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EP-3968912-B1 - OPHTHALMIC CUTTING INSTRUMENTS HAVING INTEGRATED ASPIRATION PUMP

EP3968912B1EP 3968912 B1EP3968912 B1EP 3968912B1EP-3968912-B1

Inventors

  • CARTER, BRETT
  • CLAUSON, LUKE, W.
  • SCHALLER, Michael, P.

Dates

Publication Date
20260506
Application Date
20200515

Claims (13)

  1. A device (200) for performing an ophthalmic procedure in an eye, the device comprising: a hand-held portion; an elongate member (250) extending from a distal end region of the hand-held portion, the elongate member (250) comprising a lumen and an opening near a distal end region of the elongate member (250); and an aspiration pump (245) within the hand-held portion in fluid communication with the opening of the elongate member (250), wherein the aspiration pump (245) comprises: a camshaft (405) extending along a longitudinal axis and having a plurality of lobed cams (425); tubing (415) extending parallel to the longitudinal axis; and a plurality of cam followers (410) driven by the cams (425) of the camshaft (405) to move in a plane perpendicular to the longitudinal axis to sequentially compress the tubing (415); and a drive mechanism (205) operatively coupled with the camshaft (405), wherein the drive mechanism (205) rotates the camshaft (405) and drives oscillation of the elongate member (250).
  2. The device (200) of claim 1, wherein the tubing (415) comprises a proximal flow path that splits into a pair of peripheral tubes positioned on either side of the camshaft (405), the pair of peripheral tubes combine distal to a pumping manifold (420) to form a distal flow path in fluid communication with the lumen of the elongate member (250).
  3. The device (200) of claim 2, wherein the plurality of cam followers (410) sequentially compressing the pair of peripheral tubes creates a substantially non-pulsatile aspiration.
  4. The device (200) of claim 3, wherein the substantially non-pulsatile aspiration is less than - 3 cc/minute, between 3 cc/minute to - 10 cc/minute, or greater than 10 cc/minute up to - 25 cc/minute.
  5. The device (200) of any one of the previous claims, wherein the elongate member (250) is movable in a reciprocating motion relative to the hand-held portion.
  6. The device (200) of any one of claims 1-5, wherein the elongate member (250) is configured for lens fragmentation, lens emulsification, or anterior vitrectomy.
  7. The device (200) of any one of claims 1-6, wherein the elongate member (250) is configured to slide reciprocally within an outer tube (252) that is fixedly coupled within an interior of the hand-held portion, wherein a distal tip of the elongate member (250) forms a cutting edge, wherein the outer tube (252) comprises an opening through a side wall.
  8. The device (200) of claim 7, wherein the elongate member (250) further comprises a side opening (258) near its distal end region, wherein the elongate member (250) is configured to create two cuts in concert with the outer tube (252), wherein a first cut of the two cuts is formed as a distal shaft edge (256) of the elongate member (250) is on a distal stroke within the outer tube (252) and wherein a second cut of the two cuts is formed as the elongate member (250) is on a proximal stroke within the outer tube (252).
  9. The device (200) of any one of claims 1-6, wherein the elongate member (250) is configured to oscillate at 300 cuts per minute, 500-600 cuts per minute, up to 5000 cuts per minute, or up to 7500 cuts per minute.
  10. The device (200) of any one of claims 1-6, further comprising a gear box (232) configured to amplify the input from the aspiration pump (245) to achieve an output of the elongate member configured for vitrectomy.
  11. The device (200) of claim 10, wherein the gear box (232) is a planetary gear box.
  12. The device (200) of claim 1, further comprising gearing to ramp up input from the drive mechanism.
  13. The device (200) of claim 12, wherein the camshaft (405) of the aspiration pump (425) rotates at a fixed rate to deliver between about 15 cc/minute and 30 cc/minute of aspiration potential.

