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HK1238110A1 - Percutaneous system and methods for enhanced epidural access for spine surgery - Google Patents

Percutaneous system and methods for enhanced epidural access for spine surgery Download PDF

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Publication number
HK1238110A1
HK1238110A1 HK17112110.1A HK17112110A HK1238110A1 HK 1238110 A1 HK1238110 A1 HK 1238110A1 HK 17112110 A HK17112110 A HK 17112110A HK 1238110 A1 HK1238110 A1 HK 1238110A1
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Hong Kong
Prior art keywords
tool
needle
epidural
wire
distal end
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HK17112110.1A
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Chinese (zh)
Inventor
A.A.塔哈
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特鲁米妮姆有限责任公司
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Publication of HK1238110A1 publication Critical patent/HK1238110A1/en

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Description

Percutaneous system and method for enhanced epidural access for spinal surgery
Cross Reference to Related Applications
This application claims benefit and priority to U.S. provisional patent application serial No. 62/021,637, filed 7/2014, the contents of which are incorporated herein by reference.
Technical field & background
Spinal canal stenosis and foraminal stenosis are very common spinal disorders affecting a relatively large number of people of all age groups. Spinal stenosis is a spinal disorder that results from the progressive narrowing of the spinal canal and/or neural foramen (neural) space, thus limiting and restricting the space or location for neural elements. Spinal stenosis can be attributed to hypertrophy of the posterior and/or anterior elements within the spinal canal. Spinal stenosis can also occur due to overgrowth of bone tissue, ligamentum flavum, soft tissue, or tumors inside the spinal canal. Most elderly patients suffer from disease, and the incidence of spinal stenosis increases as life expectancy increases. In the young population, congenital abnormalities can be seen, such as associated spinal stenosis secondary to short pedicles, trauma, or other factors. As the symptoms and disease progress, the neurons are further compressed, often resulting in pain, weakness, numbness, burning, stinging, and/or in severe cases can lead to bladder and bowel instability, bladder or bowel failure, and/or paralysis of the upper and/or lower body, depending on which levels of the spine are affected. Additionally, foraminal stenosis is a narrowing of the spinal foramen that pathologically compresses the spinal nerve as it leaves the spine. Additionally, foraminal stenosis may be associated with central spinal stenosis, or may be a separate lesion.
The intervertebral foramen provides a protective exit tunnel for the spinal nerves to exit the spinal canal. The intervertebral foramen is formed posteriorly by the superior articular process of the inferior vertebra and the inferior articular process of the superior vertebra, anteriorly by the vertebral body and the intervening intervertebral disc, and superiorly and inferiorly by the respective pedicles. Foraminal stenosis refers to a narrowing of the intervertebral foramen. It is usually caused by degenerative processes of the joints expanding posteriorly, by posterolateral herniation and posterolateral vertebral deformation (osteophytes) anteriorly, and by pedicles moving downward during disc disease due to disc dehydration and collapse.
As a result of spinal canal and/or foraminal stenosis, nerves and/or the spinal cord are compressed, resulting in pain, stinging, numbness and weakness in the muscles of the affected area. Current medical practice with respect to central and intervertebral foraminal stenosis has provided physicians and patients with limited viable minimally invasive options. In mild cases, spinal canal stenosis and foraminal stenosis can be treated by rest, rehabilitation, reinforcement, oral analgesics, anti-inflammatory agents, and/or other conservative measures. Moderate cases can be treated temporarily with corticosteroids, usually in the form of epidural steroid injections for spinal stenosis or transforaminal epidural steroid injections for spinal stenosis combined with conservative measures that usually have limited or mixed outcomes. Open surgery is left for progressive cases of foraminal stenosis and spinal canal stenosis with variable results. The results depend on the cause of the patient's low back pain, and most patients may expect considerable relief of pain and some functional improvement. However, there is some divergence between surgeons regarding the success rate of open spinal surgery, which appears to be due to several factors, most notably refractory back syndrome (from scar tissue after open surgery). Minimally invasive surgical procedures and devices have been developed over the years to treat spinal stenosis, but with limited success. Often these devices treat these symptoms only by limiting movement, and according to some reports, less than 50% of patients report some pain relief.
As surgical techniques, procedures and devices have advanced and improved the trend toward less invasive and minimally invasive procedures, and devices have been desired by physicians and patients. As seen in many surgical specialties and sub-specialties, including less invasive arthroscopic, laparoscopic, and minimally invasive spinal surgeries, there are many benefits associated with minimally invasive surgery. Several of the newer spine-related surgeries are claimed to be minimally invasive, but are actually open or partially open techniques, and require general anesthesia with the same or similar intraoperative risks as general open surgery. The lack of truly viable minimally invasive methods for spinal stenosis and foraminal stenosis has been a major problem affecting physicians and patients.
Disclosure of Invention
One aspect of the present disclosure generally relates to methods for treating one or more spinal disorders, particularly for spinal stenosis, spinal compression, foramen compression, and foraminal stenosis, using various T techniques with various specialized percutaneous methods. T-technique is a minimally invasive technique for treating spinal stenosis and foraminal stenosis. The present invention achieves decompression of the spinal canal and neural foramen by percutaneous techniques and methods, in which the cutting instrument or tissue modification tool is in the form of a wire tool that is made to pass through an epidural needle tool (introducer needle) and made to exit through another epidural needle tool (exit needle) with a grasper-like tool, such that the tissue modification wire tool remains behind (below) the top of the target lamina or intervertebral foramen, while the two ends (proximal and distal portions) of the tissue modification wire tool remain outside the patient's skin. In carrying out the T-technique goal, these methods will be accompanied by several additional benefits, including the use of minimally invasive surgery and experience, minimal or no scarring post-surgery, minimal or no bleeding during or post-surgery, minimal or no refractory back surgery syndrome, minimal or no scar tissue, no additional potential complications from general anesthesia through the use of surgery performed under local anesthesia, less pain post-surgery, less time in the operating room, and less time spent in the recovery phase. The patient will be awake during the procedure and will be able to feel immediately relieved of the pain. Since only minimally invasive modifications are used, manipulation and/or control of the diseased anatomy is essential, allowing for faster and more natural recovery.
One aspect of the present disclosure results in less time spent in hospitals than more invasive procedures, particularly for elderly people or relatively more complex cases, and may be performed in the outpatient clinic of younger patients or on a case-by-case basis. Unfortunately, as a person ages, the risk of complications increases during the course of prolonged surgery under general anesthesia. Complications associated with general anesthesia are well known and documented. The present invention differs from its previous other procedures, techniques or devices related to spinal stenosis and foraminal stenosis, in that it is the only procedure that provides a truly minimally invasive percutaneous laminoplasty or foraminal angioplasty, which manipulates and corrects the diseased anatomy, while the patient is awake and not under general anesthesia. Thus avoiding complications inherent to general anesthesia. Furthermore, when the patient is awake during surgery, the likelihood of acquiring nerve damage is reduced and almost negligible, as the patient will also experience paresthesia even with a light contact wire tool of the spinal cord or nerve roots. Paresthesia is accepted as an initial safety gauge in many minimally invasive percutaneous spinal procedures performed today, such as lumbar epidural injections, transforaminal epidural steroid injections, and other similar procedures. Paresthesia allows the physician to know that he is in a sensitive area and to modify his or her approach. This is only possible if the patient is awake as in the present invention. Open and/or partially open techniques do not have this level of safety because the patient is under general anesthesia. Additional safety measures can be provided, including patient feedback devices such as neurostimulators, Electromyography (EMG), evoked muscle action potentials, epiduroscopy (epiduroscopy), and other generally accepted methods for determining early damage to nerves or dura mater.
The disclosure, in its most basic description, isThe delivery wire tool is a simple idea of the T-technique and method with two needle tools as described herein. T-technique is a minimally invasive method for treating spinal stenosis and foraminal stenosis. Within the scope of medical practice, there are limited options for patients and physicians in terms of minimally invasive surgery for treating spinal and foraminal stenosis. Traditional approaches to laminoplasty, laminectomy, foraminoplasty, and other suitable treatments are open surgery and carry the inherent risk of general anesthesia, prolonged surgical time, and other documented intensive complications. X-STOPTm titanium implants manufactured by Medtronic inc. are implantable devices that treat symptoms primarily only by limiting the extension of the narrow segment of the lumbar segment of the spine.The technique or iOFLEXTM system is described as a system that utilizes a thin, flexible instrument to provide accurate lumbar decompression from the "inside out" of the membrane. Baxano technology is in practice an open or partially open technology that requires general anesthesia, so when examinedThe safety profile of the technique must include complications related to general anesthesia. In contrast, the present invention, known as the T-technique, is a truly percutaneous minimally invasive method for treating spinal and intervertebral foraminal stenosis, performed under local anesthesia to correct and treat the pathology and symptoms.
The present disclosure, described herein as T-technology, is entirely percutaneous and does not utilize open technology. This is different from other techniques, such as the Baxano Corporation technique, where the exit of the surgical tool-like wire is unclear and/or dangerously pushed continuously through the tissue, and is virtually impossible and/or where withdrawal is not possible without open techniques.
The present disclosure takes advantage of the idea of percutaneously being able to connect one epidural space to another epidural space by delivering any bonding tool, including a guidewire tool, a cutting tool, a hollow tube with a lumen capable of allowing an additional guidewire tool to pass therethrough, or by using any other suitable tissue modification device or wire including any tool or tools of a pair of epidural needles. Furthermore, T-technique may be used in this method as described herein to connect one or more epidural interlaminar spaces with one or more other epidural interlaminar spaces at the same level and/or at different levels of the spine.
