Surgical cassette manifold, system, and methods thereof

Abstract

Eliminating leaks of molded fluid channels by providing a front housing, rear housing, and a gasket, wherein the front housing has one or more molded fluid channels and one or more seal channels, and wherein at least a portion of the gasket is located between the front and rear housing; molding the gasket onto the rear housing to create a single unit, wherein the gasket has one or more seal lips configured and dimensioned to couple with the one or more seal channels; and assembling the front housing to the rear housing having the gasket, wherein the one or more seal lips couple with the seal channels. A surgical cassette manifold having a front and rear housing, and a gasket therebetween. The front housing having molded fluid channels that mate with the gasket and the gasket having multiple valves and a sensor/diaphragm accessible through the rear housing.

Claims

1. A surgical cassette manifold, comprising: a reservoir, wherein the reservoir comprises a sump and a baffle, wherein a port for fluid outflow is located within the sump; a front housing, wherein the front housing has a first side and a second side, wherein the first side comprises one or more fluid channels and a first half of the reservoir; and a rear housing, wherein the rear housing has a first side and a second side, wherein the first side comprises a second half of the reservoir and a gasket molded to at least a portion of the first side, wherein the first half of the reservoir comprises a baffle located near a top of the reservoir; wherein the sump is configured and dimensioned to draw fluid to the port to reduce turbulence in the reservoir.

2. The cassette of claim 1, further comprising a fluid level window, wherein the baffle is configured and dimensioned to limit fluid contact with the fluid level window.

3. The cassette of claim 1, wherein the baffle is angled toward the sump to direct fluid flow from the fluid channels to the port.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The present invention is best understood with reference to the following detailed description of the invention and the drawings in which:

(2) FIG. 1 schematically illustrates an eye treatment system in which a cassette couples an eye treatment probe with an eye treatment console;

(3) FIGS. 2A and 2B are exploded views of an exemplary surgical cassette manifold for use in the system of FIG. 1;

(4) FIG. 3A is perspective front view of the front housing of an exemplary surgical cassette manifold;

(5) FIG. 3B is perspective back view of the front housing of an exemplary surgical cassette manifold;

(6) FIG. 4A is a front perspective view of the rear housing of an exemplary surgical cassette manifold;

(7) FIG. 4B is a back perspective view of the rear housing of an exemplary surgical cassette manifold;

(8) FIG. 4C is front perspective view of the rear housing of an exemplary surgical cassette manifold;

(9) FIG. 4D is a back perspective view of the rear housing of an exemplary surgical cassette manifold;

(10) FIG. 4E is front perspective view of the rear housing of an exemplary surgical cassette manifold;

(11) FIG. 4F is a back perspective view of the rear housing of an exemplary surgical cassette manifold;

(12) FIG. 4G is a back perspective view of an assembled exemplary surgical cassette having rear housing shown in FIGS. 4E and 4F;

(13) FIG. 5A is back view of the rear housing of an exemplary surgical cassette manifold;

(14) FIG. 5B is a cross-sectional view of the rear housing along N-N of an exemplary surgical cassette manifold;

(15) FIG. 5C is a cross-sectional view of the rear housing of an exemplary surgical cassette manifold;

(16) FIG. 5D is a larger view of a portion of cross-sectional view of the rear housing of the exemplary surgical cassette manifold shown in FIG. 5C; and

(17) FIG. 6 is a perspective view of an exemplary surgical cassette with attached tubing and drain bag.

DETAILED DESCRIPTION OF THE INVENTION

(18) Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the invention as defined by the appended claims.

(19) Referring to FIG. 1, a system 10 for treating an eye E of a patient P generally includes an eye treatment probe handpiece 12 coupled to a console 14 by a cassette 100 mounted on the console. Handpiece 12 may include a handle for manually manipulating and supporting an insertable probe tip. The probe tip has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from the console 14 and/or cassette 100 into the eye. Aspiration fluid may also be withdrawn through a lumen of the probe tip, with the console 14 and cassette 100 generally including a vacuum aspiration source, a positive displacement aspiration pump, or both to help withdraw and control a flow of surgical fluids into and out of eye E. As the surgical fluids may include biological materials that should not be transferred between patients, cassette 100 will often comprise a disposable (or alternatively, re-sterilizable) structure, with the surgical fluids being transmitted through flexible conduits 18 of the cassette that avoid direct contact in between those fluids and the components of console 14.

