阅读说明：本技术 用于监测儿科结肠运动性的方法 (Method for monitoring pediatric colonic motility ) 是由 弗兰克三世·冈萨卢斯 于 2020-04-06 设计创作，主要内容包括：实施方式涉及一种用于监测儿科结肠运动性的方法,具有以下步骤：向儿科患者施用可摄入且可溶解的胶囊,其中所述胶囊含有多个不透射线标志物；和对所述儿科患者进行射线照相,以识别所述多个不透射线标志物中的至少一个在所述儿科患者结肠内的位置。(Embodiments relate to a method for monitoring pediatric colonic motility having the steps of: administering to a pediatric patient an ingestible and dissolvable capsule, wherein the capsule contains a plurality of radiopaque markers; and radiographing the pediatric patient to identify a location of at least one of the plurality of radiopaque markers within the colon of the pediatric patient.)

1. A method for monitoring pediatric colonic motility, comprising:

administering to a pediatric patient an ingestible and dissolvable capsule, wherein the capsule contains a plurality of radiopaque markers; and

radiographing the pediatric patient to identify a location of at least one of the plurality of radiopaque markers within the colon of the pediatric patient.

2. The method of claim 1, wherein the radiograph is taken less than six days after the pediatric patient ingests the ingestible capsule.

3. The method of claim 1, wherein the radiographing is performed three days after the pediatric patient ingests the ingestible capsule.

4. The method of claim 1, wherein the ingestible capsule contains at least 10 radiopaque markers.

5. The method of claim 1, wherein the ingestible capsule contains at least 15 radiopaque markers.

6. The method of claim 1, wherein the ingestible capsule contains at least 20 radiopaque markers.

7. The method of claim 1, wherein the ingestible capsule contains 24 radiopaque markers.

8. The method of claim 1, wherein all of the radiopaque markers have a substantially circular peripheral shape.

9. The method of claim 1, wherein the radiopaque markers have at least two different shapes: a first type of marker having a substantially circular outer peripheral shape and having a first internal configuration, and a second type of marker having a substantially circular outer peripheral shape and having a second internal configuration.

10. The method of claim 1, wherein the radiopaque markers have at least three different shapes: a first type of marker having a substantially circular outer peripheral shape and having a first internal configuration; a second marker having a substantially circular outer peripheral shape and having a second internal configuration, and a third marker having a substantially circular outer peripheral shape and having a third internal configuration.

11. The method of claim 1, wherein the pediatric patient has an age of 2 to 17 years.

12. The method of claim 1, wherein the pediatric patient has an age of 2 to 14 years.

13. The method of claim 1, wherein the pediatric patient has an age of 2 to 8 years.

14. The method of claim 1, wherein all of the radiopaque markers have a substantially circular peripheral shape and a diameter of less than 0.180 inches.

15. The method of claim 1, wherein the radiograph is an X-ray.

16. A method for monitoring pediatric colonic motility, comprising:

administering to a pediatric patient in the age range of 2 to 17 years an ingestible and dissolvable capsule, wherein the capsule contains a plurality of radiopaque markers; and

radiographing the pediatric patient to identify a location of at least one of the plurality of radiopaque markers within the colon of the pediatric patient;

wherein the radiographs are taken less than six days after the pediatric patient ingests the ingestible capsule,

wherein the ingestible capsule contains at least 5 radiopaque markers,

wherein the radiopaque marker has at least three different shapes: a first type of marker having a substantially circular outer peripheral shape and having a first internal configuration; a second marker having a substantially circular outer peripheral shape and having a second internal configuration, and a third marker having a substantially circular outer peripheral shape and having a third internal configuration, and

wherein all of the radiopaque markers have a substantially circular peripheral shape and a diameter of less than 0.180 inches.

17. A method for monitoring pediatric colonic motility, comprising:

administering to a pediatric patient in the age range of 2 to 17 years an ingestible and dissolvable capsule, wherein the capsule contains 24 radiopaque markers; and

radiographing the pediatric patient to identify a location of at least one of the plurality of radiopaque markers within the colon of the pediatric patient;

wherein the radiographs are taken less than six days after the pediatric patient ingests the ingestible capsule,

wherein the ingestible capsule contains at least 5 radiopaque markers,

wherein the radiopaque marker has at least three different shapes: a first type of marker having a substantially circular outer peripheral shape and having a first internal configuration; a second marker having a substantially circular outer peripheral shape and having a second internal configuration, and a third marker having a substantially circular outer peripheral shape and having a third internal configuration, and

wherein all of the radiopaque markers have a substantially circular peripheral shape and a diameter of less than 0.180 inches.

