CN115300774B - Medicament delivery device, medicament release method and medicament release capsule using same - Google Patents

Medicament delivery device, medicament release method and medicament release capsule using same Download PDF

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Publication number
CN115300774B
CN115300774B CN202211035872.2A CN202211035872A CN115300774B CN 115300774 B CN115300774 B CN 115300774B CN 202211035872 A CN202211035872 A CN 202211035872A CN 115300774 B CN115300774 B CN 115300774B
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China
Prior art keywords
medicament
connecting rod
delivery
medicament delivery
base
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CN202211035872.2A
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CN115300774A (en
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彭国会
董宜发
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Shenzhen Jifu Medical Technology Co ltd
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Shenzhen Jifu Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1053Stomach

Abstract

The invention discloses a medicament delivery device, which comprises a medicament delivery window, a delivery power system, a first fixing seat, a medicament delivery connecting rod, a screw rod, a nut, a guide rod and a second fixing seat, wherein the first fixing seat is used for fixing the delivery power system, and the first fixing seat and the second fixing seat are assembled and fixed together through the guide rod to serve as a fixing base of the medicament delivery device; when the delivery power system rotates, the drug delivery connecting rod drives the screw rod to rotate, the rotating motion is further converted into axial linear reciprocating motion through the nut, and the drug delivery connecting rod is pushed to expand, so that the drug which is detachably coupled to the drug delivery connecting rod is delivered into the intestinal tract arm through the drug delivery window. The invention also provides a medicine releasing capsule and a medicine releasing method. The medicine releasing capsule can release medicine according to the requirement in the gastrointestinal tract advancing process, achieves the aim of accurately releasing medicine, avoids the premature decomposition and potential risk of medicines in the gastric cavity, and improves the treatment effect.

