A medical device used to create temporary pneumoperitoneum

Abstract

A medical device for use in creating a temporary pneumoperitoneum includes a rigid dome, a sealing element, a retaining band, a septum, and a vacuum port. The rigid dome includes first and second dome sections. The first dome section engages with the second dome section to form the rigid dome. The retaining band applies a force to secure the first dome section relative to the second dome section. The sealing element seals the first and second dome sections. The septum engages at an opening between the first and second dome sections. The vacuum port connects a vacuum source to the rigid dome and reduces pressure inside the rigid dome.

Description

[Background technology]

[0001] Laparoscopic surgical procedures are often preferred over open surgery due to shorter recovery times and reduced adverse effects on patient health. As part of laparoscopic surgical procedures, a temporary pneumoperitoneum is created within the patient's abdomen to separate the skin, tissue, and muscle from the underlying organs in the abdominal cavity. This is accomplished by injecting an inert gas, usually carbon dioxide (CO2) delivered via needle injection, into the patient's abdomen. [Brief explanation of the drawings]

[0002] This specification will be more fully understood when viewed in conjunction with the accompanying drawings of various embodiments of medical devices used to create temporary pneumoperitoneum. The description is not intended to limit the medical devices to the particular embodiments. Rather, the particular embodiments shown and described are provided for explanation and understanding of medical devices used to create temporary pneumoperitoneum. Throughout the description, drawings may be referred to as drawings, figures, and / or FIGs.

[0003] [Figure 1] FIG. 1 shows an exploded view of a medical device used to create temporary pneumoperitoneum, according to one embodiment. [Figure 2] FIG. 2 shows an assembled view of the medical device of FIG. 1, according to one embodiment. [Figure 3] FIG. 3 shows a cross-sectional view of the medical device of FIG. 1, according to one embodiment. [Figure 4] FIG. 4 shows a cross-sectional view of a joint of the medical device of FIG. 1 according to one embodiment. [Figure 5] FIG. 5 illustrates a cross-sectional view of a septum of the medical device of FIG. 1, according to one embodiment. [Figure 6] FIG. 6 illustrates a cross-sectional view of the septum of the medical device of FIG. 1 with a medical implement inserted therein, according to another embodiment. [Figure 7] FIG. 7 illustrates a cross-sectional view of a septum of the medical device of FIG. 1 according to another embodiment. [Figure 8] FIG. 8 illustrates a perspective view of a septum of the medical device of FIG. 1 according to another embodiment. [Figure 9] FIG. 9 shows a perspective view of the septum of FIG. 8 in an isolated position according to another embodiment. [Figure 10] FIG. 10 shows an exploded view of a medical device, according to one embodiment. [Figure 11] FIG. 11 shows a perspective view of the medical device of FIG. 10, according to one embodiment. [Figure 12] FIG. 12 shows a side view of the medical device of FIG. 10, according to one embodiment. [Figure 13] FIG. 13 illustrates a bottom view of the septum of the medical device of FIG. 10, according to one embodiment. [Figure 14] FIG. 14 illustrates a top view of a septum of the medical device of FIG. 10, according to one embodiment. [Figure 15] FIG. 15 shows a perspective view of a retaining ring of the medical device of FIG. 10, according to one embodiment. [Figure 16] FIG. 16 shows a flow chart of a method of using the medical device of FIG. 1 according to another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0004] The medical device for use in creating temporary pneumoperitoneum disclosed herein will be better understood by considering the following detailed description in conjunction with the drawings. The detailed description and drawings merely provide examples of various embodiments of the medical device for use in creating temporary pneumoperitoneum. Many variations are contemplated for different applications and design considerations, and for the sake of brevity and clarity, not all of the contemplated variations may be individually described in the following detailed description. Those skilled in the art will understand how the embodiments of the present disclosure can be changed, modified, and altered without substantially departing from the scope of the embodiments described herein.

[0005] Conventional devices restrict the movement of medical instruments inserted into a patient's abdomen through the device and allow little or no space for adjustment of the position of the medical instrument. Second, some of the known devices have relatively complex structures, which increase manufacturing costs. Because these devices are intended to be disposable, low manufacturing costs are essential. Furthermore, the complexity of conventional devices increases the learning curve as well as the risk of user error or device failure.

[0006] As disclosed herein, implementation of a medical device for use in creating temporary pneumoperitoneum may address some or all of the above-mentioned problems. For example, the embodiments disclosed herein allow for adjustment and manipulation of the medical device relative to the surgical site, and also allow for manipulation of medical instruments within the medical device while in place at the surgical site. The embodiments described herein also allow for the continued use of an indwelling trocar line while allowing for removal of the medical device from the surgical site. In other words, there is no need to remove the trocar to remove the medical device from the surgical site. Moreover, the relative lack of complexity of the medical device reduces costs, potential user errors, and the failure rate of the medical device itself. For example, in many surgical procedures, it is advantageous to leave a trocar or other medical device in place to remove the medical device and provide clear access for laterally or otherwise introducing additional medical instruments into the surgical site without interference from the medical device.

