WO2006121754A2 - Dispositif capable d'administrer des formes posologiques pharmaceutiques solubles dans des espaces corporels - Google Patents

Dispositif capable d'administrer des formes posologiques pharmaceutiques solubles dans des espaces corporels Download PDF

Info

Publication number
WO2006121754A2
WO2006121754A2 PCT/US2006/017150 US2006017150W WO2006121754A2 WO 2006121754 A2 WO2006121754 A2 WO 2006121754A2 US 2006017150 W US2006017150 W US 2006017150W WO 2006121754 A2 WO2006121754 A2 WO 2006121754A2
Authority
WO
WIPO (PCT)
Prior art keywords
flexible tube
medicinal
plunger
applicator
medicinal applicator
Prior art date
Application number
PCT/US2006/017150
Other languages
English (en)
Other versions
WO2006121754A3 (fr
Inventor
Erin Carpenter Westerholm
Robert Hunt Carpenter
Original Assignee
Robert H. Carpenter Dvm, Pc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Robert H. Carpenter Dvm, Pc filed Critical Robert H. Carpenter Dvm, Pc
Publication of WO2006121754A2 publication Critical patent/WO2006121754A2/fr
Publication of WO2006121754A3 publication Critical patent/WO2006121754A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/007—Injectors for solid bodies, e.g. suppositories

