Patent Application
20240041301
The present disclosure relates to a device configured to move within a body cavity, such as the gastrointestinal tract, in particular, the small intestine, and methods of using the device for endoscopic purposes, for delivering a substance into the body cavity, for removing a substance or tissue from the body cavity, for capturing an image of the body cavity, and/or for performing an operation of a tissue or organ using the device. The presently disclosed device may be self-driving, and the articulation of a tip of the device may be controlled and fine tuned. The presently disclosed device may be used in a variety of body cavities such as a vascular body lumen, a digestive body lumen, a respiratory body lumen, or a urinary body lumen.
The current endoscopic procedures, such as esophagogastroduodenoscopy (EGD), colonoscopy, enteroscopy, etc., involve intensive human operation of the systems. For instance, it is generally known that a gastrointestinal examination uses an endoscope having a flexible insertion section. In inserting the above-mentioned endoscope into deep part of the digestive tract, e.g., the small intestine, when the insertion section is inserted thereinto while being pushed, a force is hardly transmitted to the distal end of the insertion section because the intestine is complicatedly curved. It is, therefore, difficult to insert the insertion section into deep part. Oftentimes, even when it is possible to insert an endoscope into deep part, it takes a long time, causes discomfort and pain, and requires sedation. There is need for a device that is easy to use and causes less discomfort. The present disclosure addresses these and other needs.
In some aspects, provided herein is a device configured to move within a body cavity, the device comprising: a) a support (e.g., an elongated support, such as a tubular structure such as a tether); b) a proximal radially expandable element and a distal radially expandable element positioned along the length of the support, optionally wherein the radially expandable elements are independently controllably expandable, wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, and wherein the distal radially expandable element is fixed relative to the support; and c) a locomotion system comprising: i) a proximal locomotion element having a part that is fixed relative to the proximal radially expandable element and slidable along the length of the support, such that the proximal radially expandable element is slidable along the length of the support, and ii) a distal locomotion element having a part fixed relative to the support, wherein the locomotion system effects sliding movement of the proximal radially expandable element along the length of the support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity. In any of the embodiments herein, the distal locomotion element can comprise a part fixed relative to the distal radially expandable element, e.g., the distal locomotion element or part thereof can be directly or indirectly fixed to the distal radially expandable element or a part thereof.
In some aspects, provided herein is a device configured to move within a body cavity, comprising: a support (e.g., a tubular structure such as a tether); controllably expandable elements positioned along the length of the support, from proximal to distal: a proximal locomotion element (e.g., a first longitudinally expandable element), a proximal radially expandable element (e.g., a first radially expandable element), a distal locomotion element (e.g., a second longitudinally expandable element), a distal radially expandable element (e.g., a second radially expandable element), wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, wherein the first radially expandable element or the second radially expandable element is slidable along the support relative to the support, and wherein the proximal and the distal locomotion elements are configured to effect relative movement between the radially expandable elements (e.g., relative movement between the outer surfaces configured to frictionally engage the body cavity wall), thereby effecting movement of the device within the body cavity. In any of the embodiments herein, the proximal end of the proximal locomotion element (e.g., the first longitudinally expandable element) and the distal end of the distal locomotion element (e.g., the second longitudinally expandable element) may have a fixed distance between each other. In any of the embodiments herein, the positions of the proximal end of the proximal locomotion element (e.g., the first longitudinally expandable element) and the distal end of the distal locomotion element (e.g., the second longitudinally expandable element) may be fixed relative to each other. In any of the embodiments herein, the positions of the proximal end of the proximal locomotion element (e.g., the first longitudinally expandable element) and the distal end of the distal locomotion element (e.g., the second longitudinally expandable element) may be fixed relative to the support.
In any of the embodiments herein, the proximal locomotion element may be moveable relative to the distal locomotion element. In any of the embodiments herein, the proximal locomotion element may be moveable relative to the support. In any of the embodiments herein, the distal locomotion element may be fixed relative to the support. In any of the embodiments herein, the proximal locomotion element may be moveable relative to the support, whereas the distal locomotion element may be fixed relative to the support, or vice versa. In any of the embodiments herein, the proximal locomotion element may comprise a floating element that is moveable relative to the support (e.g., capable of being pulled by a cable and/or pushed by a rod along the length of the support), whereas the distal locomotion element may comprise a wheel that is fixed relative to the support. In any of the embodiments herein, a cable may be fixed to the floating element and engage the wheel, such that the cable may be guided by the wheel (e.g., the cable may engage a groove such as a V-groove in the wheel) and pulled in the proximal direction, thereby pulling the floating element (and the proximal radially expandable element attached thereto) in the distal direction.
In any of the embodiments herein, the proximal end of the proximal locomotion element may be moveable relative to the distal end of the distal locomotion element. In any of the embodiments herein, the proximal end of the proximal locomotion element may be moveable relative to the support. In any of the embodiments herein, the distal end of the distal locomotion element may be fixed relative to the support. In any of the embodiments herein, the proximal end of the proximal locomotion element may be moveable relative to the support, whereas the distal end of the distal locomotion element may be fixed relative to the support.
In any of the embodiments herein, the distal locomotion element may comprise a part fixed directly or indirectly to the distal expandable element, for instance, a distal end of the distal locomotion element may be directly or indirectly to a proximal end of the distal expandable element. In any of the embodiments herein, the distal locomotion element may comprise a part fixed directly or indirectly to the promixal expandable element, for instance, a proximal end of the distal locomotion element may be directly or indirectly to a distal end of the proximal expandable element.
In any of the embodiments herein, the proximal locomotion element may comprise a part fixed directly or indirectly to the proximal expandable element, for instance, a distal end of the proximal locomotion element may be directly or indirectly to a proximal end of the proximal expandable element.
In any of the embodiments herein, the support may be an elongated support comprising a tubular wall and a lumen, optionally wherein the lumen is a central lumen.
In any of the embodiments herein, one or both of the expandable elements and/or one or both of the locomotion elements can be in fluid or gas communication with one or more chambers, one or more channels, one or more tubes, and/or one or more wires in the central lumen. In any of the embodiments herein, any one or more of the expandable elements and locomotion elements can be independently controlled.
In any of the embodiments herein, the locomotion elements may be configured to expand or collapse along the length of the elongated support, optionally wherein the locomotion elements are configured to expand or collapse only along the length of the elongated support and/or are not radially expandable.
In any of the embodiments herein, the proximal and the distal radially expandable elements may be capable of expanding radially outwardly to engage a wall of a body cavity, optionally wherein friction augmenting features are molded into the proximal and/or distal radially expanding elements.
In any of the embodiments herein, alternating extensions and retractions of a distance between the outer surfaces of the proximal and the distal radially expandable elements may effect movement of the device within the body cavity.
In any of the embodiments herein, the device may further comprise an articulation element capable of effecting articulation of a distal end of the device, optionally wherein the distal end of the device is the distal end of the elongated support or the distal end of the device directly or indirectly engages the distal end of the elongated support. In any of the embodiments herein, the articulation element may enable steering of the device, optionally wherein the device comprises a machine vision element that digitally recognizes structures assisting in navigation and identifying anomalies such as lesions and polyps, optionally wherein the machine vision assists in navigation and/or transmitting location of structures such as when moving from the large intestine to the small intestine. In any of the embodiments herein, the articulation element may comprise one or more motors and/or one or more cables. In any of the embodiments herein, the articulation element may comprise one or more closed loop cables configured to effect articulation, e.g., by pulling a distal end of the device.
In any of the embodiments herein, the device may further comprise one or more channels not in connection with the expandable elements, e.g., fluid and/or gas connection with an inside space of the expandable element(s).
In any of the embodiments herein, the proximal radially expandable element can comprise or be a proximal balloon. In any of the embodiments herein, the distal radially expandable element can comprise or be a distal balloon. In any of the embodiments herein, the proximal radially expandable element may directly or indirectly engage one or more floating elements configured to slide along the length of the elongated support, thereby sliding the proximal radially expandable element along the length of the elongated support.
In any of the embodiments herein, the locomotion system may comprise two longitudinally expandable elements. In any of the embodiments herein, the locomotion system may comprise a proximal longitudinally expandable element and a distal longitudinally expandable element, optionally wherein the longitudinally expandable elements are independently controllably expandable, and optionally wherein the longitudinally expandable elements each comprises a structure independently selected from the group consisting of a compliant balloon, a semi-compliant balloon, a pressure balloon, and a bellow.
In any of the embodiments herein, the locomotion system can comprise a pulley system. In any of the embodiments herein, the pulley system may comprise a proximal floating element, a distal wheel, and a cable connected to the proximal floating element and engaging the distal wheel.
In some aspects, provided herein is a device configured to move within a body cavity, the device comprising: a) an elongated support; b) a proximal radially expandable element and a distal radially expandable element positioned along the length of the elongated support, wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, and wherein the distal radially expandable element is fixed relative to the elongated support; c) a locomotion system comprising a proximal longitudinally expandable element and a distal longitudinally expandable element connected by a floating seal, wherein: i) the proximal longitudinally expandable element is proximal to the proximal radially expandable element, and the floating seal is fixed relative to the proximal radially expandable element and slidable along the length of the elongated support, such that the proximal radially expandable element is slidable along the length of the elongated support, and ii) the distal longitudinally expandable element is proximal to the distal radially expandable element, and the distal end of the distal longitudinally expandable element is fixed relative to the elongated support, wherein the locomotion system effects sliding movement of the proximal radially expandable element along the length of the elongated support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity.
In any of the embodiments herein, the proximal and the distal longitudinally expandable elements can be configured to expand or collapse along the length of the elongated support, optionally wherein the proximal and the distal longitudinally expandable elements configured to expand or collapse only along the length of the elongated support and/or are not radially expandable. In any of the embodiments herein, alternating expansion and collapsing of the proximal and the distal longitudinally expandable elements may change the distance between the proximal end of the proximal longitudinally expandable element and the distal end of the distal longitudinally expandable element.
Alternatively, in any of the embodiments herein, alternating expansion and collapsing of the proximal and the distal longitudinally expandable elements do not need to change the distance between the proximal end of the proximal longitudinally expandable element and the distal end of the distal longitudinally expandable element. In any of the embodiments herein, alternating expansion and collapsing of the proximal and the distal longitudinally expandable elements do not need to change the distance between the distal end of the proximal longitudinally expandable element and the proximal end of the distal longitudinally expandable element. For instance, the distal end of the proximal longitudinally expandable element and the proximal end of the distal longitudinally expandable element can be separated by a floating seal (e.g., attached to a proximal radially expandable element) and the dimension of the floating seal along the length of the support is fixed.
In any of the embodiments herein, the distance between the proximal end of the proximal longitudinally expandable element and the distal end of the distal longitudinally expandable element can be pre-determined. In any of the embodiments herein, the distance can be more than about 1 cm, more than about 2 cm, more than about 3 cm, more than about 4 cm, more than about 5 cm, more than about 6 cm, more than about 7 cm, more than about 8 cm, more than about 9 cm, or more than about 10 cm. In any of the embodiments herein, the distance can be from about 3 cm to about 6 cm, from about 6 cm to about 9 cm, or from about 9 cm to about 12 cm.
In any of the embodiments herein, the maximum distance between the radially expandable elements along the length of the support during the movement of the device (e.g., driven by the alternating expansion and collapsing of the proximal and the distal longitudinally expandable elements) within a body cavity can be pre-determined. In any of the embodiments herein, the maximum distance can be more than about 1 cm, more than about 2 cm, more than about 3 cm, more than about 4 cm, more than about 5 cm, more than about 6 cm, more than about 7 cm, more than about 8 cm, more than about 9 cm, or more than about 10 cm. In any of the embodiments herein, the maximum distance can be from about 3 cm to about 6 cm, from about 6 cm to about 9 cm, or from about 9 cm to about 12 cm.
In any of the embodiments herein, the distance and/or the maximum distance between the radially expandable elements along the length of the support during the movement of the device may be adjusted according to the curvature of the body cavity.
In any of the embodiments herein, the expansion of the proximal and/or the distal longitudinally expandable elements can be effected by positive pressure, optionally wherein negative pressure is proactively and alternatively applied to the longitudinally expandable elements in order to evacuate previously applied positive pressure, and optionally wherein the proximal and/or the distal longitudinally expandable elements do not passively deflate. In any of the embodiments herein, the expansion of the proximal longitudinally expandable element and the collapsing of the distal longitudinally expandable element can effect sliding movement of the proximal radially expandable element along the length of the elongated support. In any of the preceding embodiments, the collapsing of the proximal longitudinally expandable element and the expansion of the distal longitudinally expandable element can effect movement of the distal radially expandable element, e.g., when the distal radially expandable element is not expanded to engage a wall of the body cavity.
