GB2388549A

GB2388549A - Apparatus for treating body tissues with medicaments

Info

Publication number: GB2388549A
Application number: GB0318625A
Authority: GB
Inventors: Jacob Richter
Original assignee: Zuli Holdings Ltd
Current assignee: Zuli Holdings Ltd
Priority date: 1999-07-26
Filing date: 2000-07-25
Publication date: 2003-11-19
Anticipated expiration: 2020-07-25
Also published as: GB2388548B; GB2388549B; GB0318623D0; GB2388548A; GB0318625D0

Abstract

Apparatus for treating body tissue, comprises a housing (4) provided with a medicament storage compartment and an oscillating member (7) attached to the housing and communicating with the medicament storage compartment, the oscillating member being adapted to oscillate in response to ultrasonic stimulation. A medicament port (9) disposed on the housing (4) and in fluid communication with the medicament storage compartment is adapted to permit a medicament to be introduced into and contained in the compartment and further adapted to selectively release the medicament from the medicament storage compartment in response to oscillations of the oscillating member (7). A sensor means (11) adapted to receive preselected stimuli generated by the body tissue is adapted to communicate with and selectively energize a means (10) for selectively generating and transmitting ultrasonic vibrations (8) to the oscillating member in response to preselected stimuli generated by the body tissue.

Description

GB 2388549 A continuation (74) Agent and/or Address for Service: Saunders

& Dolleymore 9 Rickmansworth Road, WATFORD, Herts, WD18 OdU, United Kingdom

APPARATUS FOR TREATING BODY TISSUES WITH MEDICAMENTS

The present invention relates generally to devices which are implanted within the body of a living animal or human to impart a therapeutic benefit to a 5 target tissue. More particularly this invention relates to an apparatus for selectively delivering a medicament to a target tissue or organ. It is also the intention of this invention to provide improved treatment by reducing the time between the sensing of a specific activity within the tissue or organ being treated and the onset of the delivery of the medicament drug to the site of the sensed 1 0 activity.

Many disorders, e.g. brain disorders and certain types of paralysis, are treated by an electrical stimulus or local drug delivered to specific sites in the brain or the body. One shortcoming of conventional treatment devices and 15 procedures is that conventional treatment devices are large and their placement may cause damage to the patient. Another shortcoming of conventional treatment devices and procedures is that the devices are often implanted and must remain connected to the outside world for their control signal or energy supply. Another shortcoming of conventional devices and procedures is that drug delivery to the 20 target tissue may cause trauma to the patient and may not be precisely delivered to the target tissue. Another shortcoming of conventional procedures is that the physical connection to the outside world and the repeated trauma to the patient required by repeated invasion and introduction of foreign objects into the tissue

increases the likelihood of infection. Yet another shortcoming of conventional 25 devices and procedures is that they do not provide precise timing of the delivery of the electrical stimulus or drug in response to phenomena happening in, and to stimuli generated by, the tissue or the organ being treated indicating the need for the delivery of such an electrical stimulus or drug.

30 It is an object of this invention to provide an apparatus and method for

-2 selectively delivering a medicament over a period of time to a target tissue of the body, e.g. the brain, without creating a large lesion in the target area and without requiring a connection to the outside world, i.e. outside the patient's body.

5 It is a further object of this invention to provide a device for treating body tissue, comprising a housing provided with a medicament storage compartment.

An oscillating member is attached to the housing and communicates with the medicament storage compartment and is adapted to oscillate in response to ultrasonic stimulation. A medicament port is disposed on the housing and is in 10 fluid connunication with the medicament storage compartment and is adapted to permit a medicament to be introduced into and contained in the compartment.

The medicament port is farther adapted to selectively release the medicament from the medicament storage compartment in response to the oscillations of the oscillating member which produce a "pumping" action to pump the medicament 15 out of the compartment in response to external high frequency stimulation.

