Entry point guide instrument for inserting an implant

Abstract

An entry point guide instrument for inserting an implant is disclosed The entry point 5 guide instrument provides accurate insertion of a trocar guide wire at the greater trochanter and the pyriformis fossa of the femur bone. The entry point guide instrument 100 comprises gripping means including a handle 102 and a hollow cylindrical sleeve 106. The tip of the cylindrical sleeve 106 may be narrow and beveled or serrated for providing access through the human tissue and preventing 10 slipping of the instrument on the anatomical structures. The cylindrical sleeve 106 comprises a longitudinal slit or opening 112 across at least a portion of its length for providing access for cleaning the cylindrical sleeve to remove any stuck blood, blood clots, human tissues or bone splinters, and also improve sterilization of the instrument.

Description

[0001] ENTRY POINT GUIDE INSTRUMENT FOR INSERTING AN IMPLANT

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to the field of medical devices, particularly to a surgical instrument used in minimally invasive procedures. More specifically, the present disclosure pertains to an entry point guide instrument designed to facilitate accurate entry point at greater trochanter or pyriformis fossa of the femur bone for precise and safe insertion of a trocar guide wire implant during surgical procedures.

[0004] BACKGROUND & PRIOR ART

[0005] Femoral fractures are classified as femoral shaft fractures, femoral intertrochanteric fractures and femoral sub trochanteric fracture. All these fractures are typically fixed with femoral intramedullary nail. Femoral intra medullary nail are inserted in the femur or the thigh bone inside of the femoral medullary canal or bone marrow canal. These nails are inserted through the femur greater trochanter or the pyriformis fossa, although most of the modern nails are inserted through the greater trochanter.

[0006] The procedure for inserting the nails comprises making an entry point at the greater trochanter or pyriformis fossa of the femur. Minimally invasive surgical techniques have become increasingly prevalent in modern medicine due to their ability to reduce patient trauma, minimize scarring, and accelerate recovery times. These procedures often rely on the use of surgical instruments called trocars and guide wires to create access or entry points for surgical instruments or implants. The trocar is a sharp, pointed instrument typically used to create an access point into the body, while a guide wire serves as a pathway for the insertion of larger devices or implants. The entry point guide instrument is an instrument that is used to guide the trocar to its correct position in the femur. The entry point guide instrument is required to provide proper and accurate aiming of the trocar guide wire over the greater trochanter and the pyriformis fossa of the femur to provide correct access or entry point for the guide wire across the greater trochanter or pyriformis fossa of the femur into the femoral medullary canal.

[0007] The entry point guide instrument consists of a hollow penetrating tube which makes passage for the implant to be slid down inside the femur bone across the fracture. Generally, a long rod / wire implant is inserted longitudinally and generally axially into the intramedullary canal. Interlocking screws are then used to transfix the bone to the inserted rod to stabilize the fracture.

[0008] The entry point guide instrument plays a crucial role in delivering the implant correctly during the process. However, the accurate placement of a trocar guide wire remains a significant challenge in many surgical procedures. Misalignment or improper insertion can lead to complications such as tissue damage, bleeding, or the need for additional corrective surgeries. Current methods for inserting trocar guide wires often rely on the surgeon's manual dexterity and visual estimation, which can be prone to error, especially in complex anatomical regions or in patients with challenging anatomical variations.

[0009] Existing guide instruments often lack the precision and stability required to ensure consistent and accurate placement. Another drawback of the known guide instruments is that they are not easy to clean or sterilize after use. Additionally, many devices do not account for variations in patient anatomy or provide adequate feedback to the surgeon during the insertion process. This can result in suboptimal outcomes and increased risks for patients. Indian Patent No. 350965 teaches an entry point guide for guiding the trocar tip guide wire at the greater trochanter and the pyriformis fossa of the femur bone. The entry point guide comprises gripping means and a cylindrical sleeve for passing and guiding the trocar tip guide wire in the longitudinal bore. The cylindrical sleeve has a narrow-beveled tip for access through the human tissue.

[0010] A drawback of the prior art device is that bone, human tissue or blood clots can get stuck in the cylindrical sleeve during procedure, and removal of the same from the narrow sleeve can be difficult. Also, cleaning and sterilization of the cylindrical sleeve of the prior art entry point is tedious.

