WO2003007861A1

WO2003007861A1 - System for performing a micro-drilling procedure in human or animal and a method for use thereof

Info

Publication number: WO2003007861A1
Application number: PCT/IL2001/000671
Authority: WO
Inventors: Yehiel Sheffer
Original assignee: Cutmed Ltd.
Priority date: 2001-07-20
Filing date: 2001-07-20
Publication date: 2003-01-30

Abstract

The invention discloses to a system for performing a micro-drilling procedure in human or animal and a method for use thereof. The system for performing micro-drilling of a bone or cartillage, or for opening a blocked biological pathway, especially useful for a dacryocystorhinostomy, comprises; (a) a control box adapted for controlling the operation and regulation of the system, wherein said control box is adapted to be connected to an external electrical power supply; (b) a flexible tube having a proximal end and a distal end, and said flexible tube having a sleeve extending therethrough, said sleeve adapted for insertion therethrough of a micro-drill and drill cable that is attached thereto, wherein the drill cable is detachably connected to the control box such that the micro-drill is operable through the control box when said micro-drill is inserted through said sleeve and said micro-drill is located at the proximal end of the flexible tube; (c) an air suction tube in connection with a hollow inner portion of the flexible tube and detachably connected to the control box such that waste produced during the drilling of the bone can be aspirated from the surgical site.

Description

SYSTEM FOR PERFORMING A MICRO-DRILLING PROCEDURE IN HUMAN OR ANIMAL AND A METHOD FOR USE THEREOF

FIELD OF THE INVENTION

The present invention relates to a system for performing a micro-drilling

procedure in human or animal and a method for use thereof. More

specifically, the present invention relates to a system for performing

micro-drilling of a bone, cartilage, or for opening a blocked biological

pathway, that is especially useful for the performance of a

dacryocystorhinostomy (DCR).

BACKGROUND OF THE INVENTION

The lacrimal pathway that functions to drain tears from the human eye

can sometimes become blocked. Obstruction may occur in the lacrimal

duct or in the lacrimal sac, and it can lead to excessive tearing and

infection. In older people, it is not possible to correct the blockage itself

and thus, an alternative way for tears to drain must be formed. A

dacryocystorhinostomy (DCR) is a medical procedure in which an

alternative passage for tears is created from the lacrimal sac to the nasal

cavity by forming a hole in the bone of the nose. The formation of the

hole is followed by the insertion of a silicone tube or other intubation

device that remains in the lacrimal pathway until new soft tissue is formed around the intubation device and the intubation device may be

removed.

In conventionally used DCR procedures, the surgeon makes an incision

on the side of the nose, penetrates the blood vessels with an appropriate

instrument, and breaks and removes bone from the nose with a

bone-cutter in order to open a passageway from the lacrimal sac into the

nasal cavity. The canaliculi and lacrimal sac are also approached through

specialized needles in order to enable insertion of a tube through the

lacrimal pathway and the opening formed in the bone.

This procedure has many drawbacks. Since it requires an incision to be

made on the side of the nose, the procedure can be extremely bloody,

requiring a long healing time and leaving a scar. Also, the patient must be

put under general anesthesia. Typically, the procedure requires two or

more hours to complete, and involves a lengthy hospitalization and

recovery time.

It is therefore an object of the present invention to provide a system for

performing a DCR that eliminates the need to perform an incision in the

side of the nose, thus avoiding all the associated complications hereinbefore described. The system of the present invention avoids the

need to make an external incision so that there will be no scar formation

or cosmetic blemish. Furthermore, the system of the present invention

allows a traditionally complicated and difficult procedure to be performed

with relative ease, allowing for the possibility of observation through a

small optic fiber and aspiration of waste materials. The system of the

present invention utilizes the natural lacrimal pathway in order to

approach the bone. The method of the present invention allows for careful

and precise control and regulation of the procedure as it is being carried

it, with the possibility of subsequent placement of a tube into the lacrimal

pathway to restore proper tear drainage.

It is furthermore the aim of the present invention to provide a system that

is useful for performing micro-drilling in a bone or cartilage, for example,

during brain surgery. It will become appreciated by those skilled in the art

that the system proposed by the present invention can be adapted towards

use in different medical procedures, while not departing from the scope of

the invention.

These and other objects of the present invention will become more

apparent through the summary of the invention and the detailed description of the drawings that follow.

SUMMARY OF THE INVENTION

The present invention relates to a system for performing micro-drilling of

a bone or cartilage, or for opening of blocked biological pathways,

comprising;

(a) a control box adapted for controlling the operation and

regulation of the system, wherein said control box is adapted

to be connected to an external electrical power supply;

(b) a flexible tube having a proximal end and a distal end, and said

flexible tube having a sleeve extending therethrough (and

extending from the distal end of the flexible tube), said sleeve

adapted for insertion therethrough of a micro-drill and drill

cable that is attached thereto, wherein the drill cable is

detachably connected to the control box such that the

micro-drill is operable through the control box when said

micro-drill is inserted through said sleeve and said micro-drill

is located at the proximal end of the flexible tube;

(c) an air suction tube in connection with a hollow inner portion of

the flexible tube and detachably connected to the control box

such that waste produced during the drilling of the bone can be aspirated from the surgical site.

The system of the present invention is especially useful in the

performance of a dacryocystorhinostomy, though it is also useful in

corrective procedures in the ear, nose, and throat, neurological

procedures, veterinary procedures, and others, as one skilled in the art

would recognize.

It should be noted that in the context of the present invention the term

"micro-drilling" refers to the drilling of a relatively small hole, on the

order of 3-10 millimeters in length and about 0.5 millimeters in diameter,

and a "micro-drill" refers to a drill that is capable of forming a hole of

such size. It should also be noted that the diameter and length of the hole

may be larger or smaller, depending on the procedure being performed.