The present disclosure utilizes the idea of percutaneously being able to connect one epidural space to the intervertebral foramen space by delivering any bonding tool, including a guidewire tool, a cutting tool, a hollow tube with a lumen capable of allowing an additional guidewire tool to pass through it, or by using any other suitable tissue modification device or wire including any tool or tools of a pair of epidural needles. Furthermore, T-technique may be used in this method as described herein to connect one or more epidural interlaminar spaces with one or more other foramen spaces at the same level and/or at different levels of the spine.
The present disclosure also utilizes the idea of percutaneously being able to connect from one foraminal space to another foraminal space by passing any bonding tool, including a guidewire tool, a cutting tool, a hollow tube having a lumen capable of allowing an additional guidewire tool to pass therethrough, or by any other suitable tissue modification device or wire using any tool or tools including a pair of epidural needles. Furthermore, T-techniques may be used in the methods as described herein to connect one or more intervertebral foraminal spaces with one or more other intervertebral foraminal spaces at the same level and/or at different levels of the spine.
The present disclosure can be performed for any combination of percutaneous laminoplasty and percutaneous foraminoplasty. The idea of a third needle tool, a fourth needle tool, a fifth needle tool and an additional consecutive needle tool can be added such that instead of using only (two) 2 epidural needle tools, where the first needle tool would be the introducer needle tool and the second needle tool the exit needle tool, some other combination of similar needle tools can perform the same functions as used with the aforementioned methods described herein. With respect to the term needle, it is defined as any one or more tools for puncturing or accessing the epidural space or the neural foramen space by a percutaneous technique as opposed to an open technique, and as described for the purposes and intentions described herein as the T-technique. T-technique can include the delivery of any bonding tool, including a guidewire tool, a cutting tool, a hollow tube having a lumen capable of allowing an additional guidewire tool to pass through its lumen, or any other suitable tissue modification device capable of delivering a similar tool to connect the epidural space between the interlaminar epidural space and the other epidural space and/or to connect the epidural space between the interlaminar epidural space and the other intervertebral foramen space using any suitable tool or tools including a pair of epidural needles. These needle tools will include introducer needle tools and exit needle tools, and can allow other medical tools, such as forceps, graspers, wires, and other medical tools, to pass through the needle tools, and can function and perform as medical instruments, tools, or devices within the patient's body in the epidural space or the neural foramen space. A medical tool, such as a grasper tool, for example, can be functionally used to capture a guidewire tool that passes through the introducer needle tool. In addition, other functions of the medical tool passing through an introducer or outlet epidural needle tool within the patient's body may include the ability to deliver drugs, irrigation fluids, and aspiration fluids, as well as the ability to control and place other medical surgical tools and devices, including surgical cutting lines and abrasive tissue modification tools in the desired target area.
The present disclosure is a percutaneously performed method that will increase the anterior-posterior (AP) diameter of a spinal canal for spinal canal stenosis, yet create an increased intervertebral foramen space to relieve pressure on exiting spinal nerves that are compressed in spinal canal stenosis. This resulting creation of space and pressure release of neural elements will be the result of the abrasive and cutting properties of the percutaneous T-techniques and methods described herein. The grinding and cutting action of the T-technique applied to the targeted segment of the vertebra, including the lamina, spinous process, superior articular process, inferior articular process, pedicle, and other desired target tissues, will heal with or without percutaneous fusion through a natural healing process. A major benefit for patients undergoing percutaneous T-techniques for spinal or foraminal stenosis is reduced healing time, as adjacent structures will remain intact compared to open and partially open techniques that require extensive tissue modification and dissection, and thus extended healing time.
The present disclosure utilizes a variety of T-technique approaches that are percutaneous minimally invasive techniques that provide anatomical changes in the context of laminoplasty and foraminoplasty. T-technique does not require the open or partially open technique required by traditional laminoplasty or foraminoplasty. The T-technique for percutaneous laminoplasty would potentially replace most open surgical methods in current practice by simple percutaneous surgery to cut the lamina and other desired bone. In addition, the T-technique for percutaneous foraminoplasty would also potentially replace most open surgical approaches in current practice by allowing for simple percutaneous surgery through partial cuts of one or more superior and/or inferior articular processes and/or pedicles. This reduction in pressure and creation of space will cause the patient to feel a reduction in pain immediately after T-technique. The invention also includes T-technique percutaneous laminoplasty with percutaneous foraminoplasty, which is a combination of the two aforementioned techniques herein. T-technique does not require any general anesthesia and can be performed completely under local and/or regional anesthesia, avoiding the risk of general anesthesia (especially in the elderly population). T-technique can be used to treat radiculopathy and can be used to achieve decompression due to spinal cord (neurological disease) compression, where the compression is constructed from one or more posterior growth nodes. T-technique can be the procedure of choice for one or more syndromes in which young patients develop spinal stenosis due to short pedicles and other congenital abnormalities. Due to its simplicity and ease, T-technique can give physicians the ability to treat both developing and earlier stages of cases in spinal canal and foraminal stenosis to avoid complications of chronic disease. The T-technique will be used for central spinal stenosis and lateral spinal stenosis (foraminal stenosis). T-technique may be a procedure selected for all ages, particularly patients classified as high risk for intra-operative procedures. The technical aspects of performing the T-technique will be no more difficult than the procedures performed today in common pain management practice. The percutaneous T-technique will provide the patient with the required modifications of the diseased anatomy including the ligamentum flavum, pedicle, lamina and articular process. This will occur by applying the cutting and abrading properties of the invention, and subsequent stretching, pulling and movement of the cancellous bone, followed by stabilization via fusion and natural bone healing, resulting in increased space for the neurons and reduced pain.
The present disclosure will increase the AP diameter of the spinal canal by percutaneous (percutaneous) procedures that do not require a vertical or horizontal incision (as is done with traditional open procedures such as laminectomy, laminoplasty, foraminoplasty, and foraminotomy). Such incisions used in traditional open surgery must occur through many layers of tissue including skin, fat and muscle (which must be dissected and retracted). The trauma inflicted to the muscles and surrounding tissues requires a significant amount of time to heal after surgery. Since this is a percutaneous technique, there is no long incision during the T-technique. The physician does not have to cut through muscle or surrounding tissue to complete the procedure, resulting in less tissue damage and faster recovery. The present invention is a percutaneous technique described for laminoplasty and foraminoplasty patients that will experience minimal or no scarring of the skin and little or negligible scar tissue and surgical adhesions that are common causes of refractory back syndrome associated with open techniques.
T-technique can be performed in a more efficient and safer manner when compared to open surgery, resulting in less time for the patient to remain in the operating room. The patient does not have to be under general anesthesia because the T-technique is performed under local anesthesia, thus avoiding the risks and complications that accompany general anesthesia. There will be less blood loss under T-technique than with traditional open technique. Using T-technique, the patient will suffer less pain than traditional open surgery. T-technology can reduce overall hospital stay and T-technology patients can start activities earlier than patients using traditional open-technology approaches. The present invention is a minimally invasive procedure with minimal or no bleeding during or after surgery, minimal or no refractory back surgery morbidity (scar tissue), and is performed under local anesthesia without increased complications from general anesthesia. The present invention relates to less pain after surgery, less time in the operating room, less time spent in the recovery phase, and the patient will be awake during surgery and able to feel relatively immediate relief. Since only minimally invasive modifications are used, control of the diseased anatomy is essential, allowing for a relatively faster and more natural healing process. The invention also allows less time to be spent in the hospital and can be performed in the outpatient setting of relatively young patients or on a case-by-case basis.
Drawings
The techniques disclosed herein, in accordance with one or more various embodiments, are described in detail with reference to the following drawings. The drawings are provided for purposes of illustration only and merely depict typical or example embodiments of the disclosed technology. These drawings are provided to facilitate the reader's understanding of the disclosed technology and should not be considered limiting of its breadth, scope, or applicability. It should be noted that for clarity and ease of illustration, the drawings are not necessarily drawn to scale:
fig. 1 is a front perspective view of a cutting wire used during cutting of a lamina on the left or right side of a spinous process according to one embodiment of the invention.
Fig. 2 is a front perspective view of a wire used during cutting of the left lamina on the left side of the spinous process according to one embodiment of the invention.
Figure 3 is an elevational view of 4 needles in two epidural spaces holding a target lamina in a central region according to one embodiment of the invention.
Figure 4 is a front view of 4 needles with a pair of cutting wires and a pair of graspers, according to one embodiment of the present invention.
Fig. 5 is a front view of an exit needle and introducer needle in the epidural space on the left side of the spinous process targeting the L5 lamina, according to one embodiment of the invention.
Fig. 6 is a front perspective view of a pair of wires cutting the lamina on the left and right sides of the spinous process during percutaneous laminoplasty with T-technique according to one embodiment of the present invention.
Figure 7 is an anterior view of two cutting lines placed inferior to the right and left target laminae through the epidural space according to one embodiment of the invention.
Fig. 8 is a front view model of a patient's spine including a pair of interchangeable outlet needles and a pair of introducer needles, in accordance with an embodiment of the present invention.
Fig. 9 illustrates a front view of a percutaneous foraminal arthroplasty using an introducer epidural needle tool and an exit needle tool in the neural foramen space via a T-technique, according to one embodiment of the invention.
Figure 10 is a front view of the final position of the cut line after removal of a plurality of needles in a right percutaneous foraminal procedure, according to one embodiment of the invention.
Figures 11A, 11B, 11C, and 11D illustrate a flow diagram of a method for performing a percutaneous laminoplasty, according to one embodiment of the present invention.
Fig. 12A and 12B illustrate a flow diagram of a method 1500 for performing percutaneous foraminoplasty, according to one embodiment of the invention.
Fig. 13 shows a system representation of an epidural scope visualization system with a light source that is not attached to the epidural scope or visualization system, but is looking for the light source in the epidural space of the spine.
