Patent Application
20220265155
This invention relates to a device and its uses for evaluating multiple conditions. A device as described herein may be capable of being used for multiple end uses, including, for example, an endoscope, such as a nasal endoscope, a transnasal esophagoscope, a transnasal gastroscope, a transnasal duodenoscope, a transnasal enteroscope, a triple endoscope, a bronchoscope, a laryngoscope, a transnasal gastroscope, an aerodigestive scope, and/or an endoscopic device used to visualize any body cavity to which it would fit.
As described herein devices may encompass multiple functionalities while maintaining specific sizes and patient positions to allow for ease of use and/or patient comfort. In some instances, for example, in veterinary medicine and/or medicine, such as in pediatrics or small adults, it may be necessary to create devices having smaller diameters while maintaining the functionality. To create such a small device with full capabilities and keep an unsedated patient in position while interacting with a provider is complicated and technically challenging to accomplish. For example, the evaluation and treatment of eosinophilic esophagitis, esophagitis, Barrett's esophagus, esophageal cancer, gastritis, celiac disease, gastric infection, gastric ulcer, duodenal ulcer and aerodigestive conditions, in children, small adults, and in outpatient or emergent settings where a gastrointestinal procedural suite or operating room are not available may be of particular interest. More specifically, some embodiments of this invention may relate to pediatric or adult nasal endoscopes and patient and provider distraction and interaction devices.
Eosinophilic esophagitis (EoE) is an increasingly common chronic inflammatory disease that affects children and adults with an estimated incidence of 1/10,000 in the United States. [Dellon E S, Gonsalves N, Hirano I, et al. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol 2013; 108:679-92; quiz 693.] Because of its potential to progress to esophageal stricture and the fact that symptoms do not always correlate with degree of eosinophilia, much attention has been paid to repeated assessment of the esophageal mucosa to insure mucosal healing following treatment. In contrast, the risks, cost and time commitment associated with traditional sedated esophagogastroduodenoscopy (EGD) can be significant and have raised concerns for providers and parents alike. [Gleich S J, Flick R, Hu D, et al. Neurodevelopment of children exposed to anesthesia: Design of the Mayo Anesthesia Safety in Kids (MASK) study. Contemp Clin Trials 2014; 41C:45-54.] These dilemmas challenge the gastroenterologist to contemplate if EGD use in EoE is meeting the goal of Berwick's triple aim in healthcare to provide effective treatment, low cost care, and an optimal and safe healthcare experience. [Berwick D M, Nolan T W, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood) 2008; 27:759-69.] Should EGD with biopsy be performed after each therapeutic change regardless of symptomatology, should EGD be reserved for patients who are not clinically responding to treatment, or should EGD not be performed again if patients are feeling well?
To address these questions, alternative methods are urgently needed to measure esophageal inflammation. While esophagoscopy with biopsies remains the gold standard technique for assessing mucosal inflammation, other technologies such as the Cytosponge, esophageal string test and confocal tethered endomicroscopy have emerged as potential alternatives. [Furuta G T, Kagalwalla A F, Lee J, et al. The oesophageal string test: a novel, minimally invasive method measures mucosal inflammation in eosinophilic oesophagitis. Gut 2013; 62:1395-405; Tabatabaei N, Kang D, Wu T, et al. Tethered confocal endomicroscopy capsule for diagnosis and monitoring of eosinophilic esophagitis. Biomed Opt Express 2013; 5:197-207; Katzka D A, Geno D M, Ravi A, et al. Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis. Clin Gastroenterol Hepatol 2015; 13:77-83 e2.] To date, these tools, while less invasive, are still available only in research settings. [Dellon E S, Gonsalves N, Hirano I, et al. Am J Gastroenterol 2013; 108:679-92; quiz 693; Furuta G T, Kagalwalla A F, Lee J, et al., Gut 2013; 62:1395-405.]
Recent work has led to the development of trans-nasal endoscopy/esophagoscopy (TNE) to assess the esophageal mucosa in adults. [Birkner B, Fritz N, Schatke W, et al. A prospective randomized comparison of unsedated ultrathin versus standard esophagogastroduodenoscopy in routine outpatient gastroenterology practice: does it work better through the nose? Endoscopy 2003; 35:647-51; Dumortier J, Josso C, Roman S, et al. Prospective evaluation of a new ultrathin one-plane bending videoendoscope for trans-nasal EGD: a comparative study on performance and tolerance. Gastrointest Endosc 2007; 66:13-9; Dumortier J, Ponchon T, Scoazec J Y, et al. Prospective evaluation of trans-nasal esophagogastroduodenoscopy: feasibility and study on performance and tolerance. Gastrointest Endosc 1999; 49:285-91; Hu C T. Gauze pledgetting versus endoscopic-guided aerosolized spray for nasal anesthesia before trans-nasal EGD: a prospective, randomized study. Gastrointest Endosc 2010; 71:11-20; Mokhashi M S, Wildi S M, Glenn T F, et al. A prospective, blinded study of diagnostic esophagoscopy with a superthin, stand-alone, battery-powered esophagoscope. Am J Gastroenterol 2003; 98:2383-9; Mulcahy H E, Riches A, Kiely M, et al. A prospective controlled trial of an ultrathin versus a conventional endoscope in unsedated upper gastrointestinal endoscopy. Endoscopy 2001; 33:311-6; Yagi J, Adachi K, Arima N, et al. A prospective randomized comparative study on the safety and tolerability of trans-nasal esophagogastroduodenoscopy. Endoscopy 2005; 37:1226-31.] In contrast to traditional EGDs, TNE offers advantages, including that it can be performed in an outpatient clinic room, requires no anesthesia or sedation, uses an adult trans-nasal gastroscope that is tolerated by adults and procures samples adequate for assessment of Barrett's Esophagus. [Shariff M K, Bird-Lieberman E L, O'Donovan M, et al. Randomized crossover study comparing efficacy of trans-nasal endoscopy with that of standard endoscopy to detect Barrett's esophagus. Gastrointest Endosc 2012; 75:954-61; Saeian K, Staff D M, Vasilopoulos S, et al. Unsedated trans-nasal endoscopy accurately detects Barrett's metaplasia and dysplasia. Gastrointest Endosc 2002; 56:472-8.] However, the endoscopes used in the adult procedures are not appropriate for use in pediatric setting and too large for many adults. To accomplish TNE, many features have been removed and sacrifices have been made, such as the loss of distal steering and decreased visualization. Further, adult endoscopes and nasal endoscopes have large bulky heads, will not fit in many pediatric size or small adult nasal passages, are hard to control by individuals with small hands, do not have optional stiffening capability for improved maneuverability, do not have foot controls or a full array of hand button controls, are not connected to or allow voice dictation of reports, are not able to be used in pediatrics or small adults, and are unable to be used for bronchoscopy. Accordingly, what is needed is a device and associated methodology that can be used to adapt TNE to assess the esophageal mucosa, gastric, and duodenal, tracheal, and bronchial mucosa in children and small adults in both a sedated and unsedated manner with a full array of steering and a channel large enough to enable diagnostics and therapeutics while also allowing full satisfactory evaluation of the above tissues. The present invention provides tools and techniques to meet this important need. Light may be used in medical devices to aid treatment or diagnose conditions with endoscopic technologies. In particular, light may be used on probes to stimulate tissue. For example, gallium nitride microLEDs have been used on probes to stimulate light sensitive tissue as is disclosed by McAlinden (McAlinden, Niall and Massoubre, David and Richardson, Elliot and Gu, Erdan and Sakata, Shuzo and Dawson, Martin D and Mathieson, Keith (2013) Thermal and optical characterization of micro-LED probes for in vivo optogenetic neural stimulation. Optics Letters, 38 (6). pp. 992-94. http://dx.doi.org/10.1364/OL.38.000992), which is incorporated by reference.
