WO2002007632A1

WO2002007632A1 - Illuminating devices for medical use

Info

Publication number: WO2002007632A1
Application number: PCT/IL2001/000665
Authority: WO
Inventors: Ron Tenzer; Gershon Goldenberg; Benjamin Spenser; Tzachi Vider; Nachum Nesher
Original assignee: Lumen Medical Ltd.
Priority date: 2000-07-20
Filing date: 2001-07-19
Publication date: 2002-01-31
Also published as: IL137430A0; AU2001280030A1

Abstract

A self maintained, fiberoptic-free illuminating device for medical applications characterized by having at least one white LED and a built-in battery. The said illuminating device is a light-weight, portable, sterilizable, disposable, user friendly and highly effective instrument. It is easily inserted into body cavities and inside any surgery field to provide cold light in any desired direction and angle.

Description

ILLUMINATING DEVICES FOR MEDICAL USE

Field of the Invention

The present invention provides a series of new illuminating devices,

intended for use by physicians, surgeons, veterinarians and other medical

staff, in their daily activities. More specifically, it offers cord-less and

fiberoptic-less illumination devices characterized by being long lasting,

small, light-weight, portable, sterilizable, disposable, user friendly, highly

effective, energy efficient and cold light emitters.

Background of the Invention

There are several methods currently used for illuminating operating

theaters:

1. Heavy top lamps connected to the ceiling. Many operation theaters are

equipped with more than one top light. These illuminating devices have

some major disadvantages, among them are:

■High power devices (3000-6000 Watt).

■It is very difficult to keep the illumination focused on the desired

spot.

■There are shaded areas where the top light cannot provide a

satisfactory illumination effect. ■The top lamps have a side effect of heating which causes discomfort

to the surgeons and the related staff.

■Focusing and adjustment of top light lamps require special sterile

handles and may cause sterilization and cleaning problems.

■Top light lamps can get in the way of the surgeons and hit their head

or shoulders.

■Top light lamps are high cost items.

2. There is a wide range of illuminating devices based on

fiber optic technology - among them are:

- Fiberoptic head light: This device is a kind of helmet which the

surgeon carries on his head, and consequently, should direct his

head to the desired area that needs to be illuminated.

It has several major disadvantages:

(i) The device is heavy and may cause pain in the surgeon's neck and

back,

(ii) It is sometimes difficult, or impossible, to direct the illumination

to a desired angle, in particular in shaded areas in the open

abdomen or chest,

(iii) The light coming out of the fiber is focused to illuminate a certain

area, according to the distance of illumination. In other words, the

surgeon must stay at a constant distance from the operated area.

Beside the need to direct the light continuously with his head, this

causes the surgeon a further inconvenience. (iv) The device is expensive. In addition, the fiber cable that connects

the generator and the helmet, gets damaged frequently.

(v) The thick cable connected to the helmet may limit the surgeon's

movement.

- Illuminated retractors: These devices are. specifically designed to

have built-in fiberoptic cables. The beam of light is very narrow and

its direction is dictated by the shape of the retractor. Consequently,

the device is not as effective as this kind of illuminating device should

be. In addition, the fiberoptic cable that connects the device to the

generator causes further disadvantages as described above.

- Fiberoptics-based devices used in illumination of laparoscopic and

endoscopic procedures are also common.

- Some drilling equipment for dentists' use contain fiberoptic means

for illumination.

Prior art teaches mostly of fiberoptic-based illuminating devices for use in

surgery and other medical applications, among them are:

US Patent 4,551,129 provides technique and apparatus for intraocular

and microsurgery including hghter-irrigator hypodermic tube which

utilizes a central hght guide to conduct light into the area of the surgery

along the fluid infusion pathway. An auxiliary to the lighter-irrigator

comprises a fiberoptic work cord or light pipe characterized by light transmission and light dispersion along the path between a hght source

and the lighter-irrigator.

US Patent 5,569,300 relates to a surgical instrument for performing

subcutaneous surgery, specifically the utilization of the surgical

instrument to illuminate the carpal tunnel area of a patient to effect the

severance of the transverse carpal ligament. The patent discloses dilating

surgical forceps having fiberoptics illumination means on the blade inner

surface.

