U.S. patent application number 17/317374 was filed with the patent office on 2021-08-26 for devices and methods for providing hydrolyzed lipids.
This patent application is currently assigned to Alcresta Therapeutics, Inc.. The applicant listed for this patent is Alcresta Therapeutics, Inc.. Invention is credited to Eric FIRST, David Widom.
Application Number | 20210259924 17/317374 |
Document ID | / |
Family ID | 1000005579722 |
Filed Date | 2021-08-26 |
United States Patent
Application |
20210259924 |
Kind Code |
A1 |
FIRST; Eric ; et
al. |
August 26, 2021 |
DEVICES AND METHODS FOR PROVIDING HYDROLYZED LIPIDS
Abstract
Exemplary embodiments of the disclosure may be drawn to a device
having a vessel configured to contain a source of lipids and a
chamber fluidly connected to an outlet of the vessel. The chamber
may contain immobilized lipase positioned within a flow path in the
chamber along which the lipids flow when released from the vessel
into the chamber. The device may also include an outlet through
which the lipids flow after passing through the chamber.
Inventors: |
FIRST; Eric; (Morristown,
NJ) ; Widom; David; (Long Valley, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Alcresta Therapeutics, Inc. |
Newton |
MA |
US |
|
|
Assignee: |
Alcresta Therapeutics, Inc.
Newton
MA
|
Family ID: |
1000005579722 |
Appl. No.: |
17/317374 |
Filed: |
May 11, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15998410 |
Aug 15, 2018 |
11045396 |
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17317374 |
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62546817 |
Aug 17, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61J 1/067 20130101;
A61J 9/005 20130101; A61J 1/2003 20150501; A61J 7/0053 20130101;
A61J 15/0026 20130101; A61J 15/0003 20130101; A23L 33/00 20160801;
A61K 9/00 20130101; A23L 33/115 20160801; A61J 1/2093 20130101;
A61J 1/2089 20130101 |
International
Class: |
A61J 9/00 20060101
A61J009/00; A61J 1/20 20060101 A61J001/20; A23L 33/115 20060101
A23L033/115; A61J 15/00 20060101 A61J015/00 |
Claims
1-23. (canceled)
24. A device comprising: a vessel configured to store a flowable
lipid; a chamber including an inlet and an outlet, wherein the
chamber is connected to an opening of the vessel, and wherein the
chamber contains lipase; and one of an interface or an output
assembly coupled to the chamber, wherein a flow path extends
through an opening in the vessel, through the inlet of the chamber,
through the outlet of the chamber, and through the interface or the
output assembly; wherein at least one of an outlet of the interface
or the outlet assembly or the opening of the vessel is configured
to retain the flowable lipid within the vessel prior to use of the
device.
25. The device of claim 24, wherein the vessel contains the
flowable lipid.
26. The device of claim 25, wherein the flowable lipid includes at
least one of an oil, an infant fortifier, docosahexaenoic acid, or
arachidonic acid.
27. The device of claim 24, wherein the vessel is removably coupled
to the chamber.
28. The device of claim 24, wherein the vessel is prefilled.
29. The device of claim 24, wherein the vessel is refillable.
30. The device of claim 24, wherein the flowable lipid is stored
under pressure in the vessel.
31. The device of claim 24, wherein the vessel is compressible.
32. The device of claim 31, further comprising a compression roller
configured to compress the vessel.
33. The device of claim 24, wherein the chamber comprises a clear
or opaque material.
34. The device of claim 24, wherein the vessel is removably coupled
to the chamber.
35. The device of claim 34, wherein at least one of the outlet of
the interface or the outlet assembly or the opening of the vessel
is sealed prior to use of the device.
36. The device of claim 24, further comprising a valve fluidly
coupled to the vessel.
37. The device of claim 24, further comprising a filter coupled to
the chamber.
38. A device comprising: a vessel configured to store a flowable
lipid; a chamber including an inlet and an outlet, wherein the
chamber is connected to an opening of the vessel, and wherein the
chamber contains lipase; an interface coupled to the chamber,
wherein a flow path extends through an opening in the vessel,
through the inlet of the chamber, through the outlet of the
chamber, and through the interface; and a connector fluidly coupled
to an outlet of the interface, wherein the connector includes: a
first opening; a second opening; and a connector flow path
extending through the connector from the first opening to the
second opening.
39. The device of claim 38, wherein the first opening of the
connector and the second opening of the connector are each
configured to fluidly couple to a feeding tube.
40. The device of claim 38, wherein the connector is shaped as a
hollow tube, and wherein the outlet of the interface is fluidly
connected to a central region of the connector.
41. The device of claim 38, wherein the flowable lipid includes two
or more different types of lipids.
42. The device of claim 38, wherein the vessel is compressible.
43. The device of claim 38, wherein the opening of the vessel is
configured to transition from a first configuration in which the
flowable lipid is retained within the vessel, and a second
configuration in which the flowable lipid is permitted to flow out
of the opening of the vessel in response to an application of
pressure to at least a portion of the vessel.
44. A method of adding hydrolyzed lipids to a liquid prior to
ingestion, the method comprising: causing a source of flowable
lipid stored in a vessel of a device to flow out of the vessel and
through a chamber of the device that contains lipase in order to
hydrolyze the flowable lipid by exposing the flowable lipid to the
lipase in the chamber; and outputting the hydrolyzed lipids from
the chamber of the device into the liquid prior to ingestion of the
liquid.
45. The method of claim 44, further comprising filing the vessel
with the source of flowable lipid prior to causing the flowable
lipid to flow through the chamber.
46. The method of claim 44, further comprising attaching the device
to a feeding system prior to passing the flowable lipid through the
chamber.
47. The method of claim 46, wherein the feeding system is a syringe
or container holding a nutritional formula.
48. The method of claim 44, further comprising detaching the vessel
from the device, refilling the vessel with the source of flowable
lipid, and reattaching the vessel to the device.
49. The method of claim 44, wherein the flowable lipid includes two
or more different types of lipids.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority from U.S.
Provisional Application No. 62/546,817, filed on Aug. 17, 2017, the
entirety of which is incorporated herein by reference.
FIELD OF THE DISCLOSURE
[0002] Embodiments of the present disclosure are directed to
devices and methods for preparing and/or supplementing a
nutritional formula, and more particularly, to devices and methods
for supplementing a nutritional formula with hydrolyzed lipids from
a lipid source.
BACKGROUND
[0003] Premature infants are often born with an immature
gastrointestinal (GI) system. As a result, premature infants may
require specific forms of nutrients for their GI systems to digest,
which may be provided in one or more nutritional formulas, so that
they receive proper nutrition. Premature infants are often given
parenteral nutrition (PN) within hours of birth. Small amounts of
nutrition via PN may be administered while beginning to prime an
infant's GI system. As infants begin to tolerate larger volumes,
they may be weaned off of PN and transitioned to oral or enteral
feeds, which generally consist of one or more nutritional formulas,
including, e.g., mother's own milk (MoM), donor mother's milk (DM),
infant formula (IF) and/or additional nutritional fortifiers. It
may be preferred to use exclusively MoM; however, a mother may not
be able to supply enough milk to provide the required daily
calories for optimal growth and development. To make up this
deficit, MoM may be supplemented, e.g., with DM, which may be
collected, screened, and/or heat pasteurized. In some instances, it
may be less preferred to use infant formula, but MoM and DM may be
inherently low in calories. Additionally, the number of human milk
banks is rapidly increasing worldwide, yet they are largely
unregulated, and the calorie and nutrient content of the milk they
provide may vary considerably.
[0004] Long-chain fatty acids are important to human health and
development. Many long-chain fatty acids are consumed as
triglycerides, in which three long-chain fatty acids are bound to a
glycerol molecule via ester linkages. Absorption of long-chain
triglycerides (LCTs) by the body first requires the enzymatic
action of lipases (e.g., pancreatic lipase) and bile salts, which
digest triglycerides through hydrolysis, breaking them down into a
monoglyceride and two free fatty acids. Digestion products
consisting of a mixture of tri-, di-, and monoglycerides and free
fatty acids, which, together with the other fat soluble contents of
the diet (e.g., the fat soluble vitamins and cholesterol) and bile
salts, form mixed micelles in the watery duodenal contents. Once
broken down, the monoglycerides and free fatty acids may be
absorbed by enterocytes--epithelial cells lining the small
intestine--for example, in the region of the jejunum. The contents
of these micelles (but not the bile salts) enter the enterocytes,
where they are resynthesized into triglycerides and packaged into
chylomicrons, which are released into the lacteals (the capillaries
of the lymph system of the intestines). Medium-chain triglycerides
(MCTs) are absorbed directly into the bloodstream.
[0005] Exocrine pancreatic function may not be fully developed at
birth in premature infants, and so premature infants may lack
sufficient quantities of the enzyme lipase, which is necessary to
break down triglycerides. At birth, the mother provides an
"on-board lipase," called bile salt-stimulated lipase (BSSL), also
known as carboxyl ester lipase or bile salt--dependent lipase,
which is provided to the infant through breast milk. While this may
partially compensate for poor endogenous production, BSSL
production may be insufficient for supporting proper fat
absorption. Additionally, the majority of fats in mother's milk are
in the form of palmitic acid (n-16), which is an MCT, and thus
mother's milk may lack sufficient LCTs, e.g., those containing
docosahexaenoic acid (DHA, 22:6 n-3) and arachidonic acid (ARA 20:4
n-6), which are critical in membrane structure, function, and
neuronal, retinal, and other tissue development. In donor milk,
during the pasteurization process, lipase that was present may be
inactivated by exposure to high heat, and thus LCT fats are not as
readily broken down. As a result, an infant may suffer from feeding
intolerance due to the inability to absorb these larger LCTs,
irritating the gut mucosa and initiating localized
inflammation.
