Skin seal
A skin seal or trocar stabilizer with an inflatable membrane disposed inside, whereby medical instruments may be passed through the skin seal into a endoscopic work space while the inflatable membrane is inflated, thereby allowing the use of normal short conventional open surgery instruments during endoscopic procedures and during insufflation.
This application is a reissue of U.S. Pat. No. 6,238,373 which issued from U.S. patent application Ser. No. 09/340,908, filed Jun. 28, 1999, which is a continuation of U.S. application Ser. No. 08/840,104, filed on Apr. 11, 1997, now U.S. Pat. No. 5,997,515 which is a continuation-in-part of U.S. application Ser. No. 08/444,396, filed on May 19, 1995, now U.S. Pat. No. 5,634,911. The priority of these prior applications is expressly claimed and their disclosures are hereby incorporated by reference in their entirety. U.S. patent application Ser. No. 12/004,439, filed Dec. 20, 2007, is a division of U.S. application Ser. No. 10/446,365, which is a reissue of U.S. Pat. No. 6,238,373. U.S. patent application Ser. No. 12/004,441, filed Dec. 20, 2007, is a continuation of U.S. application Ser. No. 10/446,365, which is a reissue of U.S. Pat. No. 6,238,373. U.S. patent application Ser. No. 12/607,667, filed Oct. 28, 2009, is a continuation of U.S. application Ser. No. 10/446,365, which is a reissue of U.S. Pat. No. 6,238,373.
FIELD OF THE INVENTIONThis invention relates to the field of surgical endoscopy, specifically to improvements in skin seals and cannulas.
BACKGROUND OF THE INVENTIONSurgical endoscopy is a surgical technique of using small diameter long-handled tools such as graspers, forceps, scissors, retractors, dissectors, and clamps specially designed to be inserted through small incisions in the skin (or other openings in the body) to perform operations within the body. The surgeon performing the surgery often cannot see the operation directly and must watch the procedure on a video monitor fed by an endoscopic camera or endoscope. Endoscopic surgery replaces open surgery, which requires large incisions, essentially opening the body cavity completely, in order to perform surgery deep within the body. Endoscopic techniques have been used for gall stone removal, gall bladder removal, hernia repair, tumor removal, lymph node removal, appendectomy, and many other operations. Endoscopic surgery is also called laparoscopic surgery, video assisted surgery, minimally invasive surgery, and bandaid surgery, but throughout this specification the term endoscopic surgery or laparoscopic surgery will be used.
To illustrate the background of the inventions described below, the example of the laparoscopic cholecystectomy, hernia repair or lymphadenectomy, as well as the operation for harvesting a blood vessel, will be used to illustrate both the old laparoscopic procedures and the new laparoscopic procedures now possible with the new devices. In the old procedure, a workspace was created in the abdomen using the process called pneumoperitoneum or insufflation. Insufflation is the process of injecting gas into the body to blow it up like a balloon, creating a chamber filled with gas. When performed on the abdomen, the peritoneum is inflated, and the procedure is known as pneumoperitoneum. The procedure can be used for inflating a space between the peritoneum and the skin to permit laparoscopic hernia repair, as illustrated in U.S. Pat. No. 5,496,345, issued to Kieturakis et al. and entitled “An Expansible Tunneling Apparatus for Creating an Anatomic Working Space.” Insufflation can be used also to inflate a tunnel-shaped work space over a blood vessel, to facilitate blood vessel harvesting as described in U.S. Pat. No. 5,601,589 entitled “Extraluminal Balloon Dissection Apparatus and Method,” incorporated herein by reference. While the chamber is filled with gas, the surgeon inserts long slender laparoscopic tools through trocars and cannulas that pierce the skin and provide access ports into the insufflated chamber.
For abdominal surgery such as a cholecystectomy (gall bladder removal), the insufflation is accomplished by the following procedure. An incision is made at the lower edge of the belly button or umbilicus. The surgeon uses his fingers or a blunt dissection tool such as a blunt nosed obturator to uncover the fascia or abdominal muscles, then a large needle, referred to as a Verres needle, is inserted into the abdomen or peritoneal cavity. The Verres needle punctures the fascia and peritoneum that cover the abdomen. A pressurized gas such as CO2 is injected into the abdomen through the needle, in effect inflating the abdomen like a balloon. After the abdomen is inflated, the Verres needle is removed. After the needle is removed, trocars and cannulas are inserted into the space created by the insufflation. Endoscopic instruments, including an endoscope or laparoscope, scissors, graspers, etc., are inserted into the abdomen through the cannulas and manipulated to dissect tissue surrounding the gall bladder, remove the gall bladder, and stitch the internal wounds.