[0007] 1 shows an exploded view of a medical device 100 for use in creating temporary pneumoperitoneum, according to one embodiment. The use of a detachable dome allows for the creation of temporary pneumoperitoneum to aid in the preparation and performance of a surgical procedure. The detachability allows for the dome to be removed while maintaining the medical instrument in place.

[0008] In some embodiments, medical device 100 includes a rigid dome 102, a sealing element 104, a septum 106, a vacuum port 107, and a raised structure 108. Rigid dome 102 is an approximately substantially hemispherical or dome-shaped structure having a first dome section 110 and a second dome section 112. First dome section 110 and second dome section 112 form rigid dome 102 when joined together. In other words, first dome section 110 has a half-hemispherical geometry or constitutes a portion of the hemispherical geometry of rigid dome 102, while second dome section 112 has a half-hemispherical geometry complementary to first dome section 112.

[0009] First dome section 110 and second dome section 112 may each form equal halves of rigid dome 102. In some embodiments, one of first dome section 110 or second dome section 112 constitutes a larger portion of rigid dome 102 than the other. In some embodiments, at least one of first dome section 110 or second dome section 112 is transparent or translucent to facilitate visualization of the surgical site on the interior of rigid dome 102. The radius of curvature of first dome section 110 may be equal to the radius of curvature of second dome section 112. In some embodiments, the curvature or other geometry of first dome section 110 is different from the corresponding geometry of second dome section 112.

[0010] In some embodiments, the first dome section 110 is completely releasable from the second dome section 112, allowing the rigid dome 102 to be removed and a medical instrument inserted through the rigid dome 102 to remain 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, for example, at a hinge, tether, joint, etc. In some embodiments, the remaining connection between the first dome section 110 and the second dome section 112 is further separable to completely 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 the patient interface 116, a first opening portion 118 of the opening 120, and a first mating interface 122.

[0011] In some embodiments, the first patient interface portion 114 extends around the 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 the first patient interface portion 114 with an increased surface area relative to the 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 that extends across both the first dome section 110 and the second dome section 112. The patient interface 116 may reduce pressure at the surgical site around the rigid dome 102. This may reduce the impact on blood or other fluid flow or reduce the risk of tissue damage. Additionally, the increased surface area at the patient interface 116 may reduce the risk of aggravating wounds at the surgical site. In some embodiments, the patient interface 116 may include coatings, liners, treatments, etc. to improve sanitization, friction, vacuum seal, etc.

[0012] The first aperture 118 forms a portion of the aperture 120 on the first dome section 110 opposite the first patient interface portion 114. In some embodiments, the aperture 120 is a circular aperture in the rigid dome 102. In other embodiments, the aperture 120 has a non-circular geometry. In some embodiments, the aperture 120 is formed to the same extent by both the first dome section 110 and the second dome section 112. In other embodiments, the aperture 120 is formed to a greater extent by one of the first dome section 110 and the second dome section 112 than the other of the first dome section 110 and the second dome section 112. The aperture 120 may include a ridge, indentation, ring, friction fitting, etc. to improve sealing, retention, releasability, or other characteristics associated with the septum 106.

[0013] In some embodiments, the first interface interface 122 extends along an edge of the first dome section 110 between the first aperture 118 and the first patient interface portion 114. In some embodiments, the first interface interface 122 forms a flange, a lip, a tongue or groove, a ledge, or the like. In some embodiments, the first interface interface 122 is configured to align with the second interface interface 128 to couple the first dome section 110 to the second dome section 112 to form the rigid dome 102.

[0014] 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 mating interface 128. In some embodiments, the second patient interface portion 124 complements the first patient interface portion 114 to form the entire patient interface 116. In some embodiments, the first patient interface portion 114 forms a portion of the patient interface 116 that extends around the base of the second dome section 112. In some embodiments, the second patient interface portion 124 flares outward from the second dome section 112 to provide the second patient interface portion 124 with an increased surface area compared to the thickness of the second dome section 112.

[0015] The second aperture 126 is positioned on the opposite side of the second patient interface portion 124 from the second dome section 112. In some embodiments, the second aperture 126 combines with the first aperture 118 of the first dome section 110 to form the aperture 120. The second aperture 126 may define a larger or smaller amount of the aperture 120 compared to the first aperture 118. In some embodiments, one or both of the first aperture 118 and the second aperture 126 include alignment features that correspond to the geometry or characteristics of the septum 106 to facilitate alignment of the septum within the aperture 120.

[0016] In some embodiments, the second interface interface 128 extends along an edge of the second dome section 112 between the second aperture 126 and the second patient interface portion 124. The second interface interface 128 may be configured to couple to the first interface interface 122 to couple the first dome section 110 to the second dome section 112 to form the rigid dome 102.

[0017] In some embodiments, the sealing element 104 is configured to removably seal the first mating interface 122 of the first dome section 110 to the second mating interface 128 of the second dome section 112. In some embodiments, the sealing element 104 is medical tape. In some embodiments, the sealing element 104 is applied to the exterior of the rigid dome 102 so that the first mating interface 122 and the second mating interface 128 overlap and seal the first mating interface 122 to the second mating interface 128. The sealing element 104 may be removable from at least one of the first mating interface 122 or the second mating interface 128 to at least partially separate the first dome section 110 from the second dome section 112.

