Devices, systems, and related methods for delivering a medicament to a body lumen

Abstract

Systems and methods for medical devices are disclosed herein. For example, a medical device can be configured to release at least one medicament from a containment cavity upon interaction with a substance. The medical device can include a capsule wall defining at least one containment cavity and a sensor configured to detect the substance. The containment cavity can be configured to contain at least one medicament.

Description

Cross-references to related applications

[0001] This application claims priority under section 119 of 35 U.S.C., filed October 12, 2023, in U.S. Provisional Application No. 63 / 589,717, which is incorporated herein by reference in its entirety. Technical Field

[0002] Various aspects of this disclosure generally relate to medical devices, systems, and related methods. More specifically, embodiments of this disclosure relate to medical devices and systems for treating, locating, and / or imaging luminal lesions (e.g., bleeding within the small bowel wall). Background Technology

[0003] Gastrointestinal bleeding is a serious problem that can be fatal if not addressed promptly and appropriately. Small bowel bleeding can be caused by arteriovenous malformations (AVMs), tumors, polyps, Crohn's disease, and / or ulcers, and is most common in individuals over 50 years of age. Typical treatment includes hospitalization to stabilize blood pressure and heart rate, as well as providing intravenous fluids and blood transfusions. Endoscopic or surgical intervention may be necessary to locate and stop the bleeding. Summary of the Invention

[0004] Each aspect disclosed herein may include one or more features described in conjunction with any other disclosed aspect.

[0005] Various aspects of this disclosure relate to a medical device that may include a capsule wall defining at least one receiving cavity and a sensor configured to detect the substance. The receiving cavity may be configured to contain at least one pharmaceutical agent. The medical device may be configured to release the at least one pharmaceutical agent from the receiving cavity upon interaction with the substance.

[0006] Any device disclosed herein may include any of the following features in any combination. The at least one agent may comprise a hemostatic agent or a dye. The sensor may include a camera, wherein the substance is blood, and wherein the camera is configured to detect blood. The camera may be configured to detect the fluorescent characteristics of blood. The capsule wall may comprise an emulsion polymer configured to degrade in an alkaline solution. The receiving cavity may comprise more than one sub-receiving cavity. The sensor may include electronic components configured to transmit the detection of the substance to a user device. The substance may include one or more of an acidic environment, an alkaline environment, or an activating substance.

[0007] The medical device may include a release mechanism. The release mechanism may contain a biodegradable material configured to degrade upon contact with the substance. The release mechanism may be a pressurized release mechanism. The activating substance may be administered to a patient intravenously or orally. The activating substance may be at least one of an activating molecule, an enzyme, or a fluorophore. The capsule wall may contain at least one pore. The at least one pore may be configured to transition from a closed state to an open state upon detection of the substance. Each of the at least one pore may contain a biodegradable material configured to degrade upon detection of the substance, such that the at least one pore transitions from a closed state to an open state. At least a portion of the capsule may contain the biodegradable material.

[0008] In another example, the medical device may include a capsule wall defining at least one receiving cavity and a sensor configured to detect blood. The receiving cavity may be configured to contain at least one pharmaceutical agent. The sensor may include electronic components configured to communicate with a user device.

[0009] Any device disclosed herein may include any of the following features, alone or in any combination. The capsule may be configured to deliver at least one drug based on instructions from a user device. The sensor may be a camera configured to detect the fluorescent characteristics of blood.

[0010] One method may include administering a capsule to a patient and automatically releasing at least one pharmaceutical agent from the capsule upon interaction with a substance in the patient's body cavities. The capsule may contain at least one pharmaceutical agent inside.

[0011] Any exemplary method disclosed herein may include any of the following steps, alone or in any combination. The capsule may include a wall. The method may also include the automatic release of a drug through wall degradation upon interaction with a substance. The capsule may include a sensor configured to detect a substance. The method may also include the automatic release of a drug when the sensor detects the substance.

[0012] It is understood that the foregoing general description and the following detailed description are exemplary and explanatory only, and not intended to limit the claimed invention. As used herein, the terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such a process, method, article, or apparatus. Where an element is not circular, the term “diameter” may refer to width. The terms “distal” or “far” refer to a direction further into the subject’s body, and the terms “proximal” or “near” refer to the opposite direction (e.g., towards the subject’s mouth). The term “exemplary” means “example,” not “ideal.” The term “about” or similar terms (e.g., “substantially”) include values ​​specified plus or minus 10%. Attached Figure Description

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various aspects of this disclosure and, together with the specification, serve to explain the principles of this disclosure.

[0014] Figure 1A An exemplary medical device in a closed state according to one or more embodiments is depicted.

[0015] Figure 1B It depicts the open state. Figure 1A An exemplary medical device.

[0016] Figure 2A An alternative medical device in a closed state according to one or more embodiments is described.

[0017] Figure 2B Depicting Figure 2A A cross-sectional view of a medical device.

[0018] Figure 3 A medical system according to one or more embodiments is described.

[0019] Figure 4 The use of exemplary medical devices (such as those in Figure 1-) is depicted. Figure 2B The relevant methods for medical devices.

[0020] Figures 5A-5D Depicting Figure 4 Several aspects of the exemplary method.

[0021] Figure 6 A simplified functional block diagram of a computer according to one or more embodiments is depicted. Detailed Implementation

[0022] Embodiments of this disclosure relate to medical devices and systems comprising structures configured to detect, treat, and / or manage luminal lesions, such as bleeding in the small intestine. Gastrointestinal (GI) bleeding is a serious problem that can lead to death if not addressed promptly and appropriately. For example, small intestinal bleeding can be caused by arteriovenous malformations (AVMs), tumors, polyps, Crohn's disease, and ulcers, and is most common in individuals over 50 years of age. Typical treatment involves hospitalization to stabilize blood pressure and heart rate, as well as providing intravenous fluids and transfusions. Endoscopic or surgical intervention may be required to locate and stop the bleeding. However, while many areas of the gastrointestinal tract can be accessed endoscopically, much of the small intestine cannot, necessitating specialized techniques and / or surgery (which may be invasive) to address the bleeding.

