A) TECHNICAL FIELD

[0001] The embodiments herein generally relates to medical devices and particularly to patient-vital sign monitor interface cable in medical devices, and method for making the same, and more particularly to disposable-type electrocardiograph (ECG/EKG) biodegradable cable.

B) BACKGROUND OF THE INVENTION

[0002] Often, patient-vital sign monitors are used in emergency conditions to access critical parameters of the patient which becomes important for proper care of the patient. Examples of the critical parameters include, but are not limited to Electrocardiography (ECG/EKG), Electroencephalography (EEG); Electromyography (EMG), Electro-muscllography, blood pressure, percentage of oxygenated blood, respiration rate, and amount of carbon dioxide inhaled and exhaled air. In the EGG, electrical activity of the patient's heart is recorded over time. ECG devices generally measure the potential differences between various selected points on the body of the patient. The ECG measurement is performed by way of attaching electrodes on to the body of the patient on predetermined places namely right arm (RA), left arm (LA), left leg (LL), and right leg (RL). For example, the electrodes can be placed around the heart at various points on test subject.

[0003] Currently the ECG cable is made up of multiple-core cables in which various lead wires are electrically insulated from each other, are combined in a bundle. Further, the bundle is surrounded by a number of concentric insulating sheaths and by a single screening braid. The electrically conductive lead wires and the insulating shield are made from copper, tin, nickel, silver and their alloys.

[0004] There is a growing trend towards replacement of multiple use electrodes with single-use disposable electrodes when used on the patients affected with contagious diseases. Some currently available disposable electrodes tend to come loose from surface of the patient and tend to roll back away from the patient's skin during cardiac resuscitation. Moreover, the electrodes cause excessive electrical noise due to disruptions of electrical conductivity, which leads to difficulty in interpreting received electrical data associated with the patient's heart.

[0005] At present powdered coconut shell is used as a filler compound along with the plastic resin as a filler material. This will not only save the plastic resin derived from petroleum by product but also will help in fast decomposition of cables made from such composition. Here the electrical insulation a.k.a. dielectrical properties of coconut shell are utilized. But the electrically conductive properties of steam carbonized coconut shells & the powder of such coconut shell mixed with various electrically conductive additives and the binding materials along with the coir fibre as strengthening element has not been utilized in industrial scale manufacturing.

[0006] In light of the foregoing discussion, there remains a need, for an inexpensive easily disposable, environment friendly yet effective biodegradable interface cable unit using naturally available biodegradable resources.

[0007] The above-mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification.

C) OBJECT OF THE INVENTION

[0008] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

[0009] The primary object of the embodiment herein is to develop a method for manufacturing a disposable type biodegradable interfacing ECG cable unit.

[0010] Another object of the embodiment herein is to develop an improved single core biodegradable interface cable for medical devices.

[0011] Another object of the embodiment herein is to develop an improved multi-core biodegradable interface for medical devices.

[0012] Another object of the embodiment herein is to develop a disposable type biodegradable medical electrode.

[0013] Yet another object is to develop a biodegradable ECG Interface cable with electrodes which is more economical, easier to use, and reliable and with generation of less electrical noise.

[0014] Yet another object is to develop a biodegradable medical electrode, which has low and fairly constant resistance impedance over the range of desired frequency and over the time period of use.

[0015] Yet another object is to develop a biodegradable medical electrode, which is transparent for X-rays and MRI signals.

[0016] Yet another object is to develop a biodegradable medical electrode, which is water-proof, sweat-proof and able to withstand weight of cable leads, so that the electrode sticks to the body surface without causing inconvenience to the patient and does not detached during patient movement, when the electrode is positioned accurately on the body of a patient.

[0017] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

D) SUMMARY OF THE INVENTION

[0018] The above-mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification

[0019] The various embodiments of the present invention provide a biodegradable interface cable for medical devices. The interface cable comprises a non-conductive core layer. A conductive layer is formed over the non-conductive core layer. At least one shielding layer is formed around the conductive layer and an outer insulative sheath is formed around the shielding layer. The non-conductive core layer and the conductive layer are formed of a coir fibre.

[0020] According to one embodiment of the invention, the coir fibre is derived from a coconut husk. The conductive layer is formed of multiple coir fibres coated with a conductive carbon paste, which in turn derived from the steam carbonization of a coconut shell. The conductive carbon paste is a mixture of carbonized coconut shell powder, carbonized coconut husk powder, conductive karaya gel, water, glycerine, powder of aluminium, copper, nickel, carbonized coffee seed husk, carbonized rice husk powder.

