Abstract
Fluid injection device for injecting a fluid behind a tympanic membrane of a patient, comprising: a hollow needle having a needle tip with a fluid outlet at a distal end thereof, the needle tip being configured for piercing the tympanic membrane of the patient; a container for storing the fluid to be injected behind the tympanic membrane, the container being arranged in fluid communication with the hollow needle; characterised, in that the hollow needle comprises an elongated venting aperture in an outer wall thereof, the elongated venting aperture being positionable at an inner side of an ear membrane of the patient as well as at an outer ide of said ear membrane when injecting fluid, so as to allow excess fluid on the inner side of said membrane to flow through the elongated venting aperture, to the outer side of said membrane.
Claims
1. A fluid injection device for injecting a fluid behind a tympanic membrane of a patient, comprising: a hollow needle having a needle tip with a fluid outlet at a distal end thereof, the needle tip being configured for piercing the tympanic membrane of the patient; a container for storing the fluid to be injected behind the tympanic membrane, the container being arranged in fluid communication with the hollow needle; wherein the hollow needle comprises an elongated venting aperture in an outer wall thereof, the elongated venting aperture being positionable at an inner side of an ear membrane of the patient as well as at an outer side of said ear membrane when injecting fluid, so as to allow excess fluid on the inner side of said membrane to flow through the elongated venting aperture, to the outer side of said membrane.
2. The fluid injection device according to claim 1, wherein the hollow needle comprises at least two elongated venting apertures, and wherein a distance between a first elongated venting aperture and the fluid outlet differs from a distance between a second elongated venting aperture and the fluid outlet.
3. The fluid injection device according to claim 1, wherein the venting aperture is arranged in the longitudinal direction of the needle.
4. The fluid injection device according to claim 1, wherein the hollow needle is a single-walled needle.
5. The fluid injection device according to claim 1, wherein the hollow needle is a double-walled needle having an inner wall and an outer wall, a fluid injection channel being defined by the inner wall and a venting channel being defined between the outer wall and the inner wall.
6. The fluid injection device according to claim 1, wherein the needle, at or near an area where the venting aperture is arranged, comprises a positioning indicator for indicating a pre-defined insertion depth of the needle.
7. The fluid injection device according to claim 1, further comprising a grip releasably coupled to the hollow needle at or near a proximal end of the hollow needle, for holding the needle.
8. The fluid injection device according to claim 7, wherein the fluid injection device further comprises a pump for pumping the fluid from the container into the hollow needle, wherein the grip comprises a touch button for activating the pump.
9. The fluid injection device according to claim 8, wherein the coupling between the hollow needle and the grip is of the rotational type, to allow a rotation of the grip with respect to the hollow needle.
10. The fluid injection device according to claim 7, wherein the grip includes a display arranged in communication with the container, the display being configured for displaying the amount of fluid injected with the fluid injection device.
11. The fluid injection device according to claim 7, wherein the grip comprises two recesses for receiving, in use, a finger of a user, and a line of sight from an eye of a user using the fluid injection device into the ear canal of the patient is defined between the two recesses.
12. The fluid injection device according to claim 1, further comprising an endoscope that is rigidly connected to at least a proximal portion of the needle, the endoscope being arranged in communication with a screen, so as to provide a visual representation of the needle tip and its surroundings on the screen via the endoscope.
13. A hollow needle for use in a fluid injection device, the hollow needle having a needle tip with a fluid outlet at a distal end thereof, the needle tip being configured for piercing a tympanic membrane of a patient, and comprising an elongated venting aperture in an outer wall thereof, the elongated venting aperture being positionable at an inner side of an ear membrane of the patient as well as at an outer side of said ear membrane when injecting fluid, so as to allow excess fluid on the inner side of said membrane to flow through the elongated venting aperture, to the outer side of said membrane.
14. An injection assembly comprising a fluid injection device according to claim 1 and an injection fluid, wherein the injection fluid preferably has an intrinsic viscosity between 100 m.sup.3/kg and 500 m.sup.3/kg.
15. The injection assembly according to claim 14, wherein the fluid injection device comprises a heating element for heating the injection fluid before the injection fluid is injected behind the tympanic membrane.
16. The fluid injection device according to claim 1, comprising an injection fluid for use in preventing, alleviating or curing hearing loss.
17. The fluid injection device according to claim 1, wherein the injection fluid comprises a pharmaceutical component.
18. The fluid injection device according to claim 1, wherein the pharmaceutical component is sodium thiosulphate.
19. The fluid injection device according to claim 1, wherein the injection fluid has an intrinsic velocity between 100 m.sup.3/kg and 500 m.sup.3/kg.
