Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...
Reexamination Certificate
2002-02-07
2004-07-06
Dawson, Glenn K. (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material applied to or removed from external...
C604S151000, C222S401000, C222S325000
Reexamination Certificate
active
06758837
ABSTRACT:
TECHNICAL FIELD
The present invention relates to devices and methods for ejecting a liquid stream, in particular towards an eye, the stream moving from a proximal position towards a distal position, the device comprising a) a housing, b) a container for the liquid, c) at least one opening arranged for ejection of the stream and being in fluid communication with the container, d) a pump mechanism operable to deliver at least part of the liquid from the container through the opening to form the stream and e) an eyecup with a contact surface arranged for contact with the eye or its facial surroundings. The pump mechanism may include a pump driver able to store cocked energy for driving the pump mechanism and at least one activation mechanism may be present and operable to initiate the device for the liquid delivery.
BACKGROUND
Devices for ejection of liquid streams may have many utilities. In the medical area typical applications include injection or infusion, treatment of a body cavities, intrapulmonary delivery or treatment of the body surface such as topical treatment. For reasons to be explained, aspects of the present invention have special utility in ophthalmology and especially in liquid treatment of and eye. For convenience and unless otherwise indicated the invention will be described in terms of this application although-aspects of the invention has broader utility.
Devices for delivery of fluids, and in particular liquids, to the eye have been used since long for a great variety of purposes. The common eye bath for comfort, refreshment or rinsing may comprise a cup of anatomically adapted design for immersion of the eye. Delivery of large liquid amounts, usually by spray devices, has also been used in eye washes for example in emergency situations. The present invention is mainly concerned with devices suitable for administration of relatively small amounts of fluids to the eye and also devices of sufficient convenience in handling to facilitate or encourage frequent use, also in self-administration situations. A common application is the administration of medical to the eye. Typically the medical preparation has to be delivered in a fairly well defined volume to assure a specified dose to be delivered or absorbed. A large surplus cannot be allowed due to improper physiological effects from absorbency in non-target tissues or drainage of excess amounts through the tear channel into the throat cavity or the inconveniences caused by overflow on face and clothes. Also price considerations apply for expensive medications. As an example, the treatment of glaucoma requires frequent daily administrations of e.g. prostaglandins, beta-blockers or other expensive active ingredients, all having other then the desired pressure relieving action when absorbed by other body tissues than the eye. Moreover, proper administration of small amounts is complicated by the fact that the active ingredients cannot enter the eye but through the limited area of the cornea. Although the device to be described herein can be used with any fluid for any purpose, for convenience the invention will mainly be described in terms of medical applications.
The circumstances mentioned place severe demands on a device for the general purposes stated. The necessarily small preparation amount has to be positioned with great care in the eye not to invoke the dosing, overflow, side-effect and targeting errors mentioned. Typically also secondary steps have to be mastered, such as initiation steps and control of device status and preparation condition.
These demands can be met also when using the simplest delivery devices when in the hands of a skilled operator who also may initiate medically relevant corrective measures in case of accidents and malfunction. Also when using sophisticated devices for example in a hospital environment. However, a general treatment trend is to place administration responsibility on the patients themselves, also in the case of child, elderly and disabled persons. In long-term treatment the patient often develop a certain skill but less frequent administration schemes also exist, often including situations of emergency or patient imbalance. Other unique problems in patient self-administration, as compared to assistant operated administration, is that less suitable and often strained body positions are required and that apprehended or experienced pain or discomfort may interfere with the medically desirable action pattern. In summary, especially the self-administration requires more sophisticated devices to facilitate the injection procedure and avoid or reduce risks for mistakes. Patients dependent on daily or occasional administrations also have a legitimate need for convenience and devices discrete enough to be brought around in daily life. Yet it is desirable that such sophistication and convenience is kept simple and inexpensive to allow for widespread distribution and inclusion also in disposable devices.
Prior art devices have only to a limited extent been able to fulfill the demands stated. Devices with manually controlled pump mechanisms have been proposed, for example in WO 98/55059 and U.S. Pat. No. 5,607,410 having features for convenient use or compact transport form respectively. However, such devices, directed to multiple-dose containers have no specific means for self-control, e.g. in respect of initiation steps or liquid status. For some purposes it is desirable to replace manually operated pump mechanisms with some kind of automated operation, typically involving release of stored energy, e.g. for controlled initiation, triggering, forces, speed, reset or sequencing. Also special demand may be posed by requirements for high liquid speeds. Medical devices of this kind are for example auto-injectors, where liquid injection takes places automatically after triggering, and jet-injectors where penetration takes place by use of liquid speed instead of by use of a needle. In eye treatment fairly rapid liquid streams have been proposed for the purposes of delivering the liquid fast enough to beat the blink reflex and also to enable delivery of very small doses, smaller than a gravity delivered drop, by ejection of controlled amount of liquid from a pressurized chamber through a narrow orifice. Devices of this kind are described in for example in WO 96/00050 for multiple dose containers and in WO 96/06581 and our co-pending application PCT/SE00/01514 for single dose containers. The disclosed proposals of this kind are not optimized for use as portable or handheld devices, neither in respect of convenience features nor in respect of suitability for further automation.
Accordingly there is a continuing need for simple and inexpensive ejection devices able to assist the user in the various handling steps involved, preventing or ameliorating mistakes and offering an ergonomic, convenient and non-traumatic product, especially useful for patients under self-administration. Although the present invention may have a more general utility, it will mainly be described against this background.
SUMMARY OF INVENTION
A main object of the present invention is to provide an liquid delivery device meeting the general demands described herein-above better than hitherto known devices. A more specific object is to provide such a device suitable for portable or hand-held use. Another object is to provide a device convenient in use and suited for self-treatment situations. Still another object is to offer a device useful for mechanized, rather than manual, operation of its liquid pump mechanism. Yet another purpose is to offer a device having arrangements for initiation and/or control steps. A further object is to provide such a device suitable for automation or motorization of its functions. Yet another object is to provide a motorized device providing energy and/or force economy. Still another object is to provide a device suitable for high speed delivery of liquid. Another object is to provide a device compatible with multi-dose or single dose containers. A further object is to provide a device s
Gremion Emmanuel
Himbert Hans
Käser Stefan
Peclat Christian
Saurer Alain
Dawson Glenn K.
Dinsmore & Shohl LLP
Pharmacia AB
Truong Linh
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