An ultrasonic knife head with a blunt separation function and an ultrasonic knife

Abstract

The present application relates to a kind of ultrasonic knife head with blunt separation function, including knife head functional components, knife head protective sleeve, blunt separation air bag, air bag inflation pipeline, knife head protective sleeve linear drive device;Knife head protective sleeve is cylindrical, sleeve in the rod of ultrasonic knife, front end is open, rear end is slidably matched with the rod;A small shell is fixed on the inner wall of knife head protective sleeve, the front end of small shell is open, and a small hole for air bag inflation pipeline to pass through is arranged in the rear end;Blunt separation air bag is limited in small shell in uncharged state;The rear end of separation air bag is communicated with air bag inflation pipeline and is connected;Hollow spring is arranged on air bag inflation pipeline, and hollow spring is as a section in air bag inflation pipeline itself passage;Knife head protective sleeve direct drive device can drive knife head protective sleeve to move forward together with blunt separation air bag to overcome the tension of hollow spring, cover knife head functional components;Blunt separation air bag can be stretched out of knife head protective sleeve after being inflated.

Description

Technical Field

[0001] This invention relates to an ultrasonic scalpel head, specifically to an ultrasonic scalpel head and ultrasonic scalpel that also have blunt separation function. Background Technology

[0002] Toldt's space (also known as the retrocolonic mesocolonic space) is an important subspace of the retroperitoneal space. It is a potential anatomical space formed by the fusion of the mesentery and the retroperitoneal peritoneum during embryonic development, possessing well-defined anatomical boundaries and structural characteristics: located between the mesentery and the posterior abdominal wall fascia, extending superiorly from the subhepatic or subsplenic space to the pelvic inlet, and bordered laterally by Toldt's line along the medial border of the colon. It is a natural "avascular plane" in colorectal surgery. The space is primarily composed of loose connective tissue, containing a small amount of adipose tissue and fine autonomic nerve fibers. No important blood vessels or organs pass through it. Only on the lateral side of the space are key structures such as the ureter, spermatic cord / ovarian vessels, and inferior vena cava / abdominal aorta, which are separated from the space by the prerenal fascia, forming a natural protective barrier.

[0003] As a "buffer space" between the colon and the posterior abdominal wall, Toldt's space not only maintains the mobility of the colon, but also reduces the traction interference of colonic peristalsis on the blood vessels, nerves and urinary and reproductive systems of the posterior abdominal wall through the elasticity of loose connective tissue. At the same time, it provides a safe anatomical separation plane for colorectal surgery.

[0004] In surgeries such as radical resection of colon cancer, total mesorectal excision (TME) for rectal cancer, and colostomy, dissecting Toldt's space is a core operative step, and its importance is reflected in the following three points:

[0005] 1) Avoiding damage to critical structures: The ureter, reproductive vessels, renal vessels, and autonomic nerve plexus adjacent to the lateral side of Toldt's space are the most vulnerable structures to damage during colorectal surgery. When dissecting along Toldt's space, the anatomical barrier of the space can be used to avoid instruments directly touching or pulling on these structures, significantly reducing the risk of intraoperative collateral damage.

[0006] 2) Maintaining the stability of the surgical plane: Toldt's space is a natural anatomical space formed during embryonic development. The tissue space is loose and the layers are clear. Dissection along this space can avoid entering the muscle layer or deep fascia, preventing the surgical plane from "losing" (such as accidentally entering the retroperitoneal fat layer, which may lead to bleeding or anatomical structure disorder), and ensuring that the surgical operation is always carried out within the preset safe layer.

[0007] 3) Ensuring radical resection of tumors: For colon cancer surgery, Toldt's space is a key landmark for complete resection of the mesocolic tract. Dissection along the space allows for complete removal of the mesocolic tract and surrounding adipose tissue, which conforms to the principle of "total mesocolic resection". It can effectively clear the lymph nodes in the tumor drainage area, reduce the risk of tumor residue or metastasis, and ensure the radical resection effect of the surgery.

[0008] In clinical practice, accurate identification and dissection along Toldt's space can directly bring multiple benefits to surgical outcomes and patient prognosis:

[0009] 1) Reduce intraoperative bleeding: Since there are no important blood vessels in the space, only small capillaries, frequent hemostasis is not required when accurately separating the blood vessels, which can significantly reduce the amount of intraoperative bleeding, shorten the operation time, and reduce the risk of transfusion-related complications.