[0023] Although this article mentions the treatment of small bowel bleeding, it should be understood that the disclosed devices and methods can be used in other treatment procedures (e.g., during various medical procedures involving the localization, treatment, diagnosis and / or management of problems related to the body's luminal system).

[0024] The medical device disclosed herein may be a “capsule” configured to release a drug into a subject’s body lumen. In one example, the capsule may include an electronic sensor configured to sense the presence of blood. When the sensor detects blood, the capsule may be configured to deploy a drug to treat bleeding. In another example, the capsule may include a shell configured to degrade or spontaneously rupture in the jejunum and ileum to deliver the drug contained within the capsule. For example, the shell may include a material that is impermeable to liquid under acidic conditions and disintegrates under alkaline conditions. In yet another example, the capsule may carry a marker that marks the treatment area (e.g., a treatment area with blood) for subsequent medical treatment (e.g., surgical treatment).

[0025] Figure 1A and Figure 1B A first embodiment of a medical device 105 is depicted, which can be configured to be deployed to a treatment site (e.g., a lesion such as an injury) to detect substances and / or release hemostatic agents or other agents. Figure 2A and Figure 2BA second embodiment of the medical device 205, which can be similarly deployed to a treatment site, is described, as discussed in further detail below. The medical devices 105 and 205 may be capsules or capsule-like. The medical devices 105 and 205 may improve the ability to reach various body regions (e.g., the small intestine region) for locating and / or treating bleeding. Unless otherwise specified, it will be understood that the medical devices 105 and 205 may have any of the same characteristics. The medical devices 105 and 205 may be configured (e.g., in response to the detection of a substance or interaction with a substance) to contain and / or release hemostatic agents or other agents.

[0026] Examples of agents that may be disposed within or otherwise deployed by medical devices 105, 205 may include at least one of powders, fluids, foams, clays (e.g., kaolin, bentonite, etc.), patches, molecules or compounds (e.g., pharmaceutical compounds, coagulants, calcium, fibrin, etc.), biological products, mechanical packings (e.g., gel foams, starch, chitosan, cellulose, etc.), and / or cauterizing agents. Alternatively, medical devices 105, 205 may contain other agents, such as labeling agents, such as biocompatible dyes (e.g., methylene blue, patent blue, brilliant blue, endoscopic labeling dyes, etc.). Delivery of biocompatible dyes via devices 105, 205 can enable lesion localization / labeling, for example, via X-rays, CT scans, MRI scans, etc. Hemostatic agents or other agents may be attached to exposed cells of the lesion and / or other substances at or around the lesion site, such that at least a portion of the hemostatic agent or other agent becomes concentrated at the site of injury.

[0027] As described above and discussed in further detail below, in some examples, medical devices 105, 205 may be configured to deploy their payload (e.g., a hemostatic agent or marker) in response to the characteristics of the lesion site and / or nearby anatomical structures. In some examples, medical devices 105, 205 may be configured to deliver their payload in the presence of blood. Alternatively or additionally, medical devices 105, 205 may be configured to deliver their payload in response to the presence of substances such as activating molecules, acidic environments, alkaline environments, enzymes, fluorophores, etc.

[0028] In some embodiments, medical device 105 ( Figure 1A and Figure 1B This may include capsule 107, camera 310 or other imaging sensors, and / or sensor 315. As used herein, the term "camera" includes sensors configured to detect any type of optical input. Similarly, medical device 205 ( Figure 2A and Figure 2BIt may contain capsule 207. Capsules 107 and 207 may have any suitable construction, such as a two-piece capsule (as depicted for example, capsule 107), a one-piece capsule (as depicted for example, capsule 207), etc.

[0029] Capsules 107 and 207 may be composed of any suitable material or combination of materials. In some examples, capsules 107 and 207 may be disposable. In other examples, capsules 107 and 207 (or portions thereof) may be reusable. As discussed in more detail below, capsules 107 and 207 (and / or portions thereof) may include materials or components configured to degrade, dissolve, disintegrate, signal, or otherwise react in the presence of substances at or near the lesion site (e.g., in the presence of blood, activating substances, alkaline environments, acidic environments, etc.). Capsules 107 and 207 (and / or portions thereof) may be configured to remain stable in the presence of other bodily fluids.

[0030] Capsule 107 ( Figure 1A and 1B It may include an inner shell (internal housing) 140 defined by the capsule wall 125. Figure 1B The internal receiving cavity 140 may be configured to receive at least one agent 10. In some examples, the internal receiving cavity 140 may be a compartment within a portion / sub-portion of capsule 107. In other examples, the internal receiving cavity 140 may extend throughout the entire interior of capsule 107. The internal receiving cavity 140 may have any suitable size or shape. The size, shape, or other characteristics of the internal receiving cavity 140 may be selected based on the payload (e.g., agent 10) of the internal receiving cavity 140.

