

Fig. 1E

[0010]

Fig. 2

[0011] Figure 2B is an example of a top view of a link of an implantable device.

[0012] Figure 2C is an example of a side cross-sectional view of a link of an implantable device along the cutting line NN of Figure 2B.

[0013]

Fig. 3

[0014] Figure 3B is an example of a side view of a device closure pin attached to a release unit.

[0015] Figure 3C is an example of a rear view of a device closing pin attached to the release unit.

[0016]

Fig. 4

[0017] Figure 4B is an example of a side view of a device closing pin attached to the receptacle.

[0018] Figure 4C is an example of a top view of a device closing pin attached to the receptacle.

[0019]

Fig. 5A

[0020]

Fig. 5B

[0021]

Fig. 6

[0022] Figure 6B is an example of an embodiment of the wavy anchor in an expanded form.

DETAILED DESCRIPTION OF THE INVENTION

[0023] In the following detailed description, reference is made to the accompanying drawings which form a part hereof. In the drawings, like numerals generally refer to like components unless the context indicates otherwise. The exemplary 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 present disclosure as described throughout this specification and shown in the figures can be arranged, substituted, combined, and designed in various different configurations, all of which are explicitly intended and will be readily understood to form part of the present disclosure. The present disclosure is directed, inter alia, to devices that are inserted into the body of a human or animal using an oral procedure and are positioned within a body cavity by a change in the shape and stiffness of the device.

[0024] In the above example / patent of the implantable device, the proximal element is in contact with the pylorus. The proximal element has a rounded shape, which results in exerting an expanding force on the pylorus, causing the pyloric opening to widen over time and the proximal element to be expelled. Such implants suffer from movement within the lumen of the human or animal body and do not provide the long-term required implant stability. It is desirable to have a proximal element that has a three-dimensional curved surface shape that can contact the wall of the stomach, is large enough in shape, does not fold into the pylorus, and provides the long-term required implant stability.

[0025] FIG. 1A is an example of an implantable device composed of two arcuate portions and a plurality of links and configured to be flexible in at least one plane. The implantable device includes, but is 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 101-119 or 101), and each link 101 is connected to two other links 101 or is connected to one link 101, 113, 115, 117, 119 on one side and to either the lock-in unit 103 or the release unit 105 on the opposite side. The implantable device is inserted into the body cavity using an oral procedure. During insertion, the flexibility of the implantable device gives the device the ability to follow the contour of the body opening and facilitates insertion with minimal discomfort to the patient. The implantable device is connected to a delivery or insertion device by the lock-in unit 103. In one embodiment, a functional unit that provides a body-related function is attached to the quick-release unit 105. An example of a functional unit is a gastric sleeve configured to reduce food intake in the intestine.

[0026] FIG. 1B is an embodiment of an implantable device including two arcuate portions and a plurality of links, just prior to being configured to be rigid and non-bendable in all planes. The implantable device is converted from the flexible state shown in FIG. 1A to the rigid state shown in FIG. 1C by pulling the cord 121 attached to the device closure pin 111 (FIG. 1B) and passing it through the lock-in unit 103. The device closure pin 111 enters the lock-in unit 103 following the cord 121, and a locking mechanism in the lock-in unit 103 holds the device closure pin 111 in a predetermined position. The confined device closure pin 111 applies a force to the implantable device links 101-119, restricting relative movement of the links and transitioning the implantable device to the rigid state. Transitioning the implantable device from the rigid state to the flexible state facilitates removal from the body cavity. By removing the release pin 123 from the device closure pin 111, the device closure pin 111 is released from the release unit 105 and the implantable device is transitioned or converted to the flexible state. After transitioning the implantable device to the flexible state, the implantable device is removed from the body cavity by an oral procedure. Examples of materials for manufacturing the link 101 include, but are not limited to, titanium, stainless steel, cobalt, chromium, nitinol alloy, thermosetting plastics and similar materials, or mixtures of the foregoing materials.

