MULTI-LAYER ASPIRATION TUBING DESIGN FOR REDUCED POST OCCLUSION SURGE AND PUMP PULSATION

Abstract

Multilayer tubing balances the property of improved kink resistance, reduces post occlusion surge, and reduces pump pulsations after surge. A multilayer construction is provided for tubing for phacoemulsification systems. Multilayer tubing includes multiple layers having an inner layer and an outer layer, wherein the material of the inner layer is harder or stiffer than the material of the outer layer.

Claims

1. A phacoemulsification surgical system, comprising a phacoemulsification console; a surgical cassette connected to the console via at least one interface; a surgical hand piece; and at least one aspiration tube connected between the surgical hand piece and the surgical cassette, the at least one aspiration tube comprising multiple layers.

2. The surgical system of claim 1, wherein the at least one aspiration tube comprises an inner layer.

3. The surgical system of claim 2, wherein the inner layer of the at least one aspiration tube comprises a stiff material.

4. The surgical system of claim 3, wherein the stiff material of the inner layer of the at least one aspiration tube comprises, at least in part, one selected from the group consisting of a nylon, a polyvinyl chloride (PVC), or a Pebax material.

5. The surgical system of claim 1, wherein the at least one aspiration tube comprises an outer layer.

6. The surgical system of claim 5, wherein the outer layer of the at least one aspiration tube comprises a soft material.

7. The surgical system of claim 6, wherein the soft material of the outer layer of the at least one aspiration tube comprises, at least in part, one selected from the group consisting of a nylon, a polyvinyl chloride (PVC), or a Pebax material.

8. The surgical system of claim 1, wherein the multiple layers include an inner layer and an outer layer.

9. The surgical system of claim 8, wherein the inner layer comprises a stiff material and the outer layer comprises a soft material.

10. The surgical system of claim 8, wherein the outer layer comprises a material softer than a material of the inner layer.

11. A multi-layer tubing construction for improving kink resistance and reducing post occlusion surge and pump pulsations during phacoemulsification surgery, the tubing construction comprising: an inner layer comprising a stiff material; and an outer layer comprising a soft material.

12. The multi-layer tubing construction of claim 11, wherein the stiff material comprises, at least in part, one selected from the group consisting of a nylon, a polyvinyl chloride (PVC), or a Pebax material.

13. The multi-layer tubing construction of claim 11, wherein the soft material comprises, at least in part, one selected from the group consisting of a nylon, a polyvinyl chloride (PVC), or a Pebax material.

14. The multi-layer tubing construction of claim 11, wherein the tubing construction is aspiration tubing.

15. The multi-layer tubing construction of claim 11, wherein the tubing construction is irrigation tubing.

16. A phacoemulsification surgical system, comprising a phacoemulsification console; a surgical cassette connected to the console via at least one interface; a surgical hand piece; and at least one multi-layer tube connected between the surgical hand piece and the surgical cassette.

17. The phacoemulsification surgical system of claim 16, wherein layer of the layers of the at least one multi-layer tube differ in thickness to each layer of the layers of the at least one multi-layer tube.

18. The phacoemulsification surgical system of claim 17, wherein the thickness is distributed between the layers of the at least one multi-layer tube, wherein an inner layer is thicker in relation to an outer layer of the layers.

19. The phacoemulsification surgical system of claim 17, wherein a material hardness is distributed between the layers of the at least one multi-layer tube, wherein an outer layer is softer in relation to an inner layer of the layers.

20. The phacoemulsification surgical system of claim 16, wherein the at least one multi-layer tube is at least one of an aspiration tube or an irrigation tube.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The figures described below depict various aspects of the systems and methods disclosed therein. It should be understood that each figure depicts an embodiment of a particular aspect of the disclosed systems and methods, and that each of the figures is intended to accord with a possible embodiment thereof. Further, wherever possible, the following description refers to the reference numerals included in the following figures, in which features depicted in multiple figures are designated with consistent reference numerals.

