Unsedated diagnostic transpacifier endoscopy for neonates and infants

Abstract

A modified pacifier configured to allow an endoscope to pass therethrough is provided. The pacifier includes a nipple member configured to extend into an oral cavity of a patient. The nipple member is hollow and has an outlet at a distal end thereof, wherein the outlet has an inner diameter between 3.0 and 5.0 mm. The pacifier further includes a shield member attached to the nipple member and configured to remain outside of the oral cavity of the patient. The shield member has an inlet in fluid communication with the outlet of the nipple member. The endoscope is configured to pass through the pacifier and into the patient by entering the inlet of the shield member and exiting the outlet of the nipple member.

Description

UNSEDATED DIAGNOSTIC TRANSPACIFIER ENDOSCOPY FOR NEONATES AND INFANTSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application is related to and claims the benefit of priority of U.S. Provisional Application 63 / 642,862, filed on May 5, 2024, the entire contents of which is incorporated by reference.FIELD OF THE INVENTION

[0002] Embodiments relate to an apparatus for an endoscopy procedure and methods of use thereof, and particularly to a modified pacifier configured to allow an endoscope to pass therethrough.BACKGROUND OF THE INVENTION

[0003] Newborns and infants may require esophagogastroduodenoscopy (EGD) for the diagnosis and treatment of a variety of disorders of the upper gastrointestinal tract. For the youngest of children, a standard EGD necessitates general anesthesia and the use of an operating room. Performing an EGD under general anesthesia increases the cost and total duration of the procedure. For example, an anesthesiologist is required to sedate a patient who must then spend time in the recovery room after the procedure is completed, incurring healthcare expenses beyond those of the EGD itself.

[0004] Additionally, evidence from animal and human studies suggests that anesthetics and sedatives may have deleterious effects on the brain during the first year of life, arguably the most critical period of nervous system development. In particular, general anesthesia has been implicated in neuroapoptosis (nerve death) and a disordered balance between excitatory and inhibitory synapse formation (connections between nerve cells). Such alterations in neuronal activity and the synaptic "wiring" of the brain that occur very early in life have been associated with undesirable cognitive and behavioral consequences later in life. Thus, approaches to EGD that can avoid general anesthesia (i.e., unsedated procedures) in infants and children are desirable.

[0005] An endoscope's diameter and site of entry into the oropharynx are decisive factors in determining whether an unsedated procedure is feasible. A thinner endoscope diameter (e.g., less than 6 mm) that can be passed through a patient's nose has been successfully used in children as young as five years of age without anesthesia. Unsedated transnasal endoscopy (TNE) has proven to be a safe and effective technique for monitoring disease progression or remission in children with eosinophilic esophagitis. However, the endoscope diameter remains too large for younger children given the diameter of their nasal passages.

[0006] Moreover, nasopharyngeal bronchoscopy using an ultrathin endoscope is a technique widely applied for evaluation by otolaryngologists. The endoscope's diameter,however, is more than half the diameter of the average neonate's or infant's nostril. In addition, children under five years of age are unlikely to remain still enough for the transnasal procedure to be performed, regardless of the endoscope's diameter.

[0007] As such, there remains a need for an improved endoscopy apparatus for use with neonates and infants in terms of cost control, enhanced performance, reduced procedure time, ease of use, and / or reduced risk profile by avoiding anesthesia.SUMMARY OF THE INVENTION

[0008] It has been found that an unsedated transpacifier endoscopy (TPE) may provide a tolerable, unsedated endoscopy procedure for neonates and infants. Using a modified pacifier that allows for the passage of an endoscope through the patient's mouth, it is possible to view and obtain standard tissue samples from the upper gastrointestinal tract surface of newborns and infants while they suck on the pacifier. The modified pacifier and the TPE procedure allow for reduced procedure time, lower staff and facility costs, and a decreased potential risk of negative neurological sequelae resulting from general anesthesia administered during the first year of life.