In some aspect, provided herein is a method for locomotion of the device of any of the embodiments herein through a body cavity, the method comprising: i. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a first position in the body cavity; ii. expanding (e.g., using positive pressure) the distal longitudinally expandable element along the elongated support to increase the distance between the proximal and the distal radially expandable elements; iii. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the proximal radially expandable element radially inwardly; v. retracting (e.g., using negative pressure) the distal longitudinally expandable element, and/or expanding (e.g., using positive pressure) the proximal longitudinally expandable element along the elongated support, thus effecting sliding movement of the proximal radially expandable element along the elongated support and decreasing the distance between the proximal and the distal radially expandable elements; and vi. optionally expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a second position in the body cavity, optionally the second position is distal to the first position. In any of the embodiments herein, the method can further comprise step vii. expanding (e.g., using positive pressure) the distal longitudinally expandable element along the elongated support to increase the distance between the proximal and the distal radially expandable elements. In any of the embodiments herein, the method can further comprise repeating steps i-vi.
In some aspects, provided herein is a method for locomotion of the device of any of the embodiments herein through a body cavity, the method comprising: i. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a first position in the body cavity; ii. expanding (e.g., using positive pressure) the proximal longitudinally expandable element along the elongated support, thus effecting sliding movement of the proximal radially expandable element along the elongated support and decreasing the distance between the proximal and the distal radially expandable elements; iii. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the distal radially expandable element radially inwardly; v. retracting (e.g., using negative pressure) the proximal longitudinally expandable element, and/or expanding (e.g., using positive pressure) the distal longitudinally expandable element along the elongated support; and vi. optionally expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a second position in the body cavity, optionally the second position is distal to the first position. In any of the embodiments herein, the method can further comprise step vii. expanding (e.g., using positive pressure) the proximal longitudinally expandable element along the elongated support to decrease the distance between the proximal and the distal radially expandable elements. In any of the embodiments herein, the method can further comprise repeating steps i-vi.
In some aspects, provided herein is a device configured to move within a body cavity, the device comprising: a) an elongated support; b) a proximal radially expandable element and a distal radially expandable element positioned along the length of the elongated support, wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, and wherein the distal radially expandable element is fixed relative to the elongated support; c) a pulley system comprising: i) a proximal floating element that is fixed relative to the proximal radially expandable element and slidable along the length of the elongated support, such that the proximal radially expandable element is slidable along the length of the elongated support, ii) a distal wheel fixed relative to the elongated support, and iii) a cable connected to the proximal floating element and engaging the distal wheel, such that the cable is configured to pull the proximal floating element in the distal or proximal direction, wherein the pulley system effects sliding movement of the proximal radially expandable element along the length of the elongated support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity. In any of the embodiments herein, the cable can comprise or be a closed loop cable.
In any of the embodiments herein, movement of the cable can effect movement of the proximal radially expandable element along the elongated support, thereby effecting alternative extensions and retractions of a distance between the outer surfaces of the proximal and the distal radially expandable elements along the length of the elongated support. In any of the embodiments herein, the radially expandable elements are independently controllably expandably, and, optionally wherein the elongated support further comprises one or more medium channels separately connected to the radially expandable elements, optionally wherein the medium comprises gas, liquid or a mixture thereof and optionally wherein the medium comprises a vapor, and/or wherein the elongated support further comprises one or more wires or channels for a camera or sensor, optionally wherein the sensor is a pressure sensor and/or an image sensor, and/or wherein the elongated support houses or engages an endoscope assembly.
In any of the preceding embodiments, pulling the proximal floating element in the proximal direction while the proximal radially expandable element is collapsed and while the distal radially expandable element is expanded to engage a body cavity results in the proximal radially expandable element moving proximally within the body cavity, thereby increasing the distance between the proximal and the distal radially expandable elements. In any of the embodiments herein, pulling the proximal floating element in the proximal direction while the proximal radially expandable element is expanded to engage a body cavity and while the distal radially expandable element is collapsed may result in the distal radially expandable element moving distally within the body cavity, thereby increasing the distance between the proximal and the distal radially expandable elements. In any of the embodiments herein, pulling the proximal floating element in the distal direction while the proximal radially expandable element is collapsed and while the distal radially expandable element is expanded to engage a body cavity may result in the proximal radially expandable element moving distally within the body cavity, thereby decreasing the distance between the proximal and the distal radially expandable elements. In any of the embodiments herein, pulling the proximal floating element in the distal direction while the proximal radially expandable element is expanded to engage a body cavity and while the distal radially expandable element is collapsed may result in the distal radially expandable element moving proximally within the body cavity, thereby decreasing the distance between the proximal and the distal radially expandable elements.
In some aspects, provided herein is a method for locomotion of the device of any of the embodiments herein, through a body cavity, the method comprising: i. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a first position in the body cavity; ii. pulling the proximal floating element in the proximal direction along the elongated support while the distal radially expandable element is collapsed, thereby increasing the distance between the proximal and the distal radially expandable elements; iii. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the proximal radially expandable element radially inwardly; v. pulling the proximal floating element in the distal direction, thus effecting sliding movement of the proximal radially expandable element along the elongated support and decreasing the distance between the proximal and the distal radially expandable elements; and vi. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a second position in the body cavity, optionally wherein the second position is distal to the first position. In any of the embodiments herein, the method can further comprise step vii. pulling the proximal floating element in the proximal direction along the elongated support while the distal radially expandable element is collapsed, thereby increasing the distance between the proximal and the distal radially expandable elements. In any of the embodiments herein, the method can further comprise repeating steps i-vi.
In some aspects, provided herein is a method for locomotion of the device of any of the embodiments herein through a body cavity, the method comprising: i. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a first position in the body cavity; ii. pulling the proximal floating element in the distal direction along the elongated support while the proximal radially expandable element is collapsed, thereby decreasing the distance between the proximal and the distal radially expandable elements; iii. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the distal radially expandable element radially inwardly; v. pulling the proximal floating element in the proximal direction, thus effecting sliding movement of the distal radially expandable element forward along the elongated support and increasing the distance between the proximal and the distal radially expandable elements; and vi. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a second position in the body cavity, optionally wherein the second position is distal to the first position. In any of the embodiments herein, the method can further comprise step vii. pulling the proximal floating element in the distal direction along the elongated support while the proximal radially expandable element is collapsed, thereby decreasing the distance between the proximal and the distal radially expandable elements. In any of the embodiments herein, the method can further comprise repeating steps i-vi.
In any of the embodiments herein, the device provided herein can further comprise an articulation element capable of effecting articulation of a distal end of the device, optionally wherein the distal end of the device is the distal end of the elongated support or the distal end of the device directly or indirectly engages the distal end of the elongated support. In any of the embodiments herein, the articulation element can enable camera visualization and/or steering of the device (e.g., one comprising an endoscope assembly), optionally wherein the device comprises machine vision elements that digitally recognize structures assisting in navigation and identifying anomalies such as lesions and polyps, optionally wherein the machine vision assists in navigation and/or transmitting location of structures such as when moving from the large to small intestine. In any of the embodiments herein, the articulation element can comprise one o more motors and/or one or more cables. In any of the embodiments herein, the articulation element may comprises one or more closed loop cables configured to effect articulation.
In any of the embodiments herein, the method provided herein can further comprise capturing an image of the body cavity through a channel of the device. In any of the embodiments herein, the method can further comprise delivering a substance into the body cavity through a channel of the device. In any of the embodiments herein, the method can further comprise removing a substance into the body cavity through a channel of the device. In any of the embodiments herein, the method can further comprise performing an operation on a tissue within the body cavity through a channel of the device.
In any of the embodiments herein, the body cavity can be a vascular body lumen, a digestive body lumen, a respiratory body lumen, or a urinary body lumen. In any of the embodiments herein, the digestive body lumen can be a gastrointestinal tract. In any of the embodiments herein, the gastrointestinal tract can comprise small intestine. In any of the embodiments herein, the gastrointestinal tract can comprise duodenum, jejunum, and/or ileum. In any of the embodiments herein, the gastrointestinal tract can comprise large intestine. In any of the embodiments herein, the gastrointestinal tract can comprise colon. In any of the embodiments herein, a device disclosed herein can move in the gastrointestinal tract, e.g., from one part of large intestine to another part of large intestine, from large intestine to small intestine, and/or from one part of small intestine to another part of small intestine. In any of the embodiments herein, the gastrointestinal tract can comprise esophagus. In any of the embodiments herein, the gastrointestinal tract can comprise stomach.
In any of the embodiments herein, the expandable elements can be connected to the elongated support (e.g., tubular structure such as tether) using an elastic O-ring that mechanically holds the expandable elements; using adhesive only securing the edges of the expandable elements; mechanically securing the edges of an expandable element by a deformable material such as a metal by swaging or radially compressing it around the expandable element; or by a combination thereof.
In any of the embodiments herein, the device does not require a locking mechanism for directly or indirectly interlocking the first and second radially expandable elements to prevent relative movement between these radially expandable elements. In any of the embodiments herein, a method of using the device for moving inside a body cavity does not require a step of interlocking the first and second radially expandable elements to prevent relative movement between the radially expandable elements. In some embodiments, provided herein are devices and methods comprising one or more mechanisms and/or steps of effectuating and/or controlling relative movement between the radially expandable elements, in addition to mechanisms and/or steps of articulating a tip of the device.
The present invention is not intended to be limited in scope to the particular disclosed embodiments, which are provided, for example, to illustrate various aspects of the invention. Various modifications to the compositions and methods described will become apparent from the description and teachings herein. Such variations may be practiced without departing from the true scope and spirit of the disclosure and are intended to fall within the scope of the present disclosure. All publications, including patent documents, referred to in this application are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication were individually incorporated by reference. If a definition set forth herein is contrary to or otherwise inconsistent with a definition set forth in the patents, applications, published applications and other publications that are herein incorporated by reference, the definition set forth herein prevails over the definition that is incorporated herein by reference.
The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.
The small intestine is the longest and most important section of the intestine, where 90% of the digestion and absorption of nutrients and minerals occurs. Despite providing such vital functions for the human body, the small intestine remains difficult in accessibility, a ‘black box’ for physicians due to its length and location. The current understanding of small bowel physiology is limited, making diagnosis and treatment of small bowel diseases challenging to physicians. This has significant repercussions for patients. One common example is the management of Crohn's disease (CD), a disease primarily affecting the small bowel. In recent years, the prevalence of CD increased about 31% with a significant increase in Crohn's morbidity such as associated neoplastic transformation, social, psychological, financial repercussions, and impaired patient health-related quality of life (HRQoL). However, as the dearth of effective endoscopic tools makes successful performance of the procedure difficult and prohibitively expensive, diagnosis of CD is often hard to achieve, as direct mucosal examination and tissue sampling are required to make a definitive diagnosis but extremely difficult to perform. Irritable bowel syndrome (IBS) is another example in which lack of effective endoscopic tools harms patients. IBS is the most commonly diagnosed GI condition, accounting for approximately 30 percent of all referrals to gastroenterologists. IBS is associated with increased health care costs and is the second highest cause of work absenteeism. Though GI dysmotility is traditionally believed to be one of the etiologies for IBS, knowledge on small bowel motility remains nearly nil due to the lack of effective endoscopic tools for exploration into this research area.
Prevention of small bowel cancer associated with Peutz-Jeghers syndrome is a significant unmet health need. Peutz-Jeghers syndrome (PJS) is an autosomal dominant syndrome characterized by multiple hamartomatous polyps in the gastrointestinal tract, mucocutaneous pigmentation, and an increased risk of gastrointestinal and non-gastrointestinal cancer. Peutz-Jeghers syndrome (PJS) is rare with an estimated prevalence of 1:8000 to 1:200,000 births. Males and females are equally affected. Gastrointestinal hamartomatous polyps are present in most patients with PJS, and the polyps most commonly occur in the small bowel (60 to 90 percent). Gastrointestinal polyps develop in the first decade of life and most patients become symptomatic between the ages of 10 and 30. The distribution of gastrointestinal cancers in PJS is similar to that of the hamartomatous polyps, and carcinoma arising in hamartomas has been clearly documented. The average age of developing a malignancy in PJS is 42 years, and the lifetime cancer risk in the small bowel is 13%. Due to the increased risk for GI cancer in individuals with PJS, baseline endoscopic screening of the gastrointestinal tract includes upper gastrointestinal endoscopy (esophagogastroduodenoscopy), video capsule endoscopy (VCE), and colonoscopy, beginning at age eight years. The subsequent screening interval is based on the findings at baseline examination. Magnetic resonance enterography (MRE) is an alternative imaging modality for individuals with PJS for whom capsule endoscopy cannot be performed. Endoscopic polypectomy should be performed for small bowel polyps>1 cm in size in order to reduce the risk of polyp-related complications such as malignancy. Currently, a multitude of technologies need to be employed to manage small bowel polyps in PJS (e.g., capsule endoscopy and MRE) to identify and localize small bowel polyps/cancer, followed by deep enteroscopy to remove polyps. Peutz-Jeghers syndrome (PJS) and associated small bowel polyps and cancers represent a clear unmet need. The ability to diagnose and treat PJS patients to prevent cancer would be a boon, particularly in the small bowel, where few effective tools currently exist to diagnose and remove polyps.