[0021] The conductive layer is filled with granules of conductive carbon obtained from coconut shell and the shielding layer is formed with an aluminum foil, braided shield and a carbon coated cloth for preventing electromagnetic interference (EMI), (EMC) and Tribo-electric or static noise protection. The outer insulated shield is formed with a decomposable plastic material or a plastic derived from resins. The interface cable is at least one of a single core cable or a multi-core cable.

[0022] According to one embodiment, a disposable type biodegradable interface cable unit for medical devices includes a yoke, pluralities of single core biodegradable interface cables and a multicore biodegradable interface cable connected to the yoke. The yoke is formed with a coconut shell and filled with coconut shell powder. Further, the biodegradable cable unit is provided with at least one electrode connected to the single core biodegradable interface cable and at least one pinch clip connected to the single core biodegradable interface cable. A connector is attached to the multi core biodegradable interface cable.

[0023] According to one embodiment, the yoke includes a top cup and a bottom cup formed with coconut half shells. The inner surface and the outer surface of the coconut half shells in the yoke are polished to prevent a biological contamination. The yoke further includes pluralities of holes in the upper surface for connecting the pluralities of single core biodegradable interface cables and the multi-core biodegradable interface cable. The yoke has an indicator at the upper surface to indicate the position of the placement of the attached electrodes on a body of a patient. The indicator has a sticker engraved with an image showing the organs of the body where the electrodes are attached. The sticker is made from a polycarbonate or resin materials derived from a petroleum product. The image is engraved on the sticker using laser energy.

[0024] According to one embodiment, the electrode connected to a single core biodegradable interface cable is a disposable electrode, which is a biodegradable electrode. The biodegradable electrode is formed with an electrically insulated coconut shell. The electrically insulated coconut shell is formed by carbonizing a surface of the coconut shell using laser energy. The biodegradable electrode is a piece of a leaf sheath of Areca Catechu Linn palm with surface carbonized using laser energy. Further, a limited time use electrode is connected to the pinch clip formed with a conductive carbon compound.

E) BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

[0026] FIG. 1 illustrates a perspective view of a biodegradable interface cable unit fot raedical devices, according to one embodiment of the present invention.

[0027] FIG. 2 illustrates an isometric view of a biodegradable single core interface cable, according to one embodiment of the present invention.

[0028] FIG. 3A shows a table illustrating a test resuh for electrical AC impedance of the interface cable, according to one embodiment of the present invention, for various frequencies at a fixed predefined voltage.

[0029] FIG. 3B shows a table illustrating a test resuh for Electrical AC impedance of the interface cable, according to one embodiment of the present invention, for a different frequency ranges at a preset voltage.

[0030] FIG. 4 is a table illustrating a test result for Electrical AC impedance of the interface cable, according to one embodiment of the present invention, for different frequencies at another preset voltage value.

[0031] Although specific features of the present invention are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the present invention.

E) DETAILED DESCRIPTION OF THE INVENTION

[0032] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.

[0033] The various embodiments of the present invention provide a method for manufacturing a disposable type biodegradable interface cable unit, biodegradable interface cable, and biodegradable electrodes for medical devices. The disposal type biodegradable interfacing cable unit includes a yoke. Pluralities of single core biodegradable interface cables and a multicore biodegradable interface cable are connected to the yoke. The yoke is formed with a coconut shell and filled with the coconut shell powder. Further, the biodegradable cable unit is provided with at least one electrode connected to the single core biodegradable interface cable and at least one pinch clip connected to the single core biodegradable interface cable. A connector is attached to the multi core biodegradable interface cable.

[0034] According to one embodiment of the present disclosure, the single core disposal type biodegradable interfacing cable includes a non- conductive core layer and a conductive layer formed over the non-conductive core layer. The non-conductive core layer and the conductive layer are formed of a coir fiber derived from coconut husk. Further, the biodegradable interfacing cable includes at least one shielding layer formed around the conductive layer and an outer insulative sheath formed around the shielding layer. The non-conductive core layer and the conductive layer are formed of a coir fiber derived from coconut husk.