US Patent 5,722,426 discloses a coronary light probe for determining the

location of arterial structures and blockages thereof during surgery so as

to facilitate making incisions where necessary. The light probe has an

elongated portion with fiberoptic cables for conveying light to a distal tip of

the probe. The hght emitted from the distal tip illuminates the vessel

adjacent the distal tip.

US Patent 5,931,670 teaches of an illuminated dental suction appliance

that contains a suction component having a tubular member and a hght

projecting tip. Light is transmitted from a fiberoptic illuminator along the

length of the tubular member to the hght projecting tip.

WO 99,56633Al reveals an illuminated surgical retractor for creating a

working space for dissecting instruments in support of a surgical procedure such as coronary bypass procedure or other type of vessel

harvest procedures. More specifically, the patent provides an illuminated

retractor for illuminating a subcutaneous surgical field in the space

between a vessel, such as the saphenous vein, the subcutaneous tissue

when the illuminated retractor is used to retract the subcutaneous tissue

away from the superior surface of the vessel. A distal end of the second

blade section is connected to an illumination source so that the second

blade section is substantially illuminated.

The above devices suffer from the disadvantage of having cords or cables

connecting the device to an external electrical or illumination source.

Furthermore, they create heat, have a small illumination area and are

relatively expensive. Consequently, there is a need for an illuminating

device free of these shortcomings, applicable in medical fields, in

particular, in surgery.

Upon searching for such a device it was found that a combination of

self-maintained power (a battery), a cold white hght emitter (a white

LED), and various devices, applicable in medical treatment, in particular

in surgery, may provide a new device, highly effective in illumination of

the region of interest while at the same time, being free of the above

mentioned shortcomings. Such combination of a battery, white LED and a

device applicable in medical treatment, is new. The present invention is an

example of how ingenuity may provide a relatively simple solution to

several yet unsolved problems. In other words, such a solution, in this particular case, has led to a new series of illuminating devices applicable

in a wide range of medical applications, free of any of the above described

long-lasting shortcomings.

Objects and Summary of the Invention

It is the object of present invention to provide a self-maintained, fiber optic-free illuminating device characterized by being long lasting, small,

light-weight, portable, sterilizable, disposable, user friendly, highly

effective, energy efficient and cold light emitter.

It is an additional object of the present invention to provide a series of

small and portable illumination devices containing white LEDs and

batteries.

It is a further object of present invention to provide an illumination device

that is free of many disadvantages existing in present illumination devices, as described here-in-above.

The illumination device of the present invention provides a white LED light power-supplied by a built-in battery. Both, the LEDs and the battery are integrated parts of the devices. The device according to the present

invention has some major advantages over the current existing illumination devices:

1. The illuminating part is placed inside the operation field, unlike the top light which is placed distantly.

2. No need for a connecting cable that causes inconvenience. 3. No need for highly expensive fiberoptic means such as light generators,

which are placed next to the operating site and are very expensive.

4. The device is small, portable, sterilizable and disposable and as such is

easily inserted into body cavities and any surgery field to provide light

in any desired direction and angle.

5. The combination of a white LED and suitable powered battery provides

a desired amount of illumination for a significant period of time.

Furthermore, this combination intends to provide a new illumination

tool applicable in examination and treatment of "internal" cavities (such

as in laparoscopy and endoscopy procedures), as well as in examination

and treatment of "external" cavities, such as ear, nose, throat, mouth

(ENT, laryngoscopy, etc.).

6. Same principle of combination (white LEDs + baterry) is apphcable for

a series of illumination devices specifically designed for use by dentists,

general practitioners, ophthalmologists and other physicians and

specialists, including veterinary and veterinarian surgeons.