To harvest the saphenous vein using laparoscopic procedures, the surgeon may insufflate a tunnel-shaped workspace over a blood vessel. The tunnel is first created using obturators or tunneling devices, or balloons inserted through small incisions along or over the saphenous vein. After the tunnel is created, the surgeon may insert skin seals and cannulas, and insufflation gas is injected through one of the trocars. While the tunnel is insufflated, the cannulas permit the surgeon to insert laparoscopic instruments into the tunnel to perform surgery on the saphenous vein.
The cannula used in the procedures described above is a length of rigid tube. The trocars and cannula are designed to allow laparoscopic instruments to pass through them and prevent gas from escaping the abdomen or other insufflated work space. The cannula may have a flapper valve or a trumpet valve inside which opens to allow an endoscope or laparoscope or other instrument to pass through, and valve closes when the laparoscope is removed. Some trocar/cannula devices also contain a duckbill valve to assist in sealing the trocar. The cannulas are typically about 6 inches or 15 centimeters long, and come in diameters matching various laparoscopic devices, generally from 2 to 15 mm.
Some surgeons use bare cannulas, secured only by a tight fit with the skin and fascia. However, cannulas frequently slip out of the body during use, disrupting the procedure and possibly endangering the patient. To prevent this danger, surgeons have devised a variety of methods to secure the cannula to the body and prevent it from slipping out of the body. Some cannulas are provided with threaded sleeves fixed to the cannula. Some cannulas are provided with a threaded gripper with a smooth inner bore that matches the size of the cannula, so that the cannula can slide inside the gripper as shown in
The surgeon usually needs to place several trocars and cannulas into the abdomen and inserts as many as needed to accomplish the intended operation. The first cannula placed through the belly button is used to insert a laparoscope so that the placement of other trocars and cannulas can be viewed from inside the abdomen. After several cannulas are in place, the surgeon can view the procedure through any port and can insert laparoscopic scissors, cutters and graspers, and other tools through the cannulas in order to perform the surgery. The typical endoscopic graspers 3 used for stitching inside the abdomen are shown, deployed inside the cannulas, in
The arrangement of the cannulas and trocars is required because the abdomen must be inflated to make room for the surgeon to work. The small diameter of the cannulas keeps the incisions small, and the matching diameter of the laparoscopic instruments is necessary to prevent leakage of the insufflation gas from the abdomen. Laparoscopic instruments of various designs are available, and they generally are about 5 to 12 mm in diameter (to match the inside bore of the cannulas) and about 10 to 40 cm in length. They are long and therefore difficult to use, and they are usually used when the surgeon can see them only through the laparoscope. Modern laparoscopic procedures require the surgeon to view the procedure on a video monitor. It may take a surgeon a lot of practice before becoming comfortable and skillful with the laparoscopic graspers, grippers and scissors. These tools are more difficult to use than the surgical tools that every surgeon uses in normal surgery, such as those shown in
It would be advantageous to use normal surgical tools during laparoscopic procedures, but this is usually not permitted by the typical construction of the trocars and cannulas that are too narrow, long, and rigid to permit passage of the normal surgical tools. Most surgeons are very well trained in using conventional nonendoscopic instruments, such as the open-incision graspers shown in
In a typical endoscopic or laparoscopic operation, a surgeon creates a work space inside the body through insufflation. To create the working space for abdominal surgery, the surgeon makes a small incision at, for example, the inferior margin of the umbilicus 1 as shown in
As mentioned above, the trocars and cannulas can be used in endoscopic blood vessel surgery, laparoscopic cholecystectomy, and laparoscopic hernia repairs where a working space is created under the skin. In the blood vessel harvesting operation where the saphenous vein is to be removed, a surgeon creates a tunnel between two small incisions over the saphenous vein. Then a cannula and skin seal are inserted into each incision. The tunnel is insufflated through one of the cannulas. In these procedures, the laparoscopic instruments are also inserted into the working space through the cannulas, and the surgeon can watch the surgery through a laparoscope inserted through the one of the cannulas.
