KR20160129830A - Surgical access system with navigation element - Google Patents

Abstract

A surgical access assembly and method of use are disclosed. The surgical access assembly includes an outer tube and a closure. The externals and occlusions are configured to be provided as areas of interest within the brain. Either the outer tube or the occlusion can be configured to work in conjunction with a career guidance system that tracks the position of any one device in the brain.

Description

[0001] SURGICAL ACCESS SYSTEM WITH NAVIGATION ELEMENT [0002]

TECHNICAL FIELD The present invention relates generally to surgical access systems for use in fragile and critical tissues, approaches using the same, and surgical methods. The present invention also relates to the treatment of the surgical site.

Diagnosis and treatment of diseases affecting the brain is one of the most difficult and complex problems facing the healthcare industry. The brain is a complex, fragile, soft multi-component tissue structure that controls body function through a complex neural network that is connected to the rest of the body through the spinal cord. The brain and spinal cord are accommodated in important skeletal structures, such as the skull and vertebrae, and are protected by the skull and vertebrae. Strong skeletal protection In the brain that determines the difficulty of approaching the brain through the skull and the ability of the human body to perform language function, visual function, auditory function, functional mobility function, reasoning function, emotional function, respiratory function and other metabolic functions Given the fragile network and complex interactions that make up the accepted neural network, the diagnosis and treatment of brain disorders presents unique challenges that are not encountered elsewhere in the body.

For example, intracranial cerebral hematomas (ICH), abscesses, glioblastomas (GB), which appear in the brain's intraparenchymal cortical space (ie, white matter) Abnormalities such as metastases (mets) and functional diseases are particularly challenging and inaccessible. The ventricles accommodate vital communication structures (neural networks) called fiber tracts and fascicles located in the subcortical space. Thus, traditionally, access to abnormal ICH, GB, and / or tumor metastasis is not to be left untreated unless the ICH, GB, and / or tumor metastasis are considered not to be "superficial & These diseases were considered to be inaccessible just because they were considered to be harmful. Likewise, tissue abnormalities such as tumor, cyst, and fibrous membrane growth within the brain's ventricular space are believed to be difficult, often inoperable, due to their location in the brain.

In order to aid diagnosis and subsequent treatment of brain disorders, it is required to clearly and accurately image brain tissue through the skull. Recently, stereotactic X-ray imaging, computerized axial tomography (CAT), computerized tomographic angiography (CTA), positron emission tomography (PET) Significant advances have been made in imaging technology including magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), and a career guidance system (instrument location tracking system). Such imaging devices and techniques , Allowing surgeons to observe disease in the brain in a non-invasive manner without opening the skull, and to include interest in structures such as blood vessels, membranes, tumor margins, If the unsteady portion is identified using one or more imaging techniques and / or techniques, biopsy of the abnormal portion may be performed, Is removed may be necessary or desirable.

Once a policy is determined on the basis of one or more imaging techniques, surgical treatment may be required or required. To surgically operate the brain, access should be made through the cranium and soft brain tissue that accommodate vessels and nerves that may be adversely affected by some disability. Therefore, careful attention should be paid to brain surgery to avoid touching fragile blood vessels and nerves to prevent negative consequences resulting from surgical intervention.

Conventionally, approaching an abnormal part that appears in a deeper space within the brain meant that surgery was needed that produced a very invasive approach. In some cases, to access the target tissue, a significant portion of the skull is removed and the entire portion of the brain is pulled to approach. For example, a surgical brain retractor is used to pull or pull soft brain tissue, which can leave a pressure mark by the transverse edge of the retractor. In some cases, the use of a brain retractor may cause a problem known as "retraction injury ". Of course, this technique is not appropriate for all situations, and not all patients can withstand and recover from this invasive technique.

Although it is also known to approach certain parts of the brain with burr hole craniotomy, only limited surgical procedures can be performed through such smaller openings. Also, some techniques have been developed to enter through nasal passages, for example, to open access holes through the occipital bone to remove tumors located within the area of the pituitary gland. This approach is called Expanded Endonasal Approaches (EEA) and was pioneered by one of the inventors of the present invention.

Significant developments in brain surgery have been associated with stereotaxic X-ray images to guide the pathology guide system probe or other surgical instrument through the opening formed in the skull through the brain tissue to the target lesion or other body It is a stereotactic surgery involving a frame. Related developments are frame-less image induction where the image of the surgical instrument overlaps the pre-operative image to show the surgeon the location of the instrument and the additional movement trajectory of the probe or instrument. However, once the course guide system probe is removed, information regarding the location of any retractor or other surgical instrument that may be used during surgery can not be used.

Recently, surgical access systems have been developed to provide access to areas that were previously difficult to access. Such a conventional system is shown in Figs. 1A to 1C. The system 10 includes a retractor 20 and a introducer 40. The introducer 40 includes a conical distal end 42 having an opening 52 therein (best shown in FIG. 1C). The conical circle ends consist of mostly flat, flat surfaces. The introducer 40 located within the retractor 10 allows the system 10 to be inserted into the brain tissue and thereby push out the brain tissue while providing access to the area of interest. Once the system 10 is delivered to the area of interest, the retractor 10 is firmly secured in place. More specifically, using a standard or conventional neurosurgical fixation device, the retractor 10 is secured within the space. Once the retractor 10 is secured in place, then the retractor 10 is placed in its fixed position and the introducer 40 is removed from the retractor 10, thereby allowing passage through the brain tissue . However, there is no mechanism for providing career guidance information related to the retractor 10 with respect to the anatomy of the patient.

While the access system 10 may provide a way to access certain brain tissue, the blunt distal end may become damaged due to injury to the blood vessels, cranial nerves, fibers, and fibers after surgical cytoreduction It can actually cause temporary or even permanent deformations and trauma of the weak tissue structure, which itself may manifest as a temporary or permanent neurological deficit. As the introducer 40 is pushed through the tissue, the opening 52 can also cause coring of tissue, which also leads to tissue and structural damage. And because the position of the retractor 10 is firmly fixed, it is possible to release and reposition the retractor 10, even for minor movement of the retractor 10, without significant information about the peripheral structure associated with the available retractor 10. [ , The operation of the retractor 10 is delayed and requires constant attention, thereby increasing the operation time.

Another problem to solve is visibility. Typically, when employing an access system for surgical operations, it is often like surgery in a dimmed tunnel. In order to provide illumination, it is known to position the light source in an introducer barrel such as an endoscope. However, when using an endoscope, the light source occupies a considerable amount of work space in the introducer tube, thereby reducing the functional working area of other instruments and minimizing the ability to move other instruments within the surgical site.

Alternatively, the light should be transmitted from a remote or external location, such as a microscope or an exoscope. However, in the case of microscopes and external scopes, external light sources are often blocked by surgery and / or instrumentation at the surgical site. At the very least, the actual surgical operation and / or treatment is performed and the effect is greatly reduced at the distal end of the introducer tube where effective visualization is most needed.

Despite the above developments in both imaging technology and frame-based stereotactic image guidance techniques and frame-less stereotactic image guidance techniques, the need for improved brain tissue surgical surgical procedures and devices, including improved career guidance capabilities Remains.

There is also a need for improved and effective therapy and selection. Traditionally, a common and heavy chemotherapy protocol system, designed to provide a balance between sufficient poisoning to kill cancer cells and tissues without killing healthy tissues, The patient is treated with a "single size" High dose and multiple exposures to radiation are also commonly used and are provided by products such as Gamma Knife and Cyber Knife. However, these therapies are often just a series of "experiments" of patients in an effort to envision an effective treatment plan. Therefore, the patient must be observed to ascertain the effectiveness of comprehensive therapies and subsequent correction, attempting to balance the effects of saving healthy tissue and the intoxication effects of the entire patient ' s course, A change in therapy is performed based on positive or negative outcomes. These therapies effectively make the patient a guinea pig until the therapy is achieved to manage the disease or in most cases of brain tumors, until the patient dies of the disease. Unfortunately, in the case of brain tumors, patients often succumb to disease before effective therapy is achieved. Regardless of this heroic clinical effort, which is highly biologically corrosive to the patient, the present healing paradigm is rare. In fact, long-term clinical results of systemic chemotherapy or targeted radiation therapy are not known in these patients because patients diagnosed with brain tumors usually do not survive beyond 9-14 months after the initial diagnosis of the disease, If the patient survived long enough to be understood, it would be harmful.

In addition, most current treatment regimens involve systemically delivering immunotherapy or chemotherapy regimens, depending on the delivery through the bloodstream. However, the blood-brain barrier, which serves to separate circulating blood from the extracellular fluid in the central nervous system (CNS), is an additional factor in delivering therapeutic agents to certain areas of the brain through the bloodstream It causes difficulties. More specifically, the blood-brain barrier actually performs a neuroprotective role. Therefore, the blood brain barrier actually slows the delivery of the therapeutic agent to the brain. Therapeutic molecules, which may be otherwise effective at treatment, are typically larger molecules than blood cerebral sieves and, for this reason, do not pass through the blood brain barrier in an adequate amount. In addition to the blood-brain barrier, other devices such as the liver and kidneys, which filter foreign substances and chemicals, are present in the body. Such filtration causes additional difficulties in delivering an appropriate concentration of the therapeutic agent to the intended site of treatment for central nervous system disease.

In order to overcome the treatment problems associated with blood primers, a mechanical opening of the blood primer has been proposed, which can complicate the operation. In addition, the use of smaller particles has been proposed in which smaller particles (i.e., nanoparticles) have a size that passes through the blood brain barrier, and then recombination is attempted to form larger and more effective therapeutic molecules. However, in some cases, smaller particles are not recombined to therapeutic levels. Other means of piercing the blood brain barrier include temporarily opening the blood brain barrier to deliver chemicals designed to pass larger molecules of therapeutic levels through the blood brain barrier for a given period of time. When passing through the blood brain barrier, the treatment must still reach diseased tissues, resulting in harmful tissue as well as diseased tissue.

In addition, specific disease sites of the brain, such as cancer and other abnormal parts, may behave like viruses or bacteria in that the disease is often treated but not eradicated by treatment therapies delivered to the disease site, Lt; RTI ID = 0.0 > transmissible < / RTI > to the disease site. These residual, unaffected, abnormal cells can be transformed into cell variants that are resistant to previously delivered therapies. In the case of functional diseases, the effectiveness of treatment of brain tissue may be difficult to assess.

Thus, there is a need for effective therapies that overcome the difficulties caused by the blood-brain barrier, while providing targeted therapies to diseased tissues instead of healthy tissues and diseased tissues. There is also a need for a method of assessing the effectiveness of treatment.