In one preferred embodiment, the system further comprises an optic fiber.

The optic fiber extends through the flexible tube and also extends from

the distal end of the tube such that the optic fiber may be connected to a

laser diode on the control box for providing illumination at the proximal

end of the flexible tube. In a DCR procedure, this facilitates advancing of

the micro-drill through the lacrimal pathway, since the surgeon is able to visualize the illumination through the patient's skin and see the

movement of the tube through the canaliculus and the lacrimal sac (It

should be noted that in other micro-drilling procedures, the optic fiber

may or may not serve as an advantage during performance and thus it

may not be necessary as part of the system).

In another preferred embodiment of the present invention, the system

further comprises a connecting member for providing secure connection

between the flexible tube and the air suction tube, the optic fiber, and the

sleeve. Advantageously, the connecting member is formed form rubber or

other suitable material.

Preferably, the optic fiber and the sleeve are affixed to the inner wall of

the flexible tube. The affixment can be accomplished through any

appropriate adhesive means, such as silicone glue.

In one preferred embodiment, the system further comprises a cover for

covering the proximal end of the flexible tube and for enabling resetting

of the location of the micro-drill inside the flexible tube. When the

system is reset, the micro-drill becomes positioned at the "zero" location

at the proximal end of the flexible tube, immediately behind the cover, such that when the cover is removed, the micro-drilling procedure can be

initiated. In a DCR procedure, while the flexible tube is being advanced

through a canaliculus and the lacrimal sac, the micro-drill moves from the

"zero" location in slight forward and backward movements

(approximately 1-2 millimeters in each direction), and slight clockwise

and counterclockwise movements. Both of these movements ease the

entry through the lacrimal pathway. Once the bone of the nose is reached,

the resistance to the advance is sensed by the system, which causes the

micro-drill to rotate in the clockwise direction at a high speed

(determined by the surgeon) and to move forward so as to effect drilling

of the bone.

Preferably, the micro-drill has a diameter of approximately 0.5

millimeters and the sleeve has an outer diameter of approximately 0.8

millimeters and an inner diameter of approximately 0.6 millimeters.

In other preferred embodiments of the present invention, the flexible tube

has an outer diameter of approximately 1.3-1.4 millimeters, an inner

diameter of approximately 1.2 millimeters, and is approximately 70-100

millimeters in length. It should be appreciated that the dimensions herein

mentioned can be different according to the needs of the operation being performed.

In other preferred embodiments of the present invention, the control box

includes a control card containing program control and a display card

coupled to an alpha-numeric display located on the panel of the control

box.

In other preferred embodiments of the present invention, the control box

further includes a mechanism for releasing and retracting the drill cable

from the control box (hereinafter referred to as the release/retract

mechanism). The release/retract mechanism is coupled to the control

card, display card and to a plug (hereinafter referred to as the

"release/retract plug") on the panel of the control box for connection

thereto of the drill cable. In a DCR procedure, the release/retract

mechanism allows for the drill cable and micro-drill to be retracted

through the sleeve and out of the lacrimal pathway while the flexible tube

in still in the lacrimal pathway. The empty sleeve can be used to thread a

filament or optic fiber bundle (or other guiding element) through the

lacrimal pathway and the hole to allow for insertion of a silicone tube.

In other preferred embodiments of the present invention, the control box further includes a mechanism for controlling the directional and rotational

movement of the micro-drill (hereinafter referred to as the "drilling

mechanism"). The drilling mechanism is controlled by the control card

and its status is indicated by the display card and is furthermore coupled

to a plug (hereinafter referred to as the "drill mechanism plug") on the

panel of the control box for connection thereto of the drill cable

(movements produced in the drill cable are translated into corresponding

movements in the micro-drill). The drilling mechanism allows for both

the slight directional and rotational movement of the micro-drill (for

when, in a DCR procedure, the flexible tube is being advanced through

the lacrimal pathway) and for forward and higher-speed rotational

movement of the micro-drill (for drilling a hole in the bone or cartilage).

In other preferred embodiments of the present invention, the mechanism

for controlling the directional and rotational movement of the micro-drill

further includes a selector placed on the panel of the control box, through

which the speed of the drill is selected. The selector status is read by the

control card which controls the rotation speed of the micro-drill.

In other preferred embodiments of the present invention, the control box

further includes a laser diode that is connectable to a first end of an optic fiber through a plug on the panel of the control box for providing

illumination at a second end of the optic fiber. Thus, in the preferred

embodiment in which an optic fiber extends through the length of the

flexible tube, illumination is produced at the proximal end of the tube so

as to facilitate advancing through the lacrimal pathway during a DCR

procedure.

In other preferred embodiments of the present invention, the control box

further includes an air pump coupled to the control card and to the display

card. The air pump is detachably connected to the air suction tube

through a plug on the panel of the control box such that waste produced

during the drilling of the bone or cartilage can be aspirated from the

surgical site.

In other preferred embodiments of the present invention, the control box

further includes a series of indicator lamps located on the panel of the

control box and coupled to the display card such that the particular

functioning or status of the system can be monitored by the surgeon.

In other preferred embodiments of the present invention, the control box

has a foot pedal connected thereto for enabling the surgeon to stop the procedure in case of need (for example, in the case of an emergency).

The micro-drill can be made of NITINOL or any other suitable material.