(20) When a distal end of the probe tip of handpiece 12 is inserted into an eye E, for example, for removal of a lens of a patient with cataracts, an electrical conductor and/or pneumatic line (not shown) may supply energy from console 14 to an ultrasound transmitter of the handpiece, a cutter mechanism, or the like. Alternatively, the handpiece 12 may be configured as an irrigation/aspiration (FA) or vitrectomy handpiece. Also, the ultrasonic transmitter may be replaced by other means for emulsifying a lens, such as a high energy laser beam. The ultrasound energy from handpiece 12 helps to fragment the tissue of the lens, which can then be drawn into a port of the tip by aspiration flow. So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece 12 (or a separate probe structure) may also be provided, with both the aspiration and irrigations flows being controlled by console 14.

(21) So as to avoid cross-contamination between patients without incurring excessive expenditures for each procedure, cassette 100 and its flexible conduit 18 may be disposable. Alternatively, the flexible conduit or tubing may be disposable, with the cassette body and/or other structures of the cassette being sterilizable. Regardless, the disposable components of the cassette are typically configured for use with a single patient, and may not be suitable for sterilization. The cassette will interface with reusable (and often quite expensive) components of console 14, which may include one or more peristaltic pump rollers, a Venturi or other vacuum source, a controller 40, and the like.

(22) Controller 40 may include an embedded microcontroller and/or many of the components common to a personal computer, such as a processor, data bus, a memory, input and/or output devices (including a touch screen user interface 42), and the like. Controller 40 will often include both hardware and software, with the software typically comprising machine readable code or programming instructions for implementing one, some, or all of the methods described herein. The code may be embodied by a tangible media such as a memory, a magnetic recording media, an optical recording media, or the like. Controller 40 may have (or be coupled to) a recording media reader, or the code may be transmitted to controller 40 by a network connection such as an internet, an intranet, an Ethernet, a wireless network, or the like. Along with programming code, controller 40 may include stored data for implementing the methods described herein, and may generate and/or store data that records perimeters with corresponding to the treatment of one or more patients. Many components of console 14 may be found in or modified from known commercial phacoemulsification systems from Abbott Medical Optics Inc. of Santa Ana, Calif.; Alcon Manufacturing, Ltd. of Ft. Worth, Tex.; Bausch and Lomb of Rochester, N.Y.; and other suppliers.

(23) FIGS. 2A and 2B illustrates a surgical cassette manifold of the present invention, including components of surgical cassette manifold 101. Cassette or surgical cassette 100 is an assembly surgical cassette manifold 101 having fluid pathways and connected tubing configured to manage one or more of the following: fluid inflow, fluid outflow, fluid vacuum level, and fluid pressure in a patient's eye E when coupled with console 14. As shown in FIGS. 2A and 2B, surgical cassette manifold 100 has a front housing 102, a rear housing 104, a first tubing 106, and a second tubing 108. Rear housing 104 may also have gasket 110 co-molded or over-molded with rear housing 104.

(24) FIGS. 3A and 3B show front housing 102 in more detail. FIG. 3A shows a front perspective view of front housing 102, which may have a handle 112 (e.g. finger grip handle), drain port 114, and attachment clip 116. FIG. 3B shows a back perspective view of front housing 102, which may have molded fluid channels 118, a first portion 120a of reservoir 120, a first pump ramp or profile 122 configured and dimensioned for mating with a peristaltic pump, and a second pump ramp or profile 124 configured and dimensioned for mating with a peristaltic pump.

(25) A drain bag 16 (see FIG. 6) may be attached to the front of front housing 102 via the drain port 114 and attachment clip 116 such that when surgical cassette 100 is coupled with console 14 and fluid is aspirated from an eye E of a patient P, the fluid is capable of being collected in the drainage bag 16 via drain port 114. The drain bag 16 may be supported on surgical cassette manifold 101 by attachment clip 116 and/or drain port 114.

(26) Drain port 114 on front housing 102 of surgical cassette manifold 101 may be recessed allowing for a lower or low profile handle 112. Having a low or lower profile drain port 114 allows a drain bag (not shown) to sit flush again front housing 102. In an embodiment, placing drain port 114 substantially in the middle of the surgical cassette manifold from top to bottom moves the location of the center of mass of surgical cassette manifold 101 making the surgical cassette manifold more ergonomic. Moreover, locating drain port 114 closer to the upper/top edge of front housing 102 allows for a more compact assembly of the surgical cassette manifold and allows for better access to components/handles of console 14. See FIG. 6.