[0018] 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 silicone or other low shear strength polymer that can be broken by hand. The sealing element 104 may be removable to facilitate separation of the first dome section 110 from the second dome section 112. The sealing effect provided by the sealing element 104 can reduce pressure leakage into or out of the interior of the rigid dome 102 while 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 the like to facilitate removal of the sealing element 104 from the rigid dome 102.

[0019] In some embodiments, medical device 100 also includes a septum 106. Septum 106 may be positioned within opening 120 and form a permeability barrier to allow a medical instrument to penetrate septum 106 and access the interior of rigid dome 102. Septum 106 may be configured to engage first aperture 118 of first dome section 110 and to engage second aperture 126 of second dome section 112. In some embodiments, septum 106 is formed from a different material than rigid dome 102. The use of a different material may allow septum 106 to be punctured more easily than rigid dome 102, thereby facilitating insertion of a medical instrument through septum 106.

[0020] The medical device 100 may also include a vacuum port 107. In some embodiments, the vacuum port 107 is disposed within the rigid dome 102 between the patient interface 116 and the opening 120. In some embodiments, the vacuum port 107 forms a fluid pathway between the interior of the rigid dome 102 and the exterior of the rigid dome 102. In some embodiments, the vacuum port 107 facilitates connection of a vacuum source to the rigid dome 102 and reduces pressure within the rigid dome 102. In some embodiments, the vacuum port 107 protrudes outward from the rigid dome 102 in a vertical or angled orientation. The vacuum port 107 may be smooth, threaded, barbed, etc. to receive a connection to a vacuum source.

[0021] Some embodiments include a vacuum port plug 130. The vacuum port plug 130 may fit over the vacuum port 107 to form a barrier at the vacuum port 107 and maintain a reduced pressure inside 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 that allows 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 outside the rigid dome 102 to equalize the pressure inside the rigid dome 102 to the external pressure.

[0022] The medical device 100 may also include raised structures 108 extending outward from the exterior surface of the rigid dome 102 to form a physical interface for receiving forces to physically manipulate the rigid dome 102. For example, a user may use the raised structures 108 to grasp the medical device 100, position the medical device 100 relative to a surgical site, orient the medical device 100 relative to the user or the surgical site, apply or remove force from the plane of the surgical site, separate the first dome section 110 from the second dome section 112, etc. In some embodiments, the raised structures 108 include gripping elements. For example, the raised structures 108 may include ridges, knurling, indentations, a coating, etc. to increase the coefficient of friction of at least a portion of the raised structures 108.

[0023] 2 shows an assembled view of the medical device 100 of FIG. 1 , according to one embodiment. Some embodiments form a completely airtight or nearly airtight dome for covering and manipulating a surgical site to reduce the risk of unintended harm during or in preparation for surgery. In some embodiments, the first dome section 110 seals with the second dome section 112 to create a closed seam 202. In some embodiments, the seam 202 is sealed with an adhesive or other material applied within the seam 202. In other embodiments, the seam 202 is sealed with tape or other material applied to the exterior of the rigid dome 102 or to the exterior of the seam 202 on the interior of the rigid dome 102.

[0024] In some embodiments, the septum 106 is sealed to the opening 120 in the rigid dome 102. In some embodiments, the septum 106 is sealed within the opening 120 using a material similar or different from the material applied to the seam 202. In other embodiments, the structure of the septum 106 is sufficient to maintain a seal against the opening 120.

[0025] FIG. 3 shows a cross-sectional view of the medical device 100 of FIG. 1 , according to one embodiment. Some embodiments illustrate the passage of a vacuum port 107 into the interior of the medical device 100, allowing pressure within the medical device 100 to be reduced, drawing the surgical site into the interior of the medical device 100 and reducing the risk of unintended harm at the surgical site. In some embodiments, the vacuum port 107 extends substantially perpendicularly from the rigid dome 102. In other embodiments, the vacuum port 107 extends from the rigid dome 102 at an angle perpendicular to the surface of the rigid dome 102 from which the vacuum port 107 extends. In other embodiments, other angles may be used to facilitate connection to a vacuum source, reduce interference with access to the septum 106, etc. In some embodiments, the vacuum port 107 is positioned on the rigid dome 102 to reduce the likelihood of drawing, distending, deflecting, or otherwise displacing tissue at the surgical site into or within the vacuum port 107.

[0026] 4 shows a cross-sectional view of a joint 400 of the medical device of FIG. 1, according to one embodiment. In some embodiments, the first joint interface 122 is configured to contact and form a seal with the second joint interface 128. In some embodiments, the joint 400 is a tongue and groove joint, where the first joint interface 122 is inserted into a groove forming the second joint interface 128. In other embodiments, the joint 400 is a lap joint, a sunk lap joint, a butt joint, a t-bull joint, a flange joint, a standing joint, a clasp joint, etc.