Exemplary embodiments of the present invention will now be described in more detail with reference to the accompanying drawings.
Figures 1A-1C illustrate a conventional surgical access system.
Figure 2 is a cross-sectional perspective view of an exemplary configuration of a surgical access assembly.
Figure 3 is a perspective view of the outer barrel of the surgical access assembly of Figure 2;
FIG. 4A is a side view of the outer cylinder of FIG. 3; FIG.
4B is an enlarged cross-sectional view of a portion of the distal end of the outer tube of FIG. 4A.
Figure 4c is an enlarged cross-sectional view of a portion of an alternative embodiment of the distal end of the outer tube of Figure 4a.
5A is an end view of the outer cylinder of Fig. 3;
5B is an end view of an alternative configuration of the grip portion of the outer barrel.
5C is an elevational view of an alternative configuration of the outer tube and the grip.
FIG. 5D is a perspective view of the outer cylinder of FIG. 5C. FIG.
5E is a cross-sectional view of the outer cylinder according to the line 5E-5E in Fig. 5B.
FIG. 5F is an enlarged cross-sectional view of the area 5F in FIG. 5E.
6A is an elevational view of an alternative embodiment of the outer tube.
6B is an end view of the outer cylinder of Fig. 6A.
Figure 7a is a perspective view of the obturator assembly of the surgical access assembly of Figure 2;
FIG. 7B is an enlarged view of the end section of the obturator assembly according to region 7B of FIG. 7A.
8A is a top plan view of the obturator assembly of FIG. 7A.
8B is an enlarged view of the distal end of the occluder assembly according to region 8B of FIG. 8A.
8C is an alternate embodiment of the distal end of the occluder assembly according to region 8B of FIG. 8A.
8D is an alternative embodiment of the distal end of the occluder assembly according to region 8B of FIG. 8A.
9A is a side view of the obturator assembly of FIG. 7A.
Figure 9B is an enlarged view of a portion of the obturator assembly according to region 9B of Figure 9A.
Figure 10 is an end view of the obturator assembly of Figure 7a.
11A is a perspective view of an illumination ring operatively connected to an outer barrel of a surgical access assembly.
11B is a side view of the illumination ring of FIG. 11A.
11C is a top view of the illumination ring of FIG. 11A.
11D is a bottom view of the illumination ring of FIG. 11A.
11E is a cross-sectional view of an exemplary configuration of the illuminating device of Fig. 11A.
11F is a plan view of a circuit board used in the illumination ring of FIG. 11A.
FIG. 11G is an exemplary electrical schematic for use with the illumination ring of FIG. 11A.
11H is a plan view of an alternative configuration of the illumination ring of FIG. 11A.
FIG. 11I is a bottom view of the illumination ring of FIG. 11H.
Fig. 12 shows the illumination ring of Fig. 11a assembled in an exemplary embodiment of the outer tube.
Figure 13 is a flow diagram illustrating a process flow using a surgical access assembly.
14A and 14B are images of the brain representing the region of interest obtained using imaging modality.
Fig. 15 is an image obtained from the brain shown in Figs. 14A and 14B showing various important structures such as the fiber tract and fascicle of the brain.
16A is an alternative embodiment of a closure operably connected to an imaging device.
16B is an enlarged sectional view of the proximal end of the obturator and a partially exploded view of the post.
16C is an alternative configuration of a coil sensor used in a closure.
16D is an end view of the coil sensor mounted on the post of Fig. 16C.
17A is an elevational view of a surgical access system while the closure is being withdrawn from the outer barrel.
17B is an elevation view of a surgical access system in which the barrel is in place in the brain.
Figure 18 is a perspective view of an exemplary surgical device used for cytoreduction.
19A is an elevational view of an exemplary operating member.
Figure 19b is an elevational view of an alternative operating member.
Figure 19c is a top view of an outer cylinder operably connected to a first exemplary configuration of the retaining device.
Fig. 19D is an elevational view of the outer tube and holding device of Fig. 19C. Fig.
19E is a top view of an outer barrel operably connected to a second exemplary configuration of the retaining device.
Fig. 19F is an elevational view of the outer tube and holding device of Fig. 19C.
19g is a side view of an outer tube and an exoscope operatively connected to a third exemplary configuration of the retaining device.
19H is a perspective view of the outer cylinder, the holding device, and the outer diameter of Fig. 19G.
19I is an enlarged perspective view of the upper part of the outer tube showing the connection between the holding device and the outer tube.
Figure 19j is a top plan view of the top of the outer barrel, showing alternative connections of the retaining devices of Figures 19g and 19h.
20 is a partial perspective view of an exemplary delivery sleeve that may be used in a surgical device.
21A is an exemplary configuration of a treatment delivery device.
Fig. 21b is an alternative configuration of the therapy delivery device of Fig. 21a.
Figure 22 is a flow diagram illustrating the process flow of a follow-on treatment in which a surgical access assembly may be employed.

An exemplary approach to the disclosed assembly and method will now be described in detail with reference to the following description and also to the drawings. Although the figures illustrate some feasible approaches, the drawings are not necessarily to scale and some features may be exaggerated, removed, or partially separated to better illustrate and describe the present invention. It is also to be understood that the description provided herein is not intended to be exhaustive or to limit or limit the claims to the precise forms and configurations illustrated in the drawings and described in the following detailed description.

Described herein are surgical access assemblies, various components used in surgical access assemblies, and methods of using surgical access assemblies. The components disclosed herein provide the surgeon with an enhanced ability to minimize trauma to the patient, while providing an efficient, minimally invasive surgical technique, such as, for example, intracranial surgical techniques. The components disclosed herein may also be used for the application of targeted therapeutic therapies.

Referring to FIG. 2, a cross-sectional perspective view of a surgical access assembly 100 is shown. In one exemplary configuration, the surgical access assembly 100 includes a hollow outer tube 102 and an optionally removable obturator 104. As best seen in Figure 2, the obturator 104 is configured such that the distal end 106 of the obturator 104 is spaced a predetermined distance from the distal end 108 of the outer barrel 102, as will be described in greater detail below, So as to have a length longer than the length of the outer cylinder 102.

A locking member 110 may also be provided. As will be described in more detail below, the locking member 100 is configured to operably hold a separate, in-guided guide member 112 (shown in phantom) within the closure 104. The retaining member 114 may be secured within a portion of the closure 104 to prevent the locking member 110 from fully disengaging from the closure 104. [

Referring now to Figures 3-5, the outer tube 102 is described in greater detail. The outer cylinder 102 is defined as a distal end 108 and a proximal end 116 and includes a generally hollow body portion 118 and a grip portion 120. In one exemplary configuration, as shown in the figure, the grip portion 120 is comprised of a ring. However, it is understood that the gripper 120 need not be constituted as a ring. . The grip portion 120 is firmly fixed to the body portion 118 at the proximal end 116. In one exemplary configuration, the body portion 118 includes a transparent structure that permits observation of normal tissue, abnormal tissue as well as critical structures disposed outside the body portion 118 when the outer tube 102 is placed within the tissue Material. In one exemplary configuration, the outer tube 102 is comprised of polycarbonate, but other biocompatible materials, including resins, may be employed.

In another exemplary configuration, the outer tube 102 further includes an anti-glare feature. During surgery, due to the high intensity of light that can be transmitted by the illumination system, in some situations, the surgeon may experience glare, shadows due to reflections and fatigue of the surgeon. Indeed, the maximum amount of reflection and light bounce occurs from the inside of the inner diameter of the lumen 148 and from the walls of the body portion 118. As a result of reflection and light bounce, shadows can lead to clinical consequences associated with tissue abnormalities, including pseudo tissue differentiation.

To minimize this adverse effect, in one exemplary configuration, at least a portion of the outer barrel 102 may be made non-repulsive, but may still be disposed of through a wall of the body portion 118, And to observe critical structures. One way to create an anti-reflection surface is to create a texture on the surface of the body portion 118. However, to minimize trauma or wear to the soft tissue as the body portion 118 moves toward the target area, the inner surface of the lumen 148 is formed to have a textured surface to maintain a smooth outer wall while a frosted surface . Texture formation can be achieved by a molding process used to produce the outer casing 102. Alternatively, post-manufacturing processes such as, for example, grit blasting, chemical etching or abrasive honing processes may be employed. With this configuration, the outer surface of the body portion 118 remains relatively smooth, thereby eliminating any possibility of creating a wear surface when the body portion 118 traverses brain tissue or other critical structures . The abrasion-proof feature of the outer surface of such an outer surface is such that the surgical access assembly 100 is positioned below the cerebral cortex of the brain tissue and the surgical access assembly comprises a piarachnoid / Allow surgery to traverse the arachnoid. In addition, the anti-reflection treatment of the inner surface of the lumen 148 achieves the same light distribution at the surgical site, reducing the occurrence of pseudo-tissue differentiation. Proper light distribution is very important when a user tries to visually judge a healthy tissue from an unhealthy tissue that requires removal.

In one exemplary configuration, an imaging device that can visualize in real time tumors, blood vessels, fiber tracks, fascicles, and even healthy tissue can be integrated into the outer tube 102. Indeed, as will be described in more detail below, the imaging mechanism allows the physiological functional imaging to provide information about the characteristics of the cortical fibers to be visualized, thereby allowing the user to gain access to the desired location in the brain , Such fibers can be cut and positioned on both sides of the outer tube 102, instead of cutting, stretching and potentially damaging them. And, as will be described in more detail below, the imaging mechanism also allows the surgeon to position the outer tube 104 and then, in the course of an abnormality resection procedure therethrough, Information can be obtained. In addition to imaging with white matter tract, mapping of cerebral blood flow characteristics can be obtained.

In one exemplary embodiment, the imaging mechanism may be an ultrasonic probe integrated into the outer tube 102. For example, the outer tube 102 may have one or more channels within the wall defining the outer tube 102 configured to include one or more small diameter ultrasonic probes. In another configuration, a single ultrasonic probe configured to be received within the outer tube 102 may be provided. In another embodiment, a low field MRI probe may be selectively positioned within the outer tube 102 to provide improved imaging. In another embodiment, a low magnetic field MRI imaging coil may be molded or bonded into the outer casing 102. In another exemplary configuration, the probe may be optical coherent tomography (OCT) imaging or spectroscopy.

In another exemplary configuration, as will be described in greater detail below, the outer tube 102 may also (or alternatively) be configured to "read" the position of the outer shaft 102 after the user is positioned in the region of interest And may have a career guiding ability to update the position of the outer barrel 102 during surgery. In one exemplary configuration, an RFID chip or sensor configured to be tracked by a navigation system may be integrated into the barrel 102. For example, the RFID chip or sensor may be permanently attached to the outer tube 102, for example, by impregnating or shaping the RFID chip or sensor into the outer tube. In another exemplary configuration, a temporary sensor or chip may be integrated or attached to the outer casing 102. For example, the outer cylinder 102 may have one or more channels within the wall defining the outer cylinder 102. RFID chips and / or sensors may be located within the channel. Alternatively, the RFID chip and / or sensor may be located within the gripper 120.

In yet another alternative configuration, an RFID chip or sensor may be mounted to the grip 120. And, in another configuration, a reflective ball may be mounted on the distal facing side (best seen in Figure 3) of the grip 120 (similar to that described below with reference to Figures 11h and 11i) ). The reflective ball acts as an image-guided position indicator, such as an array of reflectors of the type used in connection with an optical image guidance system. The infrared reflector balls used with these systems are mounted in a conventional triangular configuration adapted to identify the outer tube to an image / navigational guidance system.

The distal end 108 of the outer barrel 102 is tapered to a tapered portion 108 extending toward the central axis AA of the outer barrel 102 with a distal edge 132 surrounding the opening 134 at the distal end 108 of the outer barrel 102 130). The tapered portion 130 defines the body portion 118 of the outer barrel 102 from the diameter defining the body portion 168 of the obturator 104 without drag, trauma, or coring of the tissue. Thereby facilitating the transition between the outer cylinder 102 and the distal distal end 172 to a certain extent. In one exemplary configuration, the distal end 108 has a radius or other configuration to create a smooth / atraumatic transition of the brain tissue when the surgical access assembly 100 is inserted into the brain Respectively.

For example, as best seen in Figure 4B, the distal edge 132 is configured to be curved rather than sharpened. In one exemplary configuration, the distal edge 132 is configured as a rim curved with a 0.3 mm diameter. The tapered portion 130 and the curved distal end 132 cooperate with the obturator 104 to provide tissue and various structures in the brain including the white matter without cutting the tissue or such structure from the outer tube 102 without trauma Move it away. In fact, unlike the prior art devices that include a blunt tip or tapered leading edge as shown in FIG. 1C, the curved distal tip 132 is tapered 130 and the closure 104 Interlocking to prevent bruising and damage of various tissues. More specifically, this configuration facilitates entry of the outer tube 102 into the soft tissue without severing the soft tissue. The insertion of the surgical access assembly 100 is described in more detail below.

The body portion 118 may further include a plurality of spaced indicators 136. 3, the indicator 136 extends generally around the periphery of the body portion 118, and each indicator further includes a secondary indicator 138 that visually indicates a predetermined position in the body portion 118 can do. Although FIG. 3 shows four indicators 136, it is understood that the body portion 118 can have various lengths and the indicator 136 can be provided in any number. The body portion 118 may also include a longitudinal indicator 140. More specifically, as best seen in FIG. 4A, the longitudinal indicator 140 extends from the proximal end 116 to the distal end 108. Indicators 136,138 and 140 may be formed of a material such as, for example, fluro-deoxyglucose (FDG), Technicium 99, Gadolinium, titanium powder, barium sulfate sulfate, combinations thereof, or other suitable imaging materials, such as inks or other imaging materials. Indicators 136 and 138 provide a reference point to the operator of system 100 as the structure may be viewed through body portion 118. Indicators 136, 138, 140 may also be configured to be viewable with MRI, CT, PET, or any other suitable imaging technique to enable easy identification of the region of interest. In one alternate embodiment, the indicators 136, 138 and / or 140 may be etched or printed on the body portion 118, i.e., the inner or outer surface of the body portion 118.

