The present disclosure pertains to the field of surgical devices and more specifically, to surgical access ports for use in minimally invasive surgical procedures such as laparoscopic and/or trans-endoscopic procedures.
Minimally invasive surgery, such as endoscopic and/or laparoscopic procedures, is a type of surgery performed through one or more small incisions in a patient's body, usually less than an inch in dimension. Some advantages of minimally invasive surgery are that patients experience reduced physical and physiological trauma, much smaller scarring, and faster post-surgery recovery times.
The single port approach to minimally invasive surgery, whether that be through a single incision or via a natural orifice such as the oral cavity, nasal passages, the navel, the vagina, and the anus, for example, provides the benefit of smaller and fewer body cavity incisions. Single-port procedures, however, require several instruments to be inserted and manipulated through a single entry into a tissue tract, thereby, limiting the freedom of movement for manipulating the multiple instruments inserted through a single port.
Access ports are commonly used in such minimally invasive surgical procedures to facilitate the introduction and manipulation of multiple instruments and equipment into a tissue tract through an incision or a natural orifice. The access ports are used to protect adjacent tissues from potential abrasion and/or tearing and/or incised damage caused by insertion and manipulation of the surgical instruments and equipment.
Some procedures further involve the use of insufflation gases to enlarge the area surrounding the target surgical site to create a larger, more accessible work area. In such procedures, access ports may be introduced into regions that require maintenance of the pressurized gas.
In Canadian Patent No. 2,778,976, the inventors described a surgical access port comprising an elongate cannula that can be fixed within a tissue tract to define a passageway for introduction of one or more surgical instruments. The cannula extends into an enclosed dome comprised of a self-sealing material through which the one or more surgical instruments can be directly introduced. Being of a self-sealing material, the dome is deformable without losing physical integrity and maintains a substantially gas tight seal with any instrument extending therethrough, as well as self-sealing upon removal of the instruments. The expanded diameter of the dome permits angular or pivotal ranges of movement for the instruments passing through the dome, thereby permitting wide triangulation of instruments inserted therethrough. As well, greater spacing apart of multiple instruments is made possible to facilitate precise manipulation of instruments during surgical procedures. The combination of these features offer the surgeon flexibility in determining the placement and positioning of instruments in the dome as well as flexibility in selecting the size of instruments to be inserted.
In use, instruments are initially inserted at the desired location through the dome of the access port before positioning the access port in the patient. Surgeons, however, will typically require instruments to be exchanged during the surgical procedure and will remove instruments from the dome in exchange for a different instrument. Often, multiple exchanges of instruments are required during a surgical procedure. The inventors have found that the removal and re-insertion of instruments through the dome of the access port while the access port is positioned in the patient can be challenging. In particular, as a sufficient amount of force is required to insert the instrument through the dome, accurate positioning of the instrument may be compromised. As well, excessive force may inadvertently be applied when inserting a replacement instrument which may introduce unnecessary risk to the patient.
The exemplary embodiments of the present disclosure pertain to instrument docking ports for sealably receiving therethrough endoscopic surgical instruments and devices. The exemplary embodiments of the present disclosure also relate to docking ports comprising gas valves for controllable insufflation and desufflation of an endoscopic or a laparoscopic surgical site with a selected gas. The exemplary instrument docking ports and gas valve docking ports are particularly suitable for cooperating with resilient surgical access ports such as those exemplified in Canadian Patent No. 2,778,976. The exemplary instrument docking ports and gas valve docking ports are useful for cooperation with such surgical access ports for the performance of trans-endoscopic and laparoscopic surgical procedures.
One exemplary embodiment of the present disclosure pertains to instrument docking ports comprising: (a) a cannula defining an internal passageway and having a receiving end through which at least one surgical instrument can be introduced and a proximal end for insertion into a surgical access port; (b) at least one sealing disc disposed within the cannula, said sealing disc having a slit to allow insertion of the surgical instrument therethrough, wherein the sealing disc sealingly engages with the surgical instrument when inserted and returns to a closed sealed position when the surgical instrument is removed; (c) an outwardly extending rim around the circumference about the receiving end of the cannula for abutting the outer surface of a surgical access port; and (d) optionally, one or more retaining protrusions outwardly extending about the external surface of the cannula interposed the outwardly extending rim and its proximal end, wherein the rim and retaining protrusions cooperate to retain and maintain the position of the cannula when installed into a surgical access port for use in a surgical procedure.
