Minimal invasive neurosurgery assembly as well as a method for neurosurgery using such a neurosurgery assembly

• US 8,690,761 B2
• Filed: 10/06/2009
• Issued: 04/08/2014
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Neurendo B. V.
• Original Assignee: Neurendo B. V.
• Inventors: Begemann, Malcolm Jon Simon, Grotenhuis, Joachim Andreas, Peters, Wimold Pieter Steven, Jonkman, Libbe Jitze
• Primary Examiner(s): Laballe, Clayton E
• Assistant Examiner(s): BUTLER, KEVIN C
• Application Number:
  US12/574,519
• Publication Number:
  US 20100145142A1
• Time in Patent Office: 1,645 Days
• Field of Search: 241/29, 128/748, 600/137, 600/207, 600/310, 600114-117, 600/121, 600/125, 604/167.01, 606/130
• US Class Current: 600/114
• CPC Class Codes: A61B 1/00 Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes examination of body cavities or body tracts using ultrasonic, sonic or infrasonic waves A61B8/12; endoscopic instruments for taking cell samples or for biopsy A61B10/04; for surgical purposes A61B17/00; endoscopic surgical cutting instruments A61B17/32; surgical instruments using a laser beam being directed along or through a flexible conduit A61B18/22; Illuminating arrangements therefor for the eyes A61B3/00
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92

Abstract

A minimal invasive neurosurgery assembly including a flush assembly having flush assembly main part with a central passage extending through the main part from the distal end to the proximal end along a longitudinal axis, and having at least one tool insertion assembly. The tool insertion assembly may include a tool handling part that is detachably connectable to the flush assembly main part and that has at least one tool insertion channel that extends from the distal end to the proximal end of the tool handling part. The tool insertion assembly may also include an inner sheath that is connected to the tool handling part and has an inner sheath wall and at least one lumen extending parallel to the longitudinal axis and in which an associated one of the at least one tool insertion channel emanates. The inner sheath may be insertable through the central passage of the flush assembly main part.

Claims

1. A minimal invasive neurosurgery assembly comprising:

a flush assembly having flush assembly main part with a distal end and a proximal end and with a central passage extending through the main part from the distal end to the proximal end along a longitudinal axis;

at least one tool insertion assembly including;

a tool handling part detachably connectable to the flush assembly main part, the tool handling part having a distal end and a proximal end and at least one tool insertion channel that extends from the distal end to the proximal end of the tool handling part; and

an inner sheath connected to the tool handling part, the inner sheath having an inner sheath wall and at least one lumen extending parallel to the longitudinal axis and in which an associated one of the at least one tool insertion channel emanates, the inner sheath being insertable through the central passage of the flush assembly main part,

wherein the flush assembly main part includes;

at least one ring channel that extends circumferentially around the central passage and that is formed by an associated portion of the central passage at an axial position of the central passage that has a diameter that is larger than the diameter of the central passage,

at least one connecting nipple configured to connect a flushing tube; and

at least one flush channel extending through the connecting nipple to the associated ring channel and emanating in the ring channel; and

wherein the inner sheath includes;

at least one flush lumen extending parallel to the longitudinal axis; and

at least one flush passage extending through the inner sheath wall and emanating in an associated one of the at least one flush lumen, the flush passage being positioned at a longitudinal position of the inner sheath that corresponds with the position of an associated one of the at least one ring channel when the tool handling part is connected to the flush assembly main part so that a fluid connection is present between the at least one flush channel extending in the associated connecting nipple and the associated lumen.

2. The neurosurgery assembly according to claim 1, wherein the inner sheath wall has a first position and a second position, the inner sheath wall in the first position having, in cross section, an outer circumference that is convex, and the inner sheath wall in the second position having, in cross section, an outer circumference that includes concave parts so that the total cross sectional area of the inner sheath having its wall in the second position is reduced relative to the total cross sectional area of the inner sheath having its wall in the first position.

3. The neurosurgery assembly according to claim 1, including:

an outer sheath with a distal end and a proximal end, the outer sheath having an outer sheath wall that bounds an outer sheath channel that extends along a longitudinal axis and that has a distal opening at the distal end and an proximal opening at the proximal end, the flush assembly main part being connected to the outer sheath adjacent the proximal end of the outer sheath and the outer sheath channel being connected to the central passage, the inner sheath being insertable into outer sheath channel.