The details of the gripper 120 are best shown in Fig. The grip portion 120 is configured as a flange member 142 that is generally defined as an outer rim 144 and an inner opening 146. The inner opening 146 may have a size corresponding generally to the diameter of the lumen 148 defined by the body portion 118. The outer surface 144 has a size that is larger in diameter than the lumen 148 of the body portion 26. The flange member 142 may further include one or more small openings 150 disposed therein. In one exemplary arrangement, a plurality of small openings 150 are provided that are generally equidistantly spaced about the inner opening 146. The small opening 150 is described in more detail below. The outer shell 144 may further include a textured surface 152 to facilitate gripping the outer tube 102. For example, in one exemplary configuration, the textured surface 152 includes a plurality of alternating ridges 154 and grooves 156. [ However, it is understood that a surface having a different texture may be employed.

An alignment feature 160 disposed on the proximal end surface 158 of the flange member 142 may be employed. The alignment feature 160 is used to indicate the position of the longitudinal indicator 140 when the barrel 102 is positioned within the brain. The alignment feature 160 is described in more detail below.

An alternative embodiment of the outer tube 202 is shown in Figures 6a and 6b. The outer tube 202 is similar to the outer tube 102 in that it is defined by a distal end 208, a proximal end 216 and a body portion 218. The distal edge 232 is configured to resemble the distal tip 132 generally. So that the phage ring 220 is firmly fixed to the body portion 218.

The phage ring 220 also includes a textured surface 252. The grip ring 220 further includes a positioning member 262. Positioning member 262 is configured to operably connect an illumination ring (best shown in FIG. 11A) 300 to outer cylinder 102. The positioning member 262 extends outwardly from the outer periphery 244 of the grip ring 220, as can be seen in one exemplary arrangement. The positioning member 262 may also serve as an alignment feature indicating the position of the longitudinal indicator 240. Alternatively, a separate alignment feature 260 may be provided. For example, in FIG. 6B, the alignment feature 260 is positioned adjacent to the positioning member 262.

The body portion 218 may also have indicators 34, 36, 38 that assist in positioning the outer tube 202 during surgery. However, in other alternative arrangements, the body portion 218 may have an indicator 264 that results in signal void or minimal artifact in a particular imaging technique. In one particular configuration, as shown in FIG. 6A, the indicator 264 may be configured as a small hole spaced a predetermined distance apart. In yet another alternative configuration, the indicator 264 may be configured as a non-penetrating groove (divot). In yet a further alternative configuration, the indicator 264 may be configured as a longitudinal groove (not shown) formed on the inner or outer surface of the body portion 218.

In one exemplary configuration, the proximal end surface 158 may include at least one retention notch 161, as described in U.S. Patent No. 13 / 786,062, the contents of which are incorporated herein by reference in its entirety. As shown in FIGS. 5B-5D, the retaining notch 161 extends from the outer periphery 144 to the periphery of the inner opening 146. As described in U.S. Patent No. 13 / 786,062, the retention notch 161 may be a string or cord from a surgical patty, other absorbent or protective surgical sponge or other object that is temporarily positioned within the outer barrel 102, thereby maintaining the cord.

Additional exemplary features of the outer tube 102 are shown in Figures 5e and 5f. For example, as best shown in FIG. 5F, at least one outer lip 163 is provided on the outer surface of the outer tube 102. In one exemplary configuration, the lip 163 is tapered inward toward the distal end of the body portion 118 to create a flange portion 165 on top of the lip 163, Section. The outer lip 163 is spaced from the bottom surface of the grip portion 120 and creates a channel 167 disposed about the outer surface of the body portion 118 to be described in more detail below.

In one exemplary configuration, a plurality of outer ribs 163 are disposed around the outer surface of the body portion 118. More specifically, as best shown in Figs. 5C and 5E, the lips 163 can be arranged equidistantly with the flange portions 165 aligned substantially in a common plane. In this manner, a continuous channel 167 is created by the cooperation of the flange portion 165 and the bottom surface of the grip portion 120. It is understood, however, that a continuous lip 163 can be formed around the entire periphery of the body portion 118, so that a continuous ring is formed by the flange portion 165. [

In another exemplary configuration, as shown in phantom in Figure 5f, a plurality of ribs 163 'may be formed in series in the distal direction along the outer cylinder 102. With this configuration, a plurality of channels 167 'are formed.

Referring now to Figures 7 to 10, a closure 104 is now described. The occluder 104 is defined as a distal end 106, a proximal end 166, a body portion 168, and a handle portion 170. Distal end 106 is configured with a generally conical distal tip 172 that tapers to distal member 174 to provide a non-traumatic extension of tissue. In one exemplary configuration, the tip 172 is tapered toward the closed tip member 174 to prevent coring of tissue when the closure 104 is inserted into the brain.

There are a number of variables that serve to select the angle [alpha] defining the taper of the tip 172. These variables, the outer diameter (D ₁₎ in size, the distal tip portion 172, the body portion distal end and the distal end member 174 of the desired length, and a course guide member 112 extending from portion 168 of the pyeswaegi 104 Lt; / RTI > More specifically, the surgical access assembly 100 is provided as part of a kit that may include an outer tube 102 and a closure 104 having a plurality of sizes to allow the surgeon to select a different diameter size and length To provide flexibility for access to areas of interest within the brain. However, in order to ensure that the distal tip 174 can be determined independently of the size diameter D ₁ of the obturator 104 used, the taper angle? Can be selectively adjusted. In an embodiment that utilizes a career guide member 112 that positions its distal end in a set position in the occluder 104 (as described in more detail below), a closure 104 having a different diameter (D ₁ ) The taper angle? Should increase as the diameter D ₁ increases, in order to maintain the same offset length between the distal and distal ends 174 of the career guide member 112.

For example, if diameter (D ₁ ) of occluder 104 is 13.5 mm, then an exemplary non-traumatic dilatation, and an exemplary angle? Capable of providing a determinable distal tip 174 position, may be 45.5 ° have. However, if the diameter D ₁ of the obturator 104 is 15.5 mm, then an exemplary angle α 'may be 52.8 °.

As best seen in FIG. 8B, the distal tip 174 is configured to be curved so that the distal member 174 is round, non-rigid or non-sharp. More specifically, tip member 174 is configured to have no flattened portion that may stretch or tear soft tissue such as blood vessels, fibers and fibers found in the brain upon insertion. And, because the tip member 174 is closed, damage to such soft tissue and fibers is also prevented. In one exemplary embodiment, the tip member 174 is configured to have a radius of 0.5 mm. As will be described in more detail below, the configuration of the tip member 174 is designed to smoothly remove and move the tissue into which the tip member is inserted; That is, when the surgical access assembly 100 is inserted into a tissue, it allows introduction into the intra-fascilar manner and para-fascilar manner, as opposed to cutting the tissue. Gt; tissue < / RTI >

The handle portion 170 is located at the proximal end 166 of the closure 104. [ 7A, 7B, 8A and 9A, the grip portion 170 includes a stop member 176 and a grip member 178. As shown in Figs. The stop member 176 is positioned over the circle of the gripping member 178 and has a diameter D ₁ of the body portion 168 and a diameter D _{1 of the} outer tube 102 (shown in FIG. 4A) (W ₁ ) as compared with the width (D ₂ ). Gripping member 178 is configured to have a width (W ₂₎ than the width (W ₁₎ of the stop member 176, provides a configuration of the step-shaped. The stop member 176 further defines an engagement surface 177 that is axially spaced from the distal surface 179 of the gripping member 178. [

In one exemplary configuration, as best shown in FIGS. 7A, 7B, and 10, the handle portion 170 is configured to have a generally planar surface 180. The plane 180 is configured to have a receiving opening 182 configured to receive the locking member 110. In one exemplary configuration, the receiving opening 182 is threaded. As best seen in Figs. 2, 7B and 8A, an engagement opening 184 is disposed in the receiving opening 182. The engaging opening 184 communicates with a channel 186 (shown in phantom in FIGS. 8A and 9A) that extends at least partially over the handle portion 170. After the locking member 110 is at least partially engaged in the receiving opening 182, the retaining member 114 (FIG. 2) is positioned within the channel 186. A portion of the retaining member 114 extends transversely across a portion of the receiving opening 182 such that the locking member 110 generally extends from the receiving opening 182 to the receiving opening 182 because the engaging opening 184 is open into the receiving opening 182. [ It is prevented from being drawn out. For example, the locking member 110 is shown having a thread cooperating with a corresponding female thread in the receiving opening 182. The retaining member 114 is positioned within the channel 186 to extend over the threads of the locking member 110 such that when the locking member 110 is removed from the receiving opening 182 the thread is in contact with the retaining member 114 , So that the locking member 110 is prevented from being completely removed from the grip portion 170.

An access opening 188 is formed through the proximal end 166. The access opening 188 extends through the handle portion 170. In one exemplary configuration, the access opening 188 may have an inwardly extending chamfered portion 189 that tapers toward the access opening 188. The chamfered portion 189 provides a self-directing feature for inserting the career guide member 112 into the access opening 188. The access opening 188 communicates with the first channel portion 191 that extends through the handle portion 170 and into the body portion 168.

As shown in Figure 8d, the obturator 104 may also be configured to receive an obturating member 167 that is operatively connected to the obturator. More specifically, the conical tip 172 may be configured to have one or more viewing windows 169 oriented at the same height as the surface of the conical tip 172. The observation window 169 communicates with an observation member channel 171 that can selectively receive an observation member, for example, an optical fiber cable or an ultrasonic probe. The observation member may additionally be present in the use of the career guide member, or may alternatively be present. Observation members allow the surgeon to observe surrounding tissues and vital tissue structures in real time (i.e., during the insertion process), minimizing trauma during insertion.

The body portion 168 extends between the distal end 106 and the proximal end 166. The body portion 168 includes one or more elongate void areas 190. The cavity area 190 serves to reduce the weight of the obturator 104 to facilitate manipulation of the obturator 104 during a surgical procedure. Cavity region 190 also allows for sterilization of closure 104 by moisture retention within body portion 168 of closure 104. The cavity region 190 also provides venting to prevent a vacuum from being generated when the obstructor 104 is withdrawn from the outer tube 102 during operation (i.e., a plunger effect).

The cavity region 190 is separated by a web portion 192 extending axially through a portion of the length of the body portion 168. One or more indicators 194 are disposed on the web portion 192 of the body portion 168. Indicator 194 is indicative of a spaced hash mark (not shown) associated with an imaging technique that provides information in real time about the location of the occluder 104 relative to various tissues, critical structures, and fibers within the brain while the occluder 104 is located within the tissue. (indicated by 194a). Indicator 194 also assists in providing information about the relative position between the closure 104 and the outer tube 102. Indicator 194 generates a signal loss or minimum noise with a specific imaging technique.

The body portion 168 may further include one or more cross webs 196. The transverse webs 196 are oriented to traverse the web portion 192 to connect the web portions 192 together. In one exemplary configuration, the body portion 168 includes at least one transverse web 196 that operatively defines the outer diameter D2 of the body portion 168. The cross- The diameter D ₂ is sized to fit within the lumen 148 of the outer tube 102 such that the closure 104 and the outer tube 102 can selectively slide relative to each other. However, the diameter D ₂ also has a size that minimizes or even eliminates any clearance between the inner surface of the outer tube 102 and the outer surface of the obturator 104. In the exemplary configuration shown in FIGS. 7-9, three transverse webs 196A, 196B, 196C are provided. First transverse web 196A is connected to distal tip 172 while second transverse web 196B is proximal from first transverse web 196A and separated by cavity region 193. The third transverse web 196C is separated from the second transverse web 196B by the hollow region 192 and is located on a circle from the first stop member 176 of the handle portion 170. [ The transverse web 196 serves to provide structural integrity and improved stiffness of the obturator 104.

One or more of the transverse webs 196 may further include one or more compensating protrusions 197 to accommodate slight manufacturing variations in the diameter of the lumen 148 of the outer tube 102. In one exemplary arrangement, For example, it is contemplated that the outer barrel 102 may be a part that is molded into a resin, which can cause some such manufacturing variations. The compensating projection 197 extends a little radially outward from the outer surface of the closure 104 and is in communication with the lumen 148 of the outer tube 102 to prevent the closure 104 from being damaged by some flexibility of the resin of the outer tube 102. [ Creating a frictional fit between the outer surface and the lumen 148. By using the compensation projection 197, the need to maintain large dimensional tolerances of the outer tube 102 during production can be reduced.

