A laparoscopic surgical procedure is often preferred to a laparotomy due to shorter recovery times and the reduced adverse impact that it has on the patient's wellbeing. As part of the laparoscopic surgical procedure, a temporary pneumoperitoneum is formed in the patient's abdomen to separate the skin, tissue, and muscle from the organs in the abdominal cavity below. This is achieved by insufflating the patient's abdomen with an inert gas, usually carbon dioxide (CO2) which is supplied via needle injection.
The present description will be understood more fully when viewed in conjunction with the accompanying drawings of various examples of medical devices for use in the creation of a temporary pneumoperitoneum. The description is not meant to limit the medical devices to the specific examples. Rather, the specific examples depicted and described are provided for explanation and understanding of medical devices for use in the creation of a temporary pneumoperitoneum. Throughout the description the drawings may be referred to as drawings, figures, and/or FIGs.
Medical devices for use in the creation of a temporary pneumoperitoneum, as disclosed herein, will become better understood through a review of the following detailed description in conjunction with the figures. The detailed description and figures provide merely examples of the various embodiments of medical devices for use in the creation of a temporary pneumoperitoneum. Many variations are contemplated for different applications and design considerations; however, for the sake of brevity and clarity, all the contemplated variations may not be individually described in the following detailed description. Those skilled in the art will understand how the disclosed examples may be varied, modified, and altered and not depart in substance from the scope of the examples described herein.
Conventional devices restrict the movement of a medical apparatus inserted through the device into the patient's abdomen and allow little or no room for positional adjustment of the medical apparatus. Secondly, some of the known devices have a relatively complex construction which increases the cost of manufacture. As these devices are intended to be disposable, a low manufacturing cost is essential. Additionally, the complexity of conventional devices increases the learning curve as well as a risk of user error or device failure.
Implementations of the medical devices for use in the creation of a temporary pneumoperitoneum, as disclosed herein, may address some or all of the problems described above. For example, embodiments disclosed herein allow for adjustment and manipulate of the medical device relative to the surgical site and also allow for the maneuvering of medical apparatuses within the medical device while in place at the surgical site. Embodiments described herein also allow for removal of the medical device from the surgical site while allowing persistent use of an indwelling trocar line. In other words, the trocar need not be removed to remove the medical device from the surgical site. Additionally, the relative lack of complexity of the medical device reduces cost, potential user error, and failure rate of the medical device itself. For example, in many surgical operations, it is advantageous to leave a trocar or other medical apparatuses indwelling while removing the medical device to provide clear access for additional medical apparatuses to be introduced, laterally or otherwise, to the surgical site without interference from the medical device.
In some embodiments, the medical device 100 includes a rigid dome 102, a sealing element 104, a septum 106, a vacuum port 107, and a raised structure 108. The rigid dome 102 is an approximately substantially hemispherical or dome-shaped structure having a first dome section 110 and a second dome section 112. The first dome section 110 and the second dome section 112 form the rigid dome 102 when joined together. In other words, the first dome section 110 has a semi-hemispherical geometry or constitutes a portion of the hemispherical geometry of the rigid dome 102 while the second dome portion 112 has a semi-hemispherical geometry complimentary to the first dome section 112.
The first dome section 110 and the second dome section 112 may each form an equal half of the rigid dome 102. In some embodiments, one of the first dome section 110 or the second dome section 112 constitutes a greater portion of the rigid dome 102 that the other. In some embodiments, at least one of the first dome section 110 or the second dome section 112 is transparent or semi-transparent to facilitate viewing of a surgical site on an interior of the rigid dome 102. A radius of curvature of the first dome section 110 may be equivalent to a radius of curvature of the second dome section 112. In some embodiments, the curvature or other geometry of the first dome section 110 is different from a corresponding geometry in the second dome section 112.
In some embodiments, the first dome section 110 is wholly releasable from the second dome section 112 to allow for the rigid dome 102 to be removed and leave a medical apparatus, inserted through the rigid dome 102, to be left in place. In other embodiments, the first dome section 110 is partially releasable from the second dome section 112 and remains coupled to the second dome section 112 at, for example, a hinge, tether, joint, or so forth. In some embodiments, the remaining connection between the first dome section 110 and the second dome section 112 is further separable to fully separate the first dome section 110 from the second dome section 112. In other embodiments, the remaining connection between the first dome section 110 and the second dome section 112 is separation resistant. The first dome section 110 of the rigid dome 102 also includes a first patient interface portion 114 of a patient interface 116, a first aperture portion 118 of an aperture 120, and a first joining interface 122.
