WO2016101521A1

WO2016101521A1 - Transcutaneous lumbar intervertebral foramen enlargement and shaping instrument with nerve monitoring function

Info

Publication number: WO2016101521A1
Application number: PCT/CN2015/079473
Authority: WO
Inventors: 萧慕东
Original assignee: 萧慕东
Priority date: 2014-12-22
Filing date: 2015-05-21
Publication date: 2016-06-30
Also published as: CN105769308A; CN105769308B

Abstract

A transcutaneous lumbar intervertebral foramen enlargement and shaping instrument with a nerve monitoring function, at least comprising a plurality of soft tissue expansion tubes (1) incrementally increasing in size, a plurality of expansion sleeves (2) incrementally increasing in size and a plurality of protective sleeves (3) incrementally increasing in size; the soft tissue expansion tubes (1), the expansion sleeves (2) and the protective sleeves (3) all comprise a tube body and an insulated handle (6) disposed on an end of the tube body; the tube bodies all comprise an insulated outer wall and a metal inner wall; a conductive portion (4) having an electrical connection with the metal inner wall and to be electrically connected to a nerve detector is disposed on the insulated outer wall. The shaping instrument has high safety when performing transcutaneous lumbar intervertebral foramen enlargement and shaping, can be used with the nerve detector, further ensuring the operational safety of a surgical procedure.

Description

Belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument

Technical field

The invention relates to a surgical instrument, in particular to a device for augmenting a lumbar intervertebral foramen through a belt nerve.

Background technique

Lumbar disc herniation is a common and frequently-occurring disease. Its symptoms mainly include low back pain and lower extremity radiation pain. In severe cases, cauda equina syndrome can occur, which seriously affects the patient's work and social life.

In 1934, the posterior lumbar discectomy was performed by total laminectomy or partial laminectomy, and the removal of the herniated disc became the standard treatment for lumbar disc herniation. However, during the operation, the ventral nucleus of the nerve root is partially removed to allow the instrument to enter the intervertebral disc to remove the nucleus pulposus. After the operation, a fibrous annulus is left. At the same time, the inner third of the joint is often removed, and the stability of the lumbar spine is affected. A certain degree of damage, the segmental degeneration is intensified after surgery, and the annulus fibrosus, cartilage endplate, and residual nucleus pulposus tissue may be exfoliated, and the fibrous annulus left by the operation is released into the spinal canal to compress the nerve root, that is, " The incidence of recurrence of intervertebral disc recurrence is more than 10%. Due to the serious adhesion in the spinal canal, it is often difficult to perform revision surgery and there are many complications.

In the lumbar fusion surgery, the incision is larger, the paravertebral muscles are more widely dissected, and the posterior spinal lamina and lateral articular joints are more extensively removed. The nerve tissue in the spinal canal is stripped and pulled more, and bone graft fusion is needed. The fixation of the device has led to a significant increase in device complications and bone graft related complications. During lumbar fusion surgery, the paravertebral muscles are extensively removed, which makes them lose innervation. After lumbar fusion surgery, the lumbar motion segments are accelerated and degenerated, and the discs are protruded.

Minimally invasive surgery for lumbar disc herniation has the characteristics of small damage, rapid recovery, and little damage to the stability of spinal motion segments. Such as percutaneous lumbar disc laser vaporization decompression, radiofrequency ablation, IDET (intervertebral disc electrothermal fiber annulus formation), chemical nucleus pulposus surgery, percutaneous lumbar discectomy, etc. are intervertebral disc treatment, mainly to achieve intervertebral disc decompression It is impossible to directly treat the protrusions and the exudates, so the indications are limited and the effect is limited. Microendoscopic Discectomy (MED), although it can directly remove the disc herniation or prolapsed intervertebral disc tissue, but the operation is similar to open surgery. The operation in the spinal canal is the same as the open surgery. Pass The nerve root and the dural sac can be pulled to reveal the protrusion, so the risk of nerve root damage and adhesion is the same as open surgery.