The compensating projection 197 also creates a slight open fit between the outer cylinder 102 and the closure 104 to provide an exhaust feature. More specifically, the compensating projection 197 cooperates with the inner surface of the lumen 148 to provide at least one annular gap at the distal end of the outer tube 102 when the surgical access assembly 100 is in the assembled configuration. . Thus, any potential intracranial pressure generated during insertion of the assembled surgical access assembly 100 when positioned within a subcortical space, such as a cystic tumor, intracerebral hematomas, and trauma, (ICP) spike or increase.

In one embodiment, the transverse web 196B has a second channel portion 198 (shown in phantom) extending therethrough. The second channel portion 198 is axially aligned with the first channel portion 191 and is configured to selectively receive the career guide member 112. In one exemplary configuration, as best seen in FIG. 9B, an inwardly extending depression 199 is disposed within the first transverse web 196A. The depression 199 is configured to align the distal end of the career guide member 112 with the distal end 108 of the outer barrel 102 when the outer barrel 102 is assembled to the obturator 104.

Referring now to Figures 11A-11F, the details of the optional illumination ring 300 are now described. The illumination ring 300 is generally defined by the top surface 302 and the wall member 304. A circuit board 306 may also be provided. As will be described in greater detail below, the top surface 302 includes at least one access opening 308 configured to receive one or more surgical instruments through the top surface. Additional small apertures 309 may be provided on the top surface 302. One or more of the small openings 309 are configured to align with the small openings 150 disposed on the flange member 142. The wall member 304 extends from the top surface 302 to create a cavity 310 that is open in the illumination ring 300. The outer surface of the wall member 304 may be textured (not shown) similar to the grip portion 120.

One or more optical elements (312) are supported by a portion of the illumination ring (300). 11E, the optical element 312 is fixedly mounted to the top surface 304 such that it faces inward toward the cavity 310, which is open proximate the access opening 308. In the embodiment shown in FIG. Each optical element 312 is electrically connected to a remote power source (not shown) by wires 314. In one exemplary configuration, the wire 314 may be held in a channel formed in the top surface 302 around the access opening 308.

In an alternative configuration (FIG. 11F), optical element 312 may be integrated within circuit board 306. The circuit board 306 is configured to have an access opening 316 that can be aligned with an access opening 308 formed in the top surface 302. And, the circuit board 306 also has a size that is located and fixed within the open cavity 310. In other words, in one configuration, the circuit board 306 has a size with an outer diameter that is smaller than the inner diameter defined by the wall member 304. A wall opening 318 may be formed through the top surface 302 or a portion of the wall member 304 to provide access to the wire 320 to electrically connect the circuit board 306 to the power source. Examples of wall openings 318 can be seen in Figures 11b, 11d and 11f. The circuit board 306 may be configured to generate a constant light output when the illumination ring 300 is turned on and in a steady state.

An exemplary circuit design 321 of circuit board 306 is shown in FIG. In an exemplary configuration, the circuit design 321 may be configured to prevent flickering of the optical element 312 and / or to prevent operation of fewer optical elements compared to all of the optical elements 312 during use of the illumination ring 300. [ do. More specifically, the circuit design 321 is such that when one of the optical elements 312 is burned or the battery that supplies power to the circuit is degraded, the illumination ring 300 is simply blocked and the replacement battery pack (not shown) ) Can be used.

In one exemplary configuration, optical element 312 is an LED optical element, but other optical devices may be utilized. The LED light element does not contribute significantly to the weight of the surgical access assembly 100 and also emits a significant amount of heat that is non-clinical. In addition, the LED light elements emit light having a different combination of colors / frequencies that can be incorporated into the illumination ring 300, thereby enhancing the visualization of the fluorescing dye to allow tissue identification.

The use of LED light elements also allows the endoscope to be used with the surgical access assembly 100, without the accompanying optical fiber source. This configuration significantly reduces the required overall outer diameter of the endoscope and improves the working space within the lumen 148 of the outer tube 102. More specifically, the lumen 148 of the outer tube 102 has more available work space, thereby increasing simultaneous use of multiple device devices and improving visualization. And, since the conventional endoscope device must be attached to a support structure that is fixed to an introducer cannula, the weight of such an assembly tends to pull the introducer cannula in one direction. This action may impair the placement of the intubation cannula during surgery and / or may result in trauma to the brain tissue. Therefore, by integrating the illumination ring 300 into the outer cylinder, this potential drawback can be avoided.

In one exemplary configuration, the illumination ring 300 is configured to support the illumination ring 300 in the grip portion 120 of the outer tube 102 in any suitable manner, while the illumination ring 300 can be secured to the grip portion 120 of the outer tube 102 in any suitable manner. 120, respectively. In one exemplary configuration, the wall member 304 has a locking channel 322 best seen in FIG. 11B. The locking channel 322 includes a wall opening 318 and opens into a second channel portion 326 that is in communication with the first channel portion 324 and the first channel portion 324. The wall opening 318 extends from the bottom surface 328 of the wall member 304. The second channel portion 326 is spaced upward from the bottom surface 328 of the wall member 304 and is oriented at an angle from the first channel portion 324. In one exemplary configuration, the second channel portion 326 is oriented at 90 [deg.] From the first channel portion 324.

The locking channel 322 interlocks with the positioning member 262 to selectively fix the illumination ring 300 to the gripper 120. [ More specifically, the illumination ring 300 is pushed down from the top of the grip 120 by the positioning member 262 entering the wall opening 318. As the illumination ring 300 is pushed downward, the positioning member 262 moves through the first channel portion 324. When the positioning member 262 contacts the end portion 330 of the first channel portion 324, the illumination ring 300 is rotated with respect to the outer tube 102 such that the positioning member 262 is rotated with respect to the second channel portion 324. [ The illumination ring 300 can be selectively locked into the outer cylinder 102, as shown in Fig. Once the illumination ring 300 is connected, it provides a hands-free light source that illuminates the lumen 148 of the outer tube 102 accordingly.

As noted above, in one exemplary configuration, a particular portion of the outer tube 102 may be frosted to reflect light to increase visualization within the outer tube 102. For example, in addition to, or alternatively to, the inner surface of the lumen 148, the inner surface of the tapered portion 130 may be frosted as this portion is closer to the surgical site. In another exemplary configuration, a portion of the grip portion 120 may also be frosted. In this configuration, the upper surface of the grip ring 102 may have a texture, since this surface will not contact the tissue.

11H and 11I, an alternative configuration of illumination ring 350 is shown. The illumination ring 350 is similar to the illumination ring 300 and includes an upper surface 302, a wall member 304, an access opening 308, an open cavity 310, a small opening 309, Are also shown in Figs. 11H and 11I. The embodiment shown in Figs. 11H and 11I further includes an outwardly extending flange member 352. Fig. In one configuration, the flange member 352 is integrally formed with the outline of the illumination ring 350. It is understood that the illustrated embodiment includes three flange members 352 spaced equidistantly around the perimeter of the wall member of the illumination ring 300, but any number of flange members 352 may be provided . And, in an optional configuration, the flange member 352 may be disposed around the periphery.

In one exemplary configuration, the flange member 352 supports a sensor 354 (see FIG. 11I) or a reflective ball that serves as a position indicator. More specifically, the sensor 354 is configured to detect the position of the outer tube 102 during and after the insertion of the illumination ring 300 into the outer vessel 102, As will be described in more detail below. In one configuration, the sensor 354 can be molded in the flange member 352 or bonded onto the flange member 352. In another configuration, the sensor 354 may be temporarily attached to the flange member 352. For example, the flange member 352 may each include a groove in which the sensor may be positioned, and a retaining ring may be secured over each sensor 354 to temporarily secure the sensor to the flange member 352. [

In another exemplary configuration, sensor 354 may be powered via circuit board 306. More specifically, the sensor 354 may be electrically connected to the circuit board 306. An additional wire electrically connects the circuit board 306 to the power source to provide power to the sensor 354 as well as the optical elements that accompany the illumination ring 350.

In yet another alternative configuration, a support ring (not shown), which may be selectively mounted to the grip portion 120 of the outer tube 102, may also be provided. The support ring is configured to extend at least partially around the outer cylinder 102 and a career guiding element such as an RFID chip or sensor can be secured thereto. As with the illumination ring 350, when the support ring is secured to the outer barrel 102, the position of the outer barrel 102 can be "read" by the career guidance system. In another configuration, the support ring may be configured to support reflective elements, such as reflective balls. The support ring may alternatively be configured to attach to the illumination ring 300 instead of the outer tube 102.

It is understood that the position of the career guidance element is not limited to the position on the flange member 352 or the support ring. It is also contemplated that the career guidance sensor may be embedded in the wall of the outer barrel 108. [ A separate array, for example, a reflective ball, may be stamped on a retaining member, such as a ring, configured to be disposed about the body portion 118 of the outer tube 102. As will be described in more detail below, a retaining member having an array may be disposed within the channel 167.

The ability to independently guide / track the position of the outer tube 108 advantageously allows the user to track the trajectory of the outer tube 108 when the surgical access assembly 100 traverses tissue. In addition, tracking of the outer tube 108 can be used to initiate activities of other devices. For example, if one device tracks the location / movement of the outer tube 108, then another device, such as a camera and / or light source attached to the robot arm, may be instructed to maintain the relationship between the camera and the outer tube 108 have. In this example, the camera maintains coaxial alignment with the lumen 148 of the outer tube 108 to deliver optimal light for optimal visualization (because the camera is attached to the robot arm) Maintains the magnification and focus of the distance of the camera from the outer tube 108 and automatically maintains the visualization at the surgical site without requiring any subsequent adjustment of the middle optical system. This feature reduces user fatigue and improves operating efficiency since movement of the outer barrel 108 during surgery does no longer require continuous adjustment of the light source and / or the camera.

The operation of the surgical access assembly is described with reference to the process flow 400 shown in FIG. Generally, before any surgical operation is determined, the patient will first be experiencing a symptom or disorder requiring evaluation. Thus, the start of the process flow 400 begins with the surgeon determining 402 the cause of such neurological symptom / disorder. Such determination may be made using a variety of imaging techniques, including, but not limited to, MRI or CT imaging. The process then proceeds to step 404.

If it is determined in step 402 that a brain disease such as a tumor or hematoma has been found, additional judgment is required. More specifically, the location of the brain disease is judged at step 404. If the imaging determines that the region of interest is located in the interior axial / cortical space, the process flow continues to step 406. However, if the brain disease is located in another, more easily accessible area of the brain, the process flow is stopped.

As noted above, any suitable imaging technique may be utilized to determine whether or not brain disease is present, and where, therefore, brain disease is located. 14A and 14B show examples of imaging results by MRI. More specifically, the region of interest 500, in this case the tumor, can be seen deep within the cortical subspace.

Once the area of interest 500 is located, in step 406, additional imaging sequences are used to determine the location of vital structures such as blood vessels and fibers and associated fibers, to envisage the safest approach path to the area of interest Is adopted. An exemplary configuration for performing this step includes CT-angiography and MRI using a Diffusion Tensor Imaging (DTI) sequence. The DTI allows the determination of the diffusion direction and scale of water along the passageways " wiring " This kind of MRI imaging can provide imaging that allows for the determination of the potential damage of the nerve fibers that connects the area of the brain that can be affected by the stroke, for example, to a region of the brain farther therefrom It can also be used to visualize white matter fibers in the brain, mapping (tracking images) subtle changes in white matter associated with diseases such as multiple sclerosis and epilepsy, treating schizophrenia and It is possible to evaluate diseases where brain wiring is abnormal such as tumor involvement.

Diffusion Tensor Tractography (DTT) can also be used. DTT allows the noninvasive racking of nerve fiber processes in living human brains. By tracking the fastest diffusion direction assumed to correspond to the longitudinal axis of the nerve tract, the white matter fiber trajectory is reconstructed throughout the brain. Diffusion tensor nerve bundle tracking provides insight into white matter integrity, fiber connectivity, surgical planning and patient prognosis. Once the imaging information is analyzed, the next process proceeds to step 408.

Referring to Fig. 15, an example of DTI imaging of the brain shown in Figs. 14A and 14B is shown. A map of the fibers and other blood vessels including the main blood vessels 502 appearing around the region of interest 500 is shown in FIG. This image provides the surgeon with valuable information relating to the potential approach to the access nerve to the area of interest 500.

In step 408, a plan for the operative trajectory is developed. More specifically, the imaging information is used to plan the approach neurons / passageways (using manual or software) to achieve metastasis to the fiber during approach to the area of interest. When evaluating metastasis from potential access nerve / pathways to fibers, the importance as a fiber can be considered based on the occupational and personal needs and / or preferences of individual patients. Once the passageway is planned, the next process proceeds to step 410.