[0027] Furthermore, a Teflon (registered trademark) (polytetrafluoroethylene) coating or protective film enhances the non-traumatic properties of the surfaces of links 101 - 119. (These surfaces are considered "non-traumatic" as 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, titanium, cobalt, chromium, nitinol alloy, thermosetting plastics, and similar materials, or mixtures of the foregoing materials. In one embodiment, link 101 of the implantable device is manufactured using an additive manufacturing process, such as 3D printing. Link 101, lock-in unit 103, quick release unit 105, and interconnect pins are manufactured simultaneously and in a connected manner such that the additive manufacturing cycle results in a connected closed contour of links 101 - 119, lock-in unit 103, and quick release unit 105.

[0028] Accordingly, in one embodiment, an implantable device is described that includes a plurality of links 101 - 119, a device closure pin 111, a lock-in unit 103 attached and disposed between two links 117, 119, and a release unit 105 attached and disposed between two links 113, 115. The plurality of links 101 - 119, lock-in unit 103, and release unit 105 form a closed contour, and the implantable device is in a flexible state when device closure pin 111 is coupled to the lock-in unit 103 or quick release unit 105, and is in a rigid state when device closure pin 111 is attached to both the lock-in unit 103 and quick release unit 105.

[0029] FIG. 1C is an example of a side view of an implantable device 135 in a rigid state, where a closed contour and a device closure pin 111 form an eight. In an alternative embodiment, the implantable device includes a plurality of links 101-119 that form a closed loop where one link 101, 113, 115, 117 is connected to the other two links 101-119, and a device closure pin 111. The implantable device is flexible when only one side of the device closure pin 111 is attached to the links 101-119, and is rigid and non-bendable when both sides of the device closure pin 111 are attached to the links 101-119. In a further embodiment, the closed contour of the implantable device 135 in the rigid state is elliptical and is configured to follow the shape of two arcuate portions 125, 127 and two interconnecting portions 131, 133. The absolute radius of the two arcuate portions 125, 127 is at least five times greater than the absolute radius of the interconnecting portions 131, 133. The respective radii of the arcuate portions 125, 127 have opposite signs. In a further embodiment, the closed contour of the implantable device in the rigid state is elliptical and consists of two arcuate portions 125, 127 and two interconnecting portions 131, 133, and the two interconnecting portions 131, 133 are substantially linear. In a further embodiment, the closed contour of the implantable device in the rigid state has an eight shape consisting of two arcuate portions and two connected interconnecting portions. The resulting shape of the implantable device in the rigid state in contact with the pylorus is substantially linear, thus exerting no expansion force on the pylorus and ensuring the long-term stability of the implanted device.

[0030] FIG. 1D is an example of an implantable device composed of three arc-shaped parts and a plurality of links. FIG. 1D shows an implantable device 140 in a first state or a flexible state. The implantable device 140 is composed of three arc-shaped parts 142, 144, and 146, and each arc-shaped part includes a plurality of links 101-119. The arc-shaped parts 142, 144, and 146 having the plurality of links 101-119 are configured to be sufficiently flexible for intraoral introduction into the recipient's body. The implantable device 140 includes, but is not limited to, at least a lock-in unit 148, a quick-release unit 155, and a plurality of links 101-119. Each of the links 101-119 is connected to two other links 101-119 or is connected to one link 101-119 on one side and to either the lock-in unit 153 or the quick-release unit 155 on the opposite side. The implantable device 140 in the first state or the flexible state is inserted into the body cavity using an intraoral procedure. During insertion, the flexibility of the implantable device gives the implantable device 140 the ability to follow the contour of the body opening. This flexibility facilitates insertion while minimizing discomfort to the patient. The implantable device 140 is connected to a delivery or insertion device by the lock-in unit 153. In one example, a functional unit that provides a body-related function is attached to the quick-release unit 155. An example of the functional unit is a gastric sleeve configured to reduce food intake in the intestine.

