SEAL FOR LAPAROSCOPIC ACCESS PORT

Abstract

A deformable seal for use together with a laparoscopic port has a deformable body with an upper region, a lower region, and a narrowed waist. A plurality of tool passing channels are individually formed in an axial direction through the deformable body, and each tool passing channel has a tool entrance on a surface of the upper region and a tool exit on a surface of the lower region. The tool passing channels are sufficiently elastic to conform to and seal about a shaft of a laparoscopic tool present in the channel and to close to inhibit leakage of an insufflation gases when the tool is removed from the tool passing channel.

Claims

1. A deformable seal for a laparoscopic port, said seal comprising: a deformable body having an upper region, a lower region, and a narrowed waist between the upper and lower regions; and a plurality of tool passing channels, each channel being formed axially through the deformable body and having a tool entrance on a surface of the upper region and a tool exit on a surface of the lower region; wherein each of the tool passing channels is sufficiently elastic to conform to and seal about a shaft of a laparoscopic tool present in the channel and to close to inhibit leakage of an insufflation gases when the tool is removed from the tool passing channel.

2. A deformable seal as in claim 1, further comprising an insufflation channel formed axially through the deformable body and having an insufflation tube entrance on a surface of the upper region and an insufflation tube exit on a surface of the lower region.

3. A deformable seal as in claim 1, wherein the upper region is larger than the lower region and the lower region is configured to be deformed to pass through an aperture in the laparoscopic port allowing the narrowed waist to seat in the aperture and seal to port.

4. A deformable seal as in claim 1, wherein at least some of plurality of tool passing channels have an arcuate shape configured to receive a laparoscopic tool having an arcuate midsection.

5. A deformable seal as in claim 1, further comprising valves formed over at least some of the tool entrances on the surface of the upper of the upper region.

6. A deformable seal as in claim 3, further comprising an insertion tool, wherein the insertion tool is configured to be inserted into an insertion channel formed laterally across the lower region of the deformable body, wherein the insertion tool can be manually advanced into the insertion channel to push and deform the lower region of the deformable body so that lower region can pass through the aperture and self-expand on the other side of the port with the narrowed waist in the aperture.

7. A deformable seal as in claim 6, further comprising a sheath lining the insertion channel.

8. A deformable seal as in claim 7, wherein the sheath is flexible and curved when free from constraint.

9. A deformable seal as in claim 7, wherein the insertion tool comprises a straight shaft, wherein insertion of the straight shaft into the sheath straightens the sheath to reduce the profile of the lower region of the deformable body.

10. A deformable seal as in claim 9, further comprising a pull strap affixed at one end to the sheath and configured to pull the lower region of the conformable through the aperture.

11. A deformable seal as in claim 1, wherein the deformable body comprises flexible shell filled with a filler material that will shift location within the flexible shell in response to external forces applied externally on the shell and/or internally within the channels.

12. A deformable seal as in claim 11, wherein the flexible shell comprises a polymeric membrane and the filler material comprises a gel, liquid, gas, or beads.

13. A deformable seal as in claim 12, wherein the tool passing channels are lined with a protective material which is configured to allow radial expansion of the tool passing channels as the tools are passed there through.

14. A deformable seal as in claim 13, wherein the protective material comprises elongate guides or spotted pavers.

15. A laparoscopic port system, said system comprising: deformable seal according to claim 1; and a laparoscopic port having an aperture for placement over a percutaneous incision and for removably receiving the deformable seal so that the lower region passes through the percutaneous incision.

16. A laparoscopic port system as in claim 15, wherein said laparoscopic port comprises: frame having a periphery and a central opening in a horizontal plane which defines said aperture; a first tool holder pivotally attached to an exterior of the frame at a first location, wherein said first tool holder is configured to removably receive a first tool having a curved mid-portion which passes through the tool passing channel of the deformable body when said deformable body is in the aperture; and a second tool holder pivotally attached to an exterior of the frame at a first location, wherein said second tool holder is configured to removably receive a second tool having a curved mid-portion which passes through the tool passing channel of the deformable body when said deformable body is in the aperture.

17. A laparoscopic port system as in claim 16, wherein the first and second tool holders are configured to allow the tools to pivot in at least two vertical planes relative to the frame and wherein the mid-portions of the tools are positioned to avoid interference as the tools are pivoted in said at least two vertical planes.

18. A laparoscopic port system as in claim 16, further comprises an attachment sleeve configured to be placed through the central opening and the percutaneous incision into a body cavity, wherein the sleeve may be rolled down to immobilize the frame over the incision.

19. A laparoscopic port system as in claim 18, wherein the attachment sleeve comprises an elastic tubular body and resilient upper and lower rings, wherein the lower ring can be deformed to be passed through the aperture and the upper ring can be rolled downward to clamp the frame over the incision between the upper and lower rings.

