WO2017021985A1 - Guide for the intracranial positioning of cerebral catheters - Google Patents

Guide for the intracranial positioning of cerebral catheters Download PDF

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Publication number
WO2017021985A1
WO2017021985A1 PCT/IT2015/000193 IT2015000193W WO2017021985A1 WO 2017021985 A1 WO2017021985 A1 WO 2017021985A1 IT 2015000193 W IT2015000193 W IT 2015000193W WO 2017021985 A1 WO2017021985 A1 WO 2017021985A1
Authority
WO
WIPO (PCT)
Prior art keywords
guide
catheter
hole
intracranial
cerebral
Prior art date
Application number
PCT/IT2015/000193
Other languages
French (fr)
Inventor
Francesco GARACI
Mario Francesco FRAIOLI
Francesco Luigi UMANA
Giuseppe Emmanuele UMANA
Original Assignee
Garaci Francesco
Fraioli Mario Francesco
Umana Francesco Luigi
Umana Giuseppe Emmanuele
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Garaci Francesco, Fraioli Mario Francesco, Umana Francesco Luigi, Umana Giuseppe Emmanuele filed Critical Garaci Francesco
Priority to PCT/IT2015/000193 priority Critical patent/WO2017021985A1/en
Publication of WO2017021985A1 publication Critical patent/WO2017021985A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3492—Means for supporting the trocar against the body or retaining the trocar inside the body against the outside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/036—Abutting means, stops, e.g. abutting on tissue or skin abutting on tissue or skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B2090/103—Cranial plugs for access to brain