The devices presented herein allow for use of normal surgical tools (such as the forceps and scissors used in open-incision surgery) in laparoscopic procedures. The skin seal is fitted with one or more balloons on the inner bore. These balloons can be inflated after the skin seal is inserted into the incision into the abdomen. Placement of the skin seal can be accomplished as usual with the aid of a blunt or sharp trocar or cannula placed within the threaded skin seal. Where the skin seal is flexible, the blunt or sharp trocar may include a circumferential lip about its distal end to prevent rollback of and streamline the distal end of the skin seal during placement of the skin seal. The threaded skin seal can be made of rigid plastic, as is customary, or preferably it may be made of soft and pliable material such as latex or silicone rubber. When the threaded skin seal is in place, the trocar may be removed and the balloon may be inflated until it expands to fill the inner bore of the threaded skin seal, thus sealing the bore to maintain the pressure created inside the abdomen with the insufflation gas. The balloons are soft and pliable and can conform around the elements of the instruments as they are moved about during use. Thus, normal or conventional surgical instruments may be passed between the balloons. Both normal surgical instruments and laparoscopic instruments may be inserted into the body through the balloons without disrupting the seal created by the balloons. The efficiency of the seal created by the balloon is further enhanced by the use of a plurality of tab-like or brush-like protrusions extending inwardly from the balloon to form a tortuous path type seal or labyrinth type seal. Alternatively, the protrusions may be inflatable.
The balloon is soft and pliable so that normal surgical tools may be operated inside the inflated balloon segments and the balloon segments will not hamper the operation of the tool to a significant degree. The skin seal may be provided with a balloon membrane that expands outside the lumen of the skin seal to create a dumbbell, dog bone, or bow tie-shaped balloon which pinches the skin and, when necessary, fills the lumen of the skin seal.
More than one tool may be inserted through a single skin seal, because the balloons are sufficiently pliable and may be inflated to a lesser degree. In this manner, normal surgical instruments may be used in laparoscopic procedures, taking advantage of the fact that they are easier to use and more surgeons know how to use them, compared to the long laparoscopic instruments. The balloon filled skin seal may be used also as a seal for laparoscopic incisions which are no longer necessary or which the surgeon desires to plug temporarily while still leaving a skin seal in place for later use.
The cannulas and grippers described below allow for use of normal surgical instruments in laparoscopic surgical procedures. The typical gripper configuration is modified by adding a balloon or inflatable membrane to the inner bore of the gripper and adding an inflation port to the wall of the gripper to allow for inflation of the balloon. When the balloon is inflated, it closes off the inner bore of the gripper, so that it provides an airtight seal during insufflation. The balloon is pliable so that tools can be inserted through the inner bore of the balloon and the balloon expands around the surgical tool to maintain the seal with little or no leakage of insufflation gas.
Referring to
A balloon membrane 20 has a generally conical or frustum shape matching the inner bore 14 of the threaded skin seal 10 and having the same overall length of the threaded skin seal. The balloon membrane fits inside the threaded skin seal and is sealed to the skin seal funnel at the upper edge and lower edge of the balloon membrane. The balloon membrane may be shorter than the skin seal, and may be sealed to the inner surface of the skin seal at points inside the skin seal, rather than at the immediate distal and proximal edges of the skin seal. Also, the balloon membrane may be longer than the skin seal and may be cuffed or folded back around the outside of the skin seal at the proximal and distal ends, and sealed at the cuffs.
An inflation port 21 is provided (see also
In the preferred embodiment, the balloon membrane 20 is made of biocompatible elastomeric or elastic material such as latex, silicone rubber, or any other suitable compliant material, elastic material or inflatable material. The cannula 10 is made of rigid or flexible material, soft or hard plastic, high density, or low density polyethylene, polypropylene, thick latex, silicone rubber, or any other suitable material including plastic, elastic or nonelastic biocompatible material.
