A system for controlled generation of tunnel openings in bones for surgical procedures.

Abstract

A system for controlled generation of tunnel openings in bones for surgical procedures comprising an assembly defining a front face and a rear face. The front face includes a pair of angularly disposed tubular drill guides; at least one drill bit cooperatively configured with respect to the drill guides and a holding pin flexibly and operatively secured with respect to said support handling and manoeuvring means for stationed and secured cooperative support for the assembly during tunnel openings in bones and also enabling controlled angular drill of tunnel through its drill guides at desired angular depths in the bone.Said ready drill bits for desired tunnel drilling and said holding pin for maintaining a drilled tunnel bore is in alignment for the other end angular drilling under said drill guides fixed with respect to said stable support handling and manoeuvring means.

Description

[0001] Title of Invention: A SYSTEM FOR CONTROLLED GENERATION OF TUNNEL OPENINGS IN BONES FOR SURGICAL PROCEDURES.

[0002] FIELD OF INVENTION

[0003] Present invention relates to a system for surgical procedures. More specifically, the invention relates to a system / tool to make a tunnel in the bone joined by two drill holes at specified angles thereby making a tunnel through only the outer cortical layer of the skull. Once the tunnel is created at the desired point a long duration absorbable or a permanent suture is then passed through the tunnel to suspend the forehead as in the procedure for brow lift and a forehead lift. Advantageously, the present invention finds application during various Plastic surgical, Cosmetic Surgical, Maxillofacial surgical, Cranio-facial surgical, Orthopaedic surgical and Hand Surgical procedures.

[0004] BACKGROUND ART

[0005] Bone suspension procedures as required in procedures such as browlift have been performed for many decades. These procedures relates to hitching of forehead and brows to frontal bone to provide longer term elevation of eye brows. In many of the initial procedures, during this procedure, two angled tunnels were made into the outer table of the frontal bone at selected points by drilling into the outer table at the specific angles. These two tunnels were connected to each other. A needle with permanent or absorbable suture was passed through these tunnels. The needle then was passed through the tissues to be hitched and the suture was tied. The tunnels had to be done free hand with a guard so that the drill should not penetrate deep into the brain or dura. More recently, some surgeons use bone anchors - which are commonly used by Orthopaedic surgeons for various procedures. These bone anchors can be made from absorbable materials or metal which have an attached suture. These anchors need a small drill-hole into the bone of specific size and the anchors are pushed into this hole. Once the attachment is considered secure, the carrying needle suture assembly is used to grab required tissue and hitch the tissue to the bone. Also used by surgeons are some brow lift specific absorbable prosthesis with a 'peg' to attach to the bone on one end and the spikes to dig into the patient's tissues on the other side. The spikes cause the hitching of the tissues to the bone. As these are single use prostheses, there is a cost associated with use of these prostheses which vary between the institutions and the types of the prosthetic device. Since multiple sites hitching is necessary in most cases the cost is also multiplied for the said patient. Also some of these devices are made from metal and are not biodegradable or absorbable, they would persist in the body beyond their duration of their intended use.

[0006] The process of free hand drilling of bone to create interosseous (inside the bone layer) is not very precise and often time consuming. There is also a risk of penetration of bony vault and inadvertent injury to the brain.

[0007] Several examples of prior art are enclosed here (Figs.1-4) which are used for hitching methods for tissues or tendons. Some of these have been in use for decades. The limitations of these devices are various. Some are imprecise and timeconsuming for making tunnels in cortical bone, some are metal and are left in the bone beyond their intended use, some are difficult to apply and can cause skin irritation or bulge, and most have significant costs associated with their use as they are simgle use devices.

[0008] Experience with cortical tunnel fixation in endoscopic brow lift: The "bevel and slide" by Malata, Charles M; Abood, Ahid. International journal of surgery (London, England), 01 / 2009, Volume 7, Issue 6 refers to the technique of cortical tunnel fixation with traditional method of using free hand drills.