In some embodiments, the first patient interface portion 114 extends around a base of the first dome section 110. The first patient interface portion 114 may be rolled outward from the first dome section 110 to provide an increased surface area in the first patient interface portion 114 relative to a thickness of the first dome section 110. In some embodiments, the first patient interface portion 114 forms a first portion of the patient interface 116 which extends across both the first dome section 110 and the second dome section 112. The patient interface 116 may reduce a pressure at the surgical site around the rigid dome 102. This may reduce impact to the flow of blood or other fluids or reduce the risk of tissue damage. Additionally, the increased surface area at the patient interface 116 may reduce a risk of exacerbating a wound at the surgical site. In some embodiments, the patient interface 116 may include a coating, liner, treatment, or so forth to improve sanitization, traction, vacuum seal, or so forth.
The first aperture portion 118 forms a portion of an aperture 120 that is opposite the first patient interface portion 114 on the first dome section 110. In some embodiments, the aperture 120 is a circular opening in the rigid dome 102. In other embodiments, the aperture 120 has a non-circular geometry. In some embodiments, the aperture 120 is formed, in equal parts, by both the first dome section 110 and the second dome section 112. In other embodiments, the aperture 120 is formed, in greater degree, by one of the first dome section 110 and the second dome section 112 that the other of the first dome section 110 and the second dome section 112. The aperture 120 may include ridges, depressions, rings, friction fittings, and so forth to improve a seal, retention, releasability, or other characteristics in relation to the septum 106.
In some embodiments, the first joining interface 122 extends along an edge of the first dome section 110 between the first aperture portion 118 and the first patient interface portion 114. In some embodiments, the first joining interface 122 forms a flange, lip, tongue or groove, ledge, or so forth. In some embodiments, the first joining interface 122 is configured to align with the second joining interface 128 to join the first dome section 110 to the second dome section 112 to form the rigid dome 102.
The second dome section 112 of the rigid dome 102 includes a second patient interface portion 124, a second aperture portion 126, and a second joining interface 128. In some embodiments, the second patient interface portion 124 compliments the first patient interface portion 114 to form the entirety of the patient interface 116. In some embodiments, the first patient interface portion 114 forms a portion of the patient interface 116 which extends around a base of the second dome section 112. In some embodiments, the second patient interface portion 124 is rolled outward from the second dome section 112 to provide increased surface area in the second patient interface portion 124 relative to a thickness of the second dome section 112.
The second aperture portion 126 is positioned opposite the second patient interface portion 124 second dome section 112. In some embodiments, the second aperture portion 126 combines with the first aperture portion 118 of the first dome section 110 to form the aperture 120. The second aperture portion 126 may constitute a greater or lesser amount of the aperture 120 relative to the first aperture portion 118. In some embodiments, one or both of the first aperture portion 118 and the second aperture portion 126 includes an alignment feature to correspond with a geometry or feature of the septum 106 to facilitate alignment of the septum within the aperture 120.
In some embodiments, the second joining interface 128 extends along an edge of the second dome section 112 between the second aperture portion 126 and the second patient interface portion 124. The second joining interface 128 may be configured to couple to the first joining interface 122 to join the first dome section 110 to the second dome section 112 to form the rigid dome 102.
In some embodiments, a sealing element 104 is configured to removably seal the first joining interface 122 of the first dome section 110 to the second joining interface 128 of the second dome section 112. In some embodiment, the sealing element 104 is a medical tape. In some embodiments, the sealing element 104 applied to the exterior of the rigid dome 102 to overlap the first joining interface 122 and the second joining interface 128 to seal the first joining interface 122 to the second joining interface 128. The sealing element 104 may be removable from at least one of the first joining interface 122 or the second joining interface 128 to at least partially separate the first dome section 110 from the second dome section 112.
