WO2015060711A2

WO2015060711A2 - A universal neurosurgical probe

Info

Publication number: WO2015060711A2
Application number: PCT/MY2014/050004
Authority: WO
Inventors: Vikneswaran A/L MATHANESWARAN; Alwin Kumar Rathinam; Yuwaraj Kumar BALAKRISHNAN; Tan SU TUNG
Original assignee: Universiti Malaya
Priority date: 2013-10-23
Filing date: 2014-10-21
Publication date: 2015-04-30
Also published as: WO2015060711A4; WO2015060711A3; MY170211A

Abstract

The present invention relates to a universal surgical device capable of locating a neurosurgical site, comprising a tubular member (110), defining a passageway, having a distal end (101) and a proximal end (102); and an elongated navigation probe (200), which is longer than the tubular member (110) and having a tapering tip (203), configured to collectively slide into the passageway until the tip protrudes from the distal end (101) of the tubular member, that the tubular member (110) and the engaged probe (200) concurrently move to the neurosurgical site under guidance of a navigation system in communication with the probe (200), wherein the probe (200) moves out from the passageway and the tubular member (110) is retained at the distal end (101) substantially contacting the neurosurgical site.

Description

A UNIVERSAL NEUROSURGICAL PROBE

FIELD OF INVENTION

The present invention relates to a neurosurgical device. More particularly, the neurosurgical device comprises a navigation probe and a tubular member fabricated to engage the probe or other surgical tools for locating a neurosurgical site and subsequently performing surgery thereon.

BACKGROUND OF THE INVENTION

Neurosurgery generally relates to the operations of locating tumours or other abnormal growths, or performing biopsy or endoscopy in the human nervous system, especially in the brain. Neurosurgical operations have to be conducted with intensive care in order to prevent any damage to the major blood vessels or critical tissues within the brain. Therefore, a neurosurgical device shall possess an innovative design which effectively facilitates the operations as well as enhances safety and accuracy of the surgery.

A neurosurgical probe is always used to determine the exact location of a tumour or abnormal growth in order to perform neurosurgical operations, as a keyhole neurosurgery which involves only a small incision on the human body, such as skull, is usually conducted. The probe shall be designed with the ability to register the neurosurgical site with high degree of positional accuracy, thus providing neurosurgeon a better envision of the operating environment for an effective neurosurgical operation.

Conventionally, the neurosurgical probe is inserted into the neurosurgical site of a subject to determine the exact location of a tumour or other abnormal growths, or the location where neurosurgical procedure is to be conducted. A wide variety of surgical tools can be applied depending on the objectives of the surgery. Even though the registration process can be facilitated with computer-aided programs which help ensure the positional accuracy of the insertion of navigation probe and other surgical tools into the neurosurgical site, the process of shifting the surgical tools, including the insertion and withdrawal of the surgical tools through the neurosurgical site may pose various technical difficulties as these procedures are tedious and error-prone. This may further lead to discrepancy in positional accuracy during the procedure and increase of the risk of neurosurgical infection, which eventually affects the overall performance of the surgery.

In order to enhance the performance of neurosurgery, a number of different neurosurgical probes have been invented. Most of the probes disclosed in the patented technologies are merely designed for location determination. For example, a system for continuous display of target location in medical treatments using an ultrasonic probe is disclosed in Germany Patent No. DE 19751761. This ultrasonic probe carries position referencing reflectors and serves as a position sensor to establish instantaneous values for each of the stored parameters and provide comprehensive update for the precise navigation of the neurosurgical treatment program which is controlled by a computer-aided primary referencing apparatus, in which a database indexing the patient's anatomical make-up, diagnostic data and the positions of treatment are incorporated.

A PCT publication No. WO 9610368 discloses an apparatus and method for displaying a path between a selected target and selected points on a patient's skull and for guiding surgical instruments along any selected path. The apparatus comprises an image display system, an articulated arm and probe, and a stereotactic system. It is also coupled with a sub- system for coregistering the external locations so that the probe condition can be displayed. It further permits the identification of a selected target within the patient's brain and to project a path from the external position to the target. These apparatus and method provide various probing and location identifying functionalities, however, it could not be further applied for the operations of other neurosurgical procedures. The undesired shifting of various surgical tools around the neurosurgical site is still involved.

