WO2002058607A2 - Infusion cannula - Google Patents

Infusion cannula Download PDF

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Publication number
WO2002058607A2
WO2002058607A2 PCT/US2002/001777 US0201777W WO02058607A2 WO 2002058607 A2 WO2002058607 A2 WO 2002058607A2 US 0201777 W US0201777 W US 0201777W WO 02058607 A2 WO02058607 A2 WO 02058607A2
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WO
WIPO (PCT)
Prior art keywords
infusion cannula
body portion
infusate
flow
infusion
Prior art date
Application number
PCT/US2002/001777
Other languages
French (fr)
Other versions
WO2002058607A3 (en
Inventor
Philip J. Ferrone
Original Assignee
Ferrone Philip J
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 Ferrone Philip J filed Critical Ferrone Philip J
Priority to AU2002240004A priority Critical patent/AU2002240004A1/en
Publication of WO2002058607A2 publication Critical patent/WO2002058607A2/en
Publication of WO2002058607A3 publication Critical patent/WO2002058607A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0279Cannula; Nozzles; Tips; their connection means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00727Apparatus for retinal reattachment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0204Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0216Pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00736Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0612Eyes

Definitions

  • the present disclosure relates to infusion cannulas and more particularly, to infusion
  • cannulas for use in connection with vitreo-retinal surgical procedures.
  • a cannula In retinal surgical procedures involving the eye, it is often desirable to use a cannula to penetrate the eye and supply an infusate in order to maintain the fluid pressure of the eye.
  • a number of ophthalmic surgical procedures involve the penetration of the chambers of the eye with a variety of surgical instruments.
  • vitreous cavity A commonly accepted technique for maintaining pressure in the ocular chambers is to
  • a fluid such as air, saline solution or other liquid or gas
  • the infusion of fluid helps to maintain a positive pressure within the eye and a normal configuration of the ocular chamber during surgery.
  • control of intraocular pressure during surgery helps to minimize danger to the eye
  • a positive pressure stretches open the pupil permitting better visualization of posterior ocular structures and ensures that any flow across a wound is outward, not inward, thereby reducing the risk of entry of foreign matter or bacteria into the ocular
  • Fluid-air exchange is also a standard and widely used technique in modern vitreous
  • an infusion cannula is placed inferotemporally so that the infused air is directed toward the supernasal mid-peripheral retina.
  • infusion cannula is placed inferonasally so that the infused air is directed at the supertemporal retina.
  • a complication observed which may arise following a fluid-air exchange in ophthalmic surgical procedures i.e., macular hole, diabetic retinopathy and subretinal surgery) is the development of visual field defects. It has been discovered that the location of the visual field defect is correlated to the location of the mfusion cannula and that the incidence of this visual
  • FIGS. 1A and IB illustrate schematically the relationship of the position of the infusion cannula and the corresponding retinal damage leading to the visual field defects.
  • the directional flow of infusate from an infusion cannula placed inferotemporally can cause nasal retinal damage resulting in a temporal visual field
  • the surface tension of the PFCL results in the formation of a PFCL bubble within the vitreous cavity of the eye.
  • the fluid for maintaining the intraocular pressure of the eye is typically introduced into the ocular chamber via a maintainer infusion cannula inserted through an incision made in the sclera of the eye.
  • the cannula is connected via a silicone elastomer tubing or other suitable fluid
  • the cannula is controlled by the surgeon or an assistant in response to a surgeon's instructions, for example by operation of a foot pedal, by fingertip control or by manually altering the height of an
  • Typical infusion cannulas deliver infusate from an axial opening formed at a distal end
  • the cannula for infusing fluids into various cavities of the eye, wherein the cannula includes a tube having a first end configured for permitting a flow of infusate axially out
  • U.S. Patent 4,692,142 to Dignam relates to an ocular infusion cannula including a first tube segment having an opening formed at a distal end along a longitudinal axis thereof and a second tube segment joined coaxially to the first tube segment at an end opposite the distal end of
  • infusion cannulas One disadvantage of such infusion cannulas is that the infusate jet exiting the distal end of the cannula is directed axially out of the end of the infusion cannula and directly onto or into the PFCL bubble, which direction may lead to emulsification of the PFCL in the vitreous cavity.
  • the emulsification of the PFCL creates a plurality of relatively smaller PFCL bubbles, as compared to the one large liquid perfluorocarbon bubble, in the eye, which plurality of smaller PFCL bubbles are difficult and time consuming to remove from the vitreous cavity of the eye
  • a further disadvantage of such infusion cannulas is that the high flow jet air/gas stream into the retina, emitted axially from the distal end opening of such cannulas, may cause damage resulting in visual field defects and even retinal damage in certain circumstances.
  • An additional disadvantage of standard infusion cannulas is the possibility of crystalline lens opacification
  • an infusion cannula for use in clearing and preventing condensation on the posterior surface of an artificial lens during a fluid-gas exchange portion of a pars plana vitrectomy.
  • the ' 158 patent discloses an infusion cannula configured and adapted to direct the flow of an infusion gas entering the eye in a single non-axial direction, i.e., toward the posterior surface of an artificial lens.
