Patent Application
20190046417
The present disclosure generally relates to a positioning of a feeding tube within an anatomical tract (e.g., a gastrointenstinal tract or a vascular tract). The present disclosure specifically relates to a novel and inventive improvement of tracking the positioning of the feeding tube within the anatomical tract.
Generally, there two (2) feeding methods to addressing malnutrition patients who cannot maintain enough caloric intake orally. The first feeding method, known as an enteral nutrition, involves a positioning of a feeding tube within a gastrointenstinal tract to provide nutritional and medical support to the patient. The second feeding method, known as a parenteral nutrition, involves a positioning of a feeding tube within a vein of the patient when the patient has a medical issue that makes safe use of the gastrointenstinal tract difficult, or where adequate nutrition is not attained by enteral nutrition.
More specific to enteral nutrition, an access point for a feeding tube can be oral or nasal whereby a distal tip of the feeding tube is positioned in the stomach of the patient (i.e., a nasogastric enteral feeding), or positioned in an upper duodenum of the small intestine (i.e., a nasoduodenal enteral feeding), or positioned in a mid-jejunum of the small intestine (i.e., a nasojejunal enteral feeding). Optionally, a gastrostomy approach may be implemented to position the distal tip of the feeding tube in the stomach, or a jejunostomy approach may be implemented to position the distal tip of the feeding tube in the mid-jejunum of the small intestine.
Generally, there are three (3) placement methods for positioning the feeding tube within a gastrointenstinal tract of a malnutrition patient. The first placement method, known as a blind placement method, involves positioning of the feeding tube the gastrointenstinal tract without any navigational guidance. A problem with this placement method when orally or nasally accessing the patient is the feeding tube can often be mis-positioned with an airway of the patient, which can lead to pneumonia or pneumothorax.
A second placement method, known as an imaging tracking method, involves endoscopic or fluoroscopic imaging of the gastrointenstinal tract for purposes of tracking the position of the feeding tube within the gastrointenstinal tract. While safer and more successful than a blind placement approach, a problem with imaging tracking methods is a requirement of a medical specialist to perform the procedure. Consequently, the patient has to be transported from a clinical ward to an endoscopy department or a radiology department, which can lead to delays in feeding tube placement, additional complexity, and higher cost.
A third placement method, known as electromagnetic (“EM”) tracking method, uses a stylet with an EM sensor at the tip that is placed within the feeding tube to thereby conduct a real-time tracking of a path of the feeding tube within the gastrointenstinal tract. After the feeding tube has been navigated into position, the EM-guided stylet is withdrawn. The advantage of the EM tracking method is that it can be done at the patient bedside, thus providing a more patient-friendly and cost-effective solution as compared with fluoroscopy and endoscopic guidance. However, because EM tracking is limited to the tip of the feeding tube, EM tracking cannot fully represent the shape that the tube is taking on at any given time. This shape of the tube is important for detecting if buckling of the tube is occurring and if the tube has been placed correctly, especially in the presence of altered or shifting anatomy.
The present disclosure improves upon prior feeding tube placement methods by providing inventions utilizing an integration of a Fiber-Optic RealShape (“FORS”) sensor and a feeding tube to configure a FORS feeding tube for facilitating a tracking of a shape of the FORS feeding tube positioned within an anatomical tract (e.g., a gastrointenstinal tract or a vascular tract).
For purposes of the inventions of the present disclosure, the term “Fiber-Optic RealShape (“FORS”) sensor broadly encompasses an optical fiber structurally configured as known in the art for extracting high density strain measurements of the optical fiber derived from light emitted into and propagated through the optical fiber and reflected back within the optical fiber in an opposite direction of the propagated light and/or transmitted from the optical fiber in a direction of the propagated light.
An example of a FORS sensor includes, but is not limited to, one (1) or more optical fibers structurally configured under the principle of Optical Frequency Domain Reflectometry (OFDR) for extracting high density strain measurements of the optical fiber derived from light emitted into and propagated through the optical fiber(s) and reflected back within the optical fiber(s) in an opposite direction of the propagated light and/or transmitted from the optical fiber(s) in a direction of the propagated light via controlled grating patterns within the optical fiber (e.g., Fiber Bragg Gratings), a characteristic backscatter of the optical fiber(s) (e.g., Rayleigh backscatter) or any other arrangement of reflective element(s) and/or transmissive element(s) embedded, etched, imprinted, or otherwise formed in the optical fiber(s).
Commercially and academically, Fiber-Optic RealShape may also be known as optical shape sensing (“OSS”).
For purposes of the inventions of the present disclosure, the terms “feeding tube” is to be interpreted as understood in the art of the present disclosure and as exemplary described herein. Examples of feeding tubes include, but are not limited to, nasogastric feeding tubes, gastrostomy feeding tubes, jejunostomy feeding tubes, and esophagostomy feeding tubes.