[0006] Human milk may not meet the high daily nutrient requirements
of a very low body weight infant. For example, standard
fortification of human milk designed to optimize nutritional intake
often falls short of the nutrient requirements with regard to
protein and fats. This problem may be further amplified with the
use of donor milk, which is often donated by the mothers of term
infants beyond 1 month postpartum, and which is likely to have
lower protein and fat content than preterm mothers' milk.
[0007] The fat and protein content of human milk is extremely
variable, and protein decreases with lactation duration. In recent
years, it has become evident that preterm infants fed fortified
human milk (mother's milk or donor milk) receive less protein than
assumed and continue to grow more slowly in the short term, even
with standard human milk fortification. Although there is some
uncertainty about optimal growth, postnatal growth failure has not
been solved with human milk fortification in standard fashion.
Thus, there is a need for improved fortification of human milk to
achieve better short-term infant growth, which is associated with
improved neurocognitive outcomes, among other improvements. The
ability to more efficiently process and absorb LCTs may lead to
better overall nutrient absorption and thus growth.
[0008] For at least the above reasons, current infant nutritional
formula (including mother's milk, donor milk, infant formula,
and/or fortifiers) may lack sufficient nutrient density for
premature infants. Accordingly, methods and devices to increase
nutrient density in nutritional formula for premature infants are
needed. Further, patients suffering from various malabsorption
impairments may be unable to adequately digest LCTs and other forms
of fat through hydrolysis, inhibiting absorption of the fatty acids
required to maintain health. Exemplary impairments include, but are
not limited to, the following: compromised pancreatic output, acute
and chronic pancreatitis, pancreatic cancer, pancreatic
insufficiency, cystic fibrosis, cerebral palsy, Crohn's disease,
irritable bowel syndrome, chronically abnormal epithelium,
amyloidosis, celiac disease, Crohn's disease, ischemia, radiation
enteritis, tropical sprue, Whipple disease, inadequate gastric
mixing, rapid emptying, or both, Billroth II gastrectomy,
gastrocolic fistula, gastroenterostomy, insufficient digestive
agents, biliary obstruction and cholestasis, cirrhosis, chronic
pancreatitis, cholestyramine-induced bile acid loss, cystic
fibrosis, lactase deficiency, pancreatic cancer, pancreatic
resection, sucrase-isomaltase deficiency, abnormal milieu, abnormal
motility secondary to diabetes, scleroderma, hypothyroidism, or
hyperthyroidism, bacterial overgrowth due to blind loops
(deconjugation of bile salts), diverticula in the small intestine,
Zollinger-Ellison syndrome (low duodenal pH), acutely abnormal
epithelium, acute intestinal infections, alcohol, neomycin,
impaired transport, abetalipoproteinemia, Addison disease, blocked
lacteals due to lymphoma or tuberculosis, intrinsic factor
deficiency (as in pernicious anemia), lymphangiectasia, jejunoileal
bypass for obesity, short bowel syndrome, or other conditions.
Other patients may need or want additional dietary supplementation.
Further improvements are required to address these and other known
issues.
SUMMARY
[0009] Exemplary embodiments of the disclosure may be drawn to a
device having a vessel configured to contain a source of lipids and
a chamber fluidly connected to an outlet of the vessel. The chamber
may contain immobilized lipase positioned within a flow path in the
chamber along which the lipids flow when released from the vessel
into the chamber. The device may also include an outlet through
which the lipids flow after passing through the chamber.
[0010] Various embodiments of the device may include one or more of
the following features. The vessel may be sealed except for the
outlet, the vessel may be removably coupled to the chamber, or the
vessel may be compressible. The device may also include a connector
fluidly coupled to the outlet, and the connector may include a
first opening for receiving a flow of fluid, a second opening for
outputting the flow of fluid, and a connector flow path extending
through the connector from the first opening to the second opening,
wherein the connector flow path is fluidly connected to the output
assembly. The device may also have an interface located between the
connector and the outlet through which the lipids flow from the
outlet and into the connector, and the interface may be removably
connected to the connector. In some aspects, the device may include
a source of lipids contained within the vessel, and the lipids may
include two or more different types of lipids.
[0011] In other exemplary embodiments, a device may include a
vessel, a source of lipids contained within the vessel, a chamber
coupled to an opening in the vessel, and an output assembly coupled
to the chamber. A flow path may extend from the opening in the
vessel, through the chamber, and through the output assembly along
which the lipids flow through the device when released from the
vessel. The device may also include immobilized lipase contained
within the chamber and located within the flow path, wherein the
lipase is configured to hydrolyze the lipids as the lipids flow
through the chamber.
[0012] Various embodiments of the device may include one or more of
the following features. The vessel may include only one opening,
the vessel may be compressible, and the output assembly may have a
first end and a second end, wherein the first end is coupled to the
chamber, and the first end has a width that is greater than a width
of the second end. In some aspects, the output assembly may have a
first end and a second end, wherein the first end is coupled to the
chamber, and the second end has an opening that is covered by a
seal when the lipids are contained within the vessel and is
uncovered by the seal when the lipids are flowing along the flow
path. In some embodiments, the lipids may include two or more
different types of lipids.
[0013] In other exemplary embodiments, a method of supplementing a
nutritional formula with hydrolyzed lipids may include passing a
source of lipids stored in a device through a chamber of the device
that contains immobilized lipase in order to hydrolyze the lipids
by exposing the lipids to the lipase in the chamber. The method may
also include outputting the hydrolyzed lipids from the chamber of
the device, and adding the hydrolyzed lipids to the nutritional
formula.
[0014] Various embodiments of the method may include one or more of
the following features. The nutritional formula may be flowed past
the device as the hydrolyzed lipids are added to the nutritional
formula, the method may further include preparing the source of
lipids prior to passing the lipids through the chamber, and
preparing the source of lipids may include mixing at least two
different types of lipids together. In some aspects, the source of
lipids may be stored in a vessel of the device prior to being
passed through the chamber, and the method may further include
attaching the vessel to the device prior to passing the source of
lipids through the chamber. The method may also include attaching
the device to a feeding system prior to passing the source of
lipids through the chamber, and the method may also include feeding
the nutritional formula to a patient after the hydrolyzed lipids
have been added to the nutritional formula. In some aspects, adding
the hydrolyzed lipids to the nutritional formula may include
outputting the hydrolyzed lipids from the device and into a
container containing the nutritional formula.
[0015] Both the foregoing general description and the following
detailed description are exemplary and explanatory only and are not
restrictive of the features, as claimed. As used herein, the terms
"comprises," "comprising," "includes," or other variations thereof,
are intended to cover a non-exclusive inclusion such that a
process, method, article, or apparatus that comprises a list of
elements does not include only those elements, but may include
other elements not expressly listed or inherent to such a process,
method, article, or apparatus. Additionally, the term "exemplary"
is used herein in the sense of "example," rather than "ideal." It
should be noted that all numeric values disclosed or claimed herein
(including all disclosed values, limits, and ranges) may have a
variation of +/-10% (unless a different variation is specified)
from the disclosed numeric value. Moreover, in the claims, values,
limits, and/or ranges means the value, limit, and/or
range+/-10%.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate the disclosed
embodiments, and together with the description, serve to explain
the principles of the disclosed embodiments. There are many aspects
and embodiments described herein. Those of ordinary skill in the
art will readily recognize that the features of a particular aspect
or embodiment may be used in conjunction with the features of any
or all of the other aspects or embodiments described in this
disclosure. In the drawings:
[0017] FIG. 1A illustrates an exemplary feeding system, according
to embodiments of the present disclosure.
[0018] FIG. 1B illustrates an exemplary feeding system, according
to embodiments of the present disclosure.
[0019] FIG. 2 illustrates an exemplary device for supplementing a
nutritional formula, according to embodiments of the present
disclosure.
[0020] FIG. 3 illustrates a feeding system of which the device of
FIG. 2 may be a part, according to embodiments of the present
disclosure.
[0021] FIG. 4 illustrates a feeding system including an exemplary
device for supplementing a nutritional formula, according to
embodiments of the present disclosure.
[0022] FIG. 5 illustrates a feeding system including an exemplary
device for supplementing a nutritional formula, according to
embodiments of the present disclosure.
[0023] FIG. 6 illustrates a feeding system including an exemplary
device for supplementing a nutritional formula, according to
embodiments of the present disclosure.
[0024] FIG. 7 illustrates a feeding system including an exemplary
device for supplementing a nutritional formula, according to
embodiments of the present disclosure.
[0025] FIG. 8 illustrates a feeding system including an exemplary
device for supplementing a nutritional formula, according to
embodiments of the present disclosure.
[0026] FIGS. 9A and 9B illustrate an exemplary device being used
with an exemplary feeding system, according to embodiments of the
present disclosure.
[0027] FIG. 10A illustrates a feeding system for use with an
exemplary device for supplementing a nutritional formula, according
to embodiments of the present disclosure.
[0028] FIG. 10B illustrates a feeding system for use with an
exemplary device for supplementing a nutritional formula, according
to embodiments of the present disclosure.
[0029] FIG. 11A illustrates an exemplary device for supplementing a
nutritional formula, according to embodiments of the present
disclosure.
[0030] FIG. 11B illustrates a feeding system of which the device of
FIG. 11A may be a part, according to embodiments of the present
disclosure.
[0031] FIG. 12A illustrates an exemplary device for supplementing a
nutritional formula, according to embodiments of the present
disclosure.