  • the infusion cannula includes a tubular body having a face provided at a distal end thereof and a pair of co-linear infusate ports formed along one side of the tubular body for directing all of the infusate flow toward the posterior of the surface of the lens.
  • the infusion cannula disclosed in the '158 patent directs all of the flow of the infusion gas in a single desired direction, i.e., toward the lens.
  • the infusion cannula disclosed in the ' 158 patent continues to share in the disadvantages of standard infusion cannulas.
  • the present disclosure relates to an infusion cannula for use in connection with vitreo-
  • the infusion cannula includes a hollow body portion including a pair of diametrically opposed delivery holes formed radially through the body portion near a tapered
  • a first hole of the pair of delivery holes is oriented to direct the infusate flow in a second direction which is orthogonal to the first direction and wherein a second hole of
  • the pair of delivery holes is oriented to direct the infusate flow in a third direction which is orthogonal to the first direction and parallel to the second direction.
  • delivery holes being configured and oriented to divide the force of the infusate flow substantially
  • the direction of infusate is not oriented directly towards or into the lens, or
  • an infusion cannula which supplies an
  • the infusion cannula directs the flow of an infusate in at least two substantially
  • the infusion cannula redirects the air and
  • FIG. 1A is a schematic illustration of an infusion cannula placed inferotemporally leading
  • FIG. IB is a schematic illustration of an infusion cannula placed inferonasally leading to
  • FIG. 2 is a partial cross-section of an eye showing one illustrative embodiment of an
  • infusion cannula constructed in accordance with the present disclosure implanted in the eye;
  • FIG. 3 is a perspective view of an infusion cannula in accordance with the present
  • FIG. 4 is a side elevational view of the infusion cannula in accordance with the present
  • FIG. 5 is a cross-sectional view of the infusion cannula of FIG. 4 taken along a
  • FIG. 6 is a plan view of the infusion cannula in accordance with the present disclosure
  • FIG. 7 is a side elevational view of the infusion cannula having a diffusion tip in
  • FIG. 8 is a cross-sectional view of the infusion cannula of FIG. 4 taken along a
  • FIG. 9 is a cross-sectional view of the infusion cannula of FIG. 4 taken along a
  • infusion flow as well as divides the flow of infusate into at least two different flow paths.
  • FIGS. 2-6 in which like reference numerals identify similar or identical
  • one illustrative embodiment of the presently disclosed infusion cannula is generally
  • cannula 10 a partial cross-section of the
  • cornea is designated as "C”; the iris as “I”; the lens as “L”; the sclera and “S”; the retina as “R”;
  • Infusion cannula 10 is shown implanted through the sclera "S" of a patient's
  • Infusion cannula 10 is shown more fully in FIGS. 3-5 and includes a hollow body portion
  • a proximal end portion 14 a distal end portion 16 and a tapered distal tip 18 integrally
  • infusion cannula 10 is approximately 4.5 mm in length from wings 36 and 38 (discussed in detail greater detail below) to the most distal tip of infusion cannula 10.
  • body portion 12 of infusion cannula 10 has an approximately 19 or 20 gauge size. It is however envisioned that the design according to the present invention can be adapted to any size cannula gauge.
  • the dimensions of infusion cannula 10 are provided for illustrative purposes only, actual dimensions may be varied depending upon the particular performance characteristics desired for a given application.
  • Infusion cannula 10 may be formed from any suitable medical grade material such as, for example, polymer or metal.
  • Infusion cannula 10 further includes a pair of substantially diametrically opposed infusate delivery holes 20 and 22 formed radially through body portion 12 near a juncture 24 between body portion 12 and tapered distal tip 18.
  • infusate delivery holes 20 and 22 are disposed substantially 180 degrees apart such that they divide the infusate flow pressure and direct it radially outward in opposite directions.
  • infusate delivery hole 20 is illustrated, infusate delivery hole 22 being oriented substantially 180 degrees away from delivery hole 20 (i.e., behind delivery hole 20) and thus not visible in FIG. 2.
  • An effective location for infusate delivery holes 20 and 22 is between approximately 3.5 mm and approximately 4.2 mm from the proximal end portion 14 of infusion cannula 10. Further, an effective diameter of infusate delivery holes 20 and 22 is approximately 0.7 mm.
  • delivery holes 20 and 22 are preferably oriented substantially tangential to the equator of the lens.
  • infusion delivery holes 20 and 22 radially through body portion 12, results in delivery holes 20 and 22 being situated substantially tangential to the equator of lens "L" upon insertion of body portion 12 into vitreous cavity "N".
  • POOL posterior chamber intraocular lens
  • infusate delivery holes 20 and 22 a distance from the proximal end 14 of infusion cannula 10 as previously noted.
  • the present infusion cannula design improves the ease with which PFCL can be removed from the eye by decreasing the emulsification of PFCL caused by the infusate jet.
  • the infusate jet is not oriented directly into or in a direction toward the PFCL bubble, thereby preventing emulsification of the PFCL and, therefore, the formation of tiny PFCL bubbles.