Definitions

  • This invention relates to a device for delivering medicaments or medical devices into body spaces. More specifically, this invention pertains to an apparatus for administering pills or tiny medical devices into a body cavity while protecting the pill or medical device from the aqueous environment in the body cavity until the pill or medical device is positioned properly in the body cavity.
  • solid or semisolid dose forms of these pharmaceuticals and biologicals may be the most suitable and stable formulation for a pharmaceutical composition. Additionally, solid or semisolid dose forms may be used to achieve a desired local pharmacological effect while avoiding the potential adverse effects accompanying systemic administration of a pharmaceutical or biological. The production of multiple sizes, concentrations and dose forms of these pharmaceuticals and biologicals may not be practical or cost efficient for manufacturers; therefore, there is occasion in medical practice where delivery of a subdivision of a highly soluble solid or semisolid dose form may be required to achieve the proper dose and clinical outcome for a treatment or procedure. [0005] Delivery of solid or semisolid dose forms is as old as the history of medicine.
  • the described device will assist the skilled practioner in accurately placing solid or semisolid dose forms in or on the patient while preventing premature dissolution of the fraction dose form.
  • This device or modifications of this device may also facilitate the manufacture and delivery of unit-dose solid, powdered or semisolid pharmaceutical products.
  • This device and its modifications can overcome all the premature dissolution and accurate hand placement problems associated with currently practiced procedures and techniques used to deliver solid or semisolid dose forms in human and veterinary medicine. Additionally this device and its modifications may be adapted for use in minimally invasive surgical procedures including, but not limited to orthopedic, laparoscopic and endoscopic procedures for delivery of solid or semisolid dose forms. Radiological markers, micro or nano scale medical devices, or other solid medical devices could benefit from an accurate location delivery system.
  • This present invention relates to a medicinal applicator for delivering compositions or tiny medical devices into body spaces.
  • the medicinal applicator is used for administering therapeutic compositions or devices (e.g. pills, micro- or nano- scale medical devices, or parts thereof) into a body cavity while preventing the therapeutic composition or device from contacting the aqueous environment in the body cavity until the precise placement of the therapeutic composition or device has been located.
  • therapeutic compositions or devices e.g. pills, micro- or nano- scale medical devices, or parts thereof
  • a first aspect of this invention is a medicinal applicator that includes a flexible tube with a bore hole or lumen traversing the entire length of the flexible tube from a proximal end of the flexible tube to a distal end of the flexible tube; a plunger traversing the bore hole or lumen of the flexible tube; an elastic membrane having a self-sealing watertight opening and covering the bore hole or lumen forming a delivery end of the flexible tube; and a removable finger retaining loop.
  • the delivery end of the flexible tube and the plunger form a therapeutic holding chamber that remains watertight until the plunger is depressed at the proximal end mechanically propelling the mendicant through the watertight opening of the elastic membrane.
  • the flexible tube can be made from medicinal grade metals, plastics, or composite materials (e.g. stainless steel, HDPE, silicon, plastic coated material, or silicon coated materials).
  • the length of the flexible tube is in the range of about 5 cm to about 1 ,000 cm, preferably in the range of about 15 cm to about 50 cm.
  • the diameter of the flexible tube is in the range of about 1 mm to about 30 mm, preferably the range of about 3 mm to about 10 mm.
  • the elastic membrane having a self- sealing and relatively watertight opening is preferably silicone, but can be made from other materials having similar mechanical properties, such as plastic, synthetic or natural rubber.
  • the medicinal applicator further comprises a camera. This camera or similar device can be used to confirm the placement location of the mendicant.
  • a second aspect of the current invention is a method of administering a medicinal product into a body cavity of a mammal using a medicinal applicator described above.
  • the method includes loading the medicinal product into the therapeutic holding chamber, forming a primed medicinal applicator; placing the delivery end of the primed medicinal applicator in a desired location in the body cavity of the mammal; depressing the plunger at the proximal end and mechanically propelling the medicinal product through the watertight opening of the self-sealing elastic membrane at the delivery end; returning the plunger to a position capable of allowing the self-sealing elastic membrane to reseal.
  • the medicinal applicator is removed from the body cavity of the mammal.
  • the medicinal product comprises a pill, medical device, a marker, or a dye.
  • FIGURE 1 shows the basic design and components of one embodiment of the device.
  • FIGURE 2 shows two views of the delivery end of one embodiment of the device, 2A shows a front view, and 2B shows a side view with a medicament being propelled through the re-sealable watertight opening.
  • FIGURE 3 shows the basic design of one embodiment of the device and having a finger loop.
  • flexible applicator rod (11 ) removable palm bar; (20) plunger; (21) beveled end for deployment; (22) end of plunger; (30) substantially water tight holder; (31 ) medicament or device; (32) reservoir space; (40) removable finger loop; (41) finger device attachment; (42) finger hole.
  • FIGURE 4 shows the basic design and palm bar.
  • FIGURE 5 shows the device inserting a medicament into the vaginal fornix of a mammal.
  • the medicinal applicator of this invention can be used in different procedures for delivery of a medicament (e.g. pills, tiny medical devices, markers, dyes, etc.) to specific areas of different types of body cavities, body spaces, wounds, or injuries in different mammals (e.g. companion animals, research animals, feed animals, and humans).
  • a medicament e.g. pills, tiny medical devices, markers, dyes, etc.
  • mammals e.g. companion animals, research animals, feed animals, and humans.
  • the present invention relates to a medicinal applicator consisting of a tubular structure containing a plunger placed in one end of the tube that when partially withdrawn allows placement an object in the opposite end of the tubular structure and when advanced would push the object out of the opposite end of the tubular structure.
  • a flexible membrane shaped reservoir On the distal end of the tubular structure is a flexible membrane shaped reservoir that can be manually opened, but when released reforms into a near-fluid-tight membrane, which prevents fluids under physiological conditions from entering the re-sealable membrane into the reservoir.
  • the reservoir would be of sufficient size and shape to accommodate an object being placed therein, such as a solid or semisolid pharmaceutical dose form or medical device.
  • the plunger would be of sufficient length to clear any object(s) in the tube and membrane shaped reservoir end and cause the object(s) to be pushed out and positioned just outside the membrane covered end. When the plunger is withdrawn the membrane would immediately close behind the plunger end, thus depositing the object(s) immediately at the end of the tubular device.