[0011] Other drawbacks of the known entry point guide instruments are that the known instruments have a complex design, cause damage to healthy tissues due to lengthy incisions and / or fixation of the instrument to bone, possibility of physical contact of the surgeon with the blood / body fluid, and do not provide universal positioning in terms of linear displacement and angulation of the guide wire in the femur bone.

[0012] There is, therefore, a need for an improved entry point guide instrument that has a simple design, and enhances the accuracy, safety, and efficiency of trocar guide wire insertion, and which is also easy to clean and sterilize after use. An improved instrument should be able to provide precise alignment, reduce the risk of complications, be 100% sterilizable, and adaptable to different patient anatomies.

[0013] OBJECTS

[0014] Accordingly, an object of the present disclosure is to provide an entry point guide instrument for accurately and conveniently inserting a trocar guide wire implant at greater trochanter or pyriformis fossa of the femur bone. Another object of the present disclosure is to provide an entry point guide instrument which is easy to clean and sterilize.

[0015] Another object of the present disclosure is to provide an entry point guide instrument which minimizes damage to healthy tissues, blood vessels and nerves, provides flexible positioning and prevents slipping of the trocar over the greater trochanter and pyriformis fossa of the femur, enhances the accuracy, safety, and efficiency of trocar guide wire insertion, and eliminates possibility of any physical contact of the surgeon with the guide wide implant or patient blood / body fluid.

[0016] Other objects and advantages of the present disclosure will be more apparent from the following description.

[0017] SUMMARY

[0018] The present disclosure addresses the afore-mentioned challenges by providing an entry point guide instrument for inserting a trocar guide wire implant. The instrument is designed to improve the accuracy and safety of guide wire placement, provide precise alignment and stabilization, is user-friendly and 100% sterilizable. By ensuring precise entry point localization and controlled insertion, the instrument reduces the risk of complications and enhances the overall success of minimally invasive surgical procedures. Also, the instrument has a simple, ergonomic design which is adaptable to different patient anatomies, and easy to clean and sterilize after the surgical procedure.

[0019] According to the present disclosure, there is provided an entry point guide instrument for inserting an implant, the instrument comprising:

[0020] a gripping means configured to provide sufficient grip and maneuvering of the instrument during insertion of the implant; a hollow cylindrical sleeve secured to the gripping means, the hollow cylindrical sleeve having a proximal end and a distal end;

[0021] wherein, a longitudinal slit is provided along at least a portion of the hollow cylindrical sleeve, the slit configured to allow cleaning and sterilization of the hollow cylindrical sleeve.

[0022] The entry point guide instrument is used for inserting trocar guide wire implant at greater trochanter or pyriformis fossa of the femur bone or thigh bone.

[0023] According to a preferred embodiment, the gripping means of the entry point guide instrument comprises an ergonomic handle to enhance instrument grip and control during insertion. The gripping means includes an opening aligned with the hollow cylindrical sleeve configured for passing the trocar guide wire implant therethrough.

[0024] According to a preferred embodiment, the gripping means is made of a material selected from the group consisting of surgical stainless steel, titanium, medical-grade polymers, anodised aluminum, ceramic, composite material, silicone, and rubber. The hollow cylindrical sleeve is made of a biocompatible material selected from the group consisting of surgical stainless steel, titanium, anodised aluminum, and medical-grade polymers.

[0025] According to a preferred embodiment, the hollow cylindrical sleeve of the entry point guide instrument has a beveled tip at the distal end, wherein the beveled tip is configured to facilitate precise penetration and alignment with anatomical structures, and minimize soft tissue damage during insertion. Preferably, the beveled tip is angled between 30 to 80 degrees relative to the longitudinal axis of the hollow cylindrical sleeve. According to another preferred embodiment, the hollow cylindrical sleeve of the entry point guide instrument has a serrated tip at the distal end, wherein the serrated tip is configured to facilitate precise penetration and alignment with anatomical structures, and prevent slipping of the instrument on the bone surface during insertion. Preferably, the serrated tip comprises between 5 to 15 serrations.

[0026] According to a preferred embodiment, the longitudinal slit extends from the distal end to the proximal end across the entire length of the hollow cylindrical sleeve. Preferably, the longitudinal slit is provided at the posterior or back-side of the hollow cylindrical sleeve.