[0009] Shifren, Jonathan MDet al. in Plastic and Reconstructive Surgery - Global Open 4(9S):p 67, September 2016. | DOI: 10.1097 / 01. GOX.0000502953. 23512.6c refers to the technique of using single use bio-degradable device for brows suspension.

[0010] The article entitled "Endoscopic Brow Lift Fixation With Mitek Suture Anchors: A 9-Year Experience of a New "Ideal" Technique. Oluwaseun A. et. al. refers to the technique of using single use anchor device for brows suspension.

[0011] Berkowitz, R. L., et. al (2005; Brow Fixation with the Endotine Forehead Device in Endoscopic Brow Lift. Plastic and Reconstructive Surgery, 116 (6), 1761-1767. doi: 10.1097 / 01. prs.0000187686.87209.5a) refers to the technique of using single use bio-degradable device for brows suspension.

[0012] The K-Wire Fixation Technique for Endoscopic Brow Lift: A Long-Term Follow- Up by Chasan, Paul E; Hauch, Adam T. Aesthetic surgery journal, 09 / 2020, Volume 40, Issue 10 refers to suspension of brows using temporary k-wires (a metal wire 0.035"), that is removed after 3-5 days after surgery.

[0013] However, there is no avaible system / kit / tool which enables making controlled bony tunnel through the outer layer of the flat bone.

[0014] OBJECT OF THE INVENTION

[0015] It is thus the basic object of the present invention to provide a system / kit which would enable making controlled bony tunnel through the outer layer of the flat bone.

[0016] It is further object of the present invention to provide a system / kit which would provide for an user friendly option for drilling holes involving a select and co-operatively disposed assembly of two drill guides and a drill bit which would not only enable generating desired tunnel openings in bones and also prevent deep penetration of the drill into the cranial cavity.

[0017] Another object of the present invention provides the system which could drill holes through the assembly of two drill guides at desired controlled angled at a specific angle whereby it would facilitate the making of two bone tunnels connecting to each other and allowing passage of a needle carrying a permanent or any other suture or wire.

[0018] Another object of the present invention is to avoid the complicated time consuming procedure of involving multiple drill guides and using free hand method of drilling holes.

[0019] Yet another object of the present invention is directed to a system to facilitate creating the bony tunnels joining together to allow passage of a needle carrying a specific suture to hitch tissues, or tendons or attaching the tissue or tendons to the bone. Still another object of the present invention provides a system for surgical procedures such that the device apart from enabling the step of making the tunnels at specific angles would also have provision for effective positioning and holding of the device which is an added advantage for effectively carrying out the surgical process with due precision and control.

[0020] Another object of the present invention is directed to the system having multi-functional and versatile applications in various specialties such as Plastic and Cosmetic surgery, Cranio-maxillo-facial surgery, Hand surgery and Orthopaedic surgery.

[0021] A further object of the present invention is directed to the system having a handle, a specific purpose made drill bit, that is effective to make the hole with hand in softer bone, a holding pin.

[0022] Yet another object of the present invention is directed to an advanced bone drilling system to make two angled tunnels into the outer table of the skull or any other bone of adequate thickness, which join together to then allow passage of a suitable size curved needle carrying the fixing suture through the tunnel.

[0023] Yet another object of the present invention is directed to the system by way of a holding pin which is inserted into the first tunnel to hold the device in place.

[0024] Yet another object of the present invention is directed the system which would be adapted for cooperative working association with a drill bit of specific custom made size to use if the bone is soft enough to be drilled into with the hand held drill bit.

[0025] Yet another object of the present invention is directed to the system comprising a pair of sharp pointy projections on the back side of the device just adjacent to the position of the holes - again to additionally prevent the slippage of the device while drilling. SUMMARY OF THE INVENTION

[0026] Thus the basic aspect of the present invention provides a system for controlled generation of tunnel openings in bones for surgical procedures including suture passage for various surgical procedures comprising an assembly of :

[0027] (I) a stable support handling and maneuvering means defining a front face and a rear face thereof, said front face of the said support handling and maneuvering means including a pair of angularly disposed tubular drill guides;

[0028] (II) at least one drill bit cooperatively configured with respect to the drill guides and a holding pin flexibly and operatively secured with respect to said support handling and maneuvering means whereby, said support handling and maneuvering means provide for stationed and secured cooperative support for the assembly during tunnel openings in bones and also enabling controlled angular drill of tunnel through its drill guides at desired angular depths in the bone , said correspondingly configured ready drill bits for desired tunnel drilling and said holding pin for maintaining a drilled tunnel bore in alignment for the other end angular drilling under said drill guides fixed with respect to said stable support handling and maneuvering means.