[0032] FIG. 12B illustrates a feeding system of which the device of
FIG. 12A may be a part, according to embodiments of the present
disclosure.
[0033] FIG. 13 is a flow chart depicting an exemplary method of
using a device, according to embodiments of the present
disclosure.
DETAILED DESCRIPTION
[0034] Reference will now be made in detail to the exemplary
embodiments of the present disclosure described below and
illustrated in the accompanying drawings. Wherever possible, the
same reference numbers will be used throughout the drawings to
refer to same or like parts.
[0035] Additional objects and advantages of the embodiments will be
set forth in part in the description that follows, and in part will
be obvious from the description, or may be learned by practice of
the embodiments. It is to be understood that both the foregoing
general description and the following detailed description are
exemplary and explanatory only and are not restrictive of the
claims.
[0036] Aspects of the present disclosure are described with
reference to devices for supplementing nutritional formulas, and,
particularly, to devices for hydrolyzing lipids. Although
embodiments of the disclosure are generally described in reference
to human milk (e.g., mother's milk or donor milk, either
pasteurized or unpasteurized), it will be understood that
embodiments of the disclosure may be used to supplement (e.g., with
hydrolyzed lipids) any nutritional formula or beverage.
[0037] As used herein, the term "nutritional formula" may include
complex mixtures containing, for example, proteins, carbohydrates,
fat, water, minerals, and/or vitamins. This may include liquid
foods that are specially formulated and processed; liquids used for
the partial or exclusive feeding of a person by means of oral
intake or feeding by tube; liquids used for the dietary management
of a person who, because of therapeutic or medical need, has
limited or impaired capacity to ingest, digest, absorb, or
metabolize ordinary foodstuffs or certain nutrients; liquids that
meet medically determined nutrient requirements; and liquids
designed to deliver to a subject nutrients that cannot be provided
to the subject via dietary management and modification of the
normal diet alone.
[0038] In some embodiments, nutritional formula 110 may be
delivered to the subject under medical supervision, may be intended
only for a person receiving active and ongoing medical supervision,
or may be delivered to the subject for home use, either when
supervised or unsupervised. Nutritional formula 110 may be packaged
as a dry powder and then mixed with a solvent to form a solution or
may be packaged as a liquid nutritional formula, beverage, or
drink. In some embodiments, nutritional formula 110 may be
commercially available, or may be prepared by a healthcare
professional before feeding. In some embodiments, nutritional
formula 110 may include at least one medicament prescribed for the
subject in need of the medicament and/or nutritional formula 110,
or nutritional formula 110 may itself be the prescribed medicament.
Nutritional formula 110 may be an infant and/or toddler formula as
a complete or partial substitute for human milk, may be donor milk,
or mother's milk (infant's own mother or other mother's milk),
whether pasteurized or unpasteurized.
[0039] Nutritional formula 110 may or may not include at least one
fat in triglyceride form, such as MCTs and LCTs. In some
embodiments, nutritional formula 110 may further include at least
one nutrient selected from water, maltodextrin, protein, hydrolyzed
protein, amino acids, peptides, MCTs, diglycerides, monoglycerides,
cornstarch, fish oil, soybean oil, rapeseed oil, cottonseed oil,
sunflower oil, olive oil (oils may or may not be refined), soluble
fiber, lecithin, magnesium chloride, sodium ascorbate, guar gum,
calcium phosphate, salt, choline chloride, phosphoric acid, calcium
citrate, sodium phosphate, taurine, magnesium oxide, zinc sulfate,
potassium chloride, niacinamide, ferrous sulfate, calcium
pantothenate, manganese sulfate, pyridoxine hydrochloride, copper
sulfate, thiamine mononitrate, beta-carotene, riboflavin, vitamin a
palmitate, folic acid, biotin, sodium selenate, chromium chloride,
potassium iodide, sodium molybdate, soluble fiber,
fructooligosaccharide, probiotic, citric acid, vitamin A, vitamin
D, vitamin E, vitamin B.sub.1, vitamin B.sub.2, vitamin B.sub.3,
vitamin B.sub.5, vitamin B.sub.6, vitamin B.sub.7, vitamin B.sub.9,
and vitamin B.sub.12. Exemplary nutritional formulas and systems
are described in U.S. patent application Ser. No. 14/378,856, filed
Aug. 14, 2014, now U.S. Pat. No. 9,668,942, which is herein
incorporated by reference in its entirety.
[0040] As described above, in some aspects, exemplary nutritional
formulas may not contain sufficient amounts of nutrients, e.g.,
lipids, for the needs of a patient, e.g., a premature infant, or a
patient may want further supplementation. Embodiments of the
present disclosure may be used to provide a nutritional formula
that, as-fed, delivers increased concentrations of hydrolyzed
lipids, e.g., of monoglycerides and free fatty acids, which may be
absorbed through the gut of an infant or other patient. As a
result, formula-fed subjects may be provided with, e.g., one or
more of docosahexaenoic acid ("DHA"), eicosapentaenoic acid
("EPA"), arachidonic acid ("ARA" or "AA"), or other lipids that
they may not otherwise have had access to or may not have been able
to digest. Some embodiments may be used to supplement mother's
milk, donor breast milk, and/or infant formulas using a lipid
source, such as supplemental oils and/or infant fortifiers. Some
embodiments of the disclosure may provide a method to hydrolyze one
or more triglyceride molecules from a lipid source to produce free
fatty acids and monoglycerides for addition to a nutritional
formula, such as mother's breast milk, donor breast milk, or infant
formulas.
[0041] Embodiments of the present disclosure are drawn to devices
and methods for increasing the amount of total calories and/or
energy in nutritional formulas while not significantly increasing
the overall volume of nutritional formula fed to the patient (e.g.,
by increasing the nutrient density of the formula). By not
substantially increasing the amount of formula to be fed to a
patient, or by decreasing the volume of nutritional formula to be
fed to a patient due to the increased concentration of nutrients,
embodiments of the present disclosure may reduce inflammatory
responses found in the patient's (e.g., a premature infant's) GI
tract and/or may condition the patient's GI tract for improved
overall absorption of nutrients, including, but not limited to,
protein and vitamins.
[0042] Exemplary devices may include a vessel for containing a
lipid source and a chamber containing immobilized lipase through
which the lipid source may be passed in order to hydrolyze the
lipids. Exemplary devices may be fluidly connected to a source of
nutritional formula and/or a feeding system for delivering a
nutritional formula in order to supplement the nutritional formula
with the hydrolyzed lipids. Exemplary devices and exemplary systems
in which they may be included are described further below.
[0043] FIG. 1A illustrates an exemplary feeding system 100 for
providing a nutritional formula 110 to a subject, e.g., via a
feeding tube. In some embodiments, system 100 may be an enteral
feeding system. As shown in later figures, devices of the present
disclosure may be incorporated in numerous different ways into
system 100 to supplement nutritional formula 110 with hydrolyzed
lipids.
[0044] An exemplary system 100 may include a pump 120 and a tube
122 fluidly connecting a source of nutritional formula 110 to an
outlet configured to output nutritional formula 110 to a patient
for ingestion. Nutritional formula 110 may be contained in, e.g., a
feeding bag, a vial, a syringe, a bottle, or any other suitable
container. Nutritional formula 110 may be flowed from the source,
through tube 122, and to the patient. Tube 122 may be an enteral
feeding tube, for example, a gastric, a nasogastric, a
nasoduodenal, a nasojejunal, a gastrostomy, a gastrojejunostomy, a
jejunostomy, a percutaneous endoscopic gastrostomy (PEG) tube, or a
transjejunal feeding tube to feed nutritional formula 110 to the GI
tract of a subject through, for example, the nose, mouth, stomach,
or abdomen of the patient. System 100 may be used in line with
standard enteral feeding practice.
[0045] FIG. 1B illustrates another exemplary embodiment of a
feeding system 100 for providing a nutritional formula 110 to a
subject, e.g., via a feeding tube. System 100 of FIG. 1B may
further include a fat hydrolysis device 200, in addition to a pump
120 and a first tube 122 fluidly connecting a source of nutritional
formula 110 to device 200. As with the system of FIG. 1A,
nutritional formula 110 may be contained in, e.g., a feeding bag, a
vial, a syringe, a bottle, or any other suitable container.
Nutritional formula 110 may be flowed from the source, through
first tube 122, and to device 200, where nutritional formula 110 is
hydrolyzed. System 100 also includes a second tube 124 having a
first end configured to connect to an outlet of device 200 and a
second end, opposite the first end, configured to connect to a
patient to deliver processed nutritional formula 110 from device
200 to the patient for ingestion. Second tube 124 may be an enteral
feeding tube, for example, a gastric, a nasogastric, a
nasoduodenal, a nasojejunal, a gastrostomy, a gastrojejunostomy, a
jejunostomy, a percutaneous endoscopic gastrostomy (PEG) tube, or a
transjejunal feeding tube to feed nutritional formula 110 to the GI
tract of a subject through, for example, the nose, mouth, stomach,
or abdomen of the patient. System 100 may be used in line with
standard enteral feeding practice. Exemplary embodiments of feeding
system 100 and fat hydrolysis device 200 are described in U.S.
patent application Ser. No. 15/291,530, filed Oct. 12, 2016, and
U.S. patent application Ser. No. 14/378,856, filed Aug. 14, 2014,
now U.S. Pat. No. 9,668,942, both of which are herein incorporated
by reference in their entireties.
