SURGICAL ACCESS DEVICE WITH CHECK VALVE AND PLURAL DISCS
20220088361 · 2022-03-24
Inventors
- Garrett P. Ebersole (Hamden, CT, US)
- Jacob C. Baril (Norwalk, CT, US)
- Matthew A. Dinino (Newington, CT, US)
- Justin Thomas (New Haven, CT, US)
- Saumya Banerjee (Hamden, CT, US)
- Roy J. Pilletere (Middletown, CT, US)
- Nicolette R. LaPierre (Windsor Locks, CT, US)
Cpc classification
A61B17/3462
HUMAN NECESSITIES
A61M2039/0276
HUMAN NECESSITIES
A61M2039/0279
HUMAN NECESSITIES
A61M39/0247
HUMAN NECESSITIES
International classification
Abstract
A surgical access device includes a check valve having baffling discs, a tube, and a housing. The housing has first and second housing halves. Baffling discs are configured to form a lumen. Each baffling disc is a conical annulus and is stacked adjacent to another baffling disc and spaced apart via spacers disposed on each baffling disc. The spacers help define a first gap between adjacent baffling discs for defining a first fluid path. A cover is coupled to the housing and permits access to the surgical access device. The housing is configured to receive the tube and the baffling discs, and the baffling discs are spaced apart from the first and second housing halves defining a second gap therebetween for defining a second fluid path. The first and second gaps form fluid convection channels for guiding fluid flowing in a proximal direction back into itself.
Claims
1. A surgical access device comprising: a tube; a housing having a first housing half and a second housing half; baffling discs configured to form a lumen, each baffling disc is a conical annulus, and each baffling disc is stacked adjacent to another baffling disc and spaced apart via spacers disposed on each baffling disc so as to define a first gap between adjacent baffling discs for defining a first fluid path; and a cover coupled to a proximal end of the housing and configured to control access to the lumen; wherein the first and second housing halves of the housing are configured to receive the tube and the baffling discs, the baffling discs spaced apart from the first and second housing halves defining a second gap therebetween for defining a second fluid path; wherein the first and second gaps form fluid convection channels for guiding fluid flowing in a proximal direction.
2. The surgical access device of claim 1, wherein the first and second housing halves include recesses configured to follow an upper guide of each baffling disc so as to further define the second gap therebetween; whereby, when the baffling discs are received by the first and second housing halves, fluid flowing in the proximal direction is encouraged to flow through the fluid convection channels, through the first gap between each baffling disc, through the second gap between the baffling discs and the recesses, and back around against the fluid flowing in the proximal direction so as to reduce net flow in the proximal direction.
3. The surgical access device of claim 1, wherein each baffling disc has a cross-sectional profile of an airfoil, with an upper guide and a lower guide, wherein the upper guide has a radius that is larger than a radius of the lower guide.
4. The surgical access device of claim 1, wherein the lumen formed by the baffling discs is configured to receive a laparoscopic instrument.
5. The surgical access device of claim 1, further including an accessory attachment configured to couple to the cover.
6. The surgical access device of claim 5, wherein the accessory attachment includes at least one luer fitting.
7. The surgical access device of claim 1, wherein the housing includes five baffling discs.
8. The surgical access device of claim 1, wherein the baffling discs define a lumen that is as long as at least a quarter of a length of the tube.
9. The surgical access device of claim 1, wherein the tube has a flared proximal end and the first and second housing halves have distal portions configured to couple to and engage the flared proximal end.
10. The surgical access device of claim 1, wherein the lumen formed by the baffling discs has a diameter equal to an inner diameter of the tube and is concentric and axially aligned with the tube.
11. A surgical assembly comprising: a surgical instrument having a shaft; and a surgical access assembly including: a housing having open proximal and distal ends, a tube extending from the housing, baffling discs disposed within the housing, each baffling disc having a cross-sectional profile of an airfoil, each baffling disc spaced apart from an adjacent baffling disc thereby defining a first gap therebetween, each baffling disc spaced from an inner surface of the housing thereby defining a second gap therebetween, the first and second gaps form fluid convection channels for guiding fluid flowing in the housing.
12. The surgical assembly of claim 11, wherein the housing includes first and second housing halves.
13. The surgical assembly of claim 12, wherein each housing half includes recesses configured to follow an upper guide of each baffling disc so as to further define the second gap therebetween and fluid flowing in a proximal direction is encouraged to flow through the fluid convection channels, through the first gap between each baffling disc, through the second gap between the baffling discs and the recesses, and back around against the fluid flowing in the proximal direction so as to reduce net flow in the proximal direction.
14. The surgical assembly of claim 11, wherein the cross-sectional profile of an airfoil is defined by an upper guide and a lower guide, wherein the upper guide has a radius that is larger than a radius of the lower guide.
15. The surgical assembly of claim 12, wherein the tube has a flared proximal end and the first and second housing halves have distal portions configured to couple to and engage the flared proximal end.
