FIELDThe present invention generally relates to methods and devices for providing access portals through which surgical instruments can be inserted. More particularly, the invention relates to devices which can be inserted into and removed from a patient with minimal tissue damage.
BACKGROUNDArthroscopic, or more generally, minimally invasive surgical procedures rely on obtaining percutaneous access to an internal surgical site using small-diameter openings to gain access to the desired surgical site. In many cases, access tubes are placed through the opening to allow a variety of elongated instruments to be passed through the access tubes to gain access to an internal surgical work site without the need for large incisions. As a result, patient trauma and recovery time are typically reduced.
Very often, these access tubes, which are often called cannulas, must be left in an incision for an extended period of time, without significant movement, as instruments are inserted and removed. This typically requires rigid surface features on the exterior of the cannula, such as corrugations or threads, to engage the tissue surrounding the cannula. These rigid surface features, however, can cause tissue damage as the cannula is inserted and usually do not result in the most secure fit once in place due to tissue trauma surrounding the cannula. The cannula can also be difficult to remove once inserted due to the rigid surface features, possibly leading to further tissue damage during removal.
Accordingly, there is a need for improved devices and methods that provide access portals which can be inserted into and removed from an incision with minimal tissue damage and can effectively engage tissue while within the incision.
SUMMARY OF THE INVENTIONThe present invention generally provides access portals through which surgical procedures can be performed and that can be inserted and removed with minimal tissue damage to form a seal with tissue while inserted. In one embodiment, a surgical access device is provided having an elongate surgical access member with a lumen extending therethrough that is configured to receive a surgical tool. The surgical access device can also include a flexible sleeve having a lumen extending therethrough that is configured to receive the elongate surgical access member. A substantially rigid collar member can be disposed adjacent to a proximal end of the flexible sleeve having a lumen extending therethrough that is configured to receive the elongate surgical access member. In an exemplary embodiment, the collar member is movable relative to the elongate surgical access member to selectively configure the flexible sleeve in a relaxed condition in which the flexible sleeve has a relatively smooth outer tissue-contacting surface and a compressed condition in which the flexible sleeve has a plurality of protrusions formed on the outer tissue-contacting surface that are configured to create a seal between the outer tissue-contacting surface and tissue. The flexible sleeve is normally in the relaxed condition and is configured to receive a compressive force to be configured in the compressed condition.
In an exemplary embodiment, the plurality of protrusions are configured to increase an outer diameter of the flexible sleeve in the compressed condition and can be threads and/or ribs. In addition, the collar member can include threads formed on an interior surface thereof which are configured to mate to corresponding threads formed on an exterior surface of the elongate surgical access member. In one exemplary embodiment, the collar member is configured to rotate via the mated threads and to move the flexible sleeve distally into the compressed condition. The surgical access device can further include at least one camming member in communication with the rigid collar member where the camming member is rotatable to configure the flexible sleeve in a compressed condition. In another exemplary embodiment, the elongate surgical access member can be a cage member coupled between the rigid collar member and a distal ring, where the rigid collar member is effective to move the cage member proximally to configure the flexible sleeve in a compressed condition.
In a further embodiment, a surgical access device is provided having a body defining a central longitudinal axis and a deformable surgical access member configured to be in communication with the body. The deformable surgical access member can define an outer tissue-contacting surface such that the deformable surgical access member is configured to receive a compressive force to effect an increase in an outer diameter thereof to configure the outer tissue-contacting surface in a condition effective to form a seal with tissue. In one exemplary embodiment, the outer tissue-contacting surface can contain threads configured to form a seal with tissue when a compressive force is applied to the deformable surgical access member.