Description

Medicament delivery device, medicament release method and medicament release capsule using same
Technical Field
The invention relates to the field of medical appliances, in particular to a medicament delivery device and a medicament release capsule using the same.
Background
At present, the medicine treatment in the medical field is mainly carried out by taking the medicine into a human body through gastrointestinal natural absorption or through intravenous injection, intramuscular injection and other modes, and in the oral mode occupying the main treatment mode, many medicines are accompanied with complications such as gastric irritation, bleeding and the like, and the medicine is decomposed/degraded in a gastric cavity, and the medicine is poorly, slowly or unstably absorbed and the like, so that the method of taking the medicine through oral administration is limited in part of scenes, and the other method of delivering the medicine through intravenous injection and intramuscular injection also has the problems of pain, infection risk and the like caused by needling.
Chinese patent application No. 2020104926438 discloses a drug release capsule type digestive tract endoscope device and a drug release method, the technical scheme is that an endoscope capsule carrying a drug cabin is sent into a digestive tract, focus position and focus reality are obtained through video information transmitted back by the endoscope capsule, a wireless transmitting antenna is controlled to give a wireless receiving antenna drug release signal in the endoscope capsule through an external transmitting control switch, the control circuit converts the signal of the wireless receiving antenna into an instruction for rotating and rotating a micro stepping motor, a cabin door of the drug cabin is opened to a corresponding opening, so that the drug in the drug cabin is released to the focus position, release time and release opening are controlled to control release amount, and the cabin door is closed immediately after release is finished to avoid scratch caused by the fact that the endoscope capsule moves again to the inner wall of the digestive tract. According to the technical scheme, the wireless signal is utilized to control the action of the drug release mechanism, and the drug release mechanism cannot be actuated under the condition of poor signal connection, so that the aim of the invention cannot be achieved.
Chinese patent application No. 2019105380071 discloses a drug release device of a capsule endoscope and a capsule endoscope, the drug release device comprising: a light emitting portion for emitting light and a drug releasing portion configured to release the drug stored in the drug releasing portion under the irradiation of the light emitted from the light emitting portion. The technical scheme adopts a photoinduced mode to carry out linkage of the drug release structure, and the drug release precision of optical control needs to be further improved.
In view of the deficiencies of the prior art, the present invention is directed to a delivery device, a method of delivering a therapeutic agent into the intestinal wall, and a delivery capsule therefor, that is safe and reliable.
Disclosure of Invention
In order to solve the defects in the prior art, the invention provides a medicament delivery device, a medicament release method and a medicament release capsule using the medicament delivery device.
In a first aspect, the present invention provides a medicament delivery device, including a medicament delivery window, a first delivery power system, a first fixing base, a medicament delivery connecting rod, a first screw rod, a nut, a guide rod, and a second fixing base, wherein the first fixing base is used for fixing the delivery power system, and the first fixing base and the second fixing base are assembled and fixed together through the guide rod to serve as a fixing base of the medicament delivery device;
when the first delivery power system rotates, the medicament delivery connecting rod drives the first screw rod to rotate, the rotating motion is further converted into axial linear reciprocating motion through the nut, and the medicament delivery connecting rod is pushed to expand, so that medicament which is detachably coupled to the medicament delivery connecting rod is delivered into the intestinal tract arm through the medicament delivery window.
Further, the medicament delivery windows are arranged on the surface of the shell of the medicament release capsule, and at least two medicament delivery windows are arranged.
Further, the drug delivery link is made of any one of polyglycolic acid, polylactic acid-glycolic acid copolymer, or maltose.
Further, the first delivery power system drives the threads with forward and reverse bidirectional rotation arranged at the two ends of the first screw rod to start to reversely rotate after 1-2s after the medicament is delivered, so that the first medicament delivery device is retracted and closed.
Further, the agent delivery window is covered by a degradable coating consisting of one or more of gelatin, cellulose or polysaccharide.
Further, the medicament further comprises a needlepoint head for penetrating the intestinal arm and a barb for hooking the medicament to the intestinal wall, which facilitates detachment from the medicament delivery link.
In a second aspect, the invention provides a medicament delivery device, which comprises a second delivery power system, a first base, a first connecting rod, a rivet, a second connecting rod, a second base and a second screw rod, wherein the second delivery power system is connected with the second screw rod, and power is transmitted through the second screw rod; the two ends of the second screw rod are respectively connected with the first base and the second base, the first base and the second base can respectively do linear motion on the second screw rod, the first base and the second base are respectively connected with the first connecting rod and the second connecting rod, the first connecting rod can rotate around the first base, the second connecting rod can rotate around the second base, the first connecting rod and the second connecting rod are riveted through rivets, and the first connecting rod and the second connecting rod swing around the center of the rivets.
Further, the first connecting rod, the second connecting rod and the rivet are all made of any one material of polyglycolic acid, polylactic acid-glycolic acid copolymer or maltose.
Further, the second delivery power system drives the threads with forward and reverse bidirectional rotation arranged at the two ends of the second screw rod to start to reversely rotate after 1-2s after the medicament is delivered, so that the medicament delivery device is retracted and closed.
In a third aspect, the present invention provides a drug delivery capsule comprising a housing, a degradable coating, a medicament and a medicament delivery device according to any one of the first to second aspects, the degradable coating being applied to an outer surface of the housing, the medicament delivery device and the medicament being both internally provided within the housing.