16. The surgical assembly of claim 11, wherein each baffling disc is a conical annulus.
17. The surgical assembly of claim 16, wherein a narrow portion of the conical annulus of each baffling disc is positioned distally relative to a user, and is positioned adjacent a wider portion of the conical annulus of an adjacent baffling disc.
18. The surgical assembly of claim 17, wherein a proximalmost portion of the tube is spaced apart from the distalmost baffling disc and is configured to follow the narrow portion of the conical annulus of the distalmost baffling disc so as to define a third gap therebetween.
19. The surgical assembly of claim 11, further including a cover disposed on a proximalmost portion of the housing of the surgical access assembly.
20. The surgical assembly of claim 19, wherein the cover is spaced apart from the proximalmost baffling disc and is configured to follow a portion of the proximalmost baffling disc so as to define a third gap therebetween that forms an extension of the proximalmost fluid convection channel.
Description
DESCRIPTION OF DRAWINGS
[0026] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects and features of the disclosure and, together with the detailed description below, serve to further explain the disclosure, in which:
[0027]
[0028]
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[0037]
[0038] Further details and various aspects of this disclosure are described in more detail below with reference to the appended figures.
DETAILED DESCRIPTION
[0039] Aspects of the presently disclosed surgical access devices are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the disclosed devices are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure.
[0040] Descriptions of technical features of an illustrative surgical access device having a check valve with plural baffling discs in accordance with the disclosure should typically be considered as available and applicable to other similar features of another device of the disclosure. Accordingly, technical features described herein in connection with one illustrative surgical access device may apply to other devices of the disclosure, and thus duplicative descriptions may be omitted herein.
[0041] As used herein the term “distal” refers to that portion of the surgical access device, or component thereof, farther from the user, while the term “proximal” refers to that portion of the surgical access device, or component thereof, closer to the user.
[0042] This disclosure relates to a surgical access device with a check valve formed from a plurality of baffling discs. The baffling discs provide little to no fluid resistance in one direction, but in the opposite direction, they passively (i.e., without any moving parts) and palpably impede fluid flow. In a typical trocar or cannula, fluids or gasses in or introduced into the housing tend to push their way through the tube of the trocar or cannula. Accordingly, many devices employ instrument seals, zero seals, duckbill seals, and the like to inhibit fluid or gasses from escaping out the surgical access device. The check valve of this disclosure inhibits fluid or gasses from escaping out the surgical access device and does not interfere with a surgical instrument inserted therein. Baffling discs direct fluid flowing in a distal to proximal direction (exiting direction) back into and against fluid flow in the exiting direction, creating eddies, surges, and/or reversed flow to impede flow in the exiting direction. In other terms, the baffling discs turn the flow back in on itself, slowing and inhibiting its motion in the exiting direction. The baffling discs provide a seal or check valve that does not interfere with any instruments inserted therethrough and provide an unobstructed path through the surgical access device.
[0043] Referring to
[0044] The housing 100, the tube 20, the cover 130, and the plurality of baffling discs 122 may be made from a variety of biocompatible materials including metals, aluminum, stainless steel, plastic, polymers, or combinations thereof. Any material suitable for use in a cannula or trocar known to those of ordinary skill in the art may be used to form any one or all components of the surgical access device 10. In aspects, the various components may be manufactured using 3D printing.
[0045] An exploded view of the surgical access device 10 is shown in
[0046] Each baffling disc 122 may have identical geometry as shown in
[0047] With additional reference to
[0048] The housing halves 110a, 110b when coupled together define a lumen through the housing 100. Typically, the lumen is cylindrical and forms an extension of the shaft of the tube 20. The lumen has a radius larger than the largest radius of a baffling disc 122 and/or the radius of the tube 20. In aspects, at a distal portion of the housing halves 110a, 110b, the lumen has a radius no larger than the radius of the tube or cannula 20. Recesses 116 are cut into the inner facing wall of each housing half 110a, 110b and are configured to receive a portion of a baffling disc 122. The recesses 116 may be semi-cylindrical recesses having a radius of curvature larger than the radius of curvature of a baffling disc 122. The inner facing walls 112 extend distally past the distalmost semi-cylindrical recess 116, and at a distal portion have a smooth, planar wall or contours 112b, configured to engage the outer wall of the flared proximal end 22 of the tube 20. Engagement arms 112c protrude from the distal portion of each housing half 110a, 110b, and define a shelf that is configured to couple below the flared proximal end 22 (see
[0049] Turning now to
[0050] In aspects, the cross-sectional profile 126 of each baffling disc resembles an airfoil as shown in
[0051] The height of each baffling disc 122, as measured vertically from the proximalmost portion of the upper surface 126a to the distalmost portion of the lower surface 126b, may be from about 1 mm to about 20 mm. In aspects, the height is about 5 mm to about 15 mm. When stacked together to form the plurality of baffling discs 120, the height measured from the proximalmost portion of the proximalmost baffling disc 122 to the distalmost portion of the distalmost baffling disc 122 may be from about 10 mm to about 100 mm, and generally may be about 50 mm to about 70 mm.