Brief Description of the Drawings

FIG. 1 demonstrates a cross section of a human under open surgery. The

illuminating device comprises of an illuminating head (3) is attached to

the inner part of the abdominal wall. A flexible cord (2) supphes energy

from a second part of the device (1), which includes a battery and an

operating switch (9) FIG. 2 depicts an illuminating device comprising a main housing (1) which

includes a 4 to 6 volt battery inside it, an illuminating head (3) carries

4-12 white LED's (5) arranged in rows or in any other desired manner. A

built- in clip is placed on the main housing including a spring-loaded

moveable clip (10) and stationary teeth (11) on the opposite side. The main

housing is connected to the illumination head in a rigid, firm manner. The

complete illuminating device may be attached to the abdominal wall by

means of the clip (8).

FIG. 3 demonstrates a miniature, disposable illuminating device

comprising a two button battery housing (12), a disposable switch (13) that

when pulled out switches the light on, one LED (14), a led housing (15)

allowing to adjust LED direction for providing optimal effective

illumination in any desired direction. Attachment means comprising at

least one long needle (16), which penetrate through the patients skin or

other surface tissues (17) and at least one short needle that insure the

device from shaking, moving, vibrating or rotating. An additional

attachment mean (18) is placed in the opposite side of the skin surface and

together with the long needle(s) attaches the device firmly to place.

FIG. 4 depicts an illuminating device which is similar to the one described

in FIG 2. The device is illustrated when the illuminating head (3) is

detached from the battery housing (1) and a thin flexible cord (2) supplies the power from the batteries to the illuminating head. The head (3) has

built in portions (19) with holes (20) allowing attachment of the device to

the patient by stitching with sutures (21) in the desired place.

The device described in 4a is similar to the device in figure 4. However, in

the first, all the 1 to 4 sutures (6) are originally built-in and connected to

the device. Furthermore, the sutures have needles (7) at their distal end

for stitching the device in place.

FIG. 5 describes attachment means (88) which allows the attachment of

an illuminating device to a rigid retractor in a firm manner (89).

FIG. 6 illustrates a surgical retractor with a built-in illuminating device

carrying a set of LED's (23) on either side of the retractor. In some

retractors there are up to four retraction elements, each may carry a set of

LEDs . A built-in operating switch (24), and batteries (25) on the retractor

is one of the preferred embodiments. When using said retractor, the whole

operation cavity (26) is illuminated sufficiently.

FIG. 7a demonstrates a Duval forceps with a built-in illuminating device,

which comprises a battery housing (27) an operating switch (28), a double

illuminating head (29) including two LEDs (30)..

FIG. 7b depicts a spatula with 2-4 built-in LEDs (31), a battery housing

(32) with one or two button batteries (33) and a battery cover (34). FIG. 8 demonstrates an illuminating device having the same battery

setting (35) as shown in FIG. .2, an attachment means (36) as shown in

FIG. 3, and an operating switch (37). This device has a 20-30 cm, flexible,

neck (38) consisting of a main tube (44), a soft stainless-steel wire (39) and

an electric cord (40) for transmitting power to a set of 6-12 LEDs (42) that

are desirely arranged in the illuminating head (41). The device is

attachable to the patient's body (45) in a firm way, wherein the

illuminating head (41) can be placed in the operation area by manually

bending the neck (43) and directing the head to the desired position and

location. The stainless-steel wire maintains the selected position of the

neck.

FIG. 9 illustrates a patient (46) in a Mediastinoscopy procedure. The

device shown (47) represents a Mediastinoscop with built-in illumination

means (48) comprising a set of LEDs arranged in a ring formation or may

be arranged in any other desired formation.

FIG. 10 describes a catheter (49) especially designed for illuminating the

point of the esophagus — gastric junction (50). The catheter comprises of a

main body portion (51), which allows good pushability of the catheter, an

inflatable flexible balloon (52) at the distal part, an inflating valve (53)

through which the balloon is inflated and deflated. 2-5 LEDs (54) are

placed in the distal portion of the catheter adjacent to the balloon. When

switched on, the light is seen through the transparent wall of the catheter. An electric cord (58) supplies the power from the battery, which is placed

in the battery housing (55) and operated by the operating switch (56).

Distance measurement marks on the catheter body (61) allow to measure

or appreciate the distance from the balloon to the catheter's proximal side.

A main lumen (59) allows access to the stomach from the entrance (57).