  • the presently disclosed infusion cannula design directs the flow of saline or infusate along the surface of the PFCL bubble "B" (see FIG. 2) or very near the surface of the PFCL bubble as opposed to directly into the bubble as is the case in a distal end infusate discharge cannula design.
  • tapeered distal tip 18 provides infusion cannula 10 with a solid distal end to prevent delivery of the infusate from flowing directly from the distal end in an axial direction.
  • the tapered design facilitates easier insertion of infusion cannula 10 through the sclera "S" into the
  • MVR microvitreoretinal
  • Tapered distal tip 18 can be any tapered design, however, it is preferred that tapered
  • distal tip 18 be conical.
  • Infusion cannula 10 further includes a connection hub 32 extending proximally from body
  • Hub 32 facilitates the connection of a length of infusion tubing 34 to infusion cannula 10.
  • Infusion cannula 10 also includes a pair of wings 36 and 38 are formed to extend radially from
  • wings 36 and 38 are oriented in
  • infusion cannula 10 may be secured to the sclera "S" using any suitable technique
  • infusion cannula 10 to the sclera "S" can be performed. Securing infusion cannula 10 to the
  • infusion cannula 10 is coupled to a distal end of infusion tubing
  • infusion coupling 40 is coupled to a proximal end of infusion tubing 34.
  • coupling 40 is configured and adapted to place infusion tubing 34 into fluid communication with a source of infusate (not shown).
  • FIG. 7 an alternative embodiment of the presently disclosed infusion
  • infusion cannula 100 which includes a tapered distal tip 118, is provided
  • holes 140 each have a diameter which is less than approximately 0.2 mm. Holes 140 direct the
  • Holes 140 may be formed in tapered distal tip 118 by a suitable technique, for example, a laser
  • holes 140 can have a diameter which is
  • a mesh screen (not shown) made of medical grade biocompatible
  • infusion cannula 100 is provided with baffling means
  • infusion cannula 100 further comprises disposed within body portion 112. Referring initially to FIG. 8, infusion cannula 100 further comprises
  • baffle such as, a hemispherical baffling surface 142 located within
  • Hemispherical baffling surface 142 contacts the inner surface of body portion 112 distally of delivery holes 120 and 122, preferably along juncture 124.
  • the surface of hemispherical baffling surface 142 extends proximally within body portion 112. Accordingly, hemispherical baffling surface 142 will reduce, if not eliminate, the formation of turbulence within tapered distal tip 118 resulting from a distal flow indicated by arrow "A" of infusate through body portion 112.
  • hemispherical baffling surface 142 will tend to cause distal flow "A" of infusate jet to be at least partially redirected in a proximal direction as indicated by arrow "A," upon delivery of an infusate to the eye. While a generally hemispherical baffling surface has been disclosed, it is envisioned that a semi-cylindrical surface (not shown) having a longitudinal axis oriented orthogonally with respect to both the longitudinal axis of infusion cannula 100 and a central axis extending between the pair of delivery holes 120 and 122 is also possible.
  • infusion cannula 100 further includes a conical baffling surface 144 located within body portion 112.
  • Conical baffling surface 144 contacts the inner surface of body portion 112 distally of delivery holes 120 and 122, preferably along juncture 124.
  • the surface of conical baffling surface 144 extends proximally within body portion 112.
  • conical baffling surface 144 will reduce, if not eliminate, the formation of turbulence within tapered distal tip 118 resulting from a distal flow as indicated by arrow "B" of infusate through body portion 112. In addition, conical baffling surface 144 will tend to cause
  • distal flow "B" of infusate jet to be at least partially redirected in a proximal direction as
  • pyramidical like surface (not shown) having a pair of planar surfaces extending transversely across the longitudinal axis of infusion cannula 100 and transversely across a central axis extending between the pair of delivery holes 120 and 122 is also possible.

Abstract

The present disclosure relates to an infusion cannula for use in connection with vitreo-retinal surgical procedures. The infusions cannula comprises a hollow body portion defining a first direction for an infusate flow. The hollow body portion includes a proximal end and a distal end, which distal end includes a tapered distal tip integrally formed therewith. The infusion cannula further includes a pair of diametrically opposed delivery holes formed radially through the body portion near the tapered distal tip, wherein a first of the pair of delivery holes is oriented to direct the infusate flow in a second direction which is orthogonal to the first direction and wherein a second of the pair of delivery holes is oriented to direct the infusate flow in a third direction which is orthogonal to the first direction and parallel to the second direction. The first and second delivery holes dividing the infusate flow such that the infusate flow is equally divided in opposite directions and directed tangentially along the equator of a lens.

Description

INFUSION CANNULA AND METHOD FOR VITREOUS SURGICAL PROCEDURES
BACKGROUND
1. Technical Field The present disclosure relates to infusion cannulas and more particularly, to infusion
cannulas for use in connection with vitreo-retinal surgical procedures.