During an endoscopic procedure, patients are often fearful and anxious and experience discomfort, and thus it is desirable to distract patients from stimulating their senses, thereby making the procedure mentally and physically easier on the patient. However, this is not enough as the patient often needs to be disassociated from their provider or the experience. The provider also needs to maintain proper position and interaction with a seated patient. There is fear of looking at the medical device or into their providers eyes from a close distance. Further the provider doing an unsedated procedure often needs to be disassociated from their patient due to fear of performing a procedure without anesthesia or sedation as is usually used in such procedures. This same provider needs to keep the patient still and be able to interact in a limited manner with their patient. Such a task in essence is anesthesia without the use of medication or drug. The present disclosure accomplishes this provider and patient dissociation and proper seated positioning while also enabling an easy insertion of the endoscope in a body cavity. These concepts are especially true when treating children, as children are less likely to stay still and have significant anxiety in a clinical setting and throughout the endoscopic procedure with long and uncomfortable devices inserted inside of them.
Citation or identification of any document in this application is not an admission that such document is available as prior art to the present invention.
In one aspect of the present disclosure, a system is provided. The system comprises a scope comprising a longitudinal length extending between a proximal end and a distal end, the scope further comprising a plurality of markers spaced along the longitudinal length. The system further comprises a patient-provider disassociation device, wherein the device is configured to at least partially occlude the vision of a patient, thereby providing a disassociating and/or distraction environment to the patient, provide proper seated positioning, and enable easy access to the body cavities to which the endoscope is being inserted. The system further comprises a sensor integrated into the disassociation device, wherein the sensor may be configured to detect the markers on the longitudinal length of the scope. The sensor may also be useful for other sensing events or additional sensors may be used for other sensing events.
In another aspect of the present disclosure, the disassociation device may comprise goggles, wherein the goggles are attachable to the patient's face to at least partially occlude the vision of the patient, wherein the goggles comprise a viewable area or region that may include a display, screen, etc. configured to display information, including but not limited to videos, images, text, emojis, indicia, designs, drawings, etc. for viewing by the patient to provide a dissociative experience. In another aspect, the viewable area or region may include a mobile device that has a display or screen, and the goggles further comprise an attachment mechanism to detachably attach the mobile device to the goggles. In yet another aspect, the viewable area or region may include one or more displays or screens integrated into the goggles. The viewable screen may be positioned via the design of the goggles to enable easy access to the nasal cavity by the provider. This is done via the lens angle and shape of the goggle device. This also enables the nasal access for children and adults. In still another aspect, the goggles may further comprise an electroacoustic transducer or loudspeaker configured as headphones or open to air audio transmission device configured to provide audio stimuli to the patient and examiner. In a further aspect, the sensor may be configured to detect the position of the scope within the patient's body via detection of the markers on the longitudinal length of the scope. In still a further aspect, the sensor may be a magnetic sensor and the markers may comprise a metallic material, wherein the magnetic sensor is configured to detect the presence of the markers. In another aspect, the sensor may be a light sensor and the markers may emit or reflect light, wherein the light sensor is configured to detect the presence of the markers. In yet another aspect, the sensor may be a mechanical sensor and the markers may be raised with respect to a surface of the longitudinal length of the scope, wherein the mechanical sensor is configured to detect the presence of the markers or pressure transmitted by the body cavity upon the scope at various distances from the tip of the scope. In still a further aspect, the sensor may be integrated into a nose-piece of the goggles. In another aspect, the scope may be a trans-nasal endoscope. In still another aspect, the sensor (or multiple sensors) may be further configured to detect at least one or multiple of the patient's heart rate, pulse oximetry, blood pressure, sweat content, gas exhalation levels, body temperature, exhalation sounds, respiratory rate, skin elasticity, ocular pressure, pupil sizes, pupil distances, tympanic membrane compliance, and hearing aid function. In one aspect, the distraction device may comprise a recess configured to removably receive an electronics module, wherein the electronics module comprises one or more of the sensors described above.
In another aspect of the present disclosure, a system is provided that comprises a scope comprising a longitudinal length extending between a proximal end and a distal end. The system further comprises a distraction and disassociation device attachable to a patient's head, wherein the distraction device is configured to at least partially occlude the vision of the patient and the viewable image to allow easy access to the nares for a medical procedure. The patient may be positioned in a seated position. Further, the distraction device comprises a proximal portion and a distal portion, wherein the proximal portion is aligned with the patient's natural line of sight and the distal portion is disposed at an angle with respect to the proximal portion.
In one aspect, the scope may be a trans-nasal endoscope and the distraction and disassociation device may comprise at least one screen configured to display videos or images for viewing by the patient, wherein the angle of the distal portion permits access to a nasal passageway of the patient when the distraction device is attached to the patient's head. The distraction device may also further comprise a cutout that permits access to the nasal passageway of the patient when the distraction device is attached to the patient's head.
In another aspect of the present disclosure, a method of conducting an endoscopy exam on a patient by a provider in close proximity to a patient is provided. The method comprises placing a distraction and disassociation device over the patient's eyes to at least partially occlude the vision of the patient, wherein the distraction device comprises a proximal portion aligned with the patient's natural line of sight and a distal portion disposed at an angle above the patient's natural line of sight to expose a nasal passageway of the patient. This same device enables easy access to the nasal cavity due to the shape of the device. The method further comprises inserting at least a portion of an endoscope into the nasal passageway of the patient and conducting one or more assessments of the patient using the endoscope.
Accordingly, it is an object of the invention not to encompass within the invention any previously known product, process of making the product, or method of using the product such that Applicants reserve the right and hereby disclose a disclaimer of any previously known product, process, or method. It is further noted that the invention does not intend to encompass within the scope of the invention any product, process, or making of the product or method of using the product, which does not meet the written description and enablement requirements of the USPTO (35 U.S.C. .sctn. 112, first paragraph) or the EPO (Article 83 of the EPC), such that Applicants reserve the right and hereby disclose a disclaimer of any previously described product, process of making the product, or method of using the product. It may be advantageous in the practice of the invention to be in compliance with Art. 53(c) EPC and Rule 28(b) and (c) EPC. All rights to explicitly disclaim any embodiments that are the subject of any granted patent(s) of applicant in the lineage of this application or in any other lineage or in any prior filed application of any third party is explicitly reserved. Nothing herein is to be construed as a promise.
It is noted that in this disclosure and particularly in the claims and/or paragraphs, terms such as “comprises,” “comprised,” “comprising” and the like can have the meaning attributed to it in U.S. patent law; e.g., they can mean “includes,” “included,” “including,” and the like; and that terms such as “consisting essentially of” and “consists essentially of” have the meaning ascribed to them in U.S. patent law, e.g., they allow for elements not explicitly recited, but exclude elements that are found in the prior art or that affect a basic or novel characteristic of the invention.
These and other embodiments are disclosed or are obvious from and encompassed by, the following Detailed Description.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
The following detailed description, given by way of example, but not intended to limit the invention solely to the specific embodiments described, may best be understood in conjunction with the accompanying drawings.
The foregoing and other features and advantages of the invention are apparent from the following detailed description of exemplary embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims and equivalents thereof.