Some neurosurgical probes are incorporated with other types of surgical tools or systems. An existing technology disclosed in U.S. Patent No. US 2007135844 relates to a surgical apparatus and process for freezing or cauterizing a particular infected body area employing a transparent sleeve insertable through a small slit in the flesh of a patient, wherein the sleeve is provided with a tip susceptible for expansion when a solid rigid probe is inserted through the sleeve. The extension on the end of the probe is placed in alignment position to locate the infected organ or area to be removed, and the monitoring of the sleeve and probe insertion can be achieved by video camera. This device is applicable for freezing a tumour. Nevertheless, such neurosurgical device can only be used for certain specific applications.

Various types of patented technologies have been disclosed in the prior art. However, most of the existing technologies disclose a neurosurgical probe device or system which possesses complicated design but not able to facilitate the administration of multiple surgical procedures nor to allow effective introduction of various types of surgical tools into the neurosurgical site to perform different surgical procedures, without affecting the positional accuracy or the need for re-determining the neurosurgical location. Clearly there is a need for the present invention to provide a multipurpose universal neurosurgical probe which can efficiently overcome the drawbacks of the prior art.

SUMMARY OF INVENTION

The primary object of the present invention is to provide a universal surgical device which is capable of facilitating the introduction of neurosurgical tool into the surgery site.

Another object of the present invention is to provide a multipurpose universal surgical device which possesses navigating function to accurately locate the neurosurgical site, as well as allowing entrance of surgical tools therethrough. Thus the universal surgical device in the present invention simplifies the need to use different surgical hardwares for one operation. Still another object of the present invention is to provide a universal surgical device which reduces the insertion and withdrawal rates of surgical tools through the neurosurgical site thus reducing the risk of surgical infection and enhance safety of the neurosurgery. Yet another object of the present invention is to provide a surgical device having simple and convenient locking mechanism. Particularly, the locking mechanism engages and disengages the probe and the tubular member at different stages of the operation. Further, the locking mechanism engages and disengages different segments of the tubular member to facilitate entrance or withdrawal of the probe or a surgical tool.

At least one of the preceding objects is met, in whole or in part, by the present invention, in which one of the embodiments of the present invention describes a universal surgical device capable of locating a neurosurgical site, comprising a tubular member (110), defining a passageway, having a distal end (101) and a proximal end (102); an elongated navigation probe (200), which is longer than the tubular member (110) and having a tapering tip (203), configured to collectively slide into the passageway until the tip protrudes from the distal end (101) of the tubular member, that the tubular member (110) and the engaged probe (200) concurrently move to the neurosurgical site under guidance of a navigation system in communication with the probe (200), wherein the probe (200) moves out from the passageway and the tubular member (110) is retained at the distal end (101) substantially contacting the neurosurgical site. In the preferred embodiment, the device further comprises a handle (104) mounted at the proximal end (102) of the tubular member (110). Particularly, the handle is preferably formed into a substantially E-shape, T-shape, volar-shape or cross-shape.

Another preferred embodiment of the present invention discloses that the tubular member (110) is straight or bayonet in shape.

Preferably, the proximal end (102) is having a slot (108) longitudinal to the tubular member (110). Further, the probe (200) preferably comprises a protruding structure (201) engages to the slot (108) to secure the probe (200) to the tubular member (110).

Preferably, the tubular member (110) is having a distal segment (105) and a proximal segment (106) which are detachably connected in a tip-to-tip fashion substantially defining the passageway. Particularly, the distal segment (105) and the proximal segment (106) are detachably connected using a male and female locking system.

In the preferred embodiment, the male locking system comprises a protruding marking. Further, the female locking system comprises an L- shaped groove (107) longitudinal to the proximal segment (106). According to one of the preferred embodiments of the present invention, the navigation system comprises a plurality of navigation reference units (103) mounted on the handle (104) and/or the tubular member (110). Preferably, the navigation reference units (103) are spherical in shape. They can also be simply named as navigation guiding balls.

Preferably, the navigation system corresponds to medical images of the neurosurgical site.

