NL2010857C2

NL2010857C2 - A cannula system, a kit and a method for assembling a cannula system.

Info

Publication number: NL2010857C2
Application number: NL2010857A
Authority: NL
Inventors: Gerrit Jan Vijfvinkel
Original assignee: D O R C Dutch Ophthalmic Res Ct International B V
Priority date: 2013-05-24
Filing date: 2013-05-24
Publication date: 2014-11-26

Description

Title: A cannula system, a kit and a method for assembling a cannula system

The invention relates to a cannula system. Cannula systems are normally used for transporting fluid towards and/or from a body.

For example, a cannula system can be used for irrigation of an eye and/or for keeping an eye at a certain pressure by infusing a fluid, e.g. a liquid or a gas such as air, into the eye.

A known ophthalmic cannula system comprises a base part provided with a fluid chamber which at a first side is provided with a passage connected to a cannula for insertion into an eye. The fluid chamber also has a further passage placed opposite to the passage at the first side and provided with a closure valve. In order to insert said cannula into a human eye a distal end portion of an inserter is inserted through the closure valve, through the fluid chamber and through the cannula to such extent that a sharp distal end of the end portion is protruding from a distal end of the cannula. The sharp distal end of the inserter is then pierced through the eye, e.g. through the conjunctiva and the sclera, and shoved further into the eye, e.g. into the intra-ocular space of the eye, while the distal end portion carries the cannula at least partly into the eye. Subsequently, the distal end portion of the inserter is withdrawn from the eye, while the cannula is at least partly left behind in the eye. When the inserter is removed from the cannula system, the closure valve automatically closes off the further passage. Subsequently, a tube shaped end portion of a tubing, or a so-called capillair, is inserted into a proximal end of the cannula through said further passage in order to obtain a fluid connection between the tubing and the cannula.

A disadvantage of such known ophthalmic cannula system is that the outer diameter of the cannula is relatively wide with respect to the inner diameter of the capillair that is inserted in said cannula. As a consequence, during irrigation or infusion of a liquid into the eye, the irrigation or infusion flow is relatively low with respect to the size of an opening created in the eye for placement of the cannula therein.

A further disadvantage of this known ophthalmic cannula system is that placing said ophthalmic cannula system into the eye is cumbersome and time consuming, for instance because a plurality of action needs to be executed subsequently.

It is an object of the present invention to provide an alternative cannula system and/or an alternative method for placing a cannula system at least partly into a human or animal body. A further objective of the present invention is to alleviate or solve at least one of the disadvantages mentioned above. In particular, the invention aims at providing a cannula system and/or installing method, wherein at least one of the disadvantages mentioned above is counteracted or advantages there above are obtained. In embodiments, the invention aims at providing a cannula system which is relatively simple and/or relatively quick to install, and/or which can provide for a relatively high irrigation or infusion flow with respect to an outer diameter of a cannula. In embodiments, the invention aims at providing a relatively easy, relatively fast and/or relatively robust method for positioning a cannula system.

In a first aspect, the present invention provides for a cannula system, comprising a base part provided with a fluid chamber, the base part having a first passage connected or connectable to a tubing for transporting fluid towards and/or from the fluid chamber, a second passage connected or connectable to a cannula for insertion into a human and/or animal body, and a third, closable passage for receiving a distal end portion of an inserter traversing the chamber via the third and the second passage.

By providing the base part with three separate passages, the distal end portion can be inserted into a proximal end of a cannula via another passage than the passage that is to be used for fluid transport towards and/or from the fluid chamber. As a consequence, the tubing can be already connected to the base part when the cannula is inserted into the body. After the cannula is installed in a body, e.g. in an eye, and the distal end portion of the inserter is withdrawn through the closable passage, there is no need to connect a tubing to the base part. Hence, the cannula system can be applied to the human or animal body relatively easily and relatively fast.

Further, because the tubing is connected to the base part no capillair has to be inserted into the cannula after withdrawal of the inserter. Hence, an inner diameter of a flow path in the cannula will thus not be decreased by the insertion of a capillair. As a consequence, an irrigation or infusion flow can be relatively high with respect to the size of an outer diameter of the cannula.