[0031] Capsule 207 may similarly include an internal receiving cavity 240 defined by capsule wall 220. Figure 2B The capsule wall 220 has any of the properties of the capsule wall 125. The internal receiving cavity 240 may have any of the characteristics of the internal receiving cavity 140. In some embodiments, such as those for... Figure 2B As depicted in capsule 207, the internal receiving cavity 240 may include at least one inner wall 215. Although in Figure 1A and Figure 1BNot shown, but capsule 107 may also include such an inner wall. The inner wall 215 may be composed of any suitable material, such as a material configured to decompose (e.g., gelatin, cellulose, etc.) or a material configured to remain intact throughout the body lumen (e.g., polymer or metal). At least one internal sub-receptacle 222 may be defined by at least one inner wall 215 of capsule 207 and capsule wall 220. Capsules 107, 207 may contain any suitable number of sub-receptacle 222. For example, capsules 107, 207 may contain one, two, three, four, etc., internal sub-receptacle 222. Each of at least one internal sub-receptacle 222 may contain at least one payload (e.g., a hemostatic agent or other agent). For example, a first internal sub-receptacle may contain a first agent, a second internal sub-receptacle may contain a second agent, a third internal sub-receptacle may contain a third agent, a fourth internal sub-receptacle may contain a marker, and a fifth internal sub-receptacle may contain another treatment agent, and so on.

[0032] like Figure 1A and Figure 1B As shown, capsule 107 may comprise a capsule body 110 and / or capsule cap 115 connected at connection point 120. In some embodiments, connection point 120 may be pressurized. Connection point 120 may be a conventional connection point, such as an interlocking ring, snap-fit, etc., or spring-loaded, and / or may include a release mechanism, as discussed in further detail below. Alternatively, capsule 107 may comprise a single outer capsule wall 125 with an opening formed therein, which may be covered by a cap having a connection point similar to connection point 120 and having any of its characteristics.

[0033] In some embodiments, connection point 120 may include a release mechanism (hereinafter referred to as "interaction point release mechanism") 132, for example, a release mechanism including at least one interaction point 135. Interaction point release mechanism 132 may be configured to release a payload (e.g., a hemostatic agent or a marker) from capsule 107. Interaction point release mechanism 132 may release and / or induce the release of at least one agent based on the detection of substances within the body cavity or the properties of the body cavity (e.g., via camera 310 or sensor 315, reception of communications (e.g., communications from a user device), etc.), as described in further detail below. When interaction point release mechanism 132 is activated, the payload can diffuse from a high concentration region (e.g., the interior of the capsule) to a lower concentration region (e.g., into the patient's body cavity).

[0034] The interaction point release mechanism 132 may be spring-loaded and / or may contain a material configured to activate (e.g., degrade) in the presence of certain substances. The spring-loaded interaction point release mechanism 132 may be user-controlled, as described further in detail herein. The degradable material of the interaction point release mechanism 132 may be of any suitable construction. For example, such as... Figure 1B As shown, at least one interaction point 135 may be located on the outer edge of the capsule body 110 and / or the inner edge of the capsule cap 115, such that at least one interaction point 135 interacts when the outer edge of the capsule body 110 and the inner edge of the capsule cap 115 are connected. In some examples, the interaction point release mechanism 132 may be configured to disintegrate, degrade, etc. (according to any mechanism discussed herein with respect to the capsule wall 125) in the presence of certain substances, thereby releasing the capsule body 110 from the capsule cap 115. The interaction point release mechanism 132 may be pressurized (e.g., via the connection between the capsule body 110 and the capsule cap 115). For example, if the medical device 105 is pressurized, the pressurization may help separate the capsule body 110 from the capsule cap 115, thereby releasing at least one drug agent.

[0035] In some embodiments, medical devices 105 or 205 may include other release mechanism configurations. For example, capsule walls 125, 220 may include a release mechanism (hereinafter referred to as a "capsule wall release mechanism") wherein capsule walls 125, 220 may be made of a material configured to degrade, disintegrate, etc., in the presence of a substance (e.g., blood), such that when medical devices 105, 205 interact with blood in a lumen of a patient's body (e.g., encounter) (e.g., due to bleeding in the lumen wall), capsule walls 125, 220 may degrade, thereby enabling the release of at least one agent. In some examples, capsule walls 125, 220 may comprise a number of portions having the same or different materials. For example, a portion of capsules 107, 207 may comprise capsule walls 125, 220 composed of, for example, biocompatible metals and / or polymers that can pass through the entire body cavity and be discharged via a natural orifice of the body (e.g., the anus). For example, a portion of the capsule 107 housing the camera 310 and / or sensor 315 may be formed of a material intended to pass through a body lumen in this manner. Another portion of the capsules 107, 207 (e.g., a portion of the capsules 107, 207 forming at least a portion of the internal receiving cavities 140, 240) may be configured to degrade in vivo.

[0036] In some embodiments, all or part of the capsule walls 125, 220 may be made of a material configured to degrade in the presence of an activating substance. For example, the activating substance may be administered intravenously and / orally to a patient and may be present at a site of injury, such as a bleeding site in the patient's small intestine. Medical devices 105, 205 may interact with the activating substance in a patient's body lumen (e.g., due to a bleeding injury in the lumen wall). This interaction may cause all or part of the capsule walls 125, 220 to degrade, thereby enabling the release of at least one agent. The material of the capsule walls 125, 220 (or a portion thereof) may be configured to degrade in the presence of the activating substance but not in other parts of the body lumen.

[0037] In some embodiments, some or all of the capsule walls 125, 220 may be composed of a material configured to degrade in an acidic solution, such that when the medical devices 105, 205 pass through the acidic environment of the stomach and / or duodenum, the capsule walls 125, 220 (or portions thereof) may degrade, thereby enabling the release of the payload of the medical device 105.