In an embodiment, the deformable surgical access member is disposed between a substantially rigid band disposed adjacent to a proximal end of the deformable surgical access member and a substantially rigid distal ring. The substantially rigid band can include threads formed on an interior surface thereof which are configured to mate with corresponding threads formed on an exterior surface of the body. The substantially rigid band can be configured to rotate via the mated threads to move the substantially rigid band distally and to cause the outer tissue-contacting surface of the deformable surgical access member to form a seal with tissue. In another embodiment, the elongate surgical access member can be a cage member and the substantially rigid band can be configured to rotate via the mated threads to move the cage member proximally to cause the outer tissue-contacting surface of the deformable surgical access member to form a seal with tissue.
Methods are also provided relating to instrument access within a patient and include providing a cannula assembly having a elongate surgical access member with a bore formed therethrough configured to receive a surgical tool. The method can also include inserting the cannula assembly into an incision in a patient in an insertion condition in which the flexible sleeve has a relatively smooth exterior surface and applying a compressive force to the flexible sleeve to move the flexible sleeve from the insertion condition to a compressed condition in which the exterior surface of the flexible sleeve includes surface features which extend radially outward from the elongate surgical access member to form a seal with tissue. In an embodiment, an outer diameter of the flexible sleeve is greater in the compressed condition than in the insertion condition.
The method can further include inserting at least one surgical tool through the bore in the elongate surgical access member to effect a surgical procedure. In an embodiment, the compressive force is applied by sliding a member distally relative to the elongate surgical access member. In another embodiment, the compressive force is applied by rotating at least one camming member. In addition, the compressive force can be applied by withdrawing a surgical tool from the elongate surgical access member and the flexible sleeve, where the compressed condition is the natural state of the flexible sleeve.
BRIEF DESCRIPTION OF THE DRAWINGSThe invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
FIG. 1A is a front view of one embodiment of a surgical access device in a relaxed condition;
FIG. 1B is a front view of the device ofFIG. 1A, in a compressed condition;
FIG. 1C is an exploded view of the device ofFIG. 1A;
FIG. 2A is a front view of another embodiment of a surgical access device in the relaxed condition;
FIG. 2B is a front view of the device ofFIG. 2A, in the compressed condition;
FIG. 2C is an exploded view of the device ofFIG. 2A;
FIG. 3A is a further embodiment of a surgical access device in the relaxed condition;
FIG. 3B is a cross-section of the device ofFIG. 3A, showing the compressed condition;
FIG. 3C is an exploded view of the device ofFIG. 3A;
FIG. 4A is a front view of an exemplary embodiment of a surgical access device having a body and a flexible sleeve; and
FIG. 4B is a front view of the device ofFIG. 4B, in the compressed condition.
DETAILED DESCRIPTIONCertain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present application.
The present application provides methods and devices useful for accessing an interior surgical site using an access portal which can be inserted and removed with minimal tissue damage and which can form a seal with tissue while inserted. In an embodiment illustrated inFIGS. 1A-1C, asurgical access device100 is provided having an elongatesurgical access member102 with a generally cylindrical body and a bore formed therethrough configured for receiving a surgical tool or other device. A proximal most end of the elongatesurgical access member102 can include two flange portions, afirst flange portion104 and asecond flange portion106, each of which have a larger diameter that the elongatesurgical access member102. As will be appreciated by those skilled in the art, the elongatesurgical access member102 and the first andsecond flanges104,106 can be configured to seat and receive surgical tools, valve systems, trocars, obturators, vacuum systems and any other devices that may aid in a surgical procedure.Threads108 can be formed on an exterior surface of the elongatesurgical access member102, and while thethreads108 can be formed at any location along a length of the elongatesurgical access member102, in the illustrated embodiment, they are formed on a proximal portion of the elongatesurgical access member102 situated at a distance below thesecond flange106. Thethreads108 are configured to mate with corresponding threads on a substantially rigid collar, as will be described in detail below. A taperedportion110 can be formed on a distal most end of the elongatesurgical access member102. As will be appreciated by a person skilled in the art, the size of the taperedportion110 and the amount of tapering can vary depending on the surgical tools expected to be received by the device. A proximal portion of the taperedportion110 can also include alip112 which has a diameter greater than a diameter of the elongatesurgical access member102. In an exemplary embodiment, thelip112 can seat and/or mate to a distal portion of a deformable surgical access member orflexible sleeve114 as will be described in detail below. As will be appreciated by those skilled in the art, the elongatesurgical access member102 can be rigid, flexible, and/or semi-rigid and can be formed from a variety of biocompatible materials, including but not limited to polycarbonate, ABS, polyetheretherketone (PEEK), polyetherimide, polystyrene, polyvinylchloride,polyester, polypropelene, polyethelene, polyurethane. One of ordinary skill in the art will appreciate that other polymers or blends thereof may be used to achieve similar properties.