[0027] 5 shows a cross-sectional view of the septum 106 of the medical device 100 of FIG. 1 , according to one embodiment. In some embodiments, the septum 106 includes an access structure 502 through which a medical instrument accesses the interior of the rigid dome 102. In some embodiments, the access structure 502 of the septum 106 is thinner than the rest of the septum 106. The reduced thickness of the access structure 502 may allow for easier penetration of the septum 106 with the access structure 502. In some embodiments, the access structure 502 includes a different material than the rest of the septum 106. For example, the access structure 502 may include a softer or more resilient material that is not included in the rest of the septum 106, or that is included in a lower amount or concentration.

[0028] Additionally, the reduction in the thickness of the septum 106 at the access structure 502 may provide a visual indicator of where a medical instrument may be inserted through the septum 106 while reducing the likelihood of impacting the medical instrument on the rigid dome 102. In some embodiments, the access structure 502 is centrally positioned on the septum 106 and forms recesses 504 on both sides of the access structure 502. In other embodiments, the access structure 502 may be positioned off-center to form recesses 504 of different sizes, or only a single recess on one side of the septum 106 may be formed, such that the access structure 502 is flush with the remainder of the septum 106 on one side of the septum 106.

[0029] In some embodiments, the septum 106 includes a retention structure 506 for applying a retention force to the opening 120. In some embodiments, the retention structure 506 includes a raised portion within a channel 508 that extends around at least a portion of the circumference of the septum 106. The retention structure 506 may be a ring formed in the channel 508. The retention structure 506 may be rounded, angular, chamfered, etc.

[0030] FIG. 6 shows a cross-sectional view of the septum 106 of the medical device 100 of FIG. 1 with a medical instrument 602 inserted therein, according to another embodiment. In some embodiments, the medical instrument 602 is inserted through the access structure 502 of the septum 106 to gain access to the interior of the medical device 100. As shown, embodiments of the septum 106 allow for insertion of the medical instrument 100 at a range of angles that may result from the surgical site, the type of surgical procedure, or other variables. In some embodiments, the septum 106 is configured to accept insertion of the medical instrument 602 at a first angle and maintain a seal with the medical instrument through a transition to a second angle different from the first angle to allow for repositioning of the medical instrument 602. Also shown is a variation of the retention structure 506 that is concave. The concave retention structure 506 mates with a corresponding raised structure on the rigid dome 102 at the opening 120.

[0031] 7 shows a cross-sectional view of the septum 106 of the medical device 100 of FIG. 1 according to another embodiment. In some embodiments, the septum 106 may include a recess 504 having an opening that narrows at the surface of the septum 106. In some embodiments, the narrowed aspect of the recess 504 may provide a self-restoring force that is applied to the medical device 602 when the medical device 602 is inserted into the access structure 502 of the septum 106.

[0032] FIG. 8 illustrates a cross-sectional view of the septum 106 of the medical device 100 of FIG. 1 according to another embodiment. In some embodiments, a separable embodiment of the septum 106 is shown, which allows the septum 106 to be removed from the surgical site without disturbing or dislodging the medical device 602. In other words, the septum 106 is at least partially separable to free it from the medical device 602 without removing the medical device 602 from the surgical site. This may reduce the risk of unintended harm or increase the likelihood of a successful surgical procedure. In some embodiments, the septum 106 is separable at a separation boundary 802 formed in the septum 106. The separation boundary 802 may include perforations, different materials, grooves or notches, or other weakening or tear-promoting structures or modifications. The separation boundary 802 may form some boundary angle 804 with the surface of the septum 106. For example, the separation boundary 802 may have a boundary angle 804 of 30 degrees. In some embodiments, the separation boundary 802 is a through cut and is held together in a sealed arrangement by the material of the septum 106, by the vacuum within the rigid dome 102, and / or by the force applied to the septum 106 by the rigid dome 102. In some embodiments, the septum 106 may be divided into a first septum portion and a second portion at the separation boundary 802. In other embodiments, the septum 106 may be divided partially from the center of the septum 106 outward to the edge of the septum 106.

[0033] 9 shows a perspective view of the septum 106 of FIG. 8 in a separated configuration according to another embodiment. In some embodiments, the septum 106 is divided into separate pieces: a first septum portion 806 and a second septum portion 808. While the first septum portion 806 is shown as being similar in size and quantity to the second septum portion 808, other embodiments may incorporate different size ratios for the first septum portion 806 and the second septum portion 808.

