Vibration-reduced vitrectomy probe

Abstract

Vitrectomy probe with combined vibration damping and attenuation. The probe may include various features to reduce vibrations felt by the surgeon during a vitrectomy procedure. These may include minimizing the amount of flow restriction within the housing and facilitating pneumatic reciprocation of the cutter. Additionally, using a softer stop on the diaphragm that drives the reciprocation of the cutter may be advantageous because it reduces compressive forces on the extension tube coupled to the diaphragm by the seal as effectively as possible. The use of softer gripping components that are actually held by the surgeon may be advantageous in terms of vibration attenuation.

Description

[Technical field]

[0001] Claiming priority This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 900,756, entitled "REDUCED VIBRATION VITRECTOMY PROBE," filed September 16, 2019, inventors Nathaniel Reyes and John R. Underwood, which is incorporated by reference in its entirety as if fully and completely set forth herein. [Background technology]

[0002] Over the years, many dramatic advances have occurred in the field of retinal ophthalmic surgery. However, regardless of the particular retinal procedure, at least a portion of the procedure typically includes a vitrectomy. Vitrectomy is the removal of some or all of the vitreous humor from the patient's eye. In some cases, where the surgery is limited to removing cloudy vitreous humor, the vitrectomy may comprise the majority of the procedure. However, vitrectomy may also be accompanied by surgery to address cataract surgery, retinal repair surgery, macular fold formation, or many other issues.

[0003] The vitreous humor itself is a clear gel that can be removed by an elongated probe when the probe is inserted through a cannula that has been previously placed in the eye. More specifically, the probe includes a central channel for removing the vitreous humor. Additionally, the cannula provides a conduit for structural support that is strategically located at an offset location in the front of the eye, such as the pars plana. In this manner, the probe may be guided into the eye in a manner that avoids damage to the patient's lens or cornea.

[0004] Unfortunately, removal of the vitreous humor requires greater care than simply applying a vacuum through the channels of the probe. This is because the vitreous humor contains a fibrous matrix of collagen fibrils. Thus, simply applying a vacuum to the gel puts the surrounding ocular structures at risk; the fibrous nature of the gel is such that drawing the gel into the probe by vacuum can translate into traction on the retina, optic nerve, or other delicate ocular structures.

[0005] To address this issue, the vitrectomy probe is configured to cut the vitreous humor as it is drawn into the probe's channel. In this way, the continuous fibrillary pulling of the gel-like material does not translate into traction of delicate ocular structures. Instead, the vitreous humor is drawn into the probe's channel in very small, chopped segments. This chipping or cutting of the vitreous humor occurs by the reciprocating motion of the cutter inside the probe's channel. More specifically, the cutter reciprocates back and forth at the port for receiving the vitreous humor in a manner that cuts the material as it is drawn into the channel. Perhaps 5,000 to 10,000 cycles of cutting per minute may be performed in this manner to protect the eye from traction by the vitreous humor as it is removed. In fact, the faster the reciprocating motion of the cutter, the greater the degree to which cutting of the vitreous humor occurs with less traction. Thus, as described, a greater degree of protection is provided to the patient's delicate ocular features.

[0006] Accordingly, the reciprocating motion of the cutter has become faster over the past few years, thus eliminating most of the concern about "pulling" the vitreous humor during the vitrectomy procedure. However, this reciprocating motion of the cutter means that vibrations are naturally transmitted through the vitrectomy probe during the vitrectomy. Thus, surgeons performing the procedure manually face the potential for vibration-related distraction while maneuvering the probe in tight, delicate spaces. Summary of the Invention [Means for solving the problem]

[0007] A vitrectomy probe is disclosed. In one embodiment, the probe includes a component housing. A diaphragm within a chamber of the housing is configured to reciprocate at a rate of at least about 2,500 cuts per minute (cpm) during a vitrectomy procedure, the reciprocating motion including the diaphragm repeatedly impacting a wall defining the chamber. First and second channels of air are used to reciprocate the diaphragm on its first and second sides, the channels having a flow rate of at least about 0.00275 in to minimize flow restriction to dampen the impacts and to facilitate air pressures of less than about 50 pounds per square inch (PSI). 2 It has a volume of.

[0008] In another embodiment, the probe includes a component housing having an extension tube disposed within a channel thereof for reciprocating motion in response to alternating supply of air pressure during a vitrectomy procedure, thereby facilitating cutting of the vitreous humor. A first sealing ring around the extension tubing exerts a first compressive load on the tube to seal the channel from air pressure inducing the reciprocating motion. At the same time, a second sealing ring around the extension tube exerts a second compressive load on the tube to seal the channel from vacuum. The second compressive load is significantly less than the first compressive load to reduce the amount of air pressure used for the reciprocating motion. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is an exploded perspective view of one embodiment of a vibration reduced vitrectomy probe. [Diagram 2] FIG. 2 is a perspective view of the vibration reduced vitrectomy probe in assembled form. [Figure 3A-3B] FIG. 3A is a side cross-sectional view of one embodiment of an inner rear housing component of the vitreous resection probe of FIG. 2 having stepped channeling, and FIG. 3B is a side cross-sectional view of a prior art inner rear housing component of a vitreous resection probe using conventional uniform channeling. [Figure 4] FIG. 4 is a side cross-sectional view of the inner rear housing of FIGS. 3A and 3B secured to the inner front housing and housing the extension tube in a friction-reducing manner. [Diagram 5] FIG. 5 is an overview of one embodiment of a vitrectomy procedure performed by the vitrectomy probe of FIG. [Figure 6] FIG. 6 is a flow chart summarizing one embodiment of using a vibration reduced vitrectomy probe in a surgical procedure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] In the following description, numerous details are set forth to provide an understanding of the present disclosure. However, it will be understood by those skilled in the art that the described embodiments may be practiced without these specific details. Moreover, numerous variations or modifications may be employed that are still contemplated in the specifically described embodiments.

[0011] The embodiments are described with reference to one particular type of vitrectomy probe surgical procedure. In particular, a procedure for removing vitreous fluid to address vitreous hemorrhage is shown. However, the instruments and techniques detailed herein may be used in a variety of other procedures. For example, the vitrectomy probe embodiments detailed herein may be used to address retinal detachment, macular fold formation, macular holes, vitreous floaters, diabetic retinopathy, or a variety of other ocular conditions. In any case, to the extent that the vitrectomy probe incorporates the vibration reduction features detailed herein, substantial benefits may be realized.

[0012] 1, an exploded perspective view of one embodiment of a vibration-reduced vitrectomy probe 100 is shown. Various features are incorporated into the probe 100 for vibration reduction purposes as discussed above. For example, a gripping component 150 is provided that provides enhanced ergonomics. Providing a soft-touch feature can help attenuate and minimize the amount of vibration that reaches the surgeon, particularly given that this component 150 is in direct contact with the surgeon's hand during the vitrectomy procedure. For example, in the illustrated embodiment, the gripping component can be made of a conventional elastomer having a hardness of less than about 60 Shore A. This is in stark contrast to conventional gripping components, which are typically hard polycarbonate overmolded.

[0013] In another variation from conventional gripping components, the illustrated components 150 may be of reduced diameter, less than about 0.5 inches. The small diameter, combined with the soft-feel gripping components 150, may allow for finer fingertip control with more room for complex manipulation by hand.

[0014] In addition to the gripping component 150, various other vibration reducing features are incorporated into the probe 100. For example, continuing with the idea of ​​selecting a softer material, the illustrated diaphragm 130 reciprocates between the housing components 160 and 165 of the probe housing 140, ultimately driving the movement of the cutter 173 within the needle 175. During this reciprocating motion of the diaphragm 130, the diaphragm 130 repeatedly impacts each of the housing components 160, 165. More specifically, the separate stops 450 of the diaphragm 130 may repeatedly strike the housing components 160, 165, resulting in the aforementioned vibrations (see FIG. 4). Nevertheless, in one embodiment, the stops 450 are made of soft silicone rubber or other suitable material having a hardness of less than about 60 Shore A. Thus, vibrations may not only be attenuated, but may also only occur to a small extent in the first place.

[0015] 1, at one end of the probe 100 is shown an ergonomic shell 125 that can rest in the surgeon's hand during a vitrectomy procedure. Near the other end of the probe 100 is shown a coupling 170 secured over a cutter 173 in front of the forward housing component 165. Rearward of the forward housing component 165, however, is an extension tube 110 that houses the cutter 173 during a vitrectomy procedure. As will be described in more detail below, the extension tube 110 is uniquely configured to reduce friction during reciprocation. As a result, the amount of force required to reciprocate the diaphragm 130 and tube 110 is reduced such that the impact of the diaphragm 130 repeatedly striking each of the housing components 160, 165 is further dampened.

[0016] 2, there is shown a perspective view of the vibration reduced vitrectomy probe 100 in an assembled form. In this view, a port 277 for drawing vitreous fluid into the needle 175 of the probe 100 is shown forward of the soft-touch gripping component 150. This component 150 is secured to the housing 140 by a shell 125 that is also mounted on the housing 140. Thus, from the surgeon's perspective, a one-piece handheld surgical instrument is provided that reduces distraction due to vibration.

[0017] In terms of reducing surgeon distraction due to vibration, another feature is provided that is not readily apparent from the outline view of the probe 100. Specifically, FIG. 3A is a side cross-sectional view of one embodiment of the inner rear housing component 160 of the vitreous resection probe of FIG. 2 having stepped channeling 315. That is, the reciprocating motion of the diaphragm 130 of FIG. 1 is achieved by air pressure being alternately induced on either side of the diaphragm 130. More specifically, with further reference to FIG. 1, air passing through the lower chamber 330 may be induced on the dorsal side of the diaphragm 130, pushing the extension tube 110 forward and advancing the cutter 173. Alternatively, air passing through the upper chamber 325 may be ultimately routed to the front side of the diaphragm 130, ultimately forcing the cutter 173 away from the end of the needle 175.

[0018] For the additional pathway involving the upper chamber 325, air reaching the front side opposite the diaphragm 130, the conventional structure would provide a uniform channel 327 in the rear housing 160 (see FIG. 3B). However, with respect to the embodiment of FIG. 3A, this type of channeling is replaced with stepped channeling 315 to substantially avoid presenting a flow restriction. Thus, the diaphragm 130 of FIG. 1 can be reciprocated rearwardly with a lower air pressure without compromising the overall speed of reciprocation. For example, in one embodiment, the stepped channeling 315 as shown allows for the application of less than 50 PSI while still achieving a reciprocation speed of 2,500 cpm. In one embodiment, less than 15 PSI may be sufficient to achieve a speed of over 2,500 cpm. This significant reduction in the air pressure driving the reciprocation also results in a corresponding reduction in the impact of the diaphragm 130 on the housing wall. Thus, there is an increased degree of minimization of vibrations that can cause distraction during vitrectomy.

[0019] As shown herein and in FIG. 4, the stepped channeling 315 has a volume of at least about 0.00275 in 2 3B. However, in contrast to the prior art of FIG. 3B, the primary difference is the significant elimination of the uniform channel 327 that leads to the outlet 300. That is, while the inlet (d) and outlet 300 may be of approximately the same size in the prior art of FIG. 3B and the embodiment of FIG. 3A, the embodiment of FIG. 3A does not have the flow-restricting uniform channel 327 that leads to the outlet 300. Instead, a stepped channel 315 is provided.

[0020] 4, a side cross-sectional view of the inner rear housing 160 of FIGS. 3A and 3B is shown secured to the inner front housing 165 and containing the extension tube 110 in a friction-reducing manner. That is, as described above, the diaphragm 130 alternately reciprocates in response to air pressure in one chamber 325 or another chamber 330. This reciprocating motion moves the extension tube 110 back and forth, ultimately providing a vitreous humor cutting function (see, for example, the surgical depiction of FIG. 5). In any event, the use of such air pressure means that the seals 400, 425, 475 can be positioned at various locations around the tube 110 within the housing 140. For example, this can prevent the potentially catastrophic event of accidentally directing high pressure air into a patient's eye 550 during surgery as shown in FIG. 5.

[0021] The use of such seals 400, 425, 475 means that frictional resistance to the reciprocating motion of the tube 110 may be introduced. Ultimately, this translates into the need to use higher pressure to drive the reciprocating motion, which in turn translates into higher impact forces by the stop 450 and therefore a greater degree of vibration. However, with respect to the embodiment shown in FIG. 4, this frictional resistance is effectively reduced. More specifically, in the embodiment of FIG. 4, it is recognized that only the forward-most seal 475 actually plays a role in protecting the patient's eye 550 during the operation as shown in FIG. 5. This is because, if not sealed by the forward seal 475, only the return stroke induced through the upper channel 325 could reach the patient's eye 550 (see FIG. 5). The other air passage is sealed by the front of the diaphragm 130 itself (see, for example, channel 330) or with a vacuum in the center of the tube 110 that removes the vitreous humor. If any of these seals 400, 425 fail to operate, the patient's eye 550 is not at risk (see FIG. 5).

[0022] With this in mind, embodiments of the extension tube 110, seals 400, 425, 475, and surrounding structure may be configured to reduce overall friction at the seal-tube interface without sacrificing patient safety. For example, in one embodiment, the outer diameter of the tube may be reduced to less than about 0.05 inches and electropolished without changing the dimensions of the inner diameter of the rear seals 400, 425. Similarly, using seals 400, 425, 475 with a hardness of less than about 70 Shore A may minimize friction. The more critical forward seal 475 may have a reduced inner diameter for patient safety. However, the overall frictional resistance is still significantly reduced to reduce air pressure and impact forces of the vibration generating stop 450 as detailed above.

[0023] In the above-described embodiments, the change in the outer diameter of tube 110 may not be accompanied by a dramatic change in the inner diameter. For example, where the conventional inner diameter of the extension tube may be approximately 0.035 inches, tube 110 may retain this same inner diameter. This result is not only to maintain the functional ability of tube 110 to capture vitreous humor, but also to provide a thinner tube 110 (e.g., approximately 0.0010 inches in diameter). As a result, a lighter tube is provided, further reducing the required pneumatic reciprocating forces and the vibrational impacts caused by stops 450 described herein.

[0024] In another embodiment, the reduction in the force of the described impact and resulting vibrations may be achieved by reducing the amount of distance that the stop 450 travels. For example, as shown, with the diaphragm 130 in the center, the distance between the stop 450 and the adjacent housing structure on either side of it may be approximately 0.015 inches, with a total travel distance of 0.030 inches. However, due to the absence of flow path obstruction of the stop 450 at the top rear of the diaphragm 130, this distance may be reduced, for example, to 0.005 inches, such that the total travel distance is limited to 0.020 inches. Thus, the impact force and the vibrations resulting from this stop position may be reduced. Similarly, the reverse may be true for stops at the bottom of the diaphragm 130, with the back stops having a larger travel distance (e.g., 0.015 inches) due to the presence of the flow paths, while the front stops have a smaller travel distance (e.g., 0.005 inches). In other words, the travel distance of the stops may be reduced by having a shorter distance between each non-flow path stop and the adjacent housing structure compared to between each flow path stop and the adjacent housing structure.

[0025] Further measures to reduce friction in tube 110 may include placing a silicone lubricant on the inner diameter of seals 400, 425, 475. This may include placing such a lubricant on the seals connecting cutter 173 and needle 175 in or near the inlet, as shown in Figure 1. In such an embodiment, seals 400, 425, 475 may also be parylene coated polymer or polytetrafluoroethylene coated.

[0026] 5, there is shown an overview of one embodiment of a vitrectomy procedure performed by the vitrectomy probe 100 of FIG. 2. In this figure, the vitrectomy probe 100 of FIG. 2 is used with the cutter 173 of FIG. 1. During this surgical procedure, a needle 175 is inserted through a pre-placed cannula 530 and directed to an area 510 from which vitreous fluid is to be removed. Specifically, as described above, suction is applied and port 177 is used for collection of vitreous fluid or other material. For example, in the procedure shown, bleeding may occur in area 510 and blood is drawn into port 177 along with the vitreous fluid.

[0027] 1 and 4, as also described above, the cutter 173 reciprocates within the needle 175 during this delicate procedure. This means that the diaphragm 130 within the housing 140 repeatedly reciprocates the cutter 173, perhaps over 10,000 times per minute. Despite this reciprocation and the high number of collisions with the stops 450 of the diaphragm 130 on the housing structure, vibrations are kept to a minimum by various features of the probe 100 detailed herein. From the surgeon's perspective, and for the benefit of the patient, noise that may cause distraction during surgery is mitigated.

[0028] 5, the procedure shown involves probe 101 and illuminator 525 reaching into eye 550 through cannulae 515, 530 that are offset into the sclera 570. In this manner, the more delicate cornea 590 and lens 580 can be avoided. Similarly, the optic nerve 560 and retina 575 are also extremely delicate. Thus, illuminator 525 can be used to illuminate both the back of eye 550 and the end of needle 175 for the surgeon, provided that needle 175 can reach these delicate features.

[0029] Referring now to Figure 6, a flow chart is shown summarizing one embodiment of using a vibration-reduced vitrectomy probe in a surgical procedure. With the probe inserted as shown in Figure 5 and described at 620, vitreous humor can be withdrawn from the patient's eye as shown at 660. This is accomplished by the reciprocating motion of a cutter within the needle of the probe (see 640). As shown at 680, this reciprocating motion is performed by dampening the vibration caused by the reciprocating motion. Whether it be soft grips, air pressure with stepped channels, reduced friction in the extension tube, silicone rubber stops with reduced travel distance, or various additional measures, significant benefits can be realized.

[0030] The embodiments described herein above include vitrectomy probes with various features and enhancements tailored to attenuate vibrations that are potentially distracting from the surgeon's perspective. In each case, the reduction in vibration is achieved without sacrificing the reciprocating speed of the cutter of the vitrectomy probe. Thus, the reduction in vibration is achieved without compromising the effectiveness of the probe in the surgical procedure at hand.

[0031] The foregoing description has been presented with reference to various embodiments. However, other embodiments and / or features of embodiments that are disclosed but not detailed above may be employed. Moreover, those skilled in the art to which these embodiments pertain will appreciate that still other modifications and variations in the described structures and methods of operation may be made without significantly departing from the principles and scope of these embodiments. Additionally, the foregoing description should not be read as relating solely to the exact structures described and shown in the accompanying drawings, but rather as consistent with and in support of the following claims, which shall have their fullest and most reasonable scope. According to aspect (1), a rear housing component for accommodating a first air flow for guiding a diaphragm to move toward a needle of a vitrectomy probe; a front housing component for receiving a second air flow for guiding the diaphragm to move away from the needle of the probe; Including, the rear housing has a stepped channel for accommodating the second air flow before it reaches the front housing. A vitrectomy probe housing. According to aspect (2), the rear housing is free of uniform channels to minimize flow restriction of the airflow through the rear housing. According to aspect (3), the stepped channel is in a chamber of the rear housing having a volume of at least about 0.00275 in2. According to aspect (4), the diaphragm occupies a space between the housing components to move toward and away from the needle, and a total travel distance of the diaphragm within the space is less than about 0.025 inches. According to aspect (5), the diaphragm includes a separate stop for impinging against the housing component during reciprocating motion between the housing components, and in the absence of an intervening flow path, the travel distance of the stop between the housing component and the diaphragm in a central position is reduced. According to aspect (6), the stop comprises a material selected from the group consisting of silicone rubber and a material having a hardness of less than about 60 Shore A. According to aspect (7), a front housing component is provided. a rear housing component; a diaphragm located between the housing components, within a space defined by the housing components, and reciprocating between the housing components in response to air flows alternately induced on either side of the diaphragm; a plurality of separate stops for impacting said housing component during said reciprocating motion, said impacts causing vibrations, said stops including a material having a hardness of less than about 60 Shore A to dampen said vibrations; a cutter coupled to the diaphragm and located within a needle of a probe for cutting vitreous humor during a vitrectomy procedure performed by a surgeon; a grasping component, the needle emerging from the grasping component and for manual holding by the surgeon during the vitrectomy procedure, the zipping component comprising an elastomer having a hardness of less than about 60 Shore A to attenuate the vibration; a vitrectomy probe comprising: According to aspect (8), the gripping component has an outer diameter of less than about 0.5 inches. According to aspect (9), the separate stop comprises silicone rubber. According to aspect (10), the present invention further includes an extension tube for facilitating coupling of the cutter to the diaphragm, the extension tube being configured to reciprocate with the diaphragm and the cutter in response to the air flow during the vitreous removal procedure. According to an eleventh aspect, the device further includes a static seal mounted around the extension tube within the housing component to seal the air flow. According to aspect (12), the seal that does not seal against airflow guiding the diaphragm away from the front housing component exerts a smaller compressive force on the extension tube than any seal that seals against the airflow guiding the diaphragm away from the front housing component. According to aspect (13), the seal is coated with one of a parylene polymer and polytetrafluoroethylene. According to an embodiment (14), the elongated tube is electropolished. According to an embodiment (15), the lubricant further comprises a silicone lubricant at an interface between the extension tube and the seal.

Claims

1. a rear housing component for containing a first air flow for directing the diaphragm to move toward the needle of the vitreous resection probe; a front housing component for receiving a second air flow for guiding the diaphragm to move away from the needle of the vitreous resection probe; Including, the rear housing component has a stepped channel adjacent an outlet leading to the front housing component for accommodating the second air flow; Vitrectomy probe housing.

2. The vitreous surgery probe housing of claim 1 , wherein the rear housing component is free of uniform channels with constant flow area to minimize flow restriction of the second air flow through the rear housing component.

3. The vitreous surgery probe housing of claim 1 , wherein the stepped channel is in a chamber of the rear housing component having a volume of at least about 0.00275 cubic inches.

4. 2. The vitreous resection probe housing of claim 1, wherein the diaphragm occupies a space between the front and rear housing components to move toward and away from the needle, the total distance of movement of the diaphragm within the space being less than about 0.025 inches (0.635 millimeters).

5. 5. The vitreous resection probe housing of claim 4, wherein the diaphragm includes separate stops for impinging against the front and rear housing components during reciprocating movement between the front and rear housing components, and when there is no flow path obstruction of the separate stops at the upper rear of the diaphragm, the total travel distance of the diaphragm is reduced between both the front and rear housing components and the diaphragm in a central position between the front and rear housing components.

6. The vitreous surgery probe housing of claim 5 , wherein the separate stop comprises a material selected from the group consisting of silicone rubber and a material having a hardness of less than about 60 Shore A.

7. a forward housing component; a rear housing component; a diaphragm between the front and rear housing components, located within a space defined by the front and rear housing components, and reciprocating between the front and rear housing components in response to air flows alternately induced on either side of the diaphragm; a plurality of separate stops for impacting the front and rear housing components during the reciprocating motion, the impacts causing vibrations, the plurality of separate stops including a material having a hardness of less than about 60 Shore A to dampen the vibrations; a cutter coupled to the diaphragm and located within a needle of a vitrectomy probe for cutting vitreous humor during a vitrectomy procedure performed by a surgeon; a grasping component from which the needle emerges and for manual holding by the surgeon during the vitrectomy procedure, the grasping component comprising an elastomer having a hardness of less than about 60 Shore A to attenuate the vibrations; Including, A vitrectomy probe, wherein the rear housing component has a stepped channel proximate to an outlet leading to the front housing component for accommodating air flow therethrough.

8. The vitrectomy probe of claim 7 , wherein the grasping component has an outer diameter of less than about 0.5 inches.

9. The vitreous resection probe of claim 7 , wherein the plurality of discrete stops comprises silicone rubber.

10. 8. The vitrectomy probe of claim 7, further comprising an extension tube for facilitating coupling of the cutter to the diaphragm, the extension tube configured to reciprocate with the diaphragm and the cutter in response to the air flow during the vitrectomy procedure.

11. The vitreous resection probe of claim 10 , further comprising a static seal mounted about the extension tube within the front and rear housing components to seal the air flow.

12. 12. The vitreous resection probe of claim 11, wherein the static seal that does not seal against air flow directing the diaphragm away from the front housing component exerts a smaller compressive force on the extension tube than any seal that seals against the air flow directing the diaphragm away from the front housing component.

13. The vitreous resection probe of claim 11 , wherein the static seal is coated with one of a parylene polymer and polytetrafluoroethylene.

14. The vitrectomy probe of claim 11 , wherein the extension tube is electropolished.

15. The vitreous resection probe of claim 11 , further comprising a silicone lubricant at an interface between the extension tube and the static seal.

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