Hollow guide fracture reducer

Abstract

The present application relates to hollow guide bone fracture reduction device, including hollow sleeve (2, 3) and fracture reduction needle (1, 4), both are made of hard material;The front end of hollow sleeve (2, 3) is hollow sleeve (2), the rear end is provided with first handle (3), and the inside of first handle (3) and front section sleeve (2) is through type hollow structure;The front end of fracture reduction needle (1, 4) is single-side angle sharp solid rod (1), the rear end is provided with second handle (4), and is set in the inside of hollow sleeve (2, 3), when second handle (4) is twisted forward, the front end angle sharp part (11) is exposed outside hollow sleeve (2). When the percutaneous minimally invasive implant internal fixation is reduced, the method can achieve the effect that both clavicle fracture can be effectively and quickly reduced and skin scar can be reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a hollow guiding bone fracture reduction device. BACKGROUND

[0002] A human clavicle has two left and right sides, respectively in S shape, and is arranged between the manubrium and the acromion, which is the most important bone connecting the upper limbs and the torso, and is one of the bones prone to fracture, with a rate of 5% to 10% of the whole body fracture, and mostly occurs in young adults and children. The clavicle fracture is prone to displacement and deformity, and since the clavicle is superficial, if not reduced and fixed, it is easy to lead to deformity healing and affect the function, and if open reduction and internal fixation (most of which is currently steel plate plus matching screw internal fixation) is performed, surgical scars will be left, affecting the appearance. How to achieve both reduction and fixation and no scars affecting the appearance is the goal pursued by surgeons and patients.

[0003] The percutaneous minimally invasive implant internal fixation technology can effectively reduce patient pain, trauma, bleeding, and complication rate, and is currently recognized by more scholars. However, in the traditional percutaneous minimally invasive implant internal fixation technology, the operator can only confirm the position of the broken bone end through hand feeling + X-ray shooting during reduction, and cannot accurately know whether the reduction is successful.

[0004] Therefore, how to accurately achieve accurate reduction of the broken bone end during percutaneous minimally invasive implant internal fixation is a problem urgently to be solved in the field. SUMMARY

[0005] In order to solve the above problems, accurate reduction of the broken bone end is achieved during percutaneous minimally invasive implant internal fixation.

[0006] The present application adopts the following scheme: a hollow guiding bone fracture reduction device, comprising a hollow sleeve and a fracture reduction needle, both of which are made of hard material;

[0007] The front end of the hollow sleeve is a hollow sleeve, and the rear end is provided with a handle, and the inside of the handle and the inside of the front sleeve are through hollow structures;

[0008] The front end of the fracture reduction needle is a single-sided angle sharp solid rod, and the rear end is provided with a handle, which is sleeved in the hollow sleeve, and when the handle is screwed to the limit position, the front end of the angle sharp part is exposed outside the hollow sleeve;

[0009] Further, the handle of the hollow sleeve is a left hemisphere, the handle of the fracture reduction needle is a right hemisphere, the diameter of the left hemisphere is greater than that of the right hemisphere, and an annular scale is arranged on the bottom of the left hemisphere facing the right hemisphere.

[0010] Further, the hollow sleeve (2) has an outer diameter of 3.0 mm and an inner diameter of 2.2 mm, the front end of 15 cm has a uniform outer diameter, the rear end of 10 cm has an outer diameter gradually increasing to 5.0 mm, and the inner diameter is still 2.2 mm. The fracture reduction needle (1, 4) has a diameter of 2.0 mm, and the front end has an angle of 30 / 45 / 60 degrees.