[0029] Another aspect of the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures wherein said support handling and maneuvering means comprises of handle plate having configured for placing on variety of bones of subjects at selected disposition as per required procedures; said drill guides comprising two angular tubular structures having open ends on the back side of front end, said tubular structures being at required angles to meet each other at a specific depth in the outer table of a flat bone of a subject including cranial bone, middle layer of diploee. A further aspect of the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures comprising : spike means adjacent to holes of the two drill guides on the back side of the front end provide for added stability.

[0030] Yet another aspect of the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures wherein said drill bit comprises hand-held drill bit of desired size and configuration adapted for drilling of soft bones with hand.

[0031] Still another aspect of the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures wherein said holding pin provides for stability to prevent slippage of assembly by engaging with said first drill hole drilled into the bone for stability and securing of assembly for drilling of the second drill hole.

[0032] Another aspect of the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures including cooperative drill bits to suit desired tunnel drilling through bone surface.

[0033] In another aspect the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures wherein said at least one drill bit cooperatively configured with respect to the drill guides and a holding pin flexibly and operatively secured with respect to said support handling and maneuvering means are flexibly secured to the said stable support handling and maneuvering means including plate handle through chain means.

[0034] A further aspect of the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures wherein said co-operating assembly units are releasably connected for desired sterilization convenience and the system length is selective based on the end utilities preferably 2 cm to 20 cm and the said stable support handling and maneuvering means including plate handle is having any selected shape and configuration preferably selected from flat and round.

[0035] Yet another aspect of the present invention provides the system for controlled generation of tunnel openings in bones for surgical procedures wherein said drill guides length vary as per requirements and preferably of 1cm to 5 cm , preferably 2.5 cm; and the two drill guides attached to the said support handling and maneuvering means are at varying angular disposition as per requirements preferably about 30° from the surface of the plate handle, the hand driven drill bit is of adequate length to drill up to 6 mm when used through the drill guides which is variable based on the thickness and type of the bone, said drill bit having required thickness preferably 2 mm thick.

[0036] BRIEF DESCRIPTION OF NON-LIMITING ACCOMPANYING FIGURES, WHEREIN:

[0037] Figure 1 is an illustration of an existing prior art drill guide device. These devices exist in various sizes to accommodate various sizes of drill bits to make holes of various sizes;

[0038] Figure 1 A is an illustration of an existing prior art drilling bone tunnel through the bones in a straight line.

[0039] Figure 2 is another embodiment of an existing prior art various types of bone anchor devices;

[0040] Figure 3 illustrates an embodiment of a prior art eye brow suspension device (Endotine®) in the related filed of surgical procedures;

[0041] Figure 4 illustrates an embodiment of a prior art - a drill bit in the related field of surgical procedures. Figure 5 represents a full view of the advanced brow suspension system of the present invention comprising Handle plate (1); Drill guides (2); Attached drill bit (3); Attached holding pin (4); Chain (5).

[0042] Figure 6 illustrates the present system comprising Holes from the drill guides on the back of front end of handle plate (1); Metal spikes adjacent to the holes (2); Handle plate - back side (3).

[0043] Figure 7 illustrates the working of the system. Cranial bone outer cortex (1); Diploee layer(2); Cranial bone inner cortex(3);Tunnel made with the device(4); Needle passing through the tunnel (5); Thread attached to the needle (6).