[0038] In additional or alternative embodiments, part or all of the capsule walls 125, 220 may be configured as a material that degrades in alkaline solutions (e.g., enteric coating 130, labeled...). Figure 1A and Figure 1B The enteric coating 130 is covered or constituted by the medical device 105, 205 such that when the medical device 105, 205 interacts with the alkaline environment of the jejunum and / or ileum, the enteric coating 130 can degrade, thereby enabling the release of at least one drug agent. In such an example, due to the acidic environment of the stomach and duodenum, the capsule wall 125, 220 (or a portion thereof) can remain intact when the medical device 105, 205 passes through the stomach and duodenum.

[0039] Enteric coating 130 can be configured to prevent and / or reduce the degradation of capsules 107 and 207 in acidic environments (e.g., in gastric acid). Enteric coating 130 can consist of any suitable material or combination of materials, such as emulsion polymers including poly(2-dimethylamino)methacrylate, chitosan, P(HEMA), methyl acrylate-methacrylic acid copolymer, cellulose acetate phthalate (CAP), cellulose acetate succinate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate (hydroxypropyl methylcellulose acetate succinate), polyvinyl acetate phthalate (PVAP), methyl methacrylate-methacrylic acid copolymer, shellac, cellulose trimellitate, sodium alginate, zein, etc.

[0040] In some embodiments, the capsule walls 125, 220 may be made of more than one material, such as a first material, a second material, etc. The first material may include an enteric coating 130 or another coating, which may be the outermost coating of capsules 107, 207. The second material may be capsule 107, 207 (hereinafter referred to as "internal material") 131 (marked on...). Figure 1B The innermost or innermost layer of the capsule wall 125, 220 is configured to degrade in the presence of a substance in the body lumen. A first material (e.g., enteric coating 130) may be configured to be external / outward relative to a second material. For example, the capsule walls 125, 220 may consist of the outermost layer of the enteric coating 130, which degrades when the medical device 105 interacts with an acidic solution in the stomach, thereby exposing the inner material 131 to an alkaline solution in the jejunum and / or ileum. When the medical device 105 interacts with an alkaline solution, the second inner material 131 of the capsule walls 125, 220 may degrade, thereby enabling the release of a payload (e.g., a drug or labeling agent).

[0041] In some examples, the additional release mechanism of capsules 107 and 207 may include multiple orifices. This release mechanism... Figure 2A It is described as being used with capsule 207, but can be used with any capsule described herein. Figure 2A As shown, the capsule 207 may include multiple pore release mechanisms 210. The pore release mechanisms 210 enable the continuous release of the drug. Each pore release mechanism 210 may include a pore 212 and / or a material configured to degrade in the presence of the substance 214 (hereinafter referred to as "degradable material"). For example, the degradable material 214 may be configured to cover, close, etc., such that the pore release mechanism 210 can have a closed state. If the degradable material 214 interacts with the substance (e.g., in a patient's body lumen), the degradable material 214 can degrade, thereby changing the pore 212 from a closed state to an open state. In some examples, the degradable material 214 may be configured to allow the drug to diffuse through the pore 212 from a high concentration region (e.g., inside the capsule) to a low concentration region (e.g., into a patient's body lumen).

[0042] In some embodiments, capsule 207 may include more than one configuration of pore release mechanisms 210. For example, capsule 207 may have a first set of pore release mechanisms 210 (which may be pores / openings) containing a first biodegradable material and a second set of pore release mechanisms 210 containing a second biodegradable material. Any suitable number of pore release mechanisms 210 configurations may be present in capsule 207. In some embodiments, the number of pore release mechanism configurations 210 may be associated with the number of internal sub-receptacle cavities 222 of capsule 207. For example, a first internal sub-receptacle 222 may be associated with a first configuration of pore release mechanism 210, a second internal sub-receptacle 222 may be associated with a second configuration of pore release mechanism 210, a third internal sub-receptacle 222 may be associated with a third configuration of pore release mechanism 210, a fourth internal sub-receptacle 222 may be associated with a fourth configuration of pore release mechanism 210, and so on. In another example, a first configuration of the orifice release mechanism 210 can be activated in an acidic environment or in the stomach and / or duodenum to release a first payload (e.g., a drug) from the first internal sub-receptacle 222, and a second configuration of the orifice release mechanism 210 can be activated in an alkaline environment or in the jejunum and / or ileum to release a second payload (e.g., a drug) from the second internal sub-receptacle 222.

[0043] In other examples, the orifice release mechanism 210 may be covered by a mechanical cover and may be operated by a mechanism similar to the interaction point release mechanism 132. For example, the orifice release mechanism 210 may include a cover that may be released by a latch or other similar mechanism to selectively deliver a drug (e.g., drug 10).

[0044] As described above, medical device 105 may also include a camera 310 or other imaging device and a sensor 315. Although medical device 205 is not depicted as having a camera 310 or sensor 315, it should be understood that medical device 205 may include such elements. In some examples of medical device 105, the camera 310 and / or sensor 315 may be omitted. The camera 310 and / or sensor 315 may be configured to transmit data collected by the camera 310 and / or sensor 315 to one or more devices, for example, to provide location data, chemical data, visual data, etc. Figure 3 The description. Figure 3 The exemplary system 300 depicts a medical device 105 configured to communicate (e.g., across network 335) with a data storage device 320 and a user device 325. The user device 325 can be executed by any suitable device (e.g., a smartphone, computer, tablet, etc.).

[0045] Camera 310 can be configured to capture camera data, such as photographs, videos, fluorescence characteristics (e.g., blood), light absorption characteristics (e.g., the light absorption characteristics of blood), etc. Camera 310 can be any suitable type of device for capturing still and / or moving images. Camera 310 may have an image sensor. Camera data captured by camera 310 can be transmitted to data storage device 320 and / or user device 325. In some embodiments, as discussed further in detail below, user 330 can interact with the camera data (e.g., via user device 325).