(27) In an embodiment, a fluid channel 118 runs in a vertical direction from lower tube connection 136 (that is fluidly connected to the second tubing segment 108 that makes up the second peristaltic pump) to drain port 114 out to the drain bag 16. This molded fluid channel 118 eliminates the need for tubing.

(28) As shown in FIG. 3B, front housing 102 also may have seal channels 125, which are configured and dimensioned to mate with a seal lip 126 (shown in FIGS. 4A, 4C, and 4E) that extends outwardly or perpendicularly from the surface of gasket 110 and is a part of gasket 110 to create a seal or lid over molded fluid channels 118. The seal lip may have any dimension suitable for mating with seal channel 125. In an embodiment, seal lip 126 may be tapered, starting thicker at its proximal end and becoming thinner towards its distal end. In another embodiment, seal lip 126 may be slightly larger than seal channel 125 to create a snug fit. In a further embodiment, co-molding or over-molding gasket 110 onto rear housing 104 eliminates the potential leak path in the direction of rear housing 104. Seal lip 126 provides positioning alignment on front housing 102 and rear housing 104.

(29) Referring to FIGS. 4A-4F, various exemplary embodiments of rear housing 104 are shown. FIG. 4A is a front perspective view of rear housing 104 and FIG. 4B is a back perspective view of rear housing 104. As shown in FIG. 4A rear housing 104 has a gasket 110 co-molded or over-molded to it. Gasket 110 has seal lip 126 which extends away or protrudes in a substantially perpendicular direction from a plane of gasket 104 and rear housing 104. Gasket 110 may include a pressure/vacuum sensor diaphragm 128, vent valve control dome 130, and/or irrigation valve control dome 132. Vacuum/pressure sensor diaphragm 128 may be a sealed flexible annular membrane with a central magnetic coupling disk which deforms: (1) proportionally outwards under fluid pressure conditions compressing a magnetically-coupled force displacement transducer of console 14 allowing for non-fluid contact measurement of fluid pressure level inside the aspiration fluid pathways of surgical cassette manifold 101; and (2) proportionally inwards under fluid vacuum conditions extending the magnetically-coupled force displacement transducer of console 14 allowing for non-fluid contact measurement of fluid vacuum level inside the aspiration fluid pathways of surgical cassette manifold 101.

(30) In an embodiment, gasket 110 may be molded, co-mold, or two-shot molded onto or with rear housing 104. Molding gasket 110 onto rear housing 104 in such a manner reduces or eliminates a leak path which is possible with molded fluid channels when using two different materials. In an embodiment, a method of eliminating leaking of molded fluid channels by combining two different materials for creating a proper seal is envisioned resulting in an easier manufacturing method by creating a self-aligning gasket 110. In an embodiment, when assembling rear housing 104 to front housing 102 mating of seal lip 126 and seal channel 125 can be achieved using a plurality of alignment pins 127 which mate with their counterpart pin holes 129. Using alignment pins 127 and pin holes 129 as opposed to the flexible seal lip 126 and seal channel 125 allows for an easier and more efficient assembly process. Thus, molding gasket 110 onto or with rear housing 104 results in pre-alignment/pre-keyed/pre-orientation of seal lip 126 for properly sealing molded fluid channels 118 on front housing 102, thus reducing or even eliminating leaking and increasing ease of manufacture.

(31) Rear housing 104 may also include a second portion 120b of reservoir 120, upper tube connections 134, lower tube connection 136, and one or more tubing retainer clips 138. In an embodiment, upper tube connections 134 have a slight taper from bottom toward the top so that the tubing stays on the upper tube connections 134. See FIG. 5D. Lower tube connection 136 may have a tapered head (as shown in FIG. 5A) to secure second tubing 108 to lower tube connections 136.

(32) In an embodiment, second tubing 108 may have a first end and a second end that couple with lower tube connections 136. Once surgical cassette manifold 101 is assembled, second tubing 108 and ramp 124 are configured to couple with a peristaltic rollers located on console 14 (not shown) to create a peristaltic pump. In an embodiment, lower tube connections 136 are on the same axis, i.e. there is axial alignment of the inflow and outflow of the tubing 108, and maintain a specific distance apart resulting in a more accurate peristaltic pump due to the controlled length of second tubing 106, which provides a consistent flow rate and a consistent interface with ramp 124 and peristaltic rollers. Moreover, such aligned and consistent interfaces results in less noise/sound generated by the peristaltic pump during operation.