[0052] The thickness of each baffling disc 122, as measured from the inner radius to an outer radius, or from the innermost portion to the outermost portion of each baffling disc, may be from about 5 mm to about 20 mm.
[0053] Each baffling disc 122 includes at least two (2) spacers 128. In aspects, each baffling disc 122 includes four (4) spacers 128. The spacers 128 are configured to prevent the upper surface 126a of a baffling disc 122 from coming into contact with the entirety of the lower surface 126b of a baffling disc 122 stacked on top of it. The spacers 128 are configured to create a gap between two baffling discs 122 such that a fluid may pass through the gap. The gaps formed by a plurality of stacked baffling discs 120 generate fluid convection channels 128a (see
[0054] The spacers 128 may form directional fins (not shown) that guide the fluid to form a vortex. Alternatively, directional fins distinct from the spacers 128 may be disposed on the baffling discs 122. In yet other alternatives, directional channels grooved into the baffling discs 122 may direct the fluid to form a vortex. In other aspects, the directional fins may be disposed on the semi-cylindrical recesses.
[0055] The spacers 128 may be extended partially or completely in an arc around the upper surface 126a of each baffling disc 122. For example, if a baffling disc 122 has four spacers 128, two of the spacers 128 may be elongated and disposed on the upper surface 126a such that the distance between the two elongated spacers 128 is less than the distance between the other two spacers 128. In aspects, the spacers 128 may fully cover the upper surface 126a of a baffling disc, such that there is no gap exists between adjacent baffling discs 122. Baffling discs 122 may alternately include spacers 128 that cover various portions of the upper surface 126a to control fluid flow through the gaps between the baffling discs 122 and between the plurality of baffling discs 120 and the housing halves 110a, 110b. For example, every other baffling disc 122 of a plurality of baffling discs 120 may have spacers 128 covering a majority or all of the upper surface 126a of every other baffling disc 122. In another example, the spacers may cover 75% of the upper surface 126a, with the remaining uncovered portions of the upper surface 126a of each baffling disc are aligned. Spacers 128 of any size and shape may be used to partially or fully cover the upper surface 126a of a baffling disc 122 and may be arranged in any desired manner to produce a desirable effect on fluid flowing between, and about the baffling discs 122.
[0056] The baffling discs 122 may be formed from a single piece of material or formed via multiple pieces. The baffling discs 122 may be made via injection molding or 3D printing. It is contemplated that the plurality of discs may be formed as a single unit via 3D printing. In aspects, the baffling discs 122 may be made from a variety of materials such as stainless steel or medical grade plastics. The spacers 128 may be formed as a part of a baffling disc or may be attached as a separate piece to a baffling disc.
[0057] With reference to
[0058] The housing halves 110a, 110b receive the check valve 120 and the flared proximal end 22 therebetween, thereby sandwiching the check valve 120 and flared proximal end 22. The housing halves 110a, 110b define a fluid tight structure when coupled together. As previously discussed, the housing halves 110a, 110b have distal portions with engagement arms 112c for coupling below the flared proximal end 22 of the tube 20. As illustrated in
[0059] The baffling discs 122 are stacked together to form a plurality of fluid convection channels 128a via the gaps between them (
[0060] With continuing reference to
[0061] The bottom surface of the cover 130 may be contoured to follow the upper surface 126a of the proximalmost baffling disc 122 and the two housing halves 110a, 110b. The bottom surface of the cover 130 is distanced and spaced apart from the proximalmost baffling disc 122 (
[0062] Referring now to
[0063] The accessory attachment 140 may be configured to provide easy surgical instrument introduction. As illustrated by
[0064] With reference to
[0065] A fluid supply is coupled to the luer fitting 142, and supplies a fluid marked by arrows “FF” (fluid flow) to the surgical site through the tube 20. The surgical instrument 30 may have a diameter that is slightly smaller than the inner diameter of the cannula. Fluid in the tube 20 is forced between the outer surface of the surgical instrument 30 and the inner surface of the tube 20 of the surgical access device 10. The lumen of the surgical access device 10 may have a variety of diameters depending on the surgical task to be performed, area of operation, preference of a surgeon, etc. to accommodate variously sized surgical instruments. Typically, an outer diameter of a surgical instrument inserted into the cannula is slightly smaller than the inner diameter (shaft diameter) of the cannula assembly. For example, the check valve 120, the tube 20, and the housing 100 may define a lumen having a 12 mm diameter to accommodate instruments with an outside diameter less than 12 mm. The difference in diameters defines a gap 26 for fluid flow between the inner surface of the tube 20 and the outer surface of the surgical instrument 30.
[0066] As shown in
[0067] It is contemplated that the presently disclosed housing 100 and check valve 120 may be used in other surgical instruments such as a vascular access device. In such a configuration, the housing 100 with the check valve is coupled to a flexible tube with a needle that is insertable into a patient. The vascular access device allows for insertion and removal of vascular access instruments while minimizing blood loss.
[0068] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).