[0044] Figure 8 illustrates the working of the system which drill holes through the assembly of two drill guides angled at a specific angle whereby it would facilitate the making of two bone tunnels connecting to each other and allowing passage of a needle carrying a permanent or any other suture or wire involving steps (1). The forehead incision and skin flap showed. (2) Two drill holes are made with innovative device - which connect to make an interosseous tunnel. (3) Suture is passed through the tunnel. (4) Suture with bite of the forehead tissue and a knot is tied. (5) The knot is tightened lifting the forehead and eyebrow up. (8) Eye-brow and forehead elevation achieved at the end of the tightened knot.

[0045] Figure 9 illustrates shows the use of the present system in hand surgery involving following steps: (1) Two drill holes are made with innovative device at the desired site of bone in hand- which connect to make an interosseous tunnel. (2) Suture is passed through the tunnel. (3) Suture with bite of the tendon to be attached (as an example) and a knot is tied. (4) The tendon end brought close to the site of attachment. (5) Tendon end attachment to desired site of bone achieved at the end of the tightened knot.

[0046] Figure 10 illustrates the working steps of the present device.

[0047] 10a illustrates Area of brow fixation marked on the bone after appropriate exposure. Figure 10-B illustrates the steps including (1) First hole drilled at the pre-marked site;(2) Hand drilling used with attached drill bite; (3) Assistant holds the metal plate handle to maintain the device in place.

[0048] Figure 10-C illustrates the steps including (1) First tunnel is secured with attached holding pin;(2) Second drill hole is made to create second tunnel; (3) Hand drilling used with attached drill bite.

[0049] Figure 10-D illustrates the steps of (1) Tunnel created by joining of first and second drill holes ;(2) Needle passed through the tunnel ;(3) Suture attached.

[0050] DETAILED DESCRIPTION OF THE INVENTION IN RELATION TO THE ACCOMPANYING NON-LIMITING EXEMPLARY EMBODIMENTS

[0051] The invention is discussed hereunder in greater detail in relation to the nonlimiting exemplary embodiments of the system. The system of the present invention achieves interosseous (meaning inside the bone) tunnel with the help of two drill holes at specified angles during various Plastic surgical, Cosmetic Surgical, Maxillofacial surgical, Cranio-facial surgical, Orthopaedic surgical and Hand Surgical procedures. The system of the invention makes a tunnel in flat or rounded surface of bone through which a suture can then be passed to hitch up a specific tissue layer or tendon or group of layers of tendons, or a prosthetic device. For example, a tunnel in the frontal bone can be used to pass a suture to hitch up forehead and eye brows in Plastic surgery and Cosmetic surgery and Cranio-Maxillo-facial surgery.

[0052] The system is responsible for drilling holes through a purpose made assembly of two drill guides using a drill bit of certain length and size to prevent deep penetration of the drill into the cranial cavity. The drill holes made through the assembly of two drill guides angled at a specific angle whereby it would facilitate the making of two bone tunnels connecting to each other and allowing passage of a needle carrying a permanent or any other suture or wire for fixation of the forehead tissue or any other tissue or muscle or tendon or fascia.

[0053] Unique features of the said system are: 1. A handle plate for placing on bone of subjects at the appropriately decided site. The front end of the handle plate has the assembly comprising of a. two angled tubular structures called as drill guides which open on the back side of the front end. These tubular structures are at specific angles to meet each other at the specific depth in the outer table of flat bone such as cranial bone, or middle layer of diploee (also called medullary canal in tubular bones). b. There are two sharp spikes adjacent to the holes of these two drill guides on the back side of the front end.

[0054] 2. A hand held drill bit of specific size to drill holes if the bone is soft enough to drill with hand.

[0055] 3. A holding pin - to pass into the first hole drilled into the bone to prevent slippage of the device before the second hole is drilled. This is to have a more secure drilling of appropriate tunnel which can meet the first tunnel inside the bone.

[0056] 4. A chain to hold all of the above pieces together for convenience.