Nitinol is formed from nickel and titanium and can exist in two different

main states: a "cold" state (martenzit) and a "hot" state (austenit). When

in the martenzit state, the micro-drill is in plastic form and it can be

deformed continuously in any direction without rupture. In a DCR

procedure, this characteristic greatly facilitates the advancing of the

micro-drill through the lacrimal pathway. When the temperature of the

micro-drill is raised during disinfection (causing a to change to the

austenit elastic state), the micro-drill returns to the original, substantially

linear state.

The present invention also relates to a method for performing a

dacryocystorhinostomy (but not restricted for use in this procedure only)

using the system hereinbefore described, comprising:

(a) performing a self check of the system and resetting of the

location of the micro-drill in the flexible tube (when reset to the

"zero" location, the micro-drill is located immediately behind a

cover at the proximal end of the flexible tube; the cover is

removed after resetting is complete and before entering the lacrimal pathway);

(b) causing slight directional and rotational movement of the

micro-drill and advancing the flexible tube through an upper or

lower puncta of the eye, a canaliculus, and lacrimal sac until

reaching the bone of the nose;

(c) adjusting the speed of the micro-drill and drilling a hole

through the bone of the nose;

(d) disconnecting the drill cable from the drill mechanism plug and

connecting the drill cable to the release/retract plug;

(e) retracting the drill cable and the micro-drill into the control

box;

(f) inserting a silicone tube through the sleeve (said sleeve is

empty following step (e)), advancing the silicone tube through

the lacrimal pathway and the nasal cavity (by means of the hole

produced in the bone), and pulling the end of the silicone tube

outside of the nostril;

(g) removing the flexible tube from the lacrimal pathway.

It should be appreciated that the aforementioned method can be adapted

for usage during other medical procedures involving micro drilling of a

bone or cartilage, or for opening of a blocked biological pathway. The method need not be restricted only to the performance of a DCR.

The present invention also relates to a control box for use in the system

hereinbefore described during micro-drilling of a bone, cartilage, or for

opening of a blocked biological pathway, comprising:

(a) a control card having a program control (the program control

is different according to the procedure that is being carried out);

(b) a mechanism for releasing and retracting the micro-drill

from or into the control box, wherein the mechanism is

connectable to the drill cable through a plug on the panel of the

control box;

(c) a mechanism for producing directional and rotational

movement in the micro-drill, wherein the mechanism is

connectable to the micro-drill through a plug on the panel of the

control box and said mechanism is directly controlled by the

control card;

(d) a display card for controlling warning lights, sounds, and

messages conveyed from a panel of the control box or from an

alpha-numeric display on said panel of the control box;

(e) an air-pump for enabling aspiration of wastes produced

during the micro-drilling procedure, wherein the air-pump is connectable to an exterior air suction tube and said air-pump is

directly controlled by the control card.

The control box is adapted for connection to an external electrical power

supply.

In one preferred embodiment, the control box further comprises a laser

diode. The laser diode is connectable to the optic fiber for enabling

visualization of the advancement of the tube through the lacrimal

pathway.

The present invention also relates to a system for performing

micro-drilling of a bone or cartilage, or for opening a blocked biological

pathway, especially useful for a dacryocystorhinostomy, comprising;

(a) a control box adapted for controlling the operation and

regulation of the system, wherein said control box is adapted

to be connected to an external electrical power supply;

(b) a handle having a proximal end and a distal end;

(c) a micro-drill positioned inside a flexible sleeve, wherein said

micro-drill and flexible sleeve. extend from the proximal end of

said handle; (d) a drill cable operationally coupled to said micro-drill inside

said handle, and said drill cable being to said control box.

According to preferred embodiments of the present invention, the flexbile

sleeve is detachably connected to the proximal end of the handle.

Preferably, the drill cable is positioned inside a sleeve, and the sleeve

being detachably connected to the distal end of the handle.

Further according to preferred embodiments of the present invention, the

micro-drill is disposable. Preferably, said micro-drill is comprised of

NITINOL and extends between 0.6-0.8mm from the end of the sleeve.

The present invention also relates to a method for performing a DCR

procedure, comprising;

(a) performing a self check of the system and resetting of the

location of the micro-drill in the flexible sleeve;

(b) causing slight directional and rotational movement of the

micro-drill and using the handle to advance the flexible sleeve

through an upper and/or lower puncta of the eye, a canaliculus,

and lacrimal sac until reaching the bone of the nose;

(c) adjusting the speed of the micro-drill and drilling a hole through the bone of the nose;

(d) disconnecting and retracting the handle and the drill cable from

the flexible sleeve such that said flexible sleeve remains inside

the lacrimal pathway;

(e) inserting a cannula through said flexible sleeve, advancing said

cannula through the lacrimal pathway and the hole in the bone;

(f) removing the flexible sleeve from the lacrimal pathway while

the cannula remains in the lacrimal pathway;

(g) inserting a first end of a silicone tube or optic fiber coated with

silicone through said cannula into the lacrimal pathway until

the end of the fiber or tube appears in the nose;

(h) pulling out the cannula from the lacrimal pathway and

disengaging said cannula from said tube or fiber;

In most preferred embodiments, steps a-h are repeated by advancing

through the second puncta of the eye and by inserting a second end of the

silicone tube or optic fiber (in step g).

Furthermore, the method preferably comprises drawing the two ends of

the silicone tube or optic fiber out of the nostril to form a loop between

the two punctae. Following this, excess tubing or fiber is preferably cut and the two ends are ligated together.

In certain preferred embodiments, a stent may be inserted into the hole in

the bone of the nose, in a manner to be described further in the detailed

description.

In certain preferred embodiments, the cannula has a slit extending on one

side of the length of the cannula for allowing disengaging of said cannula

from said optic fiber or silicone tube. In other preferred embodiments, the

cannula has two longitudinal slits positioned 180 from one another for

allowing disengaging of the said cannula from said optic fiber or silicone

tube.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is herein described, by way of example only, with

reference to the accompanying drawings, wherein:

Figure 1 is a side-view of a flexible tube and the components extending

therefrom, according to a preferred embodiment of the present invention.