(33) In an embodiment, reservoir 120 may have a sump 121. Sump 121 is a portion of reservoir 120 that extends below a bottom 120c of reservoir 120 that promotes fluid to flow from the reservoir 120 to sump 121 and out a lower tube connection 136 via the second tubing 108. Sump 121 (1) reduces turbulence of the tank by pulling bubbles away from the level detector housed in the console 14 that couples with window 131 for more accurate detection of the fluid in reservoir 120; and (2) ensures drain inlet port 133a fluidly connected to a lower tube connection 136 is always below fluid, therefore fluid is consistently pumped out and not air, which may cause the drain bag 16 to balloon. In an embodiment, window 131 may be a prism.

(34) In another embodiment, the fluid level detector and window 131 are located on one side of reservoir 120 and sump 121 and baffle 135 is on the other side of reservoir 120. This configuration ensures limited or no interaction between the fluid entering and exiting the reservoir and the fluid level detector and window 131 to allow for a more precise reading of the level of fluid in reservoir 120. Moreover, the combination of baffle 135 and sump 121 provides a guide for the fluid entering reservoir 120 from molded fluid channels 118 and exiting through drain pump inlet port 133a to reduce turbulence in reservoir 120. Fluid may exit reservoir 120 via drain pump inlet port 133a via lower tube connection 136, which may be coupled with a first end of second tubing 108 and a second end of second tubing 108 may be coupled to a second lower tube connection 136 which is coupled to drain pump outlet 133b. Drain pump outlet 133b is coupled with a drain bag 16 to allow fluid to be removed from reservoir 120 via the second peristaltic pump.

(35) Referring to FIGS. 4C and 4D, rear housing 104 is shown in an alternative embodiment with respect to how first tubing 106 couples with rear housing 104. Pump tube inlet 137a and pump tube outlet 137b couple with barbs 136, which in turn are configured and dimensioned to couple with first tubing 106. See FIG. 2b. During assembly rear housing 104 is mated with front housing 102 and first tubing 106 is configured to conform with first pump ramp or profile 122, which is configured and dimensioned for mating with a peristaltic pump located within console 14 (not shown).

(36) Referring to FIGS. 4E and 4F, rear housing 104 is shown in an alternative embodiment with respect to how first tubing 106 couples with rear housing 104. A first end and a second end of first tubing 106 are fed through a gap 139 of tubing catch 140 and pump tube inlet 137a and pump tube outlet 137b couple with the first end and the second end of first tubing 106 via upper tube connections 134 by placing the first end and the second end of the first tubing 106 over the upper tube connection 134, which connect to molded fluid channels 118. Other mechanisms of connecting the first and second ends of first tubing 106 to upper tube connection 134 known in the art are also contemplated. FIG. 4G shows assembled cassette 100 having the rear housing 104 embodiment shown in FIGS. 4E and 4F with first tubing 106 fed through gaps 139 of tubing catch 140 of rear housing 104.

(37) Referring to FIGS. 5A and 5B, tubing retainer clips 138 (shown in FIGS. 4A and 4B) may have a first prong 138a and a second prong 138b creating an opening 140. Tubing retainer clips 138 protrude substantially perpendicularly from a plane of the back side of rear housing 104. In an embodiment, tubing retainer clips 138 may slightly angle towards each other as shown in FIG. 5A. Tubing retainer clips 138 are configured and dimensioned to assist with easy assembly of surgical cassette manifold 101 and maintaining first tubing 106 in a specific orientation after assembly. Tubing retainer clips 138 may be over center clips.