The present disclosure documents the performance of TNE with biopsies using these ultra-slim flexible endoscopes to assess the esophageal, gastric, duodenal, tracheal, and bronchial mucosa in pediatric subjects with EoE. The performance was assessed in part through the evaluation of parental and patient subject responses to TNE, the assessment of the ability to procure samples that would be adequate to monitor disease, monitoring adverse events, and recording procedure duration and charges generated. This assessment showed that unsedated trans-nasal endoscopy using the pediatric nasal endoscope and gastroscope and esophagoscope and duodenoscope disclosed herein offers an excellent alternative to sedated esophagogastroduodenoscopy.
Unsedated trans-nasal endoscopy (TNE) in adults is safer and less costly than sedated esophagogastroduodenoscopy (EGD). TNE with biopsies can be adapted as an effective tool to monitor the esophageal, gastric, and duodenal mucosa of children with eosinophilic esophagitis (EoE) or other conditions of the upper gastrointestinal tract with the proper tools and techniques. This technique can dramatically increase the safety and decrease cost in the care of children. The present disclosure documents the development of the performance of TNE with biopsies in pediatric EoE.
Subjects between 8 and 17 years of age with EoE, and their parents, were enrolled in the study Unsedated TNE was performed. The currently available smaller endoscopes designed for bronchoscopy as a 2.8 mm (1.2 mm channel) or a 4 mm flexible bronchoscope (2 mm channel) were used, and esophageal biopsies were procured. These scopes were shorter than Applicants' currently proposed pediatric nasal endoscope and were without water channels, suction, air, foot control, high definition optics, or stiffening capability. Biopsy analysis, duration, adverse events, and billing charges of TNE were assessed. Immediately after TNE and a minimum of 2 weeks later, the mGHAA-9 (modified Group Health Association of America) and a preference questionnaire were completed, respectively.
Twenty-one of 22 enrolled subjects completed TNE. TNE was tolerated with no significant adverse events Histopathological analysis revealed 0 eos/hpf (n=12), <15 eos/hpf (n=4), and >15 eos/hpf (n=5) and total epithelial surface area of mucosal biopsies samples from either TNE forceps compared to those obtained with standard endoscopic forceps was not statistically different. All parents and 76.2% of subjects would undergo the TNE again. TNE was preferred over EGD by 85.7% of parents and 52.4% of subjects. mGHAA-9 revealed a high degree of satisfaction (average 43.19+/−2.6 maximum score-45) Charges associated with TNE were 60.1% less than previous EGDs. The results of this study show that unsedated TNE is a preferred, efficacious, and lower cost procedure when monitoring esophageal mucosa of children with EoE.
The emergence of EoE has led to a renewed interest in determining pathogenic mechanisms of esophageal inflammation and sampling of the esophageal mucosa to assess for mucosal healing. Despite the rapid progress in establishing diagnostic criteria, treatments, and novel genes related to pathogenic mechanisms that can significantly impact EoE patients, limited data is available to document the natural history of EoE. This lack of understanding has led to the present clinical practice of multiple. high-cost, and higher-risk sedated assessments of the esophageal mucosa to ascertain whether eosinophilia has resolved following treatment. If eosinophilia resolves, a predicate determination is made that the likelihood for EoE-related complications is diminished. If eosinophilia persists, efforts are made to resolve inflammation regardless of symptomatology, with its subsequent impact on quality of life and costs of care. In this regard, novel devices and sampling methodologies are urgently needed. To address this and offer a new tool in the evaluation of EoE, Applicants sought to determine if TNE could sample the esophageal mucosa in a way that was well-tolerated and adequate. In light of the emergent need for more efficient methods of esophageal mucosal evaluation in EoE. Applicants performed this study within the confines of a multidisciplinary team to perform TNE with biopsies in a pediatric population. Applicants chose this population because of the urgent need to minimize the repetitive risks of anesthesia, improve the understanding of EoE pathogenesis, and to ultimately identify novel therapeutic targets.
Unsedated TNE is an established technique in a number of pediatric and adult subspecialties, but it has not been used by pediatric gastroenterologists. [Birkner B, Fritz N, Schatke W, et al. Endoscopy 2003; 35.647-51; Dumortier J, Josso C, Roman S, et al Gastrointest Endosc 2007; 66:13-9; Dumortier J, Ponchon T, Scoazec J Y, et al. Gastrointesi Endosc 1999: 49:285-91; Hu C, T Gastrointest Endosc 2010; 71:11-20; Mokhashi M S, Wildi S M, Glenn T F, et al. Am J Gastroenterol 2003; 98:2383-9: Mulcahy H E, Riches A, Kiely M. et al Endoscopy 2001, 33.311-16; Yagi J, Adachi K, Arima N, et al. Endoscopy 2005; 37:1226-31]A number of studies have described the advantages, limitations, and challenges of TNE use, and in 2010, the America Society of Gastrointestinal Endoscopy developed a guideline for the use of TNE in adults. [Committee A T. Rodriguez S A, Banerjee S, et al. Ultrathin endoscopes. Gastrointest Endosc 2010; 71:893-98: Faulx A L. Catanzaro A, Zyzanski S, et al. Patient tolerance and acceptance of unsedated ultrathin esophagoscopy Gastrointest Endosc 2002; 55:620-23; Faulx A L, Vela S. Das A, et al. The changing landscape of practice patterns regarding unsedated endoscopy and propofol use: a national Web survey. Gastrointest Endosc 2005; 62:9-15; Tatsumi Y, Harada A. Matsumoto T, et al. Current status and evaluation of trans-nasal esophagogastroduodenoscopy. Dig Endosc 2009, 21:141-46] This guideline increased attention to cost containment, and the recent upswing in interest in esophageal diseases led to renewed interest in this technique. [Faulx A L, Catanzaro A, Zyzanski S, et al. Gastrointest Endosc 2002, 55:620-3; Chak A, Alashkar B M, Isenberg G A, et al. Comparative acceptability of trans-nasal esophagoscopy and esophageal capsule esophagoscopy: a randomized, controlled trial in veterans. Gastrointest Endosc 2014; 80:774-82; Lin L F, Shen H C Unsedated trans-nasal percutaneous endoscopic gastrostomy carried out by a single physician. Dig Endosc 2013; 25:130-5; Cho S. Arya N, Swan K. et al. Unsedated trans-nasal endoscopy: a Canadian experience in daily practice. Can J Gastroenterol 2008; 22:243-6] A recent study also demonstrated the utility of TNE in adults with Barrett's esophagus. [Tatsumi Y, Harada A, Matsumoto T, et al. Current status and evaluation of trans-nasal esophagogastroduodenoscopy. Dig Endosc 2009; 21:141-46: Chak A, Alashkar B M, Isenberg G A, et al. Comparative acceptability of trans-nasal esophagoscopy and esophageal capsule esophagoscopy: a randomized, controlled trial in veterans. Gastrointest Endosc 2014; 80:774-82; Bush C M, Postma G N. Trans-nasal esophagoscopy Otolaryngol Clin North Am 2013; 46:41-52]. To date, only one study evaluated unsedated transoral endoscopy in children and concluded that it improved time and safety in assessing 21 children for evaluation of abdominal pain, dyspepsia, and dysphagia. [Bishop P R, Nowicki M J, May W L, et al. Unsedated upper endoscopy in children. Gastrotnes Endose 2002; 55:624-30]
With the rapidly increasing prevalence of EoE, limited knowledge regarding its pathophysiology, and emerging clinical needs to assess the esophageal mucosa, Applicants sought to determine whether TNE in pediatric EoE would be a feasible and efficacious tool. Results of Applicants' study reveal that patients and their parents experienced with sedated EGD tolerate TNE well, and that patients and their parents prefer TNE compared to EGD. It is likely that the limited side effect profile and complete lack of serious adverse events contributed to the finding that 52.4% of child subjects (4 subjects preferring neither EGD or TNE) and the 85.7% of parents (1 parent preferring neither TNE or EGD) preferred unsedated TNE to sedated EGD. In that parents often make decisions about procedures in pediatrics and a majority of children prefer the procedure, these percentages are indicative of a highly successful alternative to EGD. Immediate benefits of this preference for patients include improved patient satisfaction and increased safety by eliminating anesthesia.