The inherent problems in understanding the small bowel and its associated diseases indicate that exploration of small intestinal pathophysiology is crucial to advancing the GI field in evaluation and treating small bowel diseases, and improving patient care outcomes. There is a need for cost-effective endoscopic tools, and the present disclosure addresses this and other needs.
In some aspects, provided herein is an endoscopic tool that is 1) of a miniature size to minimize patient's discomfort in order to eliminate sedation; 2) capable of traveling the long intestinal tract; and/or 3) capable of providing diagnosis and therapy if needed. In some aspects, provided herein is an endoscopic tool that meets all of the three criteria above.
In some aspects, provided herein is a device, including use of a double balloon mechanism, an extended tether, and advances in camera technology. For example, double balloon enteroscopes have shown the effectiveness of the double balloon mechanism, and current colonoscopes have tethers, and high-resolution cameras. In addition, advances in soft robotics enable a compact and flexible motor system that is suitable to navigate through a tortuous path such as the GI tract. The present invention uses these previous innovations as a springboard to build a new and better tool to conduct gastrointestinal polypectomies for PJS patients.
In some aspects, the present disclosure provides advantages over existing technologies. For example, wireless capsule endoscopy (WCE) avoids sedation but is limited by its inability to intervene, quality of visualization, and random passage through the intestines; deep enteroscopy (DE) is capable of endoscopic interventions but is limited by lengthy, often incomplete procedures, general anesthesia requirements, special physician training, and significant risks, costs, and time associated with the procedures. In some aspects, the present disclosure provides devices and methods that address one or more of these disadvantages.
Much research has also been conducted on robotic endoscopic capsules to address these problems, but appears to have reached a bottle neck. The three ‘ground challenges’ in designing such a robot are 1) active locomotion, and 2) enabling diagnostic and 3) therapeutic functionalities due to limitations on size and power supply. External and internal locomotion are being developed to achieve active locomotion. Magnetic field mechanisms for external locomotion have been researched. Significant drawbacks are cost and difficulty in obtaining effective visualization and locomotion. Internal locomotion has significant advantages over magnetic fields, but the excessive internal encumbrance needed to suit the size of a miniature robot (e.g., the presence of motors/actuators, transmission mechanisms, and high-capacity power modules) limits its success. Other challenges to effective locomotion are intrinsic to the intestine: slippery surface and accordion effect from intestinal deformation when the robot advances. Diagnostic and therapeutic functionalities are unable to be addressed at the same time. Again, development is constrained by size and power supply.
In some aspects, provided herein are devices and methods that address all three challenges. In some aspects, provided herein are devices and methods based on at least a double balloon mechanism (DBM), utilized in double balloon enteroscopy (DBE), and soft robotics. DBE utilizes two alternating balloons to propel the scope. Its successful clinical application has confirmed its safety feature on tissue and intestine surface holding validity. These provide strong evidence for its feasibility to overcome the slippery environment. To overcome the accordion effect, generally a long linear stroke is desired; however, a long and rigid stroke will produce discomfort. Design of soft robotics will allow us to provide a flexible motion. In some embodiments herein, a 3D printed bellow and/or manually assembled multiple longitudinally aligned balloons are used to achieve motor function, respectively. In some embodiments, the device is pneumatically powered externally, and the freedom of external power supply eliminates the large payload in current robotic capsules. Because of the extra space saved, there is room to carry accessories needed for diagnostic and therapeutic functionalities.
In some embodiments, provided herein is a flexible self-driven endoscopic robotic capsule with interventional capacity. In some embodiments, the device is small enough to avoid requiring anesthesia. In some embodiments, the device is a disposable device that reduces or eliminates infection risks associated with cleaning of re-usable scopes in current practice.
In some embodiments, using the device disclosed herein makes it possible to perform controlled examination and intervention in the entire small bowel without sedation. In some embodiments, the space for accessories in the device allows physicians to continue using existing accessory tools, which allows smooth transition from traditional endoscopy to a device disclosed herein, while avoiding the cost associated with training new users or developing specific accessories. In some embodiments, the device comprises a bellow motor design that provides both articulation and actuation motor functions and maintains small motor size at the same time, which is essential to the development for both surgical device and soft robotics.
In some embodiments, the device disclosed herein may be used to examine the colon, optionally combining evaluation of small bowel and colon into a one-step test. In some embodiments, the device disclosed herein reduces eliminates needs for anesthesia and eliminates risks of infection associated with cleaning of re-usable scopes. In some embodiments, the device disclosed herein enables delivery of other diagnostic means such as motility catheter, one or more sensor (such as ultrasound sensors), tissue sampling for research purpose. In some embodiments, the device disclosed herein enables delivery drugs to the target area more easily (without sedation) and more precisely.
In some embodiments, the device disclosed herein may be used to conduct examination of and perform intervention in the small bowel at the same time. It is small enough to avoid requiring anesthesia and is a disposable device that eliminates the possibility of cross-infection. In some embodiments, the device disclosed herein provides effective locomotion all while enabling diagnostic and therapeutic functionalities. In some embodiments, the device disclosed herein comprises a bellow motor and/or a balloon motor. In some embodiments, the device disclosed herein comprises a bellow motor is a de novo motor that provides both articulation and actuation motor functions while maintaining a small motor size at the same time.
In some embodiments, the device disclosed herein reduces or eliminates needs for anesthesia, reduces or eliminates risks of infection associated with cleaning of re-usable scopes, and enables delivery of other diagnostic means such as motility catheters, tissue sampling for research purpose, one or more sensor (such as ultrasound sensors), and delivery drugs to the target area more easily (without sedation) and more precisely.
In some embodiments, the device disclosed herein comprises double balloons such as the traction balloons disclosed herein. In some embodiments, the device disclosed herein comprises a soft robotic member comprising a 3D printed bellow and/or multiple longitudinally aligned balloons to achieve motor function.
In some embodiments, the device disclosed herein comprises a soft robotic motor comprising bellows, e.g., a bellow motor, and the bellow motor is configured to elongate more than about 1 cm, more than about 2 cm, more than about 3 cm, more than about 4 cm, more than about 5 cm, more than about 6 cm, more than about 7 cm, more than about 8 cm, more than about 9 cm, or more than about 10 cm. In some embodiments, the bellow motor is configured to elongate from about 3 cm to about 6 cm, from about 6 cm to about 9 cm, or from about 9 cm to about 12 cm. In some aspects, the longer elongation increases effectiveness and reduces procedure time.
In some embodiments, the device disclosed herein comprises a soft robotic motor comprising bellows, e.g., a bellow motor. In some embodiments, the bellow motor is configured to elongate from 3 cm to 6 cm, and can be powered by externally supplied air, which will eliminates the large payload in the current robotic capsules. In some embodiments, the bellow motor comprises a central open space, e.g., to carry accessories that include cameras, power supply, working channel, etc. In some embodiments, the bellow motor is entirely 3D printed and satisfies the requirements for flexibility, strength, and elasticity. In some embodiments, the bellow is approximately 5 cm at rest and able to expand approximately 3 cm.
In some embodiments, the device disclosed herein comprises a soft robotic motor comprising multiple balloons such as balloons enclosed in an expandable sheath, e.g., a balloon motor, and the balloon motor is configured to elongate more than about 1 cm, more than about 2 cm, more than about 3 cm, more than about 4 cm, more than about 5 cm, more than about 6 cm, more than about 7 cm, more than about 8 cm, more than about 9 cm, or more than about 10 cm. In some embodiments, the bellow motor is configured to elongate from about 3 cm to about 6 cm, from about 6 cm to about 9 cm, or from about 9 cm to about 12 cm. In some aspects, the longer elongation increases effectiveness and reduces procedure time.
In some embodiments, the device disclosed herein comprises a soft robotic motor comprising multiple balloons such as balloons enclosed in an expandable sheath, e.g., a balloon motor. In some embodiments, the balloon motor is configured to elongate from 3 cm to 6 cm, and can be powered by externally supplied medium (e.g., air, a gas, or a liquid), which will eliminates the large payload in the current robotic capsules. In some embodiments, the balloon motor comprises a central open space, e.g., to carry accessories that include cameras, power supply, working channel, etc. In some embodiments, the balloon motor combines four longitudinally aligned catheter balloons housed in a custom-made expendable sheath. In some embodiments, the balloon motor is approximately 2.5 cm at rest, expandable up to 6 cm.
In some embodiments, the device disclosed herein comprises a linear stroke of at least 3 cm, for example, to overcome the accordion effect from intestinal deformation during robotic advancements.
Provided herein is a device configured to move within a body cavity. In some embodiments, the device comprises a double-balloon system comprising an actuating or driving mechanism, as well as an articulation mechanism to navigate the complicated curves of a body cavity such as the GI tract. The device may be used but is not made exclusively for enteroscopy. It can be used in any part of the gastrointestinal tract. For example, the device may be used as a colonoscope for technically difficult cases. The device may be used for endoscopic retrograde cholangiopancreatography, e.g., in patients with Roux-en-Y anastomosis in which an endoscopic approach to the papilla of Vater is impossible with regular endoscopic insertion. In some embodiments, the present device provides not only improved accessibility to a distal portion of the GI tract, e.g., the small intestine.
In some embodiments, the present device provides not only improved accessibility to the deep small intestine, but also the ability to control the device tip in any part of the intestine. Precise control of the device tip is possible at any point in the intestine because the movement of the device is controlled from the gripped point by the balloon on the inner tube and/or the balloon on the outer tube, which can be set at any point.
In some embodiments, the present device may be used in place of or in conjunction with a traditional capsule endoscopy and/or balloon-based. Capsule endoscopy is suitable for the initial work-up of nonobstructive small intestinal disorders because it is discomfort-free and does not require the patient to be confined to a medical facility. Abnormal findings detected by a capsule can be confirmed by the presently disclosed device with biopsy examination, and endoscopic treatment can be performed using the device disclosed herein. In particular, small intestinal strictures, which are a contraindication for capsule endoscopy, can be explored by the device disclosed herein. In some embodiments, the device disclosed herein may be used to perform endoscopic balloon dilation. Moreover, in cases of capsule retention at a stricture, the capsule can be retrieved by the device disclosed herein and the stricture can be dilated endoscopically using the device.
In some embodiments, provided herein is a gastrointestinal (GI) navigation and delivery device. In some aspects, the device is designed to navigate through the gastrointestinal system with no or much less human manipulation during the navigation, as compared to conventional endoscopy. In some embodiments, the device is a self-driving device. In some embodiments, the device minimizes or ends the need for sedation. In some embodiments, the device also cuts the procedural cost that is associated with supporting staff, medical supplies, medications, and hospital stay.
In some embodiments, provided herein is a gastrointestinal navigation and delivery device capable of delivering medication to one or more target region within a body cavity. In some embodiments, provided herein is a device configured to deliver an endoscope, a diagnostic capsule, a diagnostic catheter such as a manometry catheter, a therapeutic device such as a stent, a tube, and other device or composition to one or more desired region within a body cavity.
In some embodiments, provided herein is a device configured to drive a capsule endoscopy for the small bowel and colon through the GI tract with a controlled speed and direction. In some embodiments, the device disclosed herein is configured to carry the task for bowel preparation, which is a very unpleasant process and the huge obstacle for people to adhere to colon cancer screening recommendation.
In one aspect, provided herein is a lumen navigation and delivery device comprising a first body section with a proximal end and a distal end, a second body section with a proximal end and a distal end, and a tip section with a proximal end and a distal end wherein the proximal end of the tip section is attached to the distal end of the second body section and the first and second body sections are attached to and capable of sliding within one another in a telescopic fashion. In some embodiments, the first body section, the second body section, and the tip section each comprise an elongated support (e.g., tubular structure such as tether).
In some embodiments, the first body section is larger in size than the second body section such that the second body section is capable of sliding within the first body section. In other embodiments, the second body section is larger in size than the first body section such that the first body section is capable of sliding within the second body section.