[0031] FIG. 1E is an example of an implantable device composed of three arc-shaped parts and a plurality of links, shown in a rigid state. The implantable device 140 in the first form is in a flexible state. In the second form or the rigid state, the implantable device 140 forms a closed contour, and the three arc-shaped parts 142, 144, and 146, the lock-in unit 153, and the quick-release unit 155 constitute a device with a closed three-dimensional curved surface shape. The closed three-dimensional curved surface shape of the implantable device 140 can be one of a shape group consisting of a sphere or an ellipsoid.

[0032] The surfaces of all the links (101 to 119) are non-traumatic surfaces made of titanium. Further, a Teflon (registered trademark) (polytetrafluoroethylene) coating or protective film enhances the non-traumatic properties of the surfaces of links 101 to 119. Usually, the links (101, 113, 115, 117, 119) are manufactured using a laminated manufacturing process.

[0033] Figure 2A is an example of the links (101-119 in Fig. 1A) of an implantable device. The links 101-119 include a mounting shaft 203 and a pin cavity 201. The mounting shaft 203 is configured to connect to the pin cavity 201 in a second link to form a closed contour composed of a plurality of links 101-119. In the closed contour, each of the links 101-119 is connected to two other links 101-119 or is connected to one link 101 on one side and to either a locking unit (103 in Fig. 1B and 153 in Fig. 1E) or a release device (105 in Fig. 1B and 155 in Fig. 1E) on the opposite side. Figure 2B is an example of a top view of the link 101 of the implantable device. Figure 2C is an example of a side cross-sectional view of the link of the implantable device along the cutting line N-N in Fig. 2B. The link 101 includes a mounting shaft 203 and a pin cavity 201. The link further includes an inclined side surface 205. In the flexible state of the implantable device, one link 101 is connected 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. The link 101 can move freely around the axis defined by their shafts 203. The relative movement around the axis of the link 101 provides the necessary flexibility along a plane of the flexible implantable device. In the constrained state, the inclined side surface 205 of one link 101 is pressed against the opposing surface 211 of the adjacent connecting link 101. The shape of the contour of the implantable device in the constrained state is determined by the relative angle between the inclined side surface 205 of one link 101 and the opposing surface 211 of the adjacent link 101 in contact with the inclined side surface 205. In a further embodiment, the above relative angle is different for each link to configure a specific size and shape of the closed contour of the implantable device in the rigid state.

[0034] The supporting recess 207 or 209 contacts the supporting recess 209 or 207 of the adjacent link at a preset maximum angle, providing a constraint on the relative movement of the link 101 in the flexible state. The link includes at least a base 220 (FIG. 2A), one or more connection pins 203, and one or more vias 201. All the links (101-119 in FIG. 1A and 101 in FIG. 2A) that make up the embeddable device, the pins 203, and the pinholes 205 are such that the pin 203 of one link 101 is disposed within the pinhole 205 of an adjacent link 101 or a lock-in unit (103 in FIG. 1A and 153 in FIG. 1E) or a quick-release unit (105 in FIG. 1A and 155 in FIG. 1E), and are manufactured simultaneously to provide a closed contour of the link 101, the lock-in unit (103 in FIG. 1A and 153 in FIG. 1E), and the quick-release unit (105 in FIG. 1A and 155 in FIG. 1E) at the end of the additive manufacturing cycle.

[0035] As shown in the embodiment, the link is composed of at least a base 220, one or more connection shafts 203, and one or more holes 201. The base 220 of one link and the connection shaft 203 (101-119 in FIGS. 1B-1E) located within the pinhole 201 of a second link (101-119 in FIGS. 1B-1E) are manufactured simultaneously using an additive manufacturing process.