Further, the surface of the housing is provided with at least two medicament delivery windows, which are covered by a degradable coating consisting of one or more of gelatin, cellulose or polysaccharide.
In a fourth aspect, the present invention provides a method of delivering a drug, comprising a drug delivery capsule, wherein after degradation of a degradable coating of the drug delivery capsule, the internal environment of the drug delivery capsule is communicated with the intestinal environment, a change in pressure or PH triggers a sensor and gives a signal to a control module, a motor rotates and provides power to cause a drug delivery device to be opened, and the drug is delivered and injected into the intestinal wall.
The medicament delivery device and the medicament release capsule can accurately release medicament at a diseased part according to the requirement in the gastrointestinal tract advancing process, so that the aim of accurately releasing medicament is fulfilled, the premature decomposition and potential risk of medicaments in a gastric cavity are avoided, and the treatment effect is improved.
Drawings
Fig. 1: the whole view of the drug release capsule is shown.
Fig. 2: the drug delivery device according to the first embodiment of the present invention is schematically structured.
Fig. 3: the delivery state of the first embodiment medicament delivery device is schematically represented.
Fig. 4: another angular schematic view of the first embodiment medicament delivery device.
Fig. 5: the medicament shape of the delivery device of the present invention is schematically illustrated.
Fig. 6: the drug release process of the drug release capsule is schematically shown.
Fig. 7: the drug delivery device of the second embodiment of the present invention is schematically illustrated in its expanded state.
Fig. 8: a second embodiment of the medicament delivery device of the present invention is a schematic representation of the closed state.
Each serial number and corresponding name are respectively: a housing 01; a degradable coating 02; a first agent delivery device 03; medicament 04; a medicament delivery window 0101; first delivery motive system 0301; a first fixing base 0302; medicament delivery link 0303; a first screw 0304; a nut 0305; guide bar 0306; a second fixing base 0307; a spike head 0401; barbs 0402; a second agent delivery device 05; a second delivery power system 0501, a first base 0502, a first link 0503, a rivet 0504, a second link 0505, a second base 0506, a second lead screw 0507.
Detailed Description
In order to make the technical problems, technical schemes and beneficial effects to be solved more clear, the invention is further described in detail below with reference to the accompanying drawings and embodiments.
Referring to fig. 1, an overall view of a drug delivery capsule of the present invention, fig. 2, a schematic structural diagram of a drug delivery device of a first embodiment of the present invention, and a schematic delivery state of the drug delivery device of the first embodiment of fig. 3, the drug delivery capsule provided by the present invention includes a housing 01, a degradable coating 02, a first drug delivery device 03, and a drug 04, wherein the degradable coating 02 is laid on an outer surface of the housing 01, and the drug delivery device 03 and the drug 04 are both disposed inside the housing 01.
The shell 01 is made of biocompatible materials and cannot be corroded by digestive juice, the shell can be set to be transparent or opaque according to the needs, two ends of the shell 01 are approximately spherical, the whole drug release capsule is approximately elliptical, the drug release capsule is convenient for a patient to swallow and move in the digestive tract, the shell 01 is formed by splicing at least two parts, a containing cavity is formed in the shell, setting and installation of internal components are facilitated, and the splicing position of the shell can be flexibly designed according to the needs, so that the drug release capsule is not limited.
At least two medicament delivery windows 0101 are arranged on the surface of the shell 01, the medicament delivery windows 0101 can be symmetrically distributed along the radial direction of the shell 01 when two medicament delivery windows 0101 are adopted, and the medicament delivery windows 0101 can be uniformly distributed along the radial direction of the shell 01 when three or more medicament delivery windows 0101 are adopted.
The drug delivery window 0101 is sealed by the degradable coating 02 in a closed state when the drug delivery capsule does not enter the intestinal tract, and after the drug delivery capsule enters the intestinal tract, the degradable coating 02 is contacted with body fluid in the intestinal tract to generate a degradation reaction, so that the drug delivery window 0101 is promoted to be opened, the first drug delivery device 03 in the drug delivery capsule is triggered, and the drug 04 is delivered into the intestinal arm through the drug delivery window 0101.
The degradable coating 02 is made of special film-forming materials special for medicine, including but not limited to various biodegradable materials such as gelatin, cellulose or polysaccharide, etc., the degradable coating 02 is designed to be degraded only in intestinal environment, and covers the outer surface of the corresponding medicament delivery window 0101 of the shell 01, so that the medicament release capsule is in a sealed state. After the degradable coating 02 is degraded in the intestinal tract, intestinal liquid enters the interior of the drug release capsule through the drug delivery window 0101 on the shell, so that the triggering conditions such as pressure or PH value in the interior of the drug release capsule are changed, and the first drug delivery device 03 in the interior of the drug release capsule is triggered.
Referring to another angular schematic view of the first embodiment of the medicament delivery device of fig. 4, the first medicament delivery device 03 further comprises a first delivery power system 0301, a first fixing seat 0302, a medicament delivery connecting rod 0303, a first screw 0304, a nut 0305, a guide post 0306 and a second fixing seat 0307.
The first delivery power system 0301 further includes a motor, a battery, a control module, and a pressure sensor or a PH sensor, and the connection relationship between these components is well known to those skilled in the art, and the present invention will not be repeated herein. When the degradable coating 02 is degraded, the internal environment of the drug release capsule is communicated with the intestinal environment, the pressure or PH change triggers the sensor and gives a signal to the control module, the motor rotates and provides power to prop the first drug delivery device 03 open, the drug 04 is delivered and injected into the intestinal wall, the first delivery power system 0301 is sealed in a non-degradable device with biocompatibility, and the sealing device is adaptively designed according to the requirement, so that the invention is not limited.