It is a further object of the invention to provide apparatus for treating body - hssue, compnsing: a) a housing provided with a medicament storage compartment; 20 b) an oscillating member attached to the housing and communicating with the medicament storage compartment, the oscillating member adapted to oscillate in response to ultrasonic stimulation; c) a medicament port disposed on the housing and in fluid communication with the medicament storage compartment, the medicament port 25 adapted to permit a medicament to be introduced into and contained in the compartment and further adapted to selectively release the medicament from the medicament storage compartment in response to oscillations of the oscillating member; and d) sensor means, the sensor means adapted to receive preselected 30 stimuli generated by the body tissue, the sensor means adapted to communicate

with arid selectively energize a means for selectively generating and transmitting ultrasonic vibrations to the oscillating member in response to the preselected stimuli generated by the body tissue.

5 It is a further object of the invention to provide apparatus for treating body tissue, comprising: a) a housing provided with a medicament storage compartment; b) an oscillating member attached to the housing and communicating with the medicarnent storage compartment, the oscillating member adapted to 10 oscillate in response to ultrasonic stimulation; c) a medicament port disposed on the housing and in fluid communication with the medicarnent storage compartment, the medicarnent port adapted to permit a medicarnent to be introduced into and contained in the compartment and further adapted to selectively release the medicarnent from the 15 medicament storage compartment in response to oscillations of the oscillating member; d) means for selectively generating and transmitting ultrasonic vibrations to the oscillating member, the means for generating and transmitting the ultrasonic vibrations disposed on the housing; and 20 e) sensor means, the sensor means adapted to receive preselected stimuli generated by the body tissue, the sensor means adapted to communicate with and selectively energize the means for selectively generating and transmitting ultrasonic vibrations to the oscillating member in response to the preselected stimuli generated by the body tissue.

It is yet another object of this invention to provide a sensor or an array of sensors communicating with a tissue or organ being treated, e.g. the brain. The sensors communicate with one or more actuators adapted to selectively deliver a predetermined amount of a medicarnent to the tissue or organ being treated in 30 response to the sensed stimulus generated by the tissue or organ being treated

- 4 indicating the need for the delivery of such a medicarnent. In an especially preferred embodiment, the stimulation is sensed in one tissue, e.g. the brain or a nerve and the stimulation occurs in a different tissue, e.g. a paralysed leg muscle.

5 Embodiments of the invention are described below with reference to the accompanying drawings, in which: FIG. 1 shows a device constructed in accordance with the invention for delivering a medicament to a target tissue; FIG. 2 shows an alternative embodiment of the device shown in FIG. 1; 10 and FIG. 3 shows an alternative embodiment of the device shown in FIG. 1.

FIG. 1 shows a medicament delivery device 3 constructed in accordance with the invention. FIG. I shows that medicarnent delivery device 3 is provided 15 with housing 4 provided with a medicament storage compartment 5 for storing a medicarnent 6. The housing 4 is also provided with an oscillating member 7 constructed of a material that is adapted to oscillate in response to ultrasonic stimulation 8. The oscillating member 7 communicates with the medicarnent storage compartment 5 so that the oscillating member 7 will contact a medicarnent 20 6 stored in the medicament storage compartment 5. The housing 4 is also provided with a medicament port 9 in fluid communication with the medicarnent storage compartment 5. The medicament port 9 is adapted to permit a medicament 6 to be introduced into the medicarnent storage compartment 5 and is further adapted to permit the medicament 6 to be discharged from the medicament 25 storage compartment 5 when the oscillating member 7 oscillates. A wide variety of ports or valves well known to those skilled in the art as suitable for this purpose may be utilized, however, in a preferred embodiment an elastic flap valve shown in FIG. I is utilized.