[0027] According to one embodiment, a depth marking system can be provided on the hollow cylindrical sleeve, wherein the depth marking system is configured to indicate the depth of insertion during use.

[0028] According to a preferred embodiment, the hollow cylindrical sleeve has an external diameter between 4 to 10 mm and internal diameter between 2 to 8 mm to accommodate a standard trocar guide wire, ensure small incision to reduce risk of stress fracture of the femur bone, and minimize soft tissue damage during insertion. The hollow cylindrical sleeve has length between 5 to 30 cm, and the distal end is bent at an angle between 5 to 20 degrees. Preferably, the hollow cylindrical sleeve is angled between 70 to 170 degrees relative to the longitudinal axis of the gripping means.

[0029] According to another preferred embodiment, the gripping means of the entry point guide instrument comprises an elongated connecting rod configured to provide flexibility and precise maneuvering during the insertion and maintain distance from the point of insertion to prevent any incidental injury to the surgeon. The hollow cylindrical sleeve can be adjustably secured to the elongated connecting rod of the gripping means by means of an engagement means, wherein the engagement means configured to facilitate flexibility between the hollow cylindrical sleeve and the elongated connecting rod and allow passing of the implant through the hollow cylindrical sleeve.

[0030] According to one embodiment, the hollow cylindrical sleeve can be detachable from the gripping means to allow for cleaning, sterilization or replacement.

[0031] According to one embodiment, the hollow cylindrical sleeve is radiopaque to allow visualization under imaging techniques during use.

[0032] According to the present disclosure, there is provided a method for inserting a trocar guide wire implant at the greater trochanter or pyriformis fossa of the femur using the entry point guide instrument, the method comprising:

[0033] aligning the tip of the hollow cylindrical sleeve of the entry point guide instrument with the desired entry point at the greater trochanter or pyriformis fossa;

[0034] applying force to the gripping means to advance the hollow cylindrical sleeve through soft tissue and bone into the intramedullary canal of the femur bone;

[0035] inserting the trocar guide wire implant through the hollow cylindrical sleeve; removing the hollow cylindrical sleeve from the insertion and leaving the trocar guide wire implanted in the intramedullary canal of the femur bone; and removing blood clots, soft tissues and bone splinters from the hollow cylindrical sleeve through the longitudinal slit so as to sterilize the hollow cylindrical sleeve of the entry point guide instrument.

[0036] According to the method, the entry point guide instrument is removed without disturbing the position of the trocar guide wire implant. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0037] The present disclosure will now be described with the help of the accompanying drawings, in which,

[0038] FIG. 1 illustrates one preferred embodiment of the entry point guide instrument in accordance with the present disclosure; and

[0039] FIG. 2 illustrates back-side view of one preferred embodiment of the cylindrical sleeve of the entry point guide instrument in accordance with the present disclosure.

[0040] DETAILED DESCRIPTION

[0041] The present disclosure describes an entry point guide instrument for inserting a trocar guide wire implant at the greater trochanter and the pyriformis fossa of the femur bone. Several features of the instrument thereof in accordance with exemplary embodiments are set-forth and described in the figures. The description herein after, of the specific embodiments reveals the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and / or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that these examples are for illustrating the principles, and that the disclosure is not so limited. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

[0042] It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not for limitation. Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.” The present disclosure relates to an entry point guide instrument is used for accurately and conveniently inserting trocar guide wire implant at greater trochanter or pyriformis fossa of the femur bone or thigh bone.

[0043] The entry point guide instrument comprises a gripping means configured to provide sufficient grip and maneuvering of the instrument during insertion of the implant, and a hollow cylindrical sleeve secured to the gripping means. The hollow cylindrical sleeve having a proximal end and a distal end. The gripping means is configured to allow a firm grip for the accurate positioning of the instrument at the point of insertion.

[0044] According to one embodiment, the gripping means of the entry point guide instrument comprises an ergonomic handle to enhance instrument grip and control during insertion. The gripping means shall include an opening aligned with the hollow cylindrical sleeve configured for passing the trocar guide wire implant therethrough.