In other embodiments, the sealing element 104 is a low shear strength adhesive. For example, the low shear strength adhesive may be a low shear strength silicon or other low shear strength polymer breakable by hand. The sealing element 104 may be removeable to facilitate separation of the first dome section 110 from the second dome section 112. The sealing effect provided by the sealing element 104 allows for a reduction in leakage of pressure to or from the interior of the rigid dome 102 when the rigid dome 102 is in place at the surgical site. In some embodiments, the sealing element 104 includes a tab, strip, handle, loop, or so forth, to facilitate removal of the sealing element 104 from the rigid dome 102
In some embodiments, the medical device 100 also includes a septum 106. The septum 106 may be positioned within the aperture 120 and form a permeable barrier to allow a medical apparatus to penetrate through the septum 106 to access the interior of the rigid dome 102. The septum 106 may be configured to engage with the first aperture portion 118 of the first dome section 110 and engage with the second aperture portion 126 of the second dome section 112. In some embodiments, the septum 106 is formed from a different material than the rigid dome 102. The use of a different material may allow for easier puncture of the septum 106 relative to the rigid dome 102, thereby facilitating insertion of the medical apparatus through the septum 106.
The medical device 100 may also include a vacuum port 107. In some embodiments, the vacuum port 107 is disposed in the rigid dome 102 between the patient interface 116 and the aperture 120. In some embodiments, the vacuum port 107 forms a fluid pathway between an interior of the rigid dome 102 and an exterior of the rigid dome 102. In some embodiments, the vacuum port 107 facilitates connection of a vacuum source to the rigid dome 102 to reduce a pressure on the interior of the rigid dome 102. In some embodiments, the vacuum port 107 projects outward from the rigid dome 102 in a vertical or angled orientation. The vacuum port 107 may be smooth, threaded, barbed, or so forth, to accept a connection to the vacuum source.
Some embodiments include a vacuum port plug 130. The vacuum port plug 130 may be compatible with the vacuum port 107 to form a barrier at the vacuum port 107 to maintain a reduced pressure on the interior of the rigid dome 102. In some embodiments, the vacuum port plug 130 may be incorporated into the vacuum port 107 to create a one-way valve allowing air to be evacuated from the interior of the rigid dome 102 while resisting the flow of air back into the interior of the rigid dome 102. In some embodiments, the vacuum port plug 130 is actuated by an input on the exterior of the rigid dome 102 to equalize the pressure on the interior of the rigid dome 102 to an exterior pressure.
The medical device 100 may also include a raised structure 108 extending outward from an exterior surface of the rigid dome 102 to form a physical interface to receive a force to physically manipulate the rigid dome 102. For example, a user may grasp the medical device 100 at the raised structure 108 to position the medical device 100 relative to the surgical site, orient the medical device 100 relative to the user or the surgical site, apply a force into or away from a plane of the surgical site, separate the first dome section 110 from the second dome section 112, or so forth. In some embodiments, the raised structure 108 includes grip elements. For example, the raised structure 108 may include ridges, knurling, dimples, coatings, or so forth to increase a friction coefficient of at least a portion of the raised structure 108.
In some embodiments, the septum 106 is sealed in the aperture 120 of the rigid dome 102. In some embodiments, the septum 106 is sealed within the aperture 120 using a material similar to or differing from a material applied at the seam 202. In other embodiments, a structure of the septum 106 is sufficient to maintain a seal relative to the aperture 120.
Additionally, the reduced thickness of the septum 106 at the access structure 502 may provide a visual indicator of the location at which the medical apparatus may be inserted through the septum 106 with reduced chance of impacting the medical apparatus on the rigid dome 102. In some embodiments, the access structure 502 is positioned centrally on the septum 106 forming a recess 504 other either side of the access structure 502. In other embodiments, the access structure 502 may be positioned off-center forming recesses 504 of different sizes or only a single recess on one side of the septum 106 with the access structure 502 being flush to a remainder of the septum 106 on one side of the septum 106.
In some embodiments, the septum 106 includes a retaining structure 506 to apply a retaining force at the aperture 120. In some embodiments, the retaining structure 506 includes raised portions within a channel 508 extending around at least a portion of a perimeter of the septum 106. The retaining structure 506 may be rings formed in the channel 508. The retaining structure 506 may be rounded, squared, beveled, or so forth.