Another exemplary embodiment of the present disclosure pertains to docking ports comprising a cannula having a gas valve about its distal end and a proximal end for insertion into and through surgical access ports that comprise resilient materials. The gas valves are switchable between: (i) an ingress port engageable with an external supply of a gas exemplified by carbon dioxide (CO2) for controllably insufflating an endoscopic or a laparoscopic surgery target area, and (ii) an egress port for venting i.e. desufflating insufflated gases from the endoscopic or laparoscopic surgery target area. The exemplary gas valve docking ports have an outwardly extending rim around the circumference of the cannula interposed the gas valve and its proximal end, for abutting the outer surface of a surgical access port. The exemplary gas valve docking ports may optionally have one or more retaining protrusions extending outwardly about the external surface of the cannula between the rim and the proximal end of the cannula.
Another embodiment of the present disclosure pertains to surgical access ports for sealably engaging and cooperating with one or more of the exemplary instrument docking ports and gas valve docking ports wherein the surgical access ports comprise: (a) a cylindrical body having a first end and a second end, wherein the first end is for insertion into a target site and defines a passageway for introduction of one or more surgical instruments; (b) at least one retainer outwardly extending circumferentially about the first end of the cylindrical body, wherein the retainer engages an inside surface of the target site when the first end of the cylindrical body is inserted; (c) a self-sealing dome extending from the second end of the cylindrical body, the dome comprising an expanded surface area, the expanded surface area comprising a self-sealing material; and (d) one or more docking ports as described herein inserted at one or more locations through the expanded surface area of the self-sealing dome, wherein the self-sealing dome sealingly engages with the one or more docking ports when introduced therethrough to sealably fix the one or more docking ports therein.
Another embodiment of the present disclosure pertains to use of the instrument docking ports and gas valve docking ports in combination with the surgical access port disclosed herein for performing minimally invasive surgical procedures.
Another embodiment of the present disclosure pertains to kits comprising: (a) one or more of the exemplary instrument docking ports disclosed herein; and (b) a plunger for introducing said one or more instrument docking ports into surgical access port that comprises a resilient material. The exemplary kits may optionally additionally comprise one or more of the exemplary gas valve docking ports disclosed herein. The exemplary plunger generally comprises: (i) an elongated shaft having a piercer at one end and a handle at the opposite end, wherein the piercer is sized to fit through an exemplary instrument docking port, for piercing a selected target site on the surgical access port said insertion site, and for forcing the instrument docking port into and through the target site by an application of force to the handle; and (ii) a flange extending outward about the shaft to retain the instrument docking port on the plunger shaft when the piercer is forced through the target site on the surgical access port whereby the instrument docking port is inserted into and through the surgical access port and fixed therein.
Another embodiment of the present disclosure pertains to kits for performing a minimally invasive surgical procedure. The kits comprise:
These and other features of this disclosure will become more apparent in the following detailed description in which reference is made to the appended drawings.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.
As used herein, the term “about” refers to an approximately +/−10% variation from a given value. It is to be understood that such a variation is always included in any given value provided herein, whether or not it is specifically referred to.
The terms “subject” and “patient” as used herein refer to an animal in need of treatment.
The term “animal” as used herein, includes, but is not limited to, mammals including humans.
The terms “surgical instrument(s)” and “instrument(s)” as used herein, refer to any medical instrument used in minimally invasive surgical procedures and can include, but is not limited to, standard hand instruments and articulating instruments.
The terms “minimally invasive surgery” and “minimally invasive surgical procedure(s)” as used herein, refer to surgery performed through one or more small incisions in a patient's body or through a natural orifice such as the oral cavity, nasal passages, the navel, the vagina, and the anus, and includes endoscopic and/or laparoscopic procedures.
The terms “target site” and “target cavity” as used herein, refer to the location in the patient's body where the minimally invasive surgical procedure is to occur and can include, but is not limited to, the abdominal cavity and the rectum.
The term “tissue tract” as used herein, refers to the region of tissue through which instruments must pass through to reach the target site or target cavity to conduct the minimally invasive surgical procedure.
The term “insertion site” as used herein, refers to a target location on a surgical access port for inserting therethrough and into a docking port of the present disclosure. Suitable surgical access ports are exemplified by the self-sealing dome of a surgical access port described herein and in Canadian Patent No. 2,778,976.
The terms “insufflation” and “insufflating” as used herein, mean the controlled introduction of a pressurized flow of a selected gas into a body cavity exemplified by the abdominal cavity, the rectum, the large intestine, among others.
The terms “desufflation” and “desufflating” as used herein, mean the controlled release of an insufflated gas from a body cavity into which the gas was previously introduced.