One form of the inventions of the present disclosure is a FORS feeding tube system employing a feeding tube for channeling a fluid flow (e.g., a nutritional liquid, water and/or a liquid medicine) from a proximal end to a distal end of the feeding tube, and further employing a FORS sensor for generating sensing data informative of a shape reconstruction of a segment or an entirety of the FORS sensor. The feeding tube and the FORS sensor are integrated to configure a FORS feeding tube extending between the proximal end of the feeding tube and a distal end of the FORS sensor, and the sensing data is further informative of a shape of a segment or an entirety of the FORS feeding tube derived from the integration of the FORS sensor and the feeding tube. Additionally, the FORS sensor may be integrated into a positioning guide (e.g., a guidewire, a stylet or a tube) for facilitating an integration of the FORS sensor within the feeding tube. The FORS feed tube system may further employ a navigation controller to control a tracking of a shape of a segment or an entirety of the FORS feeding tube as positioned within an anatomical tract (e.g., a gastrointenstinal tract).
A second form of the inventions of the present disclosure is a FORS feeding tube method involving a positioning of a segment or an entirety of a FORS feeding tube within an anatomical tract (e.g., a gastrointenstinal tract), wherein the FORS feeding tube includes a integration of a feeding tube and a FORS sensor. The FORS feeding method further involves the FORS sensor generating sensing data informative of a shape reconstruction of a segment or an entirety of the FORS sensor, and further informative of a shape of a segment or an entirety of the FORS feeding tube derived from the integration of the feeding tube and the FORS sensor. The FORS feeding method may further involve a navigation controller controlling a tracking of the shape of the segment or the entirety of the FORS feeding tube as positioned within the anatomical tract.
For purposes of the inventions of the present disclosure, the terms “sensing data”, “shape reconstruction”, and “tracking” are to be interpreted as understood in the art of the present disclosure and as exemplary described herein.
For purposes of the inventions of the present disclosure, the term “integrate” and any tense thereof broadly encompasses any type of permanent or temporary adjoining, coupling, connecting, affixing, clamping, mounting, etc. of the FORS sensor and the feeding tube involving direct physical contact between the FORS sensor and the feeding tube or an adjacent placement of the FORS sensor and the feeding tube as understood in the art of the present disclosure and as exemplary described herein.
The term “integrate” and any tense thereof further broadly encompasses an integration of the FORS sensor and the feeding tube whereby a known alignment of a segment or an entirety of the FORS sensor and the feeding tube are for purposes of a shape tracking of the FORS feeding tube (e.g., a parallel alignment of a segment or an entirety of the longitudinal axes of the FORS sensor and the feeding tube as exemplary described herein).
For purposes of the present disclosure, the term “positioning guide” broadly encompasses any medical device utilized for guiding purposes as understood in the art of the present disclosure and as exemplary described herein. Examples of positioning guides include, but are not limited to, a guidewire, a stylet and a tube.
For purposes of the present disclosure, the term “controller” broadly encompasses all structural configurations of an application specific main board or an application specific integrated circuit housed within or linked to a workstation for controlling an application of various inventive principles of the present disclosure as subsequently described herein. The structural configuration of the controller may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, application module(s), peripheral device controller(s), slot(s) and port(s).
For purposes of the present disclosure, the label “navigation” used herein for the term “controller” distinguishes for identification purposes the navigation controller from other controllers as described and claimed herein without specifying or implying any additional limitation to the term “controller”.
Examples of a “workstation” include, but are not limited to, an assembly of one or more computing devices, a display/monitor, and one or more input devices (e.g., a keyboard, joysticks and mouse) in the form of a client computer, a desktop or a tablet.
For purposes of the present disclosure, the term “application module” broadly encompasses a component of the workstation consisting of an electronic circuit and/or an executable program (e.g., executable software stored on non-transitory computer readable medium(s) and/firmware) for executing a specific application.
The foregoing forms and other forms of the inventions of the present disclosure as well as various features and advantages of the inventions of the present disclosure will become further apparent from the following detailed description of various embodiments of the inventions of the present disclosure read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the inventions of the present disclosure rather than limiting, the scope of the inventions of the present disclosure being defined by the appended claims and equivalents thereof.
As an improvement upon prior feeding tube placement methods, the inventions of the present disclosure propose a Fiber-Optic RealShape (“FORS”) sensing solution for facilitating an accurate placement of a feeding tube positioned within an anatomical tract. The FORS sensing solution provides a integration of a FORS sensor and a feeding tube to configure a FORS feeding tube for facilitating a tracking of a shape of a segment or an entirety of the FORS feeding tube positioned within an anatomical tract (e.g., a gastrointenstinal tract or a vascular tract).