[0019] There are shown in the drawings arrangements which are presently discussed, it being understood, however, that the present embodiments are not limited to the precise arrangements and are instrumentalities shown, wherein:

[0020] FIG. 1 schematically illustrates an eye treatment system in which a cassette couples an eye treatment probe with an eye treatment console;

[0021] FIG. 2A illustrates a cross-sectional view of a two-layer tubing construction in accordance with at least one embodiment;

[0022] FIG. 2B illustrates a side-sectional view of a two-layer tubing construction in accordance with at least one embodiment;

[0023] FIG. 3 illustrates a test matrix of a two-layer tubing construction in accordance with at least one embodiment;

[0024] FIG. 4 illustrates a delta IOP—surge response for different tubing types test matrix of a two-layer tubing construction in accordance with at least one embodiment;

[0025] FIG. 5 illustrates a POS response comparison for different aspiration tubing types for two-layer tubing construction and reduction in pulsation after the POS in accordance with at least one embodiment; and

[0026] FIG. 6 illustrates a test set-up for measuring flexibility of plastic tubing.

[0027] The figures depict preferred embodiments for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the systems and methods illustrated herein may be employed without departing from the principles of the invention described herein.

DETAILED DESCRIPTION OF THE INVENTION

[0028] It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in typical surgical, and particularly optical surgical, apparatuses, systems, and methods. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to the disclosed elements and methods known to those skilled in the art.

[0029] The figures and descriptions provided herein may have been simplified to illustrate aspects that are relevant for a clear understanding of the herein described apparatuses, systems, and methods, while eliminating, for the purpose of clarity, other aspects that may be found in typical similar devices, systems, and methods. Those of ordinary skill may thus recognize that other elements and/or operations may be desirable and/or necessary to implement the devices, systems, and methods described herein. But because such elements and operations are known in the art, and because they do not facilitate a better understanding of the present disclosure, for the sake of brevity a discussion of such elements and operations may not be provided herein. However, the present disclosure is deemed to nevertheless include all such elements, variations, and modifications to the described aspects that would be known to those of ordinary skill in the art.

[0030] Embodiments are provided throughout so that this disclosure is sufficiently thorough and fully conveys the scope of the disclosed embodiments to those who are skilled in the art. Numerous specific details are set forth, such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. Nevertheless, it will be apparent to those skilled in the art that certain specific disclosed details need not be employed, and that exemplary embodiments may be embodied in different forms. As such, the exemplary embodiments should not be construed to limit the scope of the disclosure. As referenced above, in some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies may not be described in detail.

[0031] A surgical cassette, also referred to as a medical pack, a fluidics cassette, or simply, a cassette, is typically used to facilitate irrigation and aspiration during surgical procedures, such as phacoemulsification surgery. The surgical cassette may be inserted and mounted to a surgical console and become part of an overall phacoemulsification surgery system. The surgical cassette may perform a myriad of functions, such as effluent material collection, vacuum, pressure, and/or fluid flow sensing, and the control of fluid flow through tubing encased within the cassette and between a surgical handpiece and a surgical console.

[0032] Referring to FIG. 1, a system 10 for treating an eye E of a patient P generally includes an eye treatment probe hand piece 12 coupled to a console 14 by a cassette 100 mounted on the console via interface 105. Hand piece 12 may include a handle for manually manipulating probe tip inserted to an eye. The probe tip has a distal end 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 be disposable or comprise a disposable structure or structure capable of being sterilized for re-use, with the surgical fluids being transmitted through conduits of the cassette that avoid direct contact in between those fluids and the components of console 14.

[0033] When a distal end of the probe tip of hand piece 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 hand piece, a cutter mechanism, or the like. Alternatively, the hand piece 12 may be configured as an irrigation/aspiration (I/A) or vitrectomy hand piece. 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 hand piece 12 helps to fragment the tissue of the lens, which can then be drawn into a port of the tip by aspiration flow. To balance the volume of material removed by the aspiration flow, an irrigation flow through hand piece 12 (or a separate probe structure) may also be provided, with both the aspiration and irrigations flows being controlled by console 14.

[0034] To avoid cross-contamination between patients and/or to avoid incurring excessive expenditures for each procedure, cassette 100 and its one or more conduits (e.g an irrigation line and an aspiration line) illustrated by tubing line 18 may be disposable. Alternatively, the conduit or tubing may be disposable, with the cassette body and/or other structures of the cassette being reusable following sterilization. Regardless, the disposable components of the cassette are typically configured for use with a single patient and may not be suitable for sterilization. In some embodiments, the cassette may 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, or the like.

[0035] 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 may 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 parameters corresponding to the treatment of one or more patients. Many components of console 14 may be found in or modified from known commercial phacoemulsification.