Figure 2 is a cross-sectional view of the flexible tube of Figure 1. Figure 3 is a schematic view of a control box and central components

located therein, according to a preferred embodiment of the present

invention.

Figure 4 is an isometric view of the control box of Figure 3, showing the

panel of the control box.

Figure 5 is an isometric view of a mechanism for controlling the

directional and rotational movement of a micro-drill, according to a

preferred embodiment of the present invention.

Figure 6 is an isometric view of a mechanism for releasing a drill cable

from the control box, and for retracting said drill cable into the control

box, according to a preferred embodiment of the present invention.

Figure 7 is a schematic side view of a handle for facilitating performance

of a micro-drilling procedure, according to a preferred embodiment of the

present invention.

Figures 8A and 8B are side views of two preferred embodiments of cannulas, according to preferred embodiments of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

It will be understood that the system of the present invention is not

limited to its use in lacrimal drainage surgery, and in particular to a DCR

procedure. Those skilled in the art will appreciate that the system may be

useful for other medical procedures as well that involve drilling of a bone

or cartilage or for opening of blocked biological pathways. Furthermore,

various modifications can be made to the invention without departing

from the scope of the invention, as set out in the claims.

Referring now to Figure 1, the system of the present invention includes a

flexible tube (9) that is adapted for insertion through an upper or lower

puncta of the eye, a canaliculus, and lacrimal sac for enabling drilling of

the bone of the nose by a micro-drill and subsequent insertion of a

silicone tube (alternatively, the flexible tube can be adapted in shape and

size for insertion through another biological pathway). The flexible tube

(9) has a proximal end (52) and a distal end (51). Extending from the

distal end (51) of the flexible tube (9) is a hollow sleeve (6) adapted for insertion therethrough of the micro-drill and a drill cable that is attached

thereto. A filament or optic fiber bundle used as a guide can be inserted

through the sleeve (6) (after drilling of the bone) so as to enable insertion

of a silicone tube through the lacrimal pathway. Also illustrated is an air

suction tube (2) that connects with the distal end (51) of the tube (9) to

facilitate aspiration of wastes that result from drilling of the bone. An

optic fiber (18) also extends from the distal end (51) of the tube (9) for

providing illumination at the proximal end (52) of the tube (9) as the tube

(9) is advanced through the lacrimal pathway. A connecting member (12),

preferably formed of rubber or other suitable material, serves to securely

connect between the flexible tube (9), the air-suction tube (2), the sleeve

(6) and the optic fiber (18). During a DCR procedure, the air suction tube

(2) and optic fiber (18) are detachably connected to the control box (not

shown) that controls the operation and regulation of the system. The

system further includes a removable cover (53) that can fit onto the

proximal end (52) of the tube (9) to enable resetting of the location of the

micro-drill inside the flexible tube (9), to be described shortly.

Referring now to Figure 2, the sleeve (6) and optic fiber (18) extend

through the inner length of the flexible tube (9) and are secured to the

inner wall of the flexible tube (9) through appropriate adhesive means, such as silicone glue (70). The optic fiber (18) is connectable to a laser

diode in the control box such that during a DCR procedure (for example),

the advancement of the tube through the lacrimal pathway can be

visualized, and, as a result, trauma and prodding in the lacrimal pathway

is reduced. The air suction tube (referred to in Figure 1) communicates

with a hollow inner portion (11) of the flexible tube (9) to allow removal

of wastes from the micro-drilling procedure. It should be appreciated that

the hollow inner portion (11) is essentially comprised of the longitudinal

portion of the flexible tube (9) that is not occupied by the sleeve (6), the

optic fiber (18), or the silicone glue (70). It should also be appreciated

that the flexible tube (9) is firm while having sufficient flexibility to

allow for advancing through the lacrimal pathway in a DCR procedure.

Preferably, the flexible tube (9) is approximately 1.2 millimeters in inner

diameter, 1.3-1.4 millimeters in outer diameter and 70-100 millimeters in

length (the flexible tube may be dimensioned differently according to the

procedure being carried out; the aforementioned dimensions are

especially suitable for the performance of a DCR). The optic fiber (18)

has a diameter of approximately 0.25 millimeters. The sleeve (6)

preferably has an outer diameter of approximately 0.8 millimeters and an

inner diameter of approximately 0.6 millimeters such that a micro-drill

having a diameter of approximately 0.5 millimeters can be inserted therethrough. The flexible tube (9) allows for incorporation of various

components of the surgery into one space, while also functioning as a

cannula for entering the lacrimal pathway. It should be appreciated that

the flexible tube could be adapted for insertion therethrough of other

surgical elements, depending on the type of micro-drilling procedure that

is being conducted.

Referring now to Figure 3, the control box (31) of the system includes a

control card (16) that contains information and instructions for directing

the main operation and regulation of the system, and a display card (13)

for controlling warning lights, sounds, and other features of the system to

be described below. The system is powered by an external electric power

supply, and electrical power is received through power unit (20). Other

central components of the control box (31) include a mechanism (4) for

controlling the directional and rotational movement of the micro-drill

(also referred to as the "drilling mechanism"), to be described in Figure 5,

and a mechanism (22) for releasing and retracting the drill cable from the

control box (also referred to as the "release/retract mechanism"), to be

described in Figure 6. The drill cable is connected to the drilling

mechanism (4) and to the release/retract mechanism (22) during

appropriate steps of a DCR procedure, to be described below. The control box (31) further includes an air pump (5) that is connectable, by a plug on

the control panel, to the air suction tube (referred to in Figure 1), for

aspirating wastes produced during the DCR procedure. A laser diode (3),

or other appropriate light source, is also housed in the control box (31) for

providing illumination at a first end of an optic fiber when a second end

of said optic fiber is coupled to the laser diode (3) (it should be noted that

the optic fiber referred to in Figure 1 may be plugged into the laser diode,

or alternatively, any other optic fiber or optic fiber bundle may be

plugged in as well, for example, during insertion of a silicone tube into

the lacrimal pathway). It will be appreciated by those skilled in the art

that, while not illustrated, the control box (31) is also equipped with

appropriate connections between the components of the control box and

the components of the control box panel, to be described in Figure 4.