[0036] Figure 3A shows an example of the device closure pin 111 attached to the release unit 105 (or 155). The upper surface of the device closure pin 111 is configured as a snap-in portion. The snap-in portion includes a recess 305 and a conical tip 309. In a further embodiment, when the implantable device is in a flexible state, the cord (121 in Figure 1B) is connected to the top of the conical tip 309. Pulling the cord (121 in Figure 1B) draws the device closure pin 111 into the receptacle (401 in Figure 4) and locks it in place by the recess 305 in the receptacle. The device closure pin 111 further includes one or more quick release pin holes 307. Figure 3B shows an example of a side view of the device closure pin attached to the release unit. The device closure pin 111 further includes attachment pins 315 and attachment pin cavities 311 corresponding to the attachment pins (203 in Figure 2C) and attachment pin cavities (201 in Figure 2C) of the link (101 in Figure 2A). The pins are used to attach the link to either side of the device closure unit. The device closure unit 105 / 155 further includes a quick release housing 301 and a second pin hole 303. The device attachment pin is inserted into the quick release housing 301 and held in place by inserting a quick release pin (123 in Figure 1B) through the second pin hole 303 and the quick release pin hole 307 of the device closure pin 111. Before insertion into the body, the device closure pin 111 is attached to the quick release unit 105 / 155. The effective length of the device closure pin 111 is adjusted by the choice of which quick release pin hole 307 the quick release pin (123 in Figure 1B) passes through to lock the device pin 111 in place. The effective length of the device closure pin 111 determines the contour shape when the implantable device is in a rigid state. In a further embodiment, the contour shape is configured to be substantially flat with respect to at least one link on either side of the quick release unit 105. The sleeve connection pin 321 is an anchor point for the cord connecting the implantable device to the intestinal sleeve.FIG. 3C is an example of a rear view of a device closing pin attached to the release unit.

[0037] FIG. 4A is an embodiment of a device closing pin 111 attached to the receptacle 401. FIG. 4B is an example of a side view of the device closing pin 111 attached to the receptacle 401, and FIG. 4C is an example of a top view of the device closing pin 111 attached to the receptacle 401. In one embodiment, the receptacle 401 includes an outer ring 403a and a plurality of spokes 405. The plurality of spokes 405 terminate in front of the center of the receptacle 401, allowing the conical tip 309 of the device closing pin 111 to pass through the receptacle 401 and then extend into the device closing pin recess 305 to lock the device closing pin 111 in a predetermined position. Examples of materials for manufacturing the receptacle include, but are not limited to, stainless steel titanium, stainless steel, cobalt, chromium, nitinol alloy, thermosetting plastics and similar materials, or mixtures of the foregoing materials.

[0038] The closing 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. In a further embodiment, the receptacle 401 is configured as a spring washer with slots and is configured to receive and hold the snap-in portion of the device closing pin 111.

[0039] FIG. 5A is an embodiment of a method of using an implantable device in a rigid state 135 to restrain movement of the implantable device within a body cavity. In one embodiment, the implantable device in the rigid state 135 is fixed to the stomach 511. The intestinal sleeve 505 is attached to the implantable device in the rigid state 151 with a sleeve cord 501 and inserted into the intestine 513. In a further embodiment, the intestinal sleeve 505 includes a wavy anchor 503 for positioning the intestinal sleeve in a predetermined position.

[0040] Figure 5B is an example of a method of using an implantable device composed of three arcuate portions and a plurality of links in a rigid state to restrict the movement of the implantable device within a body cavity. In the rigid state, the shape of the implantable device 140 has a contour of a closed three-dimensional curved surface shape. The three arcuate portions 142, 144, and 146 of the device 140 open within the stomach 511 to fix the device 140. The arcuate portions 142, 144, and 146 of the device 140 can contact the wall of the stomach 511. The three-dimensional curved surface shape contour of the unit 140 supports the substantially constant position of the unit 140 within the stomach.

[0041] Figure 6A is an example of the corrugated anchor 503 in a folded form, and Figure 6B is an example of the corrugated anchor in an expanded form.

[0042] Several embodiments are described. Nevertheless, it will be understood that various modifications can be made without departing from the spirit and scope of the method. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. An implantable device, comprising at least three arcuate portions convertible from a first flexible state to a second rigid state, a device closure pin, a lock-in unit attached and disposed at one end of said three arcuate portions, and a quick-release unit attached and disposed at the opposite end of said three arcuate portions, wherein when the device closure pin is connected to one of the lock-in unit or the quick-release unit, the device is in the first flexible state, and when the device closure pin is attached to both the lock-in unit and the quick-release unit, the device is in the second rigid state. An implantable device.