[0035] FIG. 1 illustrates a perspective view of a biodegradable interface cable unit 100 for medical device. The interface cable unit 100 is preferably used for ECG. With respect to FIG. 1, the biodegradable interface cable unit 100 includes a yoke 110. Pluralities of single core biodegradable interface cables 102 and a multicore biodegradable interface cable 112 are connected to the yoke 110. The yoke 110 is formed with coconut shell and filled with coconut shell powder. Further, the biodegradable cable unit 100 is provided with at least one electrode 104 connected to the single core biodegradable interface cable 102. The single core biodegradable interface cable is also connected with at least one pinch clip 106. A limited time use electrode 104 is connected to the pinch clip 106, The pinch clip 106 is formed with a conductive carbon compound. A connector 114 is attached to the multi core biodegradable interface cable 112. A mating, panel-mounted socket 116 is provided for the connector 114. The socket 116 is a part of the electrocardiograph or multi-parameter patient vital sign monitor and is connected to a front-end bioinstrumentation amplifier. The yoke 110 has a top cup and a bottom cup formed with coconut half shells. The inner surface and the outer surface of the coconut half shells in the yoke 110 are polished to prevent a biological contamination. The yoke 110 is constructed using plastic inj ection molding methods and further soldered with the single core biodegradable interface cables 102 and the multicore biodegradable interface cable 112 as shown in the FIG. 1. The yoke 110 is provided with multiple holes on the upper surface for connecting the multiple single core biodegradable interface cables 102 and the multicore biodegradable interface cable 112. The yoke 110 is provided with an indicator at the upper surface to indicate the positions at which the electrodes are to be attached on the body of a patient.

[0036] The indicator has a sticker 108 engraved with an image showing the organs of the body where the electrodes 104 are to be attached. The sticker 108 is made from a polycarbonate or resin materials derived from a petroleum product and the image is engraved on the sticker (108) using laser energy. The ECG measurement is performed by attaching the electrodes 104 on the body of a patient at predetermined locations such as right arm (RA), left arm (LA), left leg (LL), and right leg (RL). For example, the electrodes 104 are placed around a heart at various points on the body of the patient.

[0037] According to one embodiment of the present invention, the electrode 104 connected to the biodegradable single core interfacing cable 102 is disposable and is biodegradable in nature. The electrode is formed with an electrically insulated coconut shell. The electrically insulated coconut shell is formed by carbonizing the surface of the coconut shell using laser energy. In another embodiment of the present invention, the biodegradable electrode 104 is made of a piece of a leaf sheath of Areca Catechu Linn palm, wherein the surface of the leaf sheath of Areca Catechu Linn palm is carbonized using laser energy.

[0038] The biodegradable single core interfacing cable 102 through the biodegradable electrodes 104 picks up the bioelectrical signals generated from the body of the patient. The bioelectrical signals are then transmitted to an analogue front-end amplifier through the biodegradable multicore cable 112. The bioelectrical signals are filtered for noise, artefact and finally displayed on a liquid crystal flat panel display. The disposable biodegradable interfacing cable unit 100 is primarily used for measuring electrocardiograph. , The interfacing cable unit is also used in measuring Impedance cardio Vasograph (ICVG) , Electro dermal responses (EDR), Electroencephalograms (EEG), Visual evoked potential (VEP), Trans-cutaneous Electrical Nerve Stimulation (TENS), Electro-Surgical Unit (ESU), Defibrillation (DEFIB) /Medical diathermy.

[0039] According to the embodiment herein, the biodegradable interfacing cable unit 100 is used in transmission of an electrical impulse for directly stimulating a nerve or nerve pathway for restoring the physiological functions of a damaged nerve system. When used for wound healing, the biodegradable interfacing cable 102 is used for applying an electrical current for enhancing or promoting the healing of traumatized, injured or displaced tissue. In some embodiments, the long-term application of high frequency current and low voltage DC current is accomplished for enhancing the healing of bedsores in the patients.

[0040] FIG. 2 illustrates an isometric view of a biodegradable single core interfacing cable 102 according to one embodiment of the present invention. With respect to FIG. 2, the disposable type biodegradable single core interfacing cable 102 includes a non- conductive core layer 202 and a conductive layer 204 formed over the non-conductive core layer 202. The non-conductive core layer 202 and the conductive layer 204 are formed of a coir fibre derived from coconut husk. Further, the biodegradable interfacing cable includes at least one shielding layer 206 formed around the conductive layer 204 and an outer insulative sheath 208 formed around the shielding layer 206. The shielding layer 206 is formed with an aluminum foil, braided shield and a carbon coated cloth for preventing electromagnetic interference (EMI), Electromagnetic Compatibility (EMC) and tribo-electric noise protection. The outer insulative sheath 208 is formed with a decomposable plastic material derived from resins. The non-conductive core layer 202 and the conductive layer 204 are formed of a coir fibre derived from coconut husk.