Referring now to Figure 4, the panel (71) of the control box (31) includes

a main ON/OFF switch (24), a START switch (25), a push button (28) for

operating the mechanism for releasing and retracting the drill cable, a

selector (10) for controlling the speed of the micro-drill, an

alpha-numeric display (8), and an alpha-numeric display selector (23).

The panel (71) furthermore includes a series of indicator lamps, for indicating activities or providing warnings for the surgeon during a DCR

procedure. Indicator light 26 is for indicating the ON/OFF status of the

system. Indicator light 30 is for indicating READY status of the system.

Indicator light 29 is for indicating retraction and/or releasing of the drill

cable (release/retract mechanism ACTIVE/INACTIVE). Indicator light

57 is for indicating the air-pump status (ACTIVE/INACTIVE) of the

system. Indicator light 58 is for indicating the drill status (drilling

mechanism ACTIVE/INACTIVE) of the system. Warning light 17 is to

alert the surgeon when the micro-drill reaches the bone of the nose.

Warning light 15 is to alert the surgeon when the micro-drill reaches the

end of the bone.

The panel (71) further includes a series of plugs, for providing connection

between the control box (31) and the other components of the system.

Plug 27 provides for connection between the drill cable and the

release/retract mechanism (also referred to as the "retract/release plug").

Plug 19 provides for connection between the air suction tube and the

air-pump. Plug 21 provides for connection between the drill cable and the

drill mechanism (also referred to as the "drill mechanism plug"). Plug 14

provides for connection between an optic fiber plug (connected to an

optic fiber or optic fiber bundle) and the laser diode. The control box (31) is also connected to a foot pedal (1) through a foot pedal cable (7) that

allows the surgeon to stop the procedure in case of need. The functioning

of the aforementioned components will be more clearly understood from

the method for performing a DCR procedure that will be described

shortly.

Referring now to Figure 5, the drill mechanism for controlling the

directional and rotational movement of the micro-drill includes a motor

(60) for powering directional (forward and backward) movement of the

micro-drill (hereinafter referred to as the "directional motor") and a motor

(63) for powering rotational (clockwise and counterclockwise) movement

of the micro-drill (hereinafter referred to as the "rotational motor"). Both

motors (60) (63) are connected through appropriate connections to the

control card. The rotational motor (63) rests on a platform (62) and is

coupled to a connective cable (68) that transmits rotation of the motor to

the drill cable when said drill cable is connected to the drill mechanism

plug. The directional motor (60) is coupled to a gear (39) that is movable

along a grooved edge (46) of the platform (62) such that clockwise or

counterclockwise movement of the directional motor (60) is translated

into forward or backward movement of the platform (62) along a track

(33). This results in corresponding forward or backward movement of the rotational motor (63), the connective cable (68), and, consequently, the

drill cable.

Referring now to Figure 6, the release/retract mechanism includes a

motor (50) for retracting the drill cable (32) into the control box

(hereinafter referred to as the "retracting motor") and a motor (42) for

releasing the drill cable from the control box (hereinafter referred to as

the "releasing motor") for releasing the drill cable (32) from the control

box (the drill cable is released from the control box and inserted through

the sleeve of the flexible tube, so that the micro-drill is located near the

proximal end of the flexible tube, before initialization of the DCR

procedure). The release/retract mechanism further includes a connective

cord (69) that connects with the drill cable (32) when the drill cable (32)

is connected to the release/retract plug. The retracting motor (50) is

coupled to a reel (55) such that when the retracting motor (50) rotates in

the clockwise direction, the connective cord (69) begins to wind around

the reel (55), thereby effecting retraction of the drill cable (32) into the

control box. The releasing motor (42) is coupled to a lower roller (45b)

located below an upper roller (45a) and between which the connective

cord (69) and drill cable (32) can move such that when the releasing

motor (42) is operated in the counterclockwise direction, the drill cable (32) is released out from the control box. It should be emphasized that the

mechanisms illustrated in Figures 5 and 6 represent examples of

mechanisms that are useful for accomplishing their respective goals.

Other similar mechanisms could also be employed for achieving the same

ends.

A method for use of the system of the present invention in a DCR

procedure will now be described with reference to Figure 4 (however,

referral to the other drawings will prove beneficial to understanding the

method). It will be apparent to those skilled in the art that the method can

be adapted for other medical procedures involving micro-drilling of a

bone or cartilage, or for opening of a blocked biological pathway, without

departing from the scope of the claims. It should be appreciated that the

control box (31), and particularly the control card of the control box,

contains instructions and commands for controlling the operation and the

regulation of the system during a DCR procedure or any other

comparable procedure. At each step of the procedure, the surgeon is

given an indication (by audio signal, alphanumeric display, or

illumination of an indicator light) of the functioning of the different

components of the system and of what steps (if any) need to be taken. It

should be noted that before initialization of the procedure, the drill cable is put in place in plug 21 (the drill mechanism plug), the air suction tube

in plug 19, and the optic fiber in plug 14 (if any of these components are

not in their proper respective places, then a message will be conveyed

during the self-check stage).