[0045] According to another embodiment, the gripping means of the entry point guide instrument comprises a handle and an elongated connecting rod. The elongated connecting rod can be configured to provide more flexibility and precise maneuvering during the insertion and maintain distance from the point of insertion to prevent any incidental injury to the surgeon. The hollow cylindrical sleeve can be adjustably secured to the elongated connecting rod of the gripping means in such a way that the trocar guide wire implant can be passed through the hollow cylindrical sleeve. The hollow cylindrical sleeve may be adjustably connected to the elongated connecting rod by means of an engagement means. The engagement means may allow the hollow cylindrical sleeve to be flexible and adjustable. The engagement means can be configured to facilitate flexibility between the hollow cylindrical sleeve and the elongated connecting rod and allow passing of the implant through the hollow cylindrical sleeve.

[0046] The hollow cylindrical sleeve of the entry point guide instrument can be inserted into the greater trochanter or the pyriformis fossa of the femur bone to get an exact and accurate entry (access) point. The narrow dimension of the hollow cylindrical sleeve ensures minimum soft tissue damage, smaller incision and smaller diameter hole in the femur which reduces the risks of stress fracture of the femur.

[0047] The handle and the elongated connecting rod of the gripping means are made of a material selected from the group consisting of surgical stainless steel, titanium, medical-grade polymers, anodised aluminum, ceramic, composite material, silicone, and rubber. The hollow cylindrical sleeve is made of a biocompatible material selected from the group consisting of surgical stainless steel, titanium, anodised aluminum, and medical-grade polymers. Preferably, the hollow cylindrical sleeve may be made from surgical steel, more preferably stainless steel 316L. The hollow cylindrical sleeve can be made radiopaque to allow visualization under imaging techniques during the surgical procedure.

[0048] The material used for the handle and gripping means is chosen such as to provide sufficient grip of the instrument during insertion. The materials used for the gripping means and cylindrical sleeve are chosen such as to be biocompatible, durable, sterilizable, and ergonomic for precise handling during surgical procedures. These materials should be able to withstand repeated sterilization (e.g., autoclaving, chemical sterilization, or gamma radiation), must not cause adverse reactions when in contact with tissues or fluids, should be lightweight and comfortable for the surgeon to use during lengthy procedures, and must withstand mechanical stress and repeated use without degrading. A longitudinal slit or opening is provided along at least a portion of the hollow cylindrical sleeve. The cylindrical sleeve is configured to receive a trocar guide wire centrally in the longitudinal hollow bore. The longitudinal slit is configured to allow convenient and quick cleaning and sterilization of the hollow cylindrical sleeve to remove any stuck blood, soft tissues or bone splinters. According to one embodiment, the longitudinal slit can extend from the distal end to the proximal end across the entire length of the hollow cylindrical sleeve. The longitudinal slit can be provided at the posterior surface or back-side of the hollow cylindrical sleeve. The slit makes it easier to clean the cylindrical sleeve for removing any stuck blood, blood clots, human tissues, or small bone pieces / splinters. Also, the slit increases the surface area for better sterilization of the cylindrical sleeve and instrument. The bone, blood and muscle tissue which gets stuck in the cylindrical sleeve is clearly visible through the cylindrical sleeve and can be easily removed. The innovative cylindrical sleeve with slit can be easily cleaned to remove the tissue and blood debris due to the slit. Additionally, the slit increases the surface area for sterilization of the instrument during autoclave.

[0049] According to one embodiment, the hollow cylindrical sleeve of the entry point guide instrument has a beveled tip at the distal end. The beveled tip is configured to facilitate precise penetration and alignment with anatomical structures, and minimize soft tissue damage during insertion. The beveled tip can be narrow and angled between 30 to 80 degrees relative to the longitudinal axis of the hollow cylindrical sleeve for providing access through the human tissue.

[0050] According to another embodiment, the hollow cylindrical sleeve of the entry point guide instrument has a serrated tip at the distal end. The serrated tip is configured to facilitate precise penetration and alignment with anatomical structures, and prevent slipping of the instrument on the bone surface during insertion. The serrated tip may comprise between 5 to 15 serrations for providing enhanced positioning at the insertion and preventing slipping of the instrument on the bone surface.