At least one of the preceding objects is met, in whole or in part, by the present invention, in which one of the embodiments of the present invention describes a universal surgical device capable of locating a neurosurgical site, comprising a tubular member (110) having a proximal end (101) and a distal end (102) configured to receive a probe (200) until the tip (203) of the probe protrudes from the distal end (102) of the tubular member, wherein the tubular member is having a proximal segment (105) and a distal segment (106) which are detachably connected in a tip-to- tip fashion substantially defining a passageway to receive a probe therethrough, wherein the tubular member (110) moves to the neurosurgical site under guidance of the probe (200) and continues to locate the neurosurgical site upon removal of the probe (200).

In accordance with the preferred embodiment of the present invention, the universal surgical device can be fabricated into four variations, each with a different structural design from the rest, to suit different requirements of different surgical procedures. This universal surgical device is useful in facilitating a wide variety of neurosurgical procedures, including locating tumours, cysts or other abnormal growths at the neurosurgical site, marking flaps, checking position, performing biopsy or endoscopy, and others.

One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments described herein are not intended as limitations on the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of facilitating an understanding of the invention, there is illustrated in the accompanying drawing the preferred embodiments from an inspection of which when considered in connection with the following description, the invention, its construction and operation and many of its advantages would be readily understood and appreciated. Figure 1 is a front view of the tubular member (101) that is formed by two detachably connected parts (105, 106), and a plurality of navigation reference units (103) mounted thereon, which is one of the structural designs as described in one of the preferred embodiments of the present invention.

Figure 2 is the side view of Figure 1.

Figure 3 is the navigation probe (200) which slides into the tubular member

(HO) shown in Figure 1.

Figure 4 is a front view of the tubular member (101) that is formed by two detachably connected parts (105, 106) without the navigation reference units (103) mounted thereon, which is one of the structural designs as described in another preferred embodiment of the present invention.

Figure 5 is the side view of Figure 4.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a neurosurgical device. More particularly, the neurosurgical device comprises a navigation probe and a tubular member fabricated to engage the probe or other surgical tools for locating a neurosurgical site and subsequently performing surgery thereon. Hereinafter, the invention shall be described according to the preferred embodiments of the present invention and by referring to the accompanying description and drawings. However, it is to be understood that limiting the description to the preferred embodiments of the invention and to the drawings is merely to facilitate discussion of the present invention and it is envisioned that those skilled in the art may devise various modifications without departing from the scope of the appended claim. The present invention discloses a universal surgical device capable of locating a neurosurgical site, comprising a tubular member (110), defining a passageway, having a distal end (101) and a proximal end (102); an elongated navigation probe (200), which is longer than the tubular member (110) and having a tapering tip (203), configured to collectively slide into the passageway until the tip protrudes from the distal end (101) of the tubular member, that the tubular member (110) and the engaged probe (200) concurrently move to the neurosurgical site under guidance of a navigation system in communication with the probe (200), wherein the probe (200) moves out from the passageway and the tubular member (110) is retained at the distal end (101) substantially contacting the neurosurgical site.

In accordance with the preferred embodiment of the present invention, the universal surgical device can be fabricated into four variations, each with a different structural design from the rest, to suit different requirements of different surgical procedures. This universal surgical device is useful in facilitating a wide variety of neurosurgical procedures, including locating tumours, cysts or other abnormal growths at the neurosurgical site, marking flaps, checking position, performing biopsy or endoscopy, and others. One of the variations is illustrated in Figure 1. The first variation of the universal surgical device reveals a simple neurosurgical device which comprises a tubular member (110) which is mounted with a handle (104). According to one of the preferred embodiments of the present invention, the tubular member (110) can be constructed into a one-piece cylindrical structure. However, the present invention does not intend to limit the length of the tubular member (110), it shall be fabricated accordingly to meet different requirements of surgical procedures. Nevertheless, the navigation probe (200) is preferably fabricated to be longer than the tubular member in the present invention. Further, the tubular member (110) can be in a straight configuration as shown in Figure 1, or be fabricated in a bayonet configuration. The handle (104) which mounts on the proximal end (102) of the tubular member (110) can be fabricated into various shapes to accommodate the fingers of the surgeon or other surgical clamping or fixing devices. Preferably, the handle is fabricated into a substantially E-shape, T-shape, volar-shape or cross-shape. As shown in Figure 1, the handle (104) is substantially an E-shape having three slender shafts. With such a simple structural design as set forth in the foregoing description, the first variation of the universal surgical device can be applied as a generic cannula system to which any propriety navigation antenna system can be used. The second variation of the universal surgical device comprises a tubular member (110) similar to that of the first variation but is formed into two parts, as shown in Figure 4. A side view of the universal surgical device is shown in Figure 5. In accordance with another preferred embodiment of the present invention, the tubular member (110) is formed by a distal segment (105) and a proximal segment (106) which are detachably connected to each other in a tip-to-tip fashion that substantially defines the passageway. The proximal segment (106) can be disconnected from the distal segment (105) once the distal segment (105) is fixed at the neurosurgical site. In particular, the distal segment (105) preferably retains while the proximal segment (106) disconnects therefrom. The disconnection of the proximal segment (105) renders the tubular member (110) shorter, thus be able to suit the insertion and withdrawal of surgical tools of shorter length.