In the embodiment illustrated inFIGS. 1A-1C, the substantially rigid collar is in the form of a two-part rotatable bushing120 divided into aring122 and anut124. Thering122 can include threads formed on an interior surface thereof which are configured to mate with the correspondingthreads108 formed on the exterior surface of the proximal portion of the elongatesurgical access member102, as described above. Thering122 can also be configured to mate with thenut124 by way, for example, of a press fit or sliding fit, so that thering122 can be rotated with respect to thenut124. Thenut124 can include a proximalmale portion126 configured to seat thering122 and a distalmale portion128 configured to mate with aflange116 formed on a proximal end of theflexible sleeve114. In this way, thering122 can be rotated via the mated threads with respect to both thenut124 and theflexible sleeve114. As noted above, thebushing120 can be substantially rigid and can be formed from a variety of biocompatible materials, including but not limited to polycarbonate, ABS, polyetheretherketone (PEEK), polyetherimide, polystyrene, polyvinylchloride, polyester, polypropelene, polyethelene, polyurethane. One of ordinary skill in the art will appreciate that other polymers or blends thereof may be used to achieve similar properties.
Theflexible sleeve114 can be a substantially tubular member which can be configured to receive the elongatesurgical access member102 within a bore formed therein. In one embodiment, illustrated inFIGS. 1A-1C, a distalmost end118 of theflexible sleeve114 rests on thelip112 of the elongatesurgical access member102 and is mated thereto so that the distalmost end118 of theflexible sleeve114 cannot be moved relative to the elongatesurgical access member102. Theflange116 on the proximal most end of theflexible sleeve114 can be coupled to the distalmale portion128 of thebushing120, and can be configured to be movable with thebushing120 relative to the elongatesurgical access member102. Theflexible sleeve114 is deformable and can be formed from a variety of biocompatible materials, including but not limited to polyvinylchloride, polyurethane, silicone, polyetherimide, polyeetherester, thermoplastic polyolefins. One of ordinary skill in the art will appreciate that other polymers or blends thereof may be used to achieve similar properties.
The flexible sleeve is designed to be selectively configured in a relaxed condition and in a compressed condition. In the relaxed condition, which is the normal or natural state of theflexible sleeve114, an outer tissue-contactingsurface132 of theflexible sleeve114 has a relatively smooth surface, as shown inFIG. 1A, with a first diameter D1. While theflexible sleeve114 can be configured in many different ways, in one embodiment, in the relaxed condition, theflexible sleeve114 is configured to fit relatively tightly around an outer tissue-contacting surface of the elongatesurgical access member102. Accordingly, in one exemplary embodiment, in the relaxed condition, the difference between the outer diameter of the elongatesurgical access member102 and the first diameter of theflexible sleeve114 is essentially the thickness of theflexible sleeve114 itself.