[0051] According to one embodiment, the hollow cylindrical sleeve can have an external diameter between 4 to 10 mm and internal diameter between 2 to 8 mm to accommodate a standard trocar guide wire, ensure small incision to reduce risk of stress fracture of the femur bone, and minimize soft tissue damage during insertion. The hollow cylindrical sleeve can have length between 5 to 30 cm. The distal end of the hollow cylindrical sleeve can be bent at an angle between 5 to 20 degrees. The hollow cylindrical sleeve can be angled between 70 to 170 degrees relative to the longitudinal axis of the gripping means. The hollow cylindrical sleeve can be designed to be detachable from the gripping means to allow for cleaning, sterilization or replacement. Additionally, a depth marking system can be provided on the hollow cylindrical sleeve. The depth marking system can be configured to indicate the depth of insertion during procedure.

[0052] According to one embodiment, a method for inserting a trocar guide wire implant at the greater trochanter or pyriformis fossa of the femur using the entry point guide instrument is disclosed. The method comprises the steps of aligning the tip of the hollow cylindrical sleeve of the entry point guide instrument with the desired entry point at the greater trochanter or pyriformis fossa; applying force to the gripping means to advance the hollow cylindrical sleeve through soft tissue and bone into the intramedullary canal of the femur bone; inserting the trocar guide wire implant through the hollow cylindrical sleeve, where the trocar guide wire is longer than the cylindrical sleeve; removing the hollow cylindrical sleeve from the insertion and leaving the trocar guide wire implanted in the intramedullary canal of the femur bone; and removing blood clots, soft tissues and bone splinters from the hollow cylindrical sleeve through the longitudinal slit so as to sterilize the hollow cylindrical sleeve of the entry point guide instrument. The entry point guide instrument is carefully removed without disturbing the position of the trocar guide wire implant.

[0053] The present disclosure provides the entry point guide instrument for inserting the implant i.e. a trocar guide wire in the intramedullary canal of the femur bone. The instrument is particularly suitable for inserting guide wire at greater trochanter or pyriformis fossa of the femur bone or thigh bone for treatment of inter -trochanteric, sub-trochanteric and femur shaft fractures. This instrument can be used for inserting different types of femoral intramedullary implants including proximal femoral nail (PFN), trochanteric fixation nail (TFN), femoral intramedullary interlocking nail and Sirus intramedullary interlocking nail. The proximal femoral nail and the trochanteric fixation nail are generally used for the inter-trochanteric and sub-trochanteric fractures of the femur bone and are typically inserted at the greater trochanter region. The femoral intramedullary interlocking nail can be inserted at the pyriformis fossa of the femur bone and the Sirus intramedullary interlocking nail can be inserted at the greater trochanter, both of which are used for the treatment of femoral shaft fractures. The Sirus intramedullary interlocking nail can also be used for ipsilateral neck and inter-trochanteric and shaft fractures of the femur.

[0054] The entry point guide instrument must be positioned accurately for proper entry of these implants (guide wire) at the designated point. The entry point guide instrument is a single-unit, and thus easy-to-handle. The entry point guide instrument has a simple, ergonomic design which not only reduces time of the surgical procedure but also reduces damage to healthy tissues during the procedure. The entry point guide instrument is easy to clean. Particularly, the cylindrical sleeve often becomes stuck with blood, blood clots, human tissues, and splinters of bones during the surgical procedure, and cleaning and sterilization of this narrow and hollow sleeve is extremely cumbersome and tedious. The technical advantage of the present disclosure is the specifically designed cylindrical sleeve which can be cleaned easily effectively, and also has an increased surface area for improved sterilization of the instrument.

[0055] Another technical advantage of the entry point guide instrument is that it eliminates any possibility of physical contact of the surgeon with the cylindrical sleeve, the sharp guide wide or patient blood and body fluid, thereby preventing any accidental injuries to the surgeon and also eliminating any possibility of transmittable infections such as HIV, Hepatitis B and C, etc., from high-risk patients. Yet another technical advantage of the entry point guide instrument of the present disclosure over known prior arts is that it can be effectively used for locating the greater trochanter or pyriformis fossa of the femur bone in obese patients.

[0056] The present disclosure will now be described with the help of limited embodiments and / or examples, such embodiments and / or examples must not, in any manner, be construed to limit the ambit and scope of the disclosure.

[0057] A preferred embodiment of the entry point guide instrument of the present disclosure for inserting the trocar tip guide wire implant in femur bone is shown in FIGS. 1 & 2.