[0046] Sensor 315 can be configured to capture sensor data, such as the presence of a substance (e.g., blood in a patient's body lumen). Sensor 315 can be any suitable type of sensor (e.g., a substance sensor), such as a pH sensor, a blood sensor, etc. In some embodiments, sensor 315 can be an electronic, optical, biological, or chemical component configured to detect or otherwise react to the presence of a substance in a body lumen. Sensor data captured by sensor 315 can be transmitted to data storage device 320 and / or user device 325. In some embodiments, as discussed further in detail below, user 330 can interact with the sensor data (e.g., via user device 325).

[0047] Camera 310, sensor 315, and other aspects of medical devices 105, 205 can communicate with data storage device 320, user device 325, etc. Camera 310 and / or sensor 315 can be configured to transmit camera data and / or sensor data to user device 325 respectively (e.g., to a graphical user interface (GUI) associated with user device 325).

[0048] In some implementations, user 330 may interact with camera data and / or sensor data via a GUI associated with user device 325, and / or user 330 may control release mechanisms associated with medical devices 105, 205. For example, user 330 may (e.g., via a GUI associated with user device 325) instruct release mechanism 132 of medical device 105 to activate.

[0049] In some implementations, sensor 315 may be configured to determine and / or transmit (e.g., to a processor associated with user device 325, a GUI associated with user device 325, etc.) the location of a medical device (e.g., medical device 105), the location of an injury, a release state, etc. Sensor 315 may be configured to determine the location of the injury and / or medical device 105, 205 based on at least one of peristaltic time, the rate of movement through the body lumen, the composition of the surrounding contents (e.g., acidic, alkaline, neutral), and the approximate time elapsed since ingestion of the medical device. For example, if camera 310 and / or sensor 315 detects an acidic environment and then an alkaline environment, it can be understood that the medical device has moved from the duodenum to the jejunum. In another example, the time elapsed since ingestion of the medical device can be compared to a standard value or a patient-specific digestive pattern (e.g., if the bolus typically takes 4 hours to reach the patient's jejunum after swallowing, it can be estimated that the medical device may be approximately located in the jejunum approximately 4 hours after ingestion).

[0050] More than one mechanism can be used to determine the location of medical devices 105, 205. For example, sensor 315 can be configured to measure ambient pH and transmit the measured pH to user device 325 (e.g., to a processor associated with user device 325), and camera 310 can be configured to collect images and / or videos of body cavities and transmit the images and / or videos to user device 325 (e.g., to a processor associated with user device 325). The processor associated with user device 325 can determine whether the medical device is in the jejunum or ileum based on the measured ambient alkalinity, and can further determine whether the medical device is in the ileum based on the content of the images and / or videos and / or the amount of time elapsed since the ingestion of the medical device (e.g., as measured by the images and / or videos captured by camera 310).

[0051] The state of the medical device can be determined based on changes in the chemical composition of the surrounding environment sensed by sensor 315. For example, after the medical device has released its payload, sensor 315 can detect the presence of the payload in a body lumen and transmit this detection to the system (e.g., to a processor associated with user device 325). The processor associated with user device 325 can then determine whether the payload has been released based on the detection.

[0052] The medical device described herein can be incorporated into various embodiments or combinations thereof. In any embodiment, the medical device may contain a drug, such as a hemostatic agent, a marker (e.g., a dye), etc., inside the capsule.

[0053] In a first embodiment, the medical device can be configured to have diagnostic capabilities. (See Figure 1 and...) Figure 3 In more detail, the medical device 105 may be a capsule 107 connected to a camera 310 and / or a sensor 315 via a connection point 120. Alternatively, as described above, the capsule 107 may include one or more openings / orifices through which a payload (e.g., a hemostatic agent) can be delivered. The medical device 105 may be configured to transmit data collected by the camera 310 and / or the sensor 315 to one or more devices, such as a data storage device 320, a user device 325, etc. For example, the medical device 105 may be configured to transmit the position of the medical device 105 in a body lumen, for example, when the sensor 315 transmits the detection results of a substance (e.g., blood) to a processor associated with the user device 325. Furthermore, the medical device 105 may be configured to be controllable by one or more devices. For example, the medical device 105 may receive communication from the user device 325 (e.g., communication regarding the release or non-release of a drug), and the medical device 105 may or may not activate a release mechanism to release the drug based on such communication.

[0054] Medical device 105 can be swallowed by a patient with known or suspected bleeding. Any device disclosed herein can be used after surgery (e.g., post-operative period) or at any other time when bleeding may be suspected or of concern. As medical device 105 moves through a patient's gastrointestinal tract via natural peristalsis, it may encounter a bleeding site. Sensor 315 can detect the presence of blood according to any of the mechanisms discussed above, which could cause capsule 107 to rupture, dissolve, or burst. In some examples, capsule 207 may be pressurized. Capsule 107 can allow the payload of capsule 107 (e.g., stored in the internal receiving cavity 140) to be widely applied to the area surrounding capsule 107. The payload can be a hemostatic agent (including any of the agents discussed above).

[0055] In one example, capsule 107 may be a capsule endoscope (pillcam), and sensor 315 and / or camera 310 may have fluorescence readout capability. Hemoglobin may have unique fluorescence characteristics that can be detected by camera 310 and / or sensor 315 of capsule 107. For example, camera 310 may assess specific light absorption characteristics unique to hemoglobin. Camera 310 and / or sensor 315 may enable capsule 107 to automatically deploy payload. Alternatively, camera 310, sensor 315, and / or transmitter of capsule 107 communicating with camera 310 and / or sensor 315 may communicate with user device 325, as described above. User device 325 may automatically instruct capsule 107 to deploy payload, or the user may manually utilize user device 325 to deliver payload (e.g., via a spring-loaded canister).