In some embodiments, the medical device 100 includes a septum seat 1002. The septum seat 1002 may be formed around the aperture 120 to facilitate placement and securing of the septum 106. In some embodiments, the septum seat 1002 is a planar region formed around the aperture 120 on each of the first dome section 110 and the second dome section 112. The septum seat 1002 may be annular in geometry and concentric with the aperture 120. In other embodiments, the septum seat 1002 may have other shapes and may have other alignments relative to the aperture 120.
In some embodiments, the septum seat 1002 includes retention holes 1004 extending into a thickness of the first dome section 110 and the second dome section 112. In some embodiments, the retention holes 1004 extend completely through the thickness of the first dome section 110 and the thickness of the second dome section 112 to an interior of the medical device 100. In other embodiments, the retention holes 1004 do not extend completely through the thickness of the first dome section 110 and the thickness of the second dome section 112.
The retention holes 1004 may facilitate securing of the septum 106 into place on the septum seat 1002. In some embodiments, the medical device 100 further includes a retention ring 1005 which may be configured to engage with the retention holes 1004 to secure the septum 106 at the septum seat 1002. In some embodiments, the retention ring 1005 is separable into a first ring portion 1006 and a second ring portion 1008. The separability of the retention ring 1005 may allow for removal of the medical device 100 from around a medical tool such as a trocar, needle, line, or so forth. The retention ring 1005 may be separated into the first ring portion 1006 and the second ring portion 1008 or may require mechanical separation via tearing, cutting, or so forth.
In some embodiments, the medical device 100 includes a sealing element 104 that is pre-shaped to conform to a cross-sectional geometry of the joint between the first dome portion 110 and the second dome portion 112. The sealing element 104 may include a resilient material or a crushable material. For example, the sealing element 104 may include a polymer material, fluoropolymer, silicone rubber, (solid strand or tubing) to form an O-ring style seal or the sealing element 104 may be a metallic, wax, or other crushable seal material to form a gasket style seal. Other sealing methodologies may also be implemented.
In some embodiments, the first retaining band 1014 and the second retaining band 1016 are positioned to retain the first dome portion 110 closed with the second dome portion 112. The first retaining band 1014 and the second retaining band 1016 may be removed by cutting or otherwise severing to remove from the medical device 100 and facilitate separation of the first dome portion 110 from the second dome portion 112 at the joint 202.
In some embodiments, the first retaining band 1014 is positioned near a middle of the medical device 100 while the second retaining band 1016 is positioned near a bottom of the medical device 100. In some embodiments, the first retaining band 1014 and the second retaining band 1016 may apply the same amount or similar retaining force on the medical device 100 to keep the joint 202 sealed. In other embodiments, the first retaining band 1014 may apply more or less force than does the second retaining band 1016 which may be based on a position, thickness, material, or other characteristic or component of the first retaining band 1014 or the second retaining band 1016.
In some embodiments, the septum 106 includes grip tabs 1302. The grip tabs 1302 extend from the septum 106 at an angle from each other to form a location for a surgeon, or other medical personnel, to grip the septum 106. The grip tabs 1302 may include textured portions 1304 to improve grip. This may help to improve grip in the presence of blood, fats, oils, irrigation fluids, and so forth.
In some embodiments, the septum 106 includes a series of tear lines 1308 formed in the structure of the septum 106 to facilitate separation of the septum 106. The tear lines 1308 may coincide with tear notches 1306 or other designed failure points to control a position, direction, or mode of failure or tearing of the septum 106 to prevent unwanted fragmentation or a tear which does not fully separate the septum 106 to release a medical instrument inserted therethrough.
In some embodiments, the septum 106 includes alignment holes 1310. The alignment holes 1310 may be through-holes formed in the septum 106 to facilitate alignment and securing of the septum 106 in conjunction with the septum seat 1002 and the retention ring 1005. For example, the retention ring may be aligned to protrude through the alignment holes 1310 of the septum 106 and into the retention holes 1004 formed in the septum seat 1002.
In some embodiments, the seal texture 1402 is formed as a raised structure disposed in a center of the septum 106. The raised structure of the seal texture 1402 may form a ring to readily accept medical instruments with a round cross-section. Other shapes are contemplated to accommodate non-round cross-sections.