30 In operation, the physician will introduce the medicament 6 into the

( - 5 medicarnent storage compartment 5 through the medicament port 9. The 2 medicament delivery device 3 is then introduced into the target area using conventional procedures such as catheter delivery or surgical implant. As shown I in FIG. 1, the physician may subject the medicament delivery device 3 to 5 ultrasonic energy 8 generated by a means I O for selectively generating and transmitting ultrasonic vibrations 8 to the oscillating member 7. The ultrasonic energy 8 impinging upon the oscillating member 7 causes the oscillating member t 7 to oscillate as shown in FIG. 1. This causes the desired amount of medicament 6 to be discharged from the medicament storage compartment 5 through the 10 medicament port 9 to the target area. The amount of time that the device 3 is exposed to the ultrasonic vibration 8 can be varied as specific applications dictate and will depend upon factors such as the target area to be treated, the quantity of medicament 6 to be delivered, and the composition, e.g. solid or liquid and/or the viscosity of the medicament 6.

In utilizing the medicament delivery device 3, the means for generating the I ultrasonic vibrations 10 may be manually operated, may be programmed to i generate ultrasonic vibrations for a predetermined fixed period of time, e.g. 10 seconds, at predetermined fixed intervals, e.g. every hour, or may be 20 automatically energized in response to sisals received from a sensor 11. The frequencies utilized in the various embodiments of this invention may be varied as specific applications dictate. A wide range of frequencies, e.g. radio frequency (rf) or ultrasound (us), may be utilized depending upon the type and the location of the tissue being treated and the type and amount of tissue through which the 25 high frequency vibrations must pass.

One or more sensors 11 are utilized in conjunction with the device 3 as shown in FIGS. 1 to 3 to monitor the tissue being treated for a variety of preselected physiological activities and parameters which indicate the need for 30 treatment and the amount of treatment required. These physiological activities

- 6 and parameters include, e.g. but are not limited to, changes in neurological activity, temperature, pressure, fluid discharge from the target area, chemical composition of the discharge, and chemical changes in the tissue being treated. I 5 The sensor or sensors 11 may be implanted at several points on or in the tissue or organ being treated as specific applications dictate. Altematively, the sensor I 1 may be disposed on the device 3 as shown in FIGS. 2 and 3. The sensor t 1 1 is adapted to communicate with a means 10 for selectively generating and transmitting ultrasonic vibrations 8 as previously discussed. The communication 10 13 between the sensor 11 and the means 10 for generating ultrasonic vibrations 8 may be a direct one, e.g. by an electrical lead, however, in a preferred embodiment the communication 13 takes place via radio transmission. Radio communication between the sensor 11 and the means for generating ultrasonic vibrations 10 reduces discomfort to the patient and also reduces the likelihood of 15 infection because a wire connection is not required.

In operation, the sensor 11 monitors physiological parameters of the tissue i or organ being treated and senses changes in these physiological parameters.

Upon sensing a change, the sensor 11 sends a signal to the means 10 for 20 generating ultrasonic vibrations 8. En response to the signal received from the sensor I 1, the means 10 for generating ultrasonic vibrations 8 generates an ultrasonic signal 8 for a period of time sufficient for the device to deliver the desired treatment to the tissue or organ being treated as previously discussed. The period of time that the ultrasonic signal 8 is generated may be fixed or may be 25 selectively varied depending on the physiological change sensed by the sensor 11 and may be varied as a function of the type and degree of physiological change sensed by the sensor 11. In an especially preferred embodiment, the means 10 for generating the ultrasonic vibration 8 may be provided with a means 12 for calculating the amount of medicarnent required by the tissue or organ being 30 treated depending on the type and degree of sensed physiological change.

- 7 Varying the duration of the ultrasonic vibration 8 generated varies and controls 2 the amount of medicament delivered to the tissue or organ being treated. Thus, this embodiment provides a self-monitoring and selfdelivering system that I rapidly calculates the amount of treater ent required and provides rapid delivery of 5 the required amount of treatment to the target area. The means 10 for generating the ultrasonic vibration may also be disposed on the device 3 as shown in FIG. 3 to provide a one piece monitoring, dosage calculating, and administering system. t Alternatively, sensing may occur in one tissue, e.g. the brain or a nerve I O and the stimulation may occur in a different tissue, e.g. a paralyzed muscle.