Definitions

  • the present invention relates to a guide for the intracranial positioning of cerebral catheters.
  • the invention concerns a guide permitting maintaining, during the intracranial introduction of cerebral catheters, a surgical trajectory that is perpendicular with respect to the plane of the hole realised on the cranial theca of the patient, in order to ensure proper positioning of the catheter tip into the cerebral area interesting under a clinical or diagnostic point of view.
  • the guide according to the invention can be, for example, be use to carry out biopsies, liquor draining, evacuation of hematoma, positioning of electrodes for DBS (Deep Brain Stimulation) procedures, intracranial pressure monitoring, ecc .
  • DBS Deep Brain Stimulation
  • said 3D navigation devices permit very precisely localizing where the hole must be drilled, but they do not assist the operator during the intracranial introduction of the cerebral catheter. Further, said 3D navigation systems, to exactly localize the point where drilling the hole, require making magnetic resonance imaging, that not always can be carried out, e.g. in case of urgency surgical intervention .
  • disposable device for ventriculostomy manufactured by Neurodynamics Inc. permits making, by a drill, a hole having the correct angulation on patient cranial theca and to introduce a cerebral catheter following a surgical trajectory perpendicular with respect to the drilled hole.
  • the shape of the device, the tripod necessary to maintain the device positioned on patient cranial theca and introduction of catheter within the central channel of the device only after withdrawal of the drill tip used to make the hole make the device difficult to handle, require longer time to make the surgical intervention and limit surgeon intervention in case of complications, such as, for example, bleedings caused by drilling.
  • said device cannot be employed for procedures different with respect to the simple positioning of liquor shunts and does not permit using 3D navigation systems for localization of the point on cranial theca where the hole must be drilled.
  • operator does not use instruments guiding when introducing catheter, and consequently, does not succeed in properly directing catheter toward clinic/diagnostic interesting cerebral area and must repeat the introduction procedure many times, with the consequent clinical risks for patients subjected to catheter introduction.
  • the Applicants have realised a guide for intracranial positioning cerebral catheters permitting solving the above problems, with the consequent reduction of clinical risks for patients subjected to cerebral catheterization operations.
  • US' 156 describes a device realised to be left within the patient, e.g. to do monitoring over time, and providing the body and catheter guide portion within the cranial theca of the same patient.
  • the solution according to the present invention provides that only a small portion of the device body is introduced within the patient cranial theca.
  • solution according to US' 156 provides a blocking system of catheter to the same device body, while solution according to the invention provides a slot permitting blocking catheter manually or by a suitable instrument, but not on the same device body.
  • a guide for the intracranial positioning of a cerebral catheter through a hole made on the cranial theca of a patient said guide comprising a substantially cylindrical, lengthened body, hollow and open at the two ends, respectively a proximal or external end, from which a pipe for guiding the catheter, that extends for a substantial portion of the length of the body, begins, and a distal or intracranial end having a diameter corresponding to the diameter of the hole made on the cranial theca, a stop element, made on said body close to said distal end, in order to define the portion of the body that can be inserted into said hole, a slot, realized in said body, which extends partially from said distal end to said proximal end, in order to allow the clamping of the catheter when positioned.
  • said proximal or external end has a funnel-shaped entrance from which the pipe for guiding the catheter begins .
  • said guide is realized in biocompatible material, preferably in Teflon ® .
  • figure 1 is a perspective view of an embodiment of a guide for the intracranial positioning of cerebral catheters according to the invention
  • figure 2 shows a lateral view of the guide of figure 1 ;
  • figure 3 shows a rear view of the guide of figure 1 ;
  • figure. 4 shows a front view of the guide of figure 1;
  • figure 5 shows a bottom view of the guide of figure 1;
  • figure 6 shows a section view of the guide of figure 1 taken along the section line VI-VI of figure 5;
  • figure 7 shows a top view of the guide of figure 1;
  • figure 8 shows a lateral section view of a cerebral catheter introduced within the guide of figure 1, within a hole realised on the cranial theca of a patient;
  • figure 9 shows a lateral view of a cerebral catheter introduced within the guide of figure 1, within a hole realised on the cranial theca of a patient.
  • Said guide 1 has a cylindrical body 2, hollow and open at the two ends, respectively a distal or intracranial end 2" and a proximal or external end 2', a pipe 3 extending between said two ends of the body 2 , and a stop element 4, externally surrounding said guide 1 in its lower portion, close to said distal end (2" .
  • said guide 1 has an inner diameter suitable for introduction within a cerebral catheter 5 and an outer diameter slightly smaller than the diameter of the hole 6 realised on the cranial theca 7 of the patient, so that said guide 1 can be housed within said hole 6 in a sufficiently stable way.
  • Guides 1 having different sizes of the outer diameter can be provided, based on the surgery technique adopted.
  • Said guide 1 is preferably comprised of in biocompatible material, preferably in Teflon ® .
  • a hole 6 is realised on the cranial theca 7 of the patient by a standard drill.
  • Said guide 1 is then positioned within the hole 6, so that stop element 4 abuts against cranial theca 7 of the patient (as shown in figures 8 and 9) .
  • cerebral catheter 5 is passed within the pipe 3 of said guide 1 (as shown in figure 8) and is progressively introduced , following a trajectory perpendicular with respect to the hole 6 plane, within the patient theca 7, until reaching the clinical/diagnostic interesting cerebral area .
  • said guide 1 it is ensured in a simply, quick and precise way, an intracranial insertion of cerebral catheters 5 according to a surgical trajectory- perpendicular to the plane of the hole 6 realised on the cranial theca 7, thus reducing clinical risks for the patient.
  • said stop element 4 of said guide 1 permits keeping in the proper position within the hole 6 realised on the cranial theca 7 of the patient, said guide preventing its sliding within the patient cranial theca 7.
  • said guide 1 has, in its lower portion, a slot 8, partially extending from distal end 2" toward the proximal end 2' of body 2, in correspondence of which diameter of inner pipe 3 of guide 1 increases.
  • Said slot 8 and said increase of the inner diameter of pipe 3 of guide 1 in correspondence of slot 8 permit, during the catheter introduction procedure, clamping, or blocking, cerebral catheter 5 introduced within said guide 1.
  • said guide 1 has, above, in correspondence of the proximal end 2' of the body 2, a funnel-shaped entrance 9.
  • Said entrance 9 makes it easier introduction of catheter 5 within the pipe 3 of the guide 1.
  • trackers (not shown in the enclosed drawings) can be mounted on said guide 1, to localize anatomic structures, in order to be able to individuate the point on the cranial theca 7 for realising the hole 6.
  • device according to the present invention due to its use simplicity and quickness, is particularly- advantageous in urgency cases, wherein minimal mistaken in positioning guide 1 can have major negative clinical consequences on patient.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The present invention relates to a guide (1) for the intracranial positioning of a cerebral catheter (5) through a hole (6) made on the cranial theca (7) of a patient, said guide (1) comprising a substantially cylindrical, lengthened body (2), hollow and open at the two ends, respectively a proximal or external end (2') / from which a pipe (3) for guiding the catheter (5), that extends for a substantial portion of the length of the body (2), begins, and a distal or intracranial end (2") having a diameter corresponding to the diameter of the hole (6) made on the cranial theca (7), a stop element (4), made on said body (2) close to said distal end (2"), in order to define the portion of the body (2) that can be inserted into said hole (6), a slot (8), realized in said body (2), which extends partially from said distal end (2") to said proximal end, in order to allow the clamping of the catheter (5) when positioned.