Preferably, the closable passage is provided with a valve arranged for allowing insertion of a distal end portion of an inserter into the fluid chamber and arranged for closing off the third passage after removing said distal end portion from the third passage. Hence, the third passage can be automatically closed when the distal end portion of the inserted is withdrawn therefrom.

In a further aspect of the present invention, a kit is provided, which kit may include at least one cannula system according to the invention and at least one inserter.

The invention also relates to a method for assembling a cannula system and methods for placing a cannula at least partly into a human or animal body.

Advantageous embodiments according to the invention are described in the appended claims.

By way of non-limiting example only, embodiments of the present invention will now be described with reference to the accompanying figures in which:

Figure 1 shows a schematic perspective view of a cannula system according to the invention; and

Figure 2 shows a schematic perspective view of the cannula system of Fig. 1 and an inserter.

The embodiments disclosed herein are shown as examples only and should by no means be understood as limiting the scope of the claimed invention in any way. In this description the same or similar elements have the same or similar reference signs.

In this description a cannula system has to be understood as at least including hut not necessarily limited to a surgical system, preferably an ophthalmic system.

Figure 1 shows a schematic perspective view of a cannula system 1 according to the invention. The cannula system 1 comprises a base part 2 provided with a fluid chamber 3. The base part 2 has a first passage 4 connected or connectable to a tubing 5 for transporting fluid towards and/or from the fluid chamber 3. Preferably, said tubing 5 is flexible, liquid and/or gas tight, and/or transparent. For example, the tubing can comprise and/or may be made of a plastic material, a silicone material, and/or a PVC material. The tubing 5 may be a standard or so-called universal tubing such as a universal infusion line. Additionally or alternatively, the tubing 5 may at a proximal end 23 be provided with a connection element 22, such as for instance a Luer-Lock or Luer-Slip connection element 22.

Further, the base part 2 has a second passage 6 connected or connectable to a cannula 7 for insertion into a human and/or animal body. The base part 2 also comprises a third passage 8. The third passage 8 is a closable passage 8 for receiving a distal end portion of an inserter traversing the chamber 3 via the third and the second passage 8, 6.

Here, the cannula system 1 is a surgical system, actually an eye surgical or ophthalmic system 1. Alternatively or additionally, the system 1 can be a cannula system for inserting the cannula into other body parts, such as for example an organ, an abdominal wall, or a joint, such as a knee joint. The cannula system 1 and/or at least certain parts thereof can be sterile. For example therefore, the cannula 7 and/or other elements of the cannula system 1 may be manufactured from stainless steel, yielding an element that is easy to sterilize. However, the cannula 7 and/or the other elements may be manufactured from other materials, for instance from a metal such as titanium, ceramics and/or plastic.

Figure 2 shows a schematic perspective view of the cannula system 1 of Fig. 1 and shows an inserter 10 as well. It is noted that the cannula system 1 and the inserter 10 may for example both be comprised in a kit. For instance, the inserter 10 and the cannula system 1 are both disposable units 1, 10.