[0010] 2) Reduce the incidence of postoperative complications: On the one hand, avoiding damage to structures such as ureters and nerves can reduce serious complications such as postoperative urinary fistula, difficulty urinating, and sexual dysfunction; on the other hand, separation along the interstitial space does not damage the muscular and serosa layers of the colonic wall, which can reduce the probability of postoperative intestinal fistula and intestinal adhesion and promote early recovery of intestinal function.

[0011] 3) Improve surgical efficiency: The loose tissue characteristics of Toldt's gap make it easy to separate and the anatomical landmarks are clear, which can reduce the time for intraoperative anatomical confirmation. Especially for complex cases, it can quickly establish a clear surgical field, improving the safety and efficiency of the operation.

[0012] 4) Improve long-term prognosis for patients: For patients with malignant tumors, accurate separation of Toldt's space can ensure complete resection of the mesocolic tract, meet the "tumor-free principle" of radical tumor resection, reduce the local recurrence rate, protect autonomic nerve function, and improve the patient's postoperative quality of life.

[0013] Given the characteristics and importance of Toldt's space, accurate identification and maintenance of this plane during surgery is of paramount importance. In surgical practice, blunt dissection has been found to be a crucial method for maintaining this space and plane, as sharp dissection may disrupt the plane, leading to accidental entry into other spaces or damage to surrounding vital tissues or organs.

[0014] Prior art citations:

[0015] Chinese patent document with publication date of July 14, 2017, publication number CN206325112U, titled "A TEP-specific airbag separator";

[0016] Chinese patent document with publication date of January 17, 2020, publication number CN209952032U, titled "Blunt Separation Device for Retroperitoneal Soft Tissue". Summary of the Invention

[0017] The ultrasonic scalpel, currently the most commonly used medical device for surgical cutting and hemostasis, is the mainstream platform in both open and laparoscopic surgeries. It is the most frequently used instrument in laparoscopic surgery, especially for separating Toldt's space. Most ultrasonic scalpel heads on the market only possess the sharp dissection function for cutting tissue, lacking the ability to bluntly dissect tissue, and even more so, lacking the ability to freely adjust the size of the blunt dissection device.

[0018] Therefore, the present invention aims to provide an ultrasonic scalpel tip that also has blunt dissection function, and the size of the blunt dissection device can be freely adjusted, which will help to accurately and safely separate tissue areas such as Toldt's gap and other natural anatomical gaps, reduce intraoperative bleeding, reduce the incidence of postoperative complications, improve surgical efficiency, and ultimately improve the long-term prognosis of patients.

[0019] The present invention adopts the following technical solution:

[0020] An ultrasonic scalpel tip with blunt dissection function includes a scalpel tip functional component, a scalpel tip protective sleeve 15, a blunt dissection airbag 1, an airbag inflation tube 2, and a linear drive device 14 for the scalpel tip protective sleeve. The scalpel tip protective sleeve 15 is cylindrical and fits onto the shaft 3 of the ultrasonic scalpel, with an open front end and a sliding fit with the shaft 3 at the rear end. A small cover 1501 is fixed on the inner wall of the scalpel tip protective sleeve 15. The small cover 1501 has an open front end and a small hole at the rear end for the airbag inflation tube 2 to pass through. The blunt dissection airbag 1 is in an uninflated state. The lower part is confined within the small cover 1501; the rear end of the separation airbag 1 is connected to the airbag inflation pipe 2; a hollow spring 201 is provided on the airbag inflation pipe 2, and the hollow spring 201 serves as a section of the airbag inflation pipe 2's own channel; the blade protective sleeve direct drive device 14 can drive the blade protective sleeve 15 together with the blunt separation airbag 1 to move forward against the tension of the hollow spring 201, covering the blade functional component; after the blunt separation airbag 1 is inflated, it can extend forward out of the blade protective sleeve 15.

[0021] In this technical solution, the hollow spring 201 functions to pull the blunt separation airbag 1, after deflating or venting negative pressure, back into the small cover 1501 when the cutter head protective sleeve 15 returns to its original position (exposing the cutter head functional components). The hollow spring 201 also serves as part of the airbag inflation channel and combines the functions of a spring.