[0009] In exemplary embodiments, a pacifier includes a nipple member insertable into an oral cavity of a patient, wherein the nipple member is hollow and has an outlet at a distal end thereof, the outlet having an inner diameter between 3.0 and 5.0 mm. The pacifier further includes a shield member attached to the nipple member and configured to remain outside of the oral cavity, wherein the shield member has an inlet in fluid communication with the outlet of the nipple member, wherein the inlet has an inner diameter greater than or equal to the inner diameter of the outlet.

[0010] In some embodiments, the inner diameter is between 3.0 and 4.0 mm.

[0011] In some embodiments, the inner diameter is between 3.0 and 3.5 mm.

[0012] In some embodiments, the pacifier further includes a first flange protruding from a first side edge of the shield member, and a second flange protruding from a second side edge of the shield member, wherein the first side edge is opposite of the second side edge.

[0013] In some embodiments, the pacifier further includes a strap attached to the first flange and the second flange, wherein the strap is configured to pass around the patient to hold the pacifier in place.

[0014] In some embodiments, the inlet of the shield member and the outlet of the nipple member are configured to receive an endoscope passing through the pacifier and into the patient.

[0015] In some embodiments, the shield member has a concave back surface facing towards the nipple member and a convex front surface facing away from the nipple member.

[0016] In some embodiments, the pacifier is molded from a material including silicone.

[0017] In some embodiments, at least a portion of the nipple member further includes a medicament.

[0018] In exemplary embodiments, an apparatus for an endoscopy procedure includes an endoscope and a pacifier. The pacifier includes a nipple member configured to extend into an oral cavity of a patient, wherein the nipple member is hollow and has an outlet at a distal end thereof, the outlet having an inner diameter between 3.0 and 5.0 mm. The pacifier further includes a shield member attached to the nipple member and configured to remain outside of the oral cavity, wherein the shield member has an inlet in fluid communication with the outlet of the nipple member, wherein the inlet has an inner diameter greater than or equal to the inner diameter of the outlet. The endoscope is configured to pass through the pacifier and into the patient by entering the inlet of the shield member and exiting the outlet of the nipple member.

[0019] In some embodiments, the endoscope is movable within the pacifier.

[0020] In exemplary embodiments, a method for performing an endoscopy procedure includes inserting a pacifier into an oral cavity of a patient. The pacifier includes a nipple member configured to extend into the oral cavity of the patient, wherein the nipple member is hollow and has an outlet at a distal end thereof, the outlet having an inner diameter between 3.0 and 5.0 mm. The pacifier further includes a shield member attached to the nipple member and configured to remain outside of the oral cavity, wherein the shield member has an inlet in fluid communication with the outlet of the nipple member, wherein the inlet has an inner diameter greater than or equal to the inner diameter of the outlet. The method further includes passing an endoscope through the pacifier and into the patient by feeding the endoscope into the inlet of the shield member and through the outlet of the nipple member.

[0021] In some embodiments, the pacifier further includes a first flange protruding from a first side edge of the shield member, a second flange protruding from a second side edge of the shield member, wherein the first side edge is opposite of the second side edge, and a strap attached to the first flange and the second flange. In such embodiments, the method further includes passing the strap around the patient to hold the pacifier in place during the endoscopy procedure.

[0022] In some embodiments, the method further includes coating at least a portion of the nipple member with a medicament prior to inserting the pacifier into the oral cavity of the patient.

[0023] In some embodiments, the patient is not sedated by anesthesia.

[0024] Other details, objects, and advantages of our process for screening, detecting, and treating infectious diseases, apparatuses for screening, detecting, and treating infectious diseases, systems for screening, detecting, and treating, and methods of making and using the same will become apparent as the following description of certain exemplary embodiments thereof proceeds.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The above and other objects, aspects, features, advantages, and possible applications of the present innovation will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings. Like reference numbers used in the drawings may identify like components.

[0026] FIG. 1 shows a first perspective view of an exemplary embodiment of a pacifier.

[0027] FIG. 2 shows a second perspective view of an exemplary embodiment of a pacifier.DETAILED DESCRIPTION OF THE INVENTION

[0028] The following description is of exemplary embodiments and methods of use that are presently contemplated for carrying out the present invention. This description is not to be taken in a limiting sense but is made merely for the purpose of describing the general principles and features of various aspects of the present invention. The scope of the present invention is not limited by this description.