Fig. 14 shows a completed loop circuit in the spine, where contact of two medical tools in the spine forms a circuit that generates an alarm that a loop has been formed.
The drawings are not intended to be exhaustive or to limit the invention to the precise forms disclosed. The figures are not drawn to scale. It should be understood that the disclosed technology can be practiced with modification and alteration, and that the disclosed technology be limited only by the claims and the equivalents thereof.
Detailed Description
Various aspects of the illustrative embodiments will be described using terms commonly employed by those skilled in the art to convey the substance of their work to others skilled in the art. It will be apparent, however, to one skilled in the art that the present invention may be practiced with only some of the described aspects. For purposes of explanation, specific numbers, materials, and configurations are set forth in order to provide a thorough understanding of the illustrative embodiments. It will be apparent, however, to one skilled in the art that the present invention may be practiced without specific details. In other instances, well-known features are omitted or simplified in order not to obscure the illustrative embodiments.
Various operations will be described as multiple discrete operations, in a manner that is most helpful in understanding the present invention. However, the order of description should not be construed as to imply that these operations are necessarily order dependent. In particular, these operations need not be performed in the order of presentation.
The phrases in one embodiment are used repeatedly. The phrase generally does not refer to the same embodiment, however, it may. The terms including, having, and comprising are synonymous unless the context dictates otherwise.
Figure 1 is a front perspective view of a pair of cut lines for performing percutaneous laminoplasty with the T-technique. The left cut line 110 is on the left side of the body and is located to the left of the spinous process 120 below the left L5 lamina 113. Right cut line 100 is on the right side of the body and is located to the right of spinous process 120 below right L5 lamina 103. Right cut line 100 is on the right side of the body and is located to the right of spinous process 120 and has a proximal end 101 and a distal end 102, shown in fig. 1, outside the body. The left cutting line 110 on the left side has a proximal end 111 and a distal end 112, shown in fig. 1, outside the body.
Fig. 2 is a front perspective view of a left cut line 110 having a proximal end 111 and a distal end 112 utilized during percutaneous laminoplasty with a T-technique procedure according to one embodiment of the present invention. The left cut line 110 is positioned to span the left side of the L5 lamina 113 on the left side of the spinous process 120. The proximal end 111 and the distal end 112 of the left cut line 110 remain outside the body.
Figure 3 is an elevational view of 4 needles in two epidural spaces holding a target lamina in a central region according to one embodiment of the invention. Fig. 3 includes a left lamina 305, a right lamina 310, and a spinous process 315 separating the right lamina 310 and the left lamina 305 of the target vertebra 302. Fig. 3 also includes left lamina 205, spinous process 215, and right lamina 210 of one level vertebra above target vertebra 302. Fig. 3 also shows the left lamina 105, spinous process 215 'and right lamina 210' of one level of vertebra below the target vertebra 302. Fig. 3 also shows a left introducer epidural needle 320, a right introducer epidural needle 321, a left outlet epidural needle 322, and a right outlet epidural needle 323. Left introducer needle 320 has a proximal end 324 and a distal end 326. Right introducer needle 321 has a proximal end 325 and a distal end 327. The left outlet needle 322 has a proximal end 330 and a distal end 328. The right outlet needle 323 has a proximal end 331 and a distal end 329. The proximal ends of introducer needles 324, 325 and outlet needles 330, 331 remain outside the patient's body. The distal ends of the introducer needles 326, 327 enter the epidural space 399 above the target vertebra 302. The distal ends of the outlet needles 328, 329 enter the epidural space 398 below the target vertebra 302. The left introducer needle 320 and its distal end 326 are placed and introduced into the epidural space 399 above the target vertebra 302 to the left of the spinous process 315. The right introducer needle 321 and its distal end 327 are introduced into the epidural space 399 on the right side of the spinous process 315. The left outlet epidural needle 322 and its distal end 328 enter the epidural space 398 below the target vertebra 302 to the left of the spinous process 315. The right outlet needle 323 and its distal end 329 enter the epidural space 398 below the target vertebra 302 to the left of the spinous process 315. Fig. 3 shows the left distal end 326 of introducer needle 320 and the left distal end 328 of exit needle 322 facing each other. Fig. 3 also shows that right distal end 327 of introducer needle 321 and right distal end 329 of outlet needle 323 face each other.
Figure 4 is a front view of 4 needles with a pair of cutting wires and a pair of graspers, according to one embodiment of the present invention. Fig. 4 includes a pair of introducer needles 410, a pair of outlet needles 420, a pair of cut lines 430, a pair of grasper tools 440, a left lamina 452 of the target vertebra 460 and a right lamina 454 of the target vertebra 460, a spinous process 455 'of one level vertebra above and a spinous process 455' of one level vertebra below the target vertebra, a pair of distal ends 442 of the pair of grasping tools 440, a pair of lateral distal ends 432 of the pair of cut lines 430 passing through the epidural space, and a pair of distal ends 434 of the pair of cut lines 430 passing through the target vertebra 460.
The T-technique percutaneous laminoplasty is performed as illustrated by figure 4. A pair of outlet epidural needles 420 and a pair of introducer epidural needles 410 are shown in fig. 4. The distal end of the left introducer epidural needle 410 will enter the epidural space 456 above the target vertebra 460 to the left of the spinous process 455. The distal end of the right introducer epidural needle 410 will enter the epidural space 456 above the target vertebra 460 to the right of the spinous process 455. The distal end of the left exit needle 420 will enter the epidural space 466 below the target vertebra 460 to the left of the spinous process 455. The distal end of the right exit needle 420 will enter the epidural space 466 below the target vertebra 460 to the right of the spinous process 455.
The pair of cut lines 430 pass through and out of the pair of introducer epidural needles 410 and into the epidural space 456 on each respective side of the spinous process 455. The left cutting wire 430 can be any suitable tissue modification wire and is pushed manually or by mechanical or electronic means through the distal end of the left introducer epidural needle 410 to penetrate the epidural space 456 and advance behind (below) the left target lamina 452 on the left side of the spinous process 455. Similarly, the right cutting wire 430 can be any suitable tissue modification wire and is pushed manually or by mechanical or electronic means through the distal end of the right introducer needle 410 to penetrate the epidural space 456 and advance behind (below) the right target lamina 454 on the right side of the spinous process 455. The cutting wire 430 (which is a continuous wire) at the location described and shown in fig. 4 having a proximal end 430 (entering the outside of the body of the introducer epidural needle 410), a middle portion 432 (describing the portion of the cutting wire 430 that immediately exits the introducer epidural needle 410 inside the epidural space 456 and continues to reach an epidural space 466 below the level) and at this location in the T-technique is labeled as the distal end of the guidewire 434. (in the subsequent stages of the T-technique, the distal end of the guidewire 434 will be located outside the body.)
Grasper tool 440 (proximal end outside the body) is introduced through a pair of exit needles 420. The distal end of the grasper 442 is shown in fig. 4 and is seen immediately exiting the exit needle and being placed in the epidural space 466. The distal end of the grasper tool 442 will capture the distal end of the wire 434 in the epidural space 466. The distal part of the grasper 442, now controlling the distal part of the cutting wire 434, will advance to exit the epidural space and retreat in the opposite direction from where it came to exit the body through the exit needle 420 and pull the distal wire 434 it has caught through the exit needle 420. After being pulled through the exit needle 420 by means of the grasper tool 440, the distal end of the cutting wire 435 is seen once it has left the body.
Fig. 5 is a front perspective view of the exit needle 500 and introducer needle 510 in the epidural space 520 below the target vertebra 599 according to one embodiment of the invention. Outlet needle 500 has a distal tip 502 and a proximal head 504, and introducer needle 510 also has a distal tip 512 and a proximal head 514. The distal tips 502, 512 point and face each other, allowing a grasping tool (not shown) to pass through the exit needle 500 that will capture a guidewire (not shown) in the epidural space 520. The guidewire will pass through introducer needle 510. The grasping tool will pull the guidewire out through the exit needle 500.
FIG. 6 is a front perspective view showing a pair of guide wires for percutaneous laminoplasty with T-technique according to one embodiment of the present invention. The pair of guide wires includes a left guide wire 600 and a right guide wire 610. The left guide wire 600 is a bone cut line placed under (posterior to) the left lamina 623 to the left of the spinous process 620. The right guide wire 610 is a bone cut line placed under (behind) the right lamina 624 on the right side of the spinous process 620. The left guide wire 600 and the right guide wire 610 are inserted through the body of the patient, which has proximal and distal ends that extend outside the patient's body. The left guide wire 600 and the right guide wire 610 can be utilized on any vertebra along the spine of a patient. When the distal and proximal ends of the left and right guide wires 600, 610 are pushed and pulled by tension, force and/or vibration, the cutting motion or abrading action begins as the target tissue (right lamina 624 and left lamina 623) are abrasively cut from the anterior to posterior direction (from the inside to the outside) on both sides of the spinous process 620 by a percutaneous approach.
Figure 7 is a front perspective view of a right cut line and a left cut line in a final position behind a target lamina for performing percutaneous laminoplasty with the T-technique, according to one embodiment of the present invention. Fig. 7 includes a right cutting or tissue modification wire 810 having a proximal end 812 located outside of the patient's body, and a distal end 814 located outside of the patient's body. Fig. 7 shows the desired positioning of the guidewires 810, 810' according to the steps and methods described herein as the T-technique. The left guide wire 810' is in a desired position posterior (inferior) to the left lamina 820 relative to the spinous process 825, and the right guide wire 810 is in a desired position (inferior) to the right lamina 815 relative to the spinous process 825. Fig. 7 also includes a left cutting or tissue modification wire 810' having a proximal end 812' that is located outside the patient's body and a distal end 814' that is also located outside the patient's body. Three vertebral bodies are shown in fig. 7, including a target vertebra 832. First vertebra 830, which does not involve cutting, is above target vertebra 832, and second vertebra 834, which does not involve cutting, is below target vertebra 832. Connecting epidural space 840 extends above and below target vertebra 832. The dashed line of left cut line 810 'shows the left cut line 810' in a desired cut location adjacent the underside of the left target lamina 820 to the left of the spinous process 825. The dashed line of the right cut line 810 shows the right cut line 810 in a desired cut location adjacent to the underside of a right target lamina 820 to the right of the spinous process 825.