20. The fluid injection device according to claim 16, wherein the hearing loss is sensorineural hearing loss or is induced by a platinum-based drug.
21. (canceled)
Description
[0057] These and other aspects of the present invention are described in more detail with reference to the attached figures. In these figures, the same reference numerals will be used for the same or like features. In the figures:
[0058] FIG. 1 schematically shows a schematic overview of a first embodiment of the fluid injection device according to the present invention;
[0059] FIG. 2 schematically shows a detail of the fluid injection device of FIG. 1;
[0060] FIG. 3 schematically shows a detailed view of a needle of the fluid injection device of FIG. 1;
[0061] FIG. 4 schematically shows a cross-sectional view of an ear of a human, with a needle of a fluid injection device according to the invention inserted in said ear;
[0062] FIG. 5 schematically shows a detailed view of a needle tip of a needle of a fluid injection device according to the invention, penetrating a tympanic membrane;
[0063] FIGS. 6A-6E schematically show different views of a second embodiment of a needle of a fluid injection device according to the invention;
[0064] FIG. 7 schematically shows a detailed view of a needle tip of a needle of a third embodiment of a fluid injection device according to the invention, penetrating both the tympanic membrane and the oval or round window; and
[0065] FIGS. 8A-8E schematically show different views of a fourth embodiment of a needle of a fluid injection device according to the invention.
[0066] With respect to FIG. 1, a fluid injection device 1 and a fluid injection assembly 2 are shown. The fluid injection device 1 is configured for injecting a fluid behind a tympanic membrane of a patient, as will be explained in more detail with reference to FIGS. 4 and 5. The embodiment of the fluid injection device 1 shown in FIG. 1 comprises a base unit 17, that may e.g. comprise buttons 171, a screen 172 and software for operating the fluid injection device 1. Via the buttons 171 input may be provided to the software running the fluid injection device 1 and via screen 172 information about the working of the fluid injection device 1 may be displayed to a user thereof. The base unit 17 further comprises a holder 173 in which a container 12 may be placed. The fluid which is to be injected in an ear of a patient with the fluid injection device 1 is stored in said container 12. The container 12 is releasably coupled to the base unit 17 via cap 174. While the cap 174 is part of the base unit 17, the container 12 is replaceable. However, the cap 174 may also be replaceable, e.g. along with the tubing, to prevent any cross-contamination when the base unit 17 is re-used.
[0067] Via cap 174, tubing 18 and pump 13 the fluid in the container 12 is arranged in fluid communication with a needle 11. When the pump 13 is operated, it sucks fluid out of the container 12, through a first portion 181 of the tubing 18, through the pump 13 itself and displaces the fluid into the needle 11 via a second portion 182 of the tubing 18. The second tubing portion 182, arranged between the pump 13 and the needle 11, is rigidly clamped to the pump via one or two clamping members 131. This prevents any vibrations from operation of the pump 13 to be transferred to the needle 11, and thus results in a safer working of the fluid injection device 1. The clamping member(s) 131 preferably also prevent movement of the tube section inside the peristaltic pump, because movement of this tubing could affect the dose accuracy.
[0068] The tubing 18 shown in relation to the embodiment of FIG. 1 is relatively long, which results in a relatively large amount of injection fluid remaining present in the tubing 18 and not injected in the ear of the patient. For relatively inexpensive injection fluids this is fine. However, it may also be desired to inject relatively expensive, rare or hard to obtain fluid in the ear of a patient. In that case, a large amount of injection fluid remaining in the tube 18 and not injected in the ear is undesirable. In such an application, the skilled person will have no problem to change the design of the shown fluid injection device and reduce the distance between the container and the needle. For example, the container 12 storing the injection fluid may be arranged in between the pump 13 and the needle 11, close to the needle 11.
[0069] The fluid stored in the container 12 preferably comprises a therapeutic agent and preferably has a relatively high viscosity to allow the fluid to be optimally received and contained in the middle or inner ear of the patient. For example, the intrinsic viscosity of the fluid may be between 100 m.sup.3/kg-500 m.sup.3/kg.
[0070] Moving to FIG. 2, the grip 14 and the needle 11 of the fluid injection device 1 are shown in more detail. The grip 14 as shown here has an index finger receiving portion 143 and a thumb receiving portion 144, and is arranged at a proximal end 114 of the needle 11. Above the index finger receiving portion 143 a touch button 141 is arranged which may be operated with an index finger of a user of the fluid injection device. For example, the touch button 141 may be arranged in communication with the pump, and may activate and/or stop the working of said pump. The index finger receiving portion 143 and the thumb receiving portion 144 are designed and placed to allow a user of the fluid injection device to hold the grip stably and steadily. When using the fluid injection device 1, a user has a clear view into the ear of the patient when a line of sight between the eye of the user and the ear canal of the patient is defined between said index finger receiving portion 143 and said thumb receiving portion 144.