The catheter is inserted to the stomach via the esophagus, the balloon is

then inflated and the catheter is pulled back until the balloon stops at the

joining point. The illuminated distal portion is seen through the esophagus

wall, indicating the exact point of interest. The distance from the stomach

to the throat can be easily appreciated and measured by the marks on the

catheter body.

FIG.ll depicts a similar illuminating device as described in FIG. 10.

However, in this case, a set of 6-20 LEDs (62) are arranged in the distal

portion of the catheter creating a 4-15 cm portion of illuminating catheter.

The catheter is inserted to the colon or intestine via the rectum. It is then

possible to see differences in trans -illumination between normal parts of

the organ (63) and the pathologic parts. For example, a tumor (67) in the

colon causes a dark portion (64) when examining the trans-illuminated

colon. Another use of this device is in surgery procedures. For example,

trans -illumination clarifies the shape of the organ and helps avoiding

dissections in wrong places and cutting blood vessels (66). FIG.12 illustrates a rod-shaped instrument, a suction device (68) for

example. An illuminating device (69) comprised of a battery housing (70),

a head (71) a . set of 2-4 LEDs (72) attachment means (74) and an operating

switch button (73). This device is attached to the suction instrument

providing an excellent illumination.

FIG. 13 depicts a disposable dentist mirror. (75) having built-in

illuminating means in the form of LEDs (76) pointing to the mirrors sight

direction, a battery housing (77) and an operating switch (78). In one

option the battery is a reusable battery, and inserted into the disposable

mirror prior to use.

FIG. 14 demonstrates a headlight having fitting means to the surgeon's

head (84). Said headlight device comprises an illuminating head with a set

of 6-15 LEDs (79), an angle adjustment capability (82), a battery housing

(81), an operating switch (83) and a focusing lens (80).

FIG.15 demonstrates a disposable, illuminating thimble. Said illuminating

thimble comprising a housing (85), two LEDs (86) and an operating switch

button (87).

FIG.16 illustrates a miniature illuminating device comprising a battery

housing (90), an illuminating head (91) having a set of 2-5 LEDs (95),

electric cord (92) and an operating switch (93). The illustrated setting allows the illuminating head (91) to be placed apart and independently of

the battery housing. When it is placed at the operation field (94) it

provides a very close and effective illumination.

FIG. 17 describes an illuminating device (98) attached to a mounting

device which comprises a set of rods (96) and hinges (99) to maintain

positioning of the illuminating head in the desired position. The mounting

device is attachable to the operating table (97). A further way of achieving positioning of said illuminating device is by means of a flexible neck, as

described in FIG. 8.

FIG. 18 demonstrates an illuminating device (103) placed in a mouth of a

patient suffering from sinusitis (100). The light creates trans-illumination effect through the sinuses. The left sinus (101) is clear, whereas the right

(102) is blocked, as reflected by the difference in light brightness.

FIG. 19 depicts a miniature illuminating device (104), similar to the one shown in FIG. 16, including a shield (105) preventing from the light to be seen from the side, hence helps in hiding the light beam from spectators

away from the focused beam of light (106). The said shield can be moved to a second back position (107) allowing a wide beam as well.

FIG. 20 describes theracotomy retractor (108) with an illumination accessory device, including an illumination head (109) with 7-12 LEDs (110) an extension neck (113), battery housing (111), operating button

(115) and attachment means (112) to the retractor. The surgeon can move

the neck (113) and adjust it to any desired direction.

Examples and Clinical Applications

As was mentioned here-in-before there are numerous medical procedures,

in particular, surgical operations, that require highly effective

illumination means.

1. Open chest surgery is a common operation procedure that requires

effective illumination. In heart surgery, for example, the surgeon may

dissect and stitch blood vessels of less than 2 mm in diameter.

Furthermore, he may insert up to 15 miniature stitches into the vessel

wall, at a shortest possible time, usually within up to ten minutes. This

procedure may be repeated several times during a single operation.