[0056] Alternatively, sensor 315 and / or camera 310 can detect the electrical, optical, biological, and / or chemical properties of blood or other substances in a body lumen. In another alternative manner, an orally or intravenously administered compound that can be carried in the bloodstream can be administered to the patient. Bleeding in a body lumen can result in the presence of the compound in the lumen. The compound may include, for example, specific molecules, enzymes, or fluorophores. When the compound is detected (e.g., via camera 310 and / or sensor 315), capsule 107 can deliver the payload as described above.

[0057] In a second embodiment, medical device 205 may be configured to degrade under certain conditions (e.g., autodegradation), releasing a payload, such as a drug (e.g., any of the drugs discussed above). Medical device 205 may be administered as described above with respect to medical device 105. Figure 2A and 2B In more detail, the medical device 205 may be a single-piece capsule 207. The capsule 207 may include at least one internal sub-cavity 222, which may be defined by at least one inner wall 215 and capsule wall 220 of the capsule 207. The capsule 207 may include any suitable number of sub-cavities 222, for example, one, two, three, four, etc. Each of the at least one internal sub-cavity 222 may contain at least one payload (e.g., a hemostatic agent or other agent). For example, a first internal sub-cavity 222 may contain a first therapeutic agent, a second internal sub-cavity 222 may contain a second therapeutic agent, a third internal sub-cavity 222 may contain a third therapeutic agent, a fourth internal sub-cavity 222 may contain a marker, a fifth internal sub-cavity 222 may contain another therapeutic agent, and so on.

[0058] As described above, capsule 207 (or a portion thereof) may be composed of materials configured to degrade in the presence of a substance (e.g., blood) via degradation of one or more of the capsule wall 220, the pore release mechanism 210, etc. For example, as described above, medical device 205 may include a capsule wall 220 made of a biodegradable material (e.g., biodegradable material 214). When capsule wall 220 interacts with a substance (e.g., blood, activator, etc.), capsule wall 220 can degrade, thereby releasing a drug.

[0059] In another example, the pore release mechanism 210 may include multiple perforations or holes 212 containing biodegradable material 214. The biodegradable material 214 can cause the holes 212 to be closed, and the biodegradable material 214 interacts with a substance (e.g., blood, activating substances, etc.), and degradation can cause the holes 212 to be open. Alternatively, the holes 212 may be open (e.g., in communication with the internal receiving cavity 240) and may not contain biodegradable material 214. In some embodiments, the capsule 207 may contain more than one configuration of the pore release mechanism 210. For example, the capsule 207 may have a first set of pore release mechanisms 210 containing a first biodegradable material and a second set of pore release mechanisms 210 containing a second biodegradable material. Any suitable number of pore release mechanism 210 configurations may be present in the capsule 207. In some embodiments, the number of pore release mechanism 210 configurations may be associated with the number of internal receiving cavities 222 of the capsule 207. For example, a first internal sub-receptacle 222 may be associated with a first configuration of the orifice release mechanism 210, a second internal sub-receptacle 222 may be associated with a second configuration of the orifice release mechanism 210, a third internal sub-receptacle 222 may be associated with a third configuration of the orifice release mechanism 210, a fourth internal sub-receptacle 222 may be associated with a fourth configuration of the orifice release mechanism 210, and so on. In another example, the first configuration of the orifice release mechanism 210 may be activated in an acidic environment or in the stomach and / or duodenum to release a first payload (e.g., a drug) from the first internal sub-receptacle 222, and the second configuration of the orifice release mechanism 210 may be activated in an alkaline environment or in the jejunum and / or ileum to release a second payload (e.g., a drug) from the second internal sub-receptacle 222.

[0060] In some embodiments, the capsule walls 125, 220 or portions thereof and / or the pore release mechanism 210 may be made of certain materials configured to degrade in the presence of the activating substance. For example, the material may degrade in the presence of the activating substance but remain intact in the presence of other substances. Prior to deployment of the medical device, the patient may have received an intravenous and / or oral formulation of the activating substance.

[0061] In a third embodiment, medical devices 105, 205 may be configured to release a marker, such as a dye. Medical devices 105, 205 may be configured as described in the first and / or second embodiments, but the agent contained within capsules 107, 207 may be a marker (e.g., a dye) such that, upon release, the marker can mark, stain, etc., lesions. Exemplary markers are discussed above and include, for example, methylene blue, patent blue, brilliant blue, or endoscopic stains. As discussed in more detail below, the location of the lesion can then be determined based on the marked lesion, for example via X-ray, CT scan, endoscopic imaging, etc. The third embodiment provides an apparatus for marking areas for subsequent evaluation and / or treatment (e.g., via endoscopic or surgical methods).

[0062] It should be noted that although these embodiments have been discussed separately for clarity, it should be understood that aspects of one embodiment can be incorporated into another. For example, a third embodiment may be configured to release a marker and include diagnostic capabilities. In another example, a first embodiment may be configured to have diagnostic capabilities and also configured to degrade under certain conditions to release a reagent.