Percutaneous transforaminal approach for endoscopic prominence or removal of lumbar disc tissue removal, percutaneous puncture of the lumbar vertebrae to the lumbar intervertebral foramen, and intervertebral foramen enlargement by means of a side-opening laser, micro-ball milling or ring saw The molding process allows the intervertebral foramen working sleeve to directly enter the spinal canal, and the intervertebral disc tissue exposed or protruded is directly exposed under the endoscope, and the pressure-sensitive substance is directly removed. Since the nerve root and the dural sac are not required during the operation, all the surgical operations are performed in the working cannula, so there is no disturbance to the nerve tissue in the spinal canal. The use of bipolar radiofrequency coagulation can effectively stop bleeding and prevent postoperative operation. Intraspinal adhesion, local anesthesia surgery can ensure the safety of the entire surgical procedure, so the technology has a good application prospects. However, the controllability of laser and micro-ball milling is poor, and the probability of nerve root injury is high. The foreign intervertebral foramen sawing system is operated outside the working sleeve of the intervertebral disc mirror, which lacks protection against surrounding soft tissue and nerve root, and has poor safety. In addition, the existing belt nerve monitoring lumbar intervertebral foramen enlargement forming device acts on the percutaneous lumbar intervertebral space, the operator needs to be extremely careful to operate, otherwise the nerve will be touched with carelessness, which not only brings pain to the patient, but also If the nerve is damaged, the surgery will also fall short. In the prior art, a nerve detector for detecting a nerve emits an alarm signal when it is induced to the nerve by an electric wave, and the detection result is more accurate, and if it can be applied to a percutaneous lumbar intervertebral foramen surgery, The above technical problems can be solved, but the existing percutaneous lumbar intervertebral foramen surgical instruments do not have the functions to be used together.

Therefore, it is necessary to provide a device for expanding the percutaneous lumbar intervertebral foramen that is safe and suitable for the human body and can be used together with the neurodetector.

Summary of the invention

SUMMARY OF THE INVENTION The problem to be solved by the present invention is to provide a high-security, percutaneous lumbar intervertebral foramen enlargement forming instrument that can be used with a neurosensor.

In order to solve the above problems, the present invention provides a belt nerve monitoring lumbar intervertebral foramen enlargement forming apparatus, which comprises at least a plurality of soft tissue expansion tubes which are gradually enlarged, a plurality of expansion sleeves which are gradually enlarged, and a plurality of protection sleeves which are gradually enlarged. The soft tissue expansion tube, the expansion sleeve and the protective sleeve each include a tube body and an insulating handle disposed at one end of the tube body, the tube body each includes an insulating outer wall and a metal inner wall, and the insulating outer wall is provided with a conductive portion electrically connected to the inner wall of the metal for electrically connecting to the nerve detector.

Preferably, the conductive portion includes a first conductive portion and a portion disposed adjacent to the insulating handle The tube body is not provided with a second conductive portion at one end of the insulating handle.

Preferably, the tube body is formed by a metal inner tube and an insulating layer disposed outside the metal inner tube; both ends of the metal inner tube are partially provided with the insulating layer for forming the first conductive And a second conductive portion.

Preferably, the lumen of the soft tissue expansion tube forms a first guidewire channel, and the wall of the soft tissue expansion catheter further has at least one axially penetrating second guidewire channel.

Preferably, the outer wall of the protective sleeve having an inner diameter of not less than 10 mm is axially symmetrically provided with two fixing holes for threading a fixing screw to fix the protective sleeve on the human spine. The protective sleeve is penetrated.

Preferably, the outer wall of the protective sleeve is axially symmetrically disposed with two protrusions extending axially along the protective sleeve, and the two protruding portions are respectively provided with the fixing along the axial direction of the protective sleeve. hole.

Preferably, one end of the soft tissue expansion tube not provided with the insulating handle is a tapered end, and a portion of the soft tissue expansion tube near the tapered end thereof and a surface of the tapered end have a surface friction coefficient greater than a portion away from the tapered end Surface friction coefficient.

Preferably, one end of the expansion sleeve and the protective sleeve not provided with the insulating handle is a duckbill shape.