[0022] Preferably, the blunt separation airbag 1 is made of silicone, and the airbag inflation pipe 2 is made of metal. A connecting seat with an inner groove is integrally formed at the root of the rear end of the blunt separation airbag 1. At the front end of the inflation pipe 2, an outwardly turned annular flange is made. A thin-walled pressure ring is fitted on the outside of the connecting seat, and the silicone is sealed to the annular flange by laser welding.

[0023] Furthermore, the thin-walled pressure ring is made of stainless steel or titanium alloy.

[0024] Preferably, the linear drive device 14 for the cutter head protective sleeve is a linear motor.

[0025] Preferably, the blade functional components include a blade hemostatic component 16 and a blade cutting component 17.

[0026] Preferably, the diameter of the rod body 3 is 4-8mm, and the diameter of the cutter head protective sleeve 15 is 8-20mm.

[0027] Preferably, the airbag inflation pipe 2 is connected to an external gas pressure source, which can provide positive and negative pressure according to control.

[0028] Preferably, the linear drive device 14 for the cutter head protective sleeve is fixed on the rod body 3, and its protruding part is connected to the cutter head protective sleeve 15.

[0029] An ultrasonic scalpel, characterized in that it has an ultrasonic scalpel head with the aforementioned blunt dissection function.

[0030] Preferably, the ultrasonic scalpel is equipped with an airbag control button 4 for controlling the inflation and deflation of the blunt separation airbag 1, and a scalpel protective sleeve button 10 for controlling the forward and backward movement of the protective sleeve linear drive device 14.

[0031] The beneficial effects of this invention are as follows:

[0032] 1) Achieving integrated sharp and blunt separation without the need for intraoperative instrument changes: This invention integrates sharp cutting and blunt separation functions into a single ultrasonic scalpel head, which can be quickly switched during surgery, significantly reducing the number of instrument changes, shortening surgical time, and improving the smoothness of operation and surgical efficiency.

[0033] 2) The protective cover and airbag move in sync, with precise positioning and no jamming: Through the protective cover pushing and the hollow spring (tension spring) retraction structure, the airbag and the protective cover extend and retract in sync. The airbag can accurately enter narrow anatomical planes such as Toldt's gap to perform blunt separation.

[0034] 3) The hollow elastic air circuit has both ventilation and repositioning functions, and the structure is extremely simple: The air circuit is equipped with a hollow elastic tension spring structure, which simultaneously undertakes the functions of gas delivery and automatic repositioning of the airbag, eliminating the need for additional traction wires, complex buckles and transmission mechanisms. The overall structure is simpler, more reliable and has a lower failure rate, making it suitable for the design of miniaturized minimally invasive instruments.

[0035] 4) The metal and silicone seals are firmly connected, with excellent air tightness and durability: The base of the airbag adopts a mechanical locking seal structure (this sealing and locking principle is an existing technology in the field of medical devices), which realizes a reliable connection between the metal elastic air passage and the silicone airbag. The connection strength is high, the air tightness is good, and it is not easy to fall off. It can withstand repeated inflation and deflation and multiple sterilizations, and has a longer service life.

[0036] 5) Blunt dissection fits the anatomical layers better, reducing tissue damage and bleeding: The balloon blunt dissection extends along the natural anatomical gaps, without damaging the fascia layers or important structures such as nerves, blood vessels, and ureters. Intraoperative bleeding is significantly reduced, the surgical plane is more stable, and the risk of collateral damage is reduced.

[0037] 6) Improve the radicality of tumor surgery and patient prognosis: In colorectal surgery, Toldt's space can be separated in a standardized and safe manner, ensuring complete resection of the mesentery and quality of lymph node dissection, reducing the probability of tumor residue and local recurrence; at the same time, it reduces postoperative complications such as enterocutaneous fistula, urinary fistula, and urinary obstruction, promotes postoperative recovery, and improves long-term quality of life.

[0038] 7) Wide range of applications and strong versatility: This structure is compatible with existing mainstream ultrasonic scalpel platforms, does not change doctors' operating habits, and is suitable for various scenarios requiring blunt dissection in laparoscopic and open surgery, making it easy to promote in clinical practice. Attached Figure Description

[0039] Figure 1 This is a schematic diagram of the ultrasonic scalpel head of the present invention, which also has the function of blunt separation, when performing a sharp separation operation.