Description

GUIDE FOR THE INTRACRANIAL POSITIONING OF
CEREBRAL CATHETERS
The present invention relates to a guide for the intracranial positioning of cerebral catheters.
More particularly, the invention concerns a guide permitting maintaining, during the intracranial introduction of cerebral catheters, a surgical trajectory that is perpendicular with respect to the plane of the hole realised on the cranial theca of the patient, in order to ensure proper positioning of the catheter tip into the cerebral area interesting under a clinical or diagnostic point of view.
The guide according to the invention can be, for example, be use to carry out biopsies, liquor draining, evacuation of hematoma, positioning of electrodes for DBS (Deep Brain Stimulation) procedures, intracranial pressure monitoring, ecc .
It is known that, to introduce and position, without any mistaken, a cerebral catheter within the clinic/diagnostic interesting area, it is necessary making a hole on patient cranial theca, lying along a plane parallel with respect to the interesting area, so that a surgical trajectory perpendicular with respect to the hole plane can be followed. To localize the point on the cranial theca where the hole can be realised, set reference anatomic points and lines or tri-dimensional (3D) navigation devices can be used.
Particularly, said 3D navigation devices permit very precisely localizing where the hole must be drilled, but they do not assist the operator during the intracranial introduction of the cerebral catheter. Further, said 3D navigation systems, to exactly localize the point where drilling the hole, require making magnetic resonance imaging, that not always can be carried out, e.g. in case of urgency surgical intervention .
It is further known that devices exit suitable for ensuring an intracranial introduction of cerebral catheters according to a trajectory perpendicular with respect to the hole plane, but said devices, not being easily manageable and involving different clinical risks for patients, are not widely used.
Particularly, disposable device for ventriculostomy manufactured by Neurodynamics Inc. permits making, by a drill, a hole having the correct angulation on patient cranial theca and to introduce a cerebral catheter following a surgical trajectory perpendicular with respect to the drilled hole.
However, the shape of the device, the tripod necessary to maintain the device positioned on patient cranial theca and introduction of catheter within the central channel of the device only after withdrawal of the drill tip used to make the hole, make the device difficult to handle, require longer time to make the surgical intervention and limit surgeon intervention in case of complications, such as, for example, bleedings caused by drilling. Further, said device cannot be employed for procedures different with respect to the simple positioning of liquor shunts and does not permit using 3D navigation systems for localization of the point on cranial theca where the hole must be drilled. Thus, often occurs that operator does not use instruments guiding when introducing catheter, and consequently, does not succeed in properly directing catheter toward clinic/diagnostic interesting cerebral area and must repeat the introduction procedure many times, with the consequent clinical risks for patients subjected to catheter introduction.
In view of the above, the Applicants have realised a guide for intracranial positioning cerebral catheters permitting solving the above problems, with the consequent reduction of clinical risks for patients subjected to cerebral catheterization operations.
The above result is obtained, according to the present invention, by a hollow cylindrical device to be positioned within the hole drilled in the patient cranial theca, so that catheter inserted within said device, is obliged to reach the interesting clinic/diagnostic cerebral area following a surgical trajectory that is perpendicular with respect to the hole plane.
US 2001/0003156 describes a "Neurosurgical guiding device" representing the closet prior art with respect to the device according to the present patent application.
However, US' 156 describes a device realised to be left within the patient, e.g. to do monitoring over time, and providing the body and catheter guide portion within the cranial theca of the same patient.
On the contrary, the solution according to the present invention provides that only a small portion of the device body is introduced within the patient cranial theca.
Further, the solution according to US' 156 provides a blocking system of catheter to the same device body, while solution according to the invention provides a slot permitting blocking catheter manually or by a suitable instrument, but not on the same device body.
It is therefore specific object of the present invention a guide for the intracranial positioning of a cerebral catheter through a hole made on the cranial theca of a patient, said guide comprising a substantially cylindrical, lengthened body, hollow and open at the two ends, respectively a proximal or external end, from which a pipe for guiding the catheter, that extends for a substantial portion of the length of the body, begins, and a distal or intracranial end having a diameter corresponding to the diameter of the hole made on the cranial theca, a stop element, made on said body close to said distal end, in order to define the portion of the body that can be inserted into said hole, a slot, realized in said body, which extends partially from said distal end to said proximal end, in order to allow the clamping of the catheter when positioned.