Background

While methods of monitoring colon motility in adults are known, government regulations have previously placed limits on methods of monitoring pediatric colon motility. Thus, there remains a need for methods for monitoring pediatric colonic motility.

Disclosure of Invention

Embodiments relate to a method for monitoring pediatric colonic motility (pediatric colonic motility) having the steps of: administering (dosing) an ingestible and dissolvable capsule to a pediatric patient, wherein the capsule comprises a plurality of radiopaque markers; and radiographing the pediatric patient to identify a location of at least one of the plurality of radiopaque markers within the colon of the pediatric patient.

Embodiments relate to a method for monitoring pediatric colonic motility having the steps of: administering to a pediatric patient in the age range of 2 to 17 years an ingestible and dissolvable capsule, wherein the capsule contains a plurality of radiopaque markers; and radiographing the pediatric patient to identify a location of at least one of the plurality of radiopaque markers within the colon of the pediatric patient; wherein the radiographs are taken less than six days after ingestion of the ingestible capsule by the pediatric patient, wherein the ingestible capsule contains at least 5 radiopaque markers, wherein radiopaque markers having at least three different shapes: a first type of marker having a substantially circular peripheral shape (perimeter shape) and having a first internal configuration; a second marker having a substantially circular peripheral shape and having a second interior configuration, and a third marker having a substantially circular peripheral shape and having a third interior configuration, and wherein all of the radiopaque markers have a substantially circular peripheral shape and a diameter of less than 0.180 inches.

Embodiments relate to a method for monitoring pediatric colonic motility having the steps of: administering to a pediatric patient in the age range of 2 to 17 years an ingestible and dissolvable capsule, wherein the capsule contains 24 radiopaque markers; and radiographing the pediatric patient to identify a location of at least one of the plurality of radiopaque markers within the colon of the pediatric patient; wherein the radiographs are taken less than six days after ingestion of the ingestible capsule by the pediatric patient, wherein the ingestible capsule contains at least 5 radiopaque markers, wherein radiopaque markers having at least three different shapes: a first type of marker having a substantially circular outer peripheral shape and having a first internal configuration; a second marker having a substantially circular peripheral shape and having a second interior configuration, and a third marker having a substantially circular peripheral shape and having a third interior configuration, and wherein all of the radiopaque markers have a substantially circular peripheral shape and a diameter of less than 0.180 inches.

Drawings

Figure 1 shows two-dimensional views of three separate embodiments of useful radiopaque markers.

Fig. 2A shows an embodiment of an ingestible and dissolvable capsule filled with a plurality of radiopaque markers.

Fig. 2B shows an embodiment of an ingestible and dissolvable capsule filled with a plurality of radiopaque markers.

Fig. 2C shows an embodiment of an ingestible and dissolvable capsule filled with a plurality of radiopaque markers.

Figure 3A shows an embodiment of a radiograph showing a radiopaque marker in the colon of a pediatric patient.

Figure 3B shows an embodiment of a radiograph showing a radiopaque marker in the colon of a pediatric patient.

Detailed Description

Embodiments related to monitoring pediatric colonic motility are provided. Embodiments generally include administering an ingestible and dissolvable capsule 10 to a pediatric patient, wherein the capsule 10 contains a plurality of radiopaque markers 20. The pediatric patient then ingests the capsule 10, and the capsule 10 subsequently dissolves in the pediatric patient, thereby releasing the plurality of radiopaque markers 20 into the digestive tract, and more particularly into the colon 42, of the pediatric patient. After the radiopaque marker 20 is released from the capsule 10 (and into the alimentary tract of the pediatric patient), a radiograph 30 is then taken of a region of the colon of the pediatric patient to identify a location 50 of at least one of the plurality of radiopaque markers 20 within the colon 42 of the pediatric patient. The time at which the radiographies 30 are taken in conjunction with the location 50 of at least one of the radiopaque markers 20 relative to the capsule intake time may help determine the colon movement rate of a pediatric patient from a distance-per-time calculation. Any number of radiographs 30 may be taken of a colon region of a pediatric patient as needed to monitor the location 50 and the rate at which the radiopaque marker 20 moves through the colon 42 of the pediatric patient. The radiograph 30 is a useful type of radiograph 30 that can be used to monitor the location 50 of the radiopaque marker 20 within the colon 42 of a pediatric patient.