In some embodiments, the retention ring 1005 includes posts 1502 extending perpendicular from a plane of the retention ring 1005. In some embodiments, the posts 1502 are arranged in a pattern around the retention ring 1005. In some embodiments, the posts 1502 are distributed evenly around the retention ring 1005. In some embodiments, the posts 1502 retain the septum 106 to facilitate splitting of the septum 106 in response to separation of the first dome section 110 and the second dome section 112.
In some embodiments, the posts 1502 may have a consistent cross-sectional geometry. In other embodiments, the posts 1502 have a differential geometry. For example, in some embodiments, the posts 1502 have a tip section with a smaller diameter. This variation in geometry may allow the posts 1502 to engage separately with the septum 106 and the retention holes 1004 of the septum seat 1002. The posts 1502 may provide alignment of the retention ring 1005 relative to the first dome section 110 and the second dome section 112 and alignment of the septum 106 with the first dome section 110 and the second dome section 112.
The method 1600 may include coupling a vacuum source to a vacuum port of the rigid dome Block 1604). For example, a vacuum source may be coupled to the vacuum port 107 of the rigid dome 102 to supply a reduced pressure to the rigid dome 102. The method 1600 may include reducing a pressure on an interior of the rigid dome with the vacuum source to raise tissue at the surgical site at least partially into the interior of the rigid dome (Block 1606). For example, as the pressure within the rigid dome 102 is reduced, the tissue at the surgical site under the rigid dome will distend upward into the rigid dome 102.
The method 1600 may include inserting a medical apparatus into the interior of the rigid dome from the exterior of the rigid dome through a septum disposed in an aperture of the rigid dome (Block 1608). For example, the medical apparatus 602 may be inserted through the septum 106 of the rigid dome 102 to access an interior of the rigid dome 102. The method 1600 may include inserting the medical apparatus into the raised tissue at the surgical site to deliver a gas below a surface of the surgical site to form the temporary pneumoperitoneum (Block 1610). For example, the medical apparatus 602 may be introduced into the surgical site, which is distended into the rigid dome 102, to deliver an inert gas (e.g. CO2) below a surface layer of the surgical site to create a temporary pneumoperitoneum at the surgical site to facilitate laparoscopic surgery or another surgical operation.
The method 1600 may include normalizing the pressure within the rigid dome (Block 912). For example, the pressure within the rigid dome 102 may be normalized or equalized by disengaging a vacuum source from the vacuum port 107, manipulating a vacuum port plug 130, lifting the rigid dome 102 from the surgical site, removing a sealing element 104, creating an initial separation between the first dome section 110 and the second dome section 112, or so forth. The method 1600 may include separating a first dome portion from a second dome portion to remove the rigid dome from the surgical site with the medical apparatus remaining indwelling at the surgical site (Block 1614). For example, the first dome section 110 may be separated from the second dome section 112 by grasping the raised structure 108 and applying a force to the rigid dome 102 to overcome a sealing element, removing the sealing element 104, or so forth.
A feature illustrated in one of the figures may be the same as or similar to a feature illustrated in another of the figures. Similarly, a feature described in connection with one of the figures may be the same as or similar to a feature described in connection with another of the figures. The same or similar features may be noted by the same or similar reference characters unless expressly described otherwise. Additionally, the description of a particular figure may refer to a feature not shown in the particular figure. The feature may be illustrated in and/or further described in connection with another figure.
Elements of processes (i.e. methods) described herein may be executed in one or more ways such as by a human, by a processing device, by mechanisms operating automatically or under human control, and so forth. Additionally, although various elements of a process may be depicted in the figures in a particular order, the elements of the process may be performed in one or more different orders without departing from the substance and spirit of the disclosure herein.
The foregoing description sets forth numerous specific details such as examples of specific systems, components, methods and so forth, in order to provide a good understanding of several implementations. It will be apparent to one skilled in the art, however, that at least some implementations may be practiced without these specific details. In other instances, well-known components or methods are not described in detail or are presented in simple block diagram format in order to avoid unnecessarily obscuring the present implementations. Thus, the specific details set forth above are merely exemplary. Particular implementations may vary from these exemplary details and still be contemplated to be within the scope of the present implementations.