As shown in
It will be readily appreciated that such operation would not be possible using standard cannulas. The normal surgical tools are much easier to use than the long laparoscopic instruments shown in
Placement of the skin seals may be facilitated with special blunt obturators shown in
Placement of flexible skin seals may be facilitated with an alternative obturator or trocar shown in
An alternative embodiment of the screw-type skin seal uses a resilient packing in the lumen of the skin seal cannula. As shown in
Referring to
A balloon membrane 120 has a generally continuously tapered shape matching a portion of the inner bore 114 of the threaded skin seal 110. The balloon membrane 120 fits inside the threaded skin seal 110 and is sealed to the inner surface of the skin seal 110 at the upper and lower edges of the balloon membrane 120. The balloon membrane 120 may be shorter than the skin seal 110, and thus may be sealed to the inner surface of the skin seal 110 at various points inside the skin seal 110. Also, the balloon membrane 120 may be longer than the skin seal 110 and may be cuffed or folded back around the outside of the skin seal 110 at the proximal and distal ends 115 and 116, and sealed at the cuffs.
An inflation port 121 extends from the wall 122 of the threaded skin seal 110 and communicates with the balloon membrane 120 through a hole in the wall 122. Preferably, the inflation port 121 extends upwardly from the wall 122 of the skin seal at an angle θ to a horizontal plane formed by a cross-section of the skin seal 110. Preferably, the angle θ is in the range of about 30° to 70°. This configuration advantageously provides access to the inflation port 121 when the skin seal is screwed into the body tissue of a patient regardless of the patient's body type and/or angle of entry. In an obese patient, a radially extending inflation port may be obstructed by the patient's excess fatty body tissue. However, if the inflation port 121 is angled as shown in
An inflation tube 123 or Luer fitting connects the inflation port 121 to a squeeze pump 125. In addition, a one-way valve or stopcock 126 may be used to seal the balloon membrane 120 so that the squeeze pump 125 may be detached from the skin seal 110 when not needed.
To provide a more efficient seal, a plurality of tabbed protrusions 117 extend inwardly from the balloon membrane 120 in a helical pattern along the balloon membrane or in a series of rings longitudinally spaced along the balloon membrane 120. The squeeze pump 125 is used to force air into the space between the balloon membrane 120 and the wall 122 of the skin seal 110, causing the balloon membrane 120 to inflate within the skin seal 110 (see
As shown in
Turning to
The skin seals described above can be used for any endoscopic or laparoscopic surgery to permit use of normal surgical instruments, i.e., ordinary open-incision surgical instruments. While the skin seals described above are useful in procedures requiring insufflation, they may also be used in other endoscopic or laparoscopic procedures. The use of the skin seal in any endoscopic or laparoscopic procedures will allow deployment of normal surgical tools while protecting the area of the incision from trauma caused by the operation of the surgical instruments. Where insufflation or flushing is required, the bladder in the skin seal may be inflated to prevent undesired flow out of the cannula. Also, although the skin seal described above has been described in the best known embodiments, fabricated with suitable materials to the inventors, the particular materials and shapes depicted in the illustrations may be altered and improved upon without departing from the inventions as claimed. It is specifically contemplated that the materials be improved upon. Furthermore, although the devices have been described in relationship to surgery requiring insufflation and endoscopic or laparoscopic surgery, the claimed devices and methods may be used in surgical and nonsurgical applications wherever the features of these device and methods prove beneficial.
Claims
1. A method of sealing a skin incision for performing a minimally invasive surgical procedure at a surgical site in a body, said method comprising:
- providing a sealing device comprising a tube having a proximal end and a distal end, an inner bore and an outer surface, said proximal end having a larger outer diameter than said distal end, and an inflatable membrane disposed within said inner bore, said sealing device further comprising a plurality of protrusions extending inwardly from said inflatable membrane, said plurality of protrusions extending inwardly engaging one another to form a seal upon inflation of the inflatable membrane;
- making an incision in the body;
- inserting said distal end of said sealing device through said incision;
- advancing said sealing device through said incision to form a seal between said incision and said outer surface of said outer bore; and
- inflating said inflatable membrane.
2. The method of claim 1 wherein said sealing device further comprises a fastening means on said outer surface of said tube.
3. The method of claim 2 wherein said fastening means comprises screw threads.
4. The method of claim 2 wherein said fastening means comprises circumferential ribs.
5. The method of claim 1 wherein said sealing device further comprises a plurality of protrusions extending from said outer surface of said tube.
6. The method of claim 1 further comprising:
- insufflating the surgical site.
7. The method of claim 1 further comprising:
- inserting a surgical instrument through said sealing device and into the surgical site.