In an embodiment in which theflexible sleeve114 is configured to be in the compressed condition, a plurality ofprotrusions130 can form on the outer surface of theflexible sleeve114. In the illustrated embodiment, the plurality ofprotrusions130 are in the form of threads which are disposed on a distal portion of theflexible sleeve114. A person skilled in the art will appreciate, however, that theprotrusions130 can also be ridges, threads, ribs or other surface irregularities which can be formed over the entire outer surface of theflexible sleeve114, or over only a very particular area of theouter surface132. Therefore, if theflexible sleeve114 is configured in a compressed condition, theouter surface132 of theflexible sleeve114 has a second diameter D2 shown inFIG. 1B, measured from the outermost boundary of theprotrusions130, which is greater than the first diameter D1. In an exemplary embodiment, the first diameter D1 in the relaxed condition can be in the range of about 1 to 5 mm, and more preferably in the range of about 2 to 3 mm. In the compressed condition, the second diameter D2 can be in the range of about 2 to 10 mm, and more preferably in the range of about 4 to 6 mm. A person skilled in the art will appreciate that thedevice100 can have any first and second diameter necessary for a particular procedure, or to accommodate any size surgical tool as needed. Theprotrusions130 can engage and form a seal with tissue when thedevice100 is in the compressed condition.
In one embodiment, theprotrusions130 in theflexible sleeve114 can be pre-formed in the material of theflexible sleeve114 so that theouter surface132 remains relatively smooth in the relaxed condition, and threads, ribs, or other surface irregularities will form when theflexible sleeve114 is configured in the compressed condition. A person skilled in the art will appreciate the various ways that theprotrusions130 can be pre-formed in theflexible sleeve114.
In an exemplary embodiment, in use, thedevice100 can be inserted into an incision in a patient in an insertion condition in which theflexible sleeve114 is in a relaxed condition such that theouter surface132 of theflexible sleeve114 is relatively smooth. After thedevice100 is inserted and positioned as needed within the patient, thering122 can be rotated, for example, in a clockwise direction, via the mated threads to configure the flexible sleeve in a compressed condition as thenut124 and theflexible sleeve114 are moved in a distal direction. As this action moves theflexible sleeve114 in a distal direction, theflexible sleeve114 is compressed between thenut124 and thelip112 formed on the taperedportion110 of the elongatesurgical access member102 so as to causeprotrusions130 to form in theouter surface132 of theflexible sleeve114. Theprotrusions130 can be configured to engage tissue to prevent pullout and/or movement and to form a seal with the surrounding tissue. Surgical instruments can be inserted and removed through the bore in the elongatesurgical access member102 to perform surgical procedures as needed. At a point in time when thedevice100 is no longer needed within the patient, thering122 can be rotated in an opposite direction, for example, counter-clockwise, via the mated threads to cause thenut124 and theflexible sleeve114 to move in a proximal direction. As theflexible sleeve114 is moved proximally, theprotrusions130 in theflexible sleeve114 disengage from sealing contact with the surrounding tissue and essentially disappear as the compression is removed from theflexible sleeve114 so that theouter surface132 of theflexible sleeve114 is relatively smooth and in the relaxed or insertion condition. Thedevice100 can then be removed from the incision with minimal tissue damage.
In another embodiment, shown inFIGS. 2A-2C, anaccess device200 is provided having the rigid elongatesurgical access member102 andflexible sleeve114 as described above. In addition, thedevice200 can include an activation mechanism for configuring theflexible sleeve114 in the relaxed condition and the compressed condition. The activation mechanism can include aslider member220 having a bore formed therethrough for receiving the elongatesurgical access member102 and at least one camming member. In the illustrated embodiment, the activation mechanism includes twocamming members230. Theslider member220 can include aproximal flange222, abase portion224, and amale mating portion226 configured to mate with theflange116 formed on the proximal end of theflexible sleeve114. Theslider member220 can be configured in many ways, but in the illustrated embodiment, theslider member220 is adapted to slide relative to the elongatesurgical access member102. In an exemplary embodiment, thecamming members230 are rotatable members coupled to a proximal portion of the elongatesurgical access member102 and are configured to rotate viapins232 or other connection means known in the art. Thecamming members230 are disposed adjacent to theproximal flange222 of theslider member220 and are adapted to act upon theproximal flange222 when the activation mechanism is activated to configure theflexible sleeve114 in a relaxed condition or a compressed condition, as will be described below.