Related elements in the examples and/or embodiments described herein may be identical, similar, or dissimilar in different examples. For the sake of brevity and clarity, related elements may not be redundantly explained. Instead, the use of a same, similar, and/or related element names and/or reference characters may cue the reader that an element with a given name and/or associated reference character may be similar to another related element with the same, similar, and/or related element name and/or reference character in an example explained elsewhere herein. Elements specific to a given example may be described regarding that particular example. A person having ordinary skill in the art will understand that a given element need not be the same and/or similar to the specific portrayal of a related element in any given figure or example in order to share features of the related element.
It is to be understood that the foregoing description is intended to be illustrative and not restrictive. Many other implementations will be apparent to those of skill in the art upon reading and understanding the above description. The scope of the present implementations should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
The foregoing disclosure encompasses multiple distinct examples with independent utility. While these examples have been disclosed in a particular form, the specific examples disclosed and illustrated above are not to be considered in a limiting sense as numerous variations are possible. The subject matter disclosed herein includes novel and non-obvious combinations and sub-combinations of the various elements, features, functions and/or properties disclosed above both explicitly and inherently. Where the disclosure or subsequently filed claims recite “a” element, “a first” element, or any such equivalent term, the disclosure or claims is to be understood to incorporate one or more such elements, neither requiring nor excluding two or more of such elements.
As used herein “same” means sharing all features and “similar” means sharing a substantial number of features or sharing materially important features even if a substantial number of features are not shared. As used herein “may” should be interpreted in a permissive sense and should not be interpreted in an indefinite sense. Additionally, use of “is” regarding examples, elements, and/or features should be interpreted to be definite only regarding a specific example and should not be interpreted as definite regarding every example. Furthermore, references to “the disclosure” and/or “this disclosure” refer to the entirety of the writings of this document and the entirety of the accompanying illustrations, which extends to all the writings of each subsection of this document, including the Title, Background, Brief description of the Drawings, Detailed Description, Claims, Abstract, and any other document and/or resource incorporated herein by reference.
As used herein regarding a list, “and” forms a group inclusive of all the listed elements. For example, an example described as including A, B, C, and D is an example that includes A, includes B, includes C, and also includes D. As used herein regarding a list, “or” forms a list of elements, any of which may be included. For example, an example described as including A, B, C, or D is an example that includes any of the elements A, B, C, and D. Unless otherwise stated, an example including a list of alternatively-inclusive elements does not preclude other examples that include various combinations of some or all of the alternatively-inclusive elements. An example described using a list of alternatively inclusive elements includes at least one element of the listed elements. However, an example described using a list of alternatively inclusive elements does not preclude another example that includes all of the listed elements. And an example described using a list of alternatively inclusive elements does not preclude another example that includes a combination of some of the listed elements. As used herein regarding a list, “and/or” forms a list of elements inclusive alone or in any combination. For example, an example described as including A, B, C, and/or D is an example that may include: A alone; A and B; A, B and C; A, B, C, and D; and so forth. The bounds of an “and/or” list are defined by the complete set of combinations and permutations for the list.
Where multiples of a particular element are shown in a FIG., and where it is clear that the element is duplicated throughout the FIG., only one label may be provided for the element, despite multiple instances of the element being present in the FIG. Accordingly, other instances in the FIG. of the element having identical or similar structure and/or function may not have been redundantly labeled. A person having ordinary skill in the art will recognize based on the disclosure herein redundant and/or duplicated elements of the same FIG. Despite this, redundant labeling may be included where helpful in clarifying the structure of the depicted examples.
The Applicant(s) reserves the right to submit claims directed to combinations and sub-combinations of the disclosed examples that are believed to be novel and non-obvious. Examples embodied in other combinations and sub-combinations of features, functions, elements and/or properties may be claimed through amendment of those claims or presentation of new claims in the present application or in a related application. Such amended or new claims, whether they are directed to the same example or a different example and whether they are different, broader, narrower or equal in scope to the original claims, are to be considered within the subject matter of the examples described herein.
This application is a national stage application, filed under 35 U.S.C. § 371, of International Patent Application No. PCT/US20/54415, filed on Oct. 6, 2020, which is incorporated by reference herein in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/054415 | 10/6/2020 | WO |