2. Description of Related Art
In retinal surgical procedures involving the eye, it is often desirable to use a cannula to penetrate the eye and supply an infusate in order to maintain the fluid pressure of the eye. For example, a number of ophthalmic surgical procedures involve the penetration of the chambers of the eye with a variety of surgical instruments.
The penetration of the chambers of the eye and, more particularly the removal of ocular tissue from the eye by aspiration and the like, results in a loss of fluid and pressure in the respective ocular chamber. The loss of fluid pressure in the vitreous cavity during ophthalmic
surgical procedures can cause at least a partial collapse of the chamber making it difficult to
manipulate an instrument in the eye without risking damage to ocular structures such as the retina and the lens. Accordingly, it is desirable to maintain the integrity and internal pressure of the
vitreous cavity. A commonly accepted technique for maintaining pressure in the ocular chambers is to
introduce a fluid, such as air, saline solution or other liquid or gas, into the chamber of the eye during the ophthalmic surgical procedure. The infusion of fluid helps to maintain a positive pressure within the eye and a normal configuration of the ocular chamber during surgery. Furthermore, control of intraocular pressure during surgery helps to minimize danger to the eye
both during and after surgery. A positive pressure stretches open the pupil permitting better visualization of posterior ocular structures and ensures that any flow across a wound is outward, not inward, thereby reducing the risk of entry of foreign matter or bacteria into the ocular
chamber. Fluid-air exchange is also a standard and widely used technique in modern vitreous
surgery. In a conventional three-part vitrectomy, an infusion cannula is placed inferotemporally so that the infused air is directed toward the supernasal mid-peripheral retina. Alternatively, the
infusion cannula is placed inferonasally so that the infused air is directed at the supertemporal retina. A complication observed which may arise following a fluid-air exchange in ophthalmic surgical procedures (i.e., macular hole, diabetic retinopathy and subretinal surgery) is the development of visual field defects. It has been discovered that the location of the visual field defect is correlated to the location of the mfusion cannula and that the incidence of this visual
field defect was influenced by the pressure at which the infusion air is introduced into the ocular
chamber. FIGS. 1A and IB illustrate schematically the relationship of the position of the infusion cannula and the corresponding retinal damage leading to the visual field defects. As illustrated in FIG. 1A, the directional flow of infusate from an infusion cannula placed inferotemporally (as indicated by flow arrow "A") can cause nasal retinal damage resulting in a temporal visual field
defect. Concomitantly, as illustrated in FIG. IB, the directional flow of infusate from an inferonasally (as indicated by arrow "B") placed cannula can cause temporal retinal damage resulting in a nasal visual field defect. Recently, silicone oil and perfluorocarbon liquids (PFCL's) have been used as vitreous substitutes during vitreo-retinal surgery. Among the physical characteristics of PFCL's, it is important to note that the specific gravity of PFCL is between 1.8 and 1.9. Thus, when PFCL is injected into the eye, since the PFCL is heavier than the fluid in the eye, the vitreous cavity will
tend to be filled from a posterior pole of the eye forward. In addition, since the PFCL has a
greater specific gravity than the fluid in the eye, the surface tension of the PFCL results in the formation of a PFCL bubble within the vitreous cavity of the eye.
The fluid for maintaining the intraocular pressure of the eye is typically introduced into the ocular chamber via a maintainer infusion cannula inserted through an incision made in the sclera of the eye. The cannula is connected via a silicone elastomer tubing or other suitable fluid
communicating conduit to a container holding the infusion fluid. The flow of infusate through
the cannula is controlled by the surgeon or an assistant in response to a surgeon's instructions, for example by operation of a foot pedal, by fingertip control or by manually altering the height of an
infusion bottle.
Typical infusion cannulas deliver infusate from an axial opening formed at a distal end
thereof such that the infusate is permitted to flow in a direct, unobstructed, and unrestricted fluid flow path. An example of such a cannula may be found in U.S. Patent 4,781 ,675 to White which
relates to an infusion cannula for infusing fluids into various cavities of the eye, wherein the cannula includes a tube having a first end configured for permitting a flow of infusate axially out
of a distal end thereof and a second end having a hilt for connection to an infusion fluid source. Likewise, U.S. Patent 4,692,142 to Dignam, relates to an ocular infusion cannula including a first tube segment having an opening formed at a distal end along a longitudinal axis thereof and a second tube segment joined coaxially to the first tube segment at an end opposite the distal end of
the first tube, wherein an infusate is ejected from the opening formed at the distal end of the first tube segment.
One disadvantage of such infusion cannulas is that the infusate jet exiting the distal end of the cannula is directed axially out of the end of the infusion cannula and directly onto or into the PFCL bubble, which direction may lead to emulsification of the PFCL in the vitreous cavity.
The emulsification of the PFCL creates a plurality of relatively smaller PFCL bubbles, as compared to the one large liquid perfluorocarbon bubble, in the eye, which plurality of smaller PFCL bubbles are difficult and time consuming to remove from the vitreous cavity of the eye
once the surgical procedure has ended and which also make it more difficult to see the retina and perform manipulations through the smaller PFCL bubbles.