[0046] System 100 of FIG. 1B is configured to deliver and process
nutritional formula 110 at the point of care to allow device 200 to
hydrolyze fats contained in nutritional formula 110 just prior to
ingestion. As used herein, "processing" by device 200 may refer to
hydrolyzing fats already contained within nutritional formula 110
by exposing nutritional formula 110 to lipases contained within
device 200. As shown in later figures, devices of the present
disclosure may be incorporated in numerous different ways into
system 100 to supplement nutritional formula 110 with additional
lipids.
[0047] The present disclosure is drawn to devices and methods for
supplementing nutritional products in conjunction with systems that
may or may not include a fat hydrolysis device 200, or indeed may
be used in conjunction with any other feeding system. The systems
100 of FIGS. 1A and 1B are provided only as examples of feeding
systems.
[0048] At least one benefit of the disclosed devices is that they
may allow for the controlled addition of hydrolyzed lipids to a
nutritional formula without otherwise impacting the properties of
the nutritional formula. Whereas device 200 of FIG. 1B may expose
nutritional formula 110 to lipase and may pass nutritional formula
110 through device 200, embodiments of the present disclosure do
not pass nutritional formula 110 through them and are structured to
allow only a source of lipids through them for hydrolysis, which is
then output into nutritional formula 110 to supplement nutritional
formula 110. Thus, in some embodiments, only the lipids stored in
or otherwise fed into devices of the disclosure may be exposed to
lipase, and the resulting hydrolyzed lipids may be added to the
formula.
[0049] The flow of nutritional formula 110 through systems 100 of
FIGS. 1A and 1B may be controlled by pump 120 of system 100. In
some embodiments, pump 120 may be a peristaltic pump, although any
suitable type of infusion pump, e.g., an elastomeric pump, a
multi-channel pump, a syringe pump, and/or a smart pump may be
used. A flow rate of nutritional formula 110 through the tubes
and/or device 200 may be set and/or adjusted by pump 120. In some
embodiments, pump 120 may include a processor, a display, and/or
actuators (e.g. buttons, knobs, touch screen, etc.) to adjust and
control the flow rate of nutritional formula 110 in system 100 and
device 200. Pump 120 may be adjusted and set by a healthcare
provider and/or the subject receiving nutritional formula 110. Pump
120 may perform continuous feeding, pulsatile feeding, intermittent
feeding, bolus feeding, and/or flushing, and delivery of fluids may
be set or adjusted automatically, semi-automatically, or
manually.
[0050] In other embodiments, systems 100 of FIGS. 1A and 1B may not
include pump 120 and may instead depend on gravity to flow
nutritional formula 110 from the source to the patient. The
relative positioning of the source of nutritional formula 110 may
allow nutritional formula 110 to flow through the tubes and, if
included, device 200, under the influence of gravity alone. For
example, a container of nutritional formula 110 may be placed above
the attached tubing, above device 200 (if included), and/or above
the patient, as shown in FIGS. 1A and 1B.
[0051] In other embodiments, pump 120 of systems 100 may be
replaced with a syringe. The syringe may be filled with nutritional
formula 110, and the flow rate of nutritional formula 110 in the
tubes and/or device 200 (if included) may be set, and/or adjusted
by using the syringe manually, semi-automatically, or
automatically. For example, nutritional formula 110 may be
pre-packaged in a pre-filled syringe mounted inside of an
auto-injector-like device. The pre-packaged formula may also
contain a pump `engine` (e.g., a spring-loaded piston), and may be
used to deliver the formula through systems 100 and to the
patient.
[0052] In other embodiments, systems 100 may use any suitable
means, e.g., a balloon or other suitable pressure-generating
device, to generate a pressure drop or a flow-driving force that
drives nutritional formula 110 through the tubes and/or device
200.
[0053] The devices and methods disclosed herein may be used to
expose a lipid source to lipases to hydrolyze the lipids, which may
be subsequently added to nutritional formula 110, which may
include, e.g., donor milk, mother's milk, and/or infant formula,
prior to consumption. The devices and methods may provide a
convenient way to supplement nutritional formula 110 with
hydrolyzed lipids, e.g., free fatty acids and monoglycerides. In
some embodiments, the devices and methods provide formulas that
contain monoglycerides and/or free fatty acids, or an increased
concentration of monoglycerides and/or free fatty acids, but do not
contain a significant amount of lipase or contain no lipase.
[0054] FIG. 2 illustrates an exemplary device 201 in accordance
with the present disclosure. Device 201 may include a body 210
having an inlet 212, a chamber 222, and an outlet 230. Chamber 222
may contain a plurality of particles 300 or other structures on
which lipase may be immobilized, e.g., via covalent or ionic
binding or by absorption, for example. Device 201 may also include
an interface 223 through which hydrolyzed lipids 275 may pass out
of chamber 222 through outlet 230 and then into a source of
nutritional formula 110. In some embodiments, interface 223 may be
configured to fluidly connect to a feeding tube or an opening in
any other suitable container in which nutritional formula 110 may
be stored. In some embodiments, however, outlet 230 of chamber 222
may be configured to directly connect or otherwise output
hydrolyzed lipids 275 into nutritional formula 110, and device 201
may not include interface 223.
[0055] In the embodiment of FIG. 2, interface 223 is fluidly
connected to a connector 235. Connector 235 may be part of device
210 or may be separate from device 210 and configured to removeably
connect to device 210 (e.g., via interface 223). Connector 235 may
have a first connector end 240 and a second connector end 270.
Connector end 240 may be configured to fluidly couple to a source
of nutritional formula 110 and to receive an input of nutritional
formula 110. Connector end 270 may be configured to fluidly couple
to a structure, e.g., a feeding tube, configured to deliver
supplemented nutritional formula 111 to a patient and may be
configured to discharge an output of supplemented nutritional
formula 111 into which interface 223 may have delivered hydrolyzed
lipids from chamber 222. For example, in some embodiments, first
connector end 240 and second connector end 270 may be configured to
fluidly connect to one or both of first tube 122 and enteral tube
124 of system 100 (FIGS. 1A and 1B). As nutritional formula 110
flows through system 100 (or any other system), nutritional formula
110 from a source may be received within connector end 240 and may
flow into connector 235. While in connector 235, device 201 may
deliver hydrolyzed lipids into nutritional formula 110 to
supplement nutritional formula 110, and then supplemented
nutritional formula 111 may flow out of connector end 270 for
administration to a patient.
[0056] Connector end 240 and connector end 270 may include, e.g., a
luer-lock connection, threads, projections, grooves, deformable or
expandable structures, and/or any other suitable mechanism for
connecting to one or more tubes or devices for carrying nutritional
formula from a source and/or to a patient. In some embodiments,
connector end 240 and connector end 270 may be configured to engage
a baby bottle, baby bottle nipple, or any other structure to
facilitate transfer of fluid to another container and/or to assist
in feeding. Further, one or both of the connector end 240 and
connector end 270 may include a valve or other fluid flow control
mechanism.
[0057] Device 201 may also include a vessel 280 fluidly connected
to chamber 222. Vessel 280 may contain a lipid source 290. A flow
path may extend from vessel 280, through chamber 222, through
outlet 230, and through interface 223 (if included). Lipid source
290 may include one or more lipids, e.g., structured lipids or
naturally occurring lipids. Lipid source 290 may include one or
more of, e.g., a medium-chain or long-chain fatty acid, for
example, a long-chain polyunsaturated fatty acid ("LC-PUFA")
triglyceride. Exemplary fats (e.g., lipids) in lipid source 290 may
include natural or structured lipids, or omega-3 or omega-6 fatty
acids, like docosahexaenoic acid ("DHA"), eicosapentaenoic acid
("EPA"), alpha-linolenic acid ("ALA"), arachidonic acid ("ARA" or
"AA"), and/or linoleic acid ("LA"). Any suitable combination of
lipids may be included in lipid source 290.
[0058] In some embodiments, lipid source 290 may be in the form of
fish oil. In other embodiments, lipid source 290 may be from a
plant source alone or in combination with fish oil. In other
examples, lipid source 290 may be in the form of supplemental oils
and/or infant fortifiers that may be used to supplement mother's
breast milk, donor breast milk, and/or infant formulas. Examples of
infant fortifiers include Similac.RTM. and Prolacta.RTM.
fortifiers. Other examples of lipid sources may include a mixture
of an infant fortifier with DHA and/or ARA and/or any other type of
natural or structured lipid. Lipids contained in vessel 280 may be
duplicative of those already in nutritional formula 110 or may not
be present in nutritional formula 110 at all, or the lipids
contained in vessel 280 may be a combination thereof.
[0059] In some embodiments, vessel 280 may be refillable or may be
a single-use container and may be pre-filled or may need to be
filled prior to and/or during use. A refillable vessel 280 may be
refillable prior to, during, and/or after use. If vessel 280 is
refillable, it may have an inlet (not shown), e.g., a re-sealable
inlet, and/or may be configured to removeably connect to chamber
222. In some embodiments, a user (e.g., healthcare provider,
patient, patient guardian, pharmacist, or other user) may attach
vessel 280 to chamber 222 prior to use. For example, the user may
select a pre-filled vessel 280 containing the desired lipid source
290 and may attach vessel 280 to chamber 222 for use. In some
embodiments, vessel 280 may be pre-filled, and a user may select
between different types of lipids or combinations of lipids and/or
may select between different volumes of lipids, depending, e.g., on
the needs of the patient. In such embodiments, vessel 280 may have
a sealed opening that is either unsealed prior to attachment to
chamber 222, or the action of attaching vessel 280 to chamber 222
may break the seal (e.g., perforate, puncture, displace, or
otherwise open the seal). In some embodiments, a valve or other
mechanical structure may be used to maintain lipid source 290 in
vessel 280 prior to use and/or to control the flow of lipid source
290 out of vessel 280 and into chamber 222. In still other
embodiments, a user may fill vessel 280 with the desired type of
lipids, combination of lipids, and/or desired volume of lipids
prior to and/or during use.
