Patent Application
20150366551
The present invention relates generally to medical devices and methods for facilitating and performing ophthalmic surgical procedures. More particularly, the present invention relates to surgical platform apparatus and methods of use which are supported at least in part by the patient for facilitating ophthalmic surgical procedures.
Generally, ophthalmic surgical procedures require draping of the patient and of the surrounding areas with a sterile barrier to create and maintain a sterile field. The purpose of draping is to eliminate the passage of microorganisms between the non-sterile environment and the sterile surgical theater. Draping materials may be disposable or non-disposable and are generally made of absorbent or non-absorbent paper or plastic materials or a combination of both. A sterile drape is typically also applied to the face and surrounding eyelashes and eyelids to help protect the operative eye field away from potentially contaminated surfaces. Additionally, an eyelid speculum separate from the draping may also be used to help improve the exposure of the surgical field in or around one or both eyes.
However, the draping process may take up to several minutes and often requires the assistance of several sterile assistants. Moreover, because the drapes used are variable and can incorporate a large split sheet covering the patient's chest and head, an additional eyelid ophthalmic drape is often placed over the split sheet and requires the surgeon to manually cut an opening through the eyelid drape to conform it across the eyelid margins as an adhesive. The separate eyelid speculum, usually a non-disposable device, is usually placed to gain appropriate exposure to the operative ocular field.
Not only is the draping process inconvenient and time consuming, additional procedures such as placing an eyelid speculum to expose the operative field and a nasal cannula to provide supplemental oxygen to the patient take time. Such a process represents an inconvenience to the surgeons due to the prolonged time-consuming surgical set-up time and assistance of several staff members. Moreover, several different costly instruments are required in addition to the drapes such as the eyelid speculums, scissors for perforating the eyelid drape, nasal cannulas, etc. Also, the set-up may be uncomfortable to the patients due to the draping process and placement of the nasal cannula which often create irritation around the nose and the ears.
Thus, there is a need for improving the efficiency in surgical set-up time as well as for improving the efficiency during surgical procedures by providing an integrated surgical draping system which also provides a cost savings. There is also a need for providing an integrated eyelid speculum that maintains optimum exposure while relieving the globe of any posterior pressure.
A surgical platform for use in ophthalmic procedures may be supported at least in part upon a portion of a patient's face where the platform is configured to cover at least one or both eyes of the patient and further includes a conformable portion which rests upon a remainder of the patient's face. The platform may also integrate rests for the hands of the surgeon and may optionally integrate an instrument rest for allowing ready access of one or more surgical instruments to the surgeon.
One or more corresponding eyelid speculums may also be integrated with the surgical platform eliminating the need for a separate speculum. An irrigation fluid trough may also be integrated with the surgical platform for collecting and diverting any irrigating fluid and the platform may optionally be used in combination with an oxygen delivery mask or nasal cannula.
In another variation, the surgical assembly may generally comprise a support frame which is positionable upon a face of a patient, the support frame having at least a first supporting rim in proximity to at least one eye of the patient, at least one speculum adjustably attached to the first supporting rim such that the at least one speculum is configured to retract at least an upper or lower eyelid of the patient, a platform attached to the support frame and extending over at least a first part of the face of the patient, and a conformable portion attached to the support frame adjacent to the platform and extending over a second part of the face of the patient.
Another variation may generally comprise a headband adjustably securable over a head of a patient, a platform attachable to the a portion of the headband, at least one speculum adjustably attached to a second portion of the headband, where the at least one speculum extends from the second portion into proximity to at least one eye of the patient, and an irrigation trough fluidly coupled to the headband.
In yet another variation, the assembly may generally comprise a first block having a first contoured surface configured for placement against a first side of a patient's head, a second block having a second contoured surface configured for placement against a second side of the patient's head, and a conformable shield extending between the first block and second block for placement over a face of the patient's head, wherein the conformable shield defines at least one opening for alignment over at least one eye to be treated.
In one example, the ophthalmic surgical assembly may generally comprise a platform having a flattened surface to provide for an instrument rest and which is also configured to conform over a portion of the face of the patient. The platform may extend at least partially over the patient's face to cover one or both eyes. The platform may also define a contoured edge which extends around and provides a border relative to the patient's remaining eye, nose, and mouth. Optionally, a conformable portion may be attached to a portion of the contoured edge and extend over the eye to be treated as well as over a remaining portion of the patient's face.
While the platform may be comprised of any number of polymers, plastics, metals, or combination thereof which are biocompatible and which provide a relative stiffened platform, the conformable portion may be formed from a conformable polymer, such as silicone, which may extend over the patient's face and conform in part to the underlying features while further draping over a side of the patient's face where it may optionally form an irrigation trough. The irrigation trough may be formed along a distal edge of the conformable portion integrally or separately to collect any irrigating fluid and/or debris which may run off from the surgical field.
The conformable portion of the surgical assembly may be laid atop the eye to be treated such that an opening defined through the conformable portion is aligned with the eye of interest while the remainder of the patient's face is covered or draped by the portion. The opening may be aligned with the patient's eye to provide surgical access to the eye while allowing for the remainder of the patient's face to be covered or draped. Because the opening provides for a defined surgical field or theater for the eye to be treated, one or more adjustable eyelid speculums may be integrated or otherwise attached to the conformable portion in proximity to the opening such that the speculums may retract the eyelids of the patient to provide for a clear surgical field. With the speculums supported by the conformable portion pressure on the underlying surface of the eye may be alleviated by the weight of the speculums and retracted eyelids being supported by the conformable portion.
While the surgical assembly may simply rest upon the face of the patient during a procedure, the platform and/or the conformable portion may be optionally adhered temporarily to the patient's face to inhibit or prevent movement of the assembly. Alternatively and/or additionally, the surgical assembly may incorporate an adjustable band which may be used to secure the assembly to the patient's head.
In another variation, an additional hand rest or stabilizer may be positioned along an edge of the platform overlying the patient's forehead. The hand rest or stabilizer may comprise an elevated platform or cushion to provide an area where the surgeon may rest their hands during a procedure upon the eye (or eyes) or an area where the surgeon may use to position or reposition the patient's head.
In yet another variation, the surgical assembly may be configured to be supported and/or secured by the patient using a supporting scaffold or frame placed over or upon the patient's face and/or head. A supporting frame in the form of, e.g., eyeglasses, may be placed upon the face of the patient such that the supporting frame extends towards the patient's ears and has at least a first supporting rim and optional second supporting rim which may be positioned over the respective eyes of the patient. A platform may be attached or otherwise coupled to the supporting frame to provide an instrument rest such that the platform extends from a first upper portion of the frame to rest above the patient's forehead. A conformable portion may be attached to a second lower portion of the supporting frame to extend over and rest upon the patient's face. The distal edge of the conformable portion may define a contoured edge to accommodate the patient's nose and mouth and which may also incorporate an optional irrigation trough. One or both supporting rims may also incorporate one or more eyelid speculums to provide a clear surgical field to the underlying eye (or eyes) to be treated. Alternatively, one or both of the supporting rims may incorporate a covering to cover the underlying eye (or eyes) partially or completely.
In yet another variation, a surgical platform may be attached or coupled via an attachment to the supporting frame which may rest upon the patient's face. The platform may be positioned along the supporting frame over where first or second supporting rim would normally reside such that the underlying eye is covered. The remaining eye to be treated may have its eyelids retracted by the corresponding speculum adjustably integrated along the supported rim. An irrigation trough may also be integrated with the conformable portion or optionally integrated with the support frame itself as shown.
Yet another variation of a supporting frame may incorporate an optional light source having an adjustable arm attached to the supporting frame, e.g., via attachment. The light source may be attached, for instance, along second supporting rim and extend via an adjustable arm such that its distal end is in proximity to the first supporting rim to provide additional lighting to the underlying eye to be treated. Additionally and/or alternatively, the light source may incorporate a fluid lumen through which irrigation fluid, such as saline, may be flowed to provide a clearing fluid in addition to lighting to the treated eye.
In yet another variation, an ophthalmic surgical block assembly may be positioned along either side of the patient's head to provide support and stabilization rather than being positioned to rest directly upon the patient's face. The surgical block assembly may generally comprise a first block and a second block which may be positioned along both sides of the patient's head. The first block may include a first backing with a first conformable rest which may be fabricated from any number of materials suitable for cushioning against the patient's head, such as foam. The conformable rest may define a first contoured surface which may be sized for placement against a side of the patient's head. Likewise, the second block may include a second backing and a second conformable rest which defines a second contoured surface for placement and cushioning against the other side of the patient's head in apposition to the first block.
With the patient's head secured between the first and second block, a conformable polymer shield may be positioned over the patient's face to provide for draping of the patient. The shield may be attached to the first and second block via respective first and second attachment and may further define an opening through which the patient's face may be accessed. Alternatively, portions of the shield may define one or more openings to accommodate one or both eyes for treatment as well as openings to accommodate the patient's nose and/or mouth. The size of each block may be optionally adjustable in height as well as relative spacing from one another and from the patient's head to accommodate varying head sizes, if so desired. Another variation may include an optional oxygen mask incorporated for placement over the patient's mouth and nose as well as a separate instrument rest which may be positioned along one of both of the blocks.
Yet another variation may include a surgical platform which may be placed around a patient's face. The platform may provide a relatively broader surface upon which one or more instrument rests may be provided. The platform may be supported upon the patient's face or head and retained in position via a headband attached via one or more headband attachments on either side of the platform. The opening of the platform may be varied in diameter as well for allowing for adjustability of the platform relative to the patient's head. Moreover, the platform may define one or more openings suitably sized for placement around a periphery of the patient's face in which case a conformable polymer shield may be placed over the patient's face with one or more openings for providing access to one or both eyes for treatment.
An ophthalmic surgical platform may be comprised generally of a platform which is supported at least in part upon a portion of a patient's face. The platform itself may be shaped to cover at least one or both eyes of the patient and may further include a conformable portion which may rest upon a remainder of the patient's face. The portion of the platform which rests upon the patient's face may also integrate rests for the hands of the surgeon during a procedure or the portion may optionally integrate an instrument rest for allowing ready access of one or more surgical instruments to the surgeon.
Additionally, one or more corresponding eyelid speculums may also be integrated with the surgical platform eliminating the need for a separate speculum. An irrigation fluid trough may also he integrated with the surgical platform for collecting and diverting any irrigating fluid used during a procedure. Furthermore, the platform may optionally be used in combination with an oxygen delivery mask or nasal cannula as well. The platform may be reusable between different patients or it may be configured to be disposable after a single use or several uses.
One variation is illustrated in the front and perspective views of
While the platform 12 may be comprised of any number of polymers, plastics, metals, or combination thereof which are biocompatible and which provide a relative stiffened platform, the conformable portion 18 may be formed from a conformable polymer, such as silicone, which may extend over the patient's face and conform in part to the underlying features while further draping over a side of the patient's face where it may optionally form an irrigation trough 28, as shown in the end view of
The conformable portion 18 of the surgical assembly 10 may be laid atop the eye to be treated such that an opening 20 defined through the conformable portion 18 is aligned with the eye of interest while the remainder of the patient's face is covered or draped by the portion 18. The opening 20 may be aligned with the patient's eye to provide surgical access to the eye while allowing for the remainder of the patient's face to be covered or draped. Because the opening 20 provides for a defined surgical field or theater for the eye to be treated, one or more adjustable eyelid speculums 22 may be integrated or otherwise attached to the conformable portion 18 in proximity to the opening 20 such that the speculums 22 may retract the eyelids of the patient to provide for a clear surgical field. With the speculums 22 supported by the conformable portion 18 pressure on the underlying surface of the eye may be alleviated by the weight of the speculums 22 and retracted eyelids being supported by the conformable portion 18.
While the surgical assembly 10 may simply rest upon the face of the patient P during a procedure, the platform 12 and/or the conformable portion 18 may be optionally adhered temporarily to the patient's face to inhibit or prevent movement of the assembly 10. Alternatively, the surgical assembly 10 may incorporate an adjustable band 26 which may be used to secure the assembly 10 to the patient's head, as shown. While the surgical assembly 10 may be standardized in size, e.g., one or more standard sizes for adults and children, the assembly 10 shown, as well as in other variations described herein, may also be custom-fitted to a particular patient's anatomy to ensure a conforming fit to the patient's face.
In another variation,
In yet another variation, the surgical assembly may be configured to be supported and/or secured by the patient using a supporting scaffold or frame placed over or upon the patient's face and/or head. In the embodiment shown in
In this variation (or in other variations described herein), a fluid collection reservoir 76 may be optionally coupled via a fluid line 74 to the one or more troughs 72, as shown in the perspective view of
Another variation is shown in the perspective view of
In yet another variation,
Additionally and/or alternatively, the light source 90 may incorporate a fluid lumen 92 through which irrigation fluid, such as saline, may be flowed to provide a clearing fluid in addition to lighting to the treated eye.
In yet another variation,
With the patient's head secured between the first and second block 122, 124 which may be adjustably positioned relative to one another as well as relative to the patient's head, a conformable polymer shield 138 may be positioned over the patient's face to provide for draping of the patient. The shield 138 may be attached to the first and second block 122, 124 via respective first and second attachment 140, 142 and may further define an opening 144 through which the patient's face may be accessed. Alternatively, portions of the shield 138 may define one or more openings to accommodate one or both eyes for treatment as well as openings to accommodate the patient's nose and/or mouth. The size of each block 122, 124 may be optionally adjustable in height as well as relative spacing from one another and from the patient's head to accommodate varying head sizes, if so desired.
Another variation is illustrated in the perspective view of
Yet another variation is illustrated in the perspective view of
The opening 172 of the platform 170 for providing access to the patient's face may be varied in diameter as well for allowing for adjustability of the platform 170 relative to the patient's head. For instance,
The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modification of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.
This application is a continuation of International Application No. PCT/US2014/023229 filed Mar. 11, 2014 which claims the benefit of priority to U.S. Provisional Application No. 61/778,800 filed Mar. 13, 2013, which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61778800 | Mar 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2014/023229 | Mar 2014 | US |
| Child | 14843568 | US |