[0029] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this invention belongs. Specific methods, devices, and materials are described, although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention.

[0030] As used herein, the term "neonate" refers to a patient who is four weeks old or younger, and the term "infant" refers to a patient who is between four weeks and one year old. Although embodiments may be described for use with neonates and infants, it is contemplated that embodiments may further be used for patients of any age.

[0031] As used herein, the term "oral cavity" refers to the mouth and upper gastrointestinal (GI) tract of a patient.

[0032] As used herein, the term "clinician" refers to a doctor, nurse, or other care provider and may include support personnel and / or equipment operators.

[0033] As used herein, the term "distal" refers to that portion of structure closer to a patient, while the term "proximal" refers to that portion of structure farther from the patient.

[0034] Certain embodiments relate to an apparatus including an endoscope and a pacifier configured to allow the endoscope to pass therethrough and into a patient (e.g., into the mouth and upper GI tract of a patient). The apparatus described herein may be particularly advantageous when a clinician inserts the pacifier into the oral cavity of neonate and infant patients during an endoscopic diagnostic or surgical procedure, as the apparatus enables viewing and obtaining tissue samples from the upper GI tract surface of the patients via the endoscope as they suck on the pacifier.

[0035] Referring to FIGS. 1-2, a pacifier 10 includes a nipple member 12 and a shield member 14 attached to the nipple member 12. The nipple member 12 is an elongated member such that it may be at least partially inserted into an oral cavity of a patient. The nipple member 12 may be a generally tubular shape, though the shape of the nipple member 12 is not particularly limited. It is contemplated that the nipple member 12 may be any size or shape that complements one or more of the patient's oral cavity, tongue, and / or palate. It is further contemplated that the size of the nipple member 12 may additionally vary in accordance with the patient's age.

[0036] The nipple member 12 is a hollow member and includes an outlet 16 at its distal end 18. The proximal end 20 of the nipple member 12 may include a bite portion 22. The bite portion 22 may be curved or rounded in cross section, and may be configured to engage the patient's lips, gums, and / or teeth. One of ordinary skill in the art would understand that bite portion 22 may be characterized by other geometries (e.g., angular).

[0037] The shield member 14 is attached to the proximal end 20 of the nipple member 12 and is positioned generally perpendicular to a longitudinal axis of the nipple member 12. The shield member 14 extends radially outward from the nipple member 12, though the shape of the shield member 14 is not particularly limited. The shield member 14 has a sufficient radius such that at least a portion of the shield member 14 remains outside of the oral cavity of the patient when in use, thereby preventing the patient from choking or swallowing the pacifier 10. The shield member 14 has a front surface 24 facing away from the nipple member 12 and an opposite rear surface 26 facing towards the nipple member 12. In preferred embodiments, the front surface 24 has a convex shape and the rear surface 26 has a corresponding concave shape, such that the shield member 14 may accommodate the contour of the patient's face andmouth area. These shapes may further support the insertion of an endoscope 32 into and through the pacifier 10.

[0038] The shield member 14 includes an inlet 28 positioned on its front surface 24 and extending through the rear surface 26, such that the inlet 28 may be, in operation, in fluid communication with the hollow nipple member 12 and the outlet 16. For example, the hollow nipple member 12, the outlet 16, and the inlet 28 may work in conjunction to form a conduit 30 such that an endoscope 32 may freely travel through the pacifier 10 and into the oral cavity of the patient via outlet 16. In preferred embodiments, the outlet 16 has an inner diameter between 3.0 and 5.0 mm.

[0039] As nonlimiting examples, the inner diameter of the outlet 16 may be at least 3.0 mm, at least 3.1 mm, at least 3.2 mm, at least 3.3 mm, at least 3.4 mm, at least 3.5 mm, at least 4.0 mm, at least 4.5 mm, at least 4.6 mm, at least 4.7 mm, at least 4.8 mm, at least 4.9 mm, and / or the like. As further nonlimiting examples, the inner diameter of the outlet 16 may be no greater than 5.0 mm, no greater than 4.9 mm, no greater than 4.8 mm, no greater than 4.7 mm, no greater than 4.6 mm, no greater than 4.5 mm, no greater than 4.0 mm, no greater than 3.5 mm, no greater than 3.4 mm, no greater than 3.3 mm, no greater than 3.2 mm, no greater than 3.1 mm, and / or the like.