[0058] The entry point guide instrument is represented by the numeral 100 in the Fig. 1. The entry point guide instrument 100 comprises gripping means. The gripping means may comprise a handle 102 and an elongated connecting rod 104 thereto. The handle 102 has a grip for firmly holding the instrument 100 in place during the surgical procedure. A hollow cylindrical sleeve 106 is adjustably connected to the gripping means. The cylindrical sleeve 106 may be connected to the elongated connecting rod 104 by means of an engagement means 110. The engagement means 110 comprise an aperture adapted to receive the cylindrical sleeve 106. The engagement means 110 may be provided to allow the cylindrical sleeve 106 to be slightly adjustable, which would mean that the cylindrical sleeve 106 is not absolutely stiff to movement at the point of engagement with the engagement means 110. Thus, it can be understood that while the handle 102 is non-flexible for providing a tight grip for holding the entry point guide instrument 100 during the surgical procedure, the cylindrical sleeve 106 is configured to be maneuverable by the surgeon for accurate positioning of the guide wire implant.

[0059] The cylindrical sleeve 106 has a sharp, narrow and beveled tip 108, beveled at an angle in the range of about 30 - 80°, preferably between 40 - 70°, for providing access through the human tissue. The cylindrical sleeve 106 has a length between 5 -30 cms and the distal end is bent at an angle between 5 - 20°. The hollow cylindrical sleeve is inclined at an angle between 70 to 170 degrees relative to the longitudinal axis of the gripping means. The cylindrical sleeve 106 is sufficiently long to allow easy access to the femur bone of obese patients and also prevent any physical contact of the surgeon with the surgical area during the surgical procedure. The cylindrical sleeve preferably has an outer diameter between 4 - 10 mm, and inner diameter between 2 - 8 mm. The hollow cylindrical sleeve 106 of the entry point guide 100 can be inserted into the greater trochanter or the pyriformis fossa of the femur to get an exact and accurate entry point. The narrow dimension of the hollow cylindrical sleeve 106 ensures minimum tissue damage, smaller incision and smaller diameter hole in the femur which reduces the risks of stress fracture of the femur.

[0060] Fig. 2 shows that the back-side view of one preferred embodiment of the cylindrical sleeve 106 of the entry point guide instrument, represented by the numeral 200. The cylindrical sleeve 106 comprises a narrow longitudinal slit or opening 112 throughout the length of the sleeve. The narrow longitudinal slit or opening 112 is preferably provided at the back-side or posterior surface of the cylindrical sleeve 106, as can be seen in the back-side view of the cylindrical sleeve 106 in Fig. 2. The trocar guide wire implant is positioned in the longitudinal bore of the hollow cylindrical sleeve 106, where the trocar tip guide wire is longer than the cylindrical sleeve 106. The cylindrical sleeve 106 is designed so as to allow effective cleaning, quick removal of any stuck blood, blood clots, human tissues or splinters of bones, and provide improved sterilization. The bone, blood and muscle tissue which gets stuck in the cylindrical sleeve 106 is clearly visible through the cylindrical sleeve 106 due to the slit 112 and can be easily removed. The innovative cylindrical sleeve 106 with the slit 112 can be easily cleaned to remove the tissue and blood debris due to the slit 112.

[0061] Additionally, the slit 112 increases the surface area for sterilization of the instrument during autoclave.

[0062] Embodiments of the present disclosure are applicable over a wide number of uses and other embodiments may be developed beyond the embodiment discussed heretofore. Only the most preferred embodiments and their uses have been described herein for purpose of example, illustrating the advantages over the prior art obtained through the present disclosure. The disclosure is not limited to these specific embodiments or their specified uses. Thus, the forms of the disclosure described herein are to be taken as illustrative only and other embodiments may be selected without departing from the scope of the present disclosure. It should also be understood that additional changes and modifications, within the scope of the disclosure, will be apparent to one skilled in the art, and that modifications to the method described herein may fall within the scope of the disclosure.

Claims

CLAIMS:

1. An entry point guide instrument for inserting an implant, the instrument comprising:a gripping means configured to provide sufficient grip and maneuvering of the instrument during insertion of the implant;a hollow cylindrical sleeve secured to the gripping means, the hollow cylindrical sleeve having a proximal end and a distal end;wherein, a longitudinal slit is provided along at least a portion of the hollow cylindrical sleeve, the slit configured to allow cleaning and sterilization of the hollow cylindrical sleeve.