[0034] FIG. 10 shows an exploded view of a medical device 100, according to one embodiment. Some embodiments of the medical device 100 allow medical personnel to create a temporary pneumoperitoneum at a surgical site using an available vacuum source without causing undue complications or risks to the patient, significantly reducing the risk of unintended damage or harm during a surgical procedure. In some embodiments, the medical device 100 includes a first dome section 110 and a second dome section 112 having a first band region 1010 shaped to accommodate a first retaining band 1014 and a second band region 1012 shaped to accommodate a second retaining band 1016. The first band region 1010 extends around both the first dome section 110 and the second dome section 112. The first band region 1010 is sized and oriented to form a parallel cylinder, and the first band region 1010 may remain unchanged to retain the first retaining band 1014. In other embodiments, the first band region 1010 may taper toward the top or bottom of the medical device 100. The second band region 1012 may be configured similarly or differently from the first band region 1010. In some embodiments, the first band region 1010 has a smaller diameter than the second band region 1012 to accommodate the smaller diameter of the first retention band 1014 compared to the second retention band 1016. In some embodiments, the vacuum port 107 is positioned between the first band region 1010 and the opening 120. In some embodiments, the vacuum port 107 may be positioned between the first band region 1010 and the second band region 1012. Other embodiments include other placements of the vacuum port 107. In some embodiments, the first retention band 1014 or the second retention band 1016 is a shrink band having sufficient tensile strength. In other embodiments, the first retention band 1014 or the second retention band 1016 is a reinforcing tape. In some embodiments, the reinforcement tape may be self-adhesive. The reinforcement tape may include reinforcing elements such as carbon filaments, nanotubes, glass fibers, polymers, etc. In some embodiments, the reinforcement may be axial or biaxial.

[0035] In some embodiments, medical device 100 includes a septum sheet 1002. Septum sheet 1002 may be formed around opening 120 to facilitate placement and fixation of septum 106. In some embodiments, septum sheet 1002 is a planar region formed around opening 120 on each of first dome section 110 and second dome section 112. Septum sheet 1002 may be annular in geometry and concentric with opening 120. In other embodiments, septum sheet 1002 may have other shapes and alignments relative to opening 120.

[0036] In some embodiments, the septum sheet 1002 includes retention holes 1004 that extend into the 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 the 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.

[0037] The retaining holes 1004 may facilitate securing the septum 106 in place on the septum seat 1002. In some embodiments, the medical device 100 further includes a retaining ring 1005 that may be configured to engage the retaining holes 1004 to secure the septum 106 in the septum seat 1002. In some embodiments, the retaining ring 1005 is separable into a first ring portion 1006 and a second ring portion 1008. The separability of the retaining ring 1005 may allow for removal of the medical device 100 from around a medical tool, such as a trocar, needle, line, etc. The retaining 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, etc.

[0038] In some embodiments, medical device 100 includes a sealing element 104 that is pre-shaped to fit the cross-sectional shape of the junction between first dome portion 110 and second dome portion 112. Sealing element 104 may comprise a resilient or crushable material. For example, sealing element 104 may comprise a polymeric material, a fluoropolymer, a silicone rubber (solid strand or tube) to form an O-ring-type seal, or sealing element 104 may be a metal, wax, or other crushable sealing material to form a gasket-type seal. Other sealing schemes may also be implemented.

[0039] Figure 11 shows a perspective view of the medical device 100 of Figure 10, according to one embodiment. Some embodiments allow for the formation of a secure seal around a surgical site to create a temporary pneumoperitoneum, reducing the risk of unintended harm. Moreover, the medical device 100 is removable, leaving the medical instrument in situ at the surgical site, further reducing the potential harm from removal and reinsertion.

[0040] In some embodiments, the first retaining band 1014 and the second retaining band 1016 are positioned to hold the first dome portion 110 closed on the second dome portion 112. The first retaining band 1014 and the second retaining band 1016 may be removed by cutting or otherwise separating them from the medical device 100 to facilitate separating the first dome portion 110 from the second dome portion 112 at the joint 202.

[0041] 12 shows a side view of the medical device of FIG. 10, according to one embodiment. Some embodiments form a comfortable, easily deployable structure that provides the ability to create a temporary pneumoperitoneum without further harm to the patient.

[0042] In some embodiments, the first retaining band 1014 is positioned near the center of the medical device 100, while the second retaining band 1016 is positioned near the bottom of the medical device 100. In some embodiments, the first retaining band 1014 and the second retaining band 1016 may apply the same or similar amount of retaining force to 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 the second retaining band 1016, which may be based on the position, thickness, material, or other properties or components of the first retaining band 1014 or the second retaining band 1016.

[0043] Figure 13 shows a bottom view of the septum 106 of the medical instrument of Figure 10, according to one embodiment. Some embodiments of the septum 106 allow for insertion of a medical instrument while maintaining a vacuum-resistant seal on the medical instrument. The septum 106 can also be separated, allowing the septum 106 to be removed from the medical instrument without withdrawing the medical instrument from the surgical site.

[0044] In some embodiments, the septum 106 includes gripping tabs 1302. The gripping tabs 1302 extend diagonally from the septum 106 to one another and provide a location for a surgeon or other medical personnel to grasp the septum 106. The gripping tabs 1302 may include textured portions 1304 to improve grip, which may help improve grip in the presence of blood, grease, oils, cleaning solutions, etc.

[0045] In some embodiments, the septum 106 includes a series of tear lines 1308 formed within the structure of the septum 106 to facilitate separation of the septum 106. To prevent unwanted fragmentation or tearing of the septum 106 without completely separating it and releasing a medical instrument inserted therethrough, the tear lines 1308 may coincide with the tear notches 1306 or other designed breaking points to control the location, direction, or manner of rupture or tearing of the septum 106.

