Embodiments of the present invention relate generally to devices and systems comprising surgical devices and more particularly to attachments for a suction and/or irrigation device used in laparoscopy procedures.
Laparoscopic surgery is minimally invasive surgery, sometimes referred to as keyhole surgery, in which operations are performed through small incisions elsewhere on the body. During laparoscopic surgery, a long fiber optic cable system allows viewing of the surgical site by positioning the cable from a more distant, but easily accessed location. Laparoscopic surgery results in improved surgical outcomes by reducing surgical trauma for the patient.
Performing laparoscopic surgery requires that the surgical site be cleared of fluid and debris so that the surgeon may view the area being treated. Clearing the surgical site can be accomplished by introducing saline solution into the area and then removing the saline and debris via suction. Suction devices for laparoscopic procedures typically consist of straight rigid tubes inserted into the treatment area to introduce or remove fluid. However, concavities of the surgery site leave pockets or areas of fluid that are not readily accessible by a straight tube. Such pockets of fluid are currently removed via sponges which, in turn, must also be removed. A need therefore exists to introduce a flexible tip attachment that can be removably fixed to the distal end of a rigid suction device so that the combined system can maneuver within a surgical treatment site to introduce and remove fluid to aid in the viewing of and treatment of the surgical site. These and other deficiencies of the prior art are addressed by one or more embodiments of the disclosed invention.
Additional advantages and novel features of this invention shall be set forth in part in the description that follows, and in part will become apparent to those skilled in the art upon examination of the following specification or may be learned by the practice of the invention.
Features and objects of the present invention and the manner of attaining them will become more apparent, and the invention itself will be best understood, by reference to the following description of one or more embodiments taken in conjunction with the accompanying drawings attached following this description.
The Figures depict embodiments of the disclosed invention for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the invention described herein.
The invention described herein are devices and systems comprising a flexible tip attachment for use with a laparoscopic irrigation and/or suction device. A rigid laparoscopic device fitted with the disclosed flexible tip can be positioned within a surgical site to provide discrete and localized fluid evacuation and irrigation. The disclosed invention introduces a flexible, shaped probe into a laparoscopic surgical environment allowing surgical personnel to quickly and efficiently evacuate and irrigate the surgical site.
Embodiments of the present invention are hereafter described in detail with reference to the accompanying Figures. Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present disclosure has been made only by way of example and that numerous changes in the combination and arrangement of parts can be resorted to by those skilled in the art without departing from the spirit and scope of the invention.
The following description with reference to the accompanying drawings is provided to assist in a comprehensive understanding of exemplary embodiments of the disclosed invention as defined by the claims and their equivalents. It includes various specific details to assist in that understanding but these are to be regarded as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
The terms and words used in the following description and claims are not limited to the bibliographical meanings, but are merely used by the inventor to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention as defined by the appended claims and their equivalents.
By the term “substantially” it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a,” “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Thus, for example, reference to “a component surface” includes reference to one or more of such surfaces.
As used herein any reference to “one embodiment” or “an embodiment” means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.
As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present), and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity.
It will be also understood that when an element is referred to as being “on,” “attached” to, “connected” to, “coupled” with, “contacting”, “mounted” etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on,” “directly attached” to, “directly connected” to, “directly coupled” with or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Spatially relative terms, such as “under,” “below,” “lower,” “over,” “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of a device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of “over” and “under”. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly,” “downwardly,” “vertical,” “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
The disclosed flexible tip attachments are configured to be used with existing rigid laparoscopic suction and/or irrigation devices. When performing suction, the suction/irrigation device is used to remove fluid and debris from the surgical site, keeping the area clean and dry. When used for irrigation, the device flushes the surgical site with saline or another solution, allowing the surgeon to visualize the surgical field clearly. With reference to
With reference to
With reference to
The flexible tip 310A, 310B is shown in a linear or straight configuration, wherein the tip extends in line with the cannula 12. Different lengths are possible and contemplated for all flexible tip configurations, with a shorter version 310A and a longer version 310B shown. Flexible tip attachment sizes, lengths, and configurations may be chosen by the surgeon, depending on the needs of the surgery being performed.