[0060] In some embodiments, vessel 280 and/or lipid source 290 may
be mixed, heated, cooled, agitated, or otherwise prepared before
use. For example, in some embodiments, one or more lipids and one
or more fortifiers may be mixed together to form lipid source 290,
multiple types of lipids may be mixed together to form lipid source
290, or multiple types of fortifiers may be mixed together to form
lipid source 290, which may then be attached to chamber 222 for
hydrolyzation. In other embodiments, lipid source 290 may include
one type of lipid, multiple types of lipids, one type of fortifier,
or multiple types of fortifiers, which may be attached to chamber
222 for hydrolyzation. Once prepared (if preparation is necessary),
vessel 280 may be attached to chamber 222 for use.
[0061] In other embodiments, vessel 280 may not be detachable from
chamber 222, and vessel 280 may be filled/re-filled while attached
to chamber 222 or may come pre-filled and may not be refillable. In
some such embodiments, a user may select between devices 210
prefilled with different lipids, combinations of lipids, and/or
volumes of lipids prior to use.
[0062] In some embodiments, device 201 may include one or both of
an inlet filter 250 and/or an outlet filter 260. Although both an
inlet and an outlet filter are depicted in FIG. 2 for convenience,
it is contemplated that only one filter may be included in device
201, or, in some embodiments, no filter may be included. Inlet
filter 250 may be located at inlet 212 of chamber 222, and outlet
filter 260 may be located at outlet 230 of chamber 222. In some
embodiments, inlet filter 250 and outlet filter 260 may
cooperatively define chamber 222 while in some embodiments, either
or both of inlet filter 250 and outlet filter 260 may be located
within or outside of chamber 222. For example, there may be a floor
and a ceiling that cooperatively define chamber 222. The floor and
ceiling may define one or more openings at the top and bottom of
chamber 222 and/or they may be porous to allow lipids to pass into
and out of chamber 222. Inlet filter 250 may be located above an
opening in the ceiling of chamber 222 adjacent inlet 212 and/or
outlet filter 260 may be located below an opening in the floor of
chamber 222 adjacent outlet 230. In some embodiments, inlet filter
250 may be located below a ceiling within chamber 222 and/or outlet
filter 260 may be located above a floor within chamber 222, or any
combination of positions thereof. Inlet filter 250 and outlet
filter 260 may prevent particles 300 (or other structures to which
lipase may be immobilized) from exiting chamber 222 of device 201.
Additionally or alternatively, the filters may prevent foreign
objects from entering chamber 222, vessel 280, and/or enteral tube
124. This may be convenient, for example, if vessel 280 is
refillable and/or does not come pre-filled and/or is detachable
from chamber 222. Particles 300 (or other structures on which
lipase may be immobilized) may be located between inlet filter 250
and outlet filter 260 (in embodiments in which two filters are
used). Inlet filter 250 and outlet filter 260 may retain particles
300 within chamber 222 as lipid source 290 flows through device
201. In some embodiments, pore openings in inlet filter 250 and/or
outlet filter 260 may aid in the emulsification and breakdown of
fats from lipid source 290 as lipid source 290 flows through.
[0063] In one exemplary embodiment, body 210 of device 201 is made
of a clear plastic or glass so that the plurality of particles 300
inside chamber 222 of body 210 are visible to the user. In some
instances, this may allow the user to ensure proper flow through
device 201, for example, by visual inspection. In other
embodiments, chamber 222 may be opaque or may be made of any
suitable material. Particles 300 contained in device 201 have
lipase immobilized on their surfaces, and as lipid source 290 flows
through chamber 222 and particles 300, the immobilized lipase
hydrolyzes the fats and triglycerides, including triglycerides
having LC-PUFAs (if included) in lipid source 290, breaking them
down into monoglycerides and free fatty acids. After lipid source
290 flows through chamber 222 and particles 300, hydrolyzing fats
and triglycerides, the hydrolyzed lipid source flows into a
nutritional formula 110, such as mother's breast milk, donor breast
milk, infant formula, or any suitable type of nutritional formula
110, to supplement the nutritional formula.
[0064] Lipid source 290 may flow through device 201 in any suitable
manner. In some embodiments, device 201 may gravity-feed lipid
source 290 through chamber 222, where lipid source 290 is
hydrolyzed, and then hydrolyzed lipids 275 may flow into a
nutritional formula 110 under the force of gravity. In some
embodiments, fluidly connecting device 201 to a feeding system (for
example systems 100 of FIGS. 1A and 1B) may promote the flow of
lipid source 290 out of vessel 280, through chamber 222, and out of
interface 223 (if included). For example, the flow of lipid source
290 out of vessel 280 may be driven by a pressure differential. The
flow of nutritional formula 110, which may be in fluid
communication with lipid source 290, may cause a decrease in
pressure relative to lipid source 290 in vessel 280, which may in
turn cause lipid source 290 to be drawn through chamber 222 and
into the flow of nutritional formula 110, according to Bernoulli's
principle. In such embodiments, an air vent may be included in
vessel 280 and/or vessel 280 may be compressible so that it may
collapse in on itself as lipid source 290 is drawn out of vessel
280. In other embodiments, vessel 280 may be sealed except for the
opening fluidly connected to chamber 222. In some embodiments,
lipid source 290 may be stored under pressure in vessel 280.
[0065] In some embodiments, vessel 280 or portions of vessel 280
may be deformable. A user may squeeze vessel 280, forcing lipid
source 290 out of vessel 280 and into chamber 222. The vessel or
portions of vessel 280 may deform as flow evacuates lipid source
290, for example, driven via a pressure differential. In some
embodiments, a motorized compression roller or other mechanical
device may be included and may compress vessel 280 in a controlled
manner at a given rate or over a given amount of time. In some
embodiments, a pump, e.g., a continuous or peristaltic pump (which
may be manually operated or electronic), may be included in device
201 or attached to vessel 280 to urge lipid source 290 out of
vessel 280. In other embodiments, a source of negative pressure may
be connected to chamber 222, creating a vacuum into which a flow of
lipid source 290 may be drawn. In some embodiments, the flow of
nutritional formula 110 may draw lipid source 290 out of vessel
280, thereby causing it to mix into nutritional formula 110.
[0066] To facilitate the emptying of vessel 280, vessel 280 may
include a valve or other flow-control device and/or may include an
air release to equalize pressure as lipid source 290 is emptied
from vessel 280. In some embodiments, vessel 280 may include
measurement lines so that a user may observe how much of lipid
source 290 has been released into nutritional formula 110 and/or
how much lipid source 290 remains in vessel 280. In some
embodiments, a syringe or other delivery device may feed lipid
source 290 into vessel 280 either prior to and/or during use of
device 201, and lipid source 290 may then flow into chamber 222. In
some embodiments, a vibrating motor may be included in or attached
to device 201 to vibrate device 201, agitate lipid source 290
and/or chamber 222, promote mixing of lipid source 290 with the
lipase, assist the flow of lipid source 290 through chamber 222
and/or the flow of hydrolyzed lipids 275 into nutritional formula
110, and/or to assist with mixing of hydrolyzed lipids 275 into
nutritional formula 110.
[0067] In some embodiments, some or all of lipid source 290 may
pass into chamber 222 and may remain in chamber 222 for a period of
time (i.e., a residence time) to prolong exposure of lipid source
290 to lipase to allow hydrolysis to occur. For example, a user may
partially squeeze or otherwise deliver lipid source 290 from vessel
280 into chamber 222, then may wait for a period of time equal to
the desired residence time, and then may continue to squeeze or
otherwise finish deploying lipid source 290 from vessel 280. In
some aspects, vessel 280 may contain air or some other non-lipid
fluid, and lipid source 290 may first be delivered from vessel 280
into chamber 222 upon a first compression (or other delivery
method), and then after the residence period, a second compression
(or other delivery method) may deliver air or other fluid from
vessel 280 into chamber 222 to expel hydrolyzed lipid source 290
from chamber 222 and into nutritional formula 110. Accordingly,
delivery of lipid source 290 through chamber 222 and into
nutritional formula 110 may be a multi-step process. In still other
embodiments, device 201 may be configured so that lipid source 290
passes slowly through chamber 222 so that lipid source 290 remains
in chamber 222 for at least the duration of a desired residence
time. For example, chamber 222 may be filed with particles 300 of a
certain size and/or density so as to slow the passage of lipid
source 290 through chamber 222, or a valve may be used to maintain
lipid source 290 within chamber 222 for the duration of the
residence time. In such embodiments, a vibrating motor may be
included in or attached to device 201 to vibrate chamber 222 when
lipid source 290 is contained within chamber 222 (e.g., during the
residence time) to promote mixing of lipid source 290 with lipase.
Residence time may be, for example, 5 seconds, 10 seconds, 20
seconds, 30 seconds, 45 seconds, 1 minute, 2 minutes, 3 minutes, 4
minutes, 5 minutes, 10 minutes, 20 minutes, 30 minutes or more than
30 minutes.
[0068] As shown in FIG. 2, in some embodiments, particles 300 may
be formed as substantially spherical beads. In other embodiments,
particles 300 may be randomly shaped or irregular particles, or may
be elliptical, oblong, donut-shaped, a prism, polygonal, elongated,
or any other suitable shape or shapes. Particles 300 may have a
smooth or a textured surface. Particles 300 may be shaped to
increase or decrease their surface area. Particles 300 may be
formed of individual particles, which may each have substantially
the same shape and/or surface or may have two or more different
shape and/or surface combinations. Particles 300 may be formed of
any suitable material, and lipase may be immobilized on particles
300 in any suitable manner, e.g., via adsorption, ionic binding,
covalent binding, cross-linking, encapsulation, and/or entrapment.