Fig. 8 is a front view model of a patient's spine 1200 including a pair of interchangeable outlet needles and a pair of introducer needles, in accordance with an embodiment of the present invention. Figure 8 includes a pair of exit needles 1210, a first epidural space 1220, a spinous process 1230, a left target lamina 1240, a right target lamina 1250, a second epidural space 1260, a pair of introducer needles 1270, and a pair of threads 1280.
The pair of exit needles 1210 and the pair of introducer needles 1270 are interchangeable. A pair of threads 1280 pass through a pair of introducer needles 1270 and exit from a pair of exit needles 1210 such that the pair of threads 1280 remain behind (below) the right target lamina 1250 and the left target lamina 1240 on either side of the spinous process 1230.
The pair of exit needles 1210 and the pair of introducer needles 1270 are removed, leaving the pair of threads 1280 in the respective desired locations behind the target lamina 1240, 1250 while the applied tension and pressure moves back and forth, resulting in a cutting motion through the right target lamina 1250 and the left target lamina 1240 from the inside to the outside, thereby relieving pressure on the plurality of underlying neural tissue 1290 (not visible in this figure).
Figure 9 is an elevational view of a right side percutaneous laminoplasty performed by the T technique according to one embodiment of the present invention, with an introducer epidural needle placed in the epidural space and an exit needle placed in the neural foramen space.
Fig. 9 shows percutaneous foraminoplasty comprising an introducer epidural needle 910, an exit needle 920, the proximal end of a catcher or forceps tool 930, a guide wire 944 (dashed line) made of a cutting wire or abrasive material, a right transverse process 916, a right lamina 999 of a target vertebra 998, and a distal end 935 of a grasper tool 930 capable of capturing and securing the guide wire 944 in the epidural space 913 or the neural foramen space 934. Once the distal end 935 of the grasper tool 930 secures the guidewire 944, the grasper tool 930 will invert and exit the exit needle 920 and pull the guidewire 944 with it out of the patient's body.
Fig. 10 is a front view of the final position of a cutting or grinding wire 1100 after removal of a plurality of needles (not shown) in a right percutaneous foraminal procedure, according to one embodiment of the invention. Fig. 10 shows the cutting or grinding wire 1100 in a final position after a pair of introducer needles (not shown) and exit needles (not shown) are removed.
The percutaneous foraminoplasty shown in fig. 10 has a cutting or grinding wire 1100 with a proximal end 1102 (located outside the body) and a distal end 1104 (located outside the body). Fig. 10 also shows a right transverse process 1110, an epidural space 1120, a target vertebra 1130 with a neural foramen space 1199, a right lamina 1140, and target tissue 1150 (shaded area), the target tissue 1150 including a right superior articular process (not shown) and a right inferior articular process (not shown), and a neural foramen canal (not shown). The cutting or abrading wire 1100 has a proximal end 1102 (located outside the patient's body), a distal end 1104 (located outside the patient's body) of the cutting or abrading wire 1100, and a middle portion 1198 adjacent to target tissue 1150 (shaded area) including the right superior articular process (not shown) and the right inferior articular process (not shown) and the right foraminal canal (not shown). The distal and proximal ends 1104, 1102 of the cutting or abrading wire 1100 have tension applied in a pulling and pushing motion that is manually or electronically controlled, wherein the middle portion 1198 of the cutting or abrading wire 1100 is adjacent to the target tissue 1150 (shaded area) that includes the right superior articular process (not shown) and the right inferior articular process (not shown) and the right foraminal canal (not shown).
Fig. 11A, 11B, 11C, and 11D illustrate a flow diagram of a method 1400 for performing a percutaneous laminoplasty, in accordance with an embodiment of the present invention. The method 1400 for performing percutaneous laminoplasty utilizes a selected one of local and segmental anesthesia while the patient is awake and in the prone position.
The steps of method 1400 include accessing a first introducer epidural needle comprising a distal end, a proximal end outside the patient, a first hollow inner diameter disposed on the distal end that allows one or more first line tools to pass through the introducer epidural needle, and a first penetrating puncture tip placed percutaneously in the epidural space of the vertebra on the first side that allows the one or more first line tools to be introduced and accessed into the epidural space of a selected right lamina of the vertebra above the target vertebra having the side, wherein the spinous process divides the right and left laminae 1410 of the target vertebra; accessing a first exit epidural needle comprising a distal end, a proximal end outside the patient, a second hollow inner diameter and a second penetrating puncture tip, the second penetrating puncture tip disposed on the distal end, the second hollow inner diameter allowing one or more second line tools to pass through the exit epidural needle, the second penetrating puncture tip being placed percutaneously into the epidural space of the vertebra, which is introduced into and into the second line tool below a selected right lamina of the side of the target vertebra, wherein the first introducer epidural needle enters the epidural space of the vertebra below the selected right lamina, the first and second penetrating puncture tips in the epidural space causing the first and second penetrating puncture tips to face each other, the first and second penetrating puncture tips being centered on the right lamina 1420; introducing a first hook grasper tool having a distal end and a proximal end outside the patient, the distal end of the first hook grasper tool being a selected one of a first hollow inner diameter that is manually extended and mechanically extended through the first exit epidural needle, the distal end of the first hook grasper tool attaching one or more first wire tools introduced through the first introducer epidural needle within the epidural space, the one or more first wire tools and the first hook grasper tool being pulled through the first exit epidural needle and out of the patient's body, the attached first hook grasper tool and the one or more first wire tools being engaged under the selected right lamina of the target vertebra, wherein the spinous process divides the right and left lamina, the one or more first wire tools having a curved middle portion, the curved middle portion being placed adjacent to (posterior of) the right lamina, the curved middle portion cuts the right lamina 1430 of the target vertebra in an anterior-to-posterior direction; accessing a second introducer epidural needle comprising a distal end, a proximal end outside the patient, a third hollow inner diameter allowing one or more third wire tools to pass through the second introducer epidural needle, and a third penetrating puncture tip disposed on the distal end, the third penetrating puncture tip being placed percutaneously into the epidural space of the vertebra allowing the one or more third wire tools to be introduced into and enter the epidural space of a selected left lamina of the vertebra above the targeted vertebra having the lateral face, wherein the spinous process divides the right and left laminae 1440; accessing a second outlet epidural needle comprising a distal end, a proximal end outside the patient, a fourth hollow inner diameter, a fourth penetrating puncture tip disposed on the distal end, the distal end is one selected from manual extension and mechanical extension, the fourth hollow inner diameter allows a selected one or more fourth line tools to pass through the second outlet epidural needle, the fourth penetrating puncture tip is placed percutaneously into the epidural space of the spine, which introduces and accesses one or more fourth wire tools below the lateral side of the targeted vertebra, wherein a second introducer epidural needle enters the epidural space of the vertebra of the selected left lamina, a third and fourth penetrating puncture tip in the epidural space causing the third and fourth penetrating puncture tips to face each other, the third and fourth penetrating puncture tips centered 1450 on the left lamina; introducing a second hook grasper tool having a distal end and a proximal end outside the patient, the distal end of the second hook grasper tool being a selected one of a fourth hollow inner diameter that is manually extended and mechanically extended through a second exit epidural needle, the second hook grasper tool attaching a selected one or more third wire tools introduced through a second introducer epidural needle within the epidural space, the selected one or more third wire tools being pulled through the second exit needle and out of the patient's body, the attached second hook grasper tool and the one or more third wire tools engaging a selected left lamina, the one or more third wire tools having a curved middle portion that is placed adjacent to the underside (posterior) of the left lamina, the curved middle portion cutting the left lamina 1460 of the targeted vertebra in a forward to rearward direction and implementing a plurality of safety mechanisms, the plurality of safety mechanisms include intraoperative electromyography, a plurality of nerve conduction studies, and one or more neural sensors to achieve a safe transcutaneous environment 1470.