In Fig. 2, the inserter 10, or so-called insertor, comprises a distal end portion 9 that is substantially extending through the cannula system 1. It is noted that the inserter 10 may be a conventional element and/or may be of substantially conventional design. The inserter 10 can for example be a so-called stiletto inserter. Here, the distal end portion 9 is formed by a solid pin-shaped element, but may have an alternative form, e.g. it may be a tubular element. The distal end portion 9 is arranged to be at least partly accommodated by a cannula 7 during insertion of said cannula 7 into a human or animal body, e.g. into an eye. Thereto, an outer diameter of the distal end portion 9 may substantially correspond to an inner diameter of the cannula 7. For example, said diameters are substantially equal, the outer diameter of the end portion 9 preferably being slightly smaller than the inner diameter of the cannula 7. Moreover, the cross section of the end portion 9 and the cross section of an internal canal 11 of the cannula can have corresponding shapes, preferably substantially equal shapes, such as both cross sections each having a substantial round cross section. Further, the outer surface of the distal end portion 9 can be of smooth design in order to facilitate that it can smoothly slides through the cannula 7. Additionally or alternatively, the inner surface of the cannula can be of smooth design. The end portion 9 of the inserter 10 can further comprise a handle 12 for handling the inserter 10. An proximal end of the distal end portion 9 can then be mounted to said handle 12. A distal end 13 of the distal end portion 9 is preferably provided with a sharp tip 14 for piercing a body or body part such as an eye. However, the distal end 13 may in alternative embodiments be blunt. The sharp tip 14 can be of conical design, but can also be shaped differently, for instance comprising multiple facets. In embodiments, the axial length 16 of the distal end portion 9 protruding from the handle 12 can correspond to the axial length 15 of the cannula system 1. Preferably, the distal end portion 9 has an axial length 16 that is longer than the axial length 15 of the cannula system 1, such that said end portion 9 can extend through said system 1 and the distal end 13 of said end portion 9, especially at least its tip 14, can protrude from the distal end 28 of the cannula 7. Here the end portion 9 and the cannula 7 are of substantially straight design. However, in alternative embodiments they may be shaped differently. For example, they can be bent, preferably having a substantially constant curvature.

It is noted that the cannula system 1 can be arranged such that the distal end portion 9 of the inserter 10 when received in the third passage 8 can extend, via the chamber 3 of the base part 2, into a cannula 7 connected to the second passage 6.

At least during use, a distal end 24 of the tubing 5 is mounted to the base part 2 such that the interior 16 of the tubing 5 is in fluid communication, via the first passage 4, to the interior of the fluid chamber 3. The distal end 24 of the tubing 5 and/or the first passage 4 may be positioned at a side wall 27 of the base part 2. For example, the distal end 24 of the tubing 5 and/or the first passage 4 may have an axial direction that is substantially traverse to the direction of the cannula 7 and/or the second passage 6. Preferably, the distal end 24 of the tubing 5 and/or the first passage 4 are directed in a direction having a lateral component transverse to the direction of the cannula 7 and/or second passage 6 and a vertical component in the direction of the cannula 7 and/or second passage 6, such that the distal end 24 of the tubing 5 and/or the first passage 4 is tilted upwardly with respect to the transverse component.

In embodiments, said distal end 24 of the tubing 5 can be unreleasably mounted to the base part 2, and/or the tubing 5 and the base part 2 may even be integral formed parts. Alternatively, the tubing 5 can be releasably mounted or mountable to the base part 2. For example, a cannula system 1, for instance a system 1 comprised in a kit, can comprise a base part 2 and a separate tubing 5 attachable to said base part 2. The base part 2 and/or the tubing 5 may be provided with a connector for enabling such attachment. In an advantageous embodiment, the base part 2 can at its first passage 4 be provided with a stiff or rigid sleeve 17. Said sleeve 17 can form an insert for insertion into the distal end 24 of the tubing 5, which may be mounted to said sleeve 17 by means of an interference fit. The sleeve 17 may thus be used as a connector. Alternatively or additionally, the stiff or rigid sleeve 17 can counteract nodding of the tubing 5, at least near the first passage 4.

It is noted that the cannula 7 may be mounted to the base part 2 such that the interior 11 of said cannula 7 is in fluid communication, via the second passage 6, to the interior of the fluid chamber 3. In embodiments, the cannula 7 can be unreleasably mounted to the base part 2. Alternatively, the cannula 7 can be releasably mounted or mountable to the base part 2. For example, a cannula system 1, for instance a system 1 comprised in a kit, can comprise a base part 2 and a separate cannula 7 attachable to said base part 2. The base part 2 and/or the cannula 7 may be provided with a connector for enabling such attachment. In an advantageous embodiment, the cannula system 1 can be arranged such that a proximal end portion of the cannula 7 can be clicked into the second passage 6 of the base part 2.