In step 410, image data from the MRI / DTI and CT / CTA image sequences acquired during step 406 are input to the intraoperative guidance system. The intraoperative tour guide system can be used to provide a direct visualization of the area of interest 500 in real time as the surgical access system 100 is located within the brain. The next method proceeds to step 412.

Once the operation is planned and the image data is uploaded to the career guidance system, step 412 requires that the appropriately sized surgical access assembly 100 be selected. First, the appropriate size of the craniotomy should be determined. The present invention also contemplates that different diameters and length sizes of the surgical access assembly 100 may be employed and that the size is determined by the particular location of the area of interest 500. [ Thus, step 412 requires the surgeon to select the appropriate length and diameter of the surgical access system 100 to be used, based on the physical and location characteristics of the area of interest 500. Once the surgical access assembly 100 is selected, the process proceeds to step 414.

In step 414, the surgeon creates a dorsal and dural approach incision. The process then proceeds to step 416. [

In step 416, the closure 104 is inserted into the outer cylinder 102 until the gripper 120 contacts the first stopper member 176, for example, as shown in Fig. The career guide member 112 is then operatively connected to the closure 104. As shown in Fig.

As described above, various types of career guide members 112 may be employed in the surgical access assembly 100. In one exemplary configuration, the career guide member 112 is configured as a probe (as shown in FIG. 2). In this configuration, the guide guide member 112 is moved to the approach opening 188 of the gripping member 178 until the distal end 417 of the career guide member 112 is positioned within the depression 199 (see FIG. 9B) Lt; / RTI > The depressed portion 199 has a distal end 471 of the guide member 112 when the closure 102 and the outer cylinder 104 are assembled together as shown in Figure 2 to the distal end 132 of the outer cylinder 102, As shown in Fig. The locking member 110 can be tightened to hold the career guide member 112 fixedly in the closing device 102. [ A portion of the career guide member 112 may extend proximal from the gripping member 178 and may include a screen that visually indicates the information obtained from the imaging sequence along with the trajectory of the surgical access system 100. [ As shown in FIG. Therefore, while the surgical access system 100 is being guided in the body, the position of the distal end 132 of the outer tube can be displayed in real time by the career guide member 112 operatively connected to the course guide system have.

In another configuration, software for operating the course guidance system may further include an offset dimension corresponding to the distance (D ₃₎ between the distal tip 174 and outer tube of the distal tip 132 of the pyeswaegi 104. In this configuration, a dotted line may appear on the career guidance screen that displays in real time where the distal end 174 of the occluder 104 is located.

The career guide member 112 may further comprise an image-guided position indicator, such as an array of reflectors of the kind used in connection with the optical image guiding system. An infrared reflector used in such a system is mounted to the handle of a probe-shaped career guide member 112 in a conventional triangular configuration that is calibrated to identify the tool for the image guidance system. Such imaging systems are available, for example, Medtronic Surgical Navigation Technologies (Denver, Colo.), Stryker (Kalamazoo, Mich.) And Radionics (Burlington Mass.).

Typically, the positioning of the indicator is calibrated so that the image guidance system can project the image of the tool onto the display of the image of the patient's brain, such as an MRI image used to plan the operation. Thus, as discussed above, as the surgical access system 100 is inserted, the surgeon can see the relative position of the system 100 relative to the structure of the brain reflected on the image, in particular, the target tissue.

Other guidance systems, such as magnetic or electromagnetic or radio transmission systems, may also be used, and the description of the city and optical image guidance system of the infrared reflector is merely exemplary and is not intended to be limiting. Also, while the exemplary method has been described in terms of overlapping images of the surgical access system 100 over the pre-operative image, real-time imaging capabilities may be utilized, and then the image of the surgical access system 100 may be viewed in real- It is contemplated that they may appear in association with the surrounding tissue structure on the image.

In another exemplary configuration, an RFID chip operatively communicating information about a particular attribute, such as, but not limited to, length and diameter, to a career guidance system or other surgical surgical system may be embedded in the occluder 104 . This information can be used during positioning of the occluder 104 to facilitate positioning with a career guidance system or other information display or system for locus and position calculation.

In another exemplary configuration, an alternate embodiment of the occluder 504 may be used, as shown in Figs. 16A and 16B, and the occluder 504 may include a post (not shown) configured to operatively attach the career guided array 512). The post 512 may be releasably or permanently connected to the gripping member 578 of the closure 104. [ For example, as shown in FIG. 16A, the post 512 may be selectively removably configured and used to hold a small coil 513 for MRI tracing of the surgical access assembly 100. A thread may be formed on a portion of the post 512 and an access opening 588 formed in the proximal face of the retaining member 578 may be provided with a corresponding thread (not shown) to attach the post 512 to the closure 504, Respectively. Other ways of selectively attaching the post 512 to the occluder 504, including but not limited to a locking member 110 configuration similar to that shown in FIG. 2, are also contemplated. Also, as described, post 512 need not be selectively removable. In fact, the post 512 may be permanently attached to the obturator 504 in any suitable manner, whereby it is contemplated that the career guidance array may be secured to the post 512. In another alternative configuration, the closure 504 may be configured such that a post, which is an element of the array itself, may be attached.

16C and 16D, the coil sensor 513 'may be configured to be disposed about the perimeter of the post 512. In other embodiments, In this configuration, the coil sensor 513 'slides or otherwise is mounted to the post 512 such that when the post 512 is operatively attached to the closure 504, the coil sensor 513' 578 and a proximal end 514 thereof. A connecting wire 516 operatively attaches the coil sensor 513 'to the image location console 518.

Once the surgical access assembly 100 is assembled and operatively connected to the career guidance system, the process then proceeds to step 418 where the surgical access assembly 100 is guided to the area of interest 500. [ Conventional surgical techniques have indicated that the surgical passage should be created through the brain's gyrus to minimize potential damage to the vital structures and blood vessels. For example, the brain bank surrounding the sulcus and blood vessels located at the base of the brain sphere are preferably conserved to allow for the integrity and viability of the associated brain tissue. Indeed, these blood vessels are responsible for transporting nutrients to the brain and transferring metabolic waste from the brain. Thus, the conventional approach was to prevent traversing such areas to avoid potential damage to these important blood vessels.

However, the brain sphere is a natural pathway to a more internal region within the brain, thus allowing access to this region without trauma to the cortical tissue and causing trauma to the cortical tissue. Below the cortex and inside the white matter, there is a fiber that acts as a communication link to the adjacent region of the brain. For access to the various regions and abnormal parts of the brain, access to the subcortical region through the cortex, which requires undesirable cutting or coring and significant traction and ultimately damaging the cortex and underlying tissue Conversely, surgical access assembly 100 may traverse the brains and traverse the brain bank. The surgical access assembly 100 is operably configured to remove tissue and blood vessels from the surgical access assembly 100 without trauma, without cutting or coring, so that the distal area within the brain Lt; / RTI > can be achieved.

To minimize brain tissue damage, it is proposed, in one exemplary configuration, to advance the assembled surgical access assembly 100 through the brainstem. The surgical access assembly 100 may traverse the brains without causing excessive damage, since the surgical access assembly 100 does not cut or corrode the tissue and rather removes the tissue without trauma. Once the surgical access assembly 100 traverses the brainstem, the surgical access assembly 100 enters the white matter until it reaches the area of interest 500. In addition, the surgical access assembly 100 removes the white matter and associated fascicular anatomy without trauma, without cutting or coring the white matter.

In some exemplary configurations, the distal tip 178 of the obturator 104 is directed to the middle or outermost margin of the region of interest 500. For example, referring to 14b, the surgical access assembly 100 may be positioned at a location 501, which may be located within, or slightly beyond, the edge of the area of interest 500, As shown in FIG. In another exemplary arrangement, the distal tip 178 is located in its proximal end, such as in a situation known as an abnormal additional fiber form.

Due to the tapered configuration of the closure 104 and the closed and curved distal tip 174 and the curved distal tip 132 of the outer tube 102 the surgical access assembly 100 is inserted into the brain and the region of interest 500, the tissue is pushed gently to both sides of the surgical access assembly 100, causing the tissue to expand traumatically, minimizing tissue trauma. And because the surgical access assembly 100 is operatively connected to the career guide member 112, as the surgical access assembly 100 is inserted into the brain tissue, the career guide member 112 is interlocked with the imaging technique To provide real time information about the fiber tract in the locus T so that the surgeon can minimize damage or damage to the fibers during insertion of the surgical access assembly 100. [ Once the surgical access assembly 100 is positioned in the area of interest 500, the process proceeds to step 420. [

In step 420, the career guide member 112 is removed or removed from the surgical access assembly 100. The process then proceeds to step 422.

Once the career guide member 112 has been removed, the outer barrel 102 is operatively positioned relative to the region of interest 500. More specifically, as shown in Fig. 17A, the outer cylinder 102 is moved so that the distal end 108 of the outer cylinder 102 is moved toward the distal end 106 of the closure 104, Lt; RTI ID = 0.0 > 104 < / RTI > This operation is performed by holding the grip portion 120 with the other hand while holding the gripper member 178 with one hand while keeping the closure 104 in a stopped state, for example. The gripper 120 can be smoothly rotated and / or rotated about the central axis of the closure 104 to move the outer cylinder 102 relative to the closure 104 in the circle. The first stop member 176 helps to grasp and manipulate the outer tube 102 and a gap 423 (see Figure 2) is created between the distal end surfaces of the proximal end surface 158 and the grip member 178 . The outer cylinder 102 is moved until the gripper 120 is aligned with the indicator 194A (see Fig. 7A). The indicator 194A is spaced from the first stop member 176 at a distance generally corresponding to the length of the distal tip 172 of the closure 104. [ The distal end 108 of the outer tube 102 is aligned with the distal end member 174 of the obturator 104 when the grip portion 120 is aligned with the indicator 194A. In addition, the outer tube 102 is positioned within the region of interest 500. [ The process then proceeds to step 424.

In step 424, once the outer cylinder 102 is properly positioned, the closure 104 is removed from the outer cylinder 102, as shown in Fig. 17B. More specifically, the outer tube 102 remains relatively stationary in the region of interest 500 and the obturator 104 is moved in the proximal direction until it is completely removed from the outer tube 102. This action causes the outer cylinder 102 to form a passageway to the region of interest 500; The passageway not only avoids the need to cross the blood brain barrier for delivery of therapy, but also provides direct access to the area of interest within the patient.

In another embodiment, instead of providing a closure 104 with a career guide member 112, or in addition to providing a closure 104 with a career guide member 112, The RFID tag 102 may include an RFID chip or a sensor. In this configuration, the RFID chip or sensor of the outer tube 102 cooperates with the career guidance system, thereby allowing the user to see the outer tube 102 independently of the closure 104 on the career guidance system. Therefore, when the obturator 104 is removed from the outer barrel 102, the position of the barrel 102 in the patient is still visible in the career guidance system.

More specifically, the career guidance system operates in step 406 with additional images acquired during the imaging sequence. The image acquired in step 406 is uploaded to the in-surgery career guidance system, as shown in step 410. [ The RFID chip and / or sensor is configured to be read by the route guidance system and is configured to position the image of the outer cannula 102 such that the position of the outer cannula 102 is directly .

One of the illumination rings 300 and 350 may be attached to the outer tube 102 when the outer cannula 102 is positioned in the area of interest 500 and the closure 104 is removed.

In one exemplary configuration, instead of employing an RFID chip and / or sensor in the outer tube 102, the illumination ring 350 may be provided with a sensor or reflective ball, as described above with respect to Figures < RTI ID = 0.0 & . In this type of configuration, when the obturator 104 and the outer tube 102 are delivered to the area of interest 500 and the obturator 104 is removed from the outer tube 102, . When the illumination ring 350 is connected to the outer tube 102, since the illumination ring 350 includes a path guide element such as a sensor and / or a reflective ball, the path guide system can be configured such that the outer tube 102 is positioned within the body Can "read" In other words, the image of the outer barrel 102 can be projected onto the static image uploaded to the career guidance system.