[0011] Most of the human bones have marrow cavities. After the fracture of the bones, the two segments of the fractured bones (assuming two segments of A and B) need to be reset and fixed. According to the application, first, an entrance is opened in the bone cortex, and the hollow guiding bone fracture reducer (assembled with the fracture reduction needle / inner core, and the needle head is retracted in the hollow sleeve) is inserted from the entrance (the insertion end is the A segment). If the resistance is uniform and there is no empty feeling during the insertion, it indicates that the hollow guiding bone fracture reducer is moving in the cancellous bone channel without penetrating the cortex. If the resistance is obvious or the resistance suddenly disappears, it indicates that the angle and direction are incorrect, and the angle needs to be adjusted, and if necessary, the angle needs to be adjusted under the perspective. Figure 5 Or the explanation in the embodiment - therefore, the fracture reduction needle in the A segment is difficult to insert the B segment which is misaligned if the top end is a flat head without an angle. Only the sharp part with an angle can be inserted into the marrow cavity of the misaligned B segment in front. The specific principle and matching angle method are described in the embodiment. After the insertion, it is seen that the sharp part is accurately inserted into the marrow cavity of the B segment through the perspective (X-ray) or the judgment of the accurate insertion of the sharp part into the marrow cavity of the B segment by the hand feeling. Then, the fracture reduction needle is rotated, and at this time, the sharp part will drive (pull) the B segment and the A segment to align while rotating, so as to achieve the purpose of aligning the misaligned B segment with the A segment - this is the first advantage of the application. Without the aid of X-ray film shooting, the misaligned fractured bone is preliminarily reset by setting the inner core of the sharp part at the front end and rotating and prying.

[0012] The main purpose of the present application is to achieve the purpose of accurate reduction of the broken bone ends on the basis of as few X-ray films as possible through the gradual and ingenious cooperation of surgical tools during the operation. In the traditional operation of this type, after aligning the broken bones of the second segment and the first segment by hand feeling, X-ray films need to be taken continuously to accurately adjust the positions of the second segment and the first segment to achieve the purpose of complete alignment. However, by using the method of fracture reduction needle / inner core, the mechanical guidance principle generated by the ingenious rotation of the sharp part of the front segment of the inner core can be used to adjust the coincidence degree of the second segment and the first segment to the extent that the fracture reduction device can pass through (the coincidence degree is shown in the examples), and then the fracture reduction device is threaded through the broken bones of the second segment and the first segment to further calibrate the coincidence degree of the second segment and the first segment. Finally, by using the intramedullary fixation principle of screwing the Kirschner wire into the cannulated screw, the intramedullary nail that completely coincides / matches the inner diameter of the intramedullary cavity is used to accurately align the broken bones of the second segment and the first segment while pressing them towards the fracture line. When the intramedullary nail of the same outer diameter passes through the second segment and the first segment, it means that the inner diameters of the broken bones of the second segment and the first segment are accurately aligned, at which time it can be confirmed that the outer walls of the broken bones of the second segment and the first segment are also accurately aligned. This is the second advantage of the present application, which can only need to take an X-ray film at a few nodes, and does not need to repeatedly adjust the coincidence degree of the broken bones of the second segment and the first segment under the calibration of X-ray, so as to achieve the purpose of accurate alignment and fixation of the broken bone ends.

[0013] The present application is ingenious in design and uses the sharp part of the front segment of the inner core, the inner core, the hollow sleeve and the intramedullary nail in a layer-by-layer progressive manner to gradually accurately align the outer walls of the broken bones of the second segment and the first segment. The intramedullary nail in the last step can also accurately align the outer walls of the broken bones of the second segment and the first segment while pressing the two ends of the broken bones. The achievement of this advantage depends on the achievement of the first advantage, the initial reduction effect of the rotation of the inner core. As can be seen, the first advantage of the present application can lead to the second advantage, in other words, a technical feature is achieved, which produces two beneficial effects. BRIEF DESCRIPTION OF DRAWINGS

[0014] Figure 1 It is a structural schematic diagram of the present application.

[0015] Figure 2 It is the ring-like scale of the first handle 3 and the second handle 4.

[0016] Figure 3 It is the sharp part 11.

[0017] Figure 4 It is a schematic diagram of the fracture reduction device entering the intramedullary passage of the clavicle.

[0018] Figure 5 In Example 1, the fracture line angles corresponding to three different slope inner cores. DETAILED DESCRIPTION

[0019] The specific embodiments of the present invention will be further described below with reference to the accompanying drawings.