In certain embodiments, an inflatable balloon is fixed to the outer wall of the proximal end of the outer tube. In some embodiments, one or more annular inflatable balloons are fixed to the outer wall of the proximal end of the outer tube. In particular embodiments, two spherical inflatable balloons are fixed opposite one another to the outer wall of the proximal end of the outer tube. In certain embodiments, a plurality of spherical inflatable balloons are attached, fixed in position relative to one another, to the outer wall of the proximal end of the outer tube and are arranged substantially evenly in a circular pattern to form an annular-like configuration around the outer tube.
In certain embodiments, an inflatable balloon is fixed to the outer wall of the distal end of the tip section of the inner tube. In some embodiments, one or more annular inflatable balloons are fixed to the outer wall of the distal end of the tip section of the inner tube. In particular embodiments, two spherical inflatable balloons are fixed opposite one another to the outer wall of the distal end of the tip section of the inner tube. In certain embodiments, a plurality of spherical inflatable balloons are attached, fixed in position relative to one another, to the outer wall of the distal end of the tip section and are arranged substantially evenly in a circular pattern to form an annular-like configuration around the tip section.
In certain embodiments, the inflation and deflation of the balloons are controlled by the injection of fluid. In some embodiments, fluid to each balloon is delivered via one or more channels fixed along the outer and inner tubes. In particular embodiments, the one or more channels delivering fluid to the balloons attached to the first tube are fixed to the outer wall of the first tube. In some embodiments, the one or more channels delivering fluid to the balloons attached to the first tube are fixed to the inner wall of the first tube. In some embodiments, the one or more channels delivering fluid to the balloons attached to the inner tube is fixed to the outer wall of the inner tube. In some embodiments, the one or more channels delivering fluid to the balloons attached to the inner tube is fixed to the inner wall of the inner tube.
In certain embodiments, the balloons are made of a material with memory of desired shapes. In some embodiments, the balloons will have a pre-set maximum pressure. In particular embodiments, the balloons incorporates certain adhesive properties. In certain embodiments, the balloons incorporate microfibrillar adhesives from polydimethylsiloxane.
In some embodiments, the gastrointestinal navigation and delivery device disclosed herein comprises an inner tube and an outer tube. In some embodiments, the inner tube moves forward to reach its distance, and may be anchored on the bowel wall by inflating the balloon at the distal end of the inner tube. Then, the outer tube follows by moving forward over the inner tube. Once the outer tube is in place, it is anchored on the bowel wall by inflating the balloon at the proximal end of the outer tube. At this time, the balloon on the inner tube is deflated and moves forward. Once the inner tube reaches its distance, the balloon on the inner tube advances to a more distal position within the body cavity such as the GI tract. Then, the inner tube is anchored onto the bowel wall by inflating its associated balloon, and the outer tube deflates its associated balloon to move forward over the inner tube. The process continues until it reaches a destination, such as a more distal destination in the GI tract, e.g., the small intestine. In any of the embodiments disclosed herein, the tubes can be made of vinyl or polyurethane materials.
In any of the embodiments disclosed herein, the balloons can be made of a material that has memory of the desired shape. In any of the embodiments disclosed herein, the balloons can incorporate certain adhesive properties such as microfibrillar adhesives (e.g., from polydimethylsiloxane (PDMS)), UV-activated adhesives, epoxy or cyanoacrylates to generate traction. In any of the embodiments disclosed herein, the balloons may have treads molded onto the surface to increase friction. In any of the embodiments disclosed herein, an over molding process can be used to increase the thickness of the balloons and add treads to the surface of the balloons. In any of the embodiments disclosed herein, the balloons can be made of custom molded polyurethane, latex, polyisoprene or Pbax. In any of the embodiments disclosed herein, the balloons can be made of polyisoprene for its biocompatibility and desired rigidness. In any of the embodiments disclosed herein, the balloons can be circumferentially wrapping around the inner and/or outer tubes. In any of the embodiments disclosed herein, the device can comprise multiple balloons at the same longitudinal position.
In any of the embodiments disclosed herein, the balloons can have a pre-set maximum pressure (thus maximum inflation) and memory to prevent trauma to bowel wall or cause bowel perforation. For example, in some cases, the maximum allowable pressure directly applied to the bowel wall is 1.55-4.37 PSI. In some embodiments, the pressure limit is measured during use by measuring the bowel wall pressure using a sensing array. In some embodiments, the sensing array comprises MEMS pressure sensors placed inside the traction balloons.
In any of the embodiments disclosed herein, the inflation and/or deflation of the balloons may be controlled, for example, by injecting and/or drawing a gas (such as air) or a fluid via thin tubing along the inner and outer tubes, respectively. In some embodiments, there is provided a tube or an air channel that is along the outside of the outer or inner tube or inside the outer or inner tube, for each balloon, respectively. In some embodiments, there is provided a tube or an air channel that is along the outside of the outer or inner tube for each balloon, respectively. In some embodiments, there is provided a tube or an air channel that is inside the outer or inner tube, for each balloon, respectively. In some embodiments, a part of the tube or air channel is along the outside of the outer or inner tube, while another part of the tube or air channel is inside the outer or inner tube, for each balloon, respectively.
In some embodiments, the device comprises a structure similar to screw and nut, for the inner and outer tubes to move relative to each other. In some embodiments, the screw is inside the inner tube but connected to the outer tube via a stepper motor. An exemplary stepper motor is the commercially available SM3.4-20 from Minebea or vendors. In some embodiments, the stepper motor connects to the outer tube via two arms. In some embodiments, the inner tube connects to a nut which is fixed onto the inner tube. In some embodiments, the nut moves along the screw. In some embodiments, the rotation of the screw enables the nut and the inner tube to move along the outer tube. In some embodiments, with the nut and/or screw moving in one direction and the outer tube being kept stationary by its balloon, the inner tube moves forward; with the nut and/or screw moving in the other direction, and when the inner tube is kept stationary by its balloon, the outer balloon moves forward. Using the same mechanism, both tubes can also move backwards. In some embodiments, the stepper motor connects to a proximal end of the screw to provide the movements. In some embodiments, the stepper motor are connected to the proximal portion of the outer tube via two arms that are fixed onto the outer tube.
In some embodiments, a plurality of longitudinal slits are located on the walls of the inner tube. For example, two longitudinal slits may be provided on the opposite walls of the inner tube. In some embodiments, two arms extend from stepper motor for the screw through the slits and are fixed onto the outer tube. In some embodiments, the plurality of longitudinal slits provide space for the inner tube and outer tube to slide forward and backward, while slidably connecting the inner tube and outer tube during the movements, e.g., in order to prevent the two tubes from disengaging each other (e.g., the distal portion of the inner tube may slide completely into the outer tube or the inner tube may slide completely outside the outer tube) and/or control the maximum/minimum distance between the two balloons, during alternating extensions and retractions of the distance between the two balloons.
In some embodiments, the moving mechanism is advantageous over the current endoscopy in that the device drives itself forward instead of an operator pushing it forward from outside of the body a long distance away. In some embodiments, the mechanism avoids the stretching of the bowel, bowel wall and mesentery, thereby decreasing pain and consequently requiring less sedation and operation time.
In some embodiments, the distal end of the inner tube has an opening for camera. In some embodiments, the device comprises a camera at least part of which is in the inner tube. In some embodiments, the device comprises a light source, e.g., a light source for the camera. In some embodiments, the distal end of the inner tube has an opening for air and/or water. In some embodiments, the distal end of the inner tube has an opening for an irrigation and/or suction channel. In some embodiments, the inner tube can be tapered down in diameter if needed toward the distal end, especially when only an opening for camera and an opening or an irrigation and/or suction channel are needed. In some embodiments, the camera can be a fiber optic camera such as a miniature CMOS image sensor (e.g., NanEye by AMS AG), a camera used in capsule endoscopy, or a wireless camera that is often used in mini drones. In some embodiments, the very distal end of the inner tube is oval or round in shape to minimize trauma to the bowel wall.
In some embodiments, the inner tube comprises two portions, a distal tip portion and a proximal body portion. In some embodiments, the proximal end section of the inner tube tip is connected to the body of inner tube via a motor. In some embodiments, the motor is at a proximal end of the tip portion (and/or at a distal end of the body portion) and connected to a round base that can be inflated and/or deflated to form an asymmetrical shape. In some embodiments, the asymmetrically inflated base enables the tilting of the tip. In some embodiments, the base can rotate in 360 degree fashion that is controlled by another motor, for example, a servo motor or a stepper motor. In some embodiments, by combining the base rotation and tilting the tip, the tip portion of the inner tube is capable of guiding the inner tube to move in various directions. This feature is advantageous for navigating the GI tract, particularly the small intestine.
In some embodiments, the round base is a flexible conduit-like structure, except it is asymmetrical and has a hinge at one side. The hinge can be an actual hinge, such as a mechanical hinge with two parts that pivot relative to each other. In some embodiments, the hinge can be an extension from the distal section of the inner tube that is made of a material that is strong enough and yet can be bent repeatedly.
In some embodiments, the round base is a chamber that comprises a relatively rigid material (e.g., plastic) on both top and bottom surfaces and an elastic material with shape memories on the side. In some embodiments, the top surface (distal) of the round base is the base of the inner tube base. In some embodiments, the bottom surface (proximal) of the round base is separated from the distal surface of the inner tube body and connected with a motor, such as the servo or stepper motor which is connected with the body portion of the inner tube.
In some embodiments, the space between the round base and the distal surface of the inner tube body is small enough to allow the free rotation of the round base. In some embodiments, the chamber of the round base can maintain an angle from 0 degree to 180 degree at the hinge by inflating the base chamber. In some embodiments, if more than 90 degree at the hinge is needed, another chamber that is on top of the first one can be provided to share the same hinge with the first chamber. In some embodiments, in order to maintain an angle between 90 degree and 180 degree at the hinge, another chamber can be provided on top of the first one. In some embodiments, when the chamber returns to its original position with 0 degree at the hinge, there is still some room maintained between the top surface and the lower surface of the chamber. In some embodiments, the distance between the two surfaces depends on the thickness of the folded flexible conduit. In some embodiments, when the angle is at or at about 0 degree, the intra-chamber pressure can be maintained close to zero or even slightly negative to keep the tip of the inner tube and body of the inner tube as one unit.
In some embodiments, the inflation is achieved by a gas (such as sterilized air), a liquid or fluid, or a mixture thereof (such as vapor). In some embodiments, inside the round base, there is a thin cuboid shaped chamber that can be inflated asymmetrically to a triangular shape, thereby inflating the round base to a desired angle. In some embodiments, the cuboid shaped chamber extends across a diameter of the round base but leaves space for one or more flexible tube, e.g., for the air/water/suction channel and the camera cable to pass through the round base. In some embodiments, there is an air channel going through the inner tube body and connect to the round base via a flexible conduit. In some embodiments, regulation of the inflation and rotation of the round base is achieved by a computer program that receives feedback from device, such as from the camera or a sensor, such as a pressure sensor at the tip of the inner tube. Therefore, in coordination with the camera or sensor at the tip of the inner tube, the inner tube recognizes the direction of the bowel lumen and guides the direction of the tube movements.
In some embodiments, the motor on the round base is a servo motor that has a sufficiently small size. In some embodiments, a stepper motor is used, or the servo motor can be placed proximal to the first stepper motor for the screw/nut and connected to the round base with a stiff thin wire that can accurately transmit servo motor's rotation to a pin on the round base via one or more gear.
In any of the preceding embodiments, the device further comprises a controller system. In some embodiments, the controller system comprises one or more pumps, such as the NEMA 17 stepper motor driven pumps. In some embodiments, the controller system comprises one or more valves. In some embodiments, the controller system further comprises a user interface, a computer, and a custom software.
In some embodiments, the water/air/suction channel is a channel traversing the whole inner tube from the proximal inner tube, round base to the distal inner tube. In some embodiments, there is a flexible tube that is fixed to the proximal end of the channel at the distal (tip) section of the inner tube and end freely in the air channel of the inner tube body but fits tightly in the air channel of the inner tube body to maintain a seal. In some embodiments, the flexible tube traverses the round base down to the inner tube body at a length that is long enough to still remain in the tube body's air channel when the round base is inflated to its largest angle at the hinge and when the round base rotates up to 180 degree to both directions (clockwise and counter-clockwise). In some embodiments, the flexible tube is made from a flexible material but does not collapse during operation or is capable to withstand a threshold pressure. In some embodiments, the air channel remains open when the round base is collapsed. In some embodiments, a fiber optic camera such as NanEye is used, the optical fiber can traverse the entire inner tube and/or traverse the round base in the closed relationship to the pin of the servo or stepper motor on the side of the hinge. In some embodiments, this configuration ensures the length of the cable that moves when the round base is rotating is minimum. In some embodiments, the camera cable is secured at the proximal end of the distal inner tube for the same reason as the tube inside the air channel. In some embodiments, a wireless camera is used, and the length of the camera cable that moves when the round base is rotating is not a concern. In some aspects, the air/water irrigation/suction channel and the fiber optic camera traverse the round base through an air-sealed tunnel, for example, to ensure that the round base is air sealed.