Preferably, the soft tissue expansion tube, the expansion sleeve and the insulating outer wall of the protective sleeve are provided with graduations.

Preferably, further comprising a metal guide wire for positioning in the first guide wire hole and the second guide wire hole, a ring saw for piercing the protective sleeve for drilling, and A lateral posterior disc mirror working sleeve for insertion through a protective sleeve for reaming.

The beneficial effect of the belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the invention is that it has a metal sensing part and can be connected with the nerve detector to sensitively sense the nerve during operation to prevent accidental or accidental nerve injury, especially Prevent the drilling of the ring saw from injuring the nerve and improve the quality and safety of the operation.

DRAWINGS

1 is a schematic view showing the structure of a soft tissue expansion tube of a belt nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to the present invention.

2 is a partial cross-sectional view showing the soft tissue expansion tube of the belt nerve monitoring lumbar intervertebral foramen enlargement forming apparatus of the present invention.

Fig. 3 is a structural schematic view showing the expansion sleeve of the belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the present invention.

4 is a schematic view showing the structure of a protective sleeve of a belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument according to the present invention.

Fig. 5 is a structural schematic view showing the protective sleeve of the belt nerve monitoring lumbar intervertebral foramen enlargement forming apparatus having an inner diameter of not less than 10 mm.

Fig. 6 is a structural schematic view of a guide wire of a belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the present invention.

Fig. 7 is a structural schematic view of a loop saw of a belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the present invention.

8 is a schematic view showing the structure of a lateral posterior lumbar disc working sleeve of a belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the present invention.

Fig. 9 is a structural schematic view showing the combination of a guide wire, a soft tissue expansion tube, an expansion sleeve and a protective sleeve of the belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the present invention.

Reference mark:

1-soft tissue expansion tube; 2-expansion sleeve; 3-protective sleeve; 4-first conductive portion; 5-second conductive portion; 6-insulated handle; 7-guide wire; 8-side posterior disc mirror work Casing; 9-ring saw; 10 - first guide wire passage; 11 - fixing hole; 12 - second guide wire passage; 13 - projection.

detailed description

The belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the present invention will be described in detail below with reference to the accompanying drawings.

As shown in FIG. 1 to FIG. 9 , the present invention discloses a belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument, which is applied to an intervertebral foramen enlargement forming operation, and the belt nerve monitoring lumbar intervertebral foramen enlargement forming apparatus includes at least a stepwise step. The enlarged plurality of soft tissue expansion tubes 1, the plurality of expansion sleeves 2 which are expanded step by step, and the plurality of protection sleeves 3 which are expanded step by step, of course, may further include a metal threaded through the first guide wire hole and the second a guide wire 7 for positioning in a guide wire hole (described in detail below), a ring saw 9 penetrating in the protective sleeve for drilling, and a side piercing through the protective sleeve for reaming Lumbar disc mirror working sleeve 8. The soft tissue expansion tube 1, the expansion sleeve 2 and the insulating outer wall of the protective sleeve 3 are provided with scales for the operator to calculate and control the length of the body. The soft tissue expansion tube 1, the expansion sleeve 2 and the protective sleeve 3 each comprise a tube body and an insulating handle 6 disposed at one end of the tube body, the insulation The structure of the handle 6 is not unique, and may be an insulative handle 6 of a shape or other shape, or may be a sleeve type insulating handle 6 in the embodiment; further, the tube body includes an insulating outer wall and a metal inner wall, That is, the tube body is externally insulated and internally conductive, wherein the insulating outer wall of the tube body is provided with a conductive portion that can be electrically connected to the metal inner wall of the tube body, and the conductive portion is used for electrical connection with the nerve detector.