In many ways Applicants' results are quite similar to that reported in adult studies. For example, a large Canadian Study by Cho et al evaluating 231 patients with an average age of 57 years for routine TNE: their study also found that TNE was well tolerated, safe and feasible. [Cho S, Arya N, Swan K, et al. Unsedated trans-nasal endoscopy a Canadian experience in daily practice. Can J. Gastroenterol 2008, 22.243-6] This study was different, however, in that the patients were primarily adults, the scope used was larger (5.3 mm) and duodenal intubation was performed. Applicants' study evaluated the use of 2 smaller endoscopes, smaller biopsy forceps, and TNE performance in children. Some areas of divergence between Applicants' findings and similar adult studies include that (1) in Applicants' study both the parents and child subjects evaluated the technique, (2) the adequacy of smaller forceps to evaluate the esophageal mucosa in EoE was assessed, and (3) the actual rather than contemplative type of future endoscopy preferred by subjects who have undergone multiple previous EGD's was examined. These findings augment the results of this research and its potential application to adult and pediatric endoscopy practices.
Applicants are particularly encouraged by their findings for several reasons. First, there was great interest in this procedure amongst patients and parents. Applicants only needed to screen 22 subjects to enroll the 21 subjects reported here. This is likely explained by the fact that the EoE patient population represents a very engaged, experienced, and educated population that is readily seeking alternative methods. Applicants are highly confident that this is a technically feasible procedure, and are further encouraged by its overall rapid success that was facilitated by a multidisciplinary pediatric team dedicated to the care of children with aerodigestive diseases and EoE. Applicants' study provides strong support for larger studies to validate this approach that will provide novel insights into the natural history of EoE and significantly improve the lives of children with EoE in a safer, cost-effective, and efficacious manner.
Second, Applicants' study found a high level of satisfaction and enthusiasm to repeat the TNE. The overwhelming majority of patients and parents were satisfied and preferred unsedated TNE compared to standard EGD. Subject responses in the qualitative survey identified critical elements including the lack of anesthesia, the presence of parents during the procedure, the limited duration of the procedure and rapid recovery. TNE was safe, as evidenced by the fact that no significant adverse events or event needed subsequent treatment or evaluation. The subjects and parents appreciated the improvement in their quality of life with TNE, as it allowed them the ability to return to school and work and eat shortly afterwards. In fact, several families noted the patients returned to school or a sport activity after the TNE. The time at CHCO for a standard EGD is 3 hours compared to 60-90 minutes for the TNE, a time that included not only the TNE but also research protocol documentation. This 3-hour procedure center time for EGD usually includes check-in, pre-operative evaluation by nursing, gastroenterology, and anesthesia, the procedure itself, recovery, and discharge instructions. The 60-90 minute time for TNE in clinic included research documentation, pre-procedural documentation, the procedure itself, and discharge instructions. Most of these improvements in time reduction and increased satisfaction, noted above, are related to the effects of eliminating anesthesia or sedation for TNE. Not only does this practice seem to improve satisfaction of patients and parents, but there is also a significant likelihood it decreases the risk of adverse medication reactions, aspiration, and possible effects on the developing pediatric brain. [Gleich S J, Flick R, Hu D, et al. Contemp Clin Trials 2014, 41C:45-54] This is an emerging concern amongst pediatric anesthesiologists. While pediatric subjects without sedation or general anesthesia noted a mild sore throat and gagging, this was minor enough that the majority chose follow-up TNE for their EoE evaluation after their initial study procedure. This has been confirmed as more than a hypothetical question, with several of Applicants' subjects requesting follow-up TNE after the study concluded.
The third positive outcome of Applicants' study relates to the integrity of the mucosal sample. Regarding the technique's effectiveness in evaluating mucosal esophageal samples, Applicants found that the epithelial surface area needed for eosinophil count evaluation was not significantly different from the standard EGD 2.8 mm biopsy forceps compared to either of the TNE 2 mm or 1.2 mm biopsy forceps. This finding provides a high level of confidence that the sample procured at the time of TNE will have the same surface area compared to that obtained with the gold standard EGD biopsy forceps. The 2 mm forceps were also able to procure lamina propria.
The final areas of interest in this study were the reduction in cost and increase in efficiency. Financial benefits of TNE include the fact that TNE incurred fewer charges and required less time away from work and school when compared to a standard sedated pediatric EGD. The project demonstrated a significant 60.1% drop in charges. The majority of this reduction in cost is related to the lack of anesthetic/anesthesiologist during TNE. The significance of this cannot be understated. For example, if Applicants' institution were to perform 100 sedated EGDs per year for EoE at a hypothetical average, non-insurance adjusted charge of $9,390 dollars per general anesthesia-provided endoscopy encounter, this would accumulate $939,000 total charges per year for EoE This would include all facility charges, physician, pathology and anesthesia fees. If these 100 EGDs for EoE were converted to unsedated TNE, this could translate to a healthcare systems charge savings of $564,000 dollars per year. These are possible charges, however, and not respective insurance rates.
Several areas will be addressed in future evaluations. First, for practical reasons, Applicants needed to use two different sized endoscopes for TNE. Future work will standardize this for patient comfort and biopsy size. Second, although the 1.2 mm forceps were not able to procure lamina propria, the 2 mm forceps in this study were able to obtain lamina propria. While this section of the tissue has been used to grade fibrosis, this metric has not been standardized or become a gold standard for clinical assessments. Applicants' study demonstrates feasibility in pediatrics, but evaluating a much larger cohort is required to achieve a significant power for safety and other metrics. Power analysis based on Applicants' own institution's quality and safety data would necessitate over 10,000 endoscopies to find a single significant adverse event. This could be remedied with the development of further databases, as this technique is increasingly used at Applicants' institution or in a national program evaluating its use in pediatrics. Finally, Applicants undertook this study in a multidisciplinary collaboration with their pediatric pulmonary and otolaryngology colleagues. This was done for study design to maximize patient comfort during TNE development in pediatrics, a strong interest in aerodigestive and eosinophilic disorders by gastroenterologists, otolaryngologists, and pulmonologists alike, and the need for a more pragmatic multidisciplinary approach to diagnosing and managing EoE as it presents in different single specialty clinics. Since the study initiation, the gastroenterologist, otolaryngologist, and pulmonologists have been trained in single physician TNE with biopsies that further improves cost and efficiency, diagnosis, and referral for management of EoE.
In conclusion, the implementation of TNE in pediatric gastroenterology for the evaluation of pediatric EoE is safe, preferred by patients and parents alike, and has the potential to dramatically reduce costs. Thus it appears that TNE would be measured as a highly effective practice in pediatric EoE management per Berwick's description of the triple aim: the pursuit of improved experience of care, the health of populations should be improved, and the cost of per capita healthcare should be decreased. [Berwick D M, Nolan T W, Whittington J. Health Aff (Millwood) 2008; 27:759-69.] This suggests that TNE use should be highly considered as an alternative to standard sedated EGD or esophagoscopy for the follow-up evaluation of pediatric EoE. The technique will continue to be refined and improved, offering more opportunities for its use in monitoring response to therapeutics, obtaining follow-up evaluations, and performing research in EoE.