8. The method of claim 1 further comprising:
- deflating the inflatable member sufficiently to allow passage of a surgical tool through said inner bore of the sealing device while substantially maintaining a seal between said inflatable membrane and said surgical tool; and
- performing a surgical procedure through the incision with said surgical tool.
9. A method of sealing a skin incision for performing a minimally invasive surgical procedure at a surgical site in a body, said method comprising:
- providing a sealing device comprising a tube having a proximal end and a distal end, an inner bore and an outer surface, said proximal end having a larger outer diameter than said distal end, an inflatable membrane disposed within said inner bore, said inflatable membrane being adapted to completely fill said inner bore when inflated and to leave an open lumen through said inner bore when deflated, said sealing device further comprising a plurality of protrusions extending inwardly from said inflatable membrane, said plurality of protrusions extending inwardly engaging one another to form a seal upon inflation, wherein said tube further comprises a plurality of protrusions extending from said outer surface of said tube;
- making an incision in the body;
- inserting said distal end of said sealing device through said incision;
- advancing said sealing device through said incision to form a seal between said incision and said outer surface of said outer bore; and
- inflating said inflatable membrane.
10. The method of claim 9 wherein said plurality of protrusions on the outer surface of the tube comprises screw threads.
11. The method of claim 10 wherein said plurality of protrusions on the outer surface of the tube comprises circumferential ribs.
12. The method of claim 9 further comprising:
- insufflating the surgical site.
13. The method of claim 9 further comprising:
- inserting a surgical instrument through said sealing device and into the surgical site.
14. The method of claim 9 further comprising:
- deflating the inflatable member sufficiently to allow passage of a surgical tool through said inner bore of the sealing device while substantially maintaining a seal between said inflatable membrane and said surgical tool; and
- performing a surgical procedure through the incision with said surgical tool.
15. A skin seal comprising:
- a housing having at least a portion configured and dimensioned to be mounted in an incision through a patient's skin and having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore for communicating through the patient's skin to a working space under the patient's skin, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;
- a seal member positioned across the inner bore at the proximalmost opening of the housing so the seal member extends distally from the first plane into the inner bore, the seal member comprising a packing of gel material capable of conforming around a surgical instrument, the gel material extending distally from the first plane, a surface of the gel material being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, wherein direct contact between the gel material and the surgical instrument allows surgery to be performed in the working space through the skin seal while maintaining the work space in an insufflated condition, at least a portion of the gel material having a dimension less than the first dimension of the proximalmost opening.
16. The skin seal of claim 15, wherein the packing comprises a gel having a slit therethrough.
17. The skin seal of claim 15, wherein at least portion of the seal member is positioned within the inner bore.
18. The skin seal of claim 15, wherein at least a portion of the seal member is positioned within the portion of the housing mounted through the patients skin.
19. The skin seal of claim 15, wherein the housing comprises a rigid cannula.
20. The skin seal of claim 19, wherein said rigid cannula includes an external thread.
21. The skin seal of claim 15, wherein the housing is flexible.
22. A skin seal as in claim 15, wherein the housing has an internal wall and the inner bore is bounded by the internal wall, the packing of gel material having an upper surface, a lower surface, and an outer surface having a length extending from the upper surface to the lower surface, the outer surface contiguous with the internal wall of the inner bore along its length.
23. A skin seal comprising a housing having at least a portion configured and dimensioned to be mounted in an incision through a patient's skin, and having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore for communicating through the patient's skin to a working space under the patient's skin, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;
- a seal member positioned within the inner bore at the proximalmost opening of the housing so the seal member extends distally from the first plane into the inner bore, the seal member comprising a packing of a gel capable of conforming around a surgical instrument, the gel material extending distally from the first plane, a surface of the gel being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, wherein direct contact between the gel and the surgical instrument allows surgery to be performed in the working space through the skin seal while maintaining the work space in an insufflated condition, at least a portion of the packing of a gel having a dimension less than the first dimension of the proximalmost opening.
24. The skin seal of claim 23, further comprising a slit through the packing material.
25. The skin seal of claim 23, wherein the housing comprises a rigid cannula.
26. The skin seal of claim 25, wherein said rigid cannula includes an external thread.
27. The skin seal of claim 23, wherein the housing is flexible.
28. The skin seal of claim 23, wherein at least a portion of the seal member is positioned within the portion of the housing mounted in the incision through the patient's skin.