Specifically, referring to FIG. 1-4, the conductive portion includes a first conductive portion 4 disposed adjacent to the insulating handle 6 and a second conductive portion disposed at an end of the tube body not provided with the insulating handle 6 (hereinafter referred to as an operating end) 5. The first conductive portion 4 is for electrically connecting with the nerve detecting device, and the second conductive portion 5 enters the human body with the operating end during the operation, and when the metal device inside the tube body itself or the metal device touches the nerve, the second The conductive portion 5 or the metal inner wall of the tube body receives the induced current (because the instrument inside the tube body will inevitably touch the metal inner wall of the tube body, the inner wall of the tube body will inevitably receive the induced current), and the induced current passes. The inner wall of the metal is transmitted to the first conductive portion 4 and transmitted to the nerve detecting device through the first conductive portion 4. The nerve detecting device immediately sends an alarm after receiving the induced current to prompt the operator to monitor the lumbar intervertebral foramen enlargement forming instrument through the belt nerve. To the nerve, the operation must be stopped. The above-mentioned conduction process is extremely fast, so the first time can be reminded to inform the operator that the nerve is touched during operation, and it is forbidden to continue the operation to avoid damage to the nerve due to continued error operation.

Further, the tube body in this embodiment is formed by a metal inner tube (ie, forming a metal inner wall) and an insulating layer disposed outside the metal inner tube; and both ends of the metal inner tube are partially provided with an insulating layer for forming a conductive portion. That is, the first conductive portion 4 and the second conductive portion 5, of course, other structures may be used to form or provide a conductive portion, such as a metal sleeve disposed at a metal inner tube not provided with an insulating layer to form a conductive portion or the like.

Continuing with Figure 2, the lumen of the soft tissue expansion tube 1 forms a first guidewire channel 10, and the wall of the soft tissue expansion catheter 1 also has at least one axially penetrating second guidewire channel 12. The plurality of second guidewire channels 12 are provided because during the operation, the guide wire 7 is usually inserted into the human body for the focal point positioning (that is, the positioning of the expanded position), and then the soft tissue expansion tube 1 is placed along the guide wire 7, but The positioning of the lesion point is not precisely positioned by the machine operation, but is manually operated, so there will inevitably be some deviation. If only the first guide wire channel 10 is provided in the soft tissue expansion tube 1, if the position of the lesion point is to be adjusted, only The guide wire 7 can be repositioned, but this method will bring pain to the patient, and since there is no comparison point after the guide wire 7 is taken out, it is inevitable to fix the position again. In the present embodiment, by providing a plurality of second guide wire passages 12 on the soft tissue expansion tube 1, the guide wire 7 can be introduced into the appropriate second guide wire passage 12 according to the error range to achieve an accurate expansion effect, and since it is not extracted. The guide wire 7 allows the secondary positioning to have a reference point, and the positioning is more accurate.

In addition, as shown in FIG. 1 and FIG. 2, one end of the soft tissue expansion tube 1 not provided with the insulating handle 6 is a tapered end, and the portion near the tapered end and the surface of the tapered end have a surface friction coefficient larger than that of the portion away from the tapered end. The coefficient of friction is such that when the soft tissue expansion tube 1 is inserted into the body tissue, the friction is reduced. The surface roughness of the soft tissue expansion tube 1 away from the tapered end portion is slightly larger to prevent the soft tissue expansion tube 1 from slipping down, causing excessive penetration into the human body and affecting the operation.

As shown in FIG. 3 and FIG. 4, one end of the expansion sleeve 2 and the protective sleeve 3 not provided with the insulating handle 6 is a duckbill shape to block the tissue outside the lesion point in the expansion sleeve 2 or protection during the operation. The outside of the sleeve 3 is used to increase the operational field of view of the inside of the tube. Preferably, when the inner diameter of the protective sleeve 3 is too large, such as the protective sleeve 3 having an inner diameter of not less than 10 mm, in order to better fix it on the spine of the human body for optimal protection, it may be on the outer wall thereof. Two fixing holes 11 for inserting a fixing screw to fix the protective sleeve 3 to the human body are arranged axially symmetrically, and the fixing holes 11 axially penetrate the protective sleeve 3. In the embodiment, the two protruding portions 13 extending along the axial direction of the protective sleeve 3 are axially symmetrically disposed on the outer wall of the protective sleeve 3, and the two protruding portions 13 are respectively disposed with the fixing holes 11 in the axial direction. See Figure 5 for details.