As described above, and to monitor pediatric colonic motility, these pediatric embodiments use ingestible and dissolvable capsules 10 filled with a plurality of radiopaque markers 20. These types of ingestible and dissolvable capsules 10 filled with radiopaque markers 20 are known to be useful for adult colonic motility applications, but cannot be used for pediatric patient applications due to the previous lack of U.S. government approval for use in a pediatric environment. As a non-limiting example of useful and commercially available products that can be used in these pediatric colonic motility embodiments, Konsyl Pharmaceuticals previously and currently marketed for adult colonic motility applicationsAnd (5) producing the product.The product is an ingestible and dissolvable capsule 10 having a plurality of radiopaque markers 20 therein;the product has previously been used in adult patients to monitor adult colon motility and can now be used in pediatric patients to monitor pediatric colon motility.

As a useAlternative to the product, one of ordinary skill in the art can manufacture useful capsules 10 filled with radiopaque markers 20 without undue experimentation. In making the ingestible and dissolvable capsule 10, any commercially available capsule 10 may be used to contain the radiopaque marker 20. Ingestible and dissolvable capsules 10 are commonly used to transport and deliver a variety of medicaments and drugs to a patient, and one of ordinary skill in the art can select a useful capsule 10 from those known capsules 10 without undue experimentation. By way of non-limiting example, pharmaceutical grade vegetable gelatin can be used to make useful capsules 10, and is known and commercially available. Pharmaceutical grade vegetable gelatin and capsules 10 made therefrom are currently availableAnd (4) obtaining.

Radiopaque markers 20 of useful shapes are known, and any of them may be used in embodiments involving monitoring pediatric colonic motility. By way of non-limiting example, and as shown, useful peripheral shapes 22 of the radiopaque markers 20 include closed-loop circular or substantially circular peripheral shapes. In embodiments having radiopaque markers 20 with a closed-loop, substantially annular periphery, various internal configurations within the substantially annular periphery may also be used to distinguish some radiopaque markers 20 from others. As shown, the internal configurations include bar-less (bar), single bar, and multi-bar configurations. Fig. 1A shows a useful radiopaque marker shape that is circular, annular and has an open-space interior configuration; in one embodiment, this is a first marker 24 having a substantially circular outer perimeter shape and having a first open-space interior configuration. Fig. 1B shows a useful radiopaque marker shape that is circular, annular and has a single internal strip configuration; in one embodiment, this is a second marker 26 having a substantially circular outer perimeter shape and a second internal configuration. FIG. 1C shows a useful radiopaque marker shape that is circular, annular and has a plurality of internal strip-shaped configurations; in one embodiment, this is a third marker 28, which is substantially circular in its outer peripheral shape and has a third internal configuration. Any of the radiopaque marker shapes shown in fig. 1A, 1B or 1C may be used alone or in combination within the capsule 10. In some embodiments of the figures, the radiopaque marker 20 is intentionally marked with two numerical identifiers; in those embodiments having two numerical identifiers, the numerical identifier "20" indicates that it is a radiopaque marker, and the second numerical identifier, e.g., 24, 26, or 28, indicates a specific type of radiopaque marker, such as i) a first marker 24 having a substantially circular outer peripheral shape and having a first open-space interior configuration, ii) a second marker 26 having a substantially circular outer peripheral shape and having a single interior strip configuration, and iii) a third marker 26 having a substantially circular outer peripheral shape, an annular shape, and having a plurality of interior strip configurations.

Any known useful size of radiopaque markers 20 for adult colon motion rates may be used to monitor pediatric colon motion rates. In one embodiment, a non-limiting list of useful sizes includes a circular or substantially circular peripheral shape 22 having a diameter 29 of less than 0.2 inches, where the diameter 29 is from one peripheral outer edge to the opposite other. In other embodiments, useful dimensions include a circular or substantially circular peripheral shape 22 having a diameter 29 less than or equal to 0.180 inches, wherein the diameter 29 is from one peripheral outer edge to the opposite other. In other embodiments, useful dimensions include a circular or substantially circular peripheral shape 22 having a diameter 29 less than or equal to 0.177 inches, where the diameter 29 is from one peripheral outer edge to the opposite other.

In various embodiments, useful dimensions of the radiopaque markers 20 are those having a maximum measurable linear dimension of less than or equal to 0.2 inches. In other embodiments, useful dimensions of the radiopaque markers 20 are those having a maximum measurable linear dimension of less than or equal to about 0.180 inches. In other embodiments, useful dimensions of the radiopaque markers 20 are those having a maximum measurable linear dimension of less than or equal to about 0.177 inches.