[0063] Figure 4 The use of an exemplary medical device 400 (such as Figure 1-) is depicted. Figure 2B Method 400 related to medical devices, such as medical device 105, medical device 205. Figures 5A-5D Several aspects of method 400 are described. At step 402, the medical device can be navigated to a target site (e.g., a site of injury) within the patient's body lumen. In some examples, the patient may ingest the medical device (e.g., by swallowing), and peristalsis of the digestive tract may move the medical device through the patient's body lumen. In some examples, a duodenoscope or other type of endoscope, such as one that visualizes the body lumen, may be used to deliver the medical device 105, 205, etc. Figure 5A As depicted, a medical device 505 (having any of the characteristics of medical devices 105, 205) (hereinafter referred to as the "medical device") in a closed and / or intact state can move toward a target site, such as a site of injury, through a patient's body lumen 512 (e.g., the digestive tract, including the stomach, duodenum, jejunum, ileum, etc.). The lumen wall 510 may include an injury (or other type of injury) 515. In some examples, the injury 515 may be bleeding, causing a substance 520 (e.g., blood) to move into the body lumen 512.

[0064] In step 404, the properties of the blood or body lumen (e.g., acidic or alkaline environment) can be detected. Figure 5BAs shown, when the medical device 505 passes through a body lumen 512, the medical device 505 can come into contact with a substance 520 (e.g., blood or the nature of the body lumen), thereby activating a release mechanism associated with the medical device 505. As described above, this release can be automatic or via user intervention.

[0065] The release mechanism associated with medical device 505 can be any release mechanism, such as a degradable structure of capsule walls 125, 220, a pore release mechanism 210, an interaction point release mechanism 132, etc. For example, any of the above-described release mechanisms can be activated in the presence of a substance (e.g., blood, activator, etc.). In another example, the pore release mechanism 210 can be activated if the degradable material 214 interacts with the substance 520, causing the degradable material 214 to degrade, as discussed herein. In another example, the interaction point release mechanism 132 can be activated if at least one interaction point 135 interacts with the substance 520, thereby causing at least one interaction point 135 located on the outer edge of the capsule body 110 and at least one interaction point 135 located on the inner edge of the capsule cap 115 to degrade and disconnect, as discussed herein.

[0066] As discussed herein, the type of substance activating the release mechanism can vary. For example, if the substance is an activating substance, the patient may have already received an intravenous and / or oral formulation of the activating substance prior to starting step 402. Substance 520 (e.g., blood) can therefore include an activating substance that can activate the release mechanism of medical device 505, which is configured to activate in the presence of the activating substance. In another example, the release mechanism may be configured to activate in the presence of blood and may be activated upon contact with substance 520.

[0067] It should be noted that although the medical device 505 is depicted as interacting with substance 520 relatively close to injury 515, the medical device 505 can interact with substance 520 in other areas of the body lumen 512. For example, if injury 515 is located distal to the jejunum, substance 520 can be detected proximally to the jejunum. Therefore, the release mechanism of the medical device 505 can be activated before reaching injury 515. In another example, if substance 520 is an acidic environment, the release mechanism of the medical device 505 can be activated in the stomach and / or duodenum, regardless of the location of injury 515.

[0068] In some examples, the activation of the release mechanism can be controlled by user 330, for example via user device 325. Optionally, at step 406, the detection result of substance 520 can be transmitted to the user device, such as user device 325. For example, when substance 520 comes into contact with medical device 505, the detection result of substance 520 (e.g., via sensor 315, camera 310, etc.) can be transmitted to user device 325. In response to communication, user 330 can (e.g., via a GUI associated with user device 325) input a command (e.g., activate, deactivate, etc.). This command can be transmitted to the medical device, for example, to camera 310, sensor 315, etc. In this way, the activation of the release mechanism can be controlled, for example, to prevent medical device 505 from prematurely releasing the drug. For example, user 330 can instruct the spring-loaded interaction point release mechanism 132 to release the drug at a point determined by user 330.

[0069] In step 408, upon detection of substance 520, at least one agent may be released and / or at least one agent may be released from the capsule, such as... Figure 5C As depicted herein. It should be noted that although the medical device 505 is depicted as having a connection point release mechanism (e.g., interaction point release mechanism 132), it should be noted that the medical device 505 may include any suitable configuration of capsules, release mechanisms, sensors, cameras, etc., as discussed herein.

[0070] Depending on the type of agent released, lesion 515 can be stained, marked, cauterized, mechanically treated, etc. For example, if the agent is a biocompatible dye, lesion 515 can be marked or tagged with a biocompatible dye, which allows lesion 515 to be located, for example, via X-ray, CT scan, MRI scan, endoscopy, etc. In another example, if the agent is a mechanical tampon, the mechanical tampon can expand within a body lumen 512, thereby applying mechanical pressure to lesion 515. The mechanical tampon can expand across the diameter and / or circumference of the body lumen 512, allowing pressure to be applied to lesion 515 by pressing the mechanical tampon against the area of ​​the lumen wall 510 opposite to lesion 515. The mechanical tampon can be configured to degrade or pass through the body lumen 512 after any suitable time period (e.g., approximately one to thirty minutes). The mechanical tampon can be configured to degrade or pass through the body lumen 512 such that it does not obstruct the gastrointestinal tract and / or does not impede or hinder the natural shedding schedule of the gastrointestinal tract, etc. In another instance, the agent may be a molecule or compound suitable for activating the coagulation cascade (e.g., kaolin, bentonite, etc.).

[0071] like Figure 5DAs depicted, after the release of at least one agent, the medical device 505 can continue to travel within the body lumen 512 and can be excreted by the patient. Alternatively, the medical device 505 can be completely degraded within the body lumen.