Lipases may be immobilized on or in particles 300 found within the
chamber 222 such that the lipases are in fluid contact with lipid
source 290 as lipid source 290 flows through chamber 222.
[0069] While particles 300 are depicted in the exemplary figures,
it is appreciated that lipase may be immobilized in chamber 222 in
any suitable manner. For example, lipases may be immobilized or
contained within structures located inside chamber 222, such as
beads, rods, projections extending from portions of chamber 222, or
other suitable structures. In some embodiments, lipases may be
immobilized on or contained within a wall of chamber 222, and/or
may be immobilized on one or more filters included in device
201.
[0070] It is also contemplated that, in some embodiments, lipase
may not be immobilized and may simply be contained within chamber
222 or within a portion of chamber 222. In some such embodiments,
one or more filters may keep the free (i.e., not immobilized)
lipase within chamber 222 and/or device 201.
[0071] As lipid source 290 flows into chamber 222, lipid source 290
comes into contact with the lipase contained within chamber 222,
and the lipids are hydrolyzed, e.g., into monoglycerides and free
fatty acids. The lipase (immobilized or free) may be located along
the flow path of lipid source 290 as it flows out of vessel 280 and
through chamber 222. After lipid source 290 comes into contact with
the lipase, hydrolyzed lipids 275 are fed into nutritional formula
110, such as, e.g., mother's milk, donor milk, or infant formula.
After introduction of the hydrolyzed lipids into nutritional
formula 110, supplemented nutritional formula 111 may be fed to a
patient.
[0072] Lipase included in the devices herein may cleave two out of
three bonds in a triglyceride, i.e., at the sn-1 and sn-3
positions, leaving an sn-2 monoglyceride. Exemplary lipases may be
obtained from animals, plants, and from many natural or genetically
engineered microorganisms. In some embodiments, the lipase may
include one or more of, e.g., a Chromobacterium viscosum,
Pseudomonas fluorescens, Burcholderia cepacia, or Rhizopus oryzae
lipase, or any other suitable wild-type or recombinant lipase or
combination thereof.
[0073] FIGS. 3 through FIGS. 12A and 12B illustrate various devices
and exemplary ways to incorporate these devices into feeding
systems, according to embodiments of the present disclosure.
[0074] Device 201 may be configured to treat patients with lipase
deficiencies and/or malabsorption. Device 201 may be used instead
of, or in addition to, other treatments, such as the use of device
200 shown in FIG. 1B, to provide an increased concentration of
hydrolyzed lipids to nutritional formula 110. Device 201 may be
used as a point-of-care device, such as added to a syringe of
mother's milk (shown in FIGS. 9A and 9B) or other nutrient source.
Device 201 may be used with hydrolyzed nutritional formula 110,
such as nutritional formula 110 that has already been treated with
device 200 discussed herein above, or may be used by itself to add
hydrolyzed lipids to nutritional formula, e.g., without the use of
device 200.
[0075] FIG. 3 shows device 201 arranged in-line with an enteral
tube 124 supplying nutritional formula 110 to an infant patient
301. The flow of nutritional formula 110 through a proximal portion
of enteral tube 124 (not shown) and the flow of supplemented
nutritional formula 111 may be controlled by any of the mechanisms
previously discussed in relation to system 100, e.g., by gravity or
via a pump or syringe. As discussed above, device 201 may be used
to supplement nutritional formula 110 with hydrolyzed lipids as
lipids are passed from lipid source 290, through chamber 222, and
into nutritional formula 110 being fed to patient 301 through
enteral tube 124. Since hydrolyzed lipids have a short shelf-life,
a point-of-care configuration, such as the one depicted in FIG. 3,
may be advantageous to avoid hydrolyzed lipid degradation prior to
feeding the patient.
[0076] FIG. 4 shows an exemplary application of device 201. Feeding
system 500 may be substantially the same as feeding system 100 of
FIG. 1B, with the addition of device 201. Feeding system 500 may be
used in combination with device 200 for feeding a nutritional
formula 110 further supplemented with hydrolyzed lipids using
device 201. For example, hydrolyzed lipids from device 201 may be
introduced into nutritional formula 110, and any lipids already
present in nutritional formula 110 may be hydrolyzed using device
200, all prior to administration of supplemented and hydrolyzed
nutritional formula to a subject via a feeding tube 524. System 500
may include a fat hydrolysis device 200, a pump 120, and a tube 522
fluidly connecting a source of nutritional formula 110 to device
201. Nutritional formula 110 may be flowed from the source, through
tube 522, to device 201 for supplementation. As nutritional formula
110 flows past device 201, device 201 may deliver hydrolyzed lipids
to nutritional formula 110, increasing the concentration of lipids
in nutritional formula 110. From device 201, nutritional formula
110 may then flow to device 200, where the supplemented nutritional
formula may be exposed to lipase in order to hydrolyze any lipids
in nutritional formula 110. Device 200 may also hydrolyze any
lipids from device 201 that may have exited device 201 without
having been hydrolyzed by the lipase in chamber 222 (e.g., if
device 201 has less than 100% efficiency). System 500 may also
include a tube 525 having an end configured to connect to device
201 and an opposite end configured to connect to device 200 for
flowing supplemented nutritional formula from device 201 to device
200. System 500 may further include a tube 524 having an end
configured to connect to device 200 and an opposite end configured
to connect to a patient to deliver processed and supplemented
nutritional formula 110 from device 200 to the patient for
ingestion. Although tubes 522, 524, and 525 are described as
separate tubes, it is possible that additional tubes may be used in
system 500 or that the element numbers may reference different
sections of the same tube.
[0077] Although device 201 is depicted as being connected to
feeding system 500 downstream of pump 120, in some exemplary
embodiments, device 201 may be connected to tube 522 upstream of
pump 120. In some embodiments, the pumping force may be
comparatively stronger upstream of pump 120, causing a faster flow
of nutritional formula through the portion of tubing connecting the
source of nutritional formula 110 to pump 120. Locating device 201
upstream of pump 120 may allow device 201 to take advantage of the
stronger pumping force and faster flow to draw lipids in device 201
from the lipid source, through the lipase, and out of device
201.
[0078] FIG. 5 shows another exemplary application of device 201.
Feeding system 600 may be substantially the same as feeding system
500, except for the positioning of device 201. Feeding system 600
includes tube 622 fluidly connecting a source of nutritional
formula 110 to device 200 and a tube 624 fluidly connecting device
200 to device 201. Accordingly, lipids already present in
nutritional formula 110 may be passed through device 200 and
hydrolyzed by device 200, and then the hydrolyzed nutritional
formula may be flowed from device 200 to device 201 for delivery of
additional hydrolyzed lipids into the nutritional formula. System
600 may further include a tube 625 having an end configured to
connect to device 201 and an opposite end configured to connect to
a patient to deliver processed and supplemented nutritional formula
from device 201 to the patient for ingestion. Although tubes 622,
624, and 625 are described as separate tubes, it is possible that
additional tubes may be used in system 600 or that the element
numbers may reference different sections of the same tube.
[0079] FIG. 6 shows another exemplary application of device 201.
Feeding system 700 may be substantially the same as feeding systems
500 and 600 except for the positioning of device 201. Feeding
system 700 includes a tube 728 fluidly connecting device 201 with a
source of nutritional formula 110 so that hydrolyzed lipids are
introduced from device 201 directly into the source of nutritional
formula. Alternatively, hydrolyzed lipids may be added to a
container configured to hold the source of nutritional formula 110
first, and then nutritional formula 110 may be added to the
container. It should also be recognized that device 201 may be
replaced with any other suitable embodiment of device described
herein.
[0080] With device 201 arranged in this location, supplemented
nutritional formula is flowed through tube 722, which connects the
source of nutritional formula 110, already supplemented with
hydrolyzed lipids by device 201, to device 200, where lipids in the
supplemented nutritional formula are further hydrolyzed. The
hydrolyzed and supplemented nutritional formula is then flowed
through tube 724, which has an end configured to connect to device
200 and an opposite end configured to connect to a patient to
deliver hydrolyzed and supplemented nutritional formula 110 from
device 200 to the patient for ingestion. Although tubes 722 and 724
are described as separate tubes, it is possible that additional
tubes may be used in system 700 or that the element numbers may
reference different sections of the same tube. In some aspects,
device 201 may be used to supplement nutritional formula 110, and
then supplemented nutritional formula 110 may then be placed in
fluid communication with tube(s) 722, 724 to provide supplemented
nutritional formula to a subject. In other words, a healthcare
provider or subject may use device 201 to introduce hydrolyzed
lipids into nutritional formula 110 and then may attach nutritional
formula 110 to system 700 and/or assemble system 700.
[0081] FIG. 7 shows an exemplary application of device 201
substantially similar to the systems of FIGS. 4 and 5, except
without the use of device 200. Specifically, FIG. 7 shows a feeding
system 800 including a source of nutritional formula 110, a tube
822, pump 120, device 201, and a tube 824. Tube 822 fluidly
connects the source of nutritional formula 110 with device 201 for
flowing nutritional formula 110 to device 201, where device 201
supplements nutritional formula 110 with hydrolyzed lipids. System
800 may also include a tube 824 having an end configured to connect
to device 201 and an opposite end configured to connect to a
patient to deliver supplemented nutritional formula 110 from device
201 to the patient for ingestion. Although tubes 822 and 824 are
described as separate tubes, it is possible that additional tubes
may be used in system 700 or that the element numbers may reference
different sections of the same tube.