The third hollow inner diameter allows a selected one or more of the first fluid and the first drug to pass through the second introducer epidural needle. The fourth hollow inner diameter allows a selected one or more of a second fluid and a second drug to pass through the second outlet epidural needle. The introducer epidural needle is a selected one of a flat-head introducer epidural needle, a curved introducer epidural needle, a rigid introducer epidural needle, a c-shaped introducer epidural needle, an expandable introducer epidural needle, and a flexible introducer epidural needle. The introducer epidural needle has one selected from a curved penetrating puncture tip and a penetrating puncture straight tip. The introducer epidural needle has a hollow tube as a protective sheath. The one or more wire tools is one selected from a guide wire, a threading, a bone temperature sensor, and a litz wire. The one or more wire tools are made of a selected one of metal, plastic, nylon, and rubber. The one or more wire tools have a selected one of a bone cut and one or more abrasive properties that when cut can separate out nerves and dura. One or more wire tools are used to modify tissue, cut tissue, and cut bone. The one or more wire tools are selected from one or more bone cutting devices, one or more t-saw (Tomita saw) wires, one or more bone cutting wires, and a saw device. The one or more wire tools include an expanded hollow lumen that allows the one or more wires, fluids, and medical devices to pass through the expanded hollow lumen. The one or more wire tools include a plurality of channels and a plurality of holes to be passed through the expanded hollow lumen to irrigate one or more anatomical regions of the spine. One or more anatomical regions of the spine are flushed with cold water. The expanded hollow lumen is made of a selected one of plastic and a malleable polymer. One or more line tools can provide suction. The one or more thread tools are a selected one of remaining in the epidural space, immediately removed from the epidural space, and removed from the epidural space at a later date. The one or more wire tools have a plurality of grooves that pick up and carry the bone fragment osteophytes out of the patient's body by pushing and pulling a selected one of the one or more wire tools. The one or more wire tools can be a dilation balloon. The dilation balloon is a selected one of radiopaque and radiolucent, which provides a larger target for the exiting epidural needle. The one or more wire tools are a selected one of a plurality of components and a continuous component. The one or more line tools are one selected from radiolucent and radiopaque. The one or more line tools are one or more selected from magnetic, having one or more electromagnetic capabilities, generating heat, coupling to a medical device having laser-induced capabilities, generating laser light, motorized, independently vibrating, and vibrating at one or more calculated rhythms. The epidural endoscope has the ultrasonic guiding capability and the capability of wirelessly transmitting data. The hook grasper tool is a pair of grasping forceps. The hook grasper tool is one or more selected from the group consisting of having a fork shape, having one or more holes, having a locking device, having a selected one of a door closing and a door pinching, having a viscous substance, and having a selected one of a magnetic property and an electromagnetic property. The hook grasper tool is capable of suturing a selected one of a wire, a lead and a tool, and the tool accommodates a pain pump lead at more than one level along the spinal cord and accommodates a spinal cord stimulator lead. The hook grasper tool attaches one or more of one or more wires, leads, medical devices, and a desired target tissue by using a suture, one or more buttons, one or more pads, one or more bridges, and threads. The method is replicated at one or more spinal levels, including the cervical, thoracic, lumbar and sacral regions on the patient's body. The method is performed under one selected from X-ray, fluoroscopy, ultrasound, CT, MRI and 3D-MRI. In this method, the spinous process is cut to replace a selected one of the left lamina and the right lamina.
Fig. 12A and 12B illustrate a flow diagram of a method 1500 for performing percutaneous foraminoplasty, according to one embodiment of the invention. The method 1500 for performing percutaneous foraminoplasty utilizes one of local and segmental anesthesia while the patient is awake and in a prone position, the method for performing percutaneous laminoplasty being performed on a selected one of a first and second lateral side of the spine.
The method 1500 includes the steps of: accessing a first introducer epidural needle comprising a distal end, a proximal end outside the patient, a first hollow inner diameter and a first penetrating puncture tip disposed on the distal end, the first hollow inner diameter allowing one or more first line tools to pass through the first introducer epidural needle, the first penetrating puncture tip being placed percutaneously in an epidural space of a vertebra on the first side allowing the one or more first line tools to be introduced into and enter an epidural space of a selected right lamina of the vertebra above the target vertebra having a side, wherein the spinous process divides the right and left lamina 1510; accessing a first outlet epidural needle comprising a distal end, a proximal end outside the patient, a second hollow inner diameter disposed on the distal end and allowing one or more second line tools to pass through the outlet epidural needle at, and adjacent to, a selected superior one, a inferior one, and a one of the selected right lamina of the target vertebra, the second penetrating puncture tip being percutaneously placed into the neural foramen space of the spinal column, at, and adjacent to, the selected superior one, the inferior one, and the one of the selected right lamina of the target vertebra, the second penetrating puncture tip being introduced and entering the second line tool into the neural foramen space of the spinal column, the first penetrating puncture tip in the epidural space of the selected right lamina of the spinal column being above the target vertebra having a lateral face, wherein at the selected superior one level, inferior one level, and adjacent level of the selected right lamina of the target vertebra, the spinous process divides the right and left laminae and a second penetrating puncture tip in the neural foramen space of the spine, resulting in the first and second penetrating puncture tips facing each other, the first and second penetrating puncture tips centered 1520 about the neural foramen canal of the right side of the target vertebra; introducing a first hook-shaped grasper tool having a distal end and a proximal end external to the patient, the distal end of the first hook-shaped grasper tool being a selected one of a first hollow inner diameter that extends manually and mechanically through the first outlet epidural needle, at a selected superior level, an inferior level, and a level adjacent thereto of a selected right lamina of the targeted vertebra, a distal end of a first hook grasper wire tool attaches one or more first wire tools introduced through a first introducer epidural needle within a neural foramen space of the spine, the one or more first wire tools and the first hook grasper tool being pulled through a first exit epidural needle and out of the patient's body, the one or more first wire tools having a curved middle portion adjacent to the neural foramen and the neural foramen canal, the curved middle portion cutting one or more bony structures of the neural foramen and the neural foramen canal 1530; and implements multiple safety mechanisms including intraoperative electromyography, multiple nerve conduction studies, and one or more neural sensors to implement a safe transcutaneous environment 1540.
The first hollow inner diameter allows the selected one or more first fluids and first drugs to pass through the first introducer epidural needle. The second hollow inner diameter allows the selected one or more second fluids and second medicaments to pass through the second outlet epidural needle. The introducer epidural needle is one selected from a flat head introducer epidural needle, a curved introducer epidural needle, a rigid introducer epidural needle, a c-shaped introducer epidural needle, an expandable introducer epidural needle, and a flexible introducer epidural needle. The introducer epidural needle has one selected from a curved penetrating puncture tip and a penetrating puncture straight tip. The introducer epidural needle has a hollow tube as a protective sheath. The one or more wire tools is one selected from the group consisting of a guide wire, a threading, a bone temperature sensor, and a twisted wire. The one or more wire tools are made of one selected from metal, plastic, nylon, and rubber. The one or more wire tools have one selected from one or more abrasive properties that cut through bone and can separate nerves and dura when cut. One or more wire tools are used to modify tissue, cut tissue, and cut bone. The one or more wire tools are one selected from one or more bone cutting devices, one or more t-saw (fuda saw) wires, one or more bone cutting wires, and a saw device. The one or more wire tools include an expanded hollow lumen that allows the one or more wires, fluids, and medical devices to pass through the expanded hollow lumen. The one or more wire tools include a plurality of channels and a plurality of holes to be passed through the expanded hollow lumen to irrigate one or more anatomical regions of the spine. One or more anatomical regions of the spine are flushed with cold water. The expanded hollow lumen is made of one selected from plastic and a malleable polymer. One or more line tools can provide suction. The one or more thread tools are one selected from remaining in, immediately removing from, and removing from the epidural space at a later date. The one or more wire tools have a plurality of grooves that pick up and carry the bone fragment osteophytes out of the patient's body by pushing and pulling a selected one of the one or more wire tools. The one or more wire tools are dilation balloons. The dilation balloon is a selected one of radiopaque and radiolucent, which provides a larger target for the exiting epidural needle. The one or more wire tools are a selected one of a plurality of components and a continuous component. The one or more line tools are one selected from radiolucent and radiopaque. The one or more line tools are one or more selected from magnetic, having one or more electromagnetic capabilities, generating heat, coupling to a medical device having laser-induced capabilities, generating laser light, motorized, independently vibrating, and vibrating at one or more calculated rhythms. The epidural endoscope has the ultrasonic guiding capability and the capability of wirelessly transmitting data. The hook grasper tool is a pair of grasping forceps. The hook grasper tool is one or more selected from the group consisting of having a fork shape, having one or more holes, having a locking device, having one selected from closing a door and clamping a door, having a viscous substance, and having one selected from magnetic properties and electromagnetic properties. The hook grasper tool sutures one selected from the group consisting of a wire, a lead, and a tool, and the tool at more than one level along the spinal cord houses the pain pump lead and houses the spinal cord stimulator lead. The hook grasper tool attaches one or more of one or more wires, leads, medical devices, and desired target tissues using one or more of a suture, one or more buttons, one or more footplates, one or more bridges, and threads. The method is replicated at one or more spinal levels, including the cervical, thoracic, lumbar and sacral regions on the patient's body. The method is performed under one selected from X-ray, fluoroscopy, ultrasound, CT, MRI and 3D-MRI.
The present invention is a method for performing percutaneous laminoplasty and a method for performing percutaneous foraminoplasty. One or more components and one or more tools for these methods include an introducer needle tool, an exit needle tool, a guidewire tool, and a grasper tool. With respect to the term needle, it is defined as any one or more tools that pierce or enter the epidural space or the neural foramen space by a percutaneous technique as opposed to an open technique, and as described for the purposes and intentions of the T-technique herein. The introducer needle tool has an inner diameter that is capable of introducing a guidewire or threading into the epidural space. The introducer needle tool can be rigid, flat-headed, curved, c-shaped, expandable, or flexible. The introducer needle has the ability to be inserted, left during surgery, removed and reinserted into the desired epidural space, as deemed necessary by the physician when performing the T-technique. The exit needle can be rigid, flat-headed, curved, c-shaped, expandable, or flexible. The terms exit needle or introducer needle can be used interchangeably as they pertain to the T-technique described herein. The exit needle tool has an inner diameter that is capable of introducing a grasper catcher tool or other suitable medical tool that can be used to catch a guidewire tool described herein as the T-technique. The term "wire" can be interchangeably referred to as a guidewire, cutting wire, t-saw, or threading, can be rigid, flexible, or fluid, has a variety of functions including navigation through the epidural space within the patient's body and can be delivered to assist in further navigation to a desired direction toward a desired epidural space or neural foramen space where the exit needle waits with a grasper tool. The wire can have tissue modification capabilities as well as the ability to transport similar tools by coupling and pulling or pushing medical tools or medical devices to the desired location, as well as navigation capabilities, which allow for connecting the epidural space between layers with other epidural spaces, the epidural space between layers with the foramen, the foramen with other foramen, as described in the method referred to herein as the T-technique. Furthermore, the term wire can denote a tool, which can be a hollow tube with holes having an abrasive exterior that allows for the release or removal of air, gas or fluid by vacuum potential energy, which can be plastic, rubber, non-metal or metal and can vary in size. The wire can be further described and used as a guide wire, a wire saw, a connection device allowing other tools to be pulled into a desired position, a cutting wire or can represent any suitable tissue modification tool used during the T-technique procedure and the method described herein according to one embodiment of the invention.