4. The neurosurgery assembly according to claim 3, wherein the outer sheath wall has a first position and a second position, the outer sheath wall in the first position having, in cross section, an outer circumference that is convex, and the outer sheath wall in the second position having, in cross section, an outer circumference that includes concave parts so that the total cross sectional area of the outer sheath having its wall in the second position is reduced relative to the total cross sectional area of the outer sheath having its wall in the first position.

5. The neurosurgery assembly according to claim 3, including:

a dummy tool insertion assembly having a tool handling part and a dummy inner sheath of which at least a distal end is closed off, the length of the dummy inner sheath being such that in a mounted condition of the dummy tool insertion assembly on the flush assembly main part, the distal end of the dummy inner sheath also closes off the distal opening of the outer sheath.

6. The neurosurgery assembly according to claim 1, including:

a fixation assembly configured to connect with a skull of a patient the inner sheath or, alternatively an outer sheath with a distal end and a proximal end, the outer sheath having an outer sheath wall that bounds an outer sheath channel that extends along a longitudinal axis and that has a distal opening at the distal end and an proximal opening at the proximal end, the flush assembly main part being connected to the outer sheath adjacent the proximal end of the outer sheath and the outer sheath channel being connected to the central passage, the inner sheath being insertable into outer sheath channel.

7. The neurosurgery assembly according to claim 6, the fixation assembly including:

a skull clamp assembly configured to clamp the fixation assembly on the skull; and

an sheath clamp assembly configured to clamp the outer sheath, or alternatively the inner sheath to the skull clamp assembly in a range of different positions along the longitudinal axis of the outer or inner sheath.

8. The neurosurgery assembly according to claim 6, the fixation assembly including:

a ring part with a central opening;

a number of flexible legs each having a proximal end that is connected with the ring part, each leg extending, in a mounted condition substantially parallel to the longitudinal axis and each having a distal end with a protrusion that extends radial outwardly; and

the legs being positioned relative to each other so that radial inward sides of the legs define a sheath passage of which the diameter is so small that, in a mounted condition of the fixation assembly in a hole in the skull and in a mounted condition of the outer sheath or, alternatively the inner sheath the radial inward sides of the legs engage the outer sheath wall or, alternatively, the inner sheath wall to maintain the sheath in a stable position relative to the fixation assembly.

9. The neurosurgery assembly according to claim 8, wherein the fixation assembly includes:

a bush having a central passage through which the outer sheath or, alternatively the inner sheath is insertable and having external screw thread that is configured to directly engage the skull material bounding the hole in the skull.

10. The neurosurgery assembly according to claim 7, wherein the skull clamp assembly includes:

a central part having a number of flexible legs extending, in a mounted condition parallel to the longitudinal axis and each having a distal end with a protrusion that extends radial outwardly, each leg having a proximal end that is integrally connected with a distal end of a central bush that has external screw thread; and

a fixation bush having internal screw thread configured to co-operate with the external screw thread of the central bush.

11. The neurosurgery assembly according to claim 7, wherein the sheath clamp assembly includes:

a unitary piece of semi-rigid material including a circumferential part having two diametrically opposed gripping portions on a radial outward peripheral side of the circumferential part and having two diametrically opposed clamping fingers extending radial inwardly from a radial inward side of the circumferential part, the gripping portions being positioned relative to the fingers so that a radial inward movement of the gripping portions effected by pressure exerted thereon causes a radial outward movement of the fingers.

12. The neurosurgery assembly according to claim 1, including:

a connector to axially fixate the inner sheath relative to an endoscope that is inserted into the at least one lumen of the inner sheath.

13. The neurosurgery assembly according to claim 1, wherein the tool insertion assembly is rotatable relative to the flush assembly around the longitudinal axis.

14. The neurosurgery assembly according to at least claim 13, including:

a rotation assembly configured to facilitate rotational positioning of the tool insertion assembly relative to the flush assembly.

15. The neurosurgery assembly of claim 1, the tool handling part having at least one tool insertion channel extending from a proximal end to a distal end of the tool handling part and emanating in an associated one of the at least one flush lumen.

16. The neurosurgery assembly according to claim 1, wherein at least one of said tool insertion channels includes a valve.

17. The neurosurgery assembly according to claim 1, wherein the inner sheath includes a first and a second lumen the first lumen having a diameter that differs from the diameter of the second lumen.