[0046] In some embodiments, the septum 106 includes an alignment hole 1310. The alignment hole 1310 may be a through-hole formed in the septum 106 to facilitate alignment and securing of the septum 106 in conjunction with the septum sheet 1002 and the retaining ring 1005. For example, the retaining ring may be aligned to protrude through the alignment hole 1310 of the septum 106 and into the retaining hole 1004 formed in the septum sheet 1002.

[0047] Figure 14 shows a top view of the septum 106 of the medical device of Figure 10, according to one embodiment. Some embodiments provide an easy-to-use septum 106 in which the sealing texture 1402 both creates a target for insertion of the medical device, reducing awkwardness, and forms a flexible seal, accommodating a wide range of medical device sizes while maintaining a seal.

[0048] In some embodiments, sealing texture 1402 is formed as a raised structure located at the center of septum 106. The raised structure of sealing texture 1402 may form a ring to easily receive a medical instrument having a circular cross-section. Other shapes are contemplated to accommodate non-circular cross-sections.

[0049] FIG. 15 shows a perspective view of the retaining ring 1005 of the medical device of FIG. 10 , according to one embodiment. Some embodiments of the retaining ring 1005 allow for increased stability and sealing of the septum 106 against the first dome portion 110 and the second dome portion 112, while also allowing for removal from the medical instrument while the instrument remains in place. The retaining ring 1005 may be separable into the first ring portion 1006 and the second ring portion 1008. The retaining ring 1005 may be separated into the first ring portion 1006 and the second ring portion 1008 or may facilitate a user input to separate the retaining ring 1005. The retaining ring 1005 may include a central opening 1500. The central opening 1500 may be positioned within the retaining ring 1005 to allow access to the septum 106 for inserting a medical instrument therethrough.

[0050] In some embodiments, the retaining ring 1005 includes posts 1502 that extend perpendicularly from the plane of the retaining ring 1005. In some embodiments, the posts 1502 are arranged in a pattern around the retaining ring 1005. In some embodiments, the posts 1502 are evenly distributed around the retaining ring 1005. In some embodiments, the posts 1502 retain the septum 106 and facilitate the division of the septum 106 in response to separation of the first dome section 110 and the second dome section 112.

[0051] In some embodiments, the post 1502 may have a consistent cross-sectional shape. In other embodiments, the post 1502 has a differential geometry. For example, in some embodiments, the post 1502 has a tip portion with a smaller diameter. This variation in geometry may allow the post 1502 to differentially engage with the retention holes 1004 in the septum 106 and septum seat 1002. The post 1502 may provide for alignment of the retaining ring 1005 with the first dome section 110 and the second dome section 112, as well as alignment of the first dome section 110 and the second dome section 112 with the septum 106.

[0052] 1 illustrates a flow chart of a method 1600 of using the medical device 100 of FIG. 1 according to another embodiment. The method 1600 enables the creation of a temporary pneumoperitoneum for surgery. The method 1600 may include placing a rigid dome at the surgical site with a patient interface of the rigid dome surrounding the surgical site. For example, the rigid dome 102 may be placed at the surgical site with the patient interface 116 of the rigid dome 102 positioned to surround the surgical site (block 1602).

[0053] The method 1600 may include coupling a vacuum source to a vacuum port of the rigid dome (block 1604). For example, the vacuum source may be coupled to the vacuum port 107 of the rigid dome 102 to provide reduced pressure to the rigid dome 102. The method 1600 may include using the vacuum source to reduce pressure inside the rigid dome to cause tissue at the surgical site to bulge at least partially into the interior of the rigid dome (block 1606). For example, as the pressure within the rigid dome 102 is reduced, tissue at the surgical site below the rigid dome expands upward into the rigid dome 102.

[0054] The method 1600 may include inserting a medical instrument from the exterior of the rigid dome into the interior of the rigid dome through a septum disposed in the opening of the rigid dome (block 1608). For example, the medical instrument 602 may be inserted through the septum 106 of the rigid dome 102 to access the interior of the rigid dome 102. The method 1600 may include inserting the medical instrument into raised tissue at the surgical site and delivering gas below the surface of the surgical site to create a temporary pneumoperitoneum (block 1610). For example, the medical instrument 602 may be introduced into the surgical site inflated within the rigid dome 102 to deliver an inert gas (e.g., CO2) below the surface layer of the surgical site to create a temporary pneumoperitoneum at the surgical site to facilitate laparoscopic surgery or another surgical procedure.

[0055] 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 disconnecting the vacuum source from the vacuum port 107, manipulating the vacuum port plug 130, lifting the rigid dome 102 from the surgical site, removing the sealing element 104, creating an initial separation between the first dome section 110 and the second dome section 112, etc. The method 1600 may include separating the first dome section from the second dome section to remove the rigid dome from the surgical site while leaving the medical device in place 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 the sealing element and remove the sealing element 104, etc.

