Retractable backflush device

Abstract

Improve the retractable backflush device. [Solution] A particular embodiment provides a device comprising a handpiece, an outer tube connected to the handpiece, an inner tube housed within the outer tube and having a distal end connected to a flexible tip and a proximal end connected to an adapter, a proximal end of an adapter connected to the distal end of a valve, a valve slidably connected to the handpiece, and a core slidably connected to the handpiece and having a distal end connected to the proximal end of the valve. To retract the flexible tip, the valve is retracted, causing the adapter, valve, and core to slidably retract in the proximal direction relative to the handpiece, and to extend the flexible tip, the valve is extended, causing the adapter, valve, and core to slidably protrude in the distal direction relative to the handpiece.

Description

Technical Field

[0001] Priority Claim This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 126,823, entitled "A RETRACTABLE BACKFLUSH INSTRUMENT," filed on December 17, 2021, with inventors Reto Grueebler, Simon Nicola Kunz, Niccolo Maschio, and Christoph Siegenthaler, and the entire disclosure of which is incorporated herein by reference as if fully and completely set forth herein.

[0002] The present disclosure generally relates to retractable backflush instruments.

Background Art

[0003] Backflush instruments are generally used during surgery (e.g., ophthalmic surgery) to vacuum-aspirate or aspirate fluids (e.g., equilibrium salt solution (BSS), silicone oil, perfluorocarbon (PFC)) from a body site (e.g., a patient's eye). For example, during certain ophthalmic surgeries, backflush instruments may be used for fluid extraction, internal drainage of subretinal fluid, retinal fold manipulation, and simultaneous or sequential exchange (e.g., liquid / air, air / gas, liquid / gas, liquid / PFC, PFC / gas, etc.). Certain backflush instruments include a soft distal tip to ensure that the body site or any tissue within the body site is not damaged when the backflush instrument comes into contact with the body site or tissue. In one example, as part of surgery, the backflush instrument is inserted into a cannula, such as a valved cannula, to introduce the backflush instrument into the body site. However, inserting a backflush instrument with a soft tip into a cannula can be difficult and may damage the backflush instrument. For example, when a backflush device is inserted through the valve of a valved cannula, the flexible tip may bend and become stuck inside the trocar cannula, making it impossible to move. In some cases, if the flexible tip bends excessively, it may even shear the backflush device. [Overview of the project]

[0004] This disclosure relates, in general terms, to a retractable backflush device.

[0005] A particular embodiment described herein provides a device comprising: a handpiece; an outer tube having a proximal end connected to the distal end of the handpiece; an inner tube housed within the outer tube and having a distal end connected to a flexible tip and a proximal end connected to an adapter, wherein in the fully extended state, the flexible tip extends at least partially beyond the distal end of the outer tube; an adapter slidably connected to the distal end of the handpiece and having a proximal end connected to the distal end of a valve and a distal end connected to the proximal end of the inner tube; a valve housed inside the handpiece and having a distal end connected to the proximal end of the adapter; and a core housed within the handpiece and slidably connected, having a distal end connected to the proximal end of the valve. To retract the flexible tip, the valve is retracted, and the adapter, valve, and core are moved back so that they can slide proximally relative to the handpiece. To extend the flexible tip, the valve is extended, and the adapter, valve, and core are extended so that they can slide distally relative to the handpiece.

[0006] The following description and related drawings detail specific exemplary features of one or more embodiments.

[0007] The accompanying drawings illustrate specific aspects of one or more embodiments and should therefore not be considered to limit the scope of this disclosure. [Brief explanation of the drawing]

[0008] [Figure 1] An example of a conventional backflush device is shown in the diagram. [Figure 2A] The following illustrates exemplary retractable backflush devices according to several embodiments. [Figure 2B] Cross-sectional views of the backflush device shown in Figure 2A in an extended state, according to several embodiments, are illustrated. [Figure 2C] This is an enlarged cross-sectional view of the distal portion of Figure 2B, illustrating the extended soft tip in several embodiments. [Figure 2D]This is a cross-sectional view taken along the cutting line 2D-2D in Figure 2B, which shows the inside of a backflush device. [Figure 3A] Cross-sectional views of the backflush device shown in Figure 2A in the retracted position, according to several embodiments, are illustrated. [Figure 3B] This is an enlarged cross-sectional view of the distal portion of Figure 3A, illustrating the retracted soft tip in several embodiments. [Modes for carrying out the invention]

[0009] To facilitate understanding, the same reference numerals are used whenever possible to indicate identical elements common to each drawing. Elements and features of one embodiment are intended to be usefully incorporated into other embodiments without further explanation.