[0057] Reference is drawn to the illustration of an embodiment of the prevailing state of the art marker device as per Figure 1. In such a prevailing art, the drill guides are shown as a pair of same or different dimensions. These have been in use for more than a century in field of Orthopaedic surgery and cranio- maxillo-facial surgery. Reference is drawn to the illustration of an embodiment of the prevailing state of the art marker device as per Figure 1A. In such a prevailing art, bone tunnel can be drilled through in a straight line. Such devices also exist in other trades such as carpentry and wood work. It may exist in various sizes to accommodate various sizes of drill bits to make tunnels of various sizes; This prior art device may be useful for bigger bones such as tibia or for smaller hand or foot bones, in Orthopaedic surgery. However, it is not possible to use this device to drill a bony tunnel through the outer table of the skull. Reference is next invited to accompanying Figure 2 which also illustrates another embodiment of a prior art devices wherein various types of the bony anchors are used to be fixed tissues or tendons to bone after a drill hole of appropriate size is made. Many of these anchors come packaged with the needle and thread assembly as a single use device. The anchor is meant to stay in permanently fixed to the bone. These devices are commonly used by Orthopaedic surgeons and other surgeons for bony fixation and have been available for decades.

[0058] Yet another representative device of the presently available system / devices is shown in accompanying Figure 3. According to such a prior art device as illustrated, a suspension device made of biodegradable material with hooks. First an appropriate size of a hole is made into the frontal bone at a predetermined site. The device is fixed into the bone first in a predrilled hole and the tissues are pulled over the hooks to suspend. These devices are used for lifting eye brows during facial surgery.

[0059] Yet another representative system / device of the presently available devices is shown in accompanying Figure 4, which is a commonly available drill bit to make a hole. These drill bits are used for over a century to drill holes into the bone in various parts of body. They come in various sizes and are made from metal.

[0060] The system can be of various lengths - ranging from 2cm to 20cm. The handle can be flat or round with markings. The drill guides in our illustration is of 2.5 cm in length - but these lengths could vary and be longer or shorter. The two drill guides attached to the system are illustrated to be at about 30° from the surface of the plate handle, but these angles could vary and be more or less than 30°. The attached hand driven drill bit is of adequate length to drill up to 6 mm when used through the drill guides. This length can vary depending on thickness and type of the bone. The drill bit illustrated is 2 mm thick, however, the thickness of the drill bits can vary, and these could be thicker or thinner. The device can be made from material which can be malleable or non-malleable. This device in totality or in various parts can be made from metal and can be sterilizable or single use or can be made from plastics of any kind and can be sterilizable or single use. The attached drill bit and the holding pin is always made in surgically compatible hard metal. Other than the drill bit and the holding pin, rest of the assembly can be plastic or metal.

[0061] There are several embodiments of this invention.

[0062] Reference is now invited to accompanying Figure 5 which illustrates the advanced forehead brow suspension tool device in accordance with the present invention. The system may have a drill-bit and a holding pin attached to the assembly by chains or link or these can be completely separate.

[0063] The attached units are only for convenience of sterilization as a single composite system and for use. Separate elements are prone to get misplaced during sterilization process.

[0064] The handle - plate (1) in Figure - 5 works as a handle and a plate to carry the main assembly for the angled drill guides. The handle plate is of variable length and width to suit various purposes and sites for use of this invention.

[0065] For the purpose of drilling precise drill holes and making a precise tunnel at the desired site of bone, a firm grip of the device is provided by the metal handle. The metal spikes on the back surface close to the site of the back openings of the drill guides also provide protection against slipping of the device. Further stability to the device is provided by the holding pin which is inserted after the first drill hole is made.

[0066] In one embodiment, (Figure 5) the front end of the handle plate(2) has two angled drill guides fixed to the plate. The drill guides are specific dimension tubular structures which open at the back side of the front end of the handle plate. The drill guides can be made from metal and can be sterilizable or single use, or can be made from plastics of any kind and can be sterilizable or single use. The drill guides can be fixed by welding, screws, rivets, glue or by any other method.