[0020] Example 1, taking a clavicle fracture as an example. Parameters: Hollow sleeve (2) outer diameter 3.0mm, inner diameter 2.2mm, uniform outer diameter for the first 15cm, gradually increasing to 5.0mm for the last 10cm, while the inner diameter remains 2.2mm. Fracture reduction pins (1, 4) diameter 2.0mm, with an angle of 30 / 45 / 60 degrees at the front end. See Figure 4 The patient was placed in a supine position under general anesthesia. Figure 4 Make a 1-1.5cm transverse incision at the starting point of the arrow towards the affected side (often in the middle of the clavicle, usually caused by a fall or impact). Use bone forceps to create a 5.0mm cortical opening (the same as the thickest outer diameter of the hollow sleeve). Insert the fracture reduction device (equipped with the fracture reduction pin, the pin tip retracted inside the hollow sleeve) in the direction of the arrow. Adjust the direction based on feel. If the resistance is uniform and there is no feeling of falling back during insertion, it indicates that it is moving within the cancellous bone channel and has not penetrated the cortex. If the resistance is significant or suddenly disappears, it indicates that the angle or direction is incorrect and the angle needs to be adjusted appropriately. If necessary, the angle should be adjusted under fluoroscopy.

[0021] When the fracture reduction device is about to reach the fracture line, rotate the second handle (4) to push the tip (11) of the pre-selected appropriate fracture reduction pin (1, 4) / inner core out of the hollow sleeve (2). The principle for selecting the inner core is as follows: Figure 5 The main focus is on examining both ends of the fracture. Figure 5 The degree of overlap of the central axes (with segment B on the left and segment A on the right). Figure 5 For AC fractures, when the overlap of the midlines at both ends is approximately 100%, 50%, and 10-20%, respectively, the selected angles for the anterior end of the inner core are 60 degrees, 45 degrees, and 30 degrees. From this selection rule, it can be observed that the smaller the overlap, the smaller the angle of the anterior end of the inner core.

[0022] The reason is the same as Figure 5In AC surgery, the smaller the overlap, the smaller the area (area of ​​the medullary cavity) of the inner core contacting the opposite bone fragment (segment B) when it extends horizontally. In this case, only a sharper inner core tip can be selected for smoother insertion into the medullary cavity of segment B. If the overlap is excessively small, such as around 0%, even with the sharpest angle, the inner core cannot be inserted into the medullary cavity of segment B through horizontal extension. In this case, the surgeon needs to slightly press down or lift the inner core (or outer sleeve) of segment A to adjust the positions of segment A and segment B, temporarily adjusting the overlap to allow the inner core tip to smoothly insert into the medullary cavity of segment B. However, as a clinical procedure, when the overlap is around 0%, it is not advisable to forcefully press down on segment A to achieve 100% overlap. This is mainly because the overlap between segment A and segment B is unknown inside the body without radiographic imaging. However, the degree of overlap can be slightly adjusted by feeling and by slightly adjusting the positions of the fractured bone segments A and B.

[0023] This leads to the third advantage of this application. As seen in the above surgical procedure, the acute angle of the inner core's tip needs to be adjusted according to the overlap of the fracture ends. Although the overlap can be confirmed beforehand using X-rays, allowing for the selection of the appropriate inner core's acute angle, in actual fractures, the fracture ends are often uneven, resembling mountain peaks with varying heights and not smooth surfaces. Therefore, an inner core pre-matched to the X-ray overlap of the fracture ends may fail to insert into the B-segment due to burrs at the fracture ends (the presence of burrs obstructs the medullary cavity fracture). Therefore, during the insertion of the inner core's tip into the medullary cavity of the B-segment fracture, multiple inner core angles need to be selected / tried based on the actual situation. Thus, setting the acute angle of the prying tip on the inner core has the advantage of allowing for repeated replacement / trial of different acute angles (inner cores), eliminating the need for repeated insertion and removal of the inner core. During these repeated insertions and removals, the inner core enters through the inner wall of the outer sheath, eliminating the need for replacement of the hollow outer sheath itself. This design avoids friction on surgical sites, such as the bone wall entry port and the inner wall of the medullary cavity, reducing secondary damage to the surgical site and the patient.