[0010] A part of this disclosure provides a retractable backflush device.

[0011] As described above, inserting a backflush instrument with a flexible tip into a cannula such as a valved cannula can be difficult and may damage the flexible tip of the backflush instrument. The specific embodiments described in this disclosure attempt to overcome these shortcomings by providing a sliding valve for retracting the flexible tip before insertion of the instrument into a valved cannula, thereby preventing the flexible tip from bending or being damaged during insertion.

[0012] Figure 1 illustrates a prior art example of a backflushing device 100, which includes a connector 101, a handpiece 102, an outer tube 105, and a flexible tip 106 extending beyond the distal end of the outer tube 105. The flexible tip 106 of the backflushing device 100 is not retractable. The proximal end of the outer tube 105 is connected to a cap 107 located at the distal end of the handpiece 102. The cap 107 is hose-like and connected to a valve 103 which is connected directly or indirectly (for example, via several other elements within the handpiece 102) to the connector 101. As a result, the valve 103 provides a fluid connection between the outer tube 105 and the connector 101. The valve 103 also includes a hole 104, which has a different function depending on the mode in which the backflushing device 100 is operating. For example, the backflushing device 100 may be used in active suction mode or passive suction mode, as described below.

[0013] In this specification, various components are described in terms of specific shapes (such as hose-like or cylindrical), but it should be noted that components may take on other similar suitable shapes as will be understood by those skilled in the art.

[0014] The connector 101 connects the handpiece 102 to a surgical console equipped with a suction and / or cleaning mechanism. In one example, a user, such as a surgeon, uses the handpiece 102 to guide the tip of the backflush instrument 100, which includes an outer tube 105 and a flexible tip 106, into a body site, at least partially through a cannula. Once inside the body site, the backflush instrument 100 performs specific actions, such as vacuum aspiration or suction of a substance (e.g., BSS, oil, or other fluid) from the body site. During such actions, the fluid flows through the connector 101, the valve 103, and the outer tube 105.

[0015] As described above, in certain embodiments, the backflush device 100 may have two operating modes: active suction mode and passive suction mode. In active suction mode, the backflush device 100 may be connected via connector 101 to a surgical console capable of actively aspirating fluid. In active suction mode, the surgeon covers the hole 104 (for example, with a finger) to prevent air from being aspirated through the hole 104.

[0016] In passive suction mode, the backflush instrument 100 is used without being connected to a surgical console via the connector 101. In such embodiments, because the pressure within a body part (e.g., the patient's eye) is higher than atmospheric pressure, when the surgeon inserts the backflush instrument 100 into the body part, fluid can flow from the body part into the backflush instrument 100 and out through the hole 104. In other words, in passive suction mode, the hole 104 can be used as a fluid outlet.

[0017] The outer tube 105 is typically made of a rigid material such as metal (e.g., stainless steel). The flexible tip 106 is typically made of a soft, flexible material (e.g., silicone, rubber, polyurethane (PUR)) to avoid damaging the body part that the backflush instrument 100 comes into contact with. However, it can be difficult or impossible for a surgeon to insert the backflush instrument 100 with the flexible tip 106 into a valved cannula. This difficulty or impossibility stems from the fact that when the tip of the backflush instrument 100 is pushed through the valve of the valved cannula, the valve can exert a sufficient counterforce on the flexible tip 106 to bend it. In some cases, if the surgeon forcibly pushes the bent flexible tip 106 into the cannula, the flexible tip 106 may even separate or shear from the outer tube 105.

[0018] Accordingly, certain embodiments of the present disclosure provide a backflush instrument having a retractable flexible tip attached to a cylindrical hollow inner tube (e.g., inner tube 212 shown in Figure 2B). Using such a backflush instrument, a surgeon can retract the inner tube of the backflush instrument before pushing it through a valved cannula, thereby eliminating or reducing the possibility that the tip of the inner tube (e.g., flexible tip 106) may bend or shear when inserted into the valved cannula.

[0019] Figure 2A illustrates an exemplary retractable backflush device 200 according to a particular embodiment of the present disclosure. Figure 2B illustrates an exemplary cross-sectional view of the backflush device 200. Figure 2C is an enlarged cross-sectional view of the distal portion of Figure 2B, showing the extended flexible tip 206. Figure 2D is a cross-sectional view taken along the cutting line 2D-2D of Figure 2B, showing the interior of the backflush device 200 along the longitudinal axis of the handpiece 202. Therefore, for clarity, Figures 2A to 2D are described together in this specification.

[0020] As shown in the figure, the backflushing instrument 200 includes a valve 203 housed inside the handpiece 202 and configured to slide relative to the handpiece 202. The valve 203 is connected to an adapter 208 which is connected to the proximal end of the inner tube 212. The valve 203 is configured to be pulled proximal to the handpiece 202 (for example, by the user's fingers) to retract the soft tip 206. The valve 203 is further configured to be pressed distally to the handpiece 202 (for example, by the user's fingers) to extend the soft tip 206. In certain embodiments, the surgeon grasps the valve 203 directly to pull or press it. The actions of pulling and pressing the valve 203 described above may be referred to as manual retraction and manual extension, respectively.

[0021] As shown in FIGS. 2A and 2B, the valve 203 is in a fully extended state such that the flexible tip 206 extends at least partially beyond the distal end of the outer tube 205. By retracting the valve 203, the inner tube retracts in the proximal direction, whereby the flexible tip 206 retracts so that when fully retracted, the flexible tip 206 does not extend beyond the distal end of the outer tube 205. The surgeon places a finger (e.g., the thumb) on the valve 203 itself to retract and protrude the valve 203, so that while retracting and extending the flexible tip 206, the pressure can be controlled by covering and uncovering the hole 204 (e.g., with a finger). Using this mechanism, the surgeon can retract the flexible tip 206, such as before pushing the backflush instrument 200 through the valved cannula, thereby eliminating or reducing the potential for damage to the flexible tip 206. After pushing the backflush instrument 200 through the valved cannula, the surgeon can extend the flexible tip 206 to allow for safe contact with the tissue.

[0022] As shown in Figure 2B, with a fully extended flexible tip 206, the handpiece 202 includes a valve 203, which is connected to an adapter 208 at the distal end of the valve 203 and further connected to a core 215 at the proximal end of the valve 203. The adapter 208 is slidably connected to the proximal end of a cap 207. As used herein, the distal end of the handpiece 202 includes at least the cap 207. The distal end of the adapter 208 is connected to the proximal end of an inner tube 212, and the distal end of the inner tube 212 is connected to a flexible tip 206 that extends beyond the distal end of an outer tube 205 (Figure 2C). More specifically, at the distal end of the adapter 208, the adapter 208 includes a cylindrical element 211 configured to accommodate the proximal end of the inner tube 212. In certain embodiments, the distal end of the cylindrical element 211 has a shape corresponding to the inner contour of the cap 207 for maintaining alignment between the adapter 208 and the handpiece 202 during the sliding of the adapter 208. In certain embodiments, the inner tube 212 and the cylindrical element 211 are joined to each other using adhesive. In certain embodiments, the inner tube 212 and the cylindrical element 211 are joined to each other using insert molding technology. In certain embodiments, the proximal end of the inner tube 212 is press-fitted into the cylindrical element 211. In certain embodiments, the inner tube 212 may be made of polyimide or steel. Polyimide can be manufactured with a thinner wall thickness, resulting in an inner tube 212 with a larger inner diameter that allows for greater flow. Steel, on the other hand, results in an inner tube 212 with greater overall stiffness that resists bending better.

[0023] At the proximal end of the adapter 208, the adapter 208 is connected to the distal end of the valve 203, which can be tubular or hose-like as described above. As shown in the figure, the proximal end of the adapter 208 includes a cylindrical insertion body 210 configured to be inserted into the distal end of the valve 203. In certain embodiments, the cylindrical insertion body 210 and the valve 203 are connected to each other using an adhesive. In certain embodiments, the cylindrical insertion body 210 is press-fitted into the valve 203. The adapter 208 includes a disk 223 surrounding the adapter 208. The disk 223 functions as an end stopper for the adapter 208. In the fully extended position (FIG. 2B), the disk 223 is configured to contact a plurality of notches 226 formed in the inner contour of the cap 207 to limit the distal sliding of the adapter 208 relative to the handpiece 202, thereby preventing the flexible tip 206 from extending excessively beyond the distal end of the outer tube 205.

[0024] As further shown in FIG. 2B, at the proximal end of the valve 203, the valve 203 is connected to the distal end 214 of a core 215 slidably connected to the handpiece 202. The distal end 214 of the core 215 is configured to be inserted into the proximal end of the valve 203. At the proximal end 213 of the core 215, the core 215 is configured to be connected to a connector (e.g., connector 101) for connecting the handpiece 202 to the surgical console.

[0025] During operation, by retracting the valve 203 in the proximal direction, the valve 203, the core 215, the adapter 208, and thus the flexible tip 206 can slide rearwardly in the proximal direction relative to the handpiece 202. The fully retracted state is illustrated in more detail by FIGS. 3A and 3B. To extend the flexible tip 206, by protruding the valve 203 in the distal direction, the valve 203, the core 215, the adapter 208, and thus the flexible tip 206 can slide distally and extend relative to the handpiece 202.

[0026] As described above, the adapter 208 and core 215 are configured to slide retract and protrude relative to the handpiece 202 together with the valve 203. However, the adapter 208 and core 215 are flexible and indirectly connected to each other via the valve 203, which is made of a flexible material. In other words, rather than forming a rigid connection between the adapter 208 and the core 215, the valve 203 can bend and / or extend to accommodate misalignment between the cap 207 and the handpiece 202 and / or core 215. The flexible material of the valve 203 allows the adapter 208 to tilt relative to the core 215 so that the adapter 208 can self-align within the inner contour of the cap 207. Thus, the alignment of the adapter 208 relative to the cap 207 is independent of the alignment of the core 215 and the cap 207. As described herein, the cap 207 is connected to the outer tube 205, and the adapter 208 is connected to the inner tube 212. Therefore, the alignment of the inner tube 212 and the outer tube 205 directly depends on the alignment of the adapter 208 and the cap 207. Accordingly, the flexible and indirect connection between the adapter 208 and the core 215 described herein reduces friction and sticking of the inner tube 212 as it slides within the outer tube 205 by improving the alignment of the adapter 208 and the core 215.

[0027] As will be described in more detail below, in the fully protruding position, the core 215 has an end stopper that contacts the handpiece 202, separate from the end stopper provided between the adapter 208 and the cap 207. The end stopper mechanism associated with the core 215 refers to the distal end of a projection 220 formed on a slider 217 that contacts the distal shoulder 224 of a channel 221 formed within the handpiece 202, as will be described further below with respect to Figure 2B. The end stopper provided between the adapter 208 and the cap 207 refers to a disc 223 of the adapter 208 that contacts a plurality of notches 226 formed in the inner contour of the cap 207, as described above with respect to Figure 2B. The end stoppers of the adapter 208 and the core 215, which restrict the distal movement of their respective components relative to the handpiece 202, are separated from each other. The detachment of the end stopper allows for displacement of the cap 207 relative to the handpiece 202 and / or core 215, as described above, while also allowing the end stopper provided by the core 215 to give the user a predetermined sensation of the end stopper when it has moved to the fully protruding position.

[0028] As further shown in Figure 2B, at the distal end of the core 215, the core 215 is connected to a slider 217 configured to slidably support the valve 203. Details of the slider 217 are clearly depicted in Figure 2D, which shows a cross-sectional view taken along the cutting line 2D-2D in Figure 2B. The slider 217 includes a body portion 218 and a pair of side walls 219 extending longitudinally from the proximal end of the body portion 218 to the distal end 214 of the core 215. A slot 222 is formed between the pair of side walls 219 to receive the substantially square base 209 of the valve 203. The slot 222 houses the square base 209 of the valve 203 to prevent relative movement between the valve 203 and the slider 217. For example, the valve 203 may be prevented from rotating or being excessively pushed down into the handpiece 202.

[0029] As further shown in Figure 2B, in certain embodiments, the projection 220 extends radially from the main body portion 218 and is received within a channel 221 formed in the handpiece 202. The projection 220 and the corresponding channel 221 are configured to help maintain rotational alignment and to prevent snagging during the sliding of the slider 217, valve 203, and core 215 relative to the handpiece 202. The projection 220 and the corresponding channel 221 are configured to limit the range of sliding of the slider 217, valve 203, and core 215 relative to the handpiece 202. More specifically, when the valve 203 is fully extended, the distal end of the projection 220 contacts the distal shoulder 224 of the channel 221, thereby preventing further distal sliding of the slider 217, valve 203, and core 215 relative to the handpiece 202 (Figure 2B). Furthermore, when the valve 203 is fully retracted, the proximal end of the projection 220 contacts the proximal shoulder 225 of the channel 221, preventing further proximal sliding of the slider 217, valve 203, adapter 208, and core 215 relative to the handpiece 202 (Figure 3A).

[0030] Figure 2B shows the adapter 208 and valve 203 as separate components, but in certain embodiments, the adapter 208 and valve 203 may be manufactured as a single part. For example, both the adapter 208 and valve 203 may be made from the same material. In another example, the adapter 208 and valve 203 may be manufactured by a two-component injection molding process. Also, Figure 2B shows the core 215 and slider 217 manufactured as a single part, but in certain embodiments, the core 215 and slider 217 may be manufactured as separate parts. Note that whether the core 215 and slider 217 are manufactured as different parts or as the same part, they are considered to be connected to each other in this specification. Also, Figure 2C shows the flexible tip 206 and inner tube 212 as separate components that are attached to each other, but in certain embodiments, the inner tube 212 and flexible tip 206 may be manufactured as a single part using the same material. In such embodiments, the inner tube 212 may also be made of a flexible and soft material (e.g., silicone, PUR, etc.). Note that the inner tube 212 and the soft tip 206 are considered to be connected to each other in this specification, regardless of whether they are manufactured as separate parts or as the same part.

[0031] Figure 3A shows an exemplary cross-sectional view of the backflush device 200 in its fully retracted position. As shown in Figure 3A, the retraction of the valve 203 in the proximal direction causes the valve 203, adapter 208, core 215, and slider 217 to slide proximal relative to the handpiece 202. In the fully retracted position, the proximal end 213 of the core 215 extends further outward in the proximal direction relative to the handpiece 202 compared to the fully extended position (Figure 2B). As shown in Figure 3A, the proximal end of the projection 220 contacts the proximal shoulder 225 of the channel 221, preventing further proximal sliding of the valve 203, adapter 208, core 215, and slider 217 relative to the handpiece 202. The length of the channel 221 is configured so that the adapter 208 does not completely disengage from the inner contour of the cap 207. In other words, the protrusion 220 contacts the proximal shoulder 225 before the adapter 208 detaches from the cap 207, which could cause the adapter 208 to snag. As shown in Figure 3B, the flexible tip 206 is fully retracted into the outer tube 205.

[0032] The illustrated embodiment shows the extension of the flexible tip 206 resulting from the manual protrusion of the valve 203, adapter 208, and core 215, but in some other embodiments, the protrusion of the valve 203 is actuated by energy accumulated during the retraction step. For example, in certain embodiments, the valve 203 is compressed by retracting it proximal, and the valve 203 is made of a flexible and / or compressible material. For example, the valve 203 may be made of silicone. In certain embodiments, the compression of the valve 203 may occur along a portion of the valve 203 located between the hole 204 and the proximal end of the valve 203. Thus, when the retracted valve 203 is released, the valve 203 automatically restores itself (for example, based on spring force), pushing the valve 203, adapter 208, and core 215 back to their original positions, thereby causing the flexible tip 206 of the inner tube 212 to extend beyond the distal end of the outer tube 205, as shown in Figure 2C. In some other embodiments, the backflush device may be configured to have a valve 203, an adapter 208, and a spring (e.g., a coil spring) for propelling the core 215. For example, the spring may be positioned between a portion of the handpiece 202 and one of the core 215, slider 217, or projection 220 to bias the core 215 distally relative to the handpiece 202.

[0033] The foregoing description is provided to enable those skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments. Therefore, the claims are not intended to be limited to the embodiments shown herein, but rather the entire scope consistent with the language of the claims should be recognized.

Claims

1. A device used in ophthalmic surgical procedures, Handpiece and An outer tube having a proximal end connected to the distal end of the handpiece, An inner tube housed within the outer tube, having a distal end connected to a flexible tip and a proximal end connected to an adapter, wherein in a fully extended state, the flexible tip extends at least partially beyond the distal end of the outer tube, The adapter is slidably connected to the distal end of the handpiece, and has a proximal end connected to the distal end of the valve and a distal end connected to the proximal end of the inner tube. The valve is housed inside the handpiece and has a distal end connected to the proximal end of the adapter, A core housed in and slidably connected to the handpiece, having a distal end connected to the proximal end of the valve, and Includes, In order to retract the soft tip, the valve is retracted, and the adapter, the valve, and the core are moved back so that they can slide proximal to the handpiece. In order to extend the soft tip, the valve is made to protrude, and the adapter, the valve, and the core are made to protrude distally from the handpiece. Device.

2. The apparatus according to claim 1, wherein the distal end of the core is configured to be inserted into the proximal end of the valve, and the proximal end of the core is configured to be connected to a connector for connecting the handpiece to a surgical console.

3. The present invention further includes a slider configured to slidably support the valve, the slider being A main body portion located below the aforementioned valve, A pair of side walls extending longitudinally from the proximal end of the main body portion to the distal end of the core, The apparatus according to claim 2, including the following:

4. The apparatus according to claim 3, wherein a slot is formed between the pair of side walls, and the slot is configured to house the base of the valve to prevent relative movement between the valve and the slider.

5. The apparatus according to claim 3, wherein the slider further includes a projection extending from the main body portion, the projection being received in a channel formed within the handpiece to restrict the longitudinal extension and retraction of the flexible tip.

6. The apparatus according to claim 5, wherein the channel formed in the handpiece has shoulders formed at both longitudinal ends of the channel, and the contact between the protrusion and each of the shoulders is configured to restrict the extension and retraction of the soft tip.

7. The apparatus according to claim 5, wherein, in the fully extended state, the distal end of the projection contacts the distal shoulder of the channel, preventing further sliding of the valve and the core in the distal direction relative to the handpiece, and in the fully retracted state, the proximal end of the projection contacts the proximal shoulder of the channel, preventing further sliding of the adapter, the valve and the core in the proximal direction relative to the handpiece.

8. The apparatus according to claim 1, wherein the apparatus includes a backflash device.

9. The aforementioned adapter is A cylindrical insert configured to be inserted into the distal end of the valve, A cylindrical element configured to accommodate the proximal end of the inner tube and The apparatus according to claim 1, including the following:

10. The apparatus according to claim 9, wherein the distal end of the cylindrical element has a shape corresponding to the inner contour of a cap for maintaining the alignment between the adapter and the handpiece during the sliding of the adapter.

11. The apparatus according to claim 1, wherein the pressure is controlled by retracting and extending the valve.

12. The apparatus according to claim 1, further comprising a cap having a plurality of notches formed in the inner contour of the cap, wherein a disc surrounding the adapter is configured to contact the plurality of notches and restrict the distal sliding of the adapter relative to the handpiece.

13. The apparatus according to claim 12, wherein the adapter and the core are flexibly and indirectly connected to each other, and the flexibly and indirect connection is configured to allow the adapter to tilt relative to the core so as to self-align the adapter within the inner contour of the cap.

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