The third variation of the universal surgical device comprises a tubular member (110) derived from the first variation. According to one of the preferred embodiments of the present invention, the universal surgical device further comprises a plurality of navigation reference units (103) mounted on the handle (104) and/or the tubular member (110). Preferably, the navigation reference units (103) are spherical in shape. They can also be simply named as navigation guiding balls. Further, the navigation system corresponds to medical images of the neurosurgical site to ensure the neurosurgical site is located accurately. Medical images from X-ray imaging or Magnetic Resonance Imaging (MRI) are preferably used in the present invention. The fourth variation is considered as the complete version of the universal surgical device which is derived from the second and third variation. This complete version is shown in Figure 1. It contains a two-part tubular member (110) and a plurality of navigation reference units (103). As illustrated in Figure 1 and 2, the navigation reference units (103) can be mounted at the root and tips of each shaft of the handle (104), as well as the proximal segment (106) of the tubular member (110) that is close to the junction between the proximal segment (106) and the distal segment (105). The navigation reference units (103) is removable when navigation is no longer required during the surgical operation. In one of the preferred embodiment, the navigation reference units (103) can be removed by detaching the proximal segment (106) of the tubular member (110) from the distal segment (105).

Another preferred embodiment of the present invention discloses a universal surgical device comprises the distal segment (105) and the proximal segment (106) which are detachably connected to each other using a male and female locking system. The locking system can be a simple stortz lock which can be hidden from sight and a two- handed operation is required to lock and unlock the mechanism thus preventing the probe (200) being disengaged from the tubular member (110). In the preferred embodiment, the male locking system is having a protruding marking. Further, the female locking system is having an L- shaped groove (107) longitudinal to the proximal segment (106). In the present invention, the distal segment (105) and the proximal segment (106) aligns with each other to enable sliding-in of the protruding marking along the groove. Further, the proximal segment (106) and the distal segment (105) turns or twists in an opposite direction to each other for securing the protruding marking in the L- shaped groove (107). The universal navigation probe (200) described in one of the preferred embodiments of the present invention is shown in Figure 3. In the preferred embodiment, the probe (200) can be inserted into the tubular member (110) until it protrudes from the distal end (101). Once locked proximally, the length can be fixed to ensure total predictable accuracy of the tip of the probe (200) in relation to the navigation reference units (103). In such configuration, the device can be used to perform its usual functions such as marking flaps, locating tumours and checking position during the surgical operations. In the preferred embodiment, the proximal end (102) of the tubular member (110) is having a slot (108) longitudinal to the tubular member (110). Preferably, the probe (200) comprises a protruding structure (201) engages to the slot (108) to secure the probe (200) to the tubular member (110). Besides, the universal surgical device can also be used as an introducer to insert tubes directly into the ventricles, cystic lesions, abscesses or other surgical sites. A common surgical tube, such as an external ventricular catheter tube having an internal stylet can also be inserted from the proximal end (102) of the tubular member (110) until the tip of the catheter protrudes from the distal end (101).

In order to prevent disengagement of the catheter or other similar surgical tool from the distal end (101) of the universal surgical device, a clipping means, which is preferably an "O" ring can be attached at the proximal end (102). The entire universal surgical device can then be slid into the neurosurgical site, such as that in the brain, like a conventional brain cannula using navigation to ensure accurate entry into the target site. Once in position, the clipping means can be removed and the stylet of the catheter can be withdrawn. This renders the catheter floppy and the proximal part (106) of the universal surgical device can be disconnected from the distal part (105). Then the universal surgical device can be withdrawn while the catheter is inserted further at the neurosurgical site. The markings on the catheter corresponds to the depth of introduction of the universal surgical device. This technique obviates the need for special registration of the tubes or specific probes to be inserted into the catheter.