The wire has bone and target tissue cutting and molding capabilities, or can be connected to a bone cutting device or a saw device through its coupling capabilities. The wire can be hollow to allow another material or guide wire to pass through it. The distal end or proximal end of the guidewire can have magnetic properties to attract one or more forceps and grasping tools having similar attractive magnetic properties. The wire can be made of any number of suitable materials including plastic, metal, mineral, rubber, and allow fluid or gas to pass therethrough. The wire can have holes that allow fluid or gas to leak for flushing. The wire can also have suction capability and have grooves that can pick up bone fragment osteophytes and carry the fragment osteophytes out of the patient's body after pulling or pushing the wire. The wire or guide wire can also be a hollow tube made of a malleable plastic-like material that can allow other guide wires or medical tools or devices to pass therethrough. The wire tool device can be close to heat and can be interpreted as allowing a laser to be attached or capable of lasing. It can be motorized, have the ability to vibrate, and can be packaged to protect critical structures from damage from sharp edges due to poor placement, unpredictable movement, or failure of the device. The threading can have a protective covering that can be used to retain tissue in which cutting is not desired during the sawing action. The protective covering can be a plastic covering that allows the guidewire to move freely within it. The protective covering can be absorbed into the body of the patient or manually removed and can be wiped off with friction. The protective covering can be provided over the entire threading, or at multiple desired locations along the threading, such as over the cut portions of the thread. The encapsulation on the wire saw can be wiped off with friction when the wire is in contact with the bone or target tissue during cutting. Further, the packaging can be manually removed at an optimal location and time during surgery, can be manually and independently expanded, can be independently and manually removed, can be manually, independently or with an applied force contracted or reduced in size, or absorbed into the body system without damage, or broken down over time. The package can be made with one or more hooks or magnets attached to the pulley device to be removed.
The guidewire includes a plurality of cutting and abrading components and can be made from a dilation lumen, can be radiolucent or radiopaque, can be magnetic or electromagnetic capable, and can have a tip at a proximal or distal end that can serve a variety of purposes, including a balloon that can be expanded once placed in a desired location. The balloon can be radiopaque or radiolucent, and can be expanded at a desired location to create a larger target for the exiting epidural needle trap grasper tool to be located while under fluoroscopy or other imaging studies, which can aid a physician in locating and performing tasks. The balloon can be retracted, expanded, have several lumens for use, can have multiple different levels of opacity or brightness to help identify the depth of the balloon when within the body, epidural space, or neural foramen space. The balloon can have various radiolucent or opaque shapes and designs engraved on its exterior, and can absorb grasper tools such as hooks and carry attached absorbed threads out of the patient's body from the exterior. The tip of the guidewire can be a balloon or another similar expansion tool that can be coupled to a catcher tool, or can be caught by a grasper tool that has passed through the exit needle. After the wire has been captured by the grasper tool, the grasper tool now pulls the wire, and can reverse in direction and exit the exit needle tool, which enters the exit needle tool from the patient's body, and pulls the wire, which has been secured from outside the patient's body by the exit needle. The outlet needle or capture needle has an inner diameter that can allow an epidural scope, catcher, grasper tool, forceps, flexible grasper, and/or one or more hook devices or bone temperature sensors to pass internally and through the epidural space or the neural foramen space, wherein the described medical tools and devices can capture a wire, a guide wire or a cutting or tissue modifying wire and pull it out of the body. Optionally, grasping forceps, holder tool or hook can pass through the epidural scope, which can pass through the outlet needle. The terms and functions of the outlet needle or introducer needle can be used interchangeably and can have a US (ultrasound) guiding tip that can define structures in the epidural space and the intervertebral foramen space. Furthermore, image-enhanced tools such as x-ray imaging, fluoroscopy, CT, MRI, and US techniques can help the physician perform these tasks required for one or more epidural introducer tools and exit needle tools for the methods described herein as the T technique.
A hollow tube, known as a vascular tool, can be passed between the introducer epidural needle and the exit epidural needle by means of the T technique. The hollow tube can be made of rubber or plastic, can be flexible or rigid, formable, absorbable, penetrable, have a plurality of holes, can be a plurality of pieces or one continuous piece, can allow passage and placement of one or more guide wires, can serve as a protective sheath for the guide wires, can allow passage of fluids, can have suction capabilities, can allow passage of one or more gases, and can serve as a medium for delivery of medical tools and devices. The hollow tube can allow fluid to pass through to cool the threading while cutting. The hollow tube can have suction applied on either end to remove fluid from the field environment during surgery. An epidural discharge catheter can be passed through the epidural needle tool in a space above or below the surgical site, and the catheter can be attached to a negative pressure suction located outside the body to discharge any possible blood or fluid collected in the epidural space. The drainage catheter can be left in space after the procedure, removed immediately or later.
The method also utilizes a grasping forceps tool, which can be of any suitable form, and can be flexible or inflexible. Grasping the forceps tool serves to interlock or connect with the associated wire delivered from the introducer needle by the T technique when positioned in the epidural space or the neural foramen space. Once the grasper tool has formed a catch or connection with the guidewire, it can now be pulled out of the patient's body through the exit needle. The grasping forceps can be a hook mechanism with a fork shape, have holes, locking devices, close or pinch gates, can be a viscous substance, can be of a magnetic or electromagnetic nature, and/or have an attractive force that can attract the distal end of the guidewire to the grasping forceps. The grasping forceps can have a coating, wherein US (ultrasound machine outside the body) can be used to determine the distance between the grasping forceps and the guide wire. Locking or capturing the guidewire can also be done under fluoroscopy, with US, CT, MRI, three-dimensional MRI, or other suitable imaging studies that can assist the physician in such tasks.
Alternatively, the grasper tool can also have the ability to suture, lead or tool at more than one level along the spinal cord, such as leads for pain pumps or leads for spinal cord stimulators, and connect them to other wires, leads, medical devices or desired target tissues by using sutures, buttons, pads, bridges, threads or similar surgical tools and devices. This is one of the most common causes of spinal cord stimulator failure, including lead breakage and lead migration. In the application of T-technology, a grasper tool can be used for both the distal and proximal ends of the lead placement and fastening. This procedure will allow the physician to access the distal and proximal ends of the lead or wire and any point along the spine, where the wire, lead, device and target tissue can be accessed by the described T-technique, with the grasper tool entering an exit needle or introducer needle to access the neural foramen space and/or epidural space at any target level of the spine.
Fig. 13 shows a system representation of an epidural space scope visualization system lens 1662 with a light source 1672, which light source 1672 may not be attached to the epidural space scope visualization system lens 1662, but may look for the light source 1672 in the epidural space 399 at any level of the spine. As shown in fig. 13, four needles in the two epidural spaces hold the target lamina in the central region. As explained above with reference to fig. 3, fig. 13 also depicts a left lamina 305, a right lamina 310, and a spinous process 315 separating the right lamina 310 and the left lamina 305 of the target vertebra 302. Fig. 13 also includes left lamina 205, spinous process 215, and right lamina 210 of one level vertebra above target vertebra 302. The left lamina 105, spinous process 215', and right lamina 210' of one level of vertebra below the target vertebra 302 are also shown. As can be appreciated by one of ordinary skill in the art, a left introducer epidural needle 320, a right introducer epidural needle 321, a left outlet epidural needle 322, and a right outlet epidural needle 323 are also shown. The left introducer needle 320 may have a proximal end 324 and a distal end 326. Right introducer needle 321 may have a proximal end 325 and a distal end 327. The left outlet needle 322 may have a proximal end 330 and a distal end 328. The right outlet needle 323 can have a proximal end 331 and a distal end 329.
The proximal ends of the introducer needles 324, 325 and the proximal ends of the outlet needles 330, 331 may remain outside the patient's body, while the distal ends of the introducer needles 326, 327 may enter the epidural space 399 above the target vertebra 302. The distal ends of the outlet needles 328, 329 enter the epidural space 398 below the target vertebra 302. The left introducer needle 320 and its distal end 326 can be placed and introduced into the epidural space 399 above the target vertebra 302 to the left of the spinous process 315. The right introducer needle 321 and its distal end 327 may be introduced into the epidural space 399 above the right side of the spinous process 315. The left outlet epidural needle 322 and its distal end 328 may enter the epidural space 398 below the target vertebra 302 to the left of the spinous process 315. The right outlet needle 323 and its distal end 329 can enter the epidural space 398 below the target vertebra 302 to the left of the spinous process 315. As previously described, left distal end 326 of introducer needle 320 and left distal end 328 of outlet needle 322 may face each other, and correspondingly, right distal end 327 of introducer needle 321 and right distal end 329 of outlet needle 323 may face each other.
The epidural scope visualization system 1660 may be located outside the patient's body to allow visualization of the light source 1672 independent of the epidural scope visualization system 1660. An intermediately attached scope portion (scope port) 1661 accessible through the left introducer needle 320 into the epidural space 399 may have an epidural scope visualization system lens 1662 at the distal end. The epiduroscope visualization system lens 1662 may have optical fibers that allow it to be in a coaxial plane, visualizing the light source 1672 and other structures outside the patient's body by looking for the light source 1672 that is not otherwise attached to it.