When the outer cylinder 102 is positioned at the desired position, the process proceeds to step 426. [

Next, in step 426, the outer tube 102 is then held in place to prevent the intracranial pressure or the general operation of the instrument passing through the inside and the outside of the outer tube 102 from pushing or removing the outer tube 102 from the brain tissue. In one exemplary configuration, a securing member may be utilized in conjunction with a small opening 150 on the grip 120 to temporarily lock the outer tube 102. When the illumination ring 300 is used in the surgical access assembly 100, the small opening 309 of the illumination ring 300 is aligned with the small opening 150 of the grip ring. Therefore, the fixing member can also be utilized together with the small opening 309. [ However, the fixation member can be fixed to allow a limited degree of movement, and can cause a floating system that allows selective repositioning, as described below. Suitable fastening members include, but are not limited to, bridle sutures, flexible bands with retention hooks, or even retractor arms. A further alternative fixed configuration is disclosed below in paragraph [0139 - 0151]. Once the outer tube 102 is fixed, the process proceeds to step 428. [

At step 428, debulking of the region of interest 500 may be performed. Conventionally, a drug, such as mannitol, is administered to a patient prior to intracranial surgery to reduce intracranial pressure (ICP) of the brain prior to surgery. Indeed, ICPs are often experienced by patients due to the natural response to craniotomy and / or the presence of abnormal parts within the brain. The inventors have found that it may be advantageous to omit or minimize the use of drugs to reduce ICP. More specifically, after the occlusion device 104 is removed from the outer barrel 102, the target tissue is removed from the outer barrel 102 due to the cranial pressure, since the brain tends to occupy the available space within the skull. It may tend to flow into the open distal end 108 of itself and appear to itself. The region of interest 500 may be physically moved into the outer barrel 102 at the top of itself and thus assist in delivery and minimize the required manipulation of the barrel 102 during the procedure.

It is contemplated that a wide range of surgical devices may be inserted into the outer tube 102 to remove tissue anomalies. In one exemplary configuration, the outer tube 102 may have an inner diameter of up to about 20 mm, so that a grasper, a dissector, a scissors, a cautery, It is considered that a plurality of mechanisms such as a mechanism can be inserted through the outer cylinder 102.

One exemplary surgical device that may be utilized is NICO MYRIAD ^® , manufactured and distributed by Nico Corporation of Indianapolis, Indiana. Referring to FIG. 18, there is shown an exemplary surgical cutting apparatus 640 as disclosed in U. S. Patent Application No. 12 / 389,447, which is hereby incorporated by reference in its entirety and is owned by the same assignee of the present application. The surgical cutting device 640 includes a handpiece 642 and a cutting element including an outer cannula 644 and an inner cannula (not shown). In one exemplary configuration, the handpiece 642 is configured to have a generally cylindrical shape. The handpiece 642 may have a size and shape that can be gripped by one hand. The handpiece 642 also includes a lower housing 650 that includes a proximal portion 646 and a distal portion 648. A front housing portion 655 may be connected to the cam housing located at the distal portion 648. [ An upper housing 652 is also provided. The cutting element is mounted to the upper housing 652 and may be fluidly connected to a tissue collector 658. In one exemplary configuration, the tissue collector 658 may be operatively connected directly to the upper housing 652. Alternatively, the tissue collector 658 may be remotely connected to the cutting element by suitable tubing. A vacuum line (not shown) may be connected to the proximal end of the tissue collector 658 to direct the tissue into the cutting element and deliver the severed tissue to the tissue collector 658. A rotary dial 660, which selectively rotates the outer cannula 644 relative to the handpiece 642, is also mounted to the upper housing 652 to provide a controlled cutting action.

The use of surgical device 640 is advantageous in that space is limited for performing tissue loss surgery, and particularly when other instruments are inserted simultaneously into outer tube 102, the use of conventional surgical scissors is difficult . In addition, fibrosis of the tumor may make it difficult to use conventional suction-reduction devices. Conventional graspers work by tearing the tissue of interest. However, if the blood vessels or fibers are too close to the tearing tissue and such blood vessels or fibers are also torn, such tearing can be a problem.

In step 428, as the region of interest 500 is cytoreductively debulked, it may be necessary to reposition or move the outer barrel 102. If repositioning is required, the process moves to step 432. [ To this end, in one exemplary configuration, an operating member may be provided. Examples of the operating members 700 and 700 'are shown in Figs. 19A and 19B. The operating member 700 includes a handle member 702 that supports the armature 704 and a hook element 706 that extends from the armature 704. The hook elements 706 are sized to fit within the small openings 150, 309 disposed within the grip portion 120 and the illumination ring 300, respectively. In operation, the hook element 706 engages the small opening 150/309, and the pull tab 702 is used to gently push or pull the outer tube 102. Because the outer tube 102 is only loosely secured, the outer tube 102 can optionally be slightly moved for improved visualization or for access to tissue. If the outer cylinder 102 is relocated, or if it is not necessary to reposition the outer cylinder 102, the process moves to step 434 and cytoreduction of the region of interest 500 continues.

In an alternative configuration, the operating member 700 'may be secured to the flexible holder member 710. The operating member 700 'includes an armature 712 that carries a hook element 714 and an engagement portion 716. The engagement portion 716 is operably engaged with the holder member 710 to rigidly secure the operating member 700 'to the holder member 710 so that once the outer barrel 102 is positioned, Free. It is understood that a plurality of operating members 700/700 'can be utilized to selectively push or pull the surgical outer barrel 102.

Referring now to Figures 19c-19f, another alternative configuration for maintaining the barrel 102 during surgery is shown. More specifically, Figures 19c and 19d show a retention device 720 that can be used with a Greenberg retractor assembly. The retaining device 720 includes a body portion 722, a coupling barrel 724, and a retaining member 726.

The body portion 722 can be configured as a relatively thin shaft. In one exemplary configuration, the body portion 722 includes at least two bending points 728a, 728b separated by a shaft portion 730. [ The inflection point 728a is located near the distal end of the body portion 722 to define a retaining portion 732. [ The bending point 728b is located near the shaft portion 730. [ The flexion point 728b and the proximal end 734 together define a proximal shaft portion 736. The flex points 728a, 728b serve to axially dislodge the retaining portion 732 from the proximal portion 734. In one configuration, as shown in Figure 19D, the shaft portion 730 is disposed at an approximately 45 degree angle. In another exemplary configuration (not shown), the shaft portion 730 may be oriented at an approximately 90 degree angle. It is also contemplated that the shaft portion 730 may be disposed at different angles. In some exemplary configurations, flexure points 728a, 728b may be eliminated such that retaining portion 732 and proximal portion 736 are disposed along a common axis. The retaining portion 732, the shaft portion 730, and the proximal portion 736 may be integrally formed together or may be configured as separate elements connected together.

The retaining portion 732 terminates at its distal end 738 within the retaining member 726. 19c, the retaining member 726 is configured as a shepherd's hook configured to curve back toward the retaining portion 732 with the exception of the end 742 of the retaining member 726 and / A gap 740 is defined between the holding portions 732. The retaining member 726 may be integrally formed with the retaining portion 732 or may be formed as a separate component connected to the retaining portion 732. [ The retaining member 726 is configured similar to the spring clip so that the retaining member 726 is partially snapped around the outer cylinder 102.

A barrel 724 is mounted to the proximal portion 736. The engagement barrel 724 is configured to selectively rotate about the proximal portion 736. In one exemplary configuration, a stop member 744 is disposed at each end of the engagement barrel 724. In operation, a coupling barrel 724 is positioned and clamped within the Greenberg adapter. The stop member 744 serves to prevent the engagement barrel 724 from being unintentionally pulled out of the Greenberg adapter. However, due to the configuration of the engagement barrel 724 and the placement of the stop member 744, the engagement barrel 724 can be moved in a linear manner in a predetermined amount. In addition, since the engagement barrel 724 is configured to selectively rotate about the proximal portion 736, the outer barrel 102 can be selectively pivoted to a desired position along the Y direction. Since the retaining member 726 is configured as a sheeter hook having a clearance 740, the outer cylinder 102 can be pivoted in the X direction. Therefore, the retaining device 720 allows selective positioning of the outer tube 102.

An alternative retaining device 750 is shown in Figures 19e and 19f. The retaining device 750 is configured for use with a Sugita adapter (not shown). The retaining device 750 is similar to the retaining device 720 and includes a body portion 752, a coupling barrel 754, and a retaining member 756. [

The body portion 752 may be configured as a relatively thin shaft and may include one or more bending points 758a, 758b. As with retention device 720, flexure points 758a and 758b serve to axially separate retention portion 762 from proximal portion 764. The shaft portion 760 is positioned between the inflection points 758a and 758b.

The retaining portion 762 terminates at its distal end 768 within the retaining member 756. 19E, the retaining member 756 is configured as a sheeter hook configured to curve back toward the retaining portion 762, except that the end portion 772 of the retaining member 756 and the retaining portion 762 The gap 770 is defined. The retaining member 756 may be integrally formed with the retaining portion 762 or may be formed as a separate part connected to the retaining portion 762. [ The retaining member 756 is configured to resemble a spring clip such that the retaining member 756 is partially snapped around the outer tube 102.

A coupling barrel 754 is mounted to the proximal portion 764. The engagement barrel 754 is configured to selectively rotate about the proximal portion 764. The mounting member 774 is firmly fixed to the engagement barrel 754. [ The mounting member 774 is configured to be received within the Sugita clamping mechanism. In one exemplary configuration, a stop member 776 is disposed at the distal end of the engagement barrel 754. In operation, a coupling barrel 754 is positioned and clamped within the Sugita adapter. The stop member 776 serves to prevent the engagement barrel 754 from unintentionally being pulled out of the Sugita adapter. However, due to the configuration of the engagement barrel 754 and the placement of the stop member 776, the engagement barrel 754 can be moved in a linear manner in a predetermined amount. In addition, since the barrel 754 is configured to selectively rotate about the proximal portion 764, the outer barrel 102 can be selectively pivoted to a desired position along the Y direction. Since the holding member 756 is configured as a sheeter hook having a gap 770, the outer cylinder 102 can be pivoted in the X direction. Therefore, the retaining device 750 allows selective positioning of the outer cylinder 102. [

Another alternative configuration of the retaining device 780 is shown in Figures 19g-19j. The retaining device 780 is configured to maintain the longitudinal alignment of the outer mirror 782 and the outer cylinder 102. In this configuration, light is provided to the outer barrel 102 (and thus to the surgical site / area of interest) through an external mirror (Karl Storz Endoscopy, Germany) 782. Thus, while the exterior mirror 782 is spaced from the outer cylinder 102, an effective visual line and maintenance of projection of light to the bottom of the outer cylinder 102 can be achieved.

The retaining device 780 has an alignment tool 784. The alignment tool 784 is configured to include an outwardly extending arcuate portion 786. More specifically, the outwardly extending arcuate portion 786 extends along a longitudinal axis (not shown) passing through the longitudinal space between the outer barrel 782 and the outer barrel 102 when the outer barrel 782 and the outer barrel 102 are aligned LA). In this manner, the arc portion 786 cooperates with the outer mirror 782 and the outer cylinder 102 to define a working space between the outer mirror 782 and the outer cylinder 102. With this arrangement, the user can pass the device through the inside and outside of the outer casing 102 and the area of interest.

In one exemplary configuration, the arcuate portion 786 is defined as a pair of wire shaped members 786a, 786b (best seen in Figure 19h). The members 786a and 786b are configured to be substantially rigid so as to maintain the position of the outer cylinder 102 with respect to the outer mirror 782. [

In addition to the arcuate portion 786, the alignment tool 784 further includes an outer diameter attachment harness 788 and an outer tube attachment configuration 790. [ 19 (h) includes a retaining mechanism 792 attached to the reinforcement 794. The retaining mechanism 792 includes a retaining mechanism 792, The reinforcement 794 extends upward from the members 786a and 786b in the same direction as the longitudinal axis LA. The retaining mechanism 792 is configured to extend at least partially around the perimeter of the exterior mirror 782 in the snap-fit or clamping device. In one exemplary configuration, retention mechanism 792 is formed integrally with reinforcement 794. Likewise, the reinforcing portion 794 may also be integrally formed with the arc portion 786. [ The bending point 795 couples the arch portion 786 to the reinforcement portion 794.

19i, the outer tube attachment configuration 790 includes a connector member 796a configured to be received within an opening formed in the grip portion 120, sufficiently spaced to allow the alignment tool 784 to maintain a desired position, , 796b. In one exemplary configuration, the connector member is a pin that is coupled to the members 786a, 786b by inflection points 797a, 797b. With this configuration, the outer cylinder 102 can be selectively pivoted about the longitudinal axis LA, thereby allowing a certain degree of flexibility in locating the outer cylinder 102 in the region of interest.