In various embodiments, useful radiopaque markers 20 are substantially disc-shaped. By way of non-limiting example, useful radiopaque markers 20 have a diameter 29 of less than 0.2 inches and a thickness of less than 0.1 inches. In other embodiments, useful radiopaque markers 20 have a diameter 29 of less than 0.2 inches and a thickness of less than 0.08 inches. In other embodiments, useful radiopaque markers 20 have a diameter 29 of less than 0.2 inches and a thickness of less than 0.06 inches.

Any number of radiopaque markers 20 may be included within the ingestible and dissolvable capsule 10. In various embodiments, the ingestible and dissolvable capsule 10 has less than 40 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has less than 35 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has less than 30 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has less than 25 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has less than 20 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has less than 15 radiopaque markers 20 within it.

In various embodiments, the ingestible and dissolvable capsule 10 has at least 5 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has at least 10 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has at least 15 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has at least 20 radiopaque markers 20 within it. In various embodiments, the ingestible and dissolvable capsule 10 has 24 radiopaque markers 20.

In one embodiment, all of the radiopaque markers 20 within the ingestible and dissolvable capsule 10 have substantially the same shape and internal configuration. In one embodiment, at least two radiopaque markers 20 within the ingestible and dissolvable capsule 10 have different shapes, such as different internal configurations. In another embodiment, at least three radiopaque markers 20 within the ingestible and dissolvable capsule 10 have different shapes, such as different internal configurations. In yet another embodiment, at least four radiopaque markers 20 within the ingestible and dissolvable capsule 10 have different shapes, such as different internal configurations.

Any known radiopaque composition, such as one visible on a radiograph 30, can be used to make a useful radiopaque marker 20. In various embodiments, radiopaque markers 20 are manufactured using a composition comprising a polymer and at least one radiopaque filler or radiopaque component. Barium sulfate is one example of a known filler or component that is radiopaque. As a non-limiting example, radiopaque markers 20 may be manufactured using a polyvinyl chloride polymer filled with barium sulfate and further including known stabilizer(s) and known plasticizer(s). Useful and known stabilizers include commercially available calcium zinc organic soaps; useful and known plasticizer stabilizers include epoxidized soybean oil; and useful and known plasticizers include di-2-ethylhexyl phthalate. Useful amounts of polymers, fillers, stabilizers, and plasticizers can be determined by one of ordinary skill in the art without undue experimentation.

Embodiments relate to monitoring pediatric colonic motility in pediatric patients between 2 and 17 years of age. Some embodiments relate to monitoring pediatric colonic motility in a pediatric patient between 2 and 14 years of age. Some embodiments relate to monitoring pediatric colonic motility in a pediatric patient aged 2 to 8 years.

In various embodiments, one or more radiographs 30 are taken of a pediatric patient after the pediatric patient has ingested an ingestible and dissolvable capsule 10 filled with a plurality of radiopaque markers 20; the radiographs 30 are performed to identify the location 50 of one or more of the plurality of radiopaque markers 20 in the colon 42 or alimentary tract of a pediatric patient. The radiographing 30 is performed at any time after the pediatric patient has ingested an ingestible and dissolvable capsule 10 filled with a plurality of radiopaque markers 20. In one embodiment, the radiographing 30 is performed one day after ingestion. In one embodiment, the radiographs 30 are taken two days after ingestion. In one embodiment, the radiograph 30 is taken three days after ingestion. In one embodiment, the radiographs 30 are taken four days after ingestion. In one embodiment, the radiograph 30 is taken five days after ingestion. In one embodiment, the radiograph 30 is taken six days after ingestion. In one embodiment, the radiograph 30 is taken seven days after ingestion. In one embodiment, the radiographs 30 are taken less than six days after ingestion of the ingestible capsule 10 by a pediatric patient. In one embodiment, the radiographs 30 are taken less than seven days after ingestion of the ingestible capsule 10 by a pediatric patient.

Any known radiograph 30 may be taken of a pediatric patient. As a non-limiting example, X-ray photographs 30 may be used to identify the location 50 of the plurality of radiopaque markers 20 within the colon 42 or alimentary tract of a pediatric patient.

In one embodiment, the Colon Transit Time (CTT) is calculated by taking a radiograph 30 and then determining the distance traveled by one or more radiopaque markers 20 with respect to time; this distance versus time calculation will give the rate of radiopaque movement in the colon 42 of the pediatric patient. In another embodiment, the number of radiopaque markers 20 in the patient after a period of time may be used to calculate the colonic transit time; as a non-limiting example, the number of radiopaque markers 20 in the patient (in combination with the location 50 of the corresponding marker in the pediatric patient) three to seven days after ingestion may be used to determine the colon transit time.