A further disadvantage of such infusion cannulas is that the high flow jet air/gas stream into the retina, emitted axially from the distal end opening of such cannulas, may cause damage resulting in visual field defects and even retinal damage in certain circumstances. An additional disadvantage of standard infusion cannulas is the possibility of crystalline lens opacification
during fluid air exchange.
In U.S. Patent 5,919,158 to Saperstein et al. (hereinafter "the ' 158 patent"), an infusion cannula is disclosed for use in clearing and preventing condensation on the posterior surface of an artificial lens during a fluid-gas exchange portion of a pars plana vitrectomy. The ' 158 patent discloses an infusion cannula configured and adapted to direct the flow of an infusion gas entering the eye in a single non-axial direction, i.e., toward the posterior surface of an artificial lens. In the ' 158 patent, the infusion cannula includes a tubular body having a face provided at a distal end thereof and a pair of co-linear infusate ports formed along one side of the tubular body for directing all of the infusate flow toward the posterior of the surface of the lens. Thus, the infusion cannula disclosed in the '158 patent directs all of the flow of the infusion gas in a single desired direction, i.e., toward the lens. As such, the infusion cannula disclosed in the ' 158 patent continues to share in the disadvantages of standard infusion cannulas.
A need still exists, however, for an improved infusion cannula for use in vitreous surgical
procedures which overcomes the above noted disadvantages of prior art infusion cannula designs. A need also exists for an improved procedure and surgical instrument which will reduce the impact of infusion air on the retinal surface thereby reducing the occurrence of visual field defects.
SUMMARY
The present disclosure relates to an infusion cannula for use in connection with vitreo-
retinal surgical procedures. The infusion cannula includes a hollow body portion including a pair of diametrically opposed delivery holes formed radially through the body portion near a tapered
distal tip thereof, wherein a first hole of the pair of delivery holes is oriented to direct the infusate flow in a second direction which is orthogonal to the first direction and wherein a second hole of
the pair of delivery holes is oriented to direct the infusate flow in a third direction which is orthogonal to the first direction and parallel to the second direction. The first and second
delivery holes being configured and oriented to divide the force of the infusate flow substantially
equally in two opposite directions and substantially tangential to the equator of the lens of the
eye. In this manner, the direction of infusate is not oriented directly towards or into the lens, or
into the PFCL bubble and the force of the jet of the infusate is substantially divided and directed
in substantially opposite directions.
In one aspect, the present disclosure an infusion cannula is provided which supplies an
infusate into the vitreous cavity of an eye and which substantially divides the force of the infusate
jet and which directs the flow of the infusate jet into substantially diametrically opposed
directions.
The infusion cannula directs the flow of an infusate in at least two substantially
diametrically opposed directions and along a surface of a PFCL bubble.
One advantage of the presently disclosed infusion cannula is that it lessens the
emulsification of a PFCL bubble upon injection of an infusate into the eye.
In another aspect of the present disclosure, the infusion cannula redirects the air and
decreases the force of the infusate jet during retinal surgery in order to prevent retinal damage
and visual field defects.
Another advantage of the presently disclosed infusion cannula is that it helps reduce the
likelihood of lens opacification during fluid gas exchange.
These objects and advantages, together with other objects and advantages of the presently
disclosed infusion cannula, along with the various features of novelty which characterize the
disclosure, are pointed out with particularity in the claims annexed to and forming a part of this disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
By way of example only, preferred embodiments of the disclosure will be described with
reference to the accompanying drawings, in which:
FIG. 1A is a schematic illustration of an infusion cannula placed inferotemporally leading
to nasal retinal damage;
FIG. IB is a schematic illustration of an infusion cannula placed inferonasally leading to
temporal retinal damage;
FIG. 2 is a partial cross-section of an eye showing one illustrative embodiment of an
infusion cannula constructed in accordance with the present disclosure implanted in the eye;
FIG. 3 is a perspective view of an infusion cannula in accordance with the present
disclosure coupled to infusion tubing;
FIG. 4 is a side elevational view of the infusion cannula in accordance with the present
disclosure;
FIG. 5 is a cross-sectional view of the infusion cannula of FIG. 4 taken along a
longitudinal axis thereof;
FIG. 6 is a plan view of the infusion cannula in accordance with the present disclosure
coupled to an infusion tubing including an infusion coupling at a proximal end thereof;
FIG. 7 is a side elevational view of the infusion cannula having a diffusion tip in
accordance with the present disclosure; FIG. 8 is a cross-sectional view of the infusion cannula of FIG. 4 taken along a
longitudinal axis thereof and illustrating a baffling in accordance with the present disclosure; and
FIG. 9 is a cross-sectional view of the infusion cannula of FIG. 4 taken along a
longitudinal axis thereof and illustrating an alternative baffling in accordance with the present
disclosure.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The present disclosure overcomes the above-noted and other disadvantages of previous
infusion cannulas by providing an improved uniquely advantageous infusion cannula with a tip
design which redirects the flow of infusate from the usual direct, unrestricted, unobstructed
infusion flow as well as divides the flow of infusate into at least two different flow paths.