[0056] A feature illustrated in one of the figures may be identical to or similar to a feature illustrated in another of the figures. Similarly, a feature described in connection with one of the figures may be identical to or similar to a feature described in connection with another figure. Identical or similar features may be identified by identical or similar reference characters unless expressly stated otherwise. Moreover, the description of a particular figure may refer to features not shown in that particular figure. Features may be illustrated and / or further described in connection with another figure.

[0057] Elements of the processes (i.e., methods) described herein may be performed in one or more ways, for example, by a human, by a processing device, by a mechanism operating automatically or under human control, etc. Moreover, although various elements of a process may be illustrated 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.

[0058] The foregoing description sets forth numerous specific details, such as examples of particular systems, components, methods, etc., to provide a thorough understanding of some implementations. However, it will be apparent to one skilled in the art that at least some implementations may be practiced without these specific details. In other instances, well-known components or methods have not been described in detail or have been presented in simple block diagram form to avoid unnecessarily obscuring the implementations. Thus, the specific details set forth above are merely exemplary. Particular implementations may vary from these example details and still be intended to be within the scope of the implementations.

[0059] Related elements of examples and / or embodiments described herein may be identical, similar, or dissimilar in different examples. For brevity and clarity, related elements may not be described redundantly. Instead, the use of identical, similar, and / or related element names and / or reference letters may inform the reader that an element with a given name and / or related reference letter may be similar to another related element with the same, similar, and / or related element name and / or reference letter in an example described elsewhere herein. Elements unique to a given example may be described with reference to that specific example. Those skilled in the art will understand that a given element need not be identical and / or similar to the specific depiction of the related element in any given figure or example in order to share characteristics of the related element.

[0060] It should be understood that the foregoing description is intended to be illustrative, and not limiting. Many other implementations will be apparent to those skilled in the art upon reading and understanding the above description. Accordingly, the scope of this implementation should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0061] The foregoing disclosure encompasses multiple separate embodiments having independent utilities. While these embodiments are disclosed in specific forms, the specific embodiments disclosed and illustrated above are susceptible to numerous variations and should not be construed in a limiting sense. The subject matter disclosed herein includes novel and non-obvious combinations and subcombinations of the various elements, features, functions and / or properties explicitly and inherently disclosed above. When this disclosure or a claim thereafter recites "an" element, "a first" element, or any such equivalent term, the disclosure or claim should be understood to incorporate one or more such elements without requiring or excluding more than one of such elements.

[0062] As used herein, "same" means sharing all characteristics, and "similar" means sharing a substantial number of characteristics, or even if not a substantial number of characteristics, sharing substantially important characteristics. As used herein, "may" should be interpreted liberally and not indefinitely. Moreover, the use of "is" with respect to an embodiment, element, and / or feature should be interpreted as definitive only with respect to a particular embodiment, not with respect to all embodiments. Furthermore, references to "disclosure" and / or "this disclosure" refer to this entire document and all accompanying figures, including all of the documents in each subsection, including the title, background, brief description of the drawings, detailed description, claims, abstract, and other documents and / or resources incorporated by reference herein.

[0063] As used herein in reference to a list, "and" forms an inclusive group of all listed elements. For example, an embodiment described as including A, B, C, and D is an embodiment that includes A, includes B, includes C, and also includes D. As used herein in reference to a list, "or" forms a list of elements, any of which may be included. For example, an embodiment described as including A, B, C, or D is an embodiment that includes any of elements A, B, C, and D. Unless otherwise stated, an embodiment that includes a list of alternatively included elements does not exclude other embodiments that include various combinations of some or all of the alternatively included elements. An embodiment described using a list of alternatively included elements includes at least one of the listed elements. However, an embodiment described using a list of alternatively included elements does not exclude other embodiments that include all of the listed elements. And an embodiment described using a list of alternatively included elements does not exclude other embodiments that include some combination of the listed elements. As used herein in reference to a list, "and / or" forms a list of elements, either alone or in any combination. For example, an embodiment described as including A, B, C, and / or D may include A alone; A and B; A, B and C; A, B, C, and D, etc. The scope of an "and / or" listing is defined by the complete set of combinations and permutations for the listing.

[0064] Where multiples of a particular element are shown in a figure, and the element is clearly duplicated throughout the figures, only one label may be provided for that element even though multiple instances of that element are present in the figure. Thus, other instances in the figure of an element having the same or similar structure and / or function may not be redundantly labeled. One of ordinary skill in the art will recognize redundant and / or duplicated elements in the same figure based on the disclosure herein. Nevertheless, duplicate labels may be included when useful in clarifying the structure of the illustrated embodiment.

[0065] Applicant reserves the right to submit claims directed to combinations and subcombinations of the disclosed embodiments that are believed to be novel and unobvious. Embodiments embodied in other combinations and subcombinations of features, functions, elements, and / or properties may be claimed through modification of these claims or the presentation of new claims in this or a related application. Such modified or new claims, whether directed to the same or different embodiments and whether different, broader, narrower, or equal in scope to the original claims, should be considered within the subject matter of the embodiments described herein.