[0036] FIG. 2A illustrates a cross-sectional view 200A of a two-layer tubing construction in accordance with the disclosed invention. In the illustrated example, the multi-layer tubing includes two layers, however it is to be understood that more, or less, than two layers may be implemented. In at least one embodiment, the inner layer 204 may be comprised of one or more rigid or stiff materials or one or more materials stiffer than outer layer 202. As known in the art, lower Shore A values indicate soft materials and higher Shore A values indicate more rigid or stiff materials. An example of a rigid or stiff material may be a nylon material of a certain thickness and hardness. In an embodiment, the rigid or still material may be plasticized PVC, Polyolefins, Nylons (e.g. Nylon6, Nylon 66, Nylon 12, etc.) and/or Pebax of a higher Shore A value. In another embodiment, the rigid or stiff material may comprise braided tubing (with different braid materials such as stainless steel) which provides stiffness and kink resistance. In an embodiment, the inner layer 204 may have a thickness from 0.001″ to 0.10″, preferably from 0.005″ to 0.015″.

[0037] The outer layer 202 may be comprised of one or more softer materials, when compared to materials used for the inner layer. For example, the outer layer may be comprised of one or more Pebax materials and be of a certain thickness. In an embodiment, the softer material may be plasticized PVC grades less than or equal to a Shore A value of 65, or silicone or Pebax with a similar Shore A value. In an embodiment, the outer layer 202 may have a thickness from 0.002″ to 0.080″, preferably about 0.015″ to about 0.050″. In an embodiment, when two or more different materials with different Shore A values are used they may be chosen from the same family of materials, e.g. different grades of PVC, Pebax, or Nylon. In an embodiment, if dissimilar materials are used, typically a tie layer is used to bond the materials during processing.

[0038] According to an embodiment, it is envisioned that if the outer layer 202 has a lower Shore A value than the inner layer 204 then the inner layer 204 may be considered rigid or stiff. In an embodiment, 65A and lower shores of plasticized PVC may be considered soft and 65A and above may be considered rigid or stiff for plasticized PVC.

[0039] The advantage of a stiff inner layer may be the improvement of kink resistance of the tubing, such as tubing 18 of FIG. 1 between hand piece 12 and console 14. A stiff inner layer of the tubing may reduce compliance. Even further, a stiff inner layer may reduce post occlusion surge and pump pulsations.

[0040] The advantage of a soft outer layer of the tubing, such as tubing 18 of FIG. 1 between hand piece 12 and console 14 is the soft outer layer of the tubing may allow increased flexibility of tubing 18. In some embodiments, the soft outer layer may allow for easy handling of tubing 18. Even further, a soft outer layer of tubing may allow for coiling of tubing 18 without any kinks.

[0041] Overall, the two-layer example construction of the disclosed invention may have a smaller overall wall thickness due to the inclusion of a stiff inner layer 204. Due to a smaller thickness, the overall weight of the tubing 18 may be less in comparison with a single layer bulky tubing construction. Further, it should be noted that the views provided by the figures are not to scale and are merely shown for illustrative purposes.

[0042] FIG. 2B illustrates a side-sectional view 200B of a two-layer tubing construction in accordance with the disclosed invention. In the illustrated example, as set forth above with respect to FIG. 2A, the multi-layer tubing includes two layers, however it is to be understood that more, or less, than two layers may be implemented. In at least one embodiment, the inner layer 204 may comprise of stiff materials. An example of a stiff material may be a nylon material of a certain thickness. The outer layer 202 may comprise of softer materials, when compared to materials used for the inner layer. For example, the outer layer may comprise of Pebax materials of a certain thickness. As described above, the two-layer construction may allow for smaller overall wall thickness, improved handling, and reduced post occlusion surge and pump pulsations.

[0043] The multi-layer tubing design illustrated may be produced using a coextrusion technique common in the plastics processing industry. The construction may also help the socket bonding capability of the tubing due to its soft outer layer which will conform better to the geometry of the fitting compared to a single layer hard tubing material.

[0044] FIG. 3 illustrates a test matrix 300 of a two-layer tubing construction in accordance with at least one embodiment of the disclosed invention. In view of matrix 300, a total of six samples each of three types of aspiration tubing were tested. In the example, a stiff inner layer thickness was tested by varying the durometer of PVC tubing. In this example, occlusion surge response was tested on a WHITESTAR SIGNATURE PRO system with A, B, and C tubing samples inside a rigid eye chamber model with an attached pressure sensor. The occlusion was simulated for approximately three seconds each. Data was collected for IOP (mmHg) and time (milliseconds) using Data Acquisition System via LabVIEW software from National Instruments. For data analysis, an average change in IOP (Delta IOP) for occlusion surge was determined.