2. The entry point guide instrument as claimed in claim 1 , wherein the instrument is designed for inserting trocar guide wire implant at greater trochanter or pyriformis fossa of the femur bone or thigh bone.

3. The entry point guide instrument as claimed in claim 1, wherein the gripping means comprises an ergonomic handle to enhance instrument grip and control during insertion.

4. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the gripping means comprise an opening aligned with the hollow cylindrical sleeve configured for passing the trocar guide wire implant therethrough.

5. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the gripping means is made of a material selected from the group consisting of surgical stainless steel, titanium, medical-grade polymers, anodised aluminum, ceramic, composite material, silicone, and rubber.

6. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the hollow cylindrical sleeve is made of a biocompatible material selected from the group consisting of surgical stainless steel, titanium, anodised aluminum, and medical-grade polymers.

7. The entry point guide instrument as claimed in claim 1, wherein the hollow cylindrical sleeve has a beveled tip at the distal end, the beveled tip configured to facilitate precise penetration and alignment with anatomical structures, and minimize soft tissue damage during insertion.

8. The entry point guide instrument as claimed in claim 7, wherein the beveled tip is angled between 30 to 80 degrees relative to the longitudinal axis of the hollow cylindrical sleeve.

9. The entry point guide instrument as claimed in claim 1, wherein the hollow cylindrical sleeve has a serrated tip at the distal end, the serrated tip configured to facilitate precise penetration and alignment with anatomical structures, and prevent slipping of the instrument on the bone surface during insertion.

10. The entry point guide instrument as claimed in claim 9, wherein the serrated tip comprises between 5 to 15 serrations.

11. The entry point guide instrument as claimed in claim 1, wherein the longitudinal slit extends from the distal end to the proximal end of the hollow cylindrical sleeve.

12. The entry point guide instrument as claimed in claim 1, wherein the longitudinal slit is provided at the posterior or back-side of the hollow cylindrical sleeve.

13. The entry point guide instrument as claimed in anyone of the preceding claims, further comprising a depth marking system on the hollow cylindrical sleeve, the depth marking system configured to indicate the depth of insertion during use.

14. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the hollow cylindrical sleeve has an external diameter between 4 to 10 mm and internal diameter between 2 to 8 mm to accommodate a standard trocar guide wire, ensure small incision to reduce risk of stress fracture of the femur bone, and minimize soft tissue damage during insertion.

15. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the hollow cylindrical sleeve has length between 5 to 30 cm and the distal end is bent at an angle between 5 to 20 degrees.

16. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the hollow cylindrical sleeve is angled between 70 to 170 degrees relative to the longitudinal axis of the gripping means.

17. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the gripping means comprises an elongated connecting rod configured to provide flexibility and precise maneuvering during the insertion and maintain distance from the point of insertion to prevent any incidental injury to the surgeon.

18. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the hollow cylindrical sleeve is adjustably secured to the elongated connecting rod of the gripping means by means of an engagement means, the engagement means configured to facilitate flexibility between the hollowcylindrical sleeve and the elongated connecting rod and allow passing of the implant through the hollow cylindrical sleeve.

19. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the hollow cylindrical sleeve is detachable from the gripping means to allow for cleaning, sterilization or replacement.

20. The entry point guide instrument as claimed in anyone of the preceding claims, wherein the hollow cylindrical sleeve is radiopaque to allow visualization under imaging techniques during use.

21. A method for inserting a trocar guide wire implant at the greater trochanter or pyriformis fossa of the femur using the entry point guide instrument as claimed in anyone of the preceding claims, the method comprising:aligning the tip of the hollow cylindrical sleeve of the entry point guide instrument with the desired entry point at the greater trochanter or pyriformis fossa;applying force to the gripping means to advance the hollow cylindrical sleeve through soft tissue and bone into the intramedullary canal of the femur bone; inserting the trocar guide wire implant through the hollow cylindrical sleeve; removing the hollow cylindrical sleeve from the insertion and leaving the trocar guide wire implanted in the intramedullary canal of the femur bone; and removing blood clots, soft tissues and bone splinters from the hollow cylindrical sleeve through the longitudinal slit so as to sterilize the hollow cylindrical sleeve of the entry point guide instrument.

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