2. 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 surface shape. The implantable device according to claim 1.

3. The closed three-dimensional curved surface shape is one of a shape group consisting of a sphere or an ellipsoid. The implantable device according to claim 2.

4. The surface of all links is a non-traumatic surface made of titanium, and the non-traumatic surface of the link further includes a polytetrafluoroethylene coating or protective film. The implantable device according to claim 1.

5. Each of the links is composed of at least one base, an attachment shaft, and one or more pinholes, and the link is manufactured using an additive manufacturing process. The implantable device according to claim 4.

6. The base of one link and the attachment shaft located within the pinhole of a second link are manufactured simultaneously using an additive manufacturing process. The implantable device according to claim 5.

7. The device closure pin includes a conical tip configured to be inserted and locked into a receptacle. The implantable device according to claim 1.

8. The release unit includes a pull-out pin for attaching the device closure pin to the release unit, and removal of the pull-out pin releases the device closure pin from the release unit. The implantable device according to claim 1.

9. ​ The closed contour in the rigid state of the implantable device is a three-dimensional curved shape including three arc-shaped portions and two interconnecting portions, and the two interconnecting portions are substantially linear. The implantable device according to claim 1.

10. An implantable device, A plurality of links forming three arc-shaped portions constituting a closed three-dimensional curved shape, each link being connected to two other links, A device closing pin including a snap-in portion, A lock-in unit attached and disposed at one end of one of the three arc-shaped portions, A quick release unit attached and disposed at the opposite end of the three arc-shaped portions comprising, The implantable device is flexible when the device closing pin is attached to either the lock-in unit or the quick release unit, and is hard and inflexible when both sides of the device closing pin are attached to the lock-in unit and the quick release unit. The device closing pin includes a receptacle having a slotted spring washer configured to receive and hold the snap-in portion of the device closing pin. The implantable device.

11. The lock-in unit is configured as a slotted spring washer and includes a receptacle configured to receive and hold the snap-in portion of the device closing pin. The implantable device according to claim 10.

12. The device closing pin includes at least one quick release pin hole and a pull-out pin for attaching the device closing pin to the lock-in unit or the release unit. The implantable device according to claim 10.

13. The closed three-dimensional curved surface state of the implantable device is large enough to prevent the implantable device from passing through the pylorus. The implantable device according to claim 10.

14. A method of using an implantable device, Providing an implantable device including at least three arc-shaped portions, a device closing pin, a lock-in unit attached and disposed at one end of the at least three arc-shaped portions, and a quick release unit attached and disposed at the opposite end of the at least three arc-shaped portions. configuring the at least three arcuate portions, the lock-in unit, and the quick release unit into a closed and rigid form comprising the closed and rigid form of the implantable device being a three-dimensional curved surface shape a method, wherein the three-dimensional curved surface shape of the implantable device includes at least three arcuate portions and two interconnecting portions, and each interconnecting portion connects the at least three arcuate portions

15. The method according to claim 14, further comprising attaching the device closure pin to both the lock-in unit and the release unit to hold the implantable device in a rigid state

16. The method according to claim 14, providing at least three arcuate portions composed of a plurality of links, all link surfaces being non-traumatic surfaces made of titanium, and the non-traumatic surfaces of the links further including a coating or protective film of polytetrafluoroethylene

17. The method according to claim 14, wherein the implantable device is in a flexible state when the device closure pin is coupled to at least one of the lock-in unit or the quick release unit, and is in a rigid state when the device closure pin is attached to both the lock-in unit and the quick release unit

18. A method of using an implantable device, comprising providing an implantable device including a plurality of arcuate portions where each arcuate portion is a flexible linear element, a device closure pin, a lock-in unit disposed and attached between three arcuate portions, and a quick release unit disposed and attached between three arcuate portions configuring the plurality of arcuate portions, the lock-in unit, and the release unit in a closed state comprising the closed state of the implantable device in the rigid state being a three-dimensional curved shape a method, wherein the implantable device shape is composed of at least three arcuate portions and two interconnecting portions

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