Turning to
As discussed above, the flexible endoscope shaft 20 has a biopsy channel 30 running the length of the endoscope and is adapted to slidingly receive a pediatric nasal endoscope biopsy forceps 70 (See
Further embodiments of endoscopic devices, elements thereof, and/or systems utilizing endoscopes are described herein. Endoscopes may be used in combination with other elements in a system to enhance the capabilities of the scope and/or increase a number of uses for which the scope may be used.
A system including endoscope 62 is shown in
The control element may include a port or a number of ports which are used to provide and/or remove materials to/from a target area. For example, ports may be used to supply and/or remove fluids to/from a target area, such as water, air, and/or medications in specific measured amounts. In some embodiments, an interface element may be configured to deliver one or more predetermined amounts of water, air and/or medicine during use by the operator based on a procedure, protocol, patient needs (for example, patient size) and/or preferences of the operator. In alternate embodiments, an interface element may be configured to remove predetermined amounts of fluids.
In some instances, suction may connected to a port in order to provide suction to a target area. Ports may include coupling structures to couple various delivery systems to the control element.
Some embodiments of control elements may include interface elements. For example, an interface element may be used to control the positioning and/or functions of the distal element, a portion of the elongated element, the function of devices and/or sensors positioned along the elongated element and/or the distal element. In particular embodiments, an interface element may be used to determine a distance from an insertion point and/or measure luminal body findings. For example, determining a diameter of lumen, such as an esophagus or bronchus, and/or measuring the size a lumen and/or findings therein, such as a gastric polyp or ulcer. For example, interface elements may control aspects of the optical system. In some embodiments, interface elements may control image capture, video, and/or audio recording.
For example, as depicted in
In some embodiments, an auto-populate feature may be used to populate any portion of form with transcribed audio data, audio files, video files, metrics measured by sensors, in particular, dimensions, position of the endoscope, and/or other physiological conditions within a body or portion of the body being viewed. In some embodiments the recordings and information by the endoscope could be transmitted to a remote physician for interpretation and consultation.
A control element may include a steering mechanism. For example,
The control element may have a housing constructed using standard methods known in the art, as well as newly developed technologies. For example, the control element may have a housing that is constructed using three dimensional printing.
The distal element of the endoscope may have a rounded end, a flat end, and/or a combination. In some embodiments, an end of the distal element may include a soft tip, for example, a soft silicone tip.
Various embodiments of an end view of a distal element are depicted in
Elongated elements 77 of
As shown in
Distal element 80 includes channel 85. As shown in
An embodiment may include a cutout designed to house a device such as a sensor, imaging element, light or the like, cable, wire, and/or fiber optic element.
As shown in
As shown in
As illustrated in
Overmold drawings reflect a tool necessary to create the distal element. Various configurations were constructed that corresponded to the geometries of the distal element as can be seen in
As shown in
The scope may include a distal element having openings for additional devices or elements. For example, the distal element may include openings for an illumination element, such as a fiber optic cable, light, and/or light source, and/or an optical element, such as a camera.
An optical element may include a device having a field of view of greater than 60°. In some embodiments, the field of view of the optical element may be greater than 850 or as high as 150 degrees. Further, the depth of field may be as small as 5 mm greater than 15 mm. In some instances, the depth of field may be greater than 20 cm. An optical element such as a camera, for example, a high definition camera or videoscope, may include devices such as, but not limited to, miniature videoscopes.
The distal element may also include openings which may allow for manipulation at a predetermined location, delivery of materials, such as air, liquid, medicines, devices, etc., and/or retrieval of materials, such as tissue, devices, fluids. In an embodiment, the distal element may include an opening which allows for use of suction at a predetermined location and/or a target area.
Elongated elements may couple to both the distal element and the control element. A length of an elongated element may be in a range between 0.5 to 1.5 meters. For example, an elongated element may have a length in a range from about 0.8 to 1.2 meters in some embodiments. An outer diameter of an elongated element may be less than about 4.5 millimeter. In some embodiments, the outer diameter of an elongated member may be less than 4.0 millimeter. For example, an elongated element may have an outer diameter of less than about 3.5 millimeters in an embodiment.
A further illustrative example includes an elongated member and/or shaft having a diameter in a range between 4 mm to 5 mm. A channel extending through the elongated member or shaft may have a diameter in a range from about 2.5 to 3.0 mm. In such an example, it may be desirable to use a camera capable of moving on multiple axes. For example, a camera capable of four-way deflection may be used.
In one illustrative example an elongated member of a scope may have an outer diameter in a range between 4.3 to 4.5 mm and a channel or conduit having a diameter in a range from about 2.8 to 3.0 mm. Such a scope may be utilized for applications where the openings may be larger or the scope requires additional room for additional elements. This may be particularly true for applications involving adults and/or training on devices, such as simulators.
A stiffness of the elongated element may vary along its length. At least a portion of the length may be flexible. In some embodiments, variable stiffness along the length of the elongated element may be created using a stainless steel tube that is laser cut with a variable interrupted spiral pattern. The more cuts, the more material is removed and the more flexible the shaft becomes. Thus, an elongated element may be designed to have a stiffer area proximate to the control element such that torque can be transferred, while being flexible proximate to the distal element such that tight bends can be negotiated and/or patient comfort improved. In an alternate embodiment, the elongated element may include a braided metal section to provide variable stiffness. Another embodiment may include various stiffness of single plastic extrusions brought together through welds to accomplish proper steering, direction, and stiffness.
In some embodiments, a length of a flexible portion of the elongated element may be in a range from about 30 to about 50 millimeters. For example, a flexible portion of an elongated member may have a length in range from about 35 to 45 millimeters. In an embodiment, the length of the flexible portion of the elongated element may be approximately 40 mm.
An elongated element may include one or more conduits. The conduits may have various configurations. For example, the conduits may be coaxial, positioned proximate to each other, and/or positioned on opposite sides of the cross-section of the elongated element. Conduits may include one or more lumen.
Conduits may act as a housing for elements inserted into the elongated element. In some embodiments the elongated element may have one or more conduits configured to receive devices and/or sensors to provide access to a target area.
In some embodiments, conduits may provide a path for materials to reach the distal element and/or a target area. Further, a conduit may be used to transport materials from the target area to the control element or, in some cases, to a position external to the control element.
Elongated element 62 includes conduit 24 running the length of the endoscope elongated element. In some instances, the conduit may slidingly receive instruments, such as nasal endoscope biopsy forceps 70 (See
A working conduit in the elongated element may have an inner diameter of greater than about 2.0 millimeters. Further, the inner diameter of a working conduit may be greater than about 2.1 millimeters in some embodiments.
At least one conduit through the elongated element may have an inner diameter of greater than about 1.3 millimeters. Some embodiments may include conduits having an inner diameter of about 1.4 millimeters or greater.
A sensor array may be used to take measurements throughout a procedure. For example, a sensor array may take distance measurements, for example, the distance that an endoscope has traveled in the body, luminal measurements, such as diameters, lengths, and/or volumes, quantitative changes, physiological measurements within the body, such as temperature, pulse oximetry measurements, etc.
An endoscope may include an elongated element having a flexible section. This flexible section of the elongated element may be constructed from a medical-grade material. In particular, a hydrophobic material may be used. Hydrophobic materials may create a slippery surface which allows the device to be inserted with more ease and/or less discomfort to the patient.
Elongated member 62 of endoscope also includes imaging element 79 and illumination element 36. For example, a high lumen LED or MicroLED may be used to provide light, and a high-resolution video capture device may be used to capture images and/or video in the region of the distal end of the endoscope.