The device of this invention as defined by the claims may be modified and adapted for a wide rarge of treatments as specific circumstances dictate, and more specifically in an especially preferred embodiment, in cases of paralysis. For I example, if a person's leg were paralyzed, a stimulator could be provided which would communicate with the muscles of the leg. The stimulator would generate a I stimulus to the muscles in response to a sensor that could be located on, or i communicate with, e.g. the person's arm. The sensor could be adapted to be responsive to movements of the individual's arm. Thus, when the individual 2G wanted to activate the muscles of his leg he could do so by voluntarily moving his arm a predetermined distance or in a predetermined direction. The sensor in the arm would sense the movement of the arm and generate a signal that would communicate with the stimulator communicating with the muscles in the person's leg. This permits the person to selectively generate a stimulus to the muscles and 25 allow the person to selectively activate the muscles of his leg.

The devices and procedures of this invention provide minimally invasive medicarnent stimulation of tissue with reduced risk of complications, e.g. infection, that may result from conventional procedures. While the invention has 30 been described with respect to a limited number of embodiments, it will be

( - 8 appreciated that many vanations, modifications, and other applications of the invention as defined by the claims may be made. 3

Claims

( - 9 - CLAIMS

1. Apparatus for treating body tissue, comprising: a) a housing provided with a medicament storage compartment; 5 b) an oscillating member attached to the housing and communicating with the medicament storage compartment, the oscillating member adapted to oscillate in response to ultrasonic stimulation; c) a medicament port disposed on the housing and in fluid communication with the medicament storage compartment, the medicament port 10 adapted to permit a medicament to be introduced into and contained in the medicament storage compartment and further adapted to selectively release the medicament from the medicament storage compartment in response to oscillation of the oscillating member.

15

2. Apparatus for heating body tissue, comprising: a) a housing provided with a medicament storage compartment; b) an oscillating member attached to the housing and communicating with the medicament storage compartment, the oscillating member adapted to oscillate in response to ultrasoruc stimulation; 20 c) a medicament port disposed on the housing and in fluid communication with the medicament storage compartment, the medicament port adapted to permit a medicament to be introduced into and contained in the compartment and further adapted to selectively release the medicament from the medicament storage compartment in response to oscillations of the oscillating 25 member; and d) sensor means, the sensor means adapted to receive preselected stimuli generated by the body tissue, the sensor means adapted to communicate with and selectively energize a means for selectively generating and transmitting ultrasonic vibrations to the oscillating member in response to the preselected 30 stimuli generated by the body tissue.

( - 10

3. The apparatus of Claim 2, wherein the sensor means is disposed on the

housing.

4. The apparatus of Claim 2, further comprising a means for calculating the 5 duration of the ultrasonic frequency as a function of the type and degree of physiological change sensed by the sensor, the means for calculating communicating with the sensor and corrununicating with the means for selectively generating and transmitting ultrasonic vibrations.

10

5. Apparatus for treating body tissue, comprising: a) a housing provided with a medicament storage compartment; b) an oscillating member attached to the housing and communicating with the medicament storage compartment, the oscillating member adapted to oscillate in response to ultrasonic stimulation; 15 c) a medicament port disposed on the housing and in fluid communication with the medicament storage compartment, the medicament port adapted to permit a medicament to be introduced into and contained in the compartment and further adapted to selectively release the medicament from the medicament storage compartment in response to oscillations of the oscillating 20 member; d) means for selectively generating and transmitting ultrasonic vibrations to the oscillating member, the means for generating and transmitting the ultrasonic vibrations disposed on the housing; and e) sensor means, the sensor means adapted to receive preselected 25 stimuli generated by the body tissue, the sensor means adapted to communicate with and selectively energize the means for selectively generating and transmitting ultrasonic vibrations to the oscillating member in response to the preselected stimuli generated by the body tissue.