18. The neurosurgery assembly according to claim 1, wherein the inner sheath includes a lumen that is bounded by at least one flexible wall part that has at least a stable first position towards it is biased, the lumen being fit for accommodating without play a tool having a first diameter when the at least one flexible wall part is in the stable first position, the lumen being fit for accommodating without substantial play a tool having a second diameter that is different from the first diameter when the at least one flexible wall part is moved out of the first position towards which it is biased.

19. The neurosurgery assembly according to claim 1, including:

a pressure sensor configured to provide a signal that is indicative of one of fluid pressure and thrust force.

20. The neurosurgery assembly according to claim 1, including:

an insertion depth indicator that indicates a character that is indicative for the insertion depth of the outer sheath or, alternatively the inner sheath, the insertion depth indicator being configured to be visible from a proximal end of the neurosurgery assembly when looking in the direction of a distal end of the neurosurgery assembly.

21. Kit of parts including a single outer package that contains the neurosurgery assembly according to claim 1 in a sterilized atmosphere.

22. A method for performing a neurosurgery operation on the brain, including:

providing the neurosurgery assembly according to claim 1;

determining a region in which the operation has to be performed and based on that determining a position at which a hole has to be drilled in the skull;

drilling a hole in the skull;

inserting an inner sheath of the assembly through the hole; and

inserting at least one of an endoscope and a tool into the tool insertion assembly through an associated tool insertion channel into an associated one of the lumen of the inner sheath.

23. The method of claim 22 including:

providing the neurosurgery assembly having an outer sheath with a distal end and a proximal end, the outer sheath having an outer sheath wall that bounds an outer sheath channel that extends along a longitudinal axis and that has a distal opening at the distal end and an proximal opening at the proximal end, the flush assembly main part being connected to the outer sheath adjacent the proximal end of the outer sheath and the outer sheath channel being connected to the central passage, the inner sheath being insertable into outer sheath channel;

providing the neurosurgery assembly having a fixation assembly configured to connect with a skull of a patient the inner sheath or, alternatively an outer sheath with a distal end and a proximal end, the outer sheath having an outer sheath wall that bounds an outer sheath channel that extends along a longitudinal axis and that has a distal opening at the distal end and an proximal opening at the proximal end, the flush assembly main part being connected to the outer sheath adjacent the proximal end of the outer sheath and the outer sheath channel being connected to the central passage, the inner sheath being insertable into outer sheath channel;

connecting the fixation assembly to the skull of the patient after drilling the hole; and

connecting the outer sheath to the fixation assembly to keep it stationary relative to the skull.

24. The method of claim 22 including:

providing the neurosurgery assembly having a fixation assembly configured to connect with a skull of a patient the inner sheath or, alternatively an outer sheath with a distal end and a proximal end, the outer sheath having an outer sheath wall that bounds an outer sheath channel that extends along a longitudinal axis and that has a distal opening at the distal end and an proximal opening at the proximal end, the flush assembly main part being connected to the outer sheath adjacent the proximal end of the outer sheath and the outer sheath channel being connected to the central passage, the inner sheath being insertable into outer sheath channel;

connecting the fixation assembly to the skull of the patient after drilling the hole; and

connecting the inner sheath to the fixation assembly to keep it stationary relative to the skull.

25. The method of claim 22 including:

providing the neurosurgery assembly having an outer sheath with a distal end and a proximal end, the outer sheath having an outer sheath wall that bounds an outer sheath channel that extends along a longitudinal axis and that has a distal opening at the distal end and an proximal opening at the proximal end, the flush assembly main part being connected to the outer sheath adjacent the proximal end of the outer sheath and the outer sheath channel being connected to the central passage, the inner sheath being insertable into outer sheath channel, wherein the outer sheath wall has a first position and a second position, the outer sheath wall in the first position having, in cross section, an outer circumference that is convex, and the outer sheath wall in the second position having, in cross section, an outer circumference that includes concave parts so that the total cross sectional area of the outer sheath having its wall in the second position is reduced relative to the total cross sectional area of the outer sheath having its wall in the first position;

inserting the outer sheath into the skull when the outer sheath wall is in the second position in which the outer sheath wall has, in cross section, an outer circumference that includes concave parts so that the total cross sectional area of the outer sheath is reduced; and

after the inserting

bringing the outer sheath wall into the first position in which the outer sheath wall has, in cross section, an outer circumference that is convex.