To begin, the system first is switched ON (switch 24). The system then

conducts a self check, in which the micro-drill is moved backwards inside

the flexible tube. Then, a message is displayed on the alphanumeric

display (8) indicating the beginning of the resetting of the system. With

the cover in place on the proximal end of the tube, the micro-drill is

advanced through the sleeve until it reaches the cover and can go no

further. The situation is immediately marked by the control card by

sensing the sharp increase in the resistance to the directional motor to

forward movement. With the location of the micro-drill thus reset by the

control card at the "zero" location, a second message is displayed

indicating that the resetting is complete and indicator light 30 turns on to

indicate that the system is READY for operation. The surgeon then

removes the cover and presses the START button (25) (if the START

button is not pressed, an audio message will be sounded to indicate that

the START button should be pressed). Pressing the START button results

in the initiation of slight clockwise and counterclockwise movement of the micro-drill, along with slight (1-2 millimeters) forward and backward

movement of the micro-drill. The slight movements ease the surgeon's

advance of the flexible tube through the lower or upper puncta of the eye,

through a canaliculus, and through the lacrimal sac, without necessitating

prodding and poking inside the lacrimal pathway in order to reach the

bone of the nose. Advancing of the flexible tube is also facilitated by

illumination at the proximal end of the tube, resulting from the optic fiber

that is connected to the laser diode in the control box through plug 14 and

visualized through the patient's skin.

When the flexible tube has advanced through the lacrimal sac and the

micro-drill reaches the bone of the nose, the sharp change in the

resistance encountered to the forward movement of the micro-drill is

sensed by the control card and causes the following events to occur

automatically: indicator light 17 turns ON, to indicate reaching of the

bone; an audio warning is sounded, also indicating that the bone of the

nose has been reached; the micro-drill begins to move in the clockwise

direction at a high speed, according to the speed selected by the surgeon

using the selector (10); the micro-drill advances forward; indicator light

58 turns ON, indicating drilling activity, and; the air-pump is activated,

and light indicator 57 turns ON, indicating activity of the air-pump. When the end of the bone is reached, the sharp decrease in the resistance

encountered to the advance of the micro-drill causes the following events

to occur automatically: indicator light 17 turns OFF and indicator light 15

turns ON, to indicate the end of the drilling through the bone; indicator

light 58 turns OFF and the forward and rotational movement of the

micro-drill stops; the air-pump is inactivated and indicator light 57 turns

OFF, and; a message is displayed to disconnect the drill cable from plug

21 (the drill mechanism plug) and reconnect the drill cable to plug 27 (the

release/retract plug). Once the drill cable is connected to plug 27, button

28 is pressed to effect retraction of the drill cable and the micro-drill

inside the control box (if this step is not carried out, a warning message

will be sounded, directing the surgeon to press button 28 in order to cause

retraction the drill cable and micro-drill). While the release/retract

mechanism is active, indicator light 29 is ON.

With the drilling of the bone thus complete, and the sleeve for the

micro-drill (and drill cable) empty (said components having been

retracted into the control box), the sleeve can be used in order to thread a

filament or an optic fiber bundle which serves as a guide for insertion of a

silicone tube attached thereto into the lacrimal pathway and the nasal cavity through the hole produced in the bone. In this process, the flexible

tube is removed from the lacrimal pathway and advanced in the same

manner to the one described above, through the other puncta of the eye,

and a second hole (assuming that a second hole is necessary) is made in

the bone of the nose such that the second end of the silicone tube can be

placed inside the lacrimal pathway to restore proper fluid flow.

It should be appreciated that the alpha-numeric display (8) functions to

indicate to the surgeon the speed of the micro-drill, the resistance

encountered by the micro-drill, the width of the bone, and various other

instructions or warnings concerning performance of the DCR. The alpha

numeric display (8) may convey other information as well, as one skilled

in the art would recognize.

In a preferred embodiment of the present invention, illustrated in Figure

7, a handle (80) is adapted for facilitating performance of the

micro-drilling procedure. It will be appreciated that in this embodiment,

the retract/release mechanism previously described is not a necessary part

of the control box, since the handle allows for direct retracting and

releasing of the drill cable. The handle has a generally cylindrical shape

and is approximately 70mm in length and 12mm in diameter. Said handle has a distal end (87) and a proximal end (89). A circular opening (81) is

located in the center of the handle through which one end the drill cable

(32) is inserted. The opposite end of the drill cable is attached to the

control box in the manner previously described. Inside the handle (80),

the drill cable (32) is connected to the micro-drill (82) via a mechanical

connector (83) positioned at a region of the handle (80) where the circular

opening (81) has a wider diameter. Connected to the drill cable (32), the

micro-drill (82) rotates and is advanced within the handle (80) (and

external to the proximal end (89) of the handle) and within a flexible

sleeve (85). Preferably, the flexible sleeve (85) is of a flexible metal

material. Said sleeve (85) is attached to the proximal end (89) of the

handle (80) via a ring (86), said sleeve (85) being connected to the ring

(86) by a springed clamp (90).

The drill cable (32) is positioned inside a second flexible sleeve (91)

inside which it advances and rotates within the handle (80). Said second

sleeve (91) is also connected to the handle via a ring (93) clamped to the

handle (80) by a springed clamp (94).

In use, the bone is drilled in the same manner as described above. After

completion of the first drilling, the surgeon presses on a button (95) located on the top of the handle that causes the release of the flexible

sleeve (85) and the ring (86) from the handle (80). The micro-drill (82) is

retracted from inside of the flexible sleeve (85) while said sleeve (85) and

the ring (86) remain inside the lacrimal pathway.