Referring to Figure 19J, an alternative configuration for connecting the arcuate portion 786 to the outer tube 102 is shown. In this configuration, one end of the members 786a is configured as a sheeter hook 798 similar to that shown in the configuration of Figs. 19C and 19E. As described above, this configuration allows the outer cylinder 102 to be pivoted in the X-direction, allowing selective positioning of the outer cylinder 102. [

In one exemplary configuration, the retaining devices 720, 750, 790 are disposed about the outer casing 102 at any location, but in one exemplary configuration, the retaining members 726, 5E and 5F defined between the flange 165 of the handle portion 163 and the bottom surface of the grip portion 120. [ This configuration prevents the retaining members 726 and 756 from moving too far below the outer cylinder 102 once snap-fastened about its proximal end.

In one exemplary configuration, the retaining members (726, 756) have a size such that they can provide sufficient clearance to accommodate only the diameter of the retaining members (726, 756) The lips 163 can be spaced from the bottom surface of the grip portion 120 on the circle so as to stably hold the grippers 726,

In other exemplary arrangements, the channels may have a larger size relative to the width of the retaining members 726, 756 to allow some clearance. In this configuration, retaining members 726 and 756 allow selective movement of the outer tube 102 during surgical operation, but permit in a controlled and limited manner. More specifically, the retaining members 726 and 756 are allowed to float freely in the channel, but do not move significantly below the outer diameter of the outer cylinder 102 as compared to the predetermined amount. In addition, the channel also allows relaxed tolerances for the retaining members 726,756, thus reducing the manufacturing cost of the retaining device.

In another exemplary configuration, the channel 167 may have a size such that a series of articles are stacked together on the outer diameter of the outer tube 102. For example, in one configuration, a retaining member that carries the array may be provided on the retaining members 726, 756 of the retaining device to stably position the array and retaining device within the channels 167 created by the lip 163. [ As shown in FIG.

The lip 163 may be constructed by any suitable method. In one exemplary configuration, the lip 163 is molded integrally with the outer tube 102. In another exemplary configuration, lip 163 may be configured as part of a secondary operation. For example, the lip 163 can be configured after the outer tube 102 is created as a die punch operation to create a punched out feature. Additional secondary operations include, but are not limited to, water jet cutting and laser cutting.

5d and 5e show only one retaining lip 163, but it is also possible that more than one retaining lip may be provided to hold multiple articles or to provide different positions where the retaining members will be located . For example, one retaining lip 163 can be created as a molded feature, and then a secondary imprinting feature can be created anywhere in the outer casing 102, So as to be held at different positions of the outer cylinder 102. In practice, a plurality of retaining ribs can be utilized to stack the two articles together at the outer diameter of the outer cylinder 102, while keeping the two articles stably upward with respect to the lower side of the gripper 120. [ Therefore, a number of mechanisms such as a career guidance array and retaining members 726,756 may be utilized.

The outer tube 102 is configured such that a plurality of instruments can be simultaneously inserted therein, thereby increasing the speed and safety of the surgical procedure. In one exemplary configuration, the endoscope can be partially inserted into and retained at one side of the outer tube 102, so that while the surgical instrument, such as the surgical instrument 640, is also inserted into the outer tube 102, 500) to the monitor. The illumination ring 300 may also be used with endoscopes and surgical instruments that are inserted through an access opening 308 that aligns with the opening 146 of the grip 120. Because the illumination ring 300 provides the required light to the outer barrel 102, a relatively small diameter endoscope can be used, which can increase the available space within the barrel 102 for other surgical instruments. In another exemplary arrangement, the surgeon can simultaneously insert both the surgical instrument and the cautery instrument into the outer tube 102, allowing the surgeon to cauterize during surgery.

In another exemplary configuration, a fluorescent dye can be introduced into the patient in the surgery, before or during surgery. This dye is Gliolan (5-aminolevulinic acid), but other suitable dyes may also be used. Fluorescent dyes may be administered by any suitable method including, but not limited to, injecting a dye to a patient, providing the dye through the mouth to the patient prior to surgery, or injecting the dye through the shaft 102 in situ Can be introduced. In one exemplary embodiment, the dye is configured to bind to a protein in an abnormal cell such that the cell is visually distinct from a healthy cell. By visual indication of healthy tissue versus abnormal tissue, surgical instruments can be used more efficiently for ablation of abnormal tissue. In another embodiment, the light transmitted through the outer tube 102 has a predetermined wavelength configured to interact with the dye to illuminate or fluoresce the abnormal tissue. For example, the illumination cap (cap) 300 may have a pre-selected wavelength of LED light element that interacts with preselected dyes to help illuminate the abnormal tissue and distinguish healthy tissue from diseased tissue .

In another exemplary configuration, a light probe or fiber bundle (not shown) may be inserted into the outer tube 102 to help distinguish healthy and abnormal tissue. In one configuration, the probe / bundle is simply inserted into the outer tube 102 as a separate element with the surgical device. The probe / bundle is operatively connected to the console, and the reflected light is transmitted to the console. The sensor in the console (i.e., the sensor is located remotely from the detection point) receives reflected light that triggers the signal to the user based on a predetermined parameter. In other words, the natural fluorescence of the tissue is then reflected back toward the console, informing the user whether the tissue is diseased or abnormal.

In another exemplary configuration, the surgical device may further include a delivery sleeve 800 mounted to the surgical device 640, an example of which may be seen in Fig. Various embodiments of the delivery sleeve 800 may be found in co-pending U. S. Patent Application Serial No. 13 / 269,339, which is hereby incorporated by reference in its entirety. 20, the delivery sleeve 800 generally includes at least two lumens, a first lumen 802 configured to receive the outer cannula 644 of the surgical device 640, And a second lumen 804 configured to receive an optical device, such as a bundle (not shown). Use of this configuration allows the use of additional surgical tools / instruments within the outer tube 102. More specifically, as the optical device is ultimately supported within the delivery sleeve 800 that is connected to the surgical device, the surgeon can at the same time distinguish between abnormal tissue and healthy tissue, and only by maintaining the surgical device 640 The tissue can be ablated. As a result, the surgeon may also utilize a separate cauterization device within the outer tube 102 that does not require removal of the surgical device 640 and allows cauterization of any blood vessels, in real time, during the ablation procedure You can choose.

Since the outer barrel 102 can be positioned directly in the area of interest 500 in a manner that prevents unnecessary damage to the critical structure and because the surgical device 640 can be positioned directly in the field of view of the area of interest , Utilizing the surgical access system 100 provides the ability to ablate most of the area of interest 500, such as a tumor. As will be appreciated by those skilled in the art, the more tumors are ablated and removed, the less the therapies required for treatment. In other words, the more abstinence of the diseased tissue, the less the sick tissue to destroy.

Once the cytoreductive ablation of the region of interest 500 is complete, the process then proceeds to step 436. At step 436, a determination is made to remove the outer tube 102 or to place the outer tube 102 in place. More specifically, for some therapeutic applications, removal of the outer barrel 102 may be more effective than leaving the barrel in place to deliver the treatment. When the outer cylinder 102 is removed, the process 400 proceeds to step 438 after the outer cylinder 102 is removed.

As one of ordinary skill in the art will appreciate, the natural elasticity of the brain tissue will maintain access or passage to the area of interest 500 for a predetermined period of time. In step 438, in one exemplary configuration, when the passageway is still intact after removal of the outer barrel 102, a delivery device may be inserted into the passageway to deliver irrigation to the surgical site. In some cases, a syringe can be inserted into the passageway to deliver an irrigating fluid, such as a saline, directly to the surgical site. In another exemplary configuration, a drainage catheter (configured to have a plurality of small openings at its distal end) is provided in the passageway so that the distal end of the catheter is positioned at or near the surgical site. A cleaning fluid is then introduced into the proximal end (e.g., by operatively attaching the syringe barrel to the proximal end) to deliver the cleaning fluid to the surgical site. The cleaning fluid helps wash away the debris and natural tendency of the brain tissue itself to be closed again. Once the surgical site has been cleansed, it may also be desirable to transfer the specific treatment directly to the surgical site to prevent the therapeutic delivery and absorption problems traditionally encountered by systemic approaches. For example, certain treatments that may be provided in liquid form may be injected directly through the passages, just before the tissue itself is closed again. Because the passage is closed, the treatment can be held in place at the surgical site, increasing its effectiveness in the surgical site and surrounding tissues.

In some treatment methodologies, it may be necessary for the shaft 102 to assist delivery and / or deployment of such treatment, as will be described in more detail below. Accordingly, if it is determined in step 436 that the extracorporeal device 102 is held in place after the completion of the cell reduction, the process 400 proceeds to step 442.

In step 442, to remove any debris from the area again, the area of interest / surgical site 500 is cleaned. Cleaning may be performed in the same manner as described in step 438 except that it passes through the outer cylinder 102. Once the cleaning is complete, the process proceeds to step 444. [

In step 444, the therapy is delivered to the area of interest 500. In one exemplary configuration, intraoperative radiotherapy (IORT) may be employed to deliver the therapy directly to the area of interest 500 via the shaft 102. In one exemplary arrangement, an implantable therapy may be applied to the area of interest 500. Examples of implantable therapy include bioabsorbable radiation pellets, wafers or meshes, such as, for example, those manufactured by Nano-Rad LLC. Other examples include, but are not limited to, titanium capsules or seeds with radioactive contents, bioabsorbable gels or foams containing radioactive, chemotherapeutic or immunotherapeutic agents.

In another exemplary configuration, a balloon catheter may be used to perform brachytherapy after removal of diseased tissue in the area of interest 500. [ For example, a balloon catheter may be inserted through the outer tube 102 and delivered to the region of interest, and then a predetermined amount of the radioactive solution may be inserted into the balloon catheter and then delivered to the surrounding tissue. Commercially available catheters that may be used include GliaSite balloon catheters containing Iotrex radioactive solutions. The use of a balloon catheter can provide more targeted delivery of liquid radiation, thereby reducing the impact of brain tissue around diseased tissue.

In another exemplary configuration, an electron beam driven X-ray source may be provided. One such exemplary configuration is a Zeiss INTRABEAM ^®. Electrons are generated and accelerated in the main unit to be surrounded by a conical applicator tube whose tip is placed in the epicenter of the applicator sphere to provide a low energy x- ray point source at the tip And travels through an electron beam drift tube. With this configuration, a substantially isotropic field of low energy is emitted.

During operation, the applicator barrel is inserted through the outer barrel 102 into the surgical cavity in the area of interest 500. [ Ultrasound during surgery can determine the distance of the applicator surface to the skin to prevent significant skin dose. The applicator barrel may be secured in place by the surgeon using a subcutaneous suture around the neck of the sphere, as described above with respect to the outer barrel 102.

In another exemplary configuration, photodynamic therapy may be employed wherein a given chemical composition may be provided to the patient, and the chemical composition may be selectively activated by a predetermined wavelength, Can be achieved. For example, in one exemplary arrangement, the illumination ring 300 may be turned on to achieve a therapeutic response. In another exemplary configuration, a light source, such as, for example, a fiber optic bundle, may be directed through the outer tube 102, i.e., directly through the outer tube 102 or via the delivery sleeve 800. [

In another exemplary configuration, external beam high frequency ultrasound or interstitial high frequency ultrasound can also be transmitted directly to the region of interest 500 via externals.

In a further exemplary configuration, an implantable delivery device 900/900 'may be provided, as shown in Figures 21A and 21B. The implantable delivery device 900/900 'includes a neck 902 connected to the body portion 904/904'. Both the neck portion 902 and the body portion 904/904 'can be made of a relatively soft flexible material. The body portion 904/904 'defines a reservoir for retaining the therapeutic agent therein. The proximal end 905 of the neck 902 is mostly closed with access to the interior of the implantable delivery device 900/900 'provided by the luer port 906. More specifically, the therapeutic agent is introduced into the delivery device 900/900 'via the luer port 906. A sealing flange 908 operatively connected to the neck 902 to help hold the implanted delivery device 900/900 'in place within the brain.

In the configuration shown in Fig. 21A, the body portion 904 may have at least one small opening 910. Fig. In one exemplary configuration, a plurality of small openings 910 are provided and these openings may be equidistantly spaced about the perimeter of the body portion 904. The small opening 910 is configured to increase the effectiveness by allowing the therapeutic agent introduced through the luer port 906 to flow out of the reservoir formed by the body portion 904 at a controlled rate. Alternatively, the body portion 900 can be configured as a transmissive membrane that allows slow and controlled passage of treatment from the reservoir to the brain tissue 1000.