26. The method of claim 22 including:

providing the neurosurgery assembly having the inner sheath wall with a first position and a second position, the inner sheath wall in the first position having, in cross section, an outer circumference that is convex, and the inner sheath wall in the second position having, in cross section, an outer circumference that includes concave parts so that the total cross sectional area of the inner sheath having its wall in the second position is reduced relative to the total cross sectional area of the inner sheath having its wall in the first position;

inserting the inner sheath into the skull when the inner sheath wall is in the second position in which the inner sheath wall has, in cross section, an outer circumference that includes concave parts so that the total cross sectional area of the inner sheath is reduced; and

after the inserting

bringing the inner sheath wall into the first position in which the wall has, in cross section, an outer circumference that is convex.

27. The method of claim 22 including:

providing the neurosurgery assembly providing the flush assembly main part including;

at least one ring channel that extends circumferentially around the central passage and that is formed by an associated portion of the central passage at an axial position of the central passage that has a diameter that is larger than the diameter of the central passage,

at least one connecting nipple configured to connect a flushing tube; and

at least one flush channel extending through the connecting nipple to the associated ring channel and emanating in the ring channel; and

the inner sheath including;

at least one flush passage extending through the inner sheath wall and emanating in an associated flush lumen, the flush passage being positioned at a longitudinal position of the inner sheath that corresponds with the position of an associated one of the at least one ring channel when the tool handling part is connected to the flush assembly main part so that a fluid connection is present between the at least one flush channel extending in the associated connecting nipple and the associated lumen;

connecting at least one flushing tube to the at least one connecting nipple;

supplying flushing fluid via the at least one flush channel to the associated ring channel, the at least one flush passage in the inner sheath wall and into the associated flush lumen; and

manipulating at least one of an endoscope or a tool inserted into the tool insertion assembly during supplying flushing fluid while keeping the flush assembly main part stationary.

28. The method of claim 22 including:

providing the neurosurgery assembly having the inner sheath including a lumen that is bounded by at least one flexible wall part that has at least a stable first position towards it is biased, the lumen being fit for accommodating without play a tool having a first diameter when the at least one flexible wall part is in the stable first position, the lumen being fit for accommodating without substantial play a tool having a second diameter that is different from the first diameter when the at least one flexible wall part is moved out of the first position towards which it is biased;

inserting the tool having a first diameter into the lumen that is bounded by at least one flexible wall part and that is biased towards a stable first position, the tool having the first diameter being accommodated without play when the at least one flexible wall part is in the stable first position; and

inserting the tool having a second diameter that is different from the first diameter in the lumen that is bounded by at least one flexible wall part thereby bringing the flexible wall part out of the first position towards which it is biased so that the tool having the second diameter is accommodated without substantial play in the lumen with the at least one flexible wall part.

29. A minimal invasive neurosurgery assembly comprising:

a flush assembly having flush assembly main part with a distal end and a proximal end and with a central passage extending through the main part from the distal end to the proximal end along a longitudinal axis;

at least one tool insertion assembly including;

a tool handling part detachably connectable to the flush assembly main part, the tool handling part having a distal end and a proximal end and at least one tool insertion channel that extends from the distal end to the proximal end of the tool handling part; and

an inner sheath connected to the tool handling part, the inner sheath having an inner sheath wall and at least one lumen extending parallel to the longitudinal axis and in which an associated one of the at least one tool insertion channel emanates, the inner sheath being insertable through the central passage of the flush assembly main part; and

a dummy tool insertable into the at least one lumen of the inner sheath, the dummy tool having at least one dummy tool insert of which at least a distal end is closed off, the length of the at least one dummy tool insert being such that in a mounted condition of the dummy tool on tool handling part, the distal end of the at least one dummy tool insert also closes off the distal opening of an associated one of the at least one lumen.

30. A minimal invasive surgery assembly comprising at least one insertion assembly including a sheath extending along a longitudinal axis, the sheath having a sheath wall and at least one lumen extending parallel to the longitudinal axis, the sheath wall having a first position and a second position, the sheath wall in the first position having, in cross section, an outer circumference that is convex, and the sheath wall in the second position having, in cross section, an outer circumference that includes concave parts so that the total cross sectional area of the sheath having its wall in the second position is reduced relative to the total cross sectional area of the sheath having its wall in the first position.