  • This device can be used for delivering a medicament after locating the proper position for delivery by hand.
  • the tubular device is presented for use with a stretchable finger loop that is adjustable along the tube so that the practitioner can tightly secure the device to a finger and can palpate with that finger for the proper anatomical location for dose form delivery.
  • the delivery is achieved by advancing the entire device to the proper location and then advancing the plunger to discharge the solid or semisolid dose form from the reservoir onto the tissue at the desired location.
  • there is a palm bar that also is adjustable in location along the tubular device to fit the practitioner's hand. This bar allows the advancement of the tubular device with the thumb of the same hand or fine adjustment of the device membrane tip without the use of the practitioner's other hand.
  • the plunger can then be advanced with the thumb of the palpating hand, the practitioner's other hand or with the assistance of another party, object or machine.
  • This device is useful for delivering a medicament during minimally invasive surgical procedures including arthroscopic, endoscopic and laparoscopic procedure, the tubular device would be of optimal diameter and sufficient length to fit through the trocar sheath and deliver the solid or semisolid dose form, or radiological marker or other solid medical device accurately to the desired tissue structure or organ in the body cavity or tissue space desired.
  • an endoscope is a device that is usually used with an attached light, for looking inside a body cavity or organ.
  • the endoscope is inserted through a natural opening, such as the mouth during a bronchoscopy, the rectum for a sigmoidoscopy, or the vagina for a cystoscopy.
  • a medical procedure using any type of endoscope is called endoscopy (e.g.
  • One aspect of the present invention relates to the delivery of a portion of a tablet that has been sub fractionated to more accurately dose a local tissue structure or organ by surface delivery.
  • a sub fractionated tablet is exposed to body fluids as it is being advanced within the body space for specific location placement, dissolution begins immediately and this dissolution may be premature or at the wrong location to achieve the proper dose and clinical outcome desired.
  • the described device will protect the tablet or part thereof, from contact with body tissues or fluids until the plunger is advanced at the proper location and the tablet or part thereof, is pushed through the split membrane end of the tubular device.
  • Another embodiment of the present invention relates to a device that incorporates the finger loop and membrane tip and is used for intrauterine installation of solid or semisolid dose forms in domestic animals.
  • the tubular device would have to be approximately 1 meter in length and obviously would not need a palm bar, but might incorporate a similar structure near the plunger end to facilitate the movement of the tubular device with the shoulder, mouth or other hand of the practioner for accurate placement of the dose in the uterine horn or other body cavity or tissue structure.
  • the device can be constructed from any suitable material (e.g. metal, plastic, or composite materials, or a combination thereof).
  • the device tubular structures would be made from materials that are approved by the US/FDA for tissue and pharmaceutical contact as listed in the 21 C. F. R.
  • the preferred embodiment would have the tubular and plunger structures molded, formed or prefabricated from medical grade high density polyethylene (HDPE).
  • the reservoir membrane and finger loop would be made from medical grade silicone.
  • the palm bar can be made from a combination of silicone and HDPE.
  • the devices components could be sterilized by methods using heat, ethylene oxide or other suitable gas sterilent.
  • the device would be presented in "clear-on-one-side" packaging for clinic, delivery or operating room use.
  • the tubular component (10) may be of any length required by the distance from the body surface to the location of the tissue to be treated. These lengths could be substantially different for humans or domesticated animals.
  • the tube might incorporate a roughened or flared grip area (11) that would facilitate holding the device by the practioner.
  • the plunger (20) would be flared on one end (21). The plunger would be of a sufficient length to be able to push out the object (1) placed in the other end of the tube.
  • On the other end of the tube is a reservoir membrane (30) for holding the medicament.
  • the reservoir membrane (30) has two ends, the first end connects the reservoir to the end of the tube, which forms the void for holding the medicament.
  • the second end contains an opening that allows the medicament to be loaded into the device and also allows the medicament to be released at the desired location.
  • the preferred reservoir membrane contains a slit (31) in the second end of the membrane for loading and unloading the medicament, but forms a near-fluid-tight seal that can be opened manually to allow one to place the dose form inside the reservoir space (32).
  • the distal end of the plunger (22) When the proximal end of the plunger is advanced by a user, the distal end of the plunger (22) would push out any object(s) contained in the tube and/or reservoir space by forcing the object out the split end (31) as illustrated in Figure 2.
  • the reservoir membrane (30) immediately reassumes its substantially fluid-tight form and isolates the object (1) delivered from the reservoir and the device. Thus the dose is delivered.
  • the reservoir membrane is made from a material that will not allow the dose form to adhere to it in sufficient quantity to effectively alter the desired local dose or location of the dose or solid medical device delivered.
  • One embodiment of the present invention relates to the device that incorporates a finger loop (40) component that is adjustable along the tube near the reservoir membrane (Figure 3).
  • the finger loop component would consist of a tube loop (41) to go around the tubular part of the device (10) and a connected finger loop (42) of flexible and expandable material to allow the operator to insert his finger.
  • This specific embodiment would be used for intrauterine installation of solid or semisolid dose forms in humans and in domestic animals.
  • the tubular device would vary from approximately 10 cm to approximately 1 meter in length and may or may not incorporate a palm bar (50).
  • the palm bar would consist of a tube loop (51) to make the bar adjustable along the length of the tube (10) and a flat rectangular piece (52) to rest against the palm of the operator.
  • a variant device might incorporate a similar bar structure near the plunger end of the tube to facilitate the movement of the tubular device with the shoulder, mouth or other hand of the practioner for accurate placement of the dose in the uterine horn or other structure in animals.
  • This device would allow the practioner to accurately deliver the solid dose form to the correct anatomical location with ease and without the dose starting to dissolve.
  • This device design is very safe in these applications because the membrane reservoir end is soft and would not cause tissue damage or penetration when used by a practioner skilled in the art and practice of obstetrics.
  • This device would allow the veterinary practioner to utilize a wider range of intrauterine antibiotic dose forms and place them deeper into the uterus and associated structures.
  • This device design is very safe in these applications because the membrane reservoir end is soft and would not cause tissue damage or penetration when used by a practioner skilled in the art and practice of veterinary medicine.