The specific operation method of the present invention will be described below:

1. Insert the guide wire 7 into the lesion;

2, along the guide wire 7 into the soft tissue expansion tube 1;

3, the guide wire 7 is withdrawn, and the expansion cannula 2 is introduced along the soft tissue expansion tube 1;

4, take out the soft tissue expansion tube 1, along the expansion sleeve 2 into the protective sleeve 3;

5. After the expansion is completed, the protective sleeve 3 is retained, and the expansion sleeve 2 is taken out;

6. Leading the ring saw 9 along the protective sleeve 3 for drilling operation;

7. After the drilling is completed, the ring saw 9 is taken out, the protective sleeve 3 is retained, and the side posterior intervertebral disc mirror working sleeve 8 is introduced along the protective sleeve 3 for subsequent surgical operations.

The surgeon uses the belt nerve monitoring lumbar intervertebral foramen enlargement forming instrument of the present invention to perform the percutaneous transforaminal hole enlargement forming operation, and the safety is higher, and the accident of accidentally injuring the nerve can be effectively avoided, thereby greatly reducing the psychological pressure for the doctor to operate. More stable. At the same time, it can accurately locate according to the actual lesion point, so that the reaming position is accurate and not offset.

The above embodiments are merely exemplary embodiments of the present invention, and are not intended to limit the invention, and the scope of the invention is defined by the claims. A person skilled in the art can make various modifications or equivalents to the invention within the spirit and scope of the invention, and such modifications or equivalents are also considered to fall within the scope of the invention.

Claims

The belt nerve monitoring lumbar intervertebral foramen enlargement forming apparatus comprises at least a plurality of soft tissue expansion tubes which are gradually enlarged, a plurality of expansion sleeves which are expanded step by step, and a plurality of protection sleeves which are expanded step by step, characterized in that the soft tissue The expansion tube, the expansion sleeve and the protective sleeve each comprise a tube body and an insulating handle disposed at one end of the tube body, the tube body each includes an insulating outer wall and a metal inner wall, and the insulating outer wall is provided with the metal The conductive portion of the inner wall that is electrically connected to the nerve detector.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 1, wherein the conductive portion comprises a first conductive portion disposed adjacent to the insulating handle and the insulating body disposed on the tube body is not provided with insulation a second conductive portion at one end of the handle.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 2, wherein the tube body is formed of a metal inner tube and an insulating layer disposed outside the metal inner tube; The insulating layer is not provided at both ends to form the first conductive portion and the second conductive portion.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 1, wherein the lumen of the soft tissue expansion tube forms a first guide wire passage, and the soft tissue expansion tube further has at least one tube wall a second guide wire passage that is axially penetrated.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 1, wherein an outer wall of the protective sleeve having an inner diameter of not less than 10 mm is axially symmetrically provided with two fixing screws for inserting The protective sleeve is fixed to a fixing hole on a human spine, and the fixing hole axially penetrates the protective sleeve.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming instrument according to claim 5, wherein the outer wall of the protective sleeve is axially symmetrically disposed with two projections extending axially along the protective sleeve, The protrusions are respectively provided with the fixing holes along the axial direction of the protection sleeve.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 1, wherein one end of the soft tissue expansion tube not provided with the insulating handle is a tapered end, and the soft tissue expansion tube is adjacent to the taper thereof. The surface friction coefficient of the end portion and the tapered end is greater than the surface friction coefficient of the portion away from the tapered end.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 1, wherein one end of the expansion sleeve and the protective sleeve not provided with the insulating handle is a duckbill shape.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 1, wherein the soft tissue expansion tube, the expansion sleeve, and the insulating outer wall of the protective sleeve are provided with scales.
The transversal nerve monitoring lumbar intervertebral foramen enlargement forming apparatus according to claim 1, further comprising a metal guide wire for positioning in the first guide wire hole and the second guide wire hole. a ring saw for piercing the protective sleeve for drilling and a side posterior disc mirror working sleeve for threading through the protective sleeve for reaming.