As shown in
Interface elements may be positioned on a control element to provide for ease of use of the operator. For example, in some embodiments, interface elements may be positioned along a top surface, a side surface, and/or an underside of the control element. An embodiment of an interface element may act in a joystick-like manner to control movement of the distal element.
In some instances, the functionality of the interface elements may be programmable by a user for ease of use. In alternate embodiments, the functionality of the interface elements may be defined by a use of the device. For example, when then endoscope device is used to monitor a feeding tube the needs may be different from when the endoscope device is used to conduct a TNE.
In some embodiments, the control element may include multiple ports. At least one port may provide access to a channel and/or conduit within the elongated member. An insertion element, for example an instrument may be inserted into a conduit of the elongated element using a port. Further, an instrument may be coupled to a control element at a port which provides access to a conduit and/or channel within the elongated element. An insertion element may include, but is not limited to an instrument, such as forceps, in particular, biopsy forceps, a feeding tube, a cable for sensors, sensors, accessory, illumination elements and/or optical elements. Further, interface elements may be positioned on a control element such that it provides easy maneuverability of the distal element.
In some embodiments, after positioning an instrument within the elongated element, the control element may be removed. Wires and/or connectors to various elements, for example, audio and imaging elements, sensors, and the like may remain so that these elements can be used.
In some embodiments, there may be a scope-stiffening element to allow use of the endoscope in aerodigestive medicine. For example, a wire may be used as a stiffening element in the elongated element.
Additional interface elements may be used to control various aspects of the device. For example, foot pedals may be used to activate and control fluid flows and/or suction, control imaging devices and/or audio devices. Input devices capable of providing information to the various systems may include interface elements, for example, buttons, joystics, tracker balls, foot pedals, virtual reality devices, goggles, glasses, and the like, sensors, imaging elements, audio elements, and/or any device configured to report a value.
In some embodiments, an interface element may be programmed to interact with a specific a behavior of the operator to achieve a desired outcome. Thus, it may be possible to customize the inputs based on the needs and/or desires of a user and/or a use. For example, some users may prefer a specific configuration of interface elements that combine input from one or both hands and/or one or both feet. Further, some protocols may require specific movements from a user that may make it desirable to alter the inputs so that the user has an increased ability to use their hands for other purposes.
As discussed herein, the elongated element 4107 has a conduit running the length of the endoscope and is adapted to slidingly receive an inserted element, such as biopsy forceps, through port 4106 and into a lumen of the conduit. Control element 4102 also includes port 4110 for connecting to the computer control unit, a computer and/or a display. Ports 4112, 4114 may be configured to deliver fluids and/or such to a target area via the endoscope.
As shown in
The computer control element may be designed to sit on a bench. The size of the computer control element may be less than thirty centimeters by 16 centimeters by 10 centimeters. In some cases, the computer control element may be designed to be portable for easy transport.
As is shown in
Images captured on the imaging element may be displayed using a computer connected to the computer control element.
During a procedure, a screen connected to the computer will be controlled by software such that information and/or images related to a patient and/or procedure are displayed on the screen. As shown in
Images, forms and/or reports may be generated by the computer from one or more inputs from a program, a user, an audio element, an imaging element and/or sensors. The computer may follow a predetermined algorithm that displays various images depending on the type of procedure performed. For example,
In this embodiment, the disassociation device 4700 is in the form of goggles 4704 that are placed over a patient's eyes to partially or fully occlude the patient's view of the procedure and other outside distractions. In addition, the goggles 4704 may include one or more screens 4706 that can display various videos to distract the patient during the procedure, such as a movie, television show, video game or other video clip, images, text, designs, emojis, etc. One particularly interesting benefit and advantage that can be advanced with the goggles 4704 and the screen 4706 is an immersive experience that can fully distract and disassociate the patient from the procedure. In the context of a child undergoing a trans-nasal endoscopy, the child patient can be immersed in a story or environment from the night before the procedure until the end of the procedure. For example, the child may start reading, watching, or listening to a story the night before the procedure that culminates in a show or other video on the screen 4706 of the goggles 4704 during the medical procedure. Such an immersive experience can fully disassociate the child from the procedure, thereby putting less stress on the child and making the procedure easier and more successful.
The screen 4706 may be made of a variety of visual display components, including but not limited to liquid crystal displays (LCDs), light-emitting diode LCDs (LEDs), and Micro LEDs, or any other suitable visual display. The disassociation device 4700 may also utilize headphones 4708 (wired or wireless) or some other sound-producing device such as an electroacoustic transducer or speakers so that the patient can also be distracted by the audio component of any audiovisual distraction playing on the screen 4706 of the goggles 4704. Alternatively, instead of using a disassociation device 4700 with built-in screen 4706, a phone or other similar device may be placed within the goggles 4704 and used as the display for the visual distraction. Due to the short distance between the screen 4706 and the user's eyes, one or more lenses may be incorporated in the goggles 4704 to allow the user to focus on the screens without issue. The disassociation device 4700 may be attached to the patient's face of all ages from children to adults using a variety of methods known in the art, such as with an elastic strap 4710 as shown in this embodiment Specific attachments and shapes of the goggles to this elastic allow this device to attach to individuals of pediatric and adult ages while accomplishing transnasal endoscopy with easy nasal access.
The screen 4706 may be used in an interactive manner with the patient to cue the patient to move, adjust, turn, or angle the patient's head a desired by the examiner or provider in order to facilitate an efficient, effective, and successful procedure. For example, the screen 4706 may be displaying a movie during the procedure where the entire movie is in full view such that the patient can fully observe the display on the screen 4706 and the patient's gaze remains fixed and directed to the center of the display on the screen 4706. If the procedure requires the patient to move or adjust, such as to look up or move their head upwardly, the display on the screen 4706 (automatically or upon manipulation by the examiner or provider) may be “moved” such that the display on the screen 4706 is only partially viewable up and out of view of the patient's prior gaze such that the patient only sees the bottom half of the display on the screen 4706. In order to see the entire display on the screen 4706 the patient looks or moves their head up in the “direction” of where the display has moved and upon moving the appropriate amount the screen 4706 will re-center the display to the patient's adjusted gaze. The same process can be used to motivate or encourage the patient to turn left, right, or angle the head as desired. Some prior an may describe a 3D game or avatar in such an environment in which a patient interacts with the environment. The system described herein is uniquely different in that the examiner is able to control the immersive environment for the patient, which enable the adjustment of the seated medical position of the patient to more safely and effectively perform the procedure.
When the disassociation device 4700 is used with the trans-nasal endoscope 4702, the nasal passageways of the patient should be exposed so that the physician has full access and the patient properly positioned in a sitting still position with ability to communicate and interact with the physician. Prior art virtual reality or similar display-based goggles generally cover all or a portion of the nose, thereby making access to the nasal passageways as necessary for trans-nasal endoscopy difficult or impossible. Thus, in the embodiment shown in
The disassociation device 4700 may also include a distance sensor 4712. In this embodiment, the distance sensor 4712 is integrated into the nosepiece of the goggles 4704, although the distance sensor 4712 may be utilized with the disassociation device 4700 in a variety of ways. The distance sensor 4712 may be used in connection with the trans-nasal endoscope 4702 to provide information on the position of the trans-nasal endoscope 4702 during a procedure and may interpret body cavity luminal pressuring-sensing capabilities of the endoscope. The distance sensor 4712 may detect the position of the trans-nasal endoscope 4702 in a variety of ways. In the embodiment shown in
While in this embodiment a distance sensor 4712 is incorporated into the goggles 4704, a variety of other sensors may also be incorporated into the goggles 4704. This includes sensors that are capable of detecting a variety of a patient's vital signs, including but not limited to heart rate, pulse oximetry, blood pressure, sweat content, carbon dioxide and other gasses' exhalation levels, temperature of the human body, exhalation sounds and respiratory rate, skin elasticity, ocular pressure, pupil sizes and distances, tympanic membrane compliance, hearing aid function, atmospheric temperature, gas content, and interpretation of endoscopic transmission of luminal pressure readings from body cavities. In addition, sensors integrated into the goggles 4704 may be used in a variety of other medical procedures.