Consequently, a highly effective illumination of the operation area, should

facilitate the surgeon to achieve a better quality surgery procedure in a

shorter time. In this connection, it should be pointed out that top and/or

headlights, currently in use in same surgical procedures, found to be very

uncomfortable for surgeons and sometimes limited in lighting hidden

cavities, in the surgery area. The illumination device of present invention

(FIG 1) may be inserted into the operation area to provide an effective

illumination of any hidden spot. Such a. device must be attached to the

operation area by fast and friendly means, the invention reveals several

different options of attachment means as shown in drawings: built in forceps to attach the device (FIG 2), specially designed pins which are

inserted from the inner part of the open belly via the abdominal wall and

attached by a clip to the outer surface of the patients belly (FIG -3). This

allows steady and firm attachment of the device in the operation field. A

different approach to the attachment is by suturing the device to the inner

wall inside the operation area, either by means of standard stitching (FIG

4.), or by a built in suture and needle setting which already exists on the

device (FIG 5). In any case, using the device of the present invention,

should relieve the surgeon from the current headlight that was found to be

both inconvenient and not always sufficiently effective.

2. Chest surgery is carried out either in a regular approach or in a less

invasive approach, where the chest is opened in-between two ribs. In both

approaches, by using instruments such as varies retractors, it allows the

surgeon a sufficient opening for approaching the operation area.

Illumination of the operated zone, in this kind of procedures, is very

difficult to achieve, as most of the operated area is placed deep in the body,

relatively far away from the retractor. Using the device of the invention for

illuminating the operation zone in such procedures, for example a

retractor containing a built-in illumination capability (FIG. 6), or a special

illumination accessory device attached to the retractor (FIG. 20) may

overcome the above obstacle and yields an improved result, namely a more

accurate performance, in a shorter time.

3. Chest surgery also includes lung operations. In such operations, highly

effective illumination, is required for enabling manipulation of soft tissue and identifying pathological f dings. A series of manual surgical

instruments are in use in such procedures including, Collin-Duval

grasping forceps, Martel tissue holders, Israel retractors, spatulas, suction

tubes and many others. According to the present invention, a device

including white LEDs and a battery are attached to these instruments to

convert them into illuminating devices, as well (FIGS 7a and 7b).

Consequently, said surgical instruments may have dual functions: in

addition to their regular function as manual surgical instruments, they

may function as illuminating devices that provide a closed, very effective,

illumination of the operation area.

4. While performing Mediastinoscopy, a tube is inserted into the cavity of

the upper chest through the lower part of the neck. The tube provides

ability to see the inside of the chest cavity and enables the surgeon to '

observe findings that should be diagnosed in real-time. The present

invention provides a Mediastinoscope tube containing built-in illumination

means, namely, white LEDs and a battery (FIG 9).

5. Many operations in the abdominal cavity suffer from deficient

illumination. Specially, in the upper abdominal procedures (such as, liver,

spleen, esophagus, stomach, and left colon), or the lower abdominal and

pelvic procedures (such ' as, rectum and sigmoid colon), improved

illumination is necessary. The device shown in FIG. 8 comprises a housing

that includes a battery, an operation button, attachment means, an

illumination head and a flexible neck in-between. The neck having a soft

stainless steel rod in it, allows bending and moving it to the exact desired position needed for achieving the maximum illumination in the desired

spot.

6. Some of the common operations are carried out while the patient lies on

his side, for example, during spine and back surgeries. The top light is

usually not effective in such conditions and the headlights cause

inconvenience.

7. Other cold-lighted illumination special devices revealed here are

trans-illuminating devices. The devices shown in the present invention are

useful in the surgery of specific organs, such as, for example, rectum,

sigmoid, colon, esophagus and stomach. Said cold-lighted

trans-illuminating devices are in the form of a long flexible tube with

illumination means (white LEDs) at its tip or on its whole distal portion

and marks along its length to indicate the distance between the light and

the marks.

This device illuminates the operated organ from the inside and at the

same time allows the physician to estimate the location of the illuminated

end and to determine the distance from that location to the entrance to

the body.

8. When performing anti reflux procedure, in open surgery or laparoscopic surgery, it

is required to find the exact point of the esophago - gastric junction, in

order to prevent hazardous damage to the esophagus and to perform the

rap in the exact location.