Particularly, according to the invention, said proximal or external end has a funnel-shaped entrance from which the pipe for guiding the catheter begins . Preferably, according to the invention, said guide is realized in biocompatible material, preferably in Teflon®.
The present invention will be now described for illustrative, but not limitative, purposes, with particular reference to the figures of the enclosed drawings, wherein:
figure 1 is a perspective view of an embodiment of a guide for the intracranial positioning of cerebral catheters according to the invention;
figure 2 shows a lateral view of the guide of figure 1 ; figure 3 shows a rear view of the guide of figure 1 ; figure. 4 shows a front view of the guide of figure 1; figure 5 shows a bottom view of the guide of figure 1; figure 6 shows a section view of the guide of figure 1 taken along the section line VI-VI of figure 5;
figure 7 shows a top view of the guide of figure 1;
figure 8 shows a lateral section view of a cerebral catheter introduced within the guide of figure 1, within a hole realised on the cranial theca of a patient; and
figure 9 shows a lateral view of a cerebral catheter introduced within the guide of figure 1, within a hole realised on the cranial theca of a patient.
Making reference to figures 1 - 9, it is described a guide for intracranial positioning of cerebral catheters according to the present invention, generically indicated by reference number 1.
Said guide 1 has a cylindrical body 2, hollow and open at the two ends, respectively a distal or intracranial end 2" and a proximal or external end 2', a pipe 3 extending between said two ends of the body 2 , and a stop element 4, externally surrounding said guide 1 in its lower portion, close to said distal end (2" .
Particularly, said guide 1 has an inner diameter suitable for introduction within a cerebral catheter 5 and an outer diameter slightly smaller than the diameter of the hole 6 realised on the cranial theca 7 of the patient, so that said guide 1 can be housed within said hole 6 in a sufficiently stable way.
Guides 1 having different sizes of the outer diameter can be provided, based on the surgery technique adopted. Said guide 1 is preferably comprised of in biocompatible material, preferably in Teflon®.
Once localized the proper introduction cranial point for the cerebral catheter 5, by 3D navigation or anatomical reference points or lines, a hole 6 is realised on the cranial theca 7 of the patient by a standard drill.
Said guide 1 is then positioned within the hole 6, so that stop element 4 abuts against cranial theca 7 of the patient (as shown in figures 8 and 9) . Once positioned the guide 1 within the hole 6, cerebral catheter 5 is passed within the pipe 3 of said guide 1 (as shown in figure 8) and is progressively introduced , following a trajectory perpendicular with respect to the hole 6 plane, within the patient theca 7, until reaching the clinical/diagnostic interesting cerebral area .
Thus, by said guide 1 it is ensured in a simply, quick and precise way, an intracranial insertion of cerebral catheters 5 according to a surgical trajectory- perpendicular to the plane of the hole 6 realised on the cranial theca 7, thus reducing clinical risks for the patient.
Furthermore, said stop element 4 of said guide 1 permits keeping in the proper position within the hole 6 realised on the cranial theca 7 of the patient, said guide preventing its sliding within the patient cranial theca 7.
Further, said guide 1 has, in its lower portion, a slot 8, partially extending from distal end 2" toward the proximal end 2' of body 2, in correspondence of which diameter of inner pipe 3 of guide 1 increases.
Said slot 8 and said increase of the inner diameter of pipe 3 of guide 1 in correspondence of slot 8 permit, during the catheter introduction procedure, clamping, or blocking, cerebral catheter 5 introduced within said guide 1.
Further, said guide 1 has, above, in correspondence of the proximal end 2' of the body 2, a funnel-shaped entrance 9.
Said entrance 9 makes it easier introduction of catheter 5 within the pipe 3 of the guide 1.
Furthermore, trackers (not shown in the enclosed drawings) can be mounted on said guide 1, to localize anatomic structures, in order to be able to individuate the point on the cranial theca 7 for realising the hole 6.
Further, device according to the present invention, due to its use simplicity and quickness, is particularly- advantageous in urgency cases, wherein minimal mistaken in positioning guide 1 can have major negative clinical consequences on patient.
The present invention has been described for illustrative, but not limitative, purposes, according to its preferred embodiments, but it is to be understood that variations and/or modifications can be introduced by those skilled in the art without departing from the relevant scope, as defined in the enclosed claims.