In the embodiment shown in
The sensor monitoring provided by the above-mentioned embodiments is particularly important in the context of an unsedated trans-nasal endoscopy or any other procedure involving an unsedated patient disposed in a seated position (especially when unrestrained). In such procedures, the patient is at risk of sudden increased anxiety, such as a panic attack, as well as risk of falling off the chair such as by passing out during the procedure. When a disassociation device 4700 such as the one described above is used in such a procedure, this risk is amplified because the disassociation device 4700 occludes the patient's eyes and parts of the patient's face. Thus, the physician is unable to observe the patient's eyes and face and therefore is unable to detect early warning signs of the patient being in distress. The one or more sensors described above can help detect early signs of such events and warn the physician. For example, if the pulse oximetry sensor 4720 detects decreasing oxygen levels, the patient may be about to pass out and the physician can be warned with warning lights or an alarm sound. Similarly, if a pulse sensor detects an increasing heart rate, the patient may be about to have a panic attack and a similar alarm or warning may sound, including one that is distinguishable from the pulse oximetry sensor 4720 alarm. In one aspect of the present distraction device 4700, the goggles 4704 themselves may automatically act based on input received from the pulse oximetry sensor 4720, pulse sensor, and other sensors described above. For example, if the pulse oximetry sensor 4720 detects decreasing oxygen levels and the patient may be about to pass out or fall asleep, the goggles 4704 may be directed by a computer or other processing unit that receives the data from the sensors to suddenly increase the volume of the audio in the goggles 4704 or flash a warning light from the screen 4706, such as reminding the patient to breathe, etc. Similarly, if the pulse sensor detects increasing heart rate and the patient may be about the have a panic attack, the goggles 4704 may be directed by a computer or other processing unit that receives the data from the sensors to switch to audio or video in the goggles 4704 that is more calming and relaxing or flash a reminder from the screen 4706 to take slow, deep breaths. The other sensors described above may similarly assist in such detection or other useful data collection and analysis by relaying the collected data to a computer or other processing unit to analyze and output a given action.
As described previously, the goggles 4704 of the disassociation device 4700 may use a built-in screen or screens 4706 or may alternatively be designed to receive a phone or other similar device that acts as a screen.
While most of the concepts described above were discussed in the context of the disassociation device 4700 having goggles 4704 with a built-in screen 4706, these concepts are also similarly usable with goggles 4704 that incorporate various sizes of removable phones 4750.
The distal portion 4802 of the endoscope 4800 may be detached from the proximal portion 4804 via a variety of methods. For example, the detachment may occur mechanically, via an electromagnet, and other methods. In one non-limiting example, the mechanical detachment can occur via a mechanical engagement between the distal portion 4802 and proximal portion 4804 that is disengaged via a button or lever on the handle of the endoscope 4800.
Uses for the herein-described devices and/or systems may be varied. For example, the devices and/or systems described herein may be used to deliver medications to a target area, remove tissue from a target area, for example to conduct a biopsy, to promote cessation of bleeding/cautery, to remove a foreign body, to collect samples from a target area, in particular bodily fluids, study target areas, in particular the gastrointestinal tract, to evaluate existing and/or potential disease by examining tissues, in particular, pharynx/larynx/esophagus/stomach/small intestine tissues, to diagnose disease or conditions, for example, celiac disease, infection, etc., and/or to manage airways, among others.
The present invention also contemplates the use of the herein-disclosed endoscope for measuring the size of an airway or gastrointestinal tract or other human body cavity, dilation of an airway, gastrointestinal (GI) tract and/or throat, measuring the luminal body cavity pressure exerted by musculature in an airway or gastrointestinal tract, throat and/or other human body cavity, as well as placement of enteral feeding tubes and body devices in an airway and GI tract.
The assemblies, methods and systems described herein can be used to affect tissue which is located on the outside of hollow organs, such as the lung, esophagus, nasal cavity, sinus, colon, vascular vessels and the like, or other solid organs. Various types of activatable elements (e.g., energy emitters) can be utilized to output the energy. The activatable elements can be sufficiently small to facilitate percutaneous delivery to minimize or limit trauma to the patient.
The embodiments disclosed herein can treat the digestive system, urological system, nervous system, vascular system, gynecological, or other systems. The treatment systems and their components disclosed herein can be used as an adjunct during other medical procedures, such as minimally invasive procedures, open procedures, semi-open procedures or other surgical procedures (e.g., lung volume reduction surgery) that provide access to a desired target site. Various surgical procedures on the chest may provide access to lung tissue, the bronchial tree or the like. Access techniques and procedures used to provide access to a target region can be performed by a surgeon and/or a robotic system. Those skilled in the art recognize that there are many different ways that a target region can be accessed.
The devices disclosed herein can also be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning and/or replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Any of the endoscopic devices and/or elements thereof described herein may be used in conjunction with a system Endoscopic systems may include multiple elements as outlined herein.
It will be seen that the advantages set forth above, and those made apparent from the foregoing description, are efficiently attained and since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
Having thus described in detail preferred embodiments of the present invention, it is to be understood that the invention defined by the above paragraphs is not to be limited to particular details set forth in the above description as many apparent variations thereof are possible without departing from the spirit or scope of the present invention.
It is also to be understood that the following claims are intended to coverall of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.
The present invention will be further illustrated in the following examples which are given for illustrative purposes only and are not intended to limit the invention in any way.
Subjects ages 8-17 years of age between March 2014 and January 2015 with a defined diagnosis of EoE and who had undergone at least one prior EGD under anesthesia were recruited from the outpatient clinic at Children's Hospital Colorado (CHCO) At the time of the scheduled clinically indicated follow-up appointment, subjects were approached if their primary GI provider felt a follow-up esophagoscopy was needed to evaluate their clinical response to therapy Subjects were queried if they would be interested in having an unsedated TNE with movie distraction performed instead of a sedated EGD. If so, informed consent was obtained and demographic data collected.
Subjects were instructed to not eat or drink for two hours prior to the TNE. In a standard clinic room, subjects were asked to sit in a chair designed for outpatient laryngoscopic procedures. Two to six sprays of 4% aerosolized lidocaine were applied to the nares to achieve topical anesthesia. Subject distraction was accomplished using either HMZ-T3W 3D movie goggles (Sony Corporation, Tokyo, Japan) or Cinemizer Goggles (Carl Zeiss A G, Oberkochen, Germany) dependent on facial size to facilitate viewing an immersive movie or television program of their choice. Parents remained in the room for the duration of the study procedure. For study design purposes and patient comfort one of two designated pulmonologists (ED, RD) or a single otolaryngologist (JP) performed trans-nasal laryngoscopy using an Olympus BFXP160F 2.8 mm bronchoscope (1.2 mm biopsy channel) in 11/21 subjects and 10/21 subjects using a 4 mm BPMP160F (2 mm biopsy channel) ending with the endoscope in the proximal esophagus. The gastroenterologist (JF) performed esophagoscopy and biopsy collection (three from proximal and three from distal esophagus). Visual confirmation of the adequacy of the biopsy specimens was performed before withdrawing the scope. Data on adverse events, subject symptoms, duration of TNE in five minute intervals up to 15 minutes were collected. After the procedure, families were asked to answer the mGHAA-9 (modified Group Health Association of America) endoscopy satisfaction questionnaire and discharged home.