[0067] Angled drill guides have been shown in the prior art (figure 1). The present system has a paired angle drill guides at a specific angle - so that the drill holes join together to form a tunnel for suture to thread through. In yet another embodiment (Figure 6-(3)), there are sharp 1-2 mm projections adjacent to the openings of the drill guides at the back size of the front end of handle plate. These are to prevent slippage of the device during use.

[0068] In yet another embodiment, there is a drill bit (Figure 5 - (3)), for use by hand in suitably soft bone for making the drill hole. The drill bit is made from metal and can be single use or sterilizable.

[0069] The attached drill bit is only for convenience as it is made of a specific length to stop it going beyond 5 -6 mm. It can only be used for hand drilling - if the bone is soft enough to drill with hand. If the bone is not soft enough to drill with hand, then the device would need another drill bit of specific size that can fit the drill guide. Since these drill bits come in various sizes and lengths, during use of these drill bits, the length of drill bit protruding through the jaws of the chuck (part of the drill that holds the drill bit) has to be carefully adjusted (guarded) so that the tip of the drill bit would not penetrate the inner table of the skull bone.

[0070] In another embodiment, there is a holding pin ((Figure 5 - (4)), which is used to temporarily plug into the first hole made into the bone, to again prevent slippage of the device during the making of second hole. The holding pin is made from metal and can be single use or sterilizable.

[0071] In another embodiment, there is a chain (Figure 5 - (5)), to hold the whole device secured together for convenience. The chain can be made from metal of any kind or plastics of any kind and can be single use or sterilizable.

[0072] The provision of chain is for the convenience of sterilization and for convenience of use.

[0073] As would be apparent from the brows suspension system of the advancement illustrated in relation to accompanying Figures 5 and 6 discussed above, the construction of the system of the invention make it possble to drill two tunnels in one step of the operation in cranial bone or any other suitable bone - maintaining precision and safety as long as the care is taken that the depth of the penetration of drill bit is guarded with regards to the thickness of the bone involved. This thickness would vary individually - however typically the bony tunnels would meet each other approximately 3-5 mm below the bone surface - providing adequate support to the suspended tissue without breaking the bone, when performed with due care.

[0074] As would be apparent from the brows suspension device of the advancement illustrated in relation to accompanying Figures 7, the construction of the device of the invention make it possible to make two tunnels precisely which join up with each other. The tunnels join up approximately 3-4 mm beneath the surface of bone which is usually adequate thickness and strength to support tying of the suture to the attached tissue. Using the prior art devices of independent drill guides and drillbits, the imprecise angles of drilled tunnel and the depth of the tunnel may result in tunnels too deep or too shallow. It is also possible that the two tunnels may not align properly to join up. Making the tunnels too deep - especially in cranial bone may cause injury to intracranial structures. Making them too shallow could result in thin and weak bone covering the tunnels, which could break during process of tying the suture to the tissue and tightening the knot, resulting in inability to provide a strong stable hold for the tissues such as forehead or eye brows to be lifted.

[0075] The working of the system involves the following steps: first a position for the bony tunnel is determined. This would correspond to the site where the best suspension is possible for the brows or any other tissue, fascia or bone. The position of the tunnel on the bone is preferably marked with an indelible marker for convenience. The front end of the device is placed with the drill guides angled out from the point of the marked position. The drill bit attached as the embodiment is guarded to penetrate up to 5-6 mm. This can be used to drill the hole, if the bone is soft enough to allow drilling with hand. If mechanical (hand held or motorised) drill is used, the length of the drill bit protruding out is limited to go no more than 5-6 mm beyond the length of the drill guide. With appropriate assistance to hold the device in position, first hole is drilled through one of the drill guides. The holding pin is then pushed through this tunnel through the drill guide - which further stabilizes the device. The second hole is drilled through. The device is then removed as well as the holding pin. The adequacy of the drilled tunnels is checked with the needle carrying the suture and as the needle is pushed through first tunnel and brought through the second tunnel. The tissue to be suspended is then grabbed and the suture is tied to suspend the tissue under adequate tension. The procedure to make the tunnel is made precisely and safely with this device. In the prevailing methods of drilling a tunnel the drill guides were not always precisely angled and the two tunnels could miss each other. In the prevailing methods, the tunnel could be too deep or too superficial making the fixation less secure. The single use bone anchor devices can be more expensive and also have the disadvantage of a left over piece of metal or plastic in the bone which can cause future complications. The advanced device therefore helps solves the problem of repetitive steps as well as provides precision, accuracy and safety to the procedure of making a tunnel through the outer layers of cranial or other bones - without going through and through and causing inadvertent injury to the tissues on the other side of the bone such as meninges, brain, and other neurovascular structures, or organs. The device can be made in metal such as steel for re-sterilization or in plastic and metal combination for one time use - being disposable). It is designed to improve efficiency, precision, and consistency of suspension methods for these common surgical procedures (Figure 10 A-B-C-D).