[0040] The inner diameter may accommodate an advantageously thin outer diameter of an endoscope 32 that may be tolerable for neonate and infant patients. While the inlet 28 has an inner diameter that is not particularly limited, it is contemplated in certain embodiments that its inner diameter is greater than or equal to the inner diameter of the outlet 16.

[0041] The endoscope 32 is a type of endoscope that enables clinicians to carry out a variety of diagnostic and surgical procedures. The endoscope 32 may be a flexible or rigid tube including a fiberoptic bundle end or video camera located at its distal end. A clinician may control the endoscope 32 at or near its proximal end to position the distal end in a desired position within the patient's upper GI tract. In preferred embodiments, the endoscope 32 is therefore movable within the pacifier 10 such that the endoscope 32 may slide back and forth (e.g., into and out of the oral cavity of the patient at various depths). The endoscope 32 may be used in conjunction with biopsy tools to obtain tissue samples from the upper GI tract surface of the patient.

[0042] The shield member 14 may first include a first flange 34 protruding from a first side edge of the shield member 14 and a second flange 36 protruding from a second side edge of the shield member 14, such that a strap 38 may be removably connected to the first and second flanges 34, 36. After being connected to the flanges 34, 36, thestrap 38 is configured to pass around the patient's head or neck area. Accordingly, the pacifier 10 may be maintained in a proper position inside of the patient's oral cavity when the apparatus is in use and the endoscope 32 is being moved. As seen in FIGS. 1-2, the flanges 34, 36 may be "T" shaped such that a first end of the strap 38 may be wrapped around the stem of the first "T" shaped flange and a second end of the strap 38 may be wrapped around the stem of the second ’T" shaped flange.

[0043] The nipple member 12 and the shield member 14 may be formed as separate pieces of construction and attached together (e.g., via welding, non-toxic adhesive, or any other suitable attachment means) to form the pacifier 10. In preferred embodiments, the nipple member 12 and the shield member 14 are formed as a one- piece construction (e.g., by injection molding or 3D printing). The nipple member 12 and the shield member 14 may be formed from the same or different materials. In a preferred embodiment, the nipple member 12 and the shield member 14 are formed from a resilient elastomeric material such that the pacifier 10 may be durable yet nondamaging to the patient. For example, the nipple member 12 and the shield member 14 are formed from a material including silicone, though the material is not particular limited to this example. The nipple member 12 and the shield member 14 may be formed using any suitable method, including molding, 3D printing, etc.

[0044] The pacifier 10 may be constructed to be disposable (e.g., one-time-use). Alternatively, the pacifier 10 may be constructed to be reusable, for example after cleaning and / or disinfecting.

[0045] In some embodiments, at least a portion of the nipple member 12 is provided with a medicament prior to being inserted into a patient's oral cavity. The medicament may be a pain-relieving substance. For example, a solution of sucrose and water has been demonstrated to be a safe and effective mild pain-relieving substance for neonate and infant patients, and such solution may be provided on the at least a portion of the nipple member 12.

[0046] In some embodiments, at least a portion of the nipple member 12 is provided with a flavored solution prior to being inserted into a patient's oral cavity. The flavored solution may advantageously patients to accept and suck on the pacifier 10 during a procedure.

[0047] As described above, the apparatus is configured to perform endoscopic procedures. The apparatus is specifically configured to perform endoscopic procedures without the need for anesthesia (e.g., unsedated procedures) due to the thin diameter of the endoscope 32 necessitated by the small diameter of the outlet 16 and / or inlet 28. The described apparatus and methods of use may be used with patients who mayotherwise need a standard EG (e.g., failure to thrive, dysphasia, feeding intolerance, etc.).