[0071] Further shown in FIG. 2 is a display 142. The display 142 is arranged in communication with the pump and/or the container and displays 142 information regarding the amount of fluid injected with the fluid injection device. This directly indicates to a user of the fluid injection device when to stop the injection process without needing to rely on information of a second person and/or other possibly erroneous information sources.
[0072] FIG. 2 further shows an endoscope 15, rigidly connected to the needle 11 via clamp 151. The endoscope 15 provides a view inside the ear canal, but outside of the ear membrane, of the patient to a user of the fluid injection device. The endoscope 15 is preferably arranged in communication with a (non-shown) screen, e.g. via a wireless communication source, so as to provide a visual representation of the surroundings of a needle tip 111 and the needle tip 111 itself.
[0073] With reference to FIG. 3, one embodiment of a needle 11 of the fluid injection device is shown. As shown here, the needle 11 comprises a needle tip 111, slanted to allow a piercing of at least the tympanic membrane of a patient, a fluid outlet 112, an outer wall 115 and an elongated venting aperture 116. The needle 11 here comprises only a single wall, the outer wall 115 and is single-walled. As shown, the needle 11 is bent, such that a distal end 113 of the needle 11 is inclined with respect to a proximal end 114 of the needle 11. The bending of the distal end 113 may make it easier to a user of the fluid injection device to penetrate an ear membrane of a patient at a right angle—a right angle being least likely to rupture said membrane. A longitudinal direction L of the needle 11 follows the bend.
[0074] The distal portion 113 of the needle 11 comprises a positioning indicator 120 that indicates a pre-defined insertion depth of the needle 11. Depending on instruction provided along with the fluid injection device, the needle 11 is e.g. to be inserted through the ear membrane of the user until the positioning indicator 120 disappears from sight, or the positioning indicator 120 marks the position until which the needle tip 111 may be inserted through the ear membrane. Seen in a longitudinal direction L of the needle 111, in which direction the elongated venting aperture 116 is arranged, the positioning indicator 120 overlaps with the elongated venting aperture 116.
[0075] Compared to the needle 11 of FIG. 3, the needle of FIGS. 6A-6E shows an alternative embodiment thereof. The needle 11 shown in FIGS. 6A-6E comprises a total of five elongated venting apertures 116, arranged at three different distances dl, d2, d3 of the needle tip 111. Depending on the insertion depth of the needle 11, more or fewer venting apertures extend through the ear membrane of the patient, and more or less venting functionality is achieved. When the ear membrane is positioned at the cross-sectional plane of FIG. 6C, only a relatively small amount of venting is achieved, as only one venting aperture 116 is functional.
[0076] When the ear membrane is positioned at the cross-sectional plane of FIG. 6D, some more venting is achieved, as now three venting apertures 116 are functional. If the ear membrane would be positioned at the cross-sectional plane of FIG. 6E, the maximum amount of venting is achieved. Therefore, advantageously, when the needle 11 comprises several elongated venting apertures 116, arranged at different distances from the needle tip 111, the user of the fluid injection device may select the desired amount of venting and/or change the amount of venting while injecting fluid.
[0077] Compared to the needle 11 of FIGS. 6A-6E, the needle 11 shown in FIGS. 8A-8E shows an alternative solution to vary the amount of venting based on the insertion depth of the needle 11 in an ear membrane. As shown in FIGS. 8A-8E venting apertures 116 are gradually introduced in the outer wall of the needle 11. This may be effected by a double-walled solution, wherein the outer wall provides the venting effect and the inner wall provides an injection channel and outlet 112. However, the needle 11 as shown in FIGS. 8A-8E can also be made using only a single wall. As shown by the different cross-sectional views in FIGS. 8C-8E, the further the needle 11 is inserted in an ear membrane, the more venting is allowed. A particular advantage of the needle 11 shown in FIGS. 8A-8E is that the outer diameter of the needle 11 gradually increases in a direction from the needle tip towards the end of the venting apertures 116. This may further help in preventing pain and/or barotrauma.
[0078] Insertion of the needle 11 of the fluid injection device and penetration of the needle 11 through an ear membrane of a patient is illustrated with reference to FIGS. 4 and 5, to be discussed together. FIG. 4 schematically shows a cross-sectional view of an ear of a human. The ear comprises an external ear channel EC, a tympanic membrane T, an Eustachian tube ET, an oval window W1, and a round window W2. The middle ear M is generally defined between the tympanic membrane T and the round W2 and oval window W1. The inner ear is generally defined beyond the round W1 and oval window W2. In FIG. 4, the needle 11 is shown while it is partially penetrated through the tympanic membrane T, extending into the middle ear M.