A special trans -illumination catheter (FIG 10) consisting of a catheter

body, an inflatable balloon at the .distal portion, illumination means proximal to the balloon, power supply, and an open lumens through the

catheter. The device revealed here allows the surgeon to insert the

catheter into the stomach via the esophagus, inflate the balloon and pull

the catheter back, at this stage the laminated LED will indicate the exact

required point. The advantage of this device is that the surgeons will save

time finding the point and furthermore will decrease the danger of damage

to the esophagus, which can be fatal.

9. In another different procedure the surgeon needs to locate the exact

location of a tumor in the sigmoid colon, intestine or rectum (for example).

Presently it is done by feehng the organ with the fingers via the feroza

during performance of open surgery. The trans-illumination catheter

shown in FIG 11 has a series of LEDs on its distal portion, which when

inserted into the colon via the rectum allow the surgeon to see a tumor

through the colon wall. Tumors in the colon, which are thick and

non-transparent, will be clearly seen as dark areas compared to the

trans-illuminated areas, which are seen with bright light. The distance

marks on the catheter will also help in more precise description of the

operation, a feature important for the medical file (FIGS 10 and 11).

10. This trans -illumination catheter will also be used in operation of the

rectum. When performing such procedures there is a need to separate the

organ from the surrounding tissue. The trans-illumination catheter will

help identifying the exact borders of the rectum and assist in dissecting in

a more precise way. 11. Another use of a trans -illumination device shown in fig 16 is to

diagnose the sinus cavities in a patient face, the doctor inserts the device

into the patients mouth and can see clearly a difference between a clear

sinus and a sinus cavity which is blocked with liquid.

12. There are many non-surgical procedures that require effective

illumination. The devices of the present invention may be useful tools in

illumination of such procedures. Among these procedures are: ENT,

gynecological procedures, and many others (FIGS 3,4, 5, 7,15,16,17)

In addition, the device of present invention includes instruments of a

rod-shaped design, applicable in diathermia, suction, etc., in which white

LEDs and a battery are implemented, in order to convert them to

illuminating devices, as well. (FIG 12).

13. Other medical disciplines, may also get benefit resulting from the use

of the device of the present invention. For example, veterinarians who

perform all procedures in their clinic cannot usually afford purchasing

heavy top-light equipment. Dentists may use a special designed mirror in

which white LEDs and a battery are implemented (FIG 13). Same is true

regarding specially designed illumination devices for the general surgery

in form of an illuminating thimble (FIG 15). The military medicine as well

may get benefit of present invention. A special illuminating device

designed for using by an army physician, in the battle field, provides an

effective focused illumination beam with a shield which prevents the hght

from being seen from side directions, and helps in preventing disclosure of

the medical units location (FIG 19). 14. A new design of head light which is cable free and comprises LEDs

batteries as well as a focus lens is shown in FIG. 14.

Claims

1. A self maintained, fiberoptic-free illuminating device for medical

application characterized by having at least one white LED and a

battery.

2. An illuminating device, according to claim 1, characterized by having at

least one feature, or any combination of features, selected from the

group comprising: long-lasting, small, light-weight, portable,

sterilizable, disposable, user friendly, highly effective, energy efficient

and cold light emitter.

3. An illuminating device, according to claim 2, characterized by having

all said features.

4. An illuminating device, according to any of claims 1 - 3, for application

in any medical or veterinarian procedure, includ ng surgery,

non-surgery, diagnosis and treatment.

5. A device, according to claim 4, for illuminating a surgery procedure,

wherein said device is selected from the group comprising a forceps, a

retractor, a tissue holder, a spatula and a suction tube.

6. A trans -illuminating device or catheter, according to claim 4, applicable

in illumination, diagnosis and treatment of disorders in internal

cavities.

7. An illuminating device, according to claim 4, carrying in hand, or on a

finger of a hand.

8. An illuminating device, according to claim 4 , carrying on forehead.

9. An illuminating device, according to any of claims 1-4, applicable in

dentistry and ophthalmology.

10. An illuminating device, according to any of claims 1-4, applicable in

veterinary.