A cannula is then inserted through the ring and the flexible sleeve into the

lacrimal pathway and through the hole in the bone. Thereafter, a silicone

tube or an optic fiber coated with silicone is inserted through the cannula

until the end of said tube or fiber appears in the nostril and is drawn out.

The cannula is then retracted and disengaged from around the tube or

fiber.

Preferably, the cannula comprises a flexible tubular member having either

the configuration shown in Figure 8 A or in Figure 8B. In Figure 8 A, two

slits (only one (97) of which is seen), spaced 180 from one another,

extend along the length of the cannula (96), though not reaching either

end of the tube. In this embodiment, to disengage the cannula from the

fiber or tube, the surgeon grasps both sides of the cannula (96), pushes

them towards one another, and then tears them apart from one another. In

another embodiment (Figure 8B), a single slit (98) extends the entire

length of one side of the cannula (96). The slit (98) is sized to allow for removing the tube or fiber from within the cannula (96).

Referring again to Figure 7, the handle (80) is then re-connected to the

ring (86) and to the flexible sleeve (85), and the micro-drill (82) is

inserted through the flexible sleeve (85). The second drilling is the

process is repeated as above. This time, however, the opposite end of the

silicone tube or optic fiber is inserted through the cannula. Following

completion, the two ends of the tube or fiber are drawn out of the nostril

(so as to form a loop between the punctae of the eye), and said ends are

then cut and ligated together. Finally, ring (93) is separated from the

handle (80), the drill cable (32) and micro-drill (82) are drawn out of the

handle (80) and a new micro-drill and new sleeve and ring are inserted

for the next operation. It is appreciated that the micro-drill, cannula, optic

fiber or silicone tube, and the flexible sleeve are all disposable.

The following steps may be added if there is a fear that the hole in the

bone will close following removal of the silicone tube or optic fiber

coated with silicone:

Prior to insertion of the cannula inside the flexible sleeve (85), a stent is

inserted through the ring (86) and through the flexible sleeve (85). The

stent is preferably 6- 15mm in length and is comprised of nitinol (conventionally used for blood vessel stents). The diameter of the stent is

approximately the same size as the hole in the bone. When the cannula is

inserted through the ring (86) and the flexible sleeve (85), the stent is

pushed along the sleeve (85) by the cannula, until it is positioned in the

hole in the bone. The stent remains in the bone. A second stent is

preferably used for the second hole in the bone.

Claims

1. A system for performing micro-drilling of a bone or cartilage, or for

opening a blocked biological pathway, especially useful for a

dacryocystorhinostomy, comprising;

(a) a control box adapted for controlling the operation and

regulation of the system, wherein said control box is adapted to be

connected to an external electrical power supply;

(b) a flexible tube having a proximal end and a distal end, and said

flexible tube having a sleeve extending therethrough, said sleeve adapted

for insertion therethrough of a micro-drill and drill cable that is attached

thereto, wherein the drill cable is detachably connected to the control box

such that the micro-drill is operable through the control box when said

micro-drill is inserted through said sleeve and said micro-drill is located

at the proximal end of the flexible tube;

(c) an air suction tube in connection with a hollow inner portion of

the flexible tube and detachably connected to the control box such that

waste produced during the drilling of the bone can be aspirated from the

surgical site.

2. A system according to claim 1, furthermore comprising an optic fiber

that extends through the flexible tube and said optic fiber extending from the distal end of said flexible tube such that said optic fiber may be

connected to a laser diode on the control box for providing illumination at

the proximal end of the flexible tube.

3. A system according to any of the preceding claims further comprising

a connecting member for providing secure connection between the

flexible tube and the air suction tube, the optic fiber, and the sleeve.

4.A system according to any of the preceding claims wherein the sleeve

and optic fiber are affixed to the inner wall of the flexible tube.

5. A system according to any of the preceding claims wherein the sleeve

and optic fiber are affixed to the inner wall of the flexible tube through

silicone glue.

6. A system according to claim 1 further comprising a cover for covering

the proximal end of the flexible tube and for enabling resetting of the

location of the micro-drill inside the flexible tube.

7. A system according to claim 1 wherein the micro-drill has a diameter

of approximately 0.5 millimeters.

8. A system according to claim 1 wherein the sleeve has an outer

diameter of approximately 0.8 millimeters and an inner diameter of

approximately 0.6 millimeters.

9. A system according to claim 1 wherein the flexible tube has an outer

diameter of approximately 1.3-1.4 millimeters, an inner diameter of

approximately 1.2 millimeters, and is approximately 70-100 millimeters

in length.

10. A system according to claim 1 wherein the control box includes a

control card containing program control and a display card coupled to an

alpha-numeric display located on the panel of the control box.

11. A system according to claim 10 wherein the control box further

includes a mechanism for releasing and retracting the drill cable from the

control box, wherein said mechanism is coupled to the control card and

the display card and said mechanism is furthermore coupled to a

release/retract mechanism plug on the panel of the control box for

connection thereto of the drill cable.

12. A system according to claim 10 wherein the control box further includes a mechanism for controlling the directional and rotational

movement of the micro-drill, wherein said mechanism is coupled to the

control card and the display card and said mechanism is furthermore

coupled to a drill mechanism plug on the panel of the control box for

connection thereto of the drill cable.

13. A system according to claim 12 wherein the mechanism for

controlling the directional and rotational movement of the micro-drill

further includes a selector for controlling the speed of movement of the

micro-drill, wherein said selector is located on the panel of the control

box.