[0076] Embodiments of the present invention advantageously provide a system for accurately planning, designing, and executing a perfectly secure way of suspending various types of tissues such as brows, forehead tissue, muscle, fascia or tendons. In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that this invention is not limited in its application to the details of said construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as in the abstract, are for the purpose of description and should not be regarded as limiting. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.

[0077] The present advanced brow suspension system on the other hand as discussed above is multi-functional and versatile in application and user friendly by way of : a. It provides choice of various diameter drill holes and tunnels permitted by the dimensions of the specific device in specific patient at specific areas for suspension of body tissue. b. It provides secure attachment and suspension of various types of body tissues to the adjacent bony anchor points. c. It provides the advantage of minimising the steps of drilling angled tunnels to create a contiguous interosseous bony tunnel to allow the needle to pass with a permanent or a long durability suture. d. It provides a relatively inexpensive method of secure and strong suspension of various types of body tissues depending on the indication and the nature of suture, tissue and the bone involved in the procedure. e. It avoids the permanent metal or other material anchors to be embedded in the bone, which potentially may cause future problems. If the long durable absorbable suture is used for suspension, effectively, there is no foreign material left in the body with the use of this advanced device.

[0078] It is thus possible by way of the present invention to provide the required advancements for accurately planning, designing, and executing a perfectly secure way of suspending various types of tissues such as brows, forehead tissue, muscle, fascia or tendons. It also provides relatively inexpensive method of suspension of various body tissues to bony points. It provides an option which avoids using permanently buried prosthetic material in the bone as in the case with prevailing methods.

Claims

AMENDED CLAIMS received by the International Bureau on 01 November 2025 (01.11 .2025)1. A system for controlled generation of tunnels in bones including in the outer table of a flat bone of a subject including cranial bone, middle layer of diploee for surgical procedures including suture passage for various surgical procedures comprising an assembly of: (i) a stable support handling and maneuvering means comprising of a handle plate having configured for placing on bones of subjects as per required procedures and defining a front face and a rear face thereof, said front face of the said support handling and maneuvering means including a pair of angularly disposed tubular drill guides comprising of two angular tubular structures having open ends on the back side of front end, said tubular structures being at about 30° from the surface of the plate handle to meet each other for tunnel forming at a depth in the outer table of a flat bone of a subject including cranial bone, middle layer of diploee;(ii) at least one drill bit cooperatively configured with respect to the drill guides and a holding pin flexibly and operatively secured with respect to said support handling and maneuvering means whereby, said support handling and maneuvering means providing for stationed and secured cooperative support for the assembly during tunnel openings in bones including flat bone of a subject including cranial bone, middle layer of diploee and also enabling controlled angular drill of tunnel through its drill guides at desired angular depths in the bone, wherein said correspondingly configured ready drill bits for desired tunnel drilling and said co-acting holding pin for maintaining a drilled tunnel bore in alignment for the other end angular drilling under said drill guides fixed about 30° from the surface of the plate handle selective for controlled generation of tunnels in bones including in the outer table of a flat bone of a subject including cranial bone, middle layer of diploee for surgical procedures.

2. The system for controlled generation of tunnel openings in bones for surgical procedures as claimed in claim 1 comprising: spike means adjacent to holes of the tow drill guides on the back side of the front end provide for added stability.