20. A method for performing laparoscopic surgery through a single port, said method comprising: securing a frame having a central opening defining an aperture over an incision in a patient's abdomen to define the single port; introducing a deformable body into through the aperture, wherein a lower region of the seal passes through the aperture and into a patients abdominal cavity and an upper region of the seal remains above the aperture with a narrowed waist between the upper and lower regions secured in a perimeter of the aperture; introducing a first laparoscopic tool through a first tool passing channel in the seal so that the channel conforms to and seals against a shaft of the first tool; introducing a second laparoscopic tool through a second tool passing channel in the seal so that the channel conforms to and seals against a shaft of the second tool.

21. A method as in claim 20, wherein the upper region is larger than the lower region and the lower region is deformed to pass through the aperture in the laparoscopic port allowing the narrowed waist to seat in the aperture and seal to port.

22. A method as in claim 20, wherein at least some of the plurality of tool passing channels have an arcuate shape configured to receive a laparoscopic tool having an arcuate midsection.

23. A method as in claim 22, further comprising introducing the first and second laparoscopic tools through valves formed over at least some of the tool entrances on the surface of the upper of the upper region.

24. A method as in claim 20, wherein introducing the deformable body through the aperture comprises inserting an introducing tool into a channel formed laterally across the lower region of the deformable body and manually advancing the tool to push and deform the lower region of the deformable body so that lower region can pass through the aperture and self-expand on the other side of the port with the narrowed waist in the aperture.

25. A method as in claim 24, wherein the tool comprises a shaft.

26. A method as in claim 20, further comprising removing the deformable port from the aperture by pulling on a pull strap affixed to the lower region.

27. A method as in claim 20, wherein the deformable body comprises flexible shell filled with a filler material that will shift location within the flexible shell in response to external forces externally on the shell and/or internally within the channels.

28. A method as in claim 27, wherein the flexible shell comprises a polymeric membrane and the filler material comprises a gel.

29. A method as in claim 20, further comprising insufflating the cavity with gas via a gas channel embedded within the seal.

30. A method as in claim 20, further comprising: attaching the first tool to a first pivotal attachment element on a first location on an outer periphery of the frame; attaching the second tool to a second pivotal attachment element at a second location on the outer periphery of the frame; wherein each tool has distal and proximal sections which lie on axes passing through the pivotal attachment elements and mid-portions which remain positioned within the central opening of the frame but avoid interference as the tools are manipulated by a user during a surgery.

31. A method as in claim 30, further comprising detaching one of the first and second tools and attaching a third tool to the respective pivotal attachment element, wherein the third tool has distal and proximal sections which lie on an axis passing through the pivotal attachment element and a mid-portion which remains positioned within the central opening of the frame as the tools are manipulated by a user during the surgery.

32. A method as in claim 30, further comprising manipulating the proximal ends of the tools to pivotally position the distal sections at desired locations within a surgical field.

33. A method as in claim 32, further comprising axially extending and retracting the proximal ends of the tools to axially extend and retract the distal sections.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0032] FIG. 1 illustrates a prior art access port having a pair of pivotally mounted laparoscopic tools intended for use in single port laparoscopic surgery as described in US 2016/0081752.

[0033] FIG. 2 illustrates a prior art transcutaneous seal intended for use in combination with the access port of FIG. 1 as described in US 2016/0081752.

[0034] FIG. 3 illustrates the prior art transcutaneous seal of FIG. 2 mounted in the prior art access port of FIG. 1 as described in US 2016/0081752.

[0035] FIG. 4 is a perspective view of a laparoscopic access port having a pair of pivotally mounts configured to removably hold laparoscopic tools in accordance with the principles of the present invention.

[0036] FIG. 5 is a front view of the laparoscopic access port of FIG. 4.

[0037] FIG. 6 illustrates an exemplary access port seal in accordance with the principles of the present invention.

[0038] FIGS. 7A, 7B, and 7C, are front, bottom, and top views of the exemplary access port seal of FIG. 6.

[0039] FIGS. 8A, 8B, and 8C are alternative top views of the exemplary access port seal of FIG. 6.

[0040] FIGS. 9A and 9B are sectional views through a neck region of the exemplary access port seal of FIG. 6 showing an insertion channel in a serpentine configuration (FIG. 9A) and in a straightened configuration having an insertion tool therein (FIG. 9B).

[0041] FIGS. 10A through 10F illustrate the insertion and removal of the access port seal of FIG. 6 through the laparoscopic access port of FIG. 4.