29. A skin seal comprising:
- a housing having at least a portion configured and dimensioned to be mounted in an incision through a patient's skin, and having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore for communicating through the patient's skin to a working space under the patient's skin, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing:
- a gel seal positioned across the inner bore at the proximalmost opening of the housing so the gel seal extends distally from the first plane into the inner bore, a surface of the gel seal being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel seal being capable of conforming around an object inserted through and in direct contact with the gel seal and maintaining a substantially fluid-tight barrier in both the presence and the absence of the object, the gel seal extending distally from the first plane, at least a portion of the gel seal having a dimension less than the first dimension of the proximalmost opening.
30. A skin seal as in claim 29, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps.
31. A skin seal as in claim 29, wherein the object is a laparoscopic surgical instrument.
32. A skin seal as in claim 29, wherein the housing is rigid.
33. A skin seal as in claim 32, wherein the rigid housing includes an external thread.
34. A skin seal as in claim 29, wherein the housing is flexible.
35. An apparatus comprising:
- a housing supporting a seal adjacent a surface of a patient's skin the housing having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;
- the seal comprising gel positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore, and which, when directly contacted by an object inserted therethrough, conforms around the object to maintain a substantially fluid-tight barrier in both the presence and the absence of the object, a surface of the gel being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel extending distally from the first plane, at least a portion of the gel having a dimension less than the first dimension of the proximalmost opening.
36. An apparatus as in claim 35, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps.
37. An apparatus as in claim 35, wherein the object is a laparoscopic surgical instrument.
38. An apparatus as in claim 35, wherein the housing is rigid.
39. An apparatus as in claim 38, wherein the rigid housing includes an external thread.
40. An apparatus as in claim 35, wherein the housing is flexible.
41. An apparatus comprising:
- a seal member consisting essentially of gel, the seal having an upper surface and a lower surface, the seal member being capable of conforming around an object inserted therethrough and in direct contact with the gel, the seal maintaining a substantially fluid-tight barrier in both the presence and the absence of the object; and
- a housing dimensioned and configured to support the seal adjacent to the skin of the patient with the upper surface of the gel being exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening defined in the first plane, spanning the width of the top surface of the housing and having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore and the seal member being positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore with the gel extending distally from the first plane, at least a portion of the gel material having a dimension less than the first dimension of the proximalmost opening.
42. An apparatus as in claim 41, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps.
43. An apparatus as in claim 41, wherein the object is a laparoscopic surgical instrument.
44. An apparatus as in claim 41, wherein the housing is rigid.
45. An apparatus as in claim 44, wherein the rigid housing includes an external thread.
46. An apparatus as in claim 41, wherein the housing is flexible.
47. A skin seal as in claim 41, wherein the object is an obturator including a lip defining a proximally oriented recess, the lip configured to engage a distal end of the housing.
48. A skin seal comprising:
- a seal member comprising a gel that is mountable adjacent to a skin incision, wherein a surface of the gel is configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel, when directly contacted by an object inserted therethrough, conforms around the object so as to seal an insufflated workspace under the skin; and a housing dimensioned and configured to mount the seal member adjacent to a skin incision, the housing having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening defined in the first plane, spanning the width of the top surface of the housing and having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore and the seal member being positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore with the gel extending distally from the first plane, at least a portion of the gel material having a dimension less than the first dimension of the proximalmost opening.
49. A skin seal as in claim 48, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps.
50. A skin seal as in claim 48, wherein the object is a laparoscopic surgical instrument.
51. A skin seal as in claim 48, wherein the housing is rigid.
52. A skin seal as in claim 51, wherein the rigid housing includes an external thread.
53. A skin seal as in claim 48, wherein the housing is flexible.
54. A skin seal as in claim 48, wherein the housing is soft and pliable.
55. An apparatus comprising:
- a housing supporting a seal adjacent a surface of a patient's skin the housing having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;
- the seal comprising gel positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore, and which, when directly contacted by an object inserted therethrough, conforms around the object to maintain a substantially fluid-tight barrier in both the presence and the absence of the object, a surface of the gel being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel extending distally from the first plane.