[0048] In summary, the pacifier 10 as described herein allows for the passage of an endoscope 32 through the patient's mouth and upper GI tract and enables viewing and obtaining tissue samples from patients while they suck on the pacifier. The modified pacifier and corresponding endoscopic procedure allow for reduced procedure time, lower staff and facility costs, and a decreased potential risk of negative neurological sequelae resulting from general anesthesia administered during the first year of life. EXAMPLES

[0049] Studies were performed to evaluate the feasibility of unsedated TPE in infants. Procedural success, biopsy adequacy, patient stability, and parent and clinician attitudes were assessed and compared to standard EGD.

[0050] Infants six months old or younger with intact suck reflex were studied. A 3.1 mm endoscope was passed through the pacifier in accordance with the description. A flavored solution (Sweet-ease®) was provided on the pacifier for analgesia.

[0051] Patient 1

[0052] Two biopsy specimens were collected using the pacifier and the endoscope being passed therethrough. A first esophageal specimen consisted of two fragments of whitetan soft tissue measuring 0.1 x 0.1 x 0.1 cm each. A second gastral specimen consisted of two fragments of pink-tan soft tissue measuring 0.1 x 0.1 x 0.1 cm each.

[0053] Patient 2

[0054] Two biopsy specimens were collected using the pacifier and the endoscope being passed therethrough. A first proximal esophageal specimen consisted of three fragments of white soft tissue measuring 0.1 x 0.1 x 0.1 cm each. A second distal esophageal specimen consisted of two fragments of pink-tan soft tissue measuring 0.1 x 0.1 x 0.1 cm each.

[0055] Patient 3

[0056] Two biopsy specimens were collected using the pacifier and the endoscope being passed therethrough. A first esophageal specimen consisted of three fragments of white soft tissue measuring 0.2 x 0.1 x 0.1 cm and up to 0.4 x 0.2 x 0.1 cm. A second gastral specimen consisted of three fragments of white soft tissue measuring 0.3 x 0.2 x 0.1 cm each.

[0057] Patient 4

[0058] Two biopsy specimens were collected using the pacifier and the endoscope being passed therethrough. A first esophageal specimen consisted of two fragments of whitesoft tissue measuring 0.2 x 0.1 x 0.1 cm each. A second gastral specimen consisted of one fragment of white soft tissue measuring 0.2 x 0.1 x 0.1 cm.

[0059] Patient 5

[0060] Three biopsy specimens were collected using the pacifier and the endoscope being passed therethrough. A first esophageal specimen consisted of two fragments of pink-tan soft tissue measuring 0.1 x 0.1 x 0.1 cm each. A second gastric specimen consisted of two fragments of pink-tan soft tissue measuring 0.1 x 0.1 x 0.1 cm each. A third rectal specimen consisted of two fragments of pink-tan soft tissue measuring 0.3 x 0.2 x 0.2 cm each.

[0061] Results

[0062] In each case, unsedated TPE was successfully performed in each patient using the pacifier. All patients remained hemodynamically stable with no significant fluctuations in vital signs. There were no desaturations recorded during the unsedated TPE and the collected biopsy specimens were adequate for further pathology analysis.

[0063] Surveyed Gastroenterologists at the Children's Hospital of Philadelphia (n=24) had a high interest in utilizing TPE and learning how to conduct TPEs (79%) in the future. Additionally, over 85% of survey respondents agreed that "being able to perform endoscopy on infants outside of the operating room is a major advantage."

[0064] A parent survey was administered after the TPE procedure with a 5 point Likert scale (l=strongly disagree to 5=strongly agree). All five parents responded with 'strongly agree' to the following statements: "I understand the benefits of doing the endoscopy without anesthesia" and "I am glad that my child had the endoscopy through the pacifier". Four of the five parents responded with 'strongly agree' to the statement: "If my child must have this procedure again, I prefer that it be done this way." Overall, the parent surveys showed acceptability.

[0065] Ultimately, findings indicate that unsedated TPE using the pacifier is a promising, safe, anesthesia-free alternative for neonatal and infant EGD. Results demonstrate procedural success, patient safety, and positive acceptance among medial staff and families.