The first fixing seat 0302 is used for fixing a delivery power system, and the first fixing seat 0302 and the second fixing seat 0307 are assembled and fixed together through a guide rod 0306 to serve as a fixing base of the medicament delivery device 03.
When the first delivery power system 0301 receives a pressure or PH value change signal to trigger rotation, the medicament delivery connecting rod 0303 drives the first screw rod 0304 to rotate, further the rotation is converted into axial linear reciprocating motion through the nut 0305, and the medicament delivery connecting rod 0303 is pushed to expand, so that the medicament 04 which is detachably coupled on the medicament delivery connecting rod 0303 is delivered into the intestinal arm.
When the medicament delivery is finished for 1-10ms, the first delivery power system 0301 drives the screw threads with forward and reverse bidirectional rotation arranged at the two ends of the first screw rod 0304 to start to reversely rotate, so that the first medicament delivery device 03 retracts and closes after the medicament delivery is finished.
Optionally, the drug delivery link 0303 is made of a material that is digestible in the intestinal tract, for example, but not limited to, any material that is polyglycolic acid (PGA), polylactic-co-glycolic acid (PLGA), or maltose, and when the drug delivery is completed and the first drug delivery device 03 needs to be retracted and closed, the drug delivery link 0303 begins to melt after a set time (e.g., 1-2 s), so as to retract and close the first drug delivery device 03.
Referring to fig. 5, the medicament 04 is detachably coupled to the medicament delivery link 0303, the medicament 04 further includes a needle-shaped head 0401 and a barb 0402, the needle-shaped head 0401 is convenient to pierce the intestinal arm, the barb 0402 is convenient to be detached from the medicament delivery link 0303 when the medicament 04 is hooked to the intestinal wall, and the dosage of the medicament 04 coupled to the medicament delivery link 0303 can be controlled according to the dosage of the medicament according to the present invention, which is well known to those skilled in the art.
Fig. 6 is a schematic diagram of a drug release process of the drug release capsule of the invention, wherein the drug release capsule of the invention can accurately perform drug release operation at a certain position according to the requirement in the gastrointestinal tract advancing process, thereby achieving the purpose of accurately releasing the drug, avoiding the premature decomposition and potential risk of the drug in the gastric cavity and improving the treatment effect.
Referring to fig. 7, a schematic diagram of an expanded state of a drug delivery device according to a second embodiment of the present invention and a schematic diagram of a closed state of a drug delivery device according to a second embodiment of the present invention shown in fig. 8 are shown, wherein the second drug delivery device 05 comprises a second power system 0501, a first base 0502, a first link 0503, a rivet 0504, a second link 0505, a second base 0506, and a second screw 0507.
The power system 0501 is connected with a second screw rod 0507, and power is transmitted through the second screw rod; the both ends of second lead screw 0507 are connected first base 0502 and second base 0506 respectively, first base 0502 and second base 0506 can be respectively on second lead screw 0507 rectilinear motion, first connecting rod 0503 and second connecting rod 0505 are connected respectively to first base 0502 and second base 0506, and first connecting rod 0503 can rotate around first base 0502, and second connecting rod 0505 can rotate around second base 0506, and first connecting rod 0503 and second connecting rod 0505 pass through rivet 0504 riveting, first connecting rod 0503 and second connecting rod 0505 swing each other around rivet 0504 center.
When the medicament is required to be delivered, the second power system 0501 drives the second screw rod 0507 to rotate, and threads with opposite directions are arranged at the two ends of the second screw rod 0507, so that the first base 0502 and the second base 0506 are driven to move from the two ends to the middle; when the first base 0502 and the second base 0506 move towards the middle at the same time, the horizontal distance between the first base 0502 and the second base 0506 is shortened, so that the first link 0503 and the second link 0505 are forced to open from a horizontal state to a certain angle to adapt to the change of the distance, and the opening of the mechanism is realized.
When the first base 0502 and the second base 0506 are required to be retracted and closed, the second power system 0501 drives the second screw rod 0507 to rotate, and threads with opposite directions are arranged at the two ends of the second screw rod 0507, so that the first base 0502 and the second base 0506 are driven to move from the middle to the two ends; when the first and second bases 0502, 0506 move simultaneously to both ends, the horizontal distance between the first and second bases 0502, 0506 increases, forcing the relative angle between the first and second links 0503, 0505 to decrease to the horizontal to accommodate the change in distance, thereby achieving closure of the medicament delivery device.
Optionally, the first link 0503, the rivet 0504, and the second link 0505 are made of a material that is digestible in intestinal tract, for example, but not limited to, any material that is polyglycolic acid (PGA), polylactic-co-glycolic acid (PLGA), or maltose, and when the second drug delivery device 05 needs to be retracted and closed after the drug delivery is completed, the first link 0503, the rivet 0504, and the second link 0505 begin to melt after a set time (for example, 1-2 s), so as to achieve retraction and closure of the second drug delivery device 05.
Further, the number of the link groups and the bases in the drug delivery device of the second embodiment is not limited to two, but may be plural, and those skilled in the art can make appropriate adjustments as required without departing from the spirit and the essence of the present invention, and these modifications and adjustments are all within the scope of the present invention.
The invention also provides a medicament delivery method, when the degradable coating 02 of the medicament release capsule is degraded, the internal environment of the medicament release capsule is communicated with the intestinal environment, the change of pressure or PH value triggers the sensor and gives a signal to the control module, the motor rotates and provides power to enable the medicament delivery device 03 to prop open, and the medicament 04 is delivered and injected into the intestinal wall.
The medicament delivery device, the medicament release method and the medicament release capsule thereof can accurately perform medicament release operation on a patient part according to the requirements in the gastrointestinal tract advancing process, thereby achieving the purpose of accurately releasing medicament, avoiding the premature decomposition and potential risk of medicaments in the gastric cavity and improving the treatment effect.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.