[0082] Although device 201 is depicted as being connected to
feeding system 800 downstream of pump 120, in some exemplary
embodiments, device 201 may be connected to tube 822 upstream of
pump 120. In some embodiments, the pumping force may be
comparatively stronger upstream of pump 120, causing a faster flow
of nutritional formula through the portion of tubing connecting the
source of nutritional formula 110 to pump 120. Locating device 201
upstream of pump 120 may allow device 201 to take advantage of the
stronger pumping force and faster flow to draw lipids in device 201
from the lipid source, through the lipase, and out of device
201.
[0083] FIG. 8 shows an additional exemplary application of device
201 substantially similar to the system of FIG. 7, except with
device 201 positioned at the source of nutritional formula 110.
Specifically, FIG. 8 shows a feeding system 900 including a source
of nutritional formula 110, a tube 922, a tube 924, pump 120, and
device 201. Tube 922 fluidly connects device 201 with the source of
nutritional formula 110 so that hydrolyzed lipids are introduced
from device 201 directly into the source of nutritional formula.
Alternatively, hydrolyzed lipids may be added to a container
configured to hold the source of nutritional formula 110 first, and
then nutritional formula 110 may be added to the container. It
should also be noted that device 201 may be replaced with any other
suitable embodiment of device described herein. Tube 924 includes
an end configured to connect to the source of nutritional formula
110 and an opposite end configured to connect to a patient to
deliver supplemented nutritional formula 110 from the source to the
patient for ingestion. Although tubes 922 and 924 are described as
separate tubes, it is possible that additional tubes may be used in
system 900 or that the element numbers may reference different
sections of the same tube. In some aspects, device 201 may be used
to supplement nutritional formula 110, and then supplemented
nutritional formula 110 may then be placed in fluid communication
with tube 924 to provide supplemented nutritional formula to a
subject. In other words, a healthcare provider or subject may use
device 201 to introduce hydrolyzed lipids into nutritional formula
110 and then may attach nutritional formula 110 to system 900
and/or assemble system 900.
[0084] FIG. 9A shows another exemplary embodiment of the present
disclosure. Device 401 may include any of the previously described
elements of device 201, which may operate in a similar manner.
Device 401 may include a vessel 480 containing lipid source 290, a
chamber 422 containing particles 410, and an output assembly 430.
Device 401 may be used to introduce hydrolyzed lipids 475 into a
source of nutritional formula 110, such as into a syringe 450
containing nutritional formula 110. For example, a user may uncap,
unseal, break a rupturable seal, or otherwise open an outlet in
output assembly 430 to allow hydrolyzed lipids 475 to exit device
401. Once device 401 is uncovered and ready for use, a user may
squeeze vessel 480 (if deformable) to expel lipid source 290 out of
vessel 480, through chamber 422 where the lipids are hydrolyzed,
and out of output assembly 430. A flow path may extend from an
opening in vessel 480, through chamber 422, and through output
assembly 430, along which lipid source 290 may flow through device
401 when released from vessel 480. immobilized lipase may be
located in chamber 422 within the flow path so that the lipase
hydrolyzes lipid source 290 as it flows through chamber 422. In
some embodiments, a vent opening in vessel 480 may also be
uncovered in order to promote the release of lipid source 290 out
of vessel 480. In other embodiments, vessel 480 may only include
one opening--the opening in fluid communication with chamber
422.
[0085] Once hydrolyzed lipids 475 are introduced into syringe 450,
a plunger 414 may be coupled to syringe 450, and syringe 450 may be
ready to deliver supplemented nutritional formula 111 to a patient,
as shown in FIG. 9B. FIG. 9B shows a syringe filled with
supplemented nutritional formula 111 supplemented with hydrolyzed
lipids 475 from device 401.
[0086] In some embodiments, syringe 450 may be filled by attaching
device 401 to a distal end of syringe 450. For example, plunger 414
may not be removed from syringe 450, and, instead, output assembly
430 may be fluidly connected to a distal end of syringe 450
(opposite plunger 414). Output assembly 430 may be connected to
syringe 450 via a snap-fit, twist-fit, friction-fit, threaded,
Luer-lock, or any other suitable connection. Once device 401 is
connected to a distal end of syringe 450, plunger 414 may be drawn
back, creating a negative pressure in syringe 450. This negative
pressure may draw lipid source 290 out of vessel 480, through
chamber 422, and may draw hydrolyzed lipids 475 into syringe 450.
In this way, hydrolyzed lipids may be introduced into syringe 450
without breaking sterility. Nutritional formula 110 may already be
present in syringe 450 when hydrolyzed lipids 475 are drawn from
device 401 into syringe 450, or nutritional formula 110 may be
added to syringe 450 after hydrolyzed lipids 475 are drawn into
syringe 450.
[0087] Syringe 450 may be used to administer supplemented
nutritional formula 111 supplemented with hydrolyzed lipids 475 to
a patient. In some embodiments, syringe 450 filled with
supplemented nutritional formula 111 may be fluidly connected to
any of feeding systems 100 to 900 described herein to deliver
supplemented nutritional formula 111 to a patient. Device 401 may
be used to prepare supplemented nutritional formula 111
supplemented with hydrolyzed lipids 475 for storage or for
immediate administration to a patient. Device 401 may be used to
introduce hydrolyzed lipids 475 from a lipid source 290 into
nutritional formula in any form of container for use in feeding a
patient.
[0088] For example, device 401 may be used to introduce hydrolyzed
lipids 475 into a can 490 (FIG. 10A) or a bottle 495 (FIG. 10B).
Bottle 495 may be a baby bottle or a water bottle. Although not
specifically depicted, device 401 may be used to add hydrolyzed
lipids 475 into any other suitable container, including, e.g., a
cup, mug, blender, or juicer. As described above, a user may uncap,
unseal, break a rupturable seal, or otherwise open an output in
output assembly 430 to allow hydrolyzed lipids to exit 475. Once
device 401 is uncovered and ready for use, a user may squeeze
vessel 480 (if deformable) to expel lipid source 290 out of vessel
480, through chamber 422 where the lipids are hydrolyzed, and out
of output assembly 430. In some embodiments, a vent opening in
vessel 480 may also be uncovered in order to promote the release of
lipid source 290 out of vessel 480.
[0089] In some embodiments, vessel 480 may be refillable or may be
a single-use container and may be pre-filled or may need to be
filled prior to and/or during use. A refillable vessel 480 may be
refillable prior to, during, and/or after use. If vessel 480 is
refillable, it may have an inlet (not shown), e.g., a re-sealable
inlet, and/or may be configured to removeably connect to chamber
422. In some embodiments, a user (e.g., healthcare provider,
patient, patient guardian, pharmacist, or other user) may attach
vessel 480 to chamber 422 prior to use. For example, the user may
select a pre-filled vessel 480 containing the desired lipid source
290 and may attach vessel 480 to chamber 422 for use. In some
embodiments, vessel 480 may be pre-filled, and a user may select
between different types of lipids or combinations of lipids and/or
may select between different volumes of lipids, depending, e.g., on
the needs of the patient. In such embodiments, vessel 480 may have
a sealed opening that is either unsealed prior to attachment to
chamber 422, or the action of attaching vessel 480 to chamber 422
may break the seal (e.g., perforate, puncture, displace, or
otherwise open the seal). In some embodiments, a valve or other
mechanical structure may be used to maintain lipid source 290 in
vessel 480 prior to use and/or to control the flow of lipid source
290 out of vessel 480 and into chamber 422. In still other
embodiments, a user may fill vessel 480 with the desired type of
lipids, combination of lipids, and/or desired volume of lipids
prior to and/or during use.
[0090] In some embodiments, vessel 480 and/or lipid source 290 may
be mixed, heated, cooled, agitated, or otherwise prepared before
use. For example, in some embodiments, one or more lipids and one
or more fortifiers may be mixed together to form lipid source 290,
multiple types of lipids may be mixed together to form lipid source
290, or multiple types of fortifiers may be mixed together to form
lipid source 290, which may then be attached to chamber 422 for
hydrolyzation. In other embodiments, lipid source 290 may include
one type of lipid, multiple types of lipids, one type of fortifier,
or multiple types of fortifiers, which may be attached to chamber
422 for hydrolyzation. Once prepared (if preparation is necessary),
vessel 480 may be attached to chamber 422 for use.
[0091] In other embodiments, vessel 480 may not be detachable from
chamber 422, and vessel 480 may be filled/re-filled while attached
to chamber 422 or may come pre-filled and may not be refillable. In
some such embodiments, a user may select between devices 401
prefilled with different lipids, combinations of lipids, and/or
volumes of lipids prior to use.
[0092] In some embodiments, device 401 may be used to supplement a
beverage other than a nutritional formula, for example, a soft
drink, water, coffee, tea, juice, or any other suitable beverage.
In such embodiments, the beverage may be poured into a container
for the addition of hydrolyzed lipids 475 from device 401, or a
can, bottle, carton, or other suitable container already containing
the beverage may be opened, and device 401 may be used to introduce
hydrolyzed lipids 475 directly into the original container.