The exemplary instrument docking ports disclosed herein provide means for creating self-sealing openings in a variety of medical device applications. Specific embodiments described herein, for example, illustrate the use of the instrument docking ports for facilitating the self-sealing insertion for endoscopic surgical instruments into and through a surgical access port into a target surgery site within a body cavity. In such applications, the instrument docking ports can be inserted into a surgical access port to tailor the positioning of the surgical instruments to the surgeon's individual preference. The ease of insertion and removal of surgical instruments from the instrument docking ports disclosed herein enables surgeon to sequentially use multiple types of surgical instruments through two or three instrument docking ports during the performance of a surgical procedure thereby significantly reducing the clutter of surgical instruments that previously had to inserted all together at one time prior to commencing surgical procedures.
The exemplary instrument docking ports disclosed herein can be sized to accommodate a variety of different types and sizes of surgical instruments. As well, the instrument docking ports of the present disclosure can be sized to accommodate surgical instruments that are designed for larger-sized subjects as well as for juvenile/infant applications. The instrument docking ports of the present disclosure are, in this way, also adaptable to the individual patient.
The exemplary instrument docking ports disclosed herein may comprise one or more sealing discs through which surgical instruments are inserted. Specifically, the sealing discs sealingly engage the instrument when inserted and self-seal upon instrument removal, thus minimizing and/or eliminating leakage of fluids and gases from the surgical access port and enabling pressurization within a target surgery site to be maintained in procedures that require the injection and maintenance of insufflation gases. Furthermore, the sealing discs disposed within the instrument docking ports allow insertion of surgical instruments through the instrument docking ports of the present disclosure without impeding the motion of, or increasing the friction on, the surgical instrument. In this way, withdrawal or exchange of instruments from the instrument docking ports can be achieved with ease and without risk of trauma to the patient.
Referring now to the drawings in which like reference numerals identify identical or substantially similar parts throughout the several views,
The dimensions (i.e., the diameter and length) of the instrument docking ports 50 can be varied for different uses and applications. As illustrated in
In order to secure the instrument docking ports 50 to surgical access ports at the insertion sites, the outer diameter of the rim 60 and the retainer protrusions 70, 72, 74, respectively, must be larger than the external diameter of the cannula 65. In some embodiments, the outer diameter of the rim 60 and retainer protrusions 70, 72, 74 can be independently about 0.5% to about 50% larger than the outer diameter of the cannula 65. The diameter of the rim 60 and individual retainer protrusions 70, 72, 74 may be the same or may differ from one another. Alternatively, the retainer protrusions may be in the form of an outwardly extending thread winding from about the proximal end of the cannula 65 toward the rim 60.
The specific dimensions of the exemplary instrument docking ports can be selected as needed for particular applications. Specifically, it is envisioned that a wide variety of sizes will be available to a user to enable the user to select the most appropriately dimensioned aperture for the patient and procedure at hand. The overall dimensions of the exemplary instrument docking ports disclosed herein can vary. Also, the relative dimensions of the cannula, rim, and retainer protrusions of the aperture can vary. The cannula 65, rim 60 and retainer protrusions 70, 72, 74 can be a single integrated unit and may be made from any suitable materials, such as stainless steel, titanium, thermoplastics, and the like.
Disposed within the internal passageway 90 of the cannula 65, as shown in
In some exemplary embodiments, the instrument docking port 50 comprises a single sealing disc 100. In other exemplary embodiments, the instrument docking port 50 comprises a plurality of sealing discs 100. In some exemplary embodiments, the instrument docking port 50 comprises three sealing discs 100. In other exemplary embodiments, the instrument docking port 50 may comprise up to ten sealing discs 100 disposed within the cannula 65. Each sealing disc 100 is approximately circular, contains three slits 105, and is sized to securely fit within the cannula 65. The thickness of the sealing disc(s) 100 is dependent on the length of the cannula 65 and the number of sealing disc(s) 100 disposed therein. In some embodiments, the thickness of the sealing disc 100 is between about 0.5 mm to about 3 mm. Sealing disc(s) 100 may be made from any appropriate material, such as rubber or any suitable elastomer, but is most preferably made from a silicone rubber, such as Silastice silicone rubber sold by Dow Corning Corporation, Midland, Mich.