[0024] Taking a 30-degree acute-angle core as an example, after the sharp point is accurately inserted as seen through fluoroscopy (X-ray) or by touch, the sharp point is accurately inserted into the medullary canal of segment B. Then, the fracture reduction pin is rotated. At this time, the sharp point will rotate and simultaneously pull (traction) segment B and segment A to align. The principle of rotation leading to alignment of the opposite segment B and segment A is explained below. Figure 5C, D, A. If the sharp point rotates, it can move the displaced segment B of the fracture to change its position, achieving reduction (at this point, segment B and segment A may still have slight incomplete overlap), but their overlap has been greatly improved, allowing the fracture reduction device to pass smoothly through the fracture ends. Because the outer diameter of the fracture reduction device is larger than the inner core, the overlap of segment B and segment A is further improved under the calibration of the fracture reduction device (segment B and segment A are strung on the outer wall of the fracture reduction device). At this point, only the issue of segment B and segment A not contacting and applying pressure remains unresolved.

[0025] After the fracture reduction device is positioned well under fluoroscopy, the inner core of the fracture reduction device is removed, and the Kirschner wire is inserted into the hollow channel of the fracture reduction device. The wire is tapped appropriately to ensure it is firmly fixed. Then, the fracture reduction device is removed, and a hollow screw of appropriate length (Synthes, Switzerland) with a diameter of 4.0-6.5 mm (depending on the size of the bone marrow, the outer diameter of the hollow screw should be as flush as possible with the size of the bone marrow) is screwed in along the Kirschner wire. The hollow screw exerts an intramedullary effect (the hollow screw will compress the S and A segments towards the fracture line - existing technology) to ultimately better reduce and compress the displaced fracture ends.

[0026] This invention employs a minimally invasive method. The invented hollow-guided fracture reduction device, under C-arm fluoroscopic guidance, can be percutaneously inserted into the medullary canal of the clavicle. The lever principle is used to initially reduce the displaced fracture ends. Then, Kirschner wires are inserted into the hollow guide device, and hollow screws are screwed along the Kirschner wires into the fracture ends. The Kirschner wires are then withdrawn, and the fracture is ultimately reduced and fixed through the intramedullary effect. This method achieves both effective and rapid reduction of clavicle fractures while minimizing skin scarring.

Claims

1. A hollow guide fracture reduction device, comprising a hollow outer sleeve (2, 3) and fracture reduction pins (1, 4), both made of rigid material; characterized in that: The front end of the hollow outer sleeve (2, 3) is a hollow sleeve (2), and the rear end is provided with a first handle (3). The first handle (3) and the front sleeve (2) are internally connected hollow structures. The front end of the fracture reduction needle (1, 4) is a single-sided angled sharp solid rod (1), the angle being one of 30 degrees, 45 degrees or 60 degrees. The rear end is provided with a second handle (4), which is fitted inside the hollow outer sleeve (2, 3). When the second handle (4) is twisted forward, the angled sharp part (11) at the front end is exposed outside the hollow sleeve (2). When using it, the smaller the overlap of the midlines of the two ends of the fracture, the smaller the angle of the tip (11) of the matching fracture reduction pin (1, 4) should be. After the tip is inserted into the medullary cavity of segment B, rotate the fracture reduction pin. The tip will rotate while aligning segment B and segment A.

2. The hollow guide fracture reduction device as described in claim 1, characterized in that: The first handle (3) is a left hemisphere and the second handle (4) is a right hemisphere. The diameter of the left hemisphere is larger than that of the right hemisphere. A ring scale (31) is set at the bottom of the first handle (3) facing the second handle (4).

3. The hollow guide fracture reduction device as described in claim 2, characterized in that: The hollow sleeve (2) has an outer diameter of 3.0 mm and an inner diameter of 2.2 mm. The outer diameter is uniform at the front end of 15 cm and gradually increases to 5.0 mm at the rear end of 10 cm. The inner diameter remains at 2.2 mm. The fracture reduction pins (1, 4) have a diameter of 2.0 mm and the angle of the sharp tip (11) at the front end is 30 / 45 / 60 degrees.

4. The hollow guide fracture reduction device as described in claim 3, characterized in that: The hollow outer shell (2, 3) and fracture reduction pin (1, 4) are made of stainless steel, while the first handle (3) and the second handle (4) are made of engineering plastic.

5. The hollow guide fracture reduction device as described in claim 4, characterized in that: When the overlap of the midlines at both ends of the fracture is 80%, 50%, and 10-20% respectively, the angles of the tip (11) of the matching fracture reduction pins (1, 4) are 60 degrees, 45 degrees, and 30 degrees respectively.

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