In some embodiments, the inner tube body and the outer tube are relatively larger in diameter, while the rest of the inner tube distally has a smaller diameter, for example, carrying only the air/water/suction channel and/or wires (e.g., electric wires for the camera and/or one or more motor). In some embodiments, the electric wires connect the camera and/or motor to a control mechanism outside of the body of a subject.
In some embodiments, the device further comprises a guidewire attached to the outer tube distally and to the inner tube proximally, for example, as a carrier system that allows other mechanisms, such as sample collection, imaging collection, data analysis, delivery of one or more scope and/or catheters etc., to feed over the guidewire and be delivered to a desired location.
In any of the preceding embodiments, the device described herein is configured to move and/or navigate inside a body cavity, such as for intra-vascular or intra-luminal use in other organ systems, e.g., in the respiratory system or the urinary tract.
In some embodiments, provided herein is a controllably expandable structure for use in the device described herein. In some embodiments, the controllably expandable structure comprises a flexible elastomeric hollow double walled part that has a hub at the center and a traction surface at the outside radial surface like a tire. Like a tire the part is inflated with a gas, air, or fluid coming from the center hub. The outside radial surface expands with increasing radius as the hollow part is filled with pressure. It is intended to touch and stick to a lumen (such as the bowel) that is like a tube and have frictional contact with it. Then as the pressure inside the part increases the hub is moved axially due to force applied by the section between the hub and the outside radial surface. The hub is then supported axially by a drive balloon assembly. While the hub is axially supported by the drive balloon assembly, pressure is decreased within the traction-motion balloon and the overall diameter decreases back to the original uninflated shape. This process is repeated in sequence and the assembly is advanced through the body cavity such as a lumen.
In some embodiments, the controllably expandable structure (e.g., an inflatable element such as a balloon-type element) is configured to expand from a collapsed configuration to an expanded configuration, wherein, when in the collapsed configuration, the controllably expandable structure includes one or more fold or ridge extending substantially transverse to a longitudinal axis thereof so that, when a medium (e.g., a gas, a liquid, or a mixture thereof such as a vapor) is supplied thereto, e.g., for inflation, the controllably expandable structure expands substantially along the longitudinal axis. In some embodiments, the controllably expandable structure is connected to an actuator (e.g., an actuator for surgical or endoscopic applications), e.g., via a medium conduit or channel (e.g., an inflation gas/fluid/vapor conduit) or via mechanical structures (such as rods or gears).
In some embodiments, the actuator forms an integral part of the device and remains inside a patient's body during operation of the device. Exemplary actuators include miniaturized motors coupled to the controllably expandable structure, e.g., via the medium conduit or channel and/or mechanical structures.
In some embodiments, the actuator remains outside a patient's body, and the medium conduit or channel extends from the actuator to a proximal end of the controllably expandable structure, thereby coupling the actuator and the controllably expandable structure. In some embodiments, when the actuator is in a first operative configuration, a medium such as an inflation gas, fluid, or vapor is supplied to the controllably expandable structure via the medium conduit or channel. In some embodiments, when the actuator is in a second operative configuration, a medium such as an inflation gas, fluid, or vapor is withdrawn from the controllably expandable structure via the medium conduit or channel. In some embodiments, when the actuator is in a third operative configuration, a certain amount of a medium such as an inflation gas, fluid, or vapor is maintained in the controllably expandable structure, thereby maintaining the state and/or degree of expansion of the controllably expandable structure. In some embodiment, there is no net change of the amount of the medium inside the controllably expandable structure when its degree of expansion is maintained.
In any of the preceding embodiments, the controllably expandable structure may comprise a compliant balloon, a non-compliant balloon, and/or a semi-compliant balloon. The term “compliance” as it relates to balloons describes the degree to which the size of a balloon changes as a function of pressure. Compliant balloons exhibit substantially uniform expansion in response to increasing levels of pressure. A compliant balloon may be “axially compliant” and have a length that exhibits uniform axial expansion during inflation of the balloon; “radially compliant” and have a radius that exhibits uniform radial expansion during inflation of the balloon; or both. Compliant balloons are made of materials that are highly elastic and expand substantially elastically when pressurized. These materials may also have substantial elastic recoil such that upon deflation, compliant balloons return substantially to their original pre-inflation size. Compliant balloon materials include thermosetting and thermoplastic polymers that exhibit substantial stretching upon the application of tensile force. These materials include, but are not limited to, elastomeric materials such as elastomeric varieties of latex, silicone, polyurethane, and polyolefin elastomers. See for example U.S. Pat. No. 7,892,469, which is incorporated herein by reference in its entirety and for all purposes. Compliant balloon materials may be cross-linked or uncross-linked.
Non-compliant balloons, on the other hand, exhibit little expansion in response to increasing levels of pressure. A non-compliant balloon may be “axially non-compliant” and have a length that exhibits little or no axial growth during inflation of the balloon; “radially non-compliant” and have a radius that exhibits little or no radial growth during inflation of the balloon; or both. In the case of a radially non-compliant balloon, the walls of the balloon when uninflated may collapse into folded pleats, allowing the balloon to adopt an axially compressed state. Upon inflation, these pleats unfold, and the axial length of the balloon grows as the radius of the balloon remains substantially unchanged. Non-compliant balloon materials include, but are not limited to, nylon, polyethyleneterephthalate (PET), or various types of polyurethane block copolymers. See Lim et al. Non-compliant balloons can be used to open or expand a body lumen, and due to their predetermined size, they are less likely than compliant balloons either to burst or to rupture or damage lumen walls when highly pressurized. See for example U.S. Pat. No. 8,469,926, which is incorporated herein by reference in its entirety and for all purposes.
In some embodiments, semi-compliant balloons exhibit moderate expansion in response to increasing levels of pressure. In some embodiments, in response to increasing inflation pressure, a semi-compliant balloon expands less than a compliant balloon, but more than a non-compliant balloon. A non-compliant balloon may be “axially semi-compliant,” “radially semi-compliant,” or both. Thus, in some embodiments, with the same pressure, different parts of a semi-compliant balloon may exhibit different degrees of expansion. In other words, a semi-compliant balloon may be designed to expand in more than one direction, but with different degrees of expansion in different directions.
As with non-compliant balloons, semi-compliant balloons may be made of materials that include, but are not limited to, nylon, polyethyleneterephthalate (PET), or polyurethane block copolymers. Semi-compliant balloons maintain in part at least some of the advantages of non-compliant balloons detailed above, but also preserve at least some of the elasticity and flexibility of compliant balloons.
Depending upon the nature of the operation, it may be desirable to further adjust the positioning of an end portion of the inner member and/or an end portion of the outer member. In some embodiments, it is desirable to orient a distal end portion of the inner member at an axis transverse to the longitudinal axis of a body portion of the device, such as a body portion of the inner tube. The transverse movement of the end portion relative to the body portion of the device may be referred to as “articulation.” In some embodiments, articulation is accomplished by a pivot (or articulation) joint being placed between the end portion and the body portion. This articulated positioning permits an operator of the presently disclosed device to more easily engage tissue in some instances and/or navigate the device through a complicatedly curved body cavity, such as the GI tract. In combination of the self-driving mechanisms disclosed herein, the device may be used to gain access to deep parts that are complicatedly curved, such as the small intestine. In some embodiments, articulated positioning advantageously allows the end portion of the device to be positioned in the body cavity without being blocked by tissue inside the body cavity.
In some embodiments provided herein, the device comprises a hydraulic actuator in between the proximal/first controllably expandable element and the distal/second controllably expandable element of the device, and engagement of the hydraulic actuator effects the sliding movement between the outer member and the inner member of the device. In other embodiments, mechanical actuators like lead screws or cable assemblies can be used instead. In some embodiments, the device further comprises a plurality of soft, compliant fluid channels running longitudinally through the device, and individual inflation and deflation of said channels with liquid or air effects the bending of the tip of the device.
In some embodiments provided herein, the device comprises a hydraulic articulation and propulsion mechanism. In some embodiments, the device may be driven by an articulation movement powered by hydraulic actuated flexible cylinders and/or rods to bend the tip of the device. For example, three hydraulically powered flex rods may enable the instrument to bend when individually extended/retracted with non-compressible fluid. The proximal/first controllably expandable element and the distal/second controllably expandable element, e.g., balloons, may independently inflate and deflate to fasten the device to the interior walls of the GI tract while a propulsion mechanism utilizing a hydraulic or mechanically powered actuator in between the elements pushes and pulls the device through the intestines. Mechanisms including hydraulic actuators, lead screws, cable assemblies can be used for the propulsion movement.
In some embodiments provided herein, the device comprises a hydraulic actuator in between the proximal/first controllably expandable element and the distal/second controllably expandable element of the device, and engagement of the hydraulic actuator effects the sliding movement between the outer member and the inner member of the device. In other embodiments, mechanical actuators like lead screws or cable assemblies can be used instead. In some embodiments, the device further comprises a plurality of flexible rods running longitudinally through the device, and individual extension and retraction of said rods with non-compressible fluid effects the bending of the tip of the device.
In some embodiments provided herein, the device comprises a cable-driven actuator in between the proximal/first controllably expandable element and the distal/second controllably expandable element of the device, and engagement of the cable-driven actuator effects the sliding movement between the outer member and the inner member of the device. In other embodiments, hydraulic actuators or lead screws can be used instead. In some embodiments, the device further comprises additional cables running longitudinally through the device, the distal ends of said cables fixed in the tip of the device. The cables are coupled with a plurality of motor-pulley systems, and individual pulling and pushing of said cables by the motor-pulley systems effects the bending of the tip of the device.
In some embodiments provided herein, the device further comprises a plurality of closed loop cables running longitudinally through the device, the distal ends of said cables fixed in the tip of the device. The cables are coupled with a plurality of motor-pulley systems, and individual pulling and pushing of said cables by the motor-pulley systems effects the bending of the tip of the device for articulation, as shown in
In some embodiments provided herein, the device further comprises one or more closed loop cables running longitudinally through the device, the distal ends of said cables fixed between the distal and the proximal radially expandable elements. In some embodiments, the proximal radially expandable element is connected to the close loop cable. The cables can be coupled with a plurality of motor-pulley systems, and individual pulling and pushing of said cables by the motor-pulley systems effects the movement of the radially expandable elements.
In some embodiments provided herein, the device comprises a three phase servo motor actuator. In this embodiment, linearly oriented coils are energized in sequence to propel the balloon mechanism forwards and backwards. The device further comprises a bidirectional magnet installed on the balloon mechanism in order to integrate with the magnetic linear actuator.
In some aspects, provided herein is a device configured to move within a body cavity, said device comprising: an outer member comprising a distal end, a proximal end, a lumen between the distal end and the proximal end, and a proximal/first controllably expandable element; an inner member slidably disposed in the lumen of the outer member, wherein the inner member comprises a distal end, a proximal end, and a distal/second controllably expandable element; a connector that connects the outer member and the inner member; and an actuating member comprising a plurality of balloons (e.g., pressure balloons, or axially compliant balloons), a plurality of bellows or unit bellows, and/or a plurality of pressure chambers, wherein the actuating member is capable of effecting sliding movement between the outer member and the inner member, thereby alternating extensions and retractions of a distance between the proximal/first and distal/second controllably expandable elements, wherein the proximal/first and distal/second controllably expandable elements are capable of expanding radially outwardly to engage a wall of a body cavity. In any of the preceding embodiments, the actuating member is also capable of effecting articulation of the distal portion of the inner tube in a direction transverse to the longitudinal axis of the body portion of the inner tube, for example, via selective or preferential inflation and/or deflation of one or more of the plurality of balloons, the plurality of bellows or unit bellows, and/or the plurality of pressure chambers.
In some embodiments, provided herein is a device configured to move within a body cavity, the device comprising: a) an elongated support; b) a proximal radially expandable element and a distal radially expandable element positioned along the length of the elongated support, optionally wherein the radially expandable elements are independently controllably expandable, wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, and wherein the distal radially expandable element is fixed relative to the elongated support; and c) a locomotion system comprising: i) a proximal locomotion element having a part that is fixed relative to the proximal radially expandable element and slidable along the length of the elongated support, such that the proximal radially expandable element is slidable along the length of the elongated support, and ii) a distal locomotion element having a part fixed relative to the elongated support, wherein the locomotion system effects sliding movement of the proximal radially expandable element along the length of the elongated support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity.