However, alternatively or additionally, other connection means may he provided for attachment of the cannula to the base part 2, such as for example one or more connectors for providing a screw connection or a Luer-Lock or Luer-Slip connection.

The third, closable passage 8 can be provided with a valve 18, which may be an integral part of the base part 2. However, the valve 18 may alternatively be formed by a separate valve element mounted to the base part 2 at the position of the third passage 8. The valve 18 can be arranged for allowing insertion of a distal end portion 9 of an inserter 10 into the fluid chamber 3 and can be arranged for closing off the third passage 8 after removal of said distal end portion 9 from the third passage 8.

It is noted that the base part 2 may for example comprise at least one elastic closure portion 19 being biased towards a position in which it is at least partly closing off the third passage 8. For example, the base part 2 can comprise multiple elastic closure portions 19, each elastic closure portion 19 being biased towards a closing position in which it is abutting at least one other closure portion 19 and it is at least partly closing off the third passage 8. Here, the valve 18 is provided with three of such elastic closure portions 19, However, in other embodiments, another number of closure portions 19 may be provided, e.g. two, four, five or six closure portions.

Advantageously, contact surfaces 20 of the multiple elastic closure portions 19 can be abutting in a star-shaped manner, when the closure portions 19 are in their closing positions. Here, the contact surfaces 20 of the three elastic closure portions 19 form a three legged star. Alternatively, contact surfaces of multiple closure portions may in their closing positions be in another configuration, such as for instance a cross configuration or a five legged star configuration. It is noted that, in embodiments, the base part 2 can be at least partly made of an elastic material, such as a silicone or rubber material. For instance, at least a side 21 of it being provided with the third passage 8 can be made of the elastic material. Advantageously, the valve 18 may be integrally formed in said base part side 21 by providing a star-shaped cut therein.

In preferred embodiments, the cannula system 1 is arranged for guiding a distal end portion 9 of an inserter 10 inserted through the third passage 8 into the fluid chamber 3 towards inside a cannula 7 connected to the second passage 6. Thereto, the cannula system 1 may be provided with a guiding structure 25 for guiding said distal end portion 9. The guide 25 can for instance be substantially conically shaped. For example, the fluid chamber 3 can be provided with a guide 25 for guiding said end portion 9 towards inside a cannula 7 connected to the second passage 6. Said guide can be formed as an integral part of the base part 2 or can be formed by a separate part, such as a part of a hard material, e.g. a metal part, which part can be insert moulded in the base part. Alternatively or additionally, the cannula 7 can be provided with a guide 25 for guiding a distal end portion 9 of an inserter 10 towards inside said cannula 7.

It is noted that the third, closable passage 8 can be provided in line with the second passage 6 and/or the cannula 7. Preferably, the second passage 6 and/or the cannula 7 at one hand and said third passage 8 at the other hand are provided at opposite sides 21, 26 of the base part 2 and/or fluid chamber 3. For example, the cannula 7 or second passage 6 can be provided at a bottom side 26, whereas the closable, third passage 8 may be provided at a top side 21. It is noted that the first passage 4 and/or tubing 5 are preferably provided at yet another side 27 of the base part 2, e.g. at a flank 27 or side wall 27. Here, the base part 2 is of substantially cylindrical design, however the base part 2 can alternatively be shaped differently, such as for instance as a rectangular, circular or elliptical disc.

Further, it is noted that the cannula system 1 may comprise more elements than only the base part 2. For example, the cannula system 1 may comprise a cannula 7, a tubing 5 and/or an inserter 10.

The invention also relates to a kit, preferably a surgical or ophthalmic kit. The kit comprises at least one cannula system 1 according to an embodiments as disclosed herein. It is noted that the cannula system 1 of the kit does thus not need to, but may nevertheless, include a tubing 5 and/or a cannula 7. The cannula system 1 of the kit can be at least partly pre-assembled, e.g. the cannula 7 and/or the tubing 5 can be connected to the corresponding passage(s) 6, 4 of the base part 2. Alternatively, the system 1 can be not yet assembled, at least not be assembled completely.