[0041] In one embodiment, the conductive layer 204 is formed of multiple coir fibres coated with a conductive carbon paste. The coir is separated from the husk of the coconut. Further, the husk is cleaned steam sterilized and spinned to form a thin rope with diameter ranging from 1mm to 3mm. The conductive carbon paste is derived from the steam carbonization of coconut
shell. The conductive carbon paste is a mixture of carbonized coconut shell powder, carbonized coconut husk powder, conductive karaya gel, water, glycerine, powder of aiuminxun, copper, nickel, carbonized rice husk and coffee seed husk. The mixture is mixed at a predetermined quantity such that DC resistance and AC resistance of the mixture is linear over a broad range of frequency and injected into the insulative sheath 208 along with the non-conductive core layer.

[0042] In another embodiment of the present invention, the conductive layer between the non- conductive core layer 202 and the shielding layer 206 is filled with granules of conductive carbon obtained from coconut shell.

[0043] FIG. 3A shows a table illustrating a test result for Electrical AC impedance of the interface cable for varying frequencies at a fixed predefined voltage. According to FIG. 3A, the impedance of the cable is measured for a value of fi-equencies ranging from 20Hz to 3 KHz. The interface cable is filled with a carbon compound, such as a carbonized coconut shell powder without adding any other ingredients. The single core cable is formed from a plastic tube with a diameter ranging from 6mm to 20mm. The plastic tube is pressure filled with carbon granules and brass. The non-corrosive terminals of the single core cable is connected to one of a Wayne-Kerr precision component analyzer 6425, a programmable curve tracer, 370A, SONY TEKTRONIX or an Auto compute LCR-Q-METER, APLAB 4912 to determine the electrical AC impedance of the single core cable. In one embodiment, the AC impedance is measured at a preset AC voltage of lOmv and DC voltage of OV as shown in FIG. 3A.

[0044] FIG. 3B shows a table illustrating a test result for Electrical AC impedance of the interface cable for a different frequency range at a preset voltage. As shown in table 3B, the AC impedance of the interface cable is measured for a frequency ranging from 4KHz to lOOKHz. The AC impedance is measured at a preset AC voltage of lOmv and DC voltage of OV as shown in FIG. 3B.

[0045] FIG. 4 is a table illustrating a test result for Electrical AC impedance of the interface cable for different frequencies at another preset voltage value. The non-corrosive terminals of the single core cable is connected to one of a Wayne-Kerr precision component analyzer 6425, a programmable curve tracer, 370A, SONY TEKTRONIX or an Auto compute LCR-Q-METER, APLAB 4912 to determine the electrical AC impedance of the single core cable. The preset voltage value for measuring the AC impedance of the interface cable is taken as an AC vohage of lOmv and DC voltage of OV. The AC impedance is measured for a frequencies ranging from 20Hz to 300 KHz.

G) ADVANTAGES OF THE INVENTION

[0046] Thus the various embodiments of the present disclosure provide a disposal type biodegradable ECG Interfacing cable unit and a disposable type biodegradable interfacing cable integrated with disposable electrode. The interfacing cable adds no noise to the ECG or ICVG signal retrieved from a patient's body. The resistance or impedance offered by the interfacing cable is within limits over the range of desired frequency and over the time period of use. The biodegradable electrodes are waterproof, sweat-proof, and capable of withstanding weight of the interfacing cable leads. Further, the biodegradable electrodes are capable enough to adhere to the body of the patient without causing any inconvenience to the patient while retrieving electrical signals from the patient's body. The biodegradable electrodes are adhered in such a way that it does not get detached during the patient movement.

[0047] The biodegradable interfacing cables are transparent to X-rays and MRI signals such that, the image of an internal organ of the patient's body is not obstructed by the electrodes. The method of manufacturing of the interfacing cable unit and the interfacing cable utilises the naturally available bio-degradable resource to provide an economical, easily disposable, safe, flexible, and environment friendly interface cable. Further, the usage of the disposable type biodegradable cable manufactured using naturally available resources like fibre coir generates employment opportunity for rural population. The usage of the biodegradable interfacing cable manufactured using naturally available resources like coir fibre saves valuable foreign currency and increases the earning through exports to countries in need of biodegradable environment friendly ECG cable integrated with disposable electrodes.