The slits 105 in each sealing disc 100 are located slightly off center of the sealing disc 100 and extends entirely through the thickness of the sealing disc 100. The slits 105 are preferably made such that the sealing disc 100 forms resilient flaps (
As further shown in
It is optional for other types of gas-tight seals known to those skilled in these arts for forming gas-tight seals with surgical instruments passed through the seals, to be integrally disposed within the exemplary instrument docking port 50 of the present disclosure. For example, suitable is a gas-tight seal exemplified by the disclosure in U.S. Reissued Pat. No. 42,379 comprising a seal body, an instrument seal, and a laterally-compliant seal mounting device wherein the seal body includes a bore through which the surgical instrument is passed. Also suitable is the exemplary plurality of coaxial sealing elements adapted for foiming a seal with either a large or small surgical instrument, disclosed in U.S. Pat. No. 8,147,458. The plurality of coaxial sealing elements may comprise a first seal assembly, a second seal assembly, and a third seal assembly preferably mounted in the present exemplary instrument docking port 50 in a coaxial relationship. The first seal assembly comprises a plurality of protectors and a first seal element comprising a radially stretchable septum coupled to the protectors wherein at least one of the protectors comprises a proximal bump configured to contact and shield a large instrument from contracting the first seal element. The second seal assembly comprises a guide and a second seal element coupled to the guide, for forming a second seal with a large surgical instrument. The third seal assembly comprises a third seal element defining a plenum in which at least a portion of the second seal assembly is disposed, and preferably comprises a zero-seal exemplified by a duck-bill seal. Also suitable is a pleated trocar shield comprising a seal assembly exemplified in U.S. Pat. No. 8,257,317 wherein the seal assembly comprises a first zero seal for sealing the cannula 65 of the present instrument docking port 50 in the absence of a surgical instrument extending therethrough. The seal assembly also comprises a second instrument seal for sealing the cannula 65 in the presence of a surgical instrument extending therethrough, while the third seal is a trocar shield for protecting the first seal and the second seal from damage as a surgical instrument is advanced therethrough. The trocar shield comprises an open proximal end and a tapered distal end comprising a plurality of longitudinal pleats converging in an opening. Also suitable is the exemplary seal comprising a gel material as disclosed in U.S. Pat. No. 8,241,251 wherein the seal includes inner first seal portions defining an access channel for forming a sealing relationship with a surgical instrument advanced therethrough and a second material having a hardness greater than the hardness of the gel material to stabilize the first inner seal portions and to provide a substantial sealed relationship with the surgical instrument. Also suitable is the exemplary seal member disclosed in U.S. Pat. No. 8,206,358 wherein the seal member has a substantially annular member partially embedded within the seal member. The annular member is rigid relative to the seal member and defines an opening for permitting the passage therethrough of a surgical instrument while the internal seal surfaces of the seal member sealingly engage the surgical instrument, whereby the annular member minimizes the offset manipulation of the surgical instrument relative to the longitudinal plane of the present instrument docking port 50. It is to be noted that if so desired, combinations of the above-noted exemplary prior art gas-tight seals may be integrally engaged in series along the length of the cannula 65 of the present instrument docking port 50.
In certain embodiments, the exemplary instrument docking port 50 of the present disclosure may further include a cap 110 (
Installation of the Instrument Docking Port(s) into a Surgical Access Port
The exemplary instrument docking ports 50 of the present disclosure can be installed to provide access, particularly sealable access, to endoscopic and laparatoscopic surgical instruments into a surgical access port. In a preferred embodiment, the instrument docking port 50 is suitable for use with the surgical access port described in Canadian Patent No. 2,778,976 as illustrated in
Referring to
As illustrated in
After the instrument docking ports 50 are installed at the desired insertion site on a surgical access port 20, surgical instruments 170 can be repeatedly inserted and withdrawn and/or exchanged through the installed docking instrument docking port 50 (
Some exemplary embodiments of the present disclosure pertain to docking ports for sealably engaging and communicating with surgical access ports, wherein the distal ends of the docking ports comprise a gas valve switchable between an ingressing gas port, an egressing gas port, and a closed position interposed the ingressing gas port and the egressing gas port. An exemplary gas port 200 of the present disclosure is shown in
As illustrated in
Some exemplary embodiments of the present disclosure pertain to kits that comprise a plurality of the exemplary instrument docking ports of the present disclosure in a range of sizes along with a suitable sized plunger or plungers for installing the instrument docking ports. The kits may additionally comprise one or more gas valve docking ports.
Some exemplary embodiments of the present disclosure pertain to kits for performing a minimally invasive surgical procedure wherein the kits comprise a plurality of the exemplary instrument docking ports of the present disclosure in a range of sizes, one or more of the exemplary gas valve docking ports, a suitable sized plunger or plungers for installing the instrument docking ports, and a surgical access port comprising a resilient material such as described herein, and also, exemplified in Canadian Patent No. 2,778,976. The kits may optionally contain instructions or directions listing the methods for installation of the instrument docking ports and/or the gas valve docking ports. The kits may also comprise one or more endoscopic or laparoscopic surgical instruments for performing a surgical procedure. Suitable surgical instruments are exemplified by trocars, scissors, graspers, dissectors, fixation forceps, dissecting forceps, cauterizing electrodes, suturing instruments, and the like.
Number | Date | Country | Kind |
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2843679 | Feb 2014 | CA | national |
Number | Date | Country | |
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Parent | PCT/CA2015/050101 | Feb 2015 | US |
Child | 15246402 | US |