Abstract

Selon l'invention, un dispositif d'administration de médicaments comprend un tube flexible pourvu d'un trou ou d'une lumière traversant la totalité de la longueur dudit tube d'une extrémité proximale jusqu'à une extrémité distale dudit tube, un piston traversant le trou ou la lumière du tube flexible, une membrane élastique qui est pourvue d'une ouverture relativement étanche et autoscellante et qui recouvre le trou ou la lumière formant une extrémité d'administration du tube flexible, ainsi qu'une boucle de retenue de doigt amovible. Dans un mode de réalisation préféré, l'extrémité d'administration du tube flexible et le plongeur forment une chambre de support thérapeutique qui reste étanche dans les conditions physiologiques d'une cavité corporelle, jusqu'à ce que le plongeur soit enfoncé au niveau de l'extrémité proximale, ce qui permet de propulser mécaniquement le médicament à travers l'ouverture étanche de la membrane élastique dans la cavité corporelle.
PCT/US2006/017150 2005-05-05 2006-05-03 Dispositif capable d'administrer des formes posologiques pharmaceutiques solubles dans des espaces corporels WO2006121754A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US67812505P 2005-05-05 2005-05-05
US60/678,125 2005-05-05

Publications (2)

Publication Number Publication Date
WO2006121754A2 true WO2006121754A2 (fr) 2006-11-16
WO2006121754A3 WO2006121754A3 (fr) 2007-03-22

Family

ID=36809008

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/017150 WO2006121754A2 (fr) 2005-05-05 2006-05-03 Dispositif capable d'administrer des formes posologiques pharmaceutiques solubles dans des espaces corporels

Country Status (1)

Country Link
WO (1) WO2006121754A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102599988A (zh) * 2012-04-09 2012-07-25 蓝海宁 投喂器
CN102670327A (zh) * 2012-05-23 2012-09-19 扬州大学 反刍动物瘤胃缓释丸剂投服器
US9517328B2 (en) 2013-06-19 2016-12-13 Kashiv Pharma, Llc Medicament applicator
CN109224271A (zh) * 2018-11-28 2019-01-18 陈巧丽 一种肛门或阴道送药管
CN109260583A (zh) * 2018-11-28 2019-01-25 陈巧丽 一种肛门或阴道送药装置

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2524309A1 (fr) * 1982-04-01 1983-10-07 Liss Irene Dispositif pour l'administration de suppositoires pouvant egalement convenir pour l'emballage de ces derniers
US4578061A (en) * 1980-10-28 1986-03-25 Lemelson Jerome H Injection catheter and method
US5788664A (en) * 1994-11-30 1998-08-04 Scalise; Gaspare Suppository applicator
FR2794372A1 (fr) * 1999-06-07 2000-12-08 Doms Adrian Lab Dispositif d'application d'un medicament, produit de soin, d'hygiene ou de sante dans la cavite vaginale
US20030158510A1 (en) * 2002-02-13 2003-08-21 Deborah Huang Drug delivery device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4578061A (en) * 1980-10-28 1986-03-25 Lemelson Jerome H Injection catheter and method
FR2524309A1 (fr) * 1982-04-01 1983-10-07 Liss Irene Dispositif pour l'administration de suppositoires pouvant egalement convenir pour l'emballage de ces derniers
US5788664A (en) * 1994-11-30 1998-08-04 Scalise; Gaspare Suppository applicator
FR2794372A1 (fr) * 1999-06-07 2000-12-08 Doms Adrian Lab Dispositif d'application d'un medicament, produit de soin, d'hygiene ou de sante dans la cavite vaginale
US20030158510A1 (en) * 2002-02-13 2003-08-21 Deborah Huang Drug delivery device