Claims (3)

1. The medicament delivery device is characterized by comprising a medicament delivery window, a first delivery power system, a first fixing seat, a medicament delivery connecting rod, a first screw rod, a nut, a guide rod and a second fixing seat, wherein the first fixing seat is used for fixing the delivery power system, and the first fixing seat and the second fixing seat are assembled and fixed together through the guide rod to serve as a fixing base of the medicament delivery device;
when the first delivery power system rotates, the medicament delivery connecting rod drives the first screw rod to rotate, the rotational motion is further converted into axial linear reciprocating motion through the nut, the medicament delivery connecting rod is pushed to expand, and medicament which is detachably coupled to the medicament delivery connecting rod is delivered into the intestinal tract arm through medicament delivery windows, the medicament delivery windows are arranged on the surface of a shell of a medicament release capsule, at least two medicament delivery windows are covered by degradable coatings, the degradable coatings are composed of one or more of gelatin, cellulose or polysaccharide, the medicament further comprises a needle-tip-shaped head and barbs, the needle-tip-shaped head is used for penetrating the intestinal tract arm, and the barbs are used for hooking the medicament into the intestinal tract wall so as to be separated from the medicament delivery connecting rod conveniently; the medicament delivery connecting rod is made of any one of polyglycolic acid, polylactic acid-glycolic acid copolymer or maltose; and the first delivery power system drives the threads with forward and reverse bidirectional rotation arranged at the two ends of the first screw rod to start to reversely rotate after 1-2s after the medicament is delivered, so that the first medicament delivery device is retracted and closed.
2. The medicament delivery device is characterized by comprising a second delivery power system, a first base, a first connecting rod, a rivet, a second connecting rod, a second base and a second screw rod, wherein the second delivery power system is connected with the second screw rod and transmits power through the second screw rod; the two ends of the second screw rod are respectively connected with a first base and a second base, the first base and the second base can respectively do linear motion on the second screw rod, the first base and the second base are respectively connected with a first connecting rod and a second connecting rod, the first connecting rod can rotate around the first base, the second connecting rod can rotate around the second base, the first connecting rod and the second connecting rod are riveted through rivets, and the first connecting rod and the second connecting rod mutually swing around the center of the rivets; the first connecting rod, the second connecting rod and the rivet are made of any one of polyglycolic acid, polylactic acid-glycolic acid copolymer or maltose; and the second delivery power system drives the threads with forward and reverse bidirectional rotation arranged at the two ends of the second screw rod to start to reversely rotate after 1-2s after the medicament is delivered, so that the medicament delivery device is retracted and closed.
3. A drug delivery capsule comprising a shell, a degradable coating, a medicament and the medicament delivery device of any one of claims 1-2, wherein the degradable coating is applied to the outer surface of the shell, and the medicament delivery device and the medicament are both internally arranged inside the shell; the surface of the housing is provided with at least two medicament delivery windows, which are covered by a degradable coating consisting of one or more of gelatin, cellulose or polysaccharide.
CN202211035872.2A 2022-08-27 2022-08-27 Medicament delivery device, medicament release method and medicament release capsule using same Active CN115300774B (en)

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Publication number Priority date Publication date Assignee Title
CN103987422A (en) * 2011-06-29 2014-08-13 拉尼医疗有限公司 Device, system and methods for the oral delivery of therapeutic compounds
CN105705194A (en) * 2013-09-05 2016-06-22 威里利生命科学有限责任公司 Delivery of functionalized particles
CN114007638A (en) * 2019-05-03 2022-02-01 拉尼医疗有限公司 Coagulation factor formulations delivered into the intestinal tract using a swallowable drug delivery device

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9259386B2 (en) * 2010-12-23 2016-02-16 Rani Therapeutics, Llc Therapeutic preparation comprising somatostatin or somatostatin analogoue for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9149617B2 (en) * 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103987422A (en) * 2011-06-29 2014-08-13 拉尼医疗有限公司 Device, system and methods for the oral delivery of therapeutic compounds
CN105705194A (en) * 2013-09-05 2016-06-22 威里利生命科学有限责任公司 Delivery of functionalized particles
CN114007638A (en) * 2019-05-03 2022-02-01 拉尼医疗有限公司 Coagulation factor formulations delivered into the intestinal tract using a swallowable drug delivery device

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