In some embodiments, the locomotion system comprises a controllably expandable structure configured to expand or contract longitudinally. In some aspects, the controllably expandable structure is distal to the proximal/first controllably expandable element, wherein longitudinal expansion and/or contraction of the controllably expandable structure effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element. In some aspects, the controllably expandable structure is proximal to the proximal/first controllably expandable element, wherein longitudinal expansion and/or contraction of the controllably expandable structure effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element. In some aspects, the device comprises two controllably expandable structures, one of which is distal to the proximal/first controllably expandable element while the other one is proximal to the proximal/first controllably expandable element, wherein coordinated longitudinal expansion and/or contraction of the two controllably expandable structures effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element. In some aspects, the controllably expandable structure is distal to the distal/second controllably expandable element, wherein longitudinal expansion and/or contraction of the controllably expandable structure effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element. In some aspects, the controllably expandable structure is proximal to the distal/second controllably expandable element, wherein longitudinal expansion and/or contraction of the controllably expandable structure effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element. In some aspects, the device comprises two controllably expandable structures, one of which is distal to the distal/second controllably expandable element while the other one is proximal to the distal/second controllably expandable element, wherein coordinated longitudinal expansion and/or contraction of the two controllably expandable structures effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element. In some aspects, the controllably expandable structure is between the proximal/first controllably expandable element and the distal/second controllably expandable element, wherein longitudinal expansion and/or contraction of the controllably expandable structure effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element.
In any of the preceding embodiments, the device can further comprise a plurality of controllably expandable structures between the proximal/first controllably expandable element and the distal/second controllably expandable element, wherein expansion and/or contraction of the plurality of controllably expandable structures effects a longitudinal movement of the proximal/first controllably expandable element relative to the distal/second controllably expandable element. In some embodiments, the plurality of controllably expandable structures form a helix. In any of the preceding embodiments, expansion and/or contraction of the plurality of controllably expandable structures effects a rotational movement of the proximal/first or distal/second controllably expandable element relative to each other. In some aspects, the proximal/first or distal/second controllably expandable element is in a contracted or deflated state during the rotational movement. In any of the preceding embodiments, the device can further comprise two, three or more controllably expandable structures. In any of the preceding embodiments, expansion and/or contraction of the plurality of controllably expandable structures effects articulation of a distal portion of the device in a direction transverse to the longitudinal axis of the elongated support.
In any of the preceding embodiments, the controllably expandable structures can comprise one or more compliant balloon and/or one or more semi-compliant balloon. In any of the preceding embodiments, the controllably expandable structures can comprise one or more bellows, e.g., a compliant bellows. In some aspects, the plurality of controllably expandable structures comprise two or more pressure balloons. In some aspects, the plurality of controllably expandable structures comprise a pressure balloon, a pressure chamber, or combinations thereof. In some aspects, the plurality of controllably expandable structures comprise three or four pressure balloons. In some embodiments, the plurality of controllably expandable structures comprise three or four pressure chambers. In any of the preceding embodiments, a subset of the plurality of controllably expandable structures can be configured to selectively inflate and/or deflate, thereby effecting articulation of the distal/second controllably expandable element in a direction transverse to the longitudinal axis of the elongated support.
In any of the preceding embodiments, the device can further comprise a plurality of controllably expandable structures distal to the distal/second controllably expandable element, wherein a subset of the plurality of controllably expandable structures are configured to selectively inflate and/or deflate, thereby effecting articulation of the distal end of the device in a direction transverse to the longitudinal axis of the elongated support.
One or more traction-motion element can be used, in place of or in addition to one or more controllably expandable element of any of the embodiments of the device or method disclosed herein. For example, the proximal/first controllably expandable element may be a traction-motion element disclosed herein. In other examples, the distal/second controllably expandable element may be a traction-motion element disclosed herein. In yet other examples, both the proximal/first controllably expandable element and the distal/second controllably expandable element may be a traction-motion element disclosed herein. The traction-motion element(s) may provide an actuating/motion mechanism in addition to the actuating/motion mechanism(s) of any of the embodiments of the device or method disclosed herein.
In some embodiments, the locomotion system comprises two longitudinally expandable elements. In some embodiments, the locomotion system comprises a proximal longitudinally expandable element and a distal longitudinally expandable element. In some embodiments, the longitudinally expandable elements are independently controllably expandable. In some embodiments, the longitudinally expandable elements each comprises a structure independently selected from the group consisting of a compliant balloon, a semi-compliant balloon, a pressure balloon, and a bellow.
In some embodiments, the locomotion system comprises a pulley system. The pulley system effects sliding movement of the proximal radially expandable element along the length of the elongated support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity. In some embodiments, the pulley system comprises a proximal floating element. In some embodiments, the proximal floating element is fixed relative to the proximal radially expandable element and slidable along the length of the elongated support, such that the proximal radially expandable element is slidable along the length of the elongated support. In some embodiments, the pulley system comprises a distal wheel fixed relative to the elongated support. In some embodiments, the pulley system comprises a cable connected to the proximal floating element and engaging the distal wheel, such that the cable is configured to pull the proximal floating element in the distal or proximal direction. In some embodiments, the pulley system comprises a closed loop cable.
Exemplary body cavity navigation devices are described US 2021/0345862 entitled “Devices and Systems for Body Cavities and Methods of Use,” and WO 2021/173818 entitled “Devices and Systems for Body Cavities and Methods of Use,” the disclosures of which are incorporated herein by reference in their entireties.
Reference is now made to the figures, which describe certain elements or aspects of multiple embodiments of the present disclosure. The drawings are provided for illustrative purposes only and are not meant to be limiting.
In any of the embodiments herein, the support can be in the form of a tubular structure, such as inner tube 5 shown in
As shown in
The distal end of the device may be placed within the body cavity at an initial position proximal to the operator. In a retrograde (anal) approach, the initial position may be at a position in the rectum or colon, such as at the sigmoid colon, the descending colon, the transverse colon, or the ascending colon. In an anterograde approach, the initial position may be at a position in the esophagus, stomach, or small intestine, such as at the duodenum. Both balloons 4 and 6 may be completely deflated or in a less inflated state when placed at the initial position, and/or when the device is being placed at the initial position, for example, for ease of operation and patient comfort.
As an initial step, a remote control may be operated to supply a medium such as air from a pump outside the body of the subject to the balloon 4 attached in the distal end of the outer tube 3, thus inflating the balloon and fixing the balloon at the initial position. Consequently, the outer tube 3 is fixed to the initial position in the body cavity, such as the colon.
While the inflation state of the balloon 4 is maintained, sliding movement between the outer tube 3 and the inner tube 5 is actuated and optionally controlled by a control unit outside the body of the subject, to insert the inner tube 5 into a deeper part (e.g., more distal to the operator, e.g., the small intestine) of the body cavity, while the balloon 6 is deflated or in a less inflated state to permit the sliding movement. Consequently, the distance between the balloon 4 and 6 along the length of the body cavity becomes greater. After the inner tube 5 is inserted deeper by a distance, a remote control may be operated to supply a medium such as air from a pump outside the body of the subject to the balloon 6 attached in the distal end of the inner tube 5, thus inflating the balloon 6 and fixing the balloon at a more distal position. Consequently, the inner tube 5 is fixed to the more distal position, such as the small intestine.
The distance of the inner tube 5 movement may be a predetermined distance, or may be manually or automatically adjusted during operation. For example, a pressure sensor at the tip of the device may feed a detected pressure signal to a control unit outside the patient body, if the pressure sensed is over a certain threshold indicating stretching of the body cavity wall, thus the distance of inner tube advancement may be reduced or the articulation of the tip of the device may be adjusted, in order to eliminate or reduce stretching.
While the inner tube 5 is fixed at the more distal position, a remote control may be operated to exhaust air from the balloon 4, which becomes deflated or less inflated so as to permit movement of the outer tube within the body cavity to a more distal position. Sliding movement between the outer tube 3 and the inner tube 5 is once again actuated and optionally controlled by a control unit outside the body of the subject, to move the outer tube 3 more distally into the body cavity, while the balloon 6 is inflated and balloon 4 is deflated or less inflated. Consequently, the distance between the balloon 4 and 6 along the length of the body cavity becomes smaller, and both balloons are now positioned at a more distal portion of the body cavity compared to the initial position that is more proximal to the operator. A remote control may be operated to supply a medium such as air from a pump outside the body of the subject to the balloon 4 attached in the distal end of the outer tube 3, thus inflating the balloon and fixing the balloon at the more distal position. While the inflation state of the balloon 4 is maintained, sliding movement between the outer tube 3 and the inner tube 5 is once again actuated to insert the inner tube 5 into a deeper part of the body cavity, while the balloon 6 is deflated or in a less inflated state to permit the sliding movement. Operation steps described above can be repeated to advance a distal end of the device into deeper parts, such as from colon to the small intestine, from ileum to jejunum, from jejunum to duodenum, or from duodenum to stomach.
In an alternative initial step, a remote control may be operated to supply a medium such as air from a pump outside the body of the subject to the balloon 6 attached in the distal end of the inner tube 5, thus inflating the balloon and fixing the balloon at the initial position. Consequently, the inner tube 5 is fixed to the initial position in the body cavity, such as the colon.
While the inflation state of the balloon 6 is maintained, sliding movement between the outer tube 3 and the inner tube 5 is actuated and optionally controlled by a control unit outside the body of the subject, to advance the outer tube 3 into a deeper part (more distal to the operator) of the body cavity, while the balloon 4 is deflated or in a less inflated state to permit the sliding movement. After the outer tube 3 is advanced deeper by a distance, a remote control may be operated to supply a medium such as air from a pump outside the body of the subject to the balloon 4 attached in the distal end of the outer tube 3, thus inflating the balloon 4 and fixing the balloon. Consequently, the outer tube 3 is fixed to a position distal to its initial position. The distance between the balloon 4 and 6 along the length of the body cavity also becomes smaller.
The distance of the outer tube 3 movement may be a predetermined distance, or may be manually or automatically adjusted during operation.
While the outer tube 3 is fixed at the more distal position, a remote control may be operated to exhaust air from the balloon 6, which becomes deflated or less inflated so as to permit movement of the inner tube within the body cavity to a more distal position. Sliding movement between the outer tube 3 and the inner tube 5 is once again actuated and optionally controlled by a control unit outside the body of the subject, to move the inner tube 5 distally into the body cavity, while the balloon 4 remains inflated and balloon 6 is deflated or less inflated. Consequently, the distance between the balloon 4 and 6 along the length of the body cavity becomes greater. When balloon 6 reaches a more distal destination, a remote control may be operated to supply a medium such as air from a pump outside the body of the subject to the balloon 6 attached in the distal end of the inner tube 5, thus inflating the balloon and fixing the balloon at the more distal position. While the inflation state of the balloon 6 is maintained, sliding movement between the outer tube 3 and the inner tube 5 is once again actuated to advance the outer tube 3 into deeper part of the body cavity, while the balloon 4 is deflated or in a less inflated state to permit the sliding movement. Operation steps described above can be repeated to advance a distal end of the device into deeper parts, such as from colon to the small intestine, from ileum to jejunum, from jejunum to duodenum, or from duodenum to stomach.
In any of the preceding embodiments, the device disclosed herein may also be operated to move from a more distal part of a body cavity to a more proximal part of the body cavity. In other words, the device disclosed herein may also be operated to move backwards. In any of the preceding embodiments, the device disclosed herein may move forward and backward in the body cavity, in any suitable combination or order, according to medical needs.
Referring again to
As shown in
In any of the embodiments disclosed herein, the inflated balloon may comprises a wavy, ribbed, and/or saw tooth shaped or patterned outer surface that is configured to frictionally engage the body cavity wall. In some embodiments, when the balloon is deflated, the wavy, ribbed, and/or saw tooth shapes or patterns on the outer surface shrink down, effectively folding up when the balloon is not frictionally engaged to the body cavity wall.
The device may be driven by an actuating mechanism based on one or more controllably expandable telescoping structure.
The device may also be driven by a shape memory alloy-based actuating mechanism.
The device may also be driven by a snake traction mechanism, such as a snake traction sleeve shown in
In some embodiments, the multiple balloon/bellows/channel design (e.g., as shown in
The sliding movement between the outer member 33 and the inner member 35 may also be actuated or driven by one or more controllably expandable structures, such as one or more bellows 37, one or more balloons 38 in combination with one or more springs 39 (e.g., a spring spiraling or wrapping around a balloon), as shown in
The one or more controllably expandable elements, such as the proximal/first and distal/second balloons for engaging the wall of a body cavity, may comprise a tire-like or helical gear-like structure 40 having treads 41 on an outer surface, e.g., an outside radial surface capable of frictionally engaging a wall of a body cavity (e.g., similar to outer surface 74 shown in
The proximal/first and distal/second traction balloons 44a and 44b facilitate fixing the outer and inner members, respectively, to the body cavity wall 2 when the balloons are radially expanded. For example, traction balloon 44a may be radially expanded, and with the treads providing more traction, securely press against the body cavity wall, thereby fixing the outer member (not shown in
In any of the preceding embodiments, one or more of the controllably expandable structures, such as helical drives 43a, 43b, and 43c, may be selectively and/or preferentially inflated and/or deflated. For example, one or more of the controllably expandable structures may be inflated, while the remaining controllably expandable structure(s) is/are deflated, not inflated, or inflated to a greater or lesser degree. Alternatively, one or more of the controllably expandable structures may be deflated, while the remaining controllably expandable structure(s) is/are inflated, not deflated, or deflated to a greater or lesser degree. A suitable combination of the inflation/deflation statuses of the plurality of controllably expandable structures may be used to effect controllable and/or precise articulation of the inner member and/or the outer member, such as a distal portion of the inner member (e.g., the inner tube), thereby allowing the device to follow the curves of the body cavity during the movement. In some aspects, the controllable articulation avoids or reduces stretching of the body cavity wall, thereby avoiding or reducing discomfort during the procedure.
The one or more controllably expandable structures may comprise ridge bellows, for example, as shown in
The bellows may comprise internal supports, such as one or more spokes or struts, in the medium space. The internal supports may be molded into the parts (e.g., inner and outer layers) of the bellows so that the parts stay uniform when pressurized. As shown in
The bellows may comprise a plurality of unit bellows. For example, two, three, four or more unit bellows may be separately manufactured and then assembled to form a full circle of bellows, essentially as shown in
In some aspects, the unit bellows design provides the advantage of selectively and/or preferentially inflating and/or deflating the unit bellows. For example, a full bellows may be assembled from a plurality of unit bellows, and the unit bellows may be identical or different. When the unit bellows are different, for example, in the case of two quarter bellows and one half bellows forming a full bellows, the half bellows may be selectively and/or preferentially inflated to articulate the distal portion of the inner tube to one direction. If adjustment of the bending direction is needed, one of the two quarter bellows may be selectively and/or preferentially inflated to fine tune the articulation the distal portion of the inner tube. When the unit bellows are identical, fine tuning the articulation is also possible. In the case of four quarter bellows forming a full bellows, one, two, or three of the quarter bellows may be inflated, while the remaining quarter bellows is/are deflated, not inflated, or inflated to a greater or lesser degree. Alternatively, one, two, or three of the quarter bellows may be deflated, while the remaining quarter bellows is/are inflated, not deflated, or deflated to a greater or lesser degree. A suitable combination of the inflation/deflation statuses of the unit bellows may be used to effect controllable and/or precise articulation of the inner member and/or the outer member, such as a distal portion of the inner member (e.g., the inner tube), thereby allowing the device to follow the curves of the body cavity during the movement. In some aspects, the controllable articulation and the ability to fine tune the articulation avoids or reduces stretching of the body cavity wall, thereby avoiding or reducing discomfort during the procedure.
In some embodiments, the multiple balloon/bellows/channel design (e.g., as shown in
In any of the preceding embodiments, the device may comprises a soft robot articulation mechanism and/or a hydraulic propulsion or driving mechanism. For example, as shown in
In any of the preceding embodiments, the device may comprises a hydraulic articulation and/or propulsion mechanism. For example, the device 1 comprises one or more hydraulic actuator 57 in between the proximal/first controllably expandable element 4 and the distal/second controllably expandable element 6. Engagement of the inner member and outer member to the hydraulic actuator effects the sliding movement between the outer member and the inner member of the device. The device further comprises a plurality of soft, compliant fluid channels 59 running longitudinally through the device, and individual inflation and deflation of said channels with liquid or air effects the bending of the tip of the device. The device may also have a backbone 56 that flexes but does not change length, and the soft robot structures 58 allow flexing of the backbone to effect articulation of the device. As such, the distal portion of the device (such as the distal portion of the inner member) may be controlled and/or fine tuned.
In any of the preceding embodiments, the device may comprises a hydraulic articulation and propulsion mechanism. For example, as shown in
In any of the preceding embodiments, the device may comprises one or more of the following mechanisms: a cable articulation and/or propulsion mechanism, a motor/pulley articulation mechanism, and a linear servo motor propulsion mechanism. For example, as shown in
In some aspect, each of the distal and proximal controllably expandable elements is configured to expand radially outwardly. In
While
In other embodiments, one or more traction-motion element can be used in any of the device disclosed herein, including the embodiments described in
In any of the examples disclosed herein, a plurality of controllably expandable elements (e.g., traction-motion balloons) may be provided on the support (e.g., tubular structure such as tether). For instance, a plurality of traction-motion balloons can be in tandem to achieve an inchworm movement. In some examples, the distal and/or controllably expandable elements, e.g., as shown in
In some examples, as shown in
In any of the examples disclosed herein, the outer surface may be a wavy, ribbed, and/or saw tooth shaped or patterned surface configured to frictionally engage the body cavity wall. In some embodiments, when the traction-motion element is deflated, the wavy, ribbed, and/or saw tooth shapes or patterns on the outer surface shrink down, effectively folding up.
In some embodiments, disclosed herein is a method in which the controllably expandable elements of a device work in a controlled and coordinated fashion to drive the device within the body cavity. For example,
In some embodiments, disclosed herein is a device and a method in which the controllably expandable elements of the device work in a controlled and coordinated fashion to drive the device within the body cavity. For example, panel a of
In some embodiments, there is a need for a device comprising a flexible region, e.g., between the radially expandable elements, that can transmit force to achieve bi-directional movement. In some embodiments, the flexible region comprises one or more structures (e.g., layers) can be act as one piece in unity or independently if needed. In some embodiments, the flexible region comprises a core structure or layer, surround by a middle structure (e.g., cable) or layer, which is in turn surrounded by an outer structure (e.g., cable) or layer. In some embodiments, the core structure or layer is flexible and of sufficient tension, while the middle and/or outer structures or layers are cable of being compressed. In some embodiments, a device disclosed herein comprises one or more cables can be act as one piece in unity or independently if needed. In some embodiments, the one or more cables are configured to pull and/or push in order to compress or decompress the middle and/or outer structures or layers. In some embodiments, the middle structure comprises one or more cables (e.g., compressive, load carrying cables). In some embodiments, the middle structure comprises one or more cables that are configured to push and/or pull, and the outer structure comprises one or more springs. In some embodiments, the middle structure comprises one or more cables that are configured to push and/or pull, and the outer structure comprises another one or more cables that are configured to push and/or pull.
Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and/or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.
As used herein, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. For example, “a” or “an” means “at least one” or “one or more.” It is understood that aspects and variations described herein include “consisting” and/or “consisting essentially of” aspects and variations.
Throughout this disclosure, various aspects of the claimed subject matter are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the claimed subject matter. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, where a range of values is provided, it is understood that each intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the claimed subject matter. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and are also encompassed within the claimed subject matter, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the claimed subject matter. This applies regardless of the breadth of the range.
Use of ordinal terms such as “first”, “second”, “third”, etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements. Similarly, use of a), b), etc., or i), ii), etc. does not by itself connote any priority, precedence, or order of steps in the claims. Similarly, the use of these terms in the specification does not by itself connote any required priority, precedence, or order.
The term “about” as used herein refers to the usual error range for the respective value readily known. Reference to “about” a value or parameter herein includes (and describes) embodiments that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X”.
As used herein, a “subject” is a mammal, such as a human or other animal, and typically is human.
Among the provided embodiments are but not limited to:
Embodiment 1. A device configured to move within a body cavity, the device comprising: a) an elongated support; b) a proximal radially expandable element and a distal radially expandable element positioned along the length of the elongated support, optionally wherein the radially expandable elements are independently controllably expandable, wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, and wherein the distal radially expandable element is fixed relative to the elongated support; and c) a locomotion system comprising: i) a proximal locomotion element having a part that is fixed relative to the proximal radially expandable element and slidable along the length of the elongated support, such that the proximal radially expandable element is slidable along the length of the elongated support, and ii) a distal locomotion element having a part fixed relative to the elongated support, wherein the locomotion system effects sliding movement of the proximal radially expandable element along the length of the elongated support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity.
Embodiment 2. The device of embodiment 1, wherein the elongated support comprises a tubular wall and a lumen, optionally wherein the lumen is a central lumen.
Embodiment 3. The device of embodiment 2, wherein one or both of the expandable elements and/or one or both of the locomotion elements are in fluid or gas communication with one or more chambers, one or more channels, one or more tubes, and/or one or more wires in the central lumen.
Embodiment 4. The device of any one of embodiments 1-3, wherein any one or more of the expandable elements and locomotion elements are independently controlled.
Embodiment 5. The device of any one of embodiments 1-4, wherein the locomotion elements are configured to expand or collapse along the length of the elongated support, optionally wherein the locomotion elements are configured to expand or collapse only along the length of the elongated support and/or are not radially expandable.
Embodiment 6. The device of any one of embodiments 1-5, wherein the proximal and the distal radially expandable elements are capable of expanding radially outwardly to engage a wall of a body cavity, optionally wherein friction augmenting features are molded into the proximal and/or distal radially expanding elements.
Embodiment 7. The device of any one of embodiments 1-6, wherein alternating extensions and retractions of a distance between the outer surfaces of the proximal and the distal radially expandable elements effects movement of the device within the body cavity.
Embodiment 8. The device of any one of embodiments 1-7, wherein the elongated support further comprises one or more aperture on a distal end, and/or wherein the elongated support further comprises one or more medium channels separately connected to the radially expandable elements, optionally wherein the medium comprises gas, liquid or a mixture thereof, and optionally wherein the medium comprises a vapor, and/or wherein the elongated support further comprises one or more wires or channels for a camera or sensor, optionally wherein the sensor is a pressure sensor and/or an image sensor, and/or wherein the elongated support houses or engages an endoscope assembly.
Embodiment 9. The device of any one of embodiments 1-8, further comprising an articulation element capable of effecting articulation of a distal end of the device, optionally wherein the distal end of the device is the distal end of the elongated support or the distal end of the device directly or indirectly engages the distal end of the elongated support.
Embodiment 10. The device of embodiment 9, wherein the articulation element enables steering of the device, optionally wherein the device comprises a machine vision element that digitally recognizes structures assisting in navigation and identifying anomalies such as lesions and polyps, optionally wherein the machine vision assists in navigation and/or transmitting location of structures such as when moving from the large intestine to the small intestine.
Embodiment 11. The device of any one of embodiments 9-10, wherein the articulation element comprises a motor.
Embodiment 12. The device of any one of embodiments 9-11, wherein the articulation element comprises one or more closed loop cables configured to effect articulation.
Embodiment 13. The device of any one of embodiments 1-12, further comprising one or more channels not in connection with the expandable elements.
Embodiment 14. The device of any one of embodiments 1-13, wherein the proximal radially expandable element is a proximal balloon.
Embodiment 15. The device of any one of embodiments 1-14, wherein the distal radially expandable element is a distal balloon.
Embodiment 16. The device of any one of embodiments 1-15, wherein the proximal radially expandable element directly or indirectly engages one or more floating elements configured to slide along the length of the elongated support, thereby sliding the proximal radially expandable element along the length of the elongated support.
Embodiment 17. The device of any one of embodiments 1-16, wherein the locomotion system comprises two longitudinally expandable elements.
Embodiment 18. The device of embodiment 17, wherein the locomotion system comprises a proximal longitudinally expandable element and a distal longitudinally expandable element, optionally wherein the longitudinally expandable elements are independently controllably expandable, and optionally wherein the longitudinally expandable elements each comprises a structure independently selected from the group consisting of a compliant balloon, a semi-compliant balloon, a pressure balloon, and a bellow.
Embodiment 19. The device of any one of embodiments 1-16, wherein the locomotion system comprising a pulley system.
Embodiment 20. The device of embodiment 19, wherein the pulley system comprises a proximal floating element, a distal wheel, and a cable connected to the proximal floating element and engaging the distal wheel.
Embodiment 21. The device of any one of embodiments 1-20, wherein the distal locomotion element comprises a part fixed to the distal expandable element.
Embodiment 22. A device configured to move within a body cavity, the device comprising: a) an elongated support; b) a proximal radially expandable element and a distal radially expandable element positioned along the length of the elongated support, wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, and wherein the distal radially expandable element is fixed relative to the elongated support; c) a locomotion system comprising a proximal longitudinally expandable element and a distal longitudinally expandable element connected by a floating seal, wherein: i) the proximal longitudinally expandable element is proximal to the proximal radially expandable element, and the floating seal is fixed relative to the proximal radially expandable element and slidable along the length of the elongated support, such that the proximal radially expandable element is slidable along the length of the elongated support, and ii) the distal longitudinally expandable element is proximal to the distal radially expandable element, and the distal end of the distal longitudinally expandable element is fixed relative to the elongated support, wherein the locomotion system effects sliding movement of the proximal radially expandable element along the length of the elongated support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity.
Embodiment 23. The device of embodiment 22, wherein the proximal and the distal longitudinally expandable elements are configured to expand or collapse along the length of the elongated support, optionally wherein the proximal and the distal longitudinally expandable elements configured to expand or collapse only along the length of the elongated support and/or are not radially expandable.
Embodiment 24. The device of embodiments 22 or 23, wherein alternating expansion and collapsing of the proximal and the distal longitudinally expandable elements do not change the distance between the proximal end of the proximal longitudinally expandable element and the distal end of the distal longitudinally expandable element.
Embodiment 25. The device of any one of embodiments 22-24, wherein the distance between the proximal end of the proximal longitudinally expandable element and the distal end of the distal longitudinally expandable element is pre-determined.
Embodiment 26. The device of any one of embodiments 22-25, wherein expansion of the proximal and/or the distal longitudinally expandable elements is effected by positive pressure, optionally wherein negative pressure is proactively and alternatively applied to the longitudinally expandable elements in order to evacuate previously applied positive pressure, and optionally wherein the proximal and/or the distal longitudinally expandable elements do not passively deflate.
Embodiment 27. The device of any one of embodiments 22-26, wherein the expansion of the proximal longitudinally expandable element and the collapsing of the distal longitudinally expandable element effects sliding movement of the proximal radially expandable element along the length of the elongated support.
Embodiment 28. The device of any one of embodiments 22-27, wherein the collapsing of the proximal longitudinally expandable element and the expansion of the distal longitudinally expandable element effects movement of the distal radially expandable element.
Embodiment 29. The device of any one of embodiments 22-28, wherein the elongated support further comprises one or more aperture on a distal end, and/or wherein the elongated support further comprises one or more medium channels separately connected to the radially expandable elements, optionally wherein the medium comprises gas, liquid or a mixture thereof, and optionally wherein the medium comprises a vapor, and/or wherein the elongated support further comprises one or more wires or channels for a camera or sensor, optionally wherein the sensor is a pressure sensor and/or an image sensor, and/or wherein the elongated support houses or engages an endoscope assembly.
Embodiment 30. A method for locomotion of the device of any one of embodiments 22-29 through a body cavity, the method comprising: i. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a first position in the body cavity; ii. expanding (e.g., using positive pressure) the distal longitudinally expandable element along the elongated support to increase the distance between the proximal and the distal radially expandable elements; iii. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the proximal radially expandable element radially inwardly; v. retracting (e.g., using negative pressure) the distal longitudinally expandable element, and/or expanding (e.g., using positive pressure) the proximal longitudinally expandable element along the elongated support, thus effecting sliding movement of the proximal radially expandable element along the elongated support and decreasing the distance between the proximal and the distal radially expandable elements; and vi. optionally expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a second position in the body cavity, optionally the second position is distal to the first position.
Embodiment 31. The method of embodiment 30, further comprising: vii. expanding (e.g., using positive pressure) the distal longitudinally expandable element along the elongated support to increase the distance between the proximal and the distal radially expandable elements.
Embodiment 32. A method for locomotion of the device of any one of embodiments 22-29 through a body cavity, the method comprising: i. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a first position in the body cavity; ii. expanding (e.g., using positive pressure) the proximal longitudinally expandable element along the elongated support, thus effecting sliding movement of the proximal radially expandable element along the elongated support and decreasing the distance between the proximal and the distal radially expandable elements; iii. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the distal radially expandable element radially inwardly; v. retracting (e.g., using negative pressure) the proximal longitudinally expandable element, and/or expanding (e.g., using positive pressure) the distal longitudinally expandable element along the elongated support; and vi. optionally expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a second position in the body cavity, optionally the second position is distal to the first position.
Embodiment 33. The method of embodiment 32, further comprising: vii. expanding (e.g., using positive pressure) the proximal longitudinally expandable element along the elongated support to decrease the distance between the proximal and the distal radially expandable elements
Embodiment 34. A device configured to move within a body cavity, the device comprising: a) an elongated support; b) a proximal radially expandable element and a distal radially expandable element positioned along the length of the elongated support, wherein the radially expandable elements comprise outer surfaces configured to frictionally engage a wall of a body cavity, and wherein the distal radially expandable element is fixed relative to the elongated support; c) a pulley system comprising: i) a proximal floating element that is fixed relative to the proximal radially expandable element and slidable along the length of the elongated support, such that the proximal radially expandable element is slidable along the length of the elongated support, ii) a distal wheel fixed relative to the elongated support, and iii) a cable connected to the proximal floating element and engaging the distal wheel, such that the cable is configured to pull the proximal floating element in the distal or proximal direction, wherein the pulley system effects sliding movement of the proximal radially expandable element along the length of the elongated support, thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity.
Embodiment 35. The device of embodiment 34, wherein the cable is a closed loop cable.
Embodiment 36. The device of any one of embodiments 34-35, wherein movement of the cable effects movement of the proximal radially expandable element along the elongated support, thereby effecting alternative extensions and retractions of a distance between the outer surfaces of the proximal and the distal radially expandable elements along the length of the elongated support.
Embodiment 37. The device of any one of embodiments 34-36, wherein the radially expandable elements are independently controllably expandably, and, optionally wherein the elongated support further comprises one or more medium channels separately connected to the radially expandable elements, optionally wherein the medium comprises gas, liquid or a mixture thereof and optionally wherein the medium comprises a vapor, and/or wherein the elongated support further comprises one or more wires or channels for a camera or sensor, optionally wherein the sensor is a pressure sensor and/or an image sensor, and/or wherein the elongated support houses or engages an endoscope assembly.
Embodiment 38. The device of any one of embodiments 34-37, wherein pulling the proximal floating element in the proximal direction while the proximal radially expandable element is collapsed and while the distal radially expandable element is expanded to engage a body cavity results in the proximal radially expandable element moving proximally within the body cavity, thereby increasing the distance between the proximal and the distal radially expandable elements.
Embodiment 39. The device of any one of embodiments 34-38, wherein pulling the proximal floating element in the proximal direction while the proximal radially expandable element is expanded to engage a body cavity and while the distal radially expandable element is collapsed results in the distal radially expandable element moving distally within the body cavity, thereby increasing the distance between the proximal and the distal radially expandable elements.
Embodiment 40. The device of any one of embodiments 34-39, wherein pulling the proximal floating element in the distal direction while the proximal radially expandable element is collapsed and while the distal radially expandable element is expanded to engage a body cavity results in the proximal radially expandable element moving distally within the body cavity, thereby decreasing the distance between the proximal and the distal radially expandable elements.
Embodiment 41. The device of any one of embodiments 34-40, wherein pulling the proximal floating element in the distal direction while the proximal radially expandable element is expanded to engage a body cavity and while the distal radially expandable element is collapsed results in the distal radially expandable element moving proximally within the body cavity, thereby decreasing the distance between the proximal and the distal radially expandable elements.
Embodiment 42. A method for locomotion of the device of any one of embodiments 34-41 through a body cavity, the method comprising: i. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a first position in the body cavity; ii. pulling the proximal floating element in the proximal direction along the elongated support while the distal radially expandable element is collapsed, thereby increasing the distance between the proximal and the distal radially expandable elements; iii. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the proximal radially expandable element radially inwardly; v. pull the proximal floating element in the distal direction, thus effecting sliding movement of the proximal radially expandable element along the elongated support and decreasing the distance between the proximal and the distal radially expandable elements; and vi. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the proximal radially expandable element to a second position in the body cavity, optionally wherein the second position is distal to the first position.
Embodiment 43. The method of embodiment 42, further comprising: vii. pulling the proximal floating element in the proximal direction along the elongated support while the distal radially expandable element is collapsed, thereby increasing the distance between the proximal and the distal radially expandable elements.
Embodiment 44. A method for locomotion of the device of any one of embodiments 34-41 through a body cavity, the method comprising: i. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a first position in the body cavity; ii. pulling the proximal floating element in the distal direction along the elongated support while the proximal radially expandable element is collapsed, thereby decreasing the distance between the proximal and the distal radially expandable elements; iii. expanding the proximal radially expandable element radially outwardly to engage a wall of the body cavity; iv. retracting the distal radially expandable element radially inwardly; v. pulling the proximal floating element in the proximal direction, thus effecting sliding movement of the distal radially expandable element forward along the elongated support and increasing the distance between the proximal and the distal radially expandable elements; and vi. expanding the distal radially expandable element radially outwardly to engage a wall of the body cavity, thereby fixing the distal radially expandable element to a second position in the body cavity, optionally wherein the second position is distal to the first position.
Embodiment 45. The method of embodiment 44, further comprising: vii. pulling the proximal floating element in the distal direction along the elongated support while the proximal radially expandable element is collapsed, thereby decreasing the distance between the proximal and the distal radially expandable elements.
Embodiment 46. The device of any one of embodiments 22-29 and embodiments 34-41 further comprising an articulation element capable of effecting articulation of a distal end of the device, optionally wherein the distal end of the device is the distal end of the elongated support or the distal end of the device directly or indirectly engages the distal end of the elongated support.
Embodiment 47. The device of embodiment 46, wherein the articulation element enables camera visualization and steering of the device (e.g., one comprising an endoscope assembly), optionally wherein the device comprises machine vision elements that digitally recognize structures assisting in navigation and identifying anomalies such as lesions and polyps, optionally wherein the machine vision assists in navigation and/or transmitting location of structures such as when moving from the large to small intestine.
Embodiment 48. The device of any one of embodiments 46-47, wherein the articulation element comprises a motor.
Embodiment 49. The device of any one of embodiments 46-48, wherein the articulation element comprises one or more closed loop cables configured to effect articulation.
Embodiment 50. The method of any one of embodiments 30-33 and embodiments 42-45, further comprising capturing an image of the body cavity through a channel of the device.
Embodiment 51. The method of any one of embodiments 30-33, embodiments 42-45 and 50, further comprising delivering a substance into the body cavity through a channel of the device.
Embodiment 52. The method of any one of embodiments 30-33, embodiments 42-45 and 50-51, further comprising removing a substance into the body cavity through a channel of the device.
Embodiment 53. The method of any one of embodiments 30-33, embodiments 42-45 and 50-52, further comprising performing an operation on a tissue within the body cavity through a channel of the device.
Embodiment 54. The device or method of any one of embodiments 1-53, wherein the body cavity is a vascular body lumen, a digestive body lumen, a respiratory body lumen, or a urinary body lumen.
Embodiment 55. The device or method of claim 54, wherein the digestive body lumen is a gastrointestinal tract, optionally wherein the digestive body lumen comprises esophagus, stomach, small intestine, duodenum, jejunum, ileum, colon, and/or rectum.
Embodiment 56. The device or method of any of embodiments 1-55, wherein the expandable elements are connected to the elongated support (e.g., tubular structure such as tether) using an elastic O-ring that mechanically holds the expandable elements; using adhesive only securing the edges of the expandable elements; mechanically securing the edges of an expandable element by a deformable material such as a metal by swaging or radially compressing it around the expandable element; or by a combination thereof.
Embodiment 57. A device configured to move within a body cavity, the device comprising:
Embodiment 58. The device of embodiment 57, wherein the spring comprises a plurality of springs connected by one or more separators.
Embodiment 59. A device configured to move within a body cavity, the device comprising:
Embodiment 60. The device of embodiment 59, wherein the first cable comprises a plurality of first cables and the second cable comprises a plurality of second cables, optionally the first cable and/or the second cable are configured to push and/or pull the corresponding radially expandable element.
This application claims priority from U.S. provisional application No. 63/129,454 filed Dec. 22, 2020, entitled “Devices and Systems for Body Cavities and Methods of Use,” which is incorporated herein by reference in its entirety for all purposes.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US21/64730 | 12/21/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63129454 | Dec 2020 | US |