DETAILED DESCRIPTION OF THE INVENTION

[0042] Referring now to FIGS. 1-3, a prior art laparoscopic tool system 10 of the type described in US2016/0081752, previously incorporated herein by reference, comprises a tool attachment frame 12 having a first tool 14 and a second tool 20 pivotally attached thereto. The first tool has a mid-portion 16 and the second tool has a mid-portion 22, and both mid-portions extend generally inwardly from an axis 28 of the tool. Both mid-portions 16 and 22 are preferably circular and have a radius emanating from a virtual rotation point. The virtual rotation point is generally aligned with a pivoting assembly attached to an outer periphery of the tool attachment frame 12. Having the virtual rotation points of each tool located outside the periphery of the ring allows the generally circular mid portions 16 and 22 to pass and move through the central opening 18 of the frame 12 without interfering with each other. While the mid-portions 16 and 22 could alternatively have non-circular geometries which extend radially inward relative to the frame 12, for example being oval or polyhedral, the circular shape causes the passage point of the mid-portion to remain fixed within the central opening 18 of the frame so long as the tool is constrained to move in to orthogonal planes by the pivot attachment as will be explained in more detail hereinafter.

[0043] Referring now to FIG. 2, a prior art transcutaneous seal 42 comprises an upper for ring 44 and a lower end or ring 46. A flexible sheath 48 extends between the upper and lower ends. The seal may be disposed in a transcutaneous incision TI through and abdominal wall AW, as shown in FIG. 3. Conveniently, the sheath 48 may be generally elastic, and the length of the sheath may be adjusted by rolling the sheath over either the upper or lower rings, allowing the transcutaneous seal to be stretched and placed over the transcutaneous insertion.

[0044] As further shown in FIG. 3, once in place, the prior art tool attachment frame 12 may be attached to the upper end or ring 44 of the transcutaneous seal 42, thus fixing the frame in place relative to the patient. The tools 14 and 20 may then be attached to the vertical support arms 54 and the tools then used to perform a laparoscopic procedure by manipulating the proximal ends of the tools to reposition the distal ends where desired. As the procedure progresses, the tools may be interchanged for other tools by simply detaching the tool attachment blocks 60 from the vertical support arms 54.

[0045] Referring now to FIGS. 4 and 5, a laparoscopic port 100 includes a deformable body 102 having a right post 104 and a left post 106 extending upwardly from an upper surface of the body. The deformable body has a generally arcuate profile, as best seen in FIG. 5, so that it may be placed over a patient's stomach so that a central aperture 108 can align with the patient's umbilicus. Central aperture 108 has a flange structure 110 surrounding an open central portion and a vertical wall 112 extending about the outer periphery of the flange. The deformable body will have arms 54 attached to pivots 52 generally as described above with respect to the U.S. Patent Publication 2016/0081752, the full disclosure of which has been incorporated herein by reference. It will be appreciate that these arms 54 are intended for attaching laparoscopic tools so that the tools may be introduced through the aperture 108, as described in detail in the incorporated patent publications.

[0046] Referring now to FIG. 6, a deformable seal 120 has an upper region 122 and a lower region 124. A narrowed waist region 126 is disposed between a lower surface of the upper region and an upper surface of the lower region. A nose or other protrusion 128 is formed to project laterally from one side of the lower region 124 where the nose serves to facilitate introduction of the deformable seal 120 through the central aperture 108 of the laparoscopic port 100, as described in greater detail below. Both the upper region 122 and the lower region 124 have generally circular cross-sections in a lateral plane and generally oval cross-sections in an axial or vertical plane. The narrowed waist region has a generally hour-glass shape, and the nose typically has a bullet shape, i.e. being generally cylindrical with a rounded distal tip. While these geometries are exemplary, other specific shapes could be used in other designs in accordance with the principles of the present invention.

[0047] Referring now to FIGS. 7A through 7C, the deformable body 120 has a plurality of tool passing channels 130 formed axially (where the axis is aligned top to bottom of the seal) there through from an upper surface of the upper region 122 to a lower surface of the lower region 124. Upper openings are marked as 130, with the centrally aligned passages marked as 130, and the lower exit openings marked as 130. As described in more detail below, laparoscopic tools having curved mid-sections, such as though described in detail in U.S. Patent Publication Numbers 2012/00116362 and 2016/0081752, the full disclosures of which have been previously incorporated herein by reference, may be introduced through the passages 130.

[0048] As shown in FIGS. 8A through 8C, in some instances, the upper openings of the tool passing channels may be covered with conventional valve covers 136 FIG. 8A), such as split membrane valve covers, which allow tools to be passed there through but which close to form a seal when no tool is present through the slits.

[0049] Additionally or alternatively, the tool passing channels 130 may further comprise a plurality of reinforcement tracks 140 (FIG. 8B) which serve to facilitate passage of laparoscopic tools through the tool passing channels. The tracks 140 will act both to protect the integrity of the tool passing channel 130 (FIG. 7A) as the tools are introduced and also to guide and facilitate passage of the tools through the channels.