A power supply 1670 for a distal light source 1672 illuminable in the epidural space 399 may enter the left exit needle 322 through its intermediate component 1671 to connect to the distal light source 1672 for allowing the epidural scope visualization system lens 1662 to look for and visualize light, which allows the epidural scope visualization system lens 1662 to look for light to allow visualization. Finally, an epidural space scope visualization system lens 1662 looking for a light source 1672 will help facilitate the creation of a mechanical or electromagnetic coupling within the epidural space, as previously described.
As one of ordinary skill in the art can appreciate, the representations disclosed herein with respect to fig. 13 can be performed at any level and on either side of the spine. Likewise, although reference is made herein to the light source 1672 being delivered through the outlet needle 322, one of ordinary skill in the art will not be so limited, and may find other suitable arrangements for advancing the light source 1672 and lens 1662 through various combinations of outlet and inlet needles.
Fig. 14 illustrates a completed electrical loop 1780, which may be formed transcutaneously with a portion of the completed electrical loop 1780 outside the patient's body, and a portion of the completed electrical loop 1780 may be located in any portion of the spine within the epidural space 399. The completed annular circuit 1780 is formed in the spine with the two distal ends of the two medical tools 1771, 1775 in coaxial planes in the spine having a contact point 1776 in the epidural space 399.
Once the current from the power source 1749 is connected and forms a circuit with the bond wire 1770, a completed annular circuit 1780 may be formed, the bond wire 1770 may be partially outside the patient's body and partially inside the patient's body by passing percutaneously through the left introducer needle 320 distally into or out of the epidural space 399, with the two medical tools 1771, 1775 making physical contact and creating an electromagnetic contact point 1176, which electromagnetic contact point 1176 can be used to verify that a snap lock is formed along a coaxial plane. The completed annular circuit 1780 is further depicted as a bond line 1774 exiting or entering the epidural space 399 through the left outlet needle 322, wherein the proximal tip 1773 of the bond line 1774 outside of the patient's body enters the proximal portion of the other medical devices 1769, which other medical devices 1769 form the particular completed annular circuit 1780. Once the completed loop circuit 1780 is formed, the practitioner will recognize that the latch has been made as previously described. This perception may be inferred by visual or audio cues that would indicate the creation of a closed loop circuit 1780. Similarly, and although described as spanning a single level of a vertebra, the system may be used at any level and on either side of the spine.
An epidural scope or fiberscope with fiber optic capability can be passed through the epidural needle and placed in the epidural space, additional epidural space or neural foramen space, and can be left in place for direct vision while utilizing T-technique. An epiduroscope or fiberscope can be a continuous piece or multiple pieces working together from an introducer needle to an exit needle with one continuous visualization point, a single visualization point or multiple visualization points. The epiduroscope or fiberscope can also have one or more ultrasound guidance capabilities and one or more wireless capabilities for data transmission. The scope can have the option of allowing a cutting instrument to pass through to perform the cut, or the scope itself can be used as a cutting device through the use of a saw, blade, laser, thermal energy, or other suitable cutting device. The scope can have the ability to pass fluids, medical tools or materials, medically useful gases, or substances with medicinal benefits in the desired target area. The mirror can have a light source in many positions, a single position, or a succession of positions. The scope can have a lumen or multiple lumens to allow materials such as gases, fluids, or medical tools such as guidewires, grasper tools, or probes to pass through and position them in the desired target area.
In addition, a catheter with an inflatable tip balloon-like structure can be passed through an epidural scope or fiberscope through its working channel or lumen, or through one or more introducer epidural needles or exit epidural needles. The balloon structure is able to expand due to the addition of gas or liquid. In addition, the inflatable balloon can be placed in a position such that it remains a shield between the cutting line and important anterior structures, such as exiting the nerve and dura. The inflatable balloon can be designed to expand first laterally and then posteriorly so that it does not exert more pressure on the dura mater and can help push the cut lamina posteriorly (outward) after the cut from the T-technique. The inflated balloon can be deflated and removed after surgery, either left in the epidural space as a support structure or other suitable utility, or absorbed by the patient's body. The inflated balloon can have a plurality of grooves on its rear surface to accommodate cutting lines for better control during cutting. The expanded balloon can have radiopaque properties, or can be injected with a contrast agent so that its placement is well visualized under fluoroscopy. In addition, during T-technique percutaneous surgery, the patient will be awake, giving the physician immediate awareness if the neural structures immediately affected by the patient and reported are encroached, which will prompt immediate cessation and replacement of the procedure, which is a common practice in the field of pain management. The application of current safety mechanisms, such as intraoperative EMG (electromyography), NCS (nerve conduction studies), and neural sensors, can be used to achieve a desired safe surgical environment. Ultrasound technology, radio frequency, CT, MRI, three-dimensional MRI, C-arm, or other suitable instruments can be used to assist in completing tasks to identify surface anatomy, as well as distances between neural structures, threads, and other medical tools.
The invention also includes a method for fixing, fusing and lifting cancellous bone after application of the T-technique. The method includes a technique for securing the spinous process of a target vertebra with an improved spinous process screw tool. The spinous process is a bone structure of opposite surfaces in the spine and can be easily felt under the skin. The spinous processes can be easily accessed percutaneously with a modified percutaneous spinous process screw tool, epidural scope, or other similar percutaneous drilling device. The improved spinous process screw tool is inserted percutaneously into the spinous process and then secured with a locking, rotational screwing motion, wherein a plurality of serrations, inserts or hooks attach the screw tool to the spinous process. Spinous process modification screws with T-technology and a variety of other suitable types of screw tools can also be made from implantable materials such as stainless steel, titanium, and other suitable biocompatible materials. The spinous process screw tool is attached to a gauge tool outside the patient's body, which can manually or automatically adjust the desired outward (posterior) pressure on the cancellous bone, and can adjust and assist in maneuvering the cut portion of the bone to a desired location. The screw tool can have one or more holes, one or more lumens, hooks, or ports that can be attached to one or more wires, rods, needles, other screws, or tools for anchoring or other purposes. The improved spinous process screw tool allows the physician to manipulate, move and adjust cancellous bone that has been cut by the T technique. The improved spinous process method for simulating and manipulating cancellous bone can be equally applied to percutaneous T-technique laminoplasty and intervertebral foraminoplasty. In the case of percutaneous laminoplasty with T-technique, an example of a loose bone would be defined as the target vertebra intermediate the incisions of its right lamina and its left lamina. In this example, the cancellous bone will include the right lamina, spinous process, and left lamina of the targeted vertebra. After cutting of the target lamina, the cancellous bone is no longer continuously attached to the original anatomy of the target vertebra and is now completely free to move by application of posterior (outward) force and pressure with the improved spinous process screw tool attached to a gauge tool outside the patient's body. After the spinous process screw tool is secured into the spinous process by the methods described herein, a posterior (outward) pressure is applied, which can allow the cancellous bone to be placed in the desired location, which will allow the spinal canal and neural foramen to be expanded by the T-technique. Manipulation will achieve decompression by creating space for neural elements. The cancellous bone is fixed in place using subsequent tools, percutaneous fusion and methods, which will result in osteogenesis between the cut ends of the lamina where healing and fusion will occur.
There are also optional percutaneous methods for cancellous bone lifting and fixation that utilize multiple M-technique steps. The M technique requires the use of multiple modified pedicle screws and multiple modified fixation screws. After T-technique laminoplasty or foraminoplasty, a percutaneously modified spinous process screw will be placed into the target tissue, where the distal end of the screw will be inserted into the spinous process and the proximal end will protrude and have an exit from the patient's skin. Pressure will be applied in the posterior direction using a pressure gauge tool located outside the body attached to the spinous process screw. The posterior pressure exerted on the improved spinous process screw through the use of the gauge tool will be sufficient to protect the tube from anterior drift, as well as to properly place the cut lamina in the desired location to alleviate foramen and/or canal stenosis. Subsequently, the M technique is followed by percutaneously inserting a modified pedicle screw through each pedicle of the selected target vertebra in the AP position (e.g., vertebral level 5 with one modified pedicle screw in the right pedicle and one modified pedicle screw in the left pedicle). The improved pedicle screws can have the potential for angulation or bending, wherein the distal end of the screw will be inserted into the target tissue and secured into the pedicle by a percutaneous approach, and the proximal end can have the ability to interlock into one or more other screws or tools. The length of the improved pedicle screw can be variable and can be increased by interlocking features that will extend to the desired length. The proximal end of the improved pedicle screw will have one or more openings through which a fusion screw tool can pass and interlock with. The fusion screw can be expanded by automatic or manual techniques, can be reduced in size, can vibrate, can contain fluid, can absorb fluid, can independently have drilling or puncturing capabilities, or with physician assistance such as a tightening rotation, which can cause drilling or puncturing capabilities, or a plurality of teeth-like, spike-like protrusions into the palpation structure and attached to them, can have one or more rotational capabilities, and will not only detach the target tissue but also hold it in a fixed position as well. The fusion screw tool can use the improved pedicle screw for bracing because it is percutaneously interlocked with the proximal end of the improved pedicle screw. The fusion screw can interlock with the modified pedicle screw at any point along the fusion screw. The distal end of the fusion screw will target cancellous bone seen after cutting, as described in T-technique foraminoplasty and/or laminoplasty. The fusion screw can be angled toward the cancellous bone and then tightened into the target tissue to secure the lamina and cancellous bone in its new position. After several weeks following fusion and healing, the screws can be removed as needed.