[0066] It should be understood that modifications to the embodiments disclosed herein can be made to meet a particular set of design criteria. For instance, the number of or configuration of components or parameters may be used to meet a particular objective.

[0067] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternative embodiments may includesome or all the features of the various embodiments disclosed herein. For instance, it is contemplated that a particular feature described, either individually or as part of an embodiment, can be combined with other individually described features, or parts of other embodiments. The elements and acts of the various embodiments described herein can therefore be combined to provide further embodiments.

[0068] It is the intent to cover all such modifications and alternative embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points. Thus, while certain exemplary embodiments of the device and methods of making and using the same have been discussed and illustrated herein, it is to be distinctly understood that the invention is not limited thereto but may be otherwise variously embodied and practiced within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A pacifier, comprising : a nipple member configured to be inserted into an oral cavity of a patient, wherein the nipple member is hollow and has an outlet at a distal end thereof, the outlet having an inner diameter between 3.0 and 5.0 mm; and a shield member attached to the nipple member and configured to remain outside of the oral cavity, wherein the shield member has an inlet in fluid communication with the outlet of the nipple member, wherein the inlet has an inner diameter greater than or equal to the inner diameter of the outlet.

2. The pacifier of claim 1, wherein the inner diameter is between 3.0 and 4.0 mm.

3. The pacifier of claim 1, wherein the inner diameter is between 3.0 and 3.5 mm.

4. The pacifier of claim 1, further comprising : a first flange protruding from a first side edge of the shield member; and a second flange protruding from a second side edge of the shield member, wherein the first side edge is opposite of the second side edge.

5. The pacifier of claim 4, further comprising : a strap attached to the first flange and the second flange, wherein the strap is configured to pass around the patient to hold the pacifier in place.

6. The pacifier of claim 1, wherein the inlet of the shield member and the outlet of the nipple member are configured to receive an endoscope passing through the pacifier and into the patient.

7. The pacifier of claim 1, wherein the shield member has a concave back surface facing towards the nipple member and a convex front surface facing away from the nipple member.

8. The pacifier of claim 1, wherein the pacifier is molded from a material comprising silicone.

9. The pacifier of claim 1, wherein at least a portion of the nipple member further comprises a medicament.

10. An apparatus for an endoscopy procedure, the apparatus comprising: an endoscope; and a pacifier, the pacifier comprising : a nipple member configured to extend into an oral cavity of a patient, wherein the nipple member is hollow and has an outlet at a distal end thereof, the outlet having an inner diameter between 3.0 and 5.0 mm; a shield member attached to the nipple member and configured to remain outside of the oral cavity, wherein the shield member has an inlet in fluid communication with the outlet of the nipple member, wherein the inlet has an inner diameter greater than or equal to the inner diameter of the outlet, wherein the endoscope is configured to pass through the pacifier and into the patient by entering the inlet of the shield member and exiting the outlet of the nipple member.

11. The apparatus of claim 10, wherein the endoscope is movable within the pacifier.

12. A method for performing an endoscopy procedure, the method comprising : inserting a pacifier into an oral cavity of a patient, the pacifier comprising : a nipple member configured to extend into the oral cavity of the patient, wherein the nipple member is hollow and has an outlet at a distal end thereof, the outlet having an inner diameter between 3.0 and 5.0 mm, and a shield member attached to the nipple member and configured to remain outside of the oral cavity, wherein the shield member has an inlet in fluid communication with the outlet of the nipple member, wherein the inlet has an inner diameter greater than or equal to the inner diameter of the outlet; and passing an endoscope through the pacifier and into the patient by feeding the endoscope into the inlet of the shield member and through the outlet of the nipple member, wherein the patient is not sedated by anesthesia.

13. The method of claim 12, wherein the pacifier further comprises: a first flange protruding from a first side edge of the shield member, a second flange protruding from a second side edge of the shield member, wherein the first side edge is opposite of the second side edge, and a strap attached to the first flange and the second flange, the method further comprising :passing the strap around the patient to hold the pacifier in place during the endoscopy procedure.

14. The method of claim 12, further comprising : coating at least a portion of the nipple member with a medicament prior to inserting the pacifier into the oral cavity of the patient.

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