(38) During assembly of surgical cassette manifold 101, a first end and a second end of first tubing 106 are coupled with upper tube connections 134 (see FIG. 4B) via pump tube inlet 137a and pump tube outlet 137b by placing the first end and the second end of the first tubing 106 over the upper tube connection 134, which may connect to molded fluid channels 118. Once the first and second end of the first tubing 106 is coupled with the upper tube connections 134, first tubing 106 may be pushed through opening 140. First tubing 140 may pushed through opening 140 between the first prong 138a and the second prong 138b by an operators hand, using tool or through an automation step with equipment. The nature of the tubing allows for it to deform under pressure and fit between the first prong 138a and second prong 138b. In an embodiment, first tubing 106 may be stretched to minimize the diameter of the tubing to enable insertion between first prong 138a and second prong 138b. Once first tubing 106 is through first prong 138a and second prong 138b, the shape and size of first prong 138a, second prong 138b, and opening 140 prevent first tubing 106 from backing back out through opening 140 after assembly. In an embodiment, each prong has an angle to help with easing first tubing 106 into opening 140 and the angle between the first prong 138a and the second prong 138b is a as shown in FIG. 5B. In an embodiment, the angle between first prong 138a and second prong 138b may be approximately 60 degrees. In another embodiment, the larger the angle the easier to insert tubing 106 into opening 140, however a 0 degree angle would not help much. In an embodiment, the angle between first prong 138a and second prong 138b may be between 30 degrees and 90 degrees.

(39) As discussed above and shown in FIGS. 3B and 4A, reservoir 120 may be comprised of two pieces with an elastomeric seal in between the two pieces. For example, reservoir 120 may include first portion 120a and second portion 120b. In prior art tanks that are composed of multiple pieces, adhesives are used resulting in additional material for assembly. In contrast, in an embodiment of the present invention, when front housing 102 and rear housing 104 are ultrasonically welded together with gasket 110 co-molded to the rear housing, gasket 110 creates a seal around and between the edges of the first portion 120a and the second portion 120 b. In the present embodiment, the joining of the first portion 120a and the second portion 120b with the co-molded or over-molded gasket 110 results in a mechanical seal. In another embodiment, the front housing 102 and rear housing 104 may be press fit together with or without the use of adhesives to replacing ultrasonic welding. These techniques may have a cost savings advantage of avoiding extra material from a manufacturing and cost of goods perspective. In another embodiment, other mechanisms of assembly that may be used to combine front housing 102 and rear housing 104 include, but are not limited to, laser welding, a rotating latch, a snap clip latch, or fasteners, such as screws, rivets, and/or pins.

(40) According to an embodiment, having a first portion 102a and a second portion 102b with a gasket 110 decreases the dimensional tolerance requirements for the first and second portions where the gasket portion comes in contact with the reservoir 120 due to the compressive nature of the seal. In an embodiment, gasket 110 has a seal lip 126 that mates with a seal channel 125 on second portion 102b of the reservoir tank 120 of the rear housing 104, thereby creating a seal when the front housing 102 and rear housing 104 are mated. In an embodiment, there is no need to actually displace or squeeze the gasket between the two covers to create a non-leaking seal, although some pressure may be accommodated or desired, or may result from tolerances during manufacturing. See FIG. 3B.

(41) Referring to FIGS. 5A and 5C, in an embodiment, rear housing 104 may have one or more venting/securing holes 142. The functionality of venting/securing holes 142 is two-fold. First, venting/securing holes 142 assist with venting or gas release during the co-molding or over-molding process when gasket 110 is coupled with rear housing 104. Holes 142 assist with the flow of material to minimize or eliminate the back pressure. Second, venting/securing holes 142 may be reversed tapered to help secure or increase adherence of gasket 110 to rear housing 104. For example, should the chemical reaction binding gasket 110 to rear housing 104 not occur or not completely occur, a mechanical adhesion can be achieved with the reversed taper of venting/securing holes 142. FIG. 5C shows a cross-section along J-J showing holes 142. Holes 142 may have any degree of taper suitable for securing gasket 110 to rear housing 104 and/or making molding/manufacturing easier.

(42) In an embodiment, surgical cassette manifold 101 may be made substantially of a plastic material except for gasket 110. The plastic material may be acrylonitrile-butadiene-styrene (ABS), polycarbonate (PC), polyethylene, viton, or other rigid plastic or plastic material. In addition, the material may be such that it is transparent enabling a user to visualize various features of surgical cassette manifold 101. For example, all components may be transparent, including reservoir 120. In an embodiment, a lights emitted from console 14 may be shone through surgical cassette manifold 101 to provide a backlight and allow a user to visualize the fluid flow as it flows from handpiece 12 through molded fluid channels 118 into reservoir 120 out to the drain bag 16. In embodiment, the backlight may also be used as a surgical cassette manifold type detector.

(43) All references cited herein are hereby incorporated by reference in their entirety including any references cited therein.

(44) Although the present invention has been described in terms of specific embodiments, changes and modifications can be carried out without departing from the scope of the invention which is intended to be limited only by the scope of the claims.