[0040] Figure 2 This is a schematic diagram of the intermediate process state when the ultrasonic scalpel head of the present invention, which also has the function of blunt separation, is switching from sharp separation to blunt separation.

[0041] Figure 3 This is a schematic diagram of the ultrasonic scalpel head with blunt separation function of the present invention during blunt separation operation.

[0042] Figure 4 This is a left view of the front end of the ultrasonic scalpel head of the present invention, which also has a blunt separation function (the hemostatic component 16 and the cutting component 17 of the scalpel head have been removed).

[0043] Figure 5 This is a photographic illustration of an ultrasonic scalpel in existing technology.

[0044] In the diagram: 1. Blunt dissection airbag; 2. Airbag inflation channel; 3. (Ultrasonic scalpel) shaft; 4. Airbag control button; 5. Jaw closing button; 6. Handle grip; 7. High power setting button; 8. Low power setting button; 9. Handle interface; 10. Blade head protective sleeve control button; 11. Rotating wheel; 12. Blade head protective sleeve control line; 13. Ultrasonic energy transmission line; 14. Protective sleeve linear drive device (linear motor); 15. Blade head protective sleeve; 16. Blade head hemostatic component; 17. Blade head cutting component; 201. Hollow spring; 1501. Small cover. Detailed Implementation

[0045] The present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0046] First see Figure 5 , Figure 5 The image shows a physical example of an ultrasonic scalpel in the prior art, with the functional components of the scalpel head (hemostatic component and cutting component) on the left. This image can serve as a general visual understanding of the prior art.

[0047] Traditional ultrasonic scalpels only have sharp dissection capabilities. However, blunt dissection tools are more suitable for separating tissue areas with natural anatomical gaps, such as Toldt's gap. This invention adds a blunt dissection function to the traditional ultrasonic scalpel, enabling it to reduce intraoperative bleeding and improve patient prognosis when separating tissue areas with natural anatomical gaps, such as Toldt's gap. Specific details are as follows:

[0048] See Figure 1-4 An ultrasonic scalpel tip with blunt separation function includes a scalpel tip functional component, a scalpel tip protective sleeve 15, a blunt separation airbag 1, an airbag inflation pipe 2, and a scalpel tip protective sleeve linear drive device 14.

[0049] The blade protective sleeve 15 is cylindrical and is fitted onto the shaft 3 of the ultrasonic scalpel. The front end is open and the rear end is slidably engaged with the shaft 3.

[0050] Key references Figure 4 , Figure 4 yes Figure 1A left-side view of the blade protector 15 (the blade hemostatic component 16 and blade cutting component 17 have been removed). A small cover 1501 is fixed to the inner wall of the blade protector 15. The front end of the small cover 1501 is open, and the rear end has a small hole through which the airbag inflation tube 2 passes. The blunt separation airbag 1 is confined within the small cover 1501 when it is not inflated. The rear end of the separation airbag 1 is connected to the airbag inflation tube 2. A hollow spring 201 is provided on the airbag inflation tube 2, and the hollow spring 201 serves as a section of the airbag inflation tube 2's own channel. The blade protector direct drive device 14 can drive the blade protector 15 together with the blunt separation airbag 1 to move forward against the tension of the hollow spring 201, covering the blade functional components. After the blunt separation airbag 1 is inflated, it can extend forward out of the blade protector 15.

[0051] The hollow spring 201 serves to pull the blunt separation airbag 1, after deflating or venting negative pressure, back into the small cover 1501 when the cutter head protective sleeve 15 returns to its original position (exposing the cutter head functional components). The hollow spring 201 also functions as part of the airbag inflation channel and combines the functions of a spring.

[0052] In this embodiment, the blunt separation airbag 1 is made of silicone, and the airbag inflation tube 2 is made of metal. A connecting seat with an inner groove is integrally formed at the root of the rear end of the blunt separation airbag 1. At the very front end of the inflation tube 2, an outwardly flared annular flange / flare (similar to the "flare" of a water pipe connector) is made to increase the contact area and prevent the silicone from coming out. A thin-walled pressure ring is fitted over the outside of the connecting seat, and the silicone is sealed to the annular flange by laser welding. Specifically:

[0053] Modification of the front end of the airbag inflation tube 2: Make an outward-curving annular flange / flare (similar to the "flare" of a water pipe connector) at the very front end of the airbag inflation tube 2 to increase the contact area and prevent the silicone from coming out.