Claims

1. Guide (1) for the intracranial positioning of a cerebral catheter (5) through a hole (6) made on the cranial theca (7) of a patient, said guide (1) comprising a substantially cylindrical, lengthened body (2), hollow and open at the two ends, respectively a proximal or external end (2'), from which a pipe (3) for guiding the catheter (5) , that extends for a substantial portion of the length of the body (2), begins, and a distal or intracranial end (2") having a diameter corresponding to the diameter of the hole (6) made on the cranial theca (7) , a stop element (4) , made on said body (2) close to said distal end (2"), in order to define the portion of the body (2) that can be inserted into said hole (6) , a slot (8) , realized in said body (2) , which extends partially from said distal end (2") to said proximal end, in order to allow the clamping of the catheter (5) when positioned.
2. Guide (1) according to claim 1, wherein said proximal or external end (2') has a funnel-shaped entrance (9) from which the pipe (3) for guiding the catheter (5) begins.
3. Guide (1) according to any of the precedent claims, wherein said guide (1) is realized in biocompatible material, preferably in Teflon®.
PCT/IT2015/000193 2015-08-03 2015-08-03 Guide for the intracranial positioning of cerebral catheters WO2017021985A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IT2015/000193 WO2017021985A1 (en) 2015-08-03 2015-08-03 Guide for the intracranial positioning of cerebral catheters

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2015/000193 WO2017021985A1 (en) 2015-08-03 2015-08-03 Guide for the intracranial positioning of cerebral catheters

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4646752A (en) * 1983-04-25 1987-03-03 Swann Karl W Adjustable intracranial pressure measuring screw
US5927277A (en) * 1995-04-28 1999-07-27 Medtronic, Inc. Method and apparatus for securing probes within a burr hole
US5993463A (en) * 1997-05-15 1999-11-30 Regents Of The University Of Minnesota Remote actuation of trajectory guide
WO2004107953A2 (en) * 2003-05-30 2004-12-16 Innerspace Medical, Inc. System and method for intracranial access and monitoring
EP1593348A2 (en) * 2004-05-04 2005-11-09 CODMAN & SHURTLEFF, INC. Multiple lumen sensor attachment

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4646752A (en) * 1983-04-25 1987-03-03 Swann Karl W Adjustable intracranial pressure measuring screw
US5927277A (en) * 1995-04-28 1999-07-27 Medtronic, Inc. Method and apparatus for securing probes within a burr hole
US5993463A (en) * 1997-05-15 1999-11-30 Regents Of The University Of Minnesota Remote actuation of trajectory guide
WO2004107953A2 (en) * 2003-05-30 2004-12-16 Innerspace Medical, Inc. System and method for intracranial access and monitoring
EP1593348A2 (en) * 2004-05-04 2005-11-09 CODMAN & SHURTLEFF, INC. Multiple lumen sensor attachment

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