Referring now to FIGS. 2-6, in which like reference numerals identify similar or identical
elements, one illustrative embodiment of the presently disclosed infusion cannula is generally
designated as cannula 10. In particular with reference to FIG. 2, a partial cross-section of the
human eye including infusion cannula 10 implanted therein is shown. As seen in FIG. 2, the
cornea is designated as "C"; the iris as "I"; the lens as "L"; the sclera and "S"; the retina as "R";
the pars plicata of the ciliary body as "PT"; the pars plana "PN"; the vitreous cavity as "V"; and
the limbus as "M". Infusion cannula 10 is shown implanted through the sclera "S" of a patient's
eye and into the vitreous cavity "V.
Infusion cannula 10 is shown more fully in FIGS. 3-5 and includes a hollow body portion
12, a proximal end portion 14, a distal end portion 16 and a tapered distal tip 18 integrally
formed with distal end portion 16 thereby defining a closed distal end. One exemplary size for infusion cannula 10 is approximately 4.5 mm in length from wings 36 and 38 (discussed in detail greater detail below) to the most distal tip of infusion cannula 10. Preferably, body portion 12 of infusion cannula 10 has an approximately 19 or 20 gauge size. It is however envisioned that the design according to the present invention can be adapted to any size cannula gauge. The dimensions of infusion cannula 10 are provided for illustrative purposes only, actual dimensions may be varied depending upon the particular performance characteristics desired for a given application. Infusion cannula 10 may be formed from any suitable medical grade material such as, for example, polymer or metal.
Infusion cannula 10 further includes a pair of substantially diametrically opposed infusate delivery holes 20 and 22 formed radially through body portion 12 near a juncture 24 between body portion 12 and tapered distal tip 18. Preferably, infusate delivery holes 20 and 22 are disposed substantially 180 degrees apart such that they divide the infusate flow pressure and direct it radially outward in opposite directions. In FIG. 2, only infusate delivery hole 20 is illustrated, infusate delivery hole 22 being oriented substantially 180 degrees away from delivery hole 20 (i.e., behind delivery hole 20) and thus not visible in FIG. 2.
An effective location for infusate delivery holes 20 and 22 is between approximately 3.5 mm and approximately 4.2 mm from the proximal end portion 14 of infusion cannula 10. Further, an effective diameter of infusate delivery holes 20 and 22 is approximately 0.7 mm.
Upon insertion of infusion cannula 10 into the vitreous cavity, delivery holes 20 and 22 are preferably oriented substantially tangential to the equator of the lens.
The insertion of body portion 12 radially into the eye in combination with the orientation
of infusion delivery holes 20 and 22 radially through body portion 12, results in delivery holes 20 and 22 being situated substantially tangential to the equator of lens "L" upon insertion of body portion 12 into vitreous cavity "N". In this manner, the potential of damage from the pressure the infusate jet to the crystalline lens or to a posterior chamber intraocular lens ("POOL") is greatly reduced. Similarly, potential damage to the peripheral retina or vitreous base is also greatly reduced. Additionally, the likelihood of having suprachoroidal infusion is minimized due
to the positioning of infusate delivery holes 20 and 22 a distance from the proximal end 14 of infusion cannula 10 as previously noted.
In addition, the present infusion cannula design improves the ease with which PFCL can be removed from the eye by decreasing the emulsification of PFCL caused by the infusate jet. In other words, due to the configuration and orientation of infusate delivery holes 20 and 22, the infusate jet is not oriented directly into or in a direction toward the PFCL bubble, thereby preventing emulsification of the PFCL and, therefore, the formation of tiny PFCL bubbles. Specifically, the presently disclosed infusion cannula design directs the flow of saline or infusate along the surface of the PFCL bubble "B" (see FIG. 2) or very near the surface of the PFCL bubble as opposed to directly into the bubble as is the case in a distal end infusate discharge cannula design.
Further, the likelihood of damage caused by a high flow jet air stream into the retina opposite the cannula tip, which has been associated with visual field defects and retinal damage
in certain circumstances, is greatly reduced. The likelihood of lens opacification during fluid air
exchange is also reduced due to the radially oriented design of infusate delivery holes 20 and 22. Tapered distal tip 18 provides infusion cannula 10 with a solid distal end to prevent delivery of the infusate from flowing directly from the distal end in an axial direction. The tapered design facilitates easier insertion of infusion cannula 10 through the sclera "S" into the
eye after any size incision is made, for example, a 19 or 20 gauge microvitreoretinal ("MVR")
incision. Tapered distal tip 18 can be any tapered design, however, it is preferred that tapered
distal tip 18 be conical.
Infusion cannula 10 further includes a connection hub 32 extending proximally from body
portion 12, which hub 32 is in fluid communication with the hollow interior of body portion 12.
Hub 32 facilitates the connection of a length of infusion tubing 34 to infusion cannula 10.