[0048] Although the invention is described with various specific embodiments, it will be obvious for a person skilled in the art to practice the invention with modifications. However, all such modifications are deemed to be within the scope of the claims.

[0049] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the present invention described herein and all the statements of the scope of the invention which as a matter of language might be said to fall there between.

CLAIMS

1. A biodegradable interface cable for medical devices comprising:
a non- conductive core layer;
a conductive layer formed over the non-conductive core layer;
at least one shielding layer formed around the conductive layer; and
an outer insulative sheath formed around the shielding layer;
wherein the non-conductive core layer and the conductive layer are
formed of a coir fibre.

2. The interface cable according to claim I, wherein the coir fibre is derived from a coconut husk.

3. The interface cable according to claim 1, wherein the conductive layer is formed of multiple coir fibres coated with a conductive carbon paste.

4. The interface cable according to of claim 1, wherein the conductive carbon paste is derived from the steam carbonization of coconut shell.

5. The interface cable according to claim 1, wherein the conductive carbon paste is a mixture of carbonized coconut shell powder, carbonized coconut husk powder, conductive karaya gel, water, glycerine, powder of aluminum, copper, nickel, carbonized rice husk powder and coffee seed husk.

6. The interface cable according to claim 1, wherein the conductive layer is filled with granules of conductive carbon obtained from a coconut shell or carbonized rice husk and coffee seed husk powder.

7. The interface cable according to claim 1, wherein the shielding layer is formed with an aluminum foil, braided shield and a carbon coated cloth for preventing electromagnetic interference (EMI), electromagnetic compatibility (EMC) and Tribo-electric noise protection.

8. The interface cable according to claim 1, wherein the outer insulated shield is formed with a decomposable plastic material.

9. The interface cable according to claim 1, wherein the outer insulated shield is formed with a plastic derived from resins.

10. The interface cable according to claim 1, wherein the cable is a single-core cable.

11. The interface cable according to claim 1, wherein the cable is a multi-core cable.

12. A bio degradable interface cable unit for medical devices comprising:
a yoke;
pluralities of single core biodegradable interface cables connected to the
yoke;
a multicore biodegradable interface cable connected to the yoke;
atleast one electrode coimected to a single core biodegradable interface
cable;
atleast one pinch clip connected to a single core biodegradable interface
cable;
a coimector attached to the multi core biodegradable interface cable; and
wherein the yoke is formed with coconut shell and filled with coconut
shell powder.

13. The cable unit according to claim 12, wherein the yoke has a top cup and a bottom cup.

14. The cable unit according to claim 12, wherein the top cup and the bottom cup in the yoke are formed with coconut half shells.

15. The cable unit according to claim 12, wherein the inner surface and the outer surface of the coconut half shells in the yoke are polished to prevent a biological contamination.

16. The cable unit according to claim 12, wherein the yoke has pluralities of holes in the upper surface for connecting the pluralities of single core biodegradable interface cables and the multicore biodegradable interface cable.

17. The cable unit according to claim 12, wherein the yoke has an indicator at the upper surface to indicate the positions of the placement of the attached electrodes on a body of a patient.

18. The cable unit according to claim 12, wherein the indicator has a sticker engraved with an image showing the organs of the body where the electrodes are attached.

19. The cable unit according to claim 12, wherein the sticker is made from a polycarbonate or resin materials derived from a petroleum product.

20. The cable unit according to claim 12, wherein the image is engraved on the sticker using laser energy.

21. The cable unit according to claim 12, wherein the electrode connected to a single core biodegradable interface cable is a disposable electrode.

22. The cable unit according to claim 12, wherein the disposable electrode is a biodegradable electrode.

23. The cable unit according to claim 12, wherein the biodegradable electrode is formed with an electrically insulated coconut shell.

24. The cable unit according to claim 12, wherein the electrically insulated coconut shell is formed by carbonizing a surface of the coconut shell using laser energy.

25. The cable unit according to claim 12, wherein the biodegradable electrode is a piece of a leaf sheath of Areca Catechu Linn palm with a surface carbonized using laser energy.

26. The cable unit according to claim 12, wherein a limited time use electrode is coimected to the pinch clip.

27. The cable unit according to claim 12, wherein the pinch clip is formed with a conductive carbon compound.