[0079] In FIG. 5 a more detailed view of the needle tip, penetrating the tympanic membrane T, is provided. As shown, an elongated venting membrane 116 is arranged partially inside the tympanic membrane T and partially outside the tympanic membrane T. As schematically shown, fluid 100 is injected at an inside I of the tympanic membrane T, i.e. behind the tympanic membrane T, with the needle. As a result of this injection, the pressure at the inside I of the tympanic membrane T, in the middle ear, rises and the fluid residing there before injection of fluid, e.g. air, wants to move out of the middle ear. This is made possible by the elongated venting aperture 116, which provides a venting channel from the inside I of the tympanic membrane T to the outside O of the tympanic membrane T. The fluid 200 thus moves through this venting channel from inside the ear membrane T to outside of the ear membrane T.
[0080] Comparing FIG. 7 to FIG. 5, in FIG. 7 a needle 11 is shown which penetrates both the tympanic membrane T and the oval window W1 or the round window W2, such that an outlet of the needle 11 reaches the inner ear IE. As shown here, an elongated venting membrane 116 is arranged partially inside the tympanic membrane T, at the inside I of the ear, more particularly at the middle ear M, and partially outside the tympanic membrane T at the outside O of the ear. The elongated venting membrane 116 is also arranged partially inside the round window W2 or the oval window W1, in the inner ear IE, and partially outside the round window W2 or the oval window W1, in the middle ear M. As shown here the elongated venting aperture 116 extends all the way from the inner ear IE to the outside O of the ear. In alternative embodiments, there are two elongated venting apertures, one for penetrating the oval or round window and one for penetrating the eardrum T. As schematically shown, fluid 100 is injected at in the inner ear IE with the needle Compared to the outside O of the ear, the inner ear IE is arranged at the inner side I of the tympanic membrane T. As a result of this injection, the pressure in the inner ear IE, rises and the fluid 300 residing there before injection of fluid 100, wants to move out of the inner ear IE. This is made possible by the elongated venting aperture 116, which provides a venting channel from the inner ear IE to the middle ear M (i.e. from the inner side with respect to the oval or round window to the outer side with respect to the oval or round window). The fluid 300 thus moves through this venting channel from inside the ear membrane W1, W2 to outside of the ear membrane W1, W2.
[0081] As a result of the fluid 300 moving in the middle ear M, the pressure at the inside I of the tympanic membrane T, may rise and the fluid residing there may want to move out of the middle ear. This is also made possible by the elongated venting aperture 116, which additionally provides a venting channel from the inside I of the tympanic membrane T to the outside O of the tympanic membrane T. The fluid 200 thus moves through this venting channel from inside the ear membrane T to outside of the ear membrane T.
[0082] As an alternative to the solution presented in FIG. 7, of course also the conventional technique to inject fluid in the inner ear may be used without departing from the inventive concept as described herein. According to this conventional technique, the tympanic membrane is not penetrated but circumcised and folded aside to expose the middle ear. With the middle ear exposed in this way, the surgeon can access the round and/or oval window to the inner ear and pierce it with the needle described herein. This procedure is typically performed under a general anesthesia.
LIST OF REFERENCE NUMERALS
[0083] 1 fluid injection device [0084] 11 hollow needle
[0085] 111 needle tip
[0086] 112 fluid outlet
[0087] 113 distal end
[0088] 114 proximal end
[0089] 115 outer wall
[0090] 116 venting aperture
[0091] 117 inner wall
[0092] 118 injection channel
[0093] 119 venting channel
[0094] 120 positioning indicator [0095] 12 container [0096] 13 pump
[0097] 131 clamping member [0098] 14 grip
[0099] 141 touch button
[0100] 142 display [0101] 15 endoscope
[0102] 151 clamp [0103] 17 base unit
[0104] 171 buttons
[0105] 172 screen
[0106] 173 holder
[0107] 174 cap [0108] 18 tubing
[0109] 181 first tubing portion
[0110] 182 second tubing portion
2 fluid injection assembly
100 injection fluid
200 middle ear fluid
300 inner ear fluid
d1 distance between fluid outlet and first venting aperture
d2 distance between fluid outlet and second venting aperture
d3 distance between fluid outlet and third venting aperture
EC ear channel
ET Eustachian tube
I inside of ear
IE inner ear
O outside of ear
L longitudinal direction needle
M middle ear
P patient
T tympanic membrane
W1 oval window
W2 round window