For example, referring to
Still referring to
To facilitate an understanding of the various inventions of the present disclosure, the following description of
Referring to
Feeding tube 30 generally includes a tubular body 31 having a feeding lumen 32 for channeling a fluid flow (e.g., nutritional liquid, water and/or liquid medicine) from a proximal end 31p to a distal end 31d. Feeding tube 33 may further include a feeding luer 33, male or female, for connection to a source of the fluid flow (not shown). More particularly, in practice, feeding tube 30 is has dimensions suitable for a feeding a malnutrition patient. Examples of feeding tubes 30 include, but are not limited to, nasogastric feeding tubes, gastrostomy feeding tubes, jejunostomy feeding tubes, and esophagostomy feeding tubes.
FORS sensor 40 includes a single core or multi-core optical fiber 41 having controlled grating patterns (e.g., Fiber Bragg Gratings), a characteristic backscatter (e.g., Rayleigh backscatter) or any other arrangement of reflective elements and/or transmissive elements embedded, etched, imprinted, or otherwise formed in optical fiber 41. In practice, the controlled gratings, characteristic backscatter, or reflective/transmissive elements may extend along any segment or an entirety of optical fiber 41 as symbolically shown by dashed line 42 extending from a proximal end 41p to a distal end 41d. Also in practice, FORS sensor 40 may include of two (2) or more individual optical fibers 41 that may or may not be helixed.
In practice, optical fiber 41 of FORS sensor 40 may be made partially or entirely of any glass, silica, phosphate glass or other glasses, or made of glass and plastic or plastic, or other materials used for making optical fibers. For impeding any damage to FORS sensor 40 when introduced into the patient anatomy via manual or robotic insertion, each optical fiber 41 of FORS sensor 40 may be integrated into a positioning guide 50 via an embedding into a guide wire or a stylet as known in the art or permanently encircled by a protective sleeve as known in the art.
In practice, the protective sleeve may be made from any flexible material of a specified hardness including, but not limited to, pebax, nitinol, furcation tubing, and stranded metal tubing. Also in practice, the protective sleeve may consist of two or more tubular components of same or different degrees of flexibility and hardness in an overlapping and/or sequential arrangement.
FORS sensor 40 further includes an optical connector 43 for connecting optical fiber 41 to a launch or an optical source (e.g., optical integrator) as will be further described herein.
The inventions of the present disclosure are premised on an integration of feeding tube 30 and FORS sensor 40 to configure a FORS feeding tube for facilitating a tracking of a shape of a segment or an entirety of the FORS feeding tube as positioned within an anatomical tract. In practice, an integration of feeding tube 30 and FORS sensor 40 may be in any suitable configuration for a particular enteral feeding or a particular parental feeding.
For example, as shown in
Alternatively, a duel luer lock may be utilized to allow for insertion of optical fiber 41 and guidewire 51 as well an injection of saline or other fluids.
By further example, as shown in
To facilitate a further understanding of the various inventions of the present disclosure, the following description of
Referring to
In operation, a FORS sensor 40 of nasogastric FORS feeding tube 20NG distally extends from launch 47 adjoined to a rail of patient bed PB as shown or alternatively adjoined to a cart (not shown) next to patient bed PB or adjoined to a workstation (e.g., workstation 100 or a tablet (not shown)). An optical fiber 46 proximally extends from launch 47 to an optical integrator 45. In practice, optical fiber 46 may be a separate optical fiber connected to FORS sensor 40 at launch 47, or a proximal extension of FORS sensor 40 extending through launch 47.
As known in the art, a FORS controller 44 controls an emission of light by optical interrogator 45 via optical fiber 46 into FORS sensor 40 whereby the light is propagated through FORS sensor 40 to a distal end within the feeding tube to generate sensing data 48 informative of shape reconstruction of a segment or an entirety of FORS sensor 40 relative to launch 47 serving as a fixed reference position. In practice, the distal end of FORS sensor 40 may be closed, particularly for light reflective embodiments of FORS sensor 40, or may be opened, particularly for light transmissive embodiments of FORS sensor 40.
Navigation controller 110 is installed within workstation 100 including a known arrangement of a monitor 101, a keyboard 102 and a computer 103.
Navigation controller 110 includes application modules in the form of a FORS sensor tracker 111, an optional camera image tracker 112 and a navigation guide 113.
With FORS sensor 40 being connected to launch 47, FORS sensor tracker 111 processes sensing data 48 to track a shape of a segment or an entirety of nasogastric FORS feeding tube 20NG relative to launch 47 as known in the art.
Additionally, FORS sensor tracker 111 may analyze the shape of nasogastric FORS feeding tube 20NG to determine various metrics about important parameters including, but not limited to, an insertion length of a nasogastric FORS feeding tube 20NG within the gastrointenstinal tract, and a measurement of physiologically-relevant parameters (e.g., breathing motion, internal body temperature, breathing, patient swallowing, patient movement, peristatic motion, coughing, etc.). Additionally, FORS sensor tracker 111 may further process shape parameters and/or metrics to predict the likelihood of correct placement of nasogastric FORS feeding tube 20NG within the gastrointenstinal tract.