Subjects were called the evening of the procedure and >72 hours later to evaluate for any adverse events. A minimum of two weeks but not greater than ten weeks after TNE, the subjects and parents were asked to answer an electronic qualitative survey regarding their experience with TNE
A single pediatric pathologist (KC) evaluated biopsy specimens to assess for size of the sample and inflammatory findings, including eosinophil enumeration. To assure adequate high-power field (hpf) analysis, the total epithelial surface area used to count eosinophils was analyzed using graphical software and analysis (cellSens Standard, 2013, Olympus America, USA). This was accomplished by comparing the subject's available previous esophageal biopsies using a standard 2.8 mm biopsy forceps to the 1.2 or 2 mm biopsy forceps specimens that were collected during TNE.
Charges from TNEs and subjects' previous isolated sedated EGD were collected to compare the cost of the two procedures. Subjects who underwent combined procedures that may have prolonged sedation such as pH probes, pH impedance probes, colonoscopy or flexible sigmoidoscopy at their previous endoscopy were excluded from this calculation (n=12). The University of Colorado Institutional Review Board (COMIRB-13-2721) approved all study procedures.
Data was recorded into a Red-Cap Secure Database. It is reported as a qualitative measure as noted with average, mean and standard deviation (SD) Surface area analysis to assure adequate specimen size was performed using a student's paired, non-parametric, t-test. Charge analysis was performed using unpaired t-test.
Of 22 subjects referred for endoscopy, 22 were contacted and 21 subjects (95.5%) enrolled in this study. One female subject chose not to participate because of “sensory issues.” Clinical features of these 21 subjects are shown in Table 1. The average age was 13.04 yrs (+\−2.7 yrs. SD, range from 8-17 years) Subject numbers 1, and 13-21 underwent TNE using the 4 mm endoscope and were aged ranging from 8-16 years. Subject numbers 2-12 underwent TNE using the 2.8 mm endoscope and were aged ranging from 10-17 years. The average number of endoscopies previously performed on the subject cohort was 2.19 (SI)+/−1.12) All subjects tolerated TNE with no significant adverse events. Duration of TNE procedures decreased as the endoscopists (JF, ED, JP, RD) became more experienced with TNE. (Table 2). The youngest child was eight years old and was able to tolerate the 4 mm endoscope without difficulty. Symptoms associated with the TNE included gagging and sore throat (Table 3). No adverse event was associated with any emergency department evaluation or unintended evaluation or treatment. One subject had a panic attack prior to the procedure but was still able to complete the TNE without any additional medication. She had a previous history of an anxiety disorder.
Post-procedure assessment revealed a high degree of satisfaction and comfort with the TNE immediately after and at subsequent survey. mGHAA-9 satisfaction instrument average score was 43.19+/−2.6 n=21; maximum 45. A high percentage of subjects reported satisfaction with TNE, child subjects (81%) and parents (90.5%). This is as compared to 81% of combined parent/child subjects satisfied with their previous sedated EGD when asked about it at time of TNE survey. Subjects expressed greater concerns for EGD than TNE on qualitative instrument (61.9% vs. 28.6%, respectively). The majority of children (76.2%) said they would repeat TNE and 100% of parental subjects were willing to have their child undergo the procedure again More than half of the child subjects (52.4%) preferred TNE, with four subjects not preferring either TNE or sedated EGD, while 85.7% of parental subjects preferred TNE for their child. (Table 4). Reasons for parental preference of TNE included. no anesthesia (61.9%) faster procedure and recovery (52.3%), parental presence during the procedure (28.5%), and lower cost (19%).
Visual TNE findings revealed 11 subjects with normal esophagoscopy, nine with furrowing and one with furrowing and exudates Visual findings correlated to the appropriate histologic findings in 85.7% of subjects. In those subjects where visual and histological findings did not correlate, two subjects with visual furrowing had normal biopsies, and one with normal appearing mucosa showed histological evidence of eosinophilia <15 eos hpf (Image 1, Table 5).
Biopsy specimens revealed 12 normal biopsies, four with less than 15 eosinophils per hpf, and five with greater than 15 eosinophils per hpf. (Table 5, Image 1) No significant difference was identified when comparing total epithelial surface area of TNE biopsies to the biopsy surface area of the matched subject's previous EGD. (Table 5) One subject who was initially evaluated at an outside institution did not have his previous biopsies available for analysis. Total epithelial surface area of mucosal biopsies samples from TNE forceps compared to those obtained with standard endoscopic forceps was not statistically different. (0.33 mm2+/−0.09 vs. 0.38 mm+/−0.14 mm, p=0.308; n=11; TNE 1.2 mm forceps vs. EGD 2.8 mm forceps+/−SD 0.50 mm2+/−0.15 vs. 0.52 min2+/−0.19, p=0.496, n=9; TNE 2 mm forceps vs. EGD 2.8 mm forceps+/−SD) Although there appears to be a surface area difference between the two 2.8 mm control groups (0.38 mm2 and 0.52 mm2), sub-analysis revealed no significant difference was present using unpaired, non-parametric t-test. (p>0.05).
Of the 21 subjects who underwent TNE, II had charge data that was comparable and available for analysis. Charges for TNE were calculated to be 60.1% less than sedated EGD with biopsies, including anesthesia, pathology, facility fees and physician fees.
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Having thus described in detail preferred embodiments of the present invention, it is to be understood that the invention defined by the above paragraphs is not to be limited to particular details set forth in the above description, as many apparent variations thereof are possible without departing from the spirit or scope of the present invention.
This application claims priority to U.S. patent application Ser. No. 16/573,567, filed Sep. 17, 2019, which claims priority to U.S. Provisional Application No. 62/732,272, filed Sep. 17, 2018. U.S. patent application Ser. No. 16/573,567 is also a continuation-in-part application of U.S. application Ser. No. 15/853,521, filed Dec. 22, 2017, which claims benefit to and is a continuation-in-part of International Patent Application Serial No. PCT/US16/39352, filed Jun. 24, 2016, which published as PCT Publication No. WO 2016/210322 on Dec. 29, 2016, which claims benefit of U.S. Provisional Application No. 62/184,077, filed on Jun. 24, 2015. U.S. application Ser. No. 15/853,521 is also a continuation-in-part of U.S. application Ser. No. 15/850,939, filed Dec. 21, 2017. The foregoing applications, and all documents cited therein or during their prosecution (“appl'n cited documents”) and all documents cited or referenced in the appl'n cited documents, and all documents cited or referenced herein (“herein cited documents”), and all documents cited or referenced in herein cited documents, together with any manufacturer's instructions, descriptions, product specifications, and product sheets for any products mentioned herein or in any document incorporated by reference herein, are hereby incorporated herein by reference, and may be employed in the practice of the invention. More specifically, all referenced documents are incorporated by reference to the same extent as if each individual document was specifically and individually indicated to be incorporated by reference.
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|---|---|---|---|
| 62732272 | Sep 2018 | US | |
| 62184077 | Jun 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16573567 | Sep 2019 | US |
| Child | 17740883 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15853521 | Dec 2017 | US |
| Child | 16573567 | US | |
| Parent | 15850939 | Dec 2017 | US |
| Child | 15853521 | US | |
| Parent | PCT/US16/39352 | Jun 2016 | US |
| Child | 15850939 | US |