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102599988A (zh) * 2012-04-09 2012-07-25 蓝海宁 投喂器
CN102670327A (zh) * 2012-05-23 2012-09-19 扬州大学 反刍动物瘤胃缓释丸剂投服器
US9517328B2 (en) 2013-06-19 2016-12-13 Kashiv Pharma, Llc Medicament applicator
US9884173B2 (en) 2013-06-19 2018-02-06 Kashiv Pharma, Llc Medicament applicator
US10940300B2 (en) 2013-06-19 2021-03-09 Kashiv Pharma, Llc Medicament applicator
CN109224271A (zh) * 2018-11-28 2019-01-18 陈巧丽 一种肛门或阴道送药管
CN109260583A (zh) * 2018-11-28 2019-01-25 陈巧丽 一种肛门或阴道送药装置
CN109224271B (zh) * 2018-11-28 2021-04-30 盛泰英诺(嘉兴)医疗科技有限公司 一种肛门或阴道送药管
CN109260583B (zh) * 2018-11-28 2021-07-27 青岛市市立医院(青岛市临床医学研究所、青岛市医学影像中心) 一种肛门或阴道送药装置

Also Published As

Publication number Publication date
WO2006121754A3 (fr) 2007-03-22

Similar Documents

Publication Publication Date Title
US9555168B2 (en) System for delivery of medication in treatment of disorders of the pelvis
US20050021069A1 (en) Inflatable apparatus for accessing body cavity and methods of making
JPH04261667A (ja) 分配カテーテル
EP1951101A2 (fr) Appareils et procedes pour libérer un ou plusieurs produits libérables dans un corps
CN105142488A (zh) 用于评价体腔的活检和超声扫描方法与装置
US20160001051A1 (en) Method of drug delivery for ovarian cancer
US6423038B1 (en) Topical intra-uterine anesthesia device and method
US20140378754A1 (en) Uterine embryo retrieval
WO2006121754A2 (fr) Dispositif capable d'administrer des formes posologiques pharmaceutiques solubles dans des espaces corporels
US20140378751A1 (en) Uterine lavage for embryo retrieval
CA2533491A1 (fr) Appareil gonflable d'acces a une cavite corporelle et procedes de production
US7165550B1 (en) Cervical isolation and delivery apparatus
US20140378750A1 (en) Uterine lavage for embryo retrieval
WO2020182535A1 (fr) Tube de sonde utérine ayant un applicateur d'anesthésique
US20220161010A1 (en) Drug delivery and administration device
CN207532629U (zh) 一种宫颈上药装置
CN211536173U (zh) 一种用于宫颈炎症创面上药的上药器
US20210187261A1 (en) Percutaneously administered therapeutic substance for treatment of target tissue
RU2752541C1 (ru) Способ лечения тонкого эндометрия в процессе подготовки к программе ЭКО
Beasley et al. Contraceptive procedures
US20210077797A1 (en) Track endocervical lower uterine medicine inserter
CN105214208A (zh) 一种阴道内定位给覆药膨胀栓
US20150005700A1 (en) Sanitary device for applying an active principle within a body cavity
WO2019018913A1 (fr) Dispositif formant enveloppe pour distribuer des produits topiques à usage oral, vulvaire et anal, pouvant être accouplé à un applicateur portatif à usage vaginal et rectal
US20120116297A1 (en) Medication Application Device for Use in Body Cavities

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase in:

Ref country code: DE

NENP Non-entry into the national phase in:

Ref country code: RU

122 Ep: pct application non-entry in european phase

Ref document number: 06752219

Country of ref document: EP

Kind code of ref document: A2