Claims

1. A medical device, a rigid dome having a substantially hemispherical geometry configured to separate for removal from a surgical site while leaving a medical instrument in place at the surgical site, said rigid dome comprising: a first dome section having a half-hemispherical geometry forming a portion of the substantially hemispherical geometry of the rigid dome, the first dome section comprising: a first patient interface portion of a patient interface extending around a base of the first dome section, the first patient interface portion extending radially outward from the first dome section relative to a thickness of the first dome section; a first opening on the first dome section opposite the first patient interface portion; and a first interface interface extending along an edge between the first opening portion of the first dome section and the first patient interface portion; a first dome section comprising: a second dome section having a half-hemispherical geometry complementary to the first dome section, the second dome section configured to mate with the first dome section to form the rigid dome, the second dome section comprising: a second patient interface portion of the patient interface extending around a base of the second dome section, the second patient interface portion extending radially outward from the second dome section relative to a thickness of the second dome section; a second aperture portion on the second dome section opposite the second patient interface portion; and a second interface interface extending along an edge of the second dome section between the second aperture and the second patient interface portion, the second interface interface configured to mate with the first interface interface to join the first dome section to the second dome section to form the rigid dome; and a second dome section comprising: a rigid dome comprising: a retaining band configured to apply a retaining force to secure the first dome section to the second dome section, the retaining band being positioned on a band region extending around both the first dome section and the second dome section; and a sealing element configured to removably seal a first mating interface of the first dome section to a second mating interface of the second dome section; a septum positioned in the opening and configured to engage the first dome section at the first opening and the second dome section at the second opening; a vacuum port disposed in the rigid dome between the patient interface and the opening, the vacuum port forming a fluid path between an interior of the rigid dome and an exterior of the rigid dome, the vacuum port facilitating connection of a vacuum source to the rigid dome to reduce pressure within the rigid dome; and A medical device comprising:

2. 10. The medical device of claim 1, further comprising a vacuum port plug adapted to form a barrier at the vacuum port and to maintain a reduced pressure inside the rigid dome.

3. 10. The medical device of claim 1, wherein the sealing element comprises medical tape applied to an exterior of the rigid dome to overlap the first and second mating interfaces and seal the first mating interface to the second mating interface, and removable from at least one of the first mating interface or the second mating interface to at least partially separate the first dome section from the second dome section.

4. 10. The medical device of claim 1, wherein the sealing element comprises a low shear strength adhesive configured to seal the first mating interface to the second mating interface and frangible to at least partially separate the first dome section from the second dome section.

5. The medical device of claim 1 , further comprising a retaining ring for applying a retaining force to the septum at the opening.

6. 6. The medical device of claim 5, wherein the septum is configured to provide a permeability barrier to the opening and allow a medical instrument to penetrate through the septum to access an interior of the rigid dome.

7. 6. The medical device of claim 5, wherein the septum comprises an access structure formed therein and extending through a thickness of the septum to provide access to an interior of the rigid dome.

8. 1. A system comprising: a medical instrument configured to be inserted into a surgical site; a rigid dome configured to allow the medical instrument to pass through a septum and enter an interior of the rigid dome to allow the medical instrument to be inserted into the surgical site; the rigid dome is at least partially separable into a first dome section and a second dome section for removing the rigid dome from the surgical site without removing the medical instrument from the surgical site; the septum is separable from the rigid dome and remains attached to the medical device when the first dome section and the second dome section are separated from one another; the septum being at least partially splittable into a first septum portion and a second septum portion for removing the septum from the medical device without removing the medical device from the surgical site. A rigid dome and a vacuum source configured to connect to a vacuum port of the rigid dome to reduce pressure within the rigid dome and deflect the surgical site into the interior of the rigid dome for insertion of the medical instrument at the surgical site; A system comprising:

9. The system of claim 8 , wherein the medical instrument comprises a trocar for laparoscopic surgery.

10. the rigid dome: a first retaining band positioned on a first band region formed on an exterior surface of the rigid dome; a second retention band positioned on a second band region on the exterior surface of the rigid dome, the first retention band and the second retention band configured to hold the rigid dome in a closed position, the first retention band and the second retention band each being separable to facilitate at least partial separation of the rigid dome for removal of the rigid dome from the surgical site without removing the medical instrument from the surgical site; The system of claim 8 , comprising:

11. The system of claim 8 , wherein the material of the septum is different from the material of the rigid dome to allow penetration of a medical instrument into the interior of the rigid dome.

12. 9. The system of claim 8, wherein the septum comprises a sealing texture formed thereon to provide a seal with the medical instrument at the septum, the sealing texture configured to provide a seal with a variety of medical instrument sizes.

13. The system of claim 8 , wherein a first dome section of the rigid dome is completely separate from a second dome section of the rigid dome.

14. The system of claim 8 , wherein the septum further comprises a gripping tab extending from the septum to form a location for grasping or splitting the septum.

15. The system of claim 8 , wherein the first dome section and the second dome section are connected by a hinge, a tether, or a joint.

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