[0054] Silicone airbag base design: A connector with an inner groove is integrally molded at the base of the airbag. The shape of the groove perfectly matches the spring flange and just wraps around the flange.

[0055] Metal pressure ring locking: A thin-walled pressure ring made of stainless steel / titanium alloy is fitted onto the outside of the silicone connector and the silicone is firmly pressed onto the spring flange by interference fit / laser spot welding.

[0056] Sealing guarantee: The elasticity of the silicone will fill the gap between the flange and the pressure ring, forming a radial seal and completely eliminating air leakage.

[0057] In this embodiment, the linear drive device 14 for the cutter head protective sleeve is a linear motor.

[0058] In this embodiment, see Figure 1 The blade head functional components include a blade head hemostatic component 16 and a blade head cutting component 17.

[0059] In this embodiment, the diameter of the rod body 3 is 4-8mm, and the diameter of the cutter head protective sleeve 15 is 8-20mm.

[0060] Figure 2 The state shown is the shape of the ultrasonic scalpel head of the present invention before the blunt separation operation is performed.

[0061] In this embodiment, see Figure 1 The airbag inflation pipe 2 is connected to an external gas pressure source, which can provide positive and negative pressure according to control.

[0062] See also Figure 1 The linear drive device 14 for the cutter head protective sleeve is fixed on the rod body 3, and its protruding part is connected to the cutter head protective sleeve 15.

[0063] An ultrasonic scalpel having the aforementioned ultrasonic scalpel head that also has blunt dissection function.

[0064] In this embodiment, see continue to see Figure 1 The ultrasonic scalpel is equipped with an airbag control button 4 for inflating and deflating the blunt separation airbag 1, and a scalpel protective sleeve button 10 for controlling the forward and backward movement of the protective sleeve linear drive device 14.

[0065] In addition, the handle is equipped with multiple control buttons, such as jaw closing button 5, high power mode button 7, low power mode button 8, and rotating wheel 11. These control components are the same as those in the prior art.

[0066] It should be noted that, attached Figure 1-4 These are just diagrams, and are... Figure 5 Based on the existing technology shown, some structural and functional additions are made, and the positions of the functional components shown are schematic. For example, the position of the protective sleeve linear drive device 14 in the attached figure is not required, as long as it can be fixed on the rod body 3 and drive the cutter head protective sleeve 15 to move back and forth; the cutter head protective sleeve control line 12 is also schematic, indicating the existence of such a control line to realize the control function of the protective sleeve linear drive device 14; the airbag inflation channel 2 is in Figure 1 The position shown in the drawing is also illustrative. In reality, its main body (except for the hollow spring 201) can be fixedly connected to the rod body 3.

[0067] In laparoscopic surgery, when encountering tissue areas with natural anatomical gaps, such as Toldt's space, this invention activates a blunt dissection device to accurately enter the Toldt's space. By continuously activating the bulbous expansion at the tip, the Toldt's space is expanded. When resistance is encountered, the blunt dissection part is retracted, and combined with the sharp dissection of an ultrasonic scalpel, the patient re-enters a new space. The blunt dissection device is activated again, and this alternating sharp and blunt dissection process maintains the surgical plane on the correct plane at all times. This reduces intraoperative bleeding and ultimately improves patient prognosis. The specific operating steps are as follows:

[0068] S1. During laparoscopic colorectal surgery, when dissecting Toldt's space, the surgeon manipulates the protective sheath to extend forward along the scalpel shaft. The front limiting surface of the scalpel protective sheath 15 pushes the base of the balloon 1, causing the balloon 1 and the scalpel protective sheath 15 to move forward synchronously. The protective sheath precisely covers the hemostatic component 16 and the cutting component 17 of the scalpel, and the small cover 1501 inside the protective sheath separates the balloon from the cutting component 17 of the scalpel before the scalpel enters the loose anatomical space. At this time, the balloon is inflated through the balloon inflation tube 2 containing the hollow tension spring 201. The balloon gradually expands and bluntly pushes the tissue along the safe plane, clearly expanding the space and stabilizing the surgical layer.