Infusion cannula 10 also includes a pair of wings 36 and 38 are formed to extend radially from
body portion 12 adjacent to the juncture of body portion 12 and connection hub 32, which wings
36 and 38 facilitate suturing of infusion cannula 10 to sclera "S" as well as proper orientation of
infusion cannula 10 during a surgical procedure. Preferably, wings 36 and 38 are oriented in
alignment with delivery holes 20 and 22. In this manner, a surgeon can readily ascertain the orientation of delivery holes 20 and 22 after cannula 10 has been inserted into the eye.
While infusion cannula 10 may be secured to the sclera "S" using any suitable technique,
for example, by suturing it is envisioned that any other medically known technique for securing
infusion cannula 10 to the sclera "S" can be performed. Securing infusion cannula 10 to the
sclera "S" provides a fixed reference point from which infusion flow rates can be optimally
directed for the fixed position of infusate delivery holes as will be described in greater detail
herein.
Turning now to FIG. 6, infusion cannula 10 is coupled to a distal end of infusion tubing
34 while an infusion coupling 40 is coupled to a proximal end of infusion tubing 34. Infusion
coupling 40 is configured and adapted to place infusion tubing 34 into fluid communication with a source of infusate (not shown).
Turning now to FIG. 7, an alternative embodiment of the presently disclosed infusion
cannula is illustrated as infusion cannula 100, which includes a tapered distal tip 118, is provided
with a plurality of orthogonally radiating holes 140 thereby creating a diffusion tip. Preferably, holes 140 each have a diameter which is less than approximately 0.2 mm. Holes 140 direct the
flow of the infusate jet into a plurality of different directions thereby dividing and reducing the
force of the infusate jet by an amount proportional to the size of the individual holes 140 and the
quantity of the holes 140. By dividing and redirecting the flow of the infusate jet, the effects of
the infusate jet on the retina, opposite the infusion cannula insertion site, is greatly reduced.
Holes 140 may be formed in tapered distal tip 118 by a suitable technique, for example, a laser
drilling process in which a laser burns a hole into tapered distal tip 118. While laser drilling has
been disclosed, it is envisioned that any other known techniques for forming holes having a
diameter which is less than 0.2 mm can be utilized. While holes having a diameter less than
approximately 0.2 mm are preferred, it is envisioned that holes 140 can have a diameter which is
equal to or larger than 0.2 mm. Moreover, it is envisioned that if holes having a diameter which
is larger than 0.2 mm is used, a mesh screen (not shown) made of medical grade biocompatible
materials can be optionally inlayed or overlaid over holes 140 to thereby diffuse the force of the
infusate jet.
Turning now to FIGS. 8 and 9, infusion cannula 100 is provided with baffling means
disposed within body portion 112. Referring initially to FIG. 8, infusion cannula 100 further
includes an arcuately shaped baffle, such as, a hemispherical baffling surface 142 located within
body portion 112. Hemispherical baffling surface 142 contacts the inner surface of body portion 112 distally of delivery holes 120 and 122, preferably along juncture 124. The surface of hemispherical baffling surface 142 extends proximally within body portion 112. Accordingly, hemispherical baffling surface 142 will reduce, if not eliminate, the formation of turbulence within tapered distal tip 118 resulting from a distal flow indicated by arrow "A" of infusate through body portion 112. In addition, hemispherical baffling surface 142 will tend to cause distal flow "A" of infusate jet to be at least partially redirected in a proximal direction as indicated by arrow "A," upon delivery of an infusate to the eye. While a generally hemispherical baffling surface has been disclosed, it is envisioned that a semi-cylindrical surface (not shown) having a longitudinal axis oriented orthogonally with respect to both the longitudinal axis of infusion cannula 100 and a central axis extending between the pair of delivery holes 120 and 122 is also possible.
Turning now to FIG. 9, infusion cannula 100 further includes a conical baffling surface 144 located within body portion 112. Conical baffling surface 144 contacts the inner surface of body portion 112 distally of delivery holes 120 and 122, preferably along juncture 124. The surface of conical baffling surface 144 extends proximally within body portion 112.
Accordingly, conical baffling surface 144 will reduce, if not eliminate, the formation of turbulence within tapered distal tip 118 resulting from a distal flow as indicated by arrow "B" of infusate through body portion 112. In addition, conical baffling surface 144 will tend to cause
distal flow "B" of infusate jet to be at least partially redirected in a proximal direction as
indicated by arrow "B, " upon delivery of an infusate to the eye. While a generally conical baffling surface has been disclosed, it is envisioned that other geometries, for example, a
pyramidical like surface (not shown) having a pair of planar surfaces extending transversely across the longitudinal axis of infusion cannula 100 and transversely across a central axis extending between the pair of delivery holes 120 and 122 is also possible.
Although illustrative embodiments of the presently disclosed infusion cannula have been described herein with reference to the accompanying drawing, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the invention. All such changes and modifications are intended to be included within the scope of the present disclosure.

Claims

IN THE CLAIMS:
1. An infusion cannula for use in connection with vitreo-retinal surgical procedures, comprising:
a hollow body portion including a proximal end portion and a distal end portion having a distal tip integrally formed therewith, said distal tip closing said distal end portion of said
cannula; and
a pair of diametrically opposed delivery holes formed radially through said body portion
near a juncture between said body portion and said distal tip.