In the alternative configuration shown in FIG. 21B, the body portion 904 'may have a finger-shaped flexible projection 912. In one exemplary configuration, the projections 912 are equidistantly spaced from each other around the perimeter of the body portion 904 '. The projection 912 is formed as a channel that extends outward from the outer periphery of the body portion 904 'and provides communication between the reservoir and the small opening 914 formed at the distal ends 916 of the projection 912 . The opening 914 is configured to allow the therapeutic agent introduced through the luer port 906 to flow out of the reservoir. The projection 914 helps to maintain the delivery device 900 'by friction at the target site.

Referring again to process 400, when the delivery device 900/900 'is employed, the delivery device 900/900' is inserted through the outer barrel 102 in the region of interest 500. [ Once in place, the outer tube 102 is removed and a sealing flange 908 is operatively connected to the neck 902 to access the luer port 906. A sealing flange 908 is configured to extend around the periphery of the surgical access opening formed through the skull 1002 to protect the exposed brain tissue 1000. The therapeutic agent is supplied to the reservoir formed by the body portion 904/904 'before the delivery device 900/900' is positioned in the region of interest 500 or after the sealing flange 908 is in place . The sealing flange 908 and the body portion 904/904'and the neck portion 902 may be constructed of a flexible material that allows sealing against the dura and bone of the brain.

In another alternative arrangement with the delivery device 900/900 ', a permeable material similar to a foam that is configured to conform to the cell-reduced area of interest 500 may be delivered through the outer tube 102 . The foam material allows continuous contact with the therapeutic agent flowing through the body portion 904/904 'to provide a controlled dose of treatment to the region of interest 500.

After the surgery and treatment on the target tissue are completed, the process proceeds to step 446. [ At this stage, the instrument used for surgery and / or therapy is removed from the outer tube 102. When the target tissue is removed, the brain tissue naturally fills the void formed by removing the region of interest 500, so that a healthy brain tissue located beneath the currently removed target tissue is adjacent to the end of the outer tube 102 . The outer tube 102 is then gently removed and the brain tissue will naturally fill and restore the space previously occupied by the abnormal and lateral cannula 102 with the aid of cleaning of the area of interest 500. In addition, as the brain tissue has previously restored the space occupied by the abnormal and lateral cannula 102, it has been found that all of the untouched and unobstructed limitations, such as, for example, Implantable therapies such as bioabsorbable radiation pellets, wafers or meshes are maintained in place in the area of interest 500 to provide effective therapy. This process may take a few minutes, but it is relatively non-traumatic. Once the shaft 102 is removed, the process continues to step 448, whereupon the dura, skull and scalp are then closed in a known manner and the process ends. In the exemplary case where the treatment device can be implanted, complete recovery of the space is delayed due to implantation until the implant is explanted or absorbed.

It is contemplated that, in one exemplary configuration, the surgical access system 100 may be provided as part of a kit, since the location of the area of interest will vary from patient to patient. More specifically, it is contemplated that a plurality of occluders 104 having different lengths and / or diameters may be provided. The set may be provided in a container configured to be sterilized with the closure 104 secured therein. It is also contemplated that the set of manipulating tools 700/700 'may also be equipped with a kit, and that the manipulating tools 700/700' may be placed in an optional sterile container. The outer tube 102 may be provided with a kit of various lengths and diameters corresponding to the length and diameter of the closure 104 provided in the kit. However, in one exemplary configuration, the outer tube 104 is provided separately within the sterilized pouch, as a single-use device.

The system described above creates direct access to a region of interest that includes the region of interest within the cortical subspace to allow for a reduction in the area of interest that reduces the biological load of the abnormal tissue and is useful for the treatment of a particular disease Interfering and unrestricted) on-site therapy, but additional follow-up care can be assured for increased therapeutic effectiveness.

More specifically, a therapy cocktail, which may be effective in degenerating newly evolved cells and tissue variants, abnormal tissue of the region of interest, so as to define an effective follow-up therapy, is suitable for newly evolved cells and tissues To determine a therapeutic cocktail, imaging needs to be defined, which needs to be approached, needs to be approached, and requires interrogation (sampling with or without cell loss reduction of the area) to define the region of interest. This process may need to be repeated at specific times or at various time intervals for the patient's survival to ensure proper management or cure of the disease.

For functional brain diseases such as Alzheimer's, Parkinson's, epilepsy's, bi-polar's, depressions, etc., the cells and the affected tissues do not change after the initial treatment It may not change, but it may be necessary to subsequently image, access, and examine the tissue (sample or debulk), the same or another area of interest after initial delivery of treatment, to determine the effect of the previous application, It may be useful to determine the response of the tissue and to determine the need for subsequent therapy and the nature of the treatment desired for subsequent treatment.

Referring to FIG. 22, a process flow 1200 illustrating an additional method of treatment is disclosed to address a second-step therapy. Process flow 1200 begins with a predetermined period 1202 after the initial ablation and treatment process flow 400 (shown in Figure 13) is completed. If there is a need for the process flow 1200 and the predetermined period 1202, then it depends on the effect of the initial treatment and the nature of the disease being treated, the disease state change, and the type of treatment originally applied. The process then proceeds to step 1204.

In step 1204, the region of interest 500 is again imaged to determine the effect of treatment in the region of interest 500. In other words, step 402 of the process 400 is repeated. Such imaging includes, but is not limited to, MRI or CT imaging. The process then proceeds to step 1206. [

In step 1206, a determination is made as to whether any disease is visible after employing the 1204 imaging step. For a particular disease, if no visible disease is detected (step 1208), the process 1200 stops. For certain low-grade gliomas, for example, no further intervention may be required. If the external imaging technique fails to detect any visible disease for a different disease, i.e., a tumor that grows fast, such as a glioma, based on the patient history including the previous disease pathology, It can be ensured that the in-situ imaging technique is adopted. Some examples of such techniques include, but are not limited to, spectroscopy, MRI, ultrasound, fluorescence. If the visible signs of the disease are not clear after completion of step 1210, the process stops. However, if the imaging step indicates the visual evidence of the disease after steps 1206 and 1210, the process proceeds to step 1212.

In step 1212, a number of steps of the process flow 400 shown in FIG. 13 are repeated. More specifically, steps 406 through 426 of the process flow 400 are repeated to create access to the area of interest 500. The process then proceeds to step 1214. [

In step 1214, similar to steps 428 through 434 of FIG. 13, the region of interest 500 is examined (only through additional cell reduction or sampling / biopsy). Indeed, after the initial treatment process, the disease may mutate and the disease may be a slightly different variant of the diseased tissue from which it was originally treated. In such a case, the use of the same field treatment cocktail may no longer be effective. Accordingly, step 1214 includes examining the region of interest 500 to collect and determine the necessary information about the tissue formed in the region of interest 500. [ Next, the process proceeds to step 1216.

In step 1216, the tissue from the region of interest 500 is analyzed to determine an appropriate and effective treatment for treating the region of interest 500. In other words, an assessment that differentiates cells from the area of interest 500 can be utilized to provide the most effective treatment for the disease. In some cases, immunotherapy may be utilized to determine the treatment of a personalized drug for a particular disease mutation identified and analyzed in step 1216 and then to formulate a tissue sample obtained from the area of interest 500. One exemplary non-limiting type of such immunotherapy is taught and described in co-pending U.S. Serial No. 13 / 352,069, the entire contents of which are incorporated herein by reference. If appropriate treatment is determined, the process proceeds to step 1218 where treatment is applied to the area of interest.

The treatment can be applied in any suitable manner. For example, in some cases, it may be necessary to remove the barbs to deliver the treatment, as taught in steps 438 through 440 of FIG. In other situations, the externals may remain in place and the selected treatment may be delivered in a manner similar to steps 442 through 446 of FIG.

If the therapy is delivered appropriately, then the process proceeds to step 1220 where the surgical approach is closed in a manner similar to that previously described with respect to step 448 of FIG. However, it is understood that process flow 1200 can be repeated as needed until the disease is managed so that the patient's disease appears to be better or does not threaten survival.

It will be appreciated that the surgical access systems and methods described herein have wide applicability. The foregoing embodiments have been chosen and described in order to illustrate some practical applications as well as the principles of the methods and apparatuses. The foregoing description is in accordance with the particular application contemplated and, therefore, would enable those skilled in the art to utilize the various embodiments and methods of the various embodiments. In accordance with the provisions of patent laws, the principles and manner of operation of the present invention are described and illustrated in the illustrative embodiments.

The scope of the method and apparatus of the present invention is intended to be defined by the claims that follow. It is to be understood, however, that the invention can be practiced otherwise than as specifically described and shown, without departing from the spirit or scope thereof. It should be understood by those skilled in the art that various alternatives to the embodiments described herein may be employed in practicing the claims, without departing from the spirit and scope of the following claims. The scope of the present invention should not be determined with reference to the above description, but instead should be determined with reference to the appended claims and the full scope of equivalents to which such claims are entitled. It is anticipated and contemplated that future developments will occur in the techniques described herein and that the disclosed systems and methods will be included in such later examples. In addition, all terms used in the claims are intended to be accorded the broadest and most appropriate interpretation and ordinary meaning understood by those skilled in the art, unless the context clearly indicates otherwise. In particular, the use of a singular article, such as "a," "the," "said," and the like, should be understood to include one or more of the indicated elements, unless the specific limitation is contradicted by the claims. The following claims define the scope of the invention and are intended to fall within the scope of the appended claims and their equivalents. In sum, it should be understood that the present invention can be modified and modified, and is limited only by the claims that follow.

Claims (19)

A surgical access assembly comprising:
An outer tube defined by an open circular tip and an open proximal end and including a hollow body portion therebetween, wherein a portion of the outer tube is anti-reflective;
A distal end member defining a proximal end and a proximal end, the distal end terminating at a distal end,
Wherein the closure is configured to be received within the outer tube such that the tapered distal end member protrudes from the open distal end of the outer tube when the closure is in the configuration for introducing the closure. The method according to claim 1,
Wherein an inner surface of the body of the outer barrel includes an anti-reflective feature. The method according to claim 1,
Wherein the inner surface of the outer barrel is textured to create a frosted surface. The method according to claim 1,
Wherein the outer surface of the outer barrel is non-abrasive. The method according to claim 1,
Wherein said outer tube is configured to allow observation of tissue therethrough when said outer tube is introduced into and traversed tissue. The method according to claim 1,
Wherein the outer tube further comprises a tapered distal portion tapering inward toward the central axis. The method according to claim 6,
Wherein the inner surface of the tapered distal portion has a texture to create a frosted surface. The method according to claim 1,
Wherein the outer tube further comprises a grip portion located at least partially around the open proximal end, at least a portion of the grip portion having a texture to create an anti-reflection surface. The method according to claim 1,
Wherein the barrel further includes a grip portion that is at least partially located about the open proximal end thereof and at least one retaining lip that is spaced from the bottom edge of the grip portion to define a retaining channel. 10. The method of claim 9,
Wherein the lip is configured to taper inward in a distal direction along the outer barrel. 10. The method of claim 9,
Wherein the lip further comprises a retaining flange opposite the bottom edge of the gripping portion. 10. The method of claim 9,
Further comprising a plurality of retaining ribs spaced apart in a distal direction along the outer barrel, wherein the continuously disposed retaining ribs together define a retaining channel therebetween. 10. The method of claim 9,
Wherein a plurality of retaining lips are disposed around the circumference of the outer tube. 14. The method of claim 13,
Wherein the retaining ribs are spaced equidistant from each other. 14. The method of claim 13,
Each of the retaining ribs having a retaining flange opposite the bottom edge of the retaining portion, wherein the retaining flanges of the plurality of retaining ribs are coplanar with each other. 10. The method of claim 9,
Wherein a single retaining lip is formed around the entire periphery of the outer barrel. 10. The method of claim 9,
Further comprising at least one of a retention member, a career guide array, and a tracking array disposed at least partially within the outer tube circumference and the retention channel. The method according to claim 1,
Further comprising a grip ring coupled to the outer barrel and having a central opening coaxial with the hollow body portion, the grip ring including at least one retaining notch extending from an outer periphery of the grip ring to an inner periphery of the central opening , Surgical assemblies. The method according to claim 1,
Wherein the distal end of the occluder is configured to traverse the tissue without cutting or coring the tissue.

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