For example, the cannula system 1 of the kit can comprise a separate tubing 5 connectable to a base part of said system 1.

Further, the kit comprises at least one inserter 10. The cannula system 1 and the inserter 10 can be of corresponding design. For example, a distal end portion 9 of the inserter can be sized so as to cooperate with the base part 2 and/or a cannula 7 of the cannula system 1. Advantageously, the kit comprises multiple disposable cannula systems 1 and multiple corresponding disposable inserters 10, for example two, three or four cannula systems and two, three or four inserters 10. However, in embodiments, the kit, the cannula system and/or the inserter can be arranged to be reusable and/or sterilizable.

Additionally or alternatively, the kit can comprise further elements, such a so-called Eckardt pressure plate. As another example, the kit may comprise tweezers or so-called forceps for handling the cannula system 1, especially its base part 2, for instance during withdrawal of the cannula system 1 from an eye or other body part.

According to a further aspect of the invention, a method for assembling a cannula system 1 is provided.

The method comprises the step of inserting a distal end portion 9 of an inserter 10 into a closable passage 8 of a base part 2 of a cannula system 1 such that the distal end portion 9 extends through a fluid chamber 3 defined by said base part 2 and extends through a cannula 7 connected to a second passage 6 of the base part 2 to such extend that a distal end 13 of said distal end portion 9 protrudes from a distal end 28 of the cannula 7, wherein the base part 2 has a further passage 4 connected to a tubing 5 for transporting fluid towards and/or from the fluid chamber 3.

In embodiments, a cannula 7 is being connected to the second passage 6 and/or a tubing 5 is being connected to the further passage 4, prior to inserting the distal end portion 9 of the inserter 10 into the closable passage 8. Alternatively, the cannula and/or the tubing form a single unit with the base part, or are pre-assembled at another site.

Further, according to the invention, method are provided comprising surgical steps, preferably ophthalmic surgical steps. The method aremethods for placing a cannula 7 at least partly into a human or animal body, preferably into an eye. Said methods comprise a step of piercing a distal end portion 9 of an inserter 10 at least partly into a human or animal body, wherein a part 13 of said distal end portion 9 extends through a base part 2 of a cannula system 1 such that it enters a fluid chamber 3 of the base part 2 through a closable passage 8 of the base part 2 and projects partly from a cannula 7 connected to a second passage 6 of the base part 2, wherein said base 2 part has a further passage 4 connected to a tubing 5 for transporting fluid towards and/or from the fluid chamber 3. Further, a method comprises a step of inserting the cannula 7 at least partly into the body while moving the distal end portion 9 of the inserter deeper 10 into the body. Another method includes a step of shifting the cannula at least partly into the body, along the distal end portion of the inserter. In principle, the step of shifting the cannula along the distal end portion of the inserter can be performed while the inserter is maintained at its position relative to the human or animal body, or while the inserter still moves deeper into the body. During withdrawal of the inserter 10 from the cannula 7 and from the base part 2, the cannula 7 is left at least partly in the body, e.g. in a body part such as an eye.

The invention is not limited to the exemplary embodiments described above. It will be understood that many variants are possible.

For example, the cannula systems 1 can be dimensioned such that the cannula 7 has an outside dimension or caliber in the range of 12 to 27 gauge. In embodiments, especially embodiments relating to ophthalmic cannula systems, the cannula 7 may for instance be a 20-, 23-, 24-, 25 or 27-gauge cannula.

Furthermore, as noted above, the cannula system 1 can be suitable for the delivery or removal of fluid, e.g. liquid and/or gas, from a body or body part, such as an eye. The tubing 5 of the cannula system 1 or a tubing 5 connected to the cannula system 1 may therefore be an irrigation and/or aspiration line 5. Said tubing can be connected to an irrigation and/or aspiration machine for injecting and/or extraction of fluid.

Such and other variants will be apparent to those skilled in the art and are considered to fall within the scope of the invention as set forth in the following claims.