[0045] FIG. 4 illustrates a result summary 400 of test matrix 300. Result summary 400 shows the delta IOP surge response for the different tubing types of test matrix 300 of a two-layer tubing construction in accordance with at least one embodiment of the disclosed invention. In this illustrative example, the lower the delta IOP, the better the surge response. In the provided example, a single wall/material tubing produced the highest Delta IOP. The stiffest inner layer tubing type, group C, reduced the surge by 36 percent. The stiffer material with reduced compliance helped reduce pressure drop as the stiffer tubing wall helped dampen surge.

[0046] FIG. 5 shows graph 500 that illustrates a POS response comparison for different types of tubing constructions, including two-layer tubing constructions in accordance with at least one embodiment of the disclosed invention. As shown, part 502 of the graph indicates steady state bottle pressure. At step 504, the aspiration tubing is occluded. At step 506, the occlusion has been released. At step 508, Delta IOP can be measured in mmHg. At step 510, the foot pedal of the surgical system is released. It can be observed that not only is the Delta IOP reduced with a stiffer inner layer but also overall peak to trough. The pulsation after the surge is also dampened when comparing single layer A peak to trough 512 to multilayer group B peak to trough 511 and C peak to trough 513.

[0047] Based on ISO 10619-1_2017 standard, testing was performed on four different types of tubing for measuring flexibility of plastic tubing. The testing setup is shown in FIG. 6. The testing involved folding a piece of tubing 602 in half until a certain gap C is reached between segments 602a and 602b of tubing 602 using a first plate 604 and second plate 606, and measuring the force needed to cause the bend (F.sub.peak) using a force gauge (not shown) known in the art. It is at this point that the tubing is in a “kinked” state. In the present testing method, the gap was measured as 0.508″. The gap was decided based on the observation that as the tubing is compressed together between the two flat plates, it is fully kinked when the inner diameter was collapsed. To compare the flexibility of the various tubing samples, this gap was kept constant at 0.508 inches. Based on the following measurements, the multilayer tubing design of the present invention has the lowest forces. The more flexible the tubing, the lower the force. The results of the testing are set forth below in Table 1.

TABLE-US-00001 TABLE 1 Gap Between the two Nominal Nominal Nominal segments of Peak Force OD of the ID of the Wall Wall the tubing when Kinked Tubing Tubing Thk. Profile Present Gap = 0.508″ F.sub.peak = 0.435 lbf 0.148 0.050 0.049 Double Invention Wall Aspiration Tubing OPO73 Gap = 0.508″ F.sub.peak = 0.905 lbf 0.148 0.056 0.046 Single Aspiration Wall Tubing Third Party 1 Gap = 0.508″ F.sub.peak = 1.750 lbf 0.152 0.048 0.052 Single Aspiration Wall Tubing Third Party 2 Gap = 0.508″ F.sub.peak = 0.875 lbf 0.125 0.056 0.033 Single Aspiration Wall Tubing

[0048] In another embodiment of the disclosed invention, the aspiration tubing may comprise more than two layers. For example, the thickness of each layer may vary among the multiple layers across a cross section to achieve the results described herein. Further, the hardness of the material may be adjusted in each of the layers to achieve the results described herein.

[0049] In yet another embodiment of the disclosed invention, a multi-layer tubing construction may be applied similarly to an irrigation tubing system of a phacoemulsification surgical system. The disclosed embodiments of FIGS. 2A and 2B are not limited to aspiration tubing, but merely shown as illustrative examples. For example, an irrigation tubing may be comprised of an inner layer and an outer layer, as shown in cross-sectional views of FIGS. 2A and 2B.

[0050] Those of skill in the art will appreciate that the herein described apparatuses, engines, devices, systems and methods are susceptible to various modifications and alternative constructions. There is no intention to limit the scope of the invention to the specific constructions described herein. Rather, the herein described systems and methods are intended to cover all modifications, alternative constructions, and equivalents falling within the scope and spirit of the disclosure, any appended claims and any equivalents thereto.

[0051] In the foregoing detailed description, it may be that various features are grouped together in individual embodiments for the purpose of brevity in the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that any subsequently claimed embodiments require more features than are expressly recited.

[0052] Further, the descriptions of the disclosure are provided to enable any person skilled in the art to make or use the disclosed embodiments. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other variations without departing from the spirit or scope of the disclosure. Thus, the disclosure is not intended to be limited to the examples and designs described herein, but rather are to be accorded the widest scope consistent with the principles and novel features disclosed herein.