In addition to the straight configuration, the disclosed flexible tip attachment may have a preformed shape of any configuration of benefit. With reference to
Multiple curve or bend angles are possible and contemplated, as are multiple extension lengths for each shape configuration, all to be determined based on the needs of the surgeon. For example, a straight tip attachment like that depicted in
With reference to
A tip attachment having an open main port with vents, known as a Frazier or Yankauer tip, avoids tissue entrapment during suction by releasing the pressure differential created when the main port is blocked. During irrigation, the Frasier tip can disperse fluid more readily because of the additional avenues for dispersal. The number and size of venting ports is chosen to balance the increased dispersion and decreased tissue entrapment with the decrease in main port fluidic pressure that result from increasing the number or size of venting ports. A tip attachment with a closed main port with vents, known as a Poole or sump tip, allows the user to suction large amounts of fluid while decreasing the chance of the tip becoming blocked by anatomy or debris, e.g., bowel contents. During irrigation, the Poole tip disperses fluids widely because of the increased pressure supplied to the venting ports.
With reference to
With reference to
The laparoscopic system can then perform the irrigation and/or suction tasks in the areas of the surgical site facilitated by the selected flexible tip shape. To perform evacuation of the surgical site, the surgeon would select a suction control 844 that activates a suction source 824 connected to the system through medical tubing (not shown). For irrigation of the site, the surgeon would select an irrigation control 842, which would activate a fluid source 822, also connected by medical tubing (not shown). As is well known and discussed herein, laparoscopic surgery requires removal of debris and fluid at the surgical site to aid in visualization. Conversely, hydro-dissection (using high pressure fluid as a cutting tool) can also be used as an alternative to traditional cutting tools. The system shown in
When removal of the system from the surgical site is desired, the flexible tip 830 will again deflect, this time to trail behind the cannula 810, if necessary, as the system is drawn back through the laparoscopic trocar and out of the body. The user may then remove the attached flexible tip and attach another tip having a different shape to facilitate access to a different area of the surgical site, or to perform some other surgical task.
In some embodiments, the system shown in
The curved flexible tip attachment enables the user to position the laparoscopic suction/irrigation device around anatomical structures and into concave areas. The tip attachment can also help deconflict with other laparoscopic instruments being used at the surgical site and improve visualization. Rather than displacing the laparoscopic instrument to allow a traditional suction/irrigation device into the surgical site, the disclosed invention allows a properly fitted suction/irrigation device to remain out of the way while the distal end of the flexible tip attachment reaches the remote area to evacuate or irrigate the site. Further, because the tip attachment is non-conductive, it can be used in proximity to laparoscopic tools that perform cauterization or dissection without the risk of electrical arcing. The flexible tip attachment thus allows other surgical tools to remain at the surgical site while the modified laparoscopic device restores visualization. Such flexibility and concurrent use of the modified suction/irrigation device allows the surgical team to work more efficiently.
For example, typically a surgeon would use laparoscopic devices at the surgical site, invariably producing fluids and debris that obscure the surgeon's visualization. To restore visualization, the surgeon would withdraw these tools to use a laparoscopic suction/irrigation device fitted with a rigid, often metallic, suction tip. The rigid nature of existing laparoscopic suction tips, however, often causes difficulty in reaching certain areas of the surgical site, resulting in ineffective evacuation of fluids and debris. Additionally, since they are often metallic, existing suction tips also carry a risk of monopolar electrical arcing when used with dissection tools, potentially resulting in patient injury.
With reference to
In another embodiment, a flexible tip attachment is permanently bonded to a rigid attachment that is permanently incorporated into a laparoscopic device.
The flexible tip attachment may be made from medical grade tubing. Medical tubing is used for fluid management and drainage as well as with anesthesiology and respiratory equipment, IVs, catheters, peristaltic pumps, and biopharmaceutical laboratory equipment. There are a broad range of suitable materials used to construct medical tubing. As will be appreciated by one or reasonable skill in the relevant art, the type of material used in the flexible tip attachment determines important performance properties such as abrasion resistance, hardness, flexibility, and durability. Moreover, the pressure rating and vacuum rating of the flexible tip attachment is considered in selecting the grade and specification of the material used in its construction. Materials suitable for use in construction of the flexible tip attachment can include Ethylene Propylene (EP), Fluoro-elastomer (FKM), Isobutylene Isoprene Butyl (IIR), Isoprene (IR), Nitrile Rubber (NBR), Polychloroprene (CR), Polyurethane (PU), Silicone Rubber, Styrene-butadiene (SBR) and the like. Alternatively, the flexible tip attachment may be made of any suitable medical grade, sterilizable, and flexible material, e.g., silicone, nylon, polyurethane, polyurethane terephthalate, latex, elastomers, etc.