[0050] Similarly, as shown in FIG. 8C, the built passing channels may be protected by a matrix or distribution of small reinforcement pads, such as polymeric dots or beads which are formed over the entire length of the tool passing channel.

[0051] In all cases, the tool passing channels may be lubricated to further assist passage of tools, scopes, and the like therethrough.

[0052] Referring now to FIGS. 9A and 9B, in order to facilitate introduction of the deformable body through an aperture in a laparoscopic port, an insertion channel 150 may be formed laterally across the lower region 124 of the body. In specific embodiments, the deformable body will comprise an outer shell 146 which typically comprise an elastic, semi-elastic, or in some cases non-distensible polymeric material on membrane. The outer shell may consist of a single material or may comprise two or mare materials, wherein such multiple materials may be laminated, heat welded, adhesively bonded, or otherwise formed in a single, contiguous shell with an interior that is filled with a filler Material 148.

[0053] The filler material 148 is disposed in the interior of the outer shell and will comprise a flowable filler material, such as a hydrogel, viscous liquid, beads, air and other gasses, or the like. In all cases, the filler material will allow deformation of the deformable seal as it is introduced through the aperture of the laparoscopic port and also as laparoscopic tools are passed through the tool passing channels.

[0054] In preferred instances, the insertion channel 150 will have a curved or serpentine shape on the deformable seal is not deformed, as shown in FIG. 9A. In this way, an insertion tool, typically having a straight shaft 154, can be introduced through the insertion channel 150 in order to straighten the channel and elongate the lower region 124 of the seal body 120. Such elongation facilitates introduction of the lower portion through an aperture of a port as described in more detail below. Preferably, the insertion channel 150 will be protected by an insertion sheath 152 which is sufficiently flexible to allow straightening and which is sufficiently strong to prevent damage to the deformable body as the insertion tool is being introduced.

[0055] Referring now to FIGS. 10A through 10F, methods of the present invention for introducing the deformable seal 120 into the laparoscopic port 100 will be described. As shown in FIG. 10A, the laparoscopic port 100 may be placed over a patient's stomach (not shown) with the aperture 108 aligned over the patient's umbilicus. After opening the umbilicus with an incision, a transcutaneous seal 158 is introduced through the aperture 108 and the lower end of the sleeve inserted into the patient's abdomen, as shown in FIG. 10B, typically manually. Note for simplicity, the abdominal wall is not shown, but it should be appreciated that a lower ring 162 of the seal will be introduced through both the port 108 and the incision so that the ring engages an internal surface of the abdominal wall. Typically the ring will be itself deformable so that it can be squeezed to be placed through the incision allowed to expand into engagement with the internal wall.

[0056] After the transcutaneous sleeve 158 has been introduced, an upper ring 160 will be rolled downwardly, as shown by the arrows in FIG. 10B, until a rolled top 166 engages an upper surface of the flange 110, as shown in FIG. 10C. In this way, the laparoscopic port will be anchored on the patient's stomach and the aperture fixedly aligned with the incision through the umbilicus.

[0057] Once the laparoscopic port 100 has been anchored in place, as shown in FIG. 10C, the deformable seal 120 will be positioned so that nose 128 is aligned with the aperture 108 of the laparoscopic port. Shaft 154 of the insertion tool is placed in the insertion channel 150, and the insertion tool advanced in order to straighten the insertion channel 150 and reduce the profile of the nose 128 and lower region 124, as shown in FIG. 9B above. The nose 128 can then be introduced through the aperture 108, as shown in FIG. 10D, and further advanced until the lower region 124 is fully through the aperture and located in the patient's abdominal cavity, as shown in FIG. 10E. The insertion tool is then removed, and the lower region 124 self-expands into its unconstrained configuration with the narrowed waist 126 located within the interior of the aperture engaging a periphery of the transcutaneous sleeve 158.

[0058] Tools 128, shown in broken line in FIG. 10E, can then be introduced and attached to the arms of 52 of the laparoscopic port 100, as shown in FIGS. 4 and 5. The tools are generally manipulated as described in prior U.S. Patent Publications 2012/0116362 and 2016/0081752, the full disclosures of which have been previously incorporated herein and by reference.

[0059] After the laparoscopic procedure has been completed, the deformable body 120 may be removed by pulling upwardly on the pull strap 170, as shown in FIG. 10F, in order to remove the seal from the aperture. Once the deformable seal has been removed, the transcutaneous sleeve can be unrolled releasing the laparoscopic port 100 from the patient, and the incision can be closed in the conventional manner.

[0060] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0061] The foregoing examples are not intended to limit the scope of the invention. All modifications, equivalents and alternatives are within the scope of the invention.