In an alternative embodiment, a spinal guidance system fiberscope is disclosed. As will be appreciated by those of ordinary skill in the art, fiberscopes and/or epidural scopes typically have light to help guide them in the body cavity. In such a process, the skilled person may see the light as traveling in the direction of the fiberscope, or being pushed towards a desired target, as in any generally directional lighting fixture. One disadvantage of adding light to a mirror designed to operate on a micro scale for insertion into a body cavity is that the corresponding diameter of the mirror is increased to compensate for the addition of the light emitting element. This drawback is exponentially exacerbated when attempting to operate within an epidural space scope. Therefore, there is a need to have the fiberscope operate without light, so as to maintain its slender profile within the epidural space. Additionally, for smaller diameters, the design may help the guidewire find out where the catcher tool is located, as the guidewire or the catching tool may also be or have fiberscope capabilities; and once in the coaxial plane, the guidewire can be pushed to find the light that will be attached to the head of the grasper/grasper tool, and thus the guidewire will be diverted directly into the light of the grasper/grasper tool.
Unlike other mirrors, no visual access is required, but only the ability to see light or some degree of brightness. In other words, proper placement within the epidural space has not been achieved if there is no visible light visible to the physician. Conversely, if the physician is able to see the light, the correct orientation and placement has been established.
In another embodiment, a completed and closed electrical circuit is created with a portion of the circuit within the epidural space itself. A spinal guidance system Visual Engagement Indication System (VEIS) percutaneous epidural completion circuit may create a circuit in the form of a loop. Once the circuit is completed, an LED light or audio sound or some sort of alarm or other indication is generated, wherein the physician recognizes that the guidewire has actually contacted the grasper tool. As a non-limiting example, a battery having a positive side and a negative side is outside the patient's body. The negative current is passed along a wire attached to the LED lamp from the negative side of the battery. The negative charge then continues through the LED light and then through the wire and through the grasper tool. A positive current is then passed along the wire from the other side of the battery, where the current is then applied to the guidewire. The catcher tool is thus placed into the epidural space, and then the guide wires are placed in the epidural space in a coaxial plane and advanced towards each other. Once the guidewire tool contacts the grasper tool/capture tool, the circuit is complete and the LED is illuminated outside the patient's body. (the voltage of the circuit can be minimized as needed to avoid adverse normal body function, which can be less than 0.5V).
By way of further example, the guidewire or the catcher/grasper tool can be positively or negatively charged depending on the orientation of the battery. The indicating mechanism of the circuit can be an LED diode of any color that can illuminate a screen or other associated presentation device that presents a word. The alarm mechanism can be a sound or other means of alerting the physician that a circuit has been created. One, two, three, or more circuits can be created at times or at any one particular capture. Alternatively, each circuit and indication mechanism can involve a different portion of the capture tool or the guidewire tool, e.g., the interior of the capture tool can be one color and the exterior of the capture grasper tool can be another color, each separate circuit giving the physician the ability to know the exact position of the two tools relative to each other.
While various embodiments of the disclosed technology have been described above, it should be understood that they have been presented by way of example only, and not limitation. Likewise, various figures may depict example architectures or other configurations of the disclosed technology, which figures are made to aid in understanding the features and functionality that can be included in the disclosed technology. The disclosed technology is not limited to the example architectures or configurations shown, but rather is capable of implementing desired features using a variety of alternative architectures and configurations. Indeed, it will be apparent to those skilled in the art that alternative functional, logical or physical partitions and configurations may be implemented to achieve the desired features of the techniques disclosed herein. In addition, a number of different constituent module names other than those described herein can be applied to the various partitions. Additionally, with regard to flow diagrams, operational descriptions, and method claims, the order in which the steps are presented herein should not require that the various embodiments perform the recited functions in the same order, unless the context dictates otherwise.
While the disclosed technology has been described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects, and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead can be applied, alone or in various combinations, to one or more of the other embodiments of the disclosed technology, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus, the breadth and scope of the techniques disclosed herein should not be limited by any of the above-described exemplary embodiments.
The terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term "including" should be understood to mean "including but not limited to," and the like; the term "example" is used to provide exemplary instances of the items in discussion, rather than an exhaustive or limiting list thereof; the terms "a" and "an" should be understood to mean "at least one," "one or more," and the like; and adjectives such as "conventional," "traditional," "normal," "standard," "known," and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available at a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass technologies that are apparent or known to those of ordinary skill in the art now or at any time in the future.
In some instances, the presence of expansion words and phrases such as "one or more," "at least," "but not limited to," or other similar phrases should not be construed to mean that the narrower case is intended or required in instances where such expansion phrases may not be present. In addition, various embodiments set forth herein are described in terms of exemplary block diagrams, flow charts and other illustrations. As will become apparent to those of ordinary skill in the art upon reading this document, the illustrated embodiments and their various alternatives may be implemented without limitation to the illustrated examples. For example, block diagrams and their associated descriptions should not be construed as requiring a particular architecture or configuration.

Claims (20)

1. An apparatus for performing enhanced percutaneous epidural access for spinal surgery, the apparatus comprising:
a first percutaneous needle having a first lumen, a proximal end, and a distal end, wherein the distal end is configured for placement in an epidural space at a first location, the first location being at least one level removed from a target lamina;
a second percutaneous needle having a second lumen, a proximal end, and a distal end, wherein the distal end of the second percutaneous needle is configured for placement in an epidural space at a second location that is at least one level removed from a target lamina and opposite the first location;
a light seeking tool coaxially movable within one of the first lumen and the second lumen; and
a grasper tool coaxially movable within the other of the first lumen and the second lumen, and configured to emit light for pulling the light seeking tool and temporarily coupling within the epidural space of the target lamina.
2. The device of claim 1, wherein the first and second lumens are configured to deliver a fluid or drug into the epidural space through a plurality of holes fixed along a length of at least one of first and second percutaneous needles.
3. The apparatus of claim 1, wherein the first and second percutaneous needles may consist of a flat-tipped introducer epidural needle, a curved introducer epidural needle, a rigid introducer epidural needle, a c-shaped introducer epidural needle, an expandable introducer epidural needle, or a flexible introducer epidural needle.
4. The device of claim 3, further comprising a wire tool having an abrasive coating configured to enter the epidural space.
5. The device of claim 4, wherein the wire tool is selected from the group consisting of a guide wire, a threading wire, a bone temperature sensor, a twisted wire, a suction-providing wire, and a dilation balloon.
6. The apparatus of claim 5, wherein the light seeking means is made of metal, plastic, nylon, or rubber with a light sensor.
7. The device of claim 6, wherein the distal end of the grasper tool has a hook-like structure for receiving the wire tool.
8. The apparatus of claim 7, wherein the wire tool has a plurality of channels to irrigate one or more anatomical regions of the spine.
9. The device of claim 7, wherein the wire tool has a plurality of grooves to carry bone fragment osteophytes.
10. The device of claim 7, wherein the distal end of the grasper tool is configured to be coupled to the wire tool by having a pair of grasping forceps, a forked grasper, a locking device, a pinch gate, an adhesive, or a magnet.
11. The device of claim 7, wherein at least one of the first and second percutaneous needles is configured to coaxially house a pain pump catheter or a spinal cord stimulator lead.
12. A device for treating spinal stenosis, the device comprising:
a first percutaneous needle having a first lumen, a proximal end, and a distal end, wherein the distal end is configured for placement in an epidural space at a first location, the first location being at least one level removed from a target lamina;
a second percutaneous needle having a second lumen, a proximal end, and a distal end, wherein the distal end of the second percutaneous needle is configured for placement in an epidural space at a second location that is at least one level removed from a target lamina and opposite the first location;
a wire tool movable within the first lumen and the second lumen, wherein the wire tool has an engagement indication system; and
a grasper tool movable within the first and second lumens and configured to temporarily couple to the wire tool within the epidural space of the target lamina, thereby triggering the indication of engagement.
13. The device of claim 12, wherein the engagement indication system triggers one of an audible or visual cue when a closed circuit is formed within the epidural space.
14. The apparatus of claim 13, wherein the first and second lumens are configured to deliver a fluid or drug for delivery to the epidural space of the target lamina.
15. The device of claim 14, wherein the wire tool is selected from the group consisting of a guide wire, a threading wire, a bone temperature sensor, a twisted wire, a suction-providing wire, and a dilation balloon.
16. The apparatus of claim 15, wherein the wire tool is made of a conductive material configured to form the closed circuit.
17. The device of claim 16, wherein the distal end of the grasper tool has a hook-like structure for receiving the wire tool.
18. The apparatus according to claim 17, wherein one of the first epidural needle or the second epidural needle is configured to receive a pain pump catheter or a spinal cord stimulator lead.
19. A method for enhanced percutaneous epidural access, the method comprising the steps of:
percutaneously accessing a first needle into an epidural space above a target lamina, wherein the first needle defines a first lumen and has a proximal end and a distal end;
percutaneously accessing a second needle into the epidural space below the target lamina, wherein the second needle defines a second lumen and has a proximal end and a distal end;
introducing a wire tool having a light seeking circuit into the first lumen and advancing the wire tool into the epidural space above the target lamina;
introducing a grasper tool having a light source into the second lumen and advancing the grasper tool into the epidural space below the target lamina;
deploying the grasper tool to pull a light line seeking tool and temporarily couple the line tool and proximally retract the grasper tool and the line tool; and
manipulating the wire tool to modify the selected lamina.
20. A method for performing enhanced percutaneous epidural access for spinal surgery, the method comprising the steps of:
percutaneously accessing a first needle into an epidural space above a target lamina, wherein the first needle defines a first lumen and has a proximal end and a distal end;
percutaneously accessing a second needle into the epidural space below the target lamina, wherein the second needle defines a second lumen and has a proximal end and a distal end;
introducing a wire tool having an engagement indication system into the first lumen and advancing into the epidural space above the target lamina;
introducing an opposite end of the wire tool into the second lumen and advancing into the epidural space below the target lamina; and
monitoring a visual or audio cue of the engagement indication system while a closed circuit loop is formed within the epidural space.
HK17112110.1A 2014-07-07 2015-07-07 Percutaneous system and methods for enhanced epidural access for spine surgery HK1238110A1 (en)

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