In an exemplary embodiment, in use, thedevice200 can be inserted into an incision in a patient in an insertion condition in which theflexible sleeve114 is in a relaxed condition such that theouter surface132 of theflexible sleeve114 is relatively smooth, as shown inFIG. 2A. After the device is inserted and positioned as needed within the patient, thecamming members230 can be rotated, such as by ninety degrees, as shown inFIG. 2B to cause theslider member220 to move in a distal direction. As theslider member220 moves in a distal direction, the proximal end of theflexible sleeve114 is also moved distally so as to compress theflexible sleeve114 between theslider member220 and thelip112 formed on the taperedportion110 of the elongatesurgical access member102 and configure theflexible sleeve114 in a compressed condition. As theflexible sleeve114 is compressed,protrusions130 form on theouter surface132 of theflexible sleeve114 to engage and form a seal with the surrounding tissue, thereby preventing movement and pullout of thedevice200 from the incision. Surgical instruments can be inserted and removed through the bore in the elongatesurgical access member102 to perform surgical procedures as needed. At a point in time when the device is no longer needed within the patient, thecamming members230 can be rotated ninety degrees in the opposite direction, as shown inFIG. 2A, to cause theslider member220 and the proximal end of theflexible sleeve114 to move in a proximal direction. As theflexible sleeve114 is moved proximally, theprotrusions130 in theflexible sleeve114 disengage with the surrounding tissue and disappear as the compression is removed from theflexible sleeve114 so that theouter surface132 of theflexible sleeve114 is relatively smooth and in the relaxed condition. Thedevice200 can be removed from the incision with minimal tissue damage.
In a further embodiment, shown inFIGS. 3A-3C, adevice300 is provided having acage member310 coupled to areceiver body320. Thecage member310 can include aproximal ring312 that can be rigidly mated with an interior surface of thereceiver body320 by any means known in art, for example a snap fit, press fit, or adhesive. Thereceiver body320 and thecage member310 can have a bore formed therethrough for receiving a surgical tool or other instrument. In an exemplary embodiment, thereceiver body320 can include aproximal flange322 and a threadedmale portion324 adapted to mate with a corresponding threadedfemale portion328 of a substantiallyrigid collar326. Therigid collar326 can have a bore formed therethrough that is configured to receive thecage member310 when therigid collar326 is threadedly mated with thereceiver body320. Thecage member310 can also include about 2 to 10, and more preferably about 4 to 6,vertical bars316 extending from theproximal ring312 to adistal ring314 to form the cage-like structure of thecage member310. Thedistal ring314 of thecage member310 can be configured to mate with adistal compression member330 by any means known in the art such as a press fit, a snap fit, or adhesive. Aflexible sleeve114 is disposed between a distal end of therigid collar326 and a proximal surface of thedistal compression member330 and includes a bore formed therethrough for receiving thecage member310.
In an exemplary embodiment, in use, thedevice300 can be inserted into an incision in a patient in an insertion condition in which theflexible sleeve114 is in a relaxed condition such that theouter surface132 of theflexible sleeve114 is relatively smooth, as shown inFIG. 3A. After thedevice300 is inserted and positioned as needed within the patient, thereceiver body320 can be rotated via the mated threads “out” of therigid collar326 to move in a proximal direction. As thereceiver body320 is moved proximally, thecage member310 and thedistal compression member330 are both pulled proximally, thereby compressing theflexible sleeve114 between therigid collar326, which is not moving, and thedistal compression member330. As theflexible sleeve114 is compressed,protrusions130 form on theouter surface132 thereof to engage and form a seal with the surrounding tissue, thereby preventing movement and pullout of thedevice300 from the incision. Surgical instruments can be inserted and removed through the bore in the elongatesurgical access member102 to perform surgical procedures as needed. At a point in time when thedevice300 is no longer needed within the patient, thereceiver body320 can be rotated via the mated threads back “into” therigid collar326 to move in a distal direction, thereby moving thecage member310 and thedistal compression member330 distally. As thedistal compression member330 is moved distally, theflexible sleeve114 disengages from a seal with the surrