WO2012159117A1

WO2012159117A1 - Soft-tissue retractor device

Info

Publication number: WO2012159117A1
Application number: PCT/US2012/038878
Authority: WO
Inventors: Roger P. Goldberg; Douglas S. Scherr
Original assignee: Goldberg Roger P; Scherr Douglas S
Priority date: 2011-05-19
Filing date: 2012-05-21
Publication date: 2012-11-22

Abstract

A soft-tissue retractor device includes an inner ring, an outer ring, and a sleeve extending between the inner ring and the outer ring.

Description

SOFT-TISSUE RETRACTOR DEVICE

RELATED APPLICATIONS

This application claims the benefit of, and priority to, U.S. Provisional Application Serial No. 61 /488,042, filed May 19, 201 1 , the teachings of which are incorporated herein by reference.

BACKGROUND

Soft-tissue retractor devices are designed to assist in surgical operations involving a relatively small abdominal incision (commonly referred to as

"minilaparotomy"). In particular, a soft-tissue retractor device is used to expand an abdominal linear incision to provide a surgeon with an enlarged (e.g., circular) working area for greater access to bodily organs and/or other internal body parts during the surgical procedure. Some examples of existing soft-tissue retractor devices presently used in the art are disclosed in U.S. Patent No. 7,033,319 by Apple Medical Corporation (of Marlboro, MA) and U.S. Patent Application Pub. No. 2008/0281 162 by Applied Medical Resources Corporation (of Rancho Santa Margarita, CA).

Existing retractor devices are useful in abdominal surgeries, but suffer from several drawbacks. For example, existing soft-tissue retractor devices use a flexible exterior sleeve (essentially forming a cylindrical wall) to produce the enlarged work areas. The exterior sleeve extends between an outer (e.g., upper) ring and an inner (e.g., lower) ring, which combine to form an open channel extending into the body of the patient when positioned into the abdominal incision. While useful in improving access to internal body parts, these open channels formed by existing soft-tissue retractor devices can be somewhat restricted near the center or top of the cylindrical sleeve, thereby blocking at least some light from entering the open channel and illuminating the internal body parts during the surgical operation. Furthermore, when a surgeon reaches into the open channel formed by the retractor device (e.g., with his/her hands or with a medical instrument), ambient light from the room tends to be blocked by body of the surgeon and/or the medical instrument being placed therein. As a result, the work area and internal body parts situated below the open channel formed by the retractor device generally are not well illuminated during the surgical procedure. For this reason, existing retractor devices fail to provide desirable visibility to a surgeon during such surgical operations.

Furthermore, existing retractor devices possess other drawbacks, such as a tendency to shift in location during the procedure. Additionally, visibility can be further reduced by conventional hand-held retractors, which are placed from outside the body of a patient. Such hand-held retractors are situated within the incision and thus occupy space within the incision, which can further obscure a surgeon's view.

SUMMARY

Accordingly, there is a need for a soft-tissue retractor device that enables greater visibility and that experiences fewer shifts in location during use. The present disclosure is directed toward solutions to address these and other needs, in addition to having other desirable characteristics that will be appreciated by one of skill in the art upon reading the present specification.

In accordance with certain illustrative embodiments, a soft-tissue retractor device is provided and can include an outer flexible ring, an inner flexible ring, and a sleeve extending between the outer ring and the inner ring. One or more light- emitting elements can be joined with (e.g., coupled to, operationally coupled to, disposed in, disposed on, or otherwise joined with) one or more of the outer flexible ring, the inner flexible ring, or the sleeve.

The one or more light-emitting elements can be coupled or operationally coupled to one or more of the outer flexible ring, the inner flexible ring, or the sleeve.

The one or more light-emitting elements can be disposed in or on one or more of the outer flexible ring, the inner flexible ring, or the sleeve. The one or more light- emitting elements can be formed integral with the inner flexile ring. The inner flexible ring can include one or more fiber optic light tubes adapted to transmit light shining from the one or more light-emitting elements. In general, the one or more light-emitting element can include one or more light-emitting diodes (LEDs) and/or one or more liquid crystal displays (LCDs). A power source can be coupled to the one or more light-emitting elements for supplying electrical power to the one or more light-emitting elements. A control unit can be included in the retractor device for controlling operation of the one or more light-emitting elements. The control unit can include an on-off switch. The power source can include one or more disposable batteries, one or more rechargeable batteries, one or more photovoltaic cells, or a plug adapted to be received by an electrical socket. Electrical wiring can couple one or more of the light-emitting elements, the power source, and the control unit.

Electrical wiring can be included in the retractor device and can couple the one or more light-emitting elements to a power source external to the retractor device. One or more strips of material can cover the electrical wiring, and the electrical wiring can be disposed under or integral with the one or more strips of material.

The one or more light-emitting elements can be disposed on the inner flexible ring by one or more clips. The one or more light-emitting elements can be disposed in and formed integral with the inner flexible ring. The one or more light-emitting elements can be disposed in or on the inner flexible retractor, and the retractor device further can include one or more optical fibers or optical waveguides disposed in or on the sleeve and adapted to propagate light emitted from the light-emitting elements. An inner organ retractor ring can be coupled to the inner flexible ring. One or more inner retractor appendages can extend from the inner flexible ring. Each inner retractor appendage of the one or more inner retractor appendages can be adapted to pivot between a first pivotal position in which that inner retractor appendage is adapted for operational use and a second pivotal position in which that retractor appendage is adapted for storage. A notch can be disposed in each of the one or more inner retractor appendages for allowing the inner retractor appendages to more readily grip surrounding tissues and/or internal body parts during use. Each of the one or more inner retractor appendages can extend axially away from the inner organ retractor ring and radially out from the inner organ retractor ring.

An outer organ retractor ring can be coupled to the outer flexible ring. The outer organ retractor ring can be adapted to support one or more retractor appendages, one or more sutures, or both. One or more indentations can be formed in the outer organ retractor ring. The one or more indentations can be adapted to receive one or more retractor appendages, one or more sutures, or both. The one or more indentations can extend radially, axially, or both into the outer organ retractor ring. A cap can be coupled with the flexible outer ring. The cap can include a through-hole, which can provide an access port for receiving a medical instrument or device. In accordance with certain illustrative embodiments, a soft-tissue retractor device is provided that includes an outer flexible ring, an inner flexible ring, a sleeve extending between the outer ring and the inner ring, and an organ retractor ring coupled to one of the outer flexible ring or the inner flexible ring. The retractor device further can include an additional organ retractor ring coupled to the other of the outer flexible ring or the inner flexible ring.

The organ retractor ring can be coupled to the outer flexible ring. There can be one or more indentations in the organ retractor ring, and the one or more indentations can be adapted to receive sutures or retractor members.

The organ retractor ring can be coupled to the inner flexible ring. One or more retractor appendages can be coupled to the organ retractor ring. The one or more retractor appendages can extend axially and/or radially away from the organ retractor ring. Each retractor appendage of the one or more retractor appendages can be adapted to pivot between a first pivotal position in which that inner retractor appendage is adapted for operational use and a second pivotal position in which that retractor appendage is adapted for storage.

One or more light-emitting elements can be joined with one or more of the outer flexible ring, the inner flexible ring, or the sleeve. The inner flexible ring can include one or more fiber optic light tubes adapted to transmit light shining from the one or more light-emitting elements. A power source can be coupled to the one or more light-emitting elements for supplying electrical power to the one or more light- emitting elements. A control unit can be included for controlling operation of the one or more light-emitting element. Electrical wiring can couple one or more of the light- emitting elements, the power source, and the control unit.

In accordance with certain illustrative embodiments, a soft-tissue retractor device, and includes an outer flexible ring and an inner flexible ring substantially coaxially aligned on a longitudinal axis. A sleeve can extend between the outer ring and the inner ring and completely around the longitudinal axis. The sleeve can have an interior volume defining a channel between the outer flexible ring and the inner flexible ring when the retractor device is in an open configuration. An organ retractor ring can be coupled to the outer flexible ring or the inner flexible ring. One or more light-emitting elements can be joined with one or more of the outer flexible ring, the inner flexible ring, or the sleeve. The one or more light-emitting elements can be adapted (e.g., suitably positioned and oriented) to illuminate the open channel, a volume of space adjacent the retractor device, or both.

In accordance with certain illustrative embodiments, a method of using a retractor device comprises providing a retractor device that includes an outer flexible ring; an inner flexible ring; a sleeve extending between the outer ring and the inner ring; and one or more light-emitting elements joined with one or more of the outer flexible ring, the inner flexible ring, or the sleeve. The retractor device can be inserted into an incision. The one or more light-emitting elements can be caused to shine light.

An inner organ retractor assembly can be coupled to the retractor device, and the inner organ retractor assembly can be used to retract one or more organs or tissues. An outer organ retractor assembly can be coupled to the retractor device, and the outer organ retractor assembly can be used to retract one or more organs or tissues.

In accordance with certain illustrative embodiments, a method of using a retractor device comprises providing a retractor device that includes an outer flexible ring; an inner flexible ring; a sleeve extending between the outer ring and the inner ring; an organ retractor ring coupled to one of the outer flexible ring or the inner flexible ring; and one or more members coupled to the organ retractor ring for retaining one or more organs or tissues in a retracted position. The retractor device can be inserted into an incision. The one or more members can be coupled to the organ retractor ring to retract one or more organs or tissues.

The one or more members can include one or more inner retractor appendages, one or more retractor blades, one or more sutures, or one or more tissue fixation devices. One or more light-emitting elements included in the retractor device can be caused to shine light.

BRIEF DESCRIPTION OF THE FIGURES

These and other characteristics of the present invention will be more fully understood by reference to the following detailed description in conjunction with the attached drawings, in which:

FIG. 1 is a perspective view of a retractor device.

FIG. 2 is an exploded view of the retractor device of FIG. 1. FIG. 3 is a sectional view of the retractor device of FIG. 1.

FIG. 4A is a perspective view of a light-emitting diode (LED) that includes an integrated battery.

FIG. 4B is a side view of an AAAA battery adapted for use with the LED shown in FIG. 4 A.

FIG. 5 is a perspective view of an outer organ retractor ring.

FIG. 6 is a perspective view of an end of the retractor device of FIG. 1 with the outer organ retractor ring of FIG. 5 coupled to the outer flexible ring.

FIG. 7 is a perspective view of the end of the retractor device of FIG. 6 in operation, with one or more tissue fixation members coupled with the outer organ retractor ring and holding body tissue in a retracted position.

FIG. 8 is a perspective view of the end of the retractor device of FIG. 6 with one or more sutures coupled to the outer organ retractor ring.

FIG. 9 is a lower perspective view of a retractor device, in which a power source and a control unit are disposed external to the retractor device.

FIG. 10 is an upper perspective transparent view of the retractor device of FIG. 9, with the inner retractor appendages not shown.

FIG. 11 is an upper perspective view of the retractor device of FIG. 10.

FIG. 12 is a perspective transparent view of an end of the retractor device shown in FIG. 10. FIG. 13 is a perspective view of the end of the retractor device of FIG. 12, with the inner organ retractor ring not included.

FIG. 14 is a perspective view of a retractor device with an electrical wiring disposed in or underneath a strip of material.

FIG. 15 is a perspective view of a retractor device including with one or more indentations adapted to receive sutures. FIG. 16 is a perspective view of a retractor device including one or more inner retractor appendages adapted to pivot between an operable configuration and a storage configuration.

FIG. 17 is a perspective view of a retractor device with one or more optical fibers disposed in the sleeve of the retractor device.

FIG. 18 is a perspective view of a retractor device, in which an inner flexible ring of the retractor device is formed of one or more fiber optic light tubes. FIG. 19 is a perspective view of a retractor device, in which one or more light-emitting elements are coupled to an inner flexible ring of the retractor device by one or more clips.

FIG. 20 is a perspective view of a retractor device, further including a cap having an access port for receiving a medical instrument or device.

FIG. 21 is a perspective view of the retractor device of FIG. 20, in which the cap is detached from the retractor device. FIG. 22 is a perspective view of the retractor device of FIG. 20 in operation with a medical device or instrument received by the access port of the cap. DETAILED DESCRIPTION

An illustrative embodiment of this disclosure relates to a retractor device including an inner flexible ring, an outer flexible ring, and a sleeve extending between the inner and the outer flexible rings. The retractor device optionally can include a lighting assembly comprising at least one light-emitting element. The light-emitting elements can be oriented and positioned in such a way that when the retractor device is in an open configuration (e.g., during use thereof), the light-emitting elements face an interior volume of the sleeve (e.g., when the retractor device is in an open configuration) and/or face one or more volumes of space adjacent the retractor device (e.g., one or more volumes of space situated above the retractor device, below the retractor device, to the sides of the retractor device, combinations thereof, etc.). In this way, the light-emitting elements can provide enhanced visibility to a surgeon during use of the retractor device, by illuminating the open channel created, the workspace, and/or internal portions of the body of a patient.

Furthermore, the retractor device can include one or more organ retractor rings. For example, the retractor device can include an inner organ retractor ring coupled to the inner flexible ring, and/or can include an outer organ retractor ring coupled to the outer flexible ring. The inner organ retractor ring can include one or more appendages (e.g., retractor blades) extending therefrom (e.g., axial ly and/or radially away from the inner organ retractor ring). The retractor appendages can assist in anchoring the position of the retractor device, and further can assist in maintaining body tissue and/or other body parts in a retracted position, thereby providing a cleared workspace within which a surgeon may operate and maneuver. The outer organ retractor ring can include one or more indentations (e.g., slots, slits, channels, etc.) adapted to receive one or more tissue fixation elements and/or surgical sutures. Accordingly, the one or more indentations also can provide enhanced anchoring and stability of the retractor device during operation thereof, and further can contribute to maintaining the surrounding tissue and/or organs in a retracted configuration. FIGS. 1 through 22, wherein like parts are designated by like reference numerals throughout, illustrate illustrative embodiments of a soft-tissue retractor device according to the present disclosure. Although certain illustrative embodiments will be described herein with reference to the figures, it should be understood that many alternative forms can be embodied. One of skill in the art will appreciate a wide variety of different ways to alter the parameters of the embodiments disclosed, such as the size, shape, or type of elements or materials, in a manner still in keeping with the spirit and scope of the present disclosure.

FIGS. 1 through 3 depict an illustrative embodiment of a soft-tissue retractor device 10 from a perspective view, an exploded view, and a sectional view, respectively. The retractor device 10 includes an inner flexible ring 12, an outer flexible ring 14, and a sleeve 16 (e.g., constructed of a thin flexible material) extending between the inner and outer flexible rings 12, 14 in such a way as to form a contractible and expandable diaphragm. The inner flexible ring 12 and the outer flexible ring 14 can be coaxially, i.e., and aligned on a longitudinal axis 15. As depicted in FIGS. 1 through 3, the retractor device 10 is in an open, stretched configuration. When in the open, stretched configuration, the sleeve 16 can be generally cylindrical and coaxial with the inner flexible ring 12 and the outer flexible ring 14 (i.e., can be aligned on the longitudinal axis 15). When in the open, stretched configuration (e.g., as depicted in FIGS. 1 through 3), the sleeve 16 has an interior volume that defines an open channel 18 between the inner flexible ring 12 and the outer flexible ring 14.

The inner flexible ring 12 is adapted to be placed through an incision and positioned below the surface of the skin of a patient, thereby assisting in expanding the size of the work area. The outer flexible ring 14 is adapted to be positioned at or near the surface of the skin of a patient, as would be appreciated by one of skill in the art upon reading the present specification. In operation, the retractor device 10 is optionally folded or otherwise collapsed (e.g., under a force) and placed inside (e.g. fully or partially inside) an incision or aperture of a patient. Once positioned appropriately in the patient, the collapsing force on the retractor device 10 is released and the retractor device 10 assumes the open configuration of FIGS. 1 through 3, thereby forming the open channel 18 and providing a surgeon (or other user) with greater access into the internal body parts (e.g., situated in the volume of space adjacent the retractor device 10).

As used herein, "inner" generally indicates proximity to or greater proximity to an internal portion of the body of a patient, away from an incision/aperture (e.g., relative to some outer component in the retractor device 10). Similarly, "outer" generally indicates proximity to or greater proximity to an incision/aperture, away from the internal portion of the body of the patient (e.g., relative to some inner component). Thus, although in the illustrative embodiments described herein the inner flexible ring 12 is adapted to be placed inside the body of a patient and the outer flexible ring 14 is adapted to be placed generally at a surface of the skin of the body of a patient or external to the patient, other configurations are possible and contemplated within the scope of this disclosure. The embodiments described herein can be implemented, e.g., such that both the inner flexible ring 12 and the outer flexible ring 14 are adapted to be placed inside the body of a patient, with the inner flexible ring 12 being more inwardly spaced (i.e., within the body of the patient) relative to the outer flexible ring 14. Accordingly, upon reading the present specification, one of skill in the art will appreciate a wide variety of ways to utilize and position the retractor device 10 described herein. All such alternative

implementations and uses are contemplated within the scope of the present disclosure. The retractor device 10 described herein can be implemented in accordance with any suitable application or use.

The retractor device 10 additionally can include a lighting assembly 20 for directing light into the abdominal cavity formed by the retractor device 10. In the illustrative embodiment of FIGS. 1 through 3, the lighting assembly 20 includes at least one and preferably a series of light-emitting elements 22, a power source 24 (e.g., adapted to provide AC power, DC power, etc.), and a control unit 26. The lighting assembly 20 further can include electrical wiring 28 connecting the component parts of the lighting assembly 20 as necessary, and as would be appreciated by one of skill in the art upon reading the present specification.

In the illustrative embodiment of FIGS. 1 through 3, the light-emitting elements 22 are disposed on or in the inner flexible ring 12, and face inward toward the body cavity and generally away from the outer flexible ring 14 (e.g., face downward, as oriented in FIGS. 1 through 3). Thus, during operation, light that is emitted from the light-emitting elements 22 shines on the open channel formed by the retractor device 10, and/or is directed downward toward the internal body parts or lumen being operated on. In this manner, a surgeon reaching into the open channel from above does not block the light or impair visibility of the open channel or the internal body parts/lumens. In the illustrative embodiment of FIGS. 1 through 3, the light-emitting elements 22 are formed integral with the inner flexible ring 12.

Alternatively, the light-emitting elements 22 are affixed with the inner flexible ring 12 (e.g., via one or more fastening mechanisms, such as fasteners, adhesives, mating members, etc.), or otherwise adjoined with the inner flexible ring 12.

The placement and orientation of the light-emitting elements 22 as shown in the embodiment of FIGS. 1 through 3 is illustrative and in no way limiting with regard to the present disclosure. As will be appreciated by one of skill in the art upon reading the present specification, the light-emitting elements 22 alternatively can be disposed at a variety of other positions (e.g., facing inward toward the open channel). All suitable positions and placements are contemplated by the present specification. As depicted in FIG. 4A, the light-emitting elements 22 can include one or more LEDs, e.g., with a current rating of 20 mA. Optionally, the one or more LEDs can be adapted with a custom battery design, in which a battery is integrated into each of the one or more LEDs. For example, FIG. 4B depicts an AAAA battery adapted to be utilized with the LED of FIG. 4A. FIG. 4B provides various dimensions

(provided in millimeters) that can be used to build the AAAA battery. It should be appreciated that these dimensions are illustrative and in no way limit the embodiments described herein. The dimensions can be modified as would be appreciated by one of skill in the art upon reading the present specification, e.g., to meet the needs of the particular selected light-emitting elements 22. Furthermore, alternatively to using LEDs, the light-emitting elements 22 may include any other suitable light-emitting element(s). For example, the light-emitting elements 22 can include one or more LCDs (e.g., modified LCDs).

Alternatively to using an AAAA battery, the power source 24 can include any other suitable power source, including any suitable disposable battery or rechargeable battery, photovoltaic cells (e.g., modified photovoltaic cells), or any other suitable power source. The control unit 26 can include a switch (e.g., on-off membrane control switch) or any other suitable mechanism for controlling the one or more light- emitting elements 22. Optionally, the control unit 26 can include mechanisms enabling a user to modify the brightness and/or other light control functionality (e.g., light color, light polarization and any other modifiable characteristics of the light being emitted from the lighting assembly 20). The electrical wiring 28 can be of a conventional sheathed-conductor type, as would be appreciated by one of skill in the art upon reading the present specification. As stated previously herein, the electrical wiring 28 can electrically couple the control unit 26 to the light-emitting elements 22. In illustrative embodiments adapted for commercial applications, the light- emitting elements 22 can include a series of three to five white LEDs (e.g., rated 5V and 12W), which are built into the inner ring (e.g., formed integral) during the manufacture thereof. The light-emitting elements 22 can be spaced apart equally around the inner flexible ring 12. To provide an increased or decreased lighting effect, more or fewer LEDs can be included and/or can be selected with a higher or lower wattage rating. The power source 24 can include a disposable AAAA battery, which can be customized to have a curvature that conforms to the curvature of the inner flexible 12. As will be appreciated by one of skill in the art upon reading the present specification, the power source 24 can be selected to meet the various requirements (e.g., voltage, power, current, etc.) of the light-emitting elements 22. In embodiments of the retractor device 10 in which the light-emitting elements 22 are formed integral with the inner flexible ring 12, the light-emitting elements 22 can be disposed inside of the inner flexible ring 12 (i.e., disposed partially or fully within the interior volume of the inner flexible ring 12), as depicted in FIGS. 1 through 3. In such embodiments of the retractor device 10, the inner flexible ring 12 can be made of a transparent material, such as a silicon tube, allowing light from the light-emitting elements 22 to shine circumferentially outward, thereby producing an evenly distributed lighting effect on multiple sides of the inner flexible ring 12. In some alternative embodiments of the retractor device 10, the power source 24 and the control unit 26 are mounted to the outer flexible ring 14 and the electrical wiring 28 spans the length of the sleeve 16. In some alternative embodiments of the retractor device 10, some of the light-emitting elements 22 are pointed downward away from the outer flexible ring 14 and some of the light-emitting elements 22 are pointed radially (e.g., relative to the inner and outer flexible rings 12, 14) inward and/or outward, for illuminating a larger working area.

The retractor device 10 further can include an inner (e.g., lower) organ retractor assembly 30 for retracting organs radially outward within the abdominal cavity, thereby clearing a work area and providing a surgeon with greater access to the desired surgical site. For example, the inner organ retractor assembly 30 can include an inner organ retractor ring 32 and at least one (e.g., two are depicted) inner organ retractor appendage 34 adapted to press against organs or internal body parts and thereby clear a space, e.g., within which the surgeon may operate. In the illustrative embodiment of FIGS. 1 through 3, the inner organ retractor appendages 34 each include a flared and curved strip of material extending into the body cavity in a direction away from the outer flexible ring 14. The inner organ retractor appendages 34 curve slightly radially out away from the inner organ retractor ring 32 to provide greater clearance of space when pressing against internal organs or body parts (e.g., muscle walls). For each inner organ retractor appendage 34, the distal end can be wider than the proximal end, in a flared manner. The inner organ retractor appendages 34 can be formed of a malleable or resiliently deflectable material (e.g., soft stainless steel or plastic). The distal end of the inner organ retractor appendages 34 can be adapted to grip the internal organs or body parts, thereby aiding in retaining the gripped organs or body parts in a retracted (e.g., radially outward) position. For instance, in the illustrative embodiment of FIGS. 1 through 3, the inner organ retractor appendages 34 each include at least one notch 36 for gripping organs or other body parts. For example, the inner organ retractor appendages 34 can be formed by modifying conventional deep organ retractor blades such as Deaver retractor blades to produce the inner organ retractor appendages 34 described and depicted herein. In some alternative embodiments of the retractor device 10, the inner organ retractor appendages 34 include still other types of modified surgical retractor devices.

The inner organ retractor ring 32 is coupled to the inner flexible ring 12, and preferably is detachable from and re-attachable to the inner flexible ring 12 (i.e., releasably coupled to the inner flexible ring 12 and removable in an operationally viable manner). For example, the inner organ retractor ring 32 can be coupled to the inner flexible ring 12 by one or more snapping members 36 shaped in such a way as to snap onto an inner surface of the inner flexible ring 12. The snapping members 36 can be formed of similar material as the inner organ retractor ring 32.

In the illustrative embodiment of FIGS. 1 through 3, the retractor device 10 additionally includes an outer (e.g., upper) organ retractor assembly 40. The outer organ retractor assembly 40 is further depicted in FIGS. 5 and 6. As illustrated, the outer organ retractor assembly 40 can include an outer organ retractor ring 42. A series of indentations 44 (e.g., slits, slots, etc.) can be formed in the outer organ retractor ring 42 and spaced apart at regular intervals for receiving conventional malleable or other flexible retractor blades adapted to assist in retracting organs (e.g., the skin) nearer the abdominal incision in manner providing a cleared surgical work area. The outer organ retractor ring 42 couples with the outer flexible ring 14, preferably in detachable and re-attachable manner. For example, as depicted in

FIGS. 5 and 6, the outer organ retractor ring 42 can include one or more snapping members 46 configured to snap onto an outer curved surface of the outer organ retractor ring 42. The one or more snapping members 46 can be made of a material that is the same as or similar to that of the outer organ retractor ring 42.

It should be noted that the outer flexible ring 14 can include just a single ring or can include multiple co-axial rings (e.g., having the same radius). In such embodiments of the retractor device 10 where the outer flexible ring 14 includes multiple co-axial rings, the outer organ retractor ring 42 can be mounted to the distal- most (e.g., uppermost) of these multiple co-axial rings. The indentations 44 can be adapted to engage tissue fixation members. For instance, FIG. 7 depicts an illustrative embodiment of the retractor device 10 further including such tissue fixation members 45. As shown, the tissue fixation members 45 are securely received by the indentations 44 (e.g., "wedged" therein). In the illustrative embodiment of FIG. 7. the tissue fixation members 45 include hooks, wires (e.g., sterile and medical-grade) having sharp-tipped or harpoon-like ends suitable for puncturing, gripping, latching, or otherwise coupling with body tissue. The tissue fixation members 45 alternatively or additionally can include clip-type internal organ retractors (as would be understood by one of skill in the art) adapted to clip onto tissue and thereby retain the tissue in a retracted position. As illustrated, such body tissue 47 is pinned back and held in a retracted position by the tissue fixation members 45. In the illustrative embodiment of FIG. 7, the indentations 44 are formed at an outer perimeter edge of the outer organ retractor ring 42 and extend inward toward the longitudinal axis 15. As the indentations 44 move inward toward the longitudinal axis 15, the indentations 44 narrow to a thin slit adapted to securely engage the tissue fixation members 45.

Alternatively or additionally to including the indentations 44 in the outer organ retractor ring 42, the outer organ retractor ring 42 can include tabs (not shown) (e.g., T-shaped tabs) or tab pairs (not shown) (e.g., the tab pairs defining a slot therebetween), which can extend radially outward from the outer organ retractor ring

42 and which can be adapted to engage the outer tissue fixation members 45.

Furthermore, additionally or alternatively to the indentations 44 being adapted for receiving the outer tissue fixation members 45, the indentations 44 can be adapted to receive sutures. For instance, FIG. 8, depicts an illustrative embodiment of the retractor device 10 further including such sutures 49 situated in the indentations 44. As depicted in the illustrative embodiment of FIGS. 1 through 3, the power source 24 can be adjoined with the retractor device 10, for example at the inner flexible ring 12, at the outer flexible ring 14, the sleeve 16, or at another component part thereof. Alternatively, the power source 24 can be external to (e.g., distant from) the retractor device 10. For example, the power source 24 can be a multi-pronged plug configured to be inserted into an electrical socket. In such embodiments of the retractor device 10, the control unit 26 may be excluded from the retractor device 10 altogether, may be placed external to (e.g., distant from) the retractor device 10, or may be adjoined with the retractor device 10 as previously described herein.

For instance, FIGS. 9 through 13 depict an illustrative embodiment in which the power source 24 is external to the retractor device 10. In the illustrative embodiment of FIGS. 9 through 13, the electric wiring 28 includes a wire 29 running from the light-emitting elements 22 on the inner flexible ring 12, up the length of the sleeve 16 (e.g., a portion or all of the length of the sleeve 16), and away from the retractor device 10 to the externally-located power source 24. As illustrated best in

FIG. 13, the wiring 28 can run along the inner flexible ring 12 and can couple to the wire 29 at a terminal end of the wire 29, thereby electrically connecting the light- emitting elements 22 to the external power source 24. Optionally, in such embodiments of the retractor device 10, rather than utilizing an on/off control mechanism or including the control unit 26, control of the light-emitting elements 22 can be achieved by connecting and disconnecting the power source 24 (e.g., by plugging and unplugging the plug from the electrical socket).

For safety purposes, the wire 29 optionally can be formed integral with (e.g., disposed within the internal volume of) the sleeve 16, or can be mounted to the sleeve

16. For example, the wire 29 can be sandwiched between the sleeve 16 and a strip of material 48, as depicted in FIG. 14. Alternatively or additionally, the wire 29 can be formed integral with and disposed within the strip of material 48. In such

embodiments of the retractor device 10 where the wire 29 is formed integral with the strip of material 48, the strip of material 48 can be bonded to the sleeve 16 (e.g., using adhesives, etc.). Furthermore, to allow for stretching of the sleeve 16, the wire 29 can include one or more extra lengths thereof (e.g., "slack"), which can be shaped into loops or can be helically wound around the sleeve 16. As illustrated, the strip of material 48 can be a thin strip relative to the circumference of the sleeve 16.

Alternatively, the strip of material 48 can form an additional layer surrounding the entirety of a perimeter of sleeve 16.

In addition to serving as slots for receiving retractor blades, the indentations 44 can be used to receive sutures. For instance, FIG. 15 depicts an illustrative embodiment of the retractor device 10 in which the indentations 44 are adapted to receive sutures. As shown in FIG. 15, each of the indentations 44 is a V-shaped recess positioned across a top surface of the outer organ retractor ring 42. At the tip of the V-shaped recess is a narrow slit which can be sized and dimensioned to secure the sutures (e.g., can have a width that is smaller than a diameter of an uncompressed suture, so as to hold the suture tightly in place). During surgery, a surgeon can insert sutures into the indentations 44, by pulling the sutures tightly into place, thereby securing the position of the sutures.

In some alternative embodiments of the retractor device 10, the indentations 44 can be recessed radially into the outer organ retractor ring 42 (e.g., as depicted in FIGS. 5 and 6). Furthermore, tabs (not shown) can be included in the retractor device 10, adapted to secure the sutures by providing a structure around which the sutures may be wrapped. Such tabs can extend axially and/or radially outward from the outer organ retractor ring 42. Furthermore, a combination of such indentations 44 and such tabs (not shown) can be included in the retractor device 10. In such embodiments, the indentations 44 and/or tabs can be disposed directly on the outer organ retractor ring 42 and/or on a separate ring (not shown) coupled to the outer organ retractor ring 42. The inner organ retractor appendages 34 can be adapted to possess the capability to pivot from an operational position (e.g., as depicted in FIGS. 1 through 3) into a storage position. For example, FIG. 16 depicts one such embodiment of the retractor device 10 in which the inner organ retractor appendages 34 are pivotally coupled to the inner organ retractor ring 32. In particular, FIG. 16 depicts the inner organ retractor appendages 34 situated in a first position enabling storage thereof. In this first storage position depicted in FIG. 16, the inner organ retractor appendages 34 are flush against the inner organ retractor ring 32. In embodiments where the inner organ retractor appendages 34 are adapted to pivot between such a storage position (e.g., as depicted in FIG. 16) and an operational position (e.g., as depicted in FIGS. 1 through 3), the inner organ retractor appendages 34 can be coupled to the inner organ retractor ring 32 by a bearing that forms a snap fit around the inner organ retractor ring 32 or other suitable coupling mechanism enabling the pivotal motion described herein. Accordingly, in such embodiments, the inner organ retractor appendages 34 are enabled to pivot from the first pivotal position adapted for storage thereof (e.g., as depicted in FIG. 16) into a second pivotal position adapted for operation thereof (e.g., as depicted in FIGS. 1 through 3). The inner organ retractor appendages 34, when pivotal, can be pivoted while the inner organ retractor ring 32 is disconnected from inner flexible ring 12 of the retractor device 10.

It should be noted that in some embodiments of the retractor device 10, the lighting assembly 20 optionally can be excluded. For example, as depicted in FIGS.

15 and 16, the lighting assembly 20 is not included in the retractor device 10. In such embodiments, the retractor device 10 includes the flexible inner ring 12, the flexible outer ring 14, the sleeve 16, and an organ retractor ring (e.g., the inner organ retractor ring 32 and/or the outer organ retractor ring 42). Alternatively, retractor device 10 of the embodiment of FIG. 15 and/or the retractor device 10 of the embodiment of FIG.

16 can further include the lighting assembly 20. In addition to the light-emitting elements 22, the lighting assembly 20 generally can include one or more (e.g., a series of) light transmitters (e.g., optical fibers and/or other optical waveguides) disposed in or on the sleeve 16. For example, FIG. 17 depicts one such embodiment of the retractor device 10, in which a plurality of optical fibers 50 formed integral with (e.g., manufactured into or mounted onto) the sleeve 16. In operation, the optical fibers 50 can be adapted to direct light originating at one or more of the light-emitting elements 22 radially inward into the open channel formed by the retractor device 10. In this way, the optical fibers 50 can provide additional dispersal of the light produced by the light-emitting elements 22 through the open channel formed by the retractor device 10, thereby enabling yet greater visibility. The inner flexible ring 12 optionally can be constructed of one or more fiber optic light tubes. For example, FIG. 18 depicts an illustrative embodiment of the retractor device 10 in which the inner flexible ring 12 is made up of a fiber optic light tube adapted to emit light radially (in all directions) along its length. In such embodiments where the inner flexible ring 12 comprises one or more fiber optic light tubes (e.g., as depicted in FIG. 18), the light-emitting element 22 can be built into

(e.g., formed integral with) and disposed in the fiber optic light tube forming the inner flexible ring 12 (e.g., as shown in FIG. 18). Alternatively, the light-emitting elements 22 can be external to the fiber optic light tube forming the inner flexible ring 12 and can be coupled to the fiber optic light tube. Additionally, the power source 24 (not shown in the illustrative embodiment of FIG. 18) and the control unit 26 (not shown in the illustrative embodiment of FIG. 18) can be built into (e.g., formed integral with) the fiber optic light tube forming the inner flexible ring 12. Alternatively, the power source 24 and/or the control unit 26 can be external to the fiber optic light tube forming the inner flexible ring 12 and coupled to the light-element elements 22. Upon reading the present specification, one of skill in the art will appreciate a variety of ways to implement such an inner flexible ring 12 comprising one or more fiber optic light tubes. All such alternatives and modifications are contemplated within the scope of the present invention. As described previously herein, in the illustrative embodiment of FIGS. 1 through 3, the light-emitting elements 22 are formed integral with the inner flexible ring 12. Alternatively, the light-emitting elements 22 can be coupled to the inner flexible ring 12 by at least one fastening mechanism. For example, FIG. 19 depicts an embodiment of the retractor device 10 in which each of the light-transmitting elements 22 is coupled to a clip that is mounted to the inner flexible ring 12. In such embodiments, the light-emitting elements 22 can be easily replaced and coupled with the inner flexible ring 12, e.g., by snapping thereto. Alternatively or additionally to including the clips, the retractor device 10 can include any other suitable fastening mechanism(s), as would be appreciated by one of skill in the art upon reading the present specification. The retractor device 10 additionally can include a cap configured to securely and stably receive one or more medical instruments or devices. For example, the cap can be adapted to couple with the outer organ retractor ring 42 (e.g., via a snap-fit). FIGS. 20 through 22 illustrate one illustrative embodiment of the retractor device 10 including such a cap 52 adapted to couple with the outer organ retractor ring 42 and configured to securely and stably receive a medical instrument or device. As illustrated, the cap 52 can include a through-hole 54 forming an access port for receiving the medical instrument or device. The through-hole 54 can be lined with a gel (e.g., viscous) material that effectively "grips" the medical instrument or device when positioned in the through-hole, thereby stabilizing the position of the medical instrument or device relative to the position of the through-hole 54. The cap 52 thus forms a snug fit with the medical instrument or device supported in part by the friction between the medical instrument or device and the gel. For example, FIG. 22 depicts the cap 52 coupled to the outer organ retractor ring 42 with a medical device 58 received by and passing through the through-hole 54.

When the cap 52 is coupled with (e.g., snapped into) the outer organ retractor ring 42, the retractor device 1 0 provides a single port for insertion of medical instruments, e.g., during laparoscopy (such as trocars, laparoscopes, deployment devices for hernia patches, catheters, and the like). However, multiple such through- holes 54 alternatively can be included in the cap 52 for receiving multiple medical devices or instruments. In use, the retractor device 10 can be inserted into and through an incision in the body of a patient. In embodiments where the retractor device 10 includes one or more organ retractor assemblies (such as the inner organ retractor assembly 30 and/or the outer organ retractor assembly 40), the one or more organ retractor assemblies can be coupled to the flexible inner ring 12 and/or flexible outer ring 14 prior to, during, or subsequent to insertion of the retractor device 10 through the incision (as would be appreciated by one of skill in the art upon reading the present specification). Upon inserting the retractor device 10 in the incision, the retractor device 10 can be caused to assume an open configuration (e.g., as depicted in FIG. 1). In some cases, one or more members (e.g., inner organ retractor appendages 34, sutures 49, tissue fixation members 45, clip-type retractors, etc.) are coupled to the retractor assembly and used to retract one or more of the patient's tissues and/or organs. For example, depending on their type, the one or more members adapted to retract one or more organs and/or tissues can be coupled prior to or subsequent to insertion of the retractor device 10 into/through the incision. In embodiments where the retractor device 10 includes one or more light-emitting elements 22, the light-emitting elements 22 can be activated to shine light (i.e., by supplying power thereto). In this way, the retractor device 10 can assist in retracting body organ(s) and/or tissue(s) and can provide increased illumination of interior portions of the body and/or of the open channel 1 8.

The embodiments disclosed herein are described with reference to an illustrative use in abdominal surgeries involving small incisions. However, one of skill in the art will appreciate a wide variety of additional and/or alternative medical, surgical, and other applications in which the retractor device 10 can be utilized and for which the retractor device 10 is suitable. All such alternatives, modifications, and uses are contemplated within the scope of the present disclosure. The retractor device 10 can be utilized and implemented for any suitable application or use. For example, the retractor device 10 alternatively can be adapted for use in vaginal surgeries. In such embodiments, the dimensions and shapes of the inner and outer flexible rings 12, 14 (as well as of the sleeve 16) can be selected for use in a vaginal incision or passageway. Such vaginal surgeries can include, without limitation, vaginal hysterectomy and intra-peritoneal operations such as oopherectomy/GYN surgery. Additionally, the retractor device 10 possibly can be utilized to provide novel surgical approaches, such as trans-vaginal cholecystectomy (gall bladder removal), natural- orifice surgeries such as natural orifice translumenal endoscopic surgery (NOTES), and potentially in other novel surgical procedures.

Numerous modifications and alternative embodiments of this disclosure will be apparent to those skilled in the art in view of the foregoing description.

Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the retractor device 10. Details of the structure may vary substantially without departing from the spirit of the present disclosure.

Claims

CLAIMS What is claimed is:

1. A soft-tissue retractor device, comprising:

an outer flexible ring;

an inner flexible ring;

a sleeve extending between the outer ring and the inner ring; and

one or more light-emitting elements joined with one or more of the outer flexible ring, the inner flexible ring, or the sleeve.

2. The retractor device of claim 1 , wherein the one or more light-emitting elements are coupled or operationally coupled to one or more of the outer flexible ring, the inner flexible ring, or the sleeve.

3. The retractor device of claim 1, wherein the one or more light-emitting elements are disposed in or on one or more of the outer flexible ring, the inner flexible ring, or the sleeve.

4. The retractor device of claim 1 , wherein the one or more light-emitting elements are formed integral with the inner flexile ring.

5. The retractor device of claim 1, wherein the inner flexible ring comprises one or more fiber optic light tubes.

6. The retractor device of claim 1 , wherein the one or more light-emitting element comprise one or more light-emitting diodes (LEDs) or one or more liquid crystal displays (LCDs).

7. The retractor device of claim 1 , further comprising a power source coupled to the one or more light-emitting elements for supplying electrical power to the one or more light-emitting elements, and further comprising a control unit for controlling operation of the one or more light-emitting elements.

8. The retractor device of claim 7, wherein the control unit comprises an on-off switch.

9. The retractor device of claim 7, wherein the power source comprises one or more disposable batteries, one or more rechargeable batteries, one or more photovoltaic cells, or a plug adapted to be received by an electrical socket.