Description

FIELD The present technology relates generally to ophthalmic microsurgical tools and systems, in particular, ophthalmic cutting tools having a reusable durable driver portion configured to operatively couple with different disposable working portions in an interchangeable manner. BACKGROUND Certain types of conventional ophthalmic surgery require breaking up lenticular tissue and intraocular objects, such as the intraocular lens or vitreous so that they can be extracted from the eye. For example, extraction of lenses for cataract surgery is one of the most common surgical procedures with more than 3 million cases performed annually in the United States alone. During cataract surgery, a commonly used method for lens extraction is phacoemulsification, which uses ultrasonic energy to emulsify the lens and aspiration to remove the lens emulsate from the eye. Other methods of lens fragmentation and extraction may include the use of instruments such as hooks, knives, or lasers to fragment the lens into pieces small enough to be extracted through an incision in the cornea in an ab interno approach. Intraocular, ab interno fragmentation of the lenticular tissue is important in cataract surgery in order to allow removal of cataracts from ocular incisions that are typically not exceeding 2.8-3.0 mm. Typical phacoemulsification systems include a console in operative communication with a phacoemulsification hand piece that provides the control of the electronics of the hand piece, aspiration, and irrigation. During typical phacoemulsification procedures, the phaco tip is inserted into the anterior segment of the eye through a small incision in the cornea. The phaco tip is brought into contact with the lens of the eye so that the oscillating phaco top emulsifies the lens. The emulsate is then aspirated through the lumen of the phaco tip. A challenge associated with conventional phaco devices and other devices using a remote vacuum source is that the suction lines are quite long and flexible contributing to the fluidic system compliance. Phacoemulsification machines incorporate remote pumps, typically a peristaltic pump, venturi pump, or a combination of both, to provide fluid management during a procedure. Peristaltic pumps function by sequentially compressing a segment of tubing between a plate or rollers to move an amount of fluid or tissue away from the operative site. The plates or rollers are arranged so that at any time at least one is occluding the tubing. A transient pressure increase is experienced in the tubing. Peristaltic pumps can cause mild flow fluctuations as the rollers compress the tube. Turbulence can cause posterior capsule bounce and iris flutter, which are undesirable movements. Long, compliant suction lines containing compressible material affects the responsive times at the tip when suction is turned on and off. These remote pumps suffer from post-occlusion surge. In the context of cataract surgery, vitrectomy is used when a complication occurs during lens removal. For example, phacoemulsification has a risk of penetrating the posterior lens capsule leading to inadvertent prolapse of vitreous into the anterior segment. Vitrectomy is essentially a rescue procedure performed during cataract surgery. The goals of anterior vitrectomy are to remove the vitreous from the anterior chamber, to clear vitreous from entry incisions, and to allow the IOL to be placed. Vitreous has an unpredictable flow behavior that is difficult to characterize due to its semi-solid structure. Vitreous is composed of mostly water, but also collagen fiber and hyaluronic acid. Vitreous requires cutting before going through the probe. Chopped vitreous has a lower viscosity than intact gel-like vitreous. Small bite sizes pieces are preferred to improve aspiration and removal of vitreous. Most commercially available anterior vitrectors are designed for coaxial irrigation and vitreous cutting. Local turbulent flow and vitreous volume expansion from hydration can be an issue with coaxial irrigation and cutting systems. Irrigation can also be performed with a bimanual approach separating the vitrector from the irrigation. Vitrectors are typically inserted through limbal incisions although vitrector can also be inserted through a stab incision made 3 mm posterior to the limbus through the pars plana using a microvitreoretinal blade. Low level cutting (300 cuts per minute (cpm)) and aspiration can be used to remove the lens fragments prior to initiation of the vitreous removal. For vitreous removal, the cut rate is set high (500-600 cpm), with low to moderate aspiration. The high cut speed for vitreous removal causes the vitreous to flow continuously into the cutter. The vitrector is placed through the capsular tear just below the capsule with the aspiration port facing up toward the cornea. The vitreous is removed to a level just posterior to the capsule. SUMMARY US2015/144514 discloses a device for performing an ophthalmic procedure