[0093] Output assembly 430 of FIGS. 9A through 10B may be
configured to attach to a container holding nutritional formula 110
to deliver hydrolyzed lipids 475 to nutritional formula 110, or
output assembly 430 may be configured to deliver hydrolyzed lipids
475 while spaced apart from nutritional formula 110 and a container
holding the nutritional formula. For example, some devices 401 may
simply be held above an opening in the container so that hydrolyzed
lipids 475 are delivered from output assembly 430 into the open
container and into nutritional formula 110. Although output
assembly 430 is depicted in the figures as being funnel-shaped and
having an end connected to chamber 422 that is wider than an end
through which hydrolyzed lipids 475 are output from device 401, it
is contemplated that output assembly 430 may have any suitable
shape or size.
[0094] Although the description of FIGS. 9A, 9B, 10A, and 10B above
reference hydrolyzed lipids 475 being added to a syringe or other
container containing nutritional formula 110, it is also
contemplated that hydrolyzed lipids 475 may be added first to the
syringe or container, and then nutritional formula 110 may be added
to the syringe or container.
[0095] The embodiments of FIGS. 11A and 11B depict a slightly
different variation of the devices described above for use with a
feeding system like that of FIG. 1A. For example, a vessel 501
containing a source of lipids may be included upstream of device
200, which may be configured to hydrolyze nutritional formula 110
flowing through it. In this way, nutritional formula 110 may first
be supplemented with un-hydrolyzed lipids from vessel 501, and then
nutritional formula 110 supplemented with the additional lipids may
together be flowed through device 200. Accordingly, device 200 may
hydrolyze the lipids introduced by vessel 501 into the flow of
nutritional formula 110, as well as any lipids that may have
already been present in nutritional formula 110. Hydrolyzed,
supplemented nutritional formula 111 may then flow out of device
200. For example, as is shown in FIG. 11B, hydrolyzed, supplemented
nutritional formula 111 may be flowed into a feeding tube 516 to
provide a nutritional formula containing pre-hydrolyzed lipids to a
patient 515.
[0096] Although vessel 501 is depicted as being immediately
upstream of device 200, it is contemplated that vessel 501 may be
included in any suitable location upstream of device 200. Further,
a source of lipids contained in vessel 501 may be driven out of
device 501 in any of the ways described above in reference to
devices 201 and/or 401.
[0097] FIGS. 12A and 12B depict another exemplary embodiment in
which lipids from a vessel 601 are added directly into device 200.
Device 200, which may contain immobilized lipase and may be
configured to hydrolyze lipids, may receive a flow of nutritional
formula 110 via a first path and may receive a flow of lipids from
vessel 601 via a second path. Whereas FIGS. 11A and 11B depict an
embodiment in which nutritional formula is first supplemented with
un-hydrolyzed lipid prior to passing through device 200, FIGS. 12A
and 12B depict an embodiment in which nutritional formula 110 and
lipids from vessel 601 are separately fed into device 200 via
discrete paths. The lipids and nutritional formula 110 may be
combined within device 200, as the lipids are hydrolyzed, and as
any lipids already present in nutritional formula 110 are also
hydrolyzed. Hydrolyzed nutritional formula supplemented with
hydrolyzed lipids from vessel 601 may then exit device 200 along a
combined flow path. For example, as is shown in FIG. 12B,
hydrolyzed, supplemented nutritional formula 111 may be flowed into
a feeding tube 616 to provide a nutritional formula containing
pre-hydrolyzed lipids to a patient 615.
[0098] Lipids from vessel 601 may be drawn into device 200 and into
the flow of nutritional formula 110 in any suitable manner
described above in reference to devices 201 and/or 401.
[0099] Although FIG. 12A depicts a vessel 601 containing a source
of lipids, it is contemplated that rather than being stored in a
vessel, lipids may be directed into device 200 through a tube or
via any other suitable source.
[0100] Numerous different aspects of devices 201 and 401 and
vessels 501 and 601 have been described. Particular aspects include
a vessel for containing a lipid source and an immobilized lipase
enzyme configured to hydrolyze the lipids to supplement a
nutritional formula. The supplementation of nutritional formula may
promote the delivery of hydrolyzed fats (e.g., free fatty acids
and/or monoglycerides) to the patient, for example, to the
intestine (e.g., the small intestine) of a patient to promote the
absorption of hydrolyzed fats by the body.
[0101] Use of the disclosed devices may provide one or more
benefits. For example, surprisingly, it was found that when lipids
were hydrolyzed in the presence of MCTs and/or I-Carnitine, there
was an improvement in absorption of lipids and other nutrients by
patients. As a result of this surprising finding, premature infants
and other patients may be able to more efficiently absorb LCTs, as
well as other fats, using embodiments of the disclosure.
[0102] Further, use of the devices may increase the number of total
calories and/or energy obtained by a patient while keeping the
volumes of nutritional formula ingested by the patient relatively
low due to the increased density of nutrients of the nutritional
formula consumed. For example, a larger volume of un-supplemented
nutritional formula may need to be ingested in order to obtain the
same nutrient amount as a smaller volume of nutritional formula
supplemented with hydrolyzed lipids. Additionally, although device
200 may be able to hydrolyze lipids already present in a
nutritional formula, it cannot increase the nutrient content of the
nutritional formula--it can only make what is already present more
available to the body for absorption by the body. Devices of the
disclosure (e.g., devices 201 or 401) have the ability to not only
provide lipids to a supplemented nutritional that are more
biologically available, they also increase the overall
concentration of lipids in the supplemented nutritional formula.
This is useful, because, as described above, nutritional formula
(e.g., mother's milk, donor milk, or infant formula or fortifiers)
may not otherwise contain a high enough concentration of lipids or
other nutrients.
[0103] Additionally, devices 201, 401 and vessels 501, 601 may be
used to introduce lipids into a nutritional formula that are not
otherwise found in a nutritional formula or are found only in lower
concentrations. For example, nutritional formulas that already
contain certain lipids, e.g., DHA or EPA, may be more expensive
than other nutritional formulas. Use of exemplary devices disclosed
herein may allow a consumer to use less expensive nutritional
formulas that do not contain certain lipids and then to add the
missing lipids to the formula in a more-digestible form via use of
the disclosed devices. For example, rather than purchasing a
nutritional formula with the expensive lipids already in it,
devices 201, 401 and vessels 501, 601 with a lipid source
containing the expensive lipids may be used to introduce a
hydrolyzed version of the expensive lipids into the nutritional
formula.
[0104] Use of devices of the disclosure may decrease the
inflammatory response found in the GI tract of a premature infant
(or other patient) and/or may condition the GI tract for improved
overall absorption of other nutrients, such as, but not limited to,
protein and vitamins. The surprising findings may be due to the
synergistic effect of pre-hydrolyzing the oils (structured and/or
naturally occurring oils, including, but not limited to, DHA and
ARA) and/or pre-hydrolyzing fortifiers (including, but not limited
to, liquid human-based or non-human-derived fortifiers), as well as
their anti-inflammatory effects on the GI tract, thus allowing for
better overall GI health.
[0105] Exemplary devices 201, 401 and vessels 501, 601 may be used
in the manner shown in FIG. 13. Those of ordinary skill in the art
will recognize that one or more steps of the method depicted in
FIG. 13 may be omitted or performed out of the order depicted in
FIG. 13, or other steps may also be performed.
[0106] The first three steps of the method of FIG. 13 are optional,
and, depending on the embodiments of device 201 or device 401
(collectively referred to as `the device` in reference to FIG. 13),
any combination of those steps may be performed, or none of the
steps may be performed. First optional step 950 includes preparing
a lipid source. As described above, preparing the lipid source may
involve mixing, heating, cooling, agitating, or otherwise preparing
the lipid source for use in the device. Preparation may occur while
the lipid source is already contained in the vessel of the device,
preparation may occur prior to introduction of the lipid source
into the device, or both. In some embodiments, preparation may
include mixing one or more lipids and/or one or more fortifiers
together. Additionally, it is recognized that although step 950 is
shown as preceding step 951, which precedes 952, it is understood
that these steps may be performed in any order.
[0107] Step 951 may include attaching the vessel to the lipase
chamber (in embodiments in which the vessel is detachable from the
device) and/or filling the vessel with the lipid source. In some
embodiments, both attaching and filling may occur, while in other
embodiments, one (or none) of these may occur. If both actions are
taken, the vessel may be filled and then attached to the chamber,
while in other embodiments, the vessel may be attached to the
chamber and then filled.
[0108] At step 952, the device may be attached to a feeding system
for adding hydrolyzed lipids to a nutritional formula as the
nutritional formula is fed to a patient. For example, the device
may be attached to the feeding systems of FIG. 1A or 1B, or may be
attached to a feeding system as shown in any of FIGS. 3-9 and
described above. Indeed, the device may be attached to or otherwise
incorporated in any suitable feeding system.
[0109] At step 953, the lipid source of the device may be released
from the vessel and passed through the immobilized lipase contained
in the chamber of the device. As the lipid source passes through
the lipase in the chamber, it reacts with the lipase and is
hydrolyzed into monoglycerides and free fatty acids. At step 954,
the hydrolyzed lipid source may exit the chamber and may be added
to a nutritional formula to supplement the nutritional formula with
hydrolyzed lipids. At optional step 955, the supplemented
nutritional formula may be fed to a patient either immediately or
after some passage of time. The supplemented nutritional formula
may be fed to a patient in any suitable manner, for example, via a
feeding tube, via a drink (e.g., the hydrolyzed lipids may be added
to a beverage), or in any other manner.
[0110] While principles of the present disclosure are described
herein with reference to illustrative aspects for particular
applications, the disclosure is not limited thereto. Those having
ordinary skill in the art and access to the teachings provided
herein will recognize additional modifications, applications,
aspects, and substitution of equivalents that all fall in the scope
of the aspects described herein. Accordingly, the present
disclosure is not to be considered as limited by the foregoing
description.
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