56. An apparatus as in claim 55, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps.
57. An apparatus as in claim 55, wherein the object is a laparoscopic surgical instrument.
58. An apparatus as in claim 55, wherein the housing is rigid.
59. An apparatus as in claim 58, wherein the rigid housing includes an external thread.
60. An apparatus as in claim 55, wherein the housing is flexible.
61. An apparatus as in claim 55, wherein the top surface of the housing is flat.
62. An apparatus as in claim 55, wherein the gel seal has a top surface that is positioned below the top surface of the housing.
63. An apparatus as in claim 55, wherein the gel is positioned entirely below the top surface of the housing.
1690995 | November 1928 | Pratt |
3057350 | October 1962 | Cowley |
3313299 | April 1967 | Spademan |
3799166 | March 1974 | Marsan |
3853127 | December 1974 | Spademan |
3970089 | July 20, 1976 | Saice |
4475548 | October 9, 1984 | Muto |
4555242 | November 26, 1985 | Saudagar |
4610665 | September 9, 1986 | Matsumoto et al. |
4654030 | March 31, 1987 | Moll et al. |
4738666 | April 19, 1988 | Fuqua |
4760933 | August 2, 1988 | Christner et al. |
4796629 | January 10, 1989 | Grayzel |
4828554 | May 9, 1989 | Griffin |
5071411 | December 10, 1991 | Hillstead |
5127626 | July 7, 1992 | Hilal et al. |
5158553 | October 27, 1992 | Berry et al. |
5211633 | May 18, 1993 | Stouder, Jr. |
5226890 | July 13, 1993 | Ianniruberto et al. |
5273545 | December 28, 1993 | Hunt et al. |
5290310 | March 1, 1994 | Makower et al. |
5300034 | April 5, 1994 | Behnke et al. |
5330437 | July 19, 1994 | Durman |
5331975 | July 26, 1994 | Bonutti |
5338313 | August 16, 1994 | Mollenauer et al. |
5360417 | November 1, 1994 | Gravener et al. |
5364372 | November 15, 1994 | Danks et al. |
5366478 | November 22, 1994 | Brinkerhoff et al. |
5391153 | February 21, 1995 | Haber et al. |
5391156 | February 21, 1995 | Hildwein et al. |
5403336 | April 4, 1995 | Kieturakis et al. |
5413571 | May 9, 1995 | Katsaros et al. |
5460616 | October 24, 1995 | Weinstein |
5468248 | November 21, 1995 | Chin et al. |
5480410 | January 2, 1996 | Cuschieri et al. |
5514109 | May 7, 1996 | Mollenauer et al. |
5514133 | May 7, 1996 | Golub et al. |
5538509 | July 23, 1996 | Dunlap et al. |
5540711 | July 30, 1996 | Kieturakis et al. |
5545150 | August 13, 1996 | Danks et al. |
5545179 | August 13, 1996 | Williamson, IV |
5580344 | December 3, 1996 | Hasson |
5607443 | March 4, 1997 | Kieturakis et al. |
5634911 | June 3, 1997 | Hermann et al. |
5634937 | June 3, 1997 | Mollenauer et al. |
5653705 | August 5, 1997 | De La Torre et al. |
5662615 | September 2, 1997 | Blake, III |
5697914 | December 16, 1997 | Brimhall |
5720730 | February 24, 1998 | Blake, III |
5741298 | April 21, 1998 | MacLeod |
5743884 | April 28, 1998 | Hasson et al. |
5803921 | September 8, 1998 | Bonadio |
5814026 | September 29, 1998 | Yoon |
5865807 | February 2, 1999 | Blake, III |
5906577 | May 25, 1999 | Beane et al. |
5913847 | June 22, 1999 | Yoon |
5916198 | June 29, 1999 | Dillow |
5964781 | October 12, 1999 | Mollenauer et al. |
5989232 | November 23, 1999 | Yoon |
5989233 | November 23, 1999 | Yoon |
6004303 | December 21, 1999 | Peterson |
6440063 | August 27, 2002 | Beane et al. |
6578577 | June 17, 2003 | Bonadio et al. |
WO 94/22357 | October 1994 | WO |
Type: Grant
Filed: May 28, 2003
Date of Patent: Mar 4, 2014
Inventors: Roger A. de la Torre (Columbia, MO), George D. Hermann (Portola Valley, CA), Kelly Thayer (Truckee, CA)
Primary Examiner: Manuel Mendez
Application Number: 10/446,365
International Classification: A61M 5/14 (20060101);