10. The retractor device of claim 7, further comprising electrical wiring coupling one or more of the light-emitting elements, the power source, and the control unit.

1 1. The retractor device of claim 1 , further comprising electrical wiring coupling the one or more light-emitting elements to a power source external to the retractor device.

12. The retractor device of claim 1 1 , further comprising one or more strips of material covering the electrical wiring, the electrical wiring being disposed under or integral with the one or more strips of material.

13. The retractor device of claim 1, wherein the one or more light-emitting elements are disposed on the inner flexible ring by one or more clips.

14. The retractor device of claim 1 , wherein the one or more light-emitting elements are disposed in and formed integral with the inner flexible ring.

1 5. The retractor device of claim 1 , wherein the one or more light-emitting elements are disposed in or on the inner flexible retractor, and wherein the retractor device further comprises one or more optical fibers or optical waveguides disposed in or on the sleeve and adapted to propagate light emitted from the light-emitting elements.

16. The retractor device of claim 1 , further comprising an inner organ retractor ring coupled to the inner flexible ring and one or more inner retractor appendages extending from the inner flexible ring.

17. The retractor device of claim 16, wherein each inner retractor appendage of the one or more inner retractor appendages is adapted to pivot between a first pivotal position in which that inner retractor appendage is adapted for operational use and a second pivotal position in which that retractor appendage is adapted for storage.

18. The retractor device of claim 16, further comprising a notch in each of the one or more inner retractor appendages.

19. The retractor device of claim 16, wherein each of the one or more inner retractor appendages extends axialiy away from the inner organ retractor ring and radially out from the inner organ retractor ring.

20. The retractor device of claim 1 , further comprising an outer organ retractor ring coupled to the outer flexible ring, the outer organ retractor ring adapted to support one or more retractor appendages, one or more sutures, or both.

21. The retractor device of claim 20, further comprising one or more indentations formed in the outer organ retractor ring, the one or more indentations adapted to receive one or more retractor appendages, one or more sutures, or both.

22. The retractor device of claim 21 , wherein the one or more indentations extend radially, axialiy, or both into the outer organ retractor ring.

23. The retractor device of claim 1 , further comprising a cap coupled with the flexible outer ring, the cap comprising a through-hole, the through-hole providing an access port for receiving a medical instrument or device.

24. A retractor device, comprising: an outer flexible ring;

an inner flexible ring;

a sleeve extending between the outer ring and the inner ring; and

an organ retractor ring coupled to one of the outer flexible ring or the inner flexible ring.

25. The retractor device of claim 24, further comprising an additional organ retractor ring coupled to the other of the outer flexible ring or the inner flexible ring.

26. The retractor device of claim 24, wherein the organ retractor ring is coupled to the outer flexible ring.

27. The retractor device of claim 26, further comprising one or more indentations in the organ retractor ring adapted to receive sutures or retractor members.

28. The retractor device of claim 24, wherein the organ retractor ring is coupled to the inner flexible ring.

29. The retractor device of claim 28, further comprising one or more retractor appendages coupled to the organ retractor ring, the one or more retractor appendages extending axially and radially away from the organ retractor ring.

30. The retractor device of claim 29, wherein each retractor appendage of the one or more retractor appendages are adapted to pivot between a first pivotal position in which that inner retractor appendage is adapted for operational use and a second pivotal position in which that retractor appendage is adapted for storage.

31. The retractor device of claim 24, further comprising one or more light-emitting elements joined with one or more of the outer flexible ring, the inner flexible ring, or the sleeve.

32. The retractor device of claim 31 , wherein the inner flexible ring comprises one or more fiber optic light tubes adapted to transmit light shining from the one or more light-emitting elements.

33. The retractor device of claim 31 , further comprising a power source coupled to the one or more light-emitting elements for supplying electrical power to the one or more light-emitting elements, and further comprising a control unit for controlling operation of the one or more light-emitting element.

34. The retractor device of claim 33, further comprising electrical wiring coupling one or more of the light-emitting elements, the power source, and the control unit.

35. A soft-tissue retractor device, comprising:

an outer flexible ring and an inner flexible ring substantially coaxially aligned on a longitudinal axis;

a sleeve extending between the outer ring and the inner ring and completely around the longitudinal axis, the sleeve having an interior volume defining an open channel between the outer flexible ring and the inner flexible ring when the retractor device is in an open configuration;

an organ retractor ring coupled to the outer flexible ring or the inner flexible ring; and

one or more light-emitting elements joined with one or more of the outer flexible ring, the inner flexible ring, or the sleeve, the one or more light-emitting elements adapted to illuminate the open channel, a volume of space adjacent the retractor device, or both.

36. A method, comprising:

providing a retractor device, comprising:

an outer flexible ring;

an inner flexible ring;

a sleeve extending between the outer ring and the inner ring; and one or more light-emitting elements joined with one or more of the outer flexible ring, the inner flexible ring, or the sleeve;

inserting the retractor device into an incision; and

causing the one or more light-emitting elements to shine light.

37. The method of claim 36, further comprising coupling an inner organ retractor assembly to the retractor device and using the inner organ retractor assembly to retract one or more organs or tissues.

38. The method of claim 36, further comprising coupling an outer organ retractor assembly to the retractor device and using the outer organ retractor assembly to retract one or more organs or tissues.

39. A method, comprising:

providing a retractor device, comprising:

an outer flexible ring;

an inner flexible ring;

a sleeve extending between the outer ring and the inner ring;

an organ retractor ring coupled to one of the outer flexible ring or the inner flexible ring; and

one or more members coupled to the organ retractor ring for retaining one or more organs or tissues in a retracted position;

inserting the retractor device into an incision; and

using the one or more members coupled to the organ retractor ring to retract one or more organs or tissues.

40. The method of claim 39, wherein the one or more members comprise one or more inner retractor appendages, one or more retractor blades, one or more sutures, or one or more tissue fixation devices.

41 . The method of claim 39, further comprising causing one or more light-emitting elements included in the retractor device to shine light.