[0069] S2. After blunt dissection, the balloon is deflated (or negative pressure is applied) to retract into the protective sheath. Subsequently, the protective sheath retracts backward under the control of the linear motor 14, and the hollow tension spring 201, relying on its own elasticity, simultaneously and smoothly pulls the balloon back into the protective sheath, ensuring the balloon is not exposed or jammed. Then, the procedure can be switched to the ultrasonic scalpel sharp dissection mode to continue the cutting and hemostasis operations. This embodiment allows for rapid switching between sharp and blunt dissection, reliable linkage between the protective sheath and the balloon, and synchronized advance and retreat, effectively maintaining the correct anatomical plane, reducing intraoperative bleeding, lowering the risk of ureteral, nerve, and vascular injury, and improving surgical safety and operational efficiency.

Claims

1. An ultrasonic scalpel tip with both blunt dissection function, characterized in that: Includes a cutting head functional component, a cutting head protective sleeve (15), a blunt separation airbag (1), an airbag inflation pipe (2), and a cutting head protective sleeve linear drive device (14). The blade protective sleeve (15) is cylindrical and is fitted onto the shaft (3) of the ultrasonic scalpel. The front end is open and the rear end is slidably fitted with the shaft (3). A small cover (1501) is fixed on the inner wall of the blade protective sleeve (15). The front end of the small cover (1501) is open and the rear end is provided with a small hole through which the airbag inflation pipe (2) passes. The blunt separation airbag (1) is confined within the small cover (1501) in the uninflated state; the rear end of the separation airbag (1) is connected to the airbag inflation pipe (2); A hollow spring (201) is installed on the airbag inflation pipe (2), and the hollow spring (201) serves as a section of the airbag inflation pipe (2) itself. The direct drive device (14) for the cutter head protective sleeve can drive the cutter head protective sleeve (15) together with the blunt separation airbag (1) to move forward against the tension of the hollow spring (201) and cover the cutter head functional components. After the blunt separation airbag (1) is inflated, the blade protective sleeve (15) can extend forward.

2. The ultrasonic scalpel head with blunt separation function as described in claim 1, characterized in that: The blunt separation airbag (1) is made of silicone, and the airbag inflation pipe (2) is made of metal. A connecting seat with an inner groove is integrally formed at the root of the rear end of the blunt separation airbag (1). At the very front end of the inflation pipe (2), make an outward-facing annular flange, and use a thin-walled pressure ring to fit around the outside of the connecting seat. Seal the silicone to the annular flange by laser welding.

3. The ultrasonic scalpel head with blunt separation function as described in claim 2, characterized in that: The thin-walled pressure ring is made of stainless steel or titanium alloy.

4. The ultrasonic scalpel head with blunt separation function as described in claim 1, characterized in that: The linear drive device (14) for the cutter head protective sleeve is a linear motor.

5. The ultrasonic scalpel head with blunt separation function as described in claim 1, characterized in that: The blade head functional components include a blade head hemostatic component (16) and a blade head cutting component (17).

6. The ultrasonic scalpel head with blunt separation function as described in claim 1, characterized in that: The diameter of the rod body (3) is 4-8mm, and the diameter of the cutter head protective sleeve (15) is 8-20mm.

7. The ultrasonic scalpel head with blunt separation function as described in claim 1, characterized in that: The airbag inflation pipe (2) is connected to an external gas pressure source, which can provide positive and negative pressure according to control.

8. The ultrasonic scalpel head with blunt separation function as described in claim 1, characterized in that: The linear drive device (14) for the cutter head protective sleeve is fixed on the rod body (3), and its protruding part is connected to the cutter head protective sleeve (15).

9. An ultrasonic scalpel, characterized in that, An ultrasonic scalpel head with blunt separation function as described in any one of claims 1-8.

10. The ultrasonic scalpel as described in claim 9, characterized in that: The ultrasonic scalpel is equipped with an airbag control button (4) for inflating and deflating the blunt separation airbag (1) and a scalpel protective sleeve button (10) for advancing and retracting the protective sleeve linear drive device (14).

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