Apart from introducer, the universal surgical device can also be applied as a biopsy sleeve for tumour or other abnormal growths, which does not require sub-millimetre accuracy. For this application, the universal surgical device can be used together with the trocar, and being inserted together into the tumour or other neurosurgical sites. Once in position at the depth of the tumour, the universal surgical device can be clamped in position using a simple holding device such as the commercially available Yasargil clamp. Accordingly, a small cup biopsy forceps can also be introduced through the cavity of the tubular member (110). This forceps will be marked to indicate the point the cups just exit the distal end (101) and biopsies can thus be obtained. This technique is capable of providing a better specimen of biopsy. In cases where unexpected haemorrhage is encountered, haemostatic agents such as the commercially available Avitene®, Surgicel® and FloSeal® can be easily delivered to the neurosurgical site. Another application of the universal surgical device is to facilitate the operation of endoscopy. The tubular member (110) of the universal surgical device can be clamped in position once its distal end (101) reaches the target site. A fine endoscope can that be inserted into the cavity of the tubular member (110) from its proximal end (102) to its distal end (101) for inspection of the target site.

The universal surgical device can be made of various biocompatible metals, such as surgical steels. It can also be made of low cost biocompatible plastics for disposable usage. The present disclosure includes as contained in the appended claims, as well as that of the foregoing description. Although this invention has been described in its preferred form with a degree of particularity, it is understood that the present disclosure of the preferred form has been made only by way of example and that numerous changes in the details of construction and the combination and arrangements of parts may be resorted to without departing from the scope of the invention.

Claims

1. A universal surgical device capable of locating a neurosurgical site, comprising

a tubular member (110), defining a passageway, having a distal end (101) and a proximal end (102);

an elongated navigation probe (200), which is longer than the tubular member (110) and having a tapering tip (203), configured to collectively slide into the passageway until the tip protrudes from the distal end (101) of the tubular member, that the tubular member (110) and the engaged probe (200) concurrently move to the neurosurgical site under guidance of a navigation system in communication with the probe (200), wherein the probe (200) moves out from the passageway and the tubular member (110) is retained at the distal end (101) substantially contacting the neurosurgical site.

2. A universal surgical device according to claim 1 further comprising a handle (104) mounted at the proximal end (102) of the tubular member (110).

3. A universal surgical device according to claim 2, wherein the handle (104) is formed into a substantially E-shape, T-shape, volar-shape or cross-shape.

4. A universal surgical device according to claim 1, wherein the proximal end (102) is having a slot (108) longitudinal to the tubular member (110).

5. A universal surgical device according to claim 4, wherein the probe (200) comprises a protruding structure (201) engages to the slot (108) to secure the probe (200) to the tubular member (110).

6. A universal surgical device according to claim 1, wherein the tubular member (110) is having a distal segment (105) and a proximal segment (106) which are detachably connected in a tip-to-tip fashion substantially defining the passageway.

7. A universal surgical device according to claim 6, wherein the distal segment (105) and the proximal segment (106) are detachably connected using male and female locking system.

8. A universal surgical device according to claim 7, wherein the male locking system comprises a protruding marking.

9. A universal surgical device according to claim 7, wherein the female locking system comprises an L-shaped groove (107) longitudinal to the proximal segment (106).

10. A universal surgical device according to claim 1, wherein the tubular member (HO) is straight or bayonet in shape.

11. A universal surgical device according to claim 1 or 2, wherein the navigation system comprises a plurality of navigation reference units (103) mounted on the handle (104) and/or the tubular member (110).

12. A universal surgical device according to claim 1, wherein the navigation system corresponds to medical images of the neurosurgical site.

13. A universal surgical device capable of locating a neurosurgical site, comprising a tubular member (110) having a proximal end (101) and a distal end (102) configured to receive a probe (200) until the tip (203) of the probe protrudes from the distal end (102) of the tubular member,

wherein the tubular member is having a proximal segment (105) and a distal segment (106) which are detachably connected in a tip-to-tip fashion substantially defining a passageway to receive a probe therethrough, wherein the tubular member (110) moves to the neurosurgical site under guidance of the probe (200) and continues to locate the neurosurgical site upon removal of the probe (200).