Claims

A cannula system comprising a base member provided with a fluid chamber, the base member having a first passage connected or connectable to a tube for transporting a fluid to and / or from the fluid chamber, a second passage connected or connectable to a cannula for entry into a human and / or animal body, and a third, lockable passage for receiving a distal end portion of an input element that traverses the chamber through the third and the second passage.

A cannula system according to claim 1, arranged so that the distal end portion of the input element, when received in the third passageway, can extend, through the chamber, into a cannula connected to the second passageway.

The cannula system of claim 1 or 2, wherein a distal end of the tube is attached to the base member so that the interior of the tube is in fluid communication, via the first passage, with the interior of the fluid chamber.

A cannula system according to any one of the preceding claims, wherein the third closable passage is provided with a valve adapted to allow the introduction of a distal end portion of the input element into the fluid chamber, and adapted to close the third passage after removal of the distal end portion from the third passage.

A cannula system according to any one of the preceding claims, wherein the base part comprises at least one elastic closing part that is biased to a position in which it at least partially closes the third passage.

A cannula system according to any one of the preceding claims, wherein the base member comprises a plurality of elastic closure members, wherein each elastic closure member is biased to a closure position in which it abuts against at least one other closure member and at least partially closes off the third passage.

The cannula system of claim 6, wherein contact surfaces of the plurality of elastic closure members adhere in a star shape when the closure members are in their closure position.

A cannula system according to any one of the preceding claims, wherein the cannula system is adapted to guide a distal end portion of an input element introduced through the third passageway into the fluid chamber into a cannula connected to the second passageway.

The cannula system of any one of the preceding claims, wherein the cannula is substantially straight.

A cannula system according to any one of the preceding claims, wherein the third closable passage is aligned with the second passage and / or cannula, wherein the third passage and the second passage and / or cannula are preferably provided on opposite sides of the base part and / or fluid chamber.

A cannula system according to any one of the preceding claims, wherein the system is a surgical system, preferably an eye surgical system.

A cannula system according to any one of the preceding claims, comprising a cannula, tube and / or input element.

A kit comprising at least one cannula system according to any one of the preceding claims and at least one input element.

A method for assembling a cannula system, comprising the step of: - introducing a distal end portion of an insertion element into a closable passage of a base portion of a cannula system so that the distal end portion extends through a fluid chamber provided in the base portion and extends extending through a cannula connected to a second passage of the base portion such that a distal end of the distal end portion extends from a distal end of the cannula, the base portion having a further passage connected to a tube for transporting a fluid to and / or from the fluid chamber.

The method of claim 14, wherein prior to introducing the distal end portion of the introducer into the closable passageway, the cannula is connected to the second passageway and / or the tube is connected to the further passageway.

A method, preferably according to claim 14 or 15, wherein the method is a method for at least partially placing a cannula in the human or animal body, comprising the steps of: - at least partially in the human body or animal protruding from a distal end portion of an insertion member, a portion of the distal end portion extending through a base portion of a cannula system such that it enters a fluid chamber of the base portion through a closable passageway of the base portion and portion from a cannula connected to a second passageway protrudes from the base member, the base member having a further passage connected to a tube for transporting a fluid to and / or from the fluid chamber; introducing the cannula into the body at least partially while moving the distal end portion of the insertion element deeper into the body; and withdrawing the insertion element from the cannula and from the base part while the cannula remains at least partially in the body.

A method, preferably according to claim 14 or 15, wherein the method is a method for at least partially placing a cannula in the human or animal body, comprising the steps of: - at least partially in the human body or animal protruding from a distal end portion of an insertion member, a portion of the distal end portion extending through a base portion of a cannula system such that it enters a fluid chamber of the base portion through a closable passageway of the base portion and portion from a cannula connected to a second passageway protrudes from the base part, the base part having a further passage connected to a tube for transporting a fluid to and / or from the fluid chamber; - sliding the cannula at least partially into the body, along the distal end portion of the insertion element; and withdrawing the insertion element from the cannula and from the base part while the cannula remains at least partially in the body.