14. A system according to any one of the preceding claims wherein the

control box further includes a laser diode that is connectable to a first end

of an optic fiber through a plug on the panel of the control box for

providing illumination at a second end of said optic fiber.

15. A system according to claim 10 wherein the control box further

includes an air pump coupled to the control card and to the display card,

wherein the air pump is detachably connected to the air suction tube

through a plug on the panel of the control box such that waste produced during the drilling of the bone can be aspirated from the surgical site.

16. A system according to claim 10 wherein the control box further

includes a series of indicator lamps located on the panel of the control

box and coupled to the display card such that the particular functioning or

status of the system can be monitored by the surgeon.

17. A system according to claim 10 wherein the control box has a foot

pedal connected thereto for enabling the surgeon to stop the operation of

the system in case of need.

18. A system according to claim 1 wherein the micro-drill is made of

NITINOL or other suitable material.

19. A method for performing a dacryocystorhinostomy using the system

described in any one of the preceding claims, comprising:

(a) performing a self check of the system and resetting of the

location of the micro-drill in the flexible tube;

(b) causing slight directional and rotational movement of the

micro-drill and advancing the flexible tube through an upper or lower

puncta of the eye, a canaliculus, and lacrimal sac until reaching the bone

of the nose; (c) adjusting the speed of the micro-drill and drilling a hole through

the bone of the nose;

(d) disconnecting the drill cable from the drill mechanism plug and

connecting the drill cable to the release/retract plug;

(e) retracting the drill cable and the micro-drill into the control box;

(f) inserting a silicone tube through the sleeve, advancing the silicone

tube through the lacrimal pathway and the nasal cavity, and pulling the

end of the silicone tube outside of the nostril;

(g) removing the flexible tube from the lacrimal pathway.

20. A control box for use in the system described in claim 1 or 2 during a

dacryocystorhinostomy or other micro-drilling procedure of a bone,

cartilage, or tissue, and/or for opening blockage in a biological pathway,

comprising:

(a) a control card having a program control;

(b) a mechanism for releasing and retracting the micro-drill

from the control box, wherein the mechanism is connectable to

the micro-drill through a plug on the panel of the control box;

(c) a mechanism for producing directional and rotational

movement in the micro-drill, wherein the mechanism is

connectable to the drill cable through a plug on the panel of the control box, and said mechanism is directly controlled by the

control card;

(d) a display card for controlling warning lights, sounds, and

messages conveyed from a panel of the control box or from an

alpha-numeric display on said panel of the control box;

(e) an air-pump for aspirating wastes produced during the

micro-drilling procedure, wherein the air pump is connectable

to the air suction tube and said air-pump is directly controlled

by the control card;

wherein the control box is adapted for connection to an external

electrical power supply.

21. A control box according to claim 20 furthermore comprising a laser

diode for enabling visualization of the advancement of a flexible tube

through the lacrimal pathway when said laser diode is connected to an

optic fiber.

22. A system for performing micro-drilling of a bone or cartilage, or

for opening a blocked biological pathway, especially useful for a

dacryocystorhinostomy, comprising;

(a) a control box adapted for controlling the operation and

regulation of the system, wherein said control box is adapted to be

connected to an external electrical power supply;

(b) a handle having a proximal end and a distal end;

(c) a micro-drill positioned inside a flexible sleeve, wherein said

micro-drill and flexible sleeve extend from the distal end of said handle;

(d) a drill cable operationally coupled to said micro-drill inside said

handle, and said drill cable being to said control box.

23. A system according to claim 22, wherein the flexible sleeve is

detachably connected to the distal end of the handle.

24. A system according to claim 22, wherein the drill cable is

positioned inside a sleeve, said sleeve being detachably connected to the

proximal end of the handle.

25. A system according to claim 22, wherein the micro-drill is

disposable.

26. A method for performing a dacryocystorhinostomy using the

system described in claim 22, comprising:

(a) performing a self check of the system and resetting of the location of the micro-drill in the flexible sleeve;

(b) causing slight directional and rotational movement of the

micro-drill and using the handle to advance the flexible sleeve through an

upper or lower puncta of the eye, a canaliculus, and lacrimal sac until

reaching the bone of the nose;

(c) adjusting the speed of the micro-drill and drilling a hole through

the bone of the nose;

(d) disconnecting and retracting the handle and the drill cable from

the flexible sleeve such that said flexible sleeve remains inside the

lacrimal pathway;

(e) inserting a cannula through said flexible sleeve, advancing said

cannula through the lacrimal pathway and the hole in the bone;

(f) removing the flexible sleeve from the lacrimal pathway while

said cannula remains in the lacrimal pathway and inside the hole in the

bone;

(g) inserting a first end of a silicone tube or optic fiber coated with

silicone through said cannula into the lacrimal pathway until the end of

said fiber or tube appears in the nose;

(h) pulling out the cannula from the lacrimal pathway and

disengaging said cannula from said tube or fiber;

27. A method according to claim 26, further comprising repeating steps a-h by advancing through the second puncta of the eye and by

inserting a second end of said silicone tube or optic fiber in step g.

28. A method according to claim 27, further comprising drawing the

two ends of the silicone tube or optic fiber out of the nostril to form a

loop between the two punctae.

29. A method according to claim 28, further comprising cutting excess

tubing or fiber and ligating said tubing or fiber together inside the nose.

30. A method according to claim 26, further comprising inserting a

stent into the hole in the bone of the nose.

31. A method according to claim 26, wherein the cannula has a slit

extending on one side of the length of the cannula for allowing

disengaging of said cannula from said optic fiber or silicone tube.

32. A method according to claim 26, wherein the cannula has two

longitudinal slits positioned 180 from one another for allowing

disengaging of the said cannula from said optic fiber or silicone tube.