2. The infusion cannula according to claim 1, wherein said delivery holes divide a
supply of infusate into a pair of radially opposed directions from said distal end portion of said cannula, thereby dividing an infusate flow pressure into said two radially opposed directions.
3. The infusion cannula according to claim 1, wherein said distal tip is conical.
4. The infusion cannula according to claim 1, further comprising a connection hub
extending proximally from said proximal end portion of said body portion, wherein said hub is in
fluid communication with an interior of said hollow body portion.
5. The infusion cannula according to claim 4, further comprising a pair of wings
extending radially outward from said body portion and located adjacent a juncture between said
body portion and said connection hub.
6. The infusion cannula according to claim 5, wherein said infusion cannula measures approximately 4.5 mm in length from said wings to a distal most tip of said infusion cannula.
7. The infusion cannula according to claim 6, wherein said delivery holes are located between approximately 3.5 mm and approximately 4.2 mm from said pair of wings.
8. The infusion cannula according to claim 7, wherein an effective diameter of each
delivery hole is approximately 0.7 mm.
9. The infusion cannula according to claim 8, wherein said body portion has a size selected from the group consisting of approximately 19 gauge and approximately 20 gauge.
10. The infusion cannula according to claim 1 , further comprising a flow vectoring structure disposed within said hollow body portion, wherein said flow vectoring structure is configured and adapted to redirect said supply of infusate.
11. The infusion cannula according to claim 10, wherein said flow vectoring structure is a baffle operatively associated with at least one of said pair of delivery holes in order to
facilitate at least one of redirecting the flow and decreasing the flow force of said supply of infusate outward from said distal end portion.
12. A method for maintaining an internal fluid pressure of an eye during a vitreo- retinal surgical procedure, comprising the steps of:
providing an infusion cannula, wherein said infusion cannula includes:
a hollow body portion having a proximal end portion and a distal end portion having a distal tip integrally formed therewith, said distal tip closing said distal end portion of said cannula, and
a pair of diametrically opposed delivery holes formed radially through said body portion near a juncture between said body portion and said distal tip;
inserting said infusion cannula through the sclera of the eye;
coupling an infusion tubing to a comiection hub formed at said proximal end portion of
said body portion;
infusing a supply of infusate to an interior of said eye via said infusion tubing and via said infusion cannula; and
dividing said supply of infusate into a plurality of flow paths.
13. The method according to claim 12, further comprising the step of orienting said
infusion cannula in a direction such that said delivery holes are oriented tangential to the equator of the lens of said eye.
14. An infusion cannula for use in connection with vitreo-retinal surgical procedures, comprising:
a hollow body portion defining a first direction for an infusate flow, said hollow body portion including a proximal end and a distal end, which distal end includes a distal tip integrally formed therewith; and a pair of diametrically opposed delivery holes formed radially through said body portion of said distal tip, wherein a first hole of said pair of delivery holes is oriented to direct said infusate flow in a second direction which is orthogonal to said first direction and wherein a second hole of said pair of delivery holes is oriented to direct said infusate flow in a third direction which is orthogonal to said first direction and parallel to said second direction.
15. The infusion cannula according to claim 14, wherein said first and second delivery holes divide said infusate flow such that said infusate flow is divided in a plurality of flow paths.
16. ' The infusion cannula according to claim 14, further comprising a connection hub extending proximally from said proximal end of said infusion cannula and wherein said hub is in fluid communication with an interior of said hollow body portion.
17. The infusion cannula according to claim 16, further comprising a pair of wings extending radially outward from said body portion at a location adjacent to a juncture between said body portion and said connection hub.
18. The infusion cannula according to claim 14, further comprising a flow vectoring structure disposed within said hollow body portion, wherein said flow vectoring structure is configured and adapted to facilitate at least one of redirecting the flow and decreasing the flow force of said supply of infusate.
19. The infusion cannula according to claim 18, wherein said flow vectoring structure is a baffle operatively coupled to at least one of said pair of delivery holes in order to direct said supply of infusate outward from said distal end portion.
20. An infusion cannula for use in connection with vitreo-retinal surgical procedures, comprising: a hollow body portion including a proximal end and a distal end portion having a distal tip integrally formed therewith, said distal tip including a plurality of delivery holes formed therein.
PCT/US2002/001777 2001-01-25 2002-01-22 Infusion cannula WO2002058607A2 (en)

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KR20180048500A (en) * 2016-06-14 2018-05-10 아이 하스피틀, 웬조우 메디칼 유니버시티 A phakic intraocular lens position adjustor
CN105919724A (en) * 2016-06-14 2016-09-07 温州眼视光发展有限公司 Anterior chamber infusion device
KR101879504B1 (en) * 2016-06-14 2018-07-17 아이 하스피틀, 웬조우 메디칼 유니버시티 An anterior chamber irrigation maintainer
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US10543122B2 (en) 2016-12-19 2020-01-28 New World Medical, Inc. Ocular treatment devices and related methods of use
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