The distal end of the flexible tip attachment can achieve 180° deflection, 90° deflection, 450 deflection, or other required angle with respect to the distal end of the rigid cannula of a traditional laparoscopic suction/irrigation device. Curves may be shaped as a tight curve, a long curve, or a slight curve with long extension. The tip attachment may also have a taper wherein the diameter gradually decreases toward the main port. The curved configuration of the flexible tip attachment can be achieved by various techniques known in the art. For example, the shape of the tip attachment may be a pre-formed shape, or may be formed by using a mold, such as through an injection molding process. Alternatively, temperature curing techniques, such as thermoforming or vacuum forming, or any other suitable manufacturing process may be used to create the required curve.
Another feature of the flexible tip attachment is its insulating characteristics. During laparoscopic surgery, the presence of surgical devices using monopolar electricity can result in electrical arcs discharged at the surgical site. If the surgeon is controlling active bleeding or performing dissection with electrocautery, the flexible tip attachment can be used to provide better visualization, better outcomes, and create a safer environment since it can be used closer to electrocautery without causing arcing. Cauterization devices use electrical arc technology to fuse tissue and control hemorrhaging at the surgical site. Such electrical discharges, when uncontrolled, can be harmful. Without the disclosed tip attachment in place, the traditional metallic suction/irrigation devices can cause arcing to occur when used in proximity to electrocautery devices, which may injure adjacent tissue. The flexible tip attachment insulates metallic suction/irrigation devices, substantially reducing or even eliminating any arcing risk.
Another feature of the flexible tip attachment is its ability to protect delicate tissue from abrasion or penetrating injury caused by the rigid metal tips currently in use.
In another embodiment of the present invention, a method for localized fluid injection, or fluid and debris removal, during laparoscopic surgery using the disclosed invention includes positioning the distal end of the tip attachment proximate to a surgical site. As described above, a flexible tip attachment of the required shape is removably attached to the distal end of the cannula of a laparoscopic suction/irrigation device. The tip attachment shape is selected based on the needs of the surgeon to improve visualization as required by the shape of the surgical cavity, the presence of other laparoscopic instruments, or the location of needed suction or irrigation. The modified suction/irrigation device thus includes an elongated substantially rigid cannula having a lumen extending from its distal end to its proximal end. The device further includes the flexible tip attachment having a main port and a lumen extending therethrough. A portion of the tip attachment overlaps a portion of the rigid cannula and a removable seal is created. The shape of the modified rigid cannula with tip attachment is helpful to reach concavities at the surgical site. Upon applying a fluid force to the proximal end of the rigid cannula, suction/irrigation device removes fluid from the surgical site (by application of a suction force) and/or injects fluid to the surgical site (upon application of an irrigation force).
The flexible tip attachment is positioned around anatomical structures to access areas at the surgical site that would be otherwise unreachable with a straight rigid cannula to facilitate effective irrigation or fluid/debris evacuation. Once positioned, a fluidic force (suction or pressure) to the flexible tip attachment is applied via the rigid cannula 1150. Upon completion of the evacuation or irrigation, the fluid force is removed, and the device can then be repositioned or removed from the body 1160. Once outside the body, the user may remove the tip attachment and replace it with an attachment having a different shape to access other areas in the surgical site to perform dissection, retraction, suction, or irrigation. The process can be performed at any time as needed during the procedure to exploit the benefits of the different tip attachment shapes.
As will be understood by those familiar with the art, the disclosed invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Likewise, the particular naming and division of the modules, managers, functions, systems, layers, features, attributes, methodologies, and other aspects are not mandatory or significant, and the mechanisms that implement the invention or its features may have different names, divisions, and/or formats. Accordingly, the disclosure of the present invention is intended to be illustrative, but not limiting, of the scope of the invention.
This has been a description of the disclosed invention along with a preferred method of practicing the invention.
This application claims priority to U.S. Provisional Patent Application No. 63/508,977, filed Jun. 19, 2023, and has specification that builds upon U.S. patent application Ser. No. 16/388,244, filed Apr. 18, 2019, which are hereby incorporated by reference herein in their entirety.
Number | Date | Country | |
---|---|---|---|
63508977 | Jun 2023 | US |