[0072] Figure 6 A simplified functional block diagram of a computer 600 is depicted. The computer 600 may be configured as an apparatus for performing the methods disclosed herein, according to exemplary embodiments of the present disclosure. For example, the computer 600 may be configured as a system according to exemplary embodiments of the present disclosure. In various embodiments, any system herein may be the computer 600, including, for example, a data communication interface 620 for packet data communication. The computer 600 may also include a central processing unit (CPU) 602 in the form of one or more processors for executing program instructions. The computer 600 may include an internal communication bus 608 and a storage unit 606 (e.g., ROM, HDD, SDD, etc.) which may store data on a computer-readable medium 622; however, the computer 600 may also receive programming and data via network communication. The computer 600 may also have a memory 604 (e.g., RAM) storing instructions 624 for performing the techniques given herein; however, the instructions 624 may also be temporarily or permanently stored in other modules of the computer 600 (e.g., processor 602 and / or computer-readable medium 622). Computer 600 may also include input and output ports 612 and / or a display 610 for connecting input and output devices such as a keyboard, mouse, touchscreen, monitor, display, etc. Various system functions can be implemented in a distributed manner on many similar platforms to distribute the processing load. Alternatively, the system can be implemented through appropriate programming of a single computer hardware platform.

[0073] The various procedural aspects of technology can be considered "products" or "manufactured goods," typically existing or embodied in a machine-readable medium in the form of executable code and / or related data. "Storage" media include any or all tangible memory, such as various semiconductor memories, tape drives, disk drives, etc., of computers, processors, or their associated modules, which can provide non-transitory storage for software programming at any time. Software, in whole or in part, can sometimes be communicated via the Internet or various other telecommunications networks. For example, such communication enables the loading of software from one computer or processor to another, such as from a management server or host computer of a mobile communication network to a server's computer platform and / or from a server to a mobile device. Therefore, another type of medium that can carry software elements includes light waves, radio waves, and electromagnetic waves, such as those used through physical interfaces between local devices, through wired and optical landline networks, and through various air links. Physical elements carrying such waves (e.g., wired or wireless links, optical links, etc.) can also be considered as media carrying software. As used herein, unless limited to non-temporary, tangible "storage" media, terms such as "computer or machine readable medium" refer to any medium that participates in providing instructions to a processor for execution.

[0074] It should be understood that in the above description of exemplary embodiments of the invention, various features of the invention are sometimes combined in a single embodiment, drawing, or description in order to simplify the disclosure and facilitate understanding of one or more aspects of the various inventive aspects. However, this method of disclosure should not be construed as reflecting an intention that the claimed invention requires more features than expressly listed in each claim. Rather, as reflected in the appended claims, inventive aspects lie in fewer than all features of a single foregoing disclosed embodiment. Therefore, the claims following “details” are expressly incorporated herein by reference to “details,” each claim being an independent embodiment of the invention.

[0075] Furthermore, while some embodiments described herein include features included in other embodiments but not others, it will be understood by those skilled in the art that combinations of features from different embodiments are intended to be within the scope of the invention and to form different embodiments. For example, in the appended claims, any claimed embodiment may be used in any combination.

[0076] Therefore, although certain embodiments have been described, those skilled in the art will recognize that other modifications and further alterations can be made thereto without departing from the spirit of the invention, and all such changes and modifications falling within the scope of the invention are intended to be claimed. For example, functions can be added or removed from the block diagram, and operations can be exchanged between functional blocks. Steps can be added or removed from the methods described within the scope of the invention.

[0077] The subject matter disclosed above is intended to be illustrative rather than restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other implementations that fall within the true spirit and scope of this disclosure. Therefore, to the maximum extent permitted by law, the scope of this disclosure shall be determined by the broadest permissible interpretation of the appended claims and their equivalents, and shall not be limited or restricted by the foregoing detailed description. While various implementations of this disclosure have been described, it will be apparent to those skilled in the art that many implementations are possible within the scope of this disclosure. Therefore, this disclosure is limited only by the appended claims and their equivalents.

Claims

1. A medical device comprising: A capsule wall defining at least one receiving cavity, wherein the receiving cavity is configured to contain at least one pharmaceutical agent; as well as A sensor, which is configured to detect substances; The medical device is configured to release the at least one agent from the containment cavity upon interaction with the substance.

2. The medical device of claim 1, wherein the at least one agent comprises a hemostatic agent or a dye.

3. The medical device as claimed in any of the preceding claims, wherein the sensor includes a camera, wherein the substance is blood, and wherein the camera is configured to detect blood.

4. The medical device of claim 3, wherein the camera is configured to detect the fluorescence characteristics of blood.

5. The medical device as claimed in any of the preceding claims, wherein the capsule wall comprises an emulsion polymer configured to degrade in an alkaline solution.

6. The medical device as claimed in any of the preceding claims, wherein the receiving cavity comprises more than one sub-receiving cavity.

7. The medical device as claimed in any of the preceding claims further comprises a release mechanism, wherein the release mechanism comprises a degradable material configured to degrade upon contact with the substance.

8. The medical device as claimed in any of the preceding claims further comprises a pressure release mechanism.

9. The medical device as claimed in any of the preceding claims, wherein the sensor comprises electronic components configured to transmit detection results of the substance to a user device.

10. The medical device as claimed in any of the preceding claims, wherein the substance comprises one or more of an acidic environment, an alkaline environment, or an activating substance.

11. The medical device of claim 10, wherein the activating substance is administered to a patient intravenously or orally.

12. The medical device of claim 10, wherein the activating substance is at least one of an activating molecule, an enzyme, or a fluorophore.

13. The medical device as claimed in any of the preceding claims, wherein the capsule wall includes at least one hole in the wall, the at least one hole being configured to change from a closed state to an open state upon detection of the substance.

14. The medical device of claim 13, wherein each of the at least one aperture comprises a biodegradable material configured to degrade upon detection of the substance, such that the at least one aperture transitions from a closed state to an open state.

15. The medical device as claimed in any of the preceding claims, wherein at least a portion of the capsule comprises a biodegradable material.

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