3. The system for controlled generation of tunnel openings in bones for surgical procedures as claimed in anyone of claims 1 to 2 wherein said drill bit comprises hand held drill bit of desired size and configuration adapted for drilling of soft bones with hand.

4. The system for controlled generation of tunnel openings in bones for surgical procedures as claimed in anyone of claims 1 to 3 wherein said holding pin provides for stability to prevent slippage of assembly by engaging with said first drill hole drilled into the bone for stability and securing of assembly for drilling of the second drill hole.

5. The system for controlled generation of tunnel openings in bones for surgical procedures as claimed in anyone of claims 1 to 4 including cooperative drill bits to suit desired tunnel drilling through bone surface.

6. The system for controlled generation of tunnels in bones for surgical procedures as claimed in anyone of claims 1 to 5 wherein said at least one drill bit cooperatively configured with respect to the drill guides and a holding pin flexibly and operatively secured with respect to said support handling and maneuvering means are flexibly secured to the said stable support handling and maneuvering means including plate handle through chain means.

7. The system for controlled generation of tunnel openings in bones for surgical procedures as claimed in anyone of claims 1 to 6 wherein said co-operating assembly units are releasably connected for desired sterilization convenience and the system length is selective based on the end utilities preferably 2 cm to 20 cm and the said stable supporthandling and maneuvering means including plate handle is having any selected shape and configuration preferably selected from flat and round.

8. The system for controlled generation of tunnel openings in bones for surgical procedures as claimed in anyone of claims 1 to 7 wherein said drill guides length vary as per requirements and preferably of 1 cm to 5 cm ; preferably 2.5 cm and the two drill guides attached to the said support handling and maneuvering means are at varying angular disposition as per requirements preferably about 30° from the surface of the plate handle, the hand driven drill bit is of adequate length to drill up to 6 mm when used through the drill guides which is variable based on the thickness and type of the bone, said drill bit having required thickness preferably 2 mm thick.[0001][0002]STATEMENT UNDER ARTI CLE 19 OF PCT[0003]Amended claims are directed to further clarify and qualify inventive aspects of the present invention residing in the system / tool to make a tunnel in the bone joined by two drill holes including in the outer table of a flat bone of a subject including cranial bone, m iddle layer of diploee for surgical procedures which none of the prevailing art devices could address and there has been a limitation in tunneling in flat bones especially cranial bone, middle layer of diploee.[0004]Distinguishing features of the said system now brought out in amended principal claim 1 are thus directed to : i) Cover the workability of system even for the outer table of a flat bone of a subject including cranial bone, middle layer of diploee for surgical procedures; ii) The cooperative handle plate; ill) The selective comprising of two angular tubular structures having open ends on the back side of front end, said tubular structures being at about 30° from the surface of the plate handle to meet each other for tunnel forming at a depth in the outer table of a flat bone of a subject including cranial bone, middle layer of diploee; and iv) Co-activity of the holding pin for maintaining a drilled tunnel bore in alignment for the other end angular drilling under said drill guides fixed about 30° from the surface of the plate handle with respect to said stable support handling and maneuvering means selective for controlled generation of tunnels in bones including in the outer table of a flat bone of a subject including cranial bone, m iddle layer of diploee for surgical procedures.[0005]The advancement and qualifying amendments are thus directed to limit to embodiments of the system and its co-acting facilitating components which make it possible to make two tunnels precisely which join up with each other. The tunnels join up approximately 3-4 mm beneath the surface of bone which is usually adequate thickness and strength to support tying of the suture to the attached tissue. Using the prior art devices of independent drill guides and drillbits, the imprecise angles of drilled tunnel and the depth of the tunnel may result in tunnels too deep or too shallow. It is also possible that the two tunnels may not align properly to join up. Making the tunnels too deep - especially in cranial bone may cause injury to intracranial structures. Making them too shallow could result in thin and weak bone covering the tunnels, which could break during process of tying the suture to the tissue and tightening the knot, resulting in inability to provide a strong stable hold for the tissues such as forehead or eye brows to be lifted.

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