More particularly, FORS sensor tracker 111 may perform a measurement of a length of nasogastric FORS feeding tube 20NG inserted within the gastrointenstinal tract by detecting the FORS axial strain change caused by the temperature change from room temperature to 37° C. after nasogastric FORS feeding tube 20NG enters patient P.
Furthermore, FORS sensor tracker 111 may perform a prediction of a position of nasogastric FORS feeding tube 20NG inserted within the gastrointenstinal tract by using curvature along the shape and the length of insertion (e.g., a specific bend occurring 10 cm into feed tube 20NG representing a correct positioning of feed tube 20NG into the patient's esophagus as opposed to the patient's lungs).
In addition, FORS sensor tracker 111 may implement an automatic detection of a degree of respiratory motion to detect if nasogastric FORS feeding tube 20NG is misplaced in a lung of patient P. This could also be extended to include detecting sphincter locations.
The FORS feeding tube system optionally employs a camera 90 for generating image data 91 illustrative of still images and/or a live video of patient P as nasogastric FORS feeding tube 20NG is being manually or robotically positioned within a gastrointenstinal tract of patient P as known in the art. If camera 90 is employed by the system, then camera image tracker 112 processes image data 90 for a guidance display 114 on monitor 101.
Based on the processing of sensing data 49 and imaging data 91, navigation guide 113 controls guidance display 114 of the shape of nasogastric FORS feeding tube 20NG in any suitable form for navigation purposes. A first exemplary form is a guidance display 114a of the shape of a segment or an entirety of nasogastric FORS feeding tube 20NG in space as exemplary shown in
Referring to
Referring to
In one embodiment of stage S122, nasogastric FORS feeding tube 20NG is constructed after sterilization by a clamping via proximal FORS sensor lock 70 of a full insertion of FORS sensor 40 within feeding tube 30. Next, nasogastric FORS feeding tube 20NG is registered on dependence of the particular display 114 of the shape of a segment or an entirety of nasogastric FORS feeding tube 20NG within the gastrointenstinal tract.
For guidance display 114a as shown in
For guidance display 114b as shown in
For guidance display 114c as shown in
Still referring to
More particularly, in practice, virtual reality or augmented reality (“AR”) may be implemented for a display of a position of nasogastric FORS feeding tube 20NG. For example, a shape of a segment or an entirety of nasogastric FORS feeding tube 20NG may be projected directly onto patient P, or may be shown to the user through AR glasses, or may be superimposed on a live image stream from a tablet or smartphone. For virtual reality, the user may see a model of patient P and then be able to move along nasogastric FORS feeding tube 20NG and see the pathway that it is taking.
Prior to, during and/or subsequent to nasogastric FORS feeding tube 20NG is manually or robotically navigated into the gastrointenstinal tract, FORS sensor tracker 111 may determine various metrics as previously described herein. Of particular importance is a determination of insertion depth and tip location.
Still referring to
Flowchart 120 is terminated upon manual or robotic removal of nasogastric FORS feeding tube 20NG from within the gastrointenstinal tract.
Referring to
Further, as one having ordinary skill in the art will appreciate in view of the teachings provided herein, features, elements, components, etc. described in the present disclosure/specification and/or depicted in the Figures may be implemented in various combinations of hardware and software, and provide functions which may be combined in a single element or multiple elements. For example, the functions of the various features, elements, components, etc. shown/illustrated/depicted in the Figures can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software for added functionality. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, memory (e.g., read only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process.
Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (e.g., any elements developed that can perform the same or substantially similar function, regardless of structure). Thus, for example, it will be appreciated by one having ordinary skill in the art in view of the teachings provided herein that any block diagrams presented herein can represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, one having ordinary skill in the art should appreciate in view of the teachings provided herein that any flow charts, flow diagrams and the like can represent various processes which can be substantially represented in computer readable storage media and so executed by a computer, processor or other device with processing capabilities, whether or not such computer or processor is explicitly shown.
Having described preferred and exemplary embodiments of novel and inventive Fiber Optical RealShape feeding tubes, systems and methods, (which embodiments are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons skilled in the art in light of the teachings provided herein, including the Figures. It is therefore to be understood that changes can be made in/to the preferred and exemplary embodiments of the present disclosure which are within the scope of the embodiments disclosed herein.
Moreover, it is contemplated that corresponding and/or related systems incorporating and/or implementing the device/system or such as may be used/implemented in/with a device in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure. Further, corresponding and/or related method for manufacturing and/or using a device and/or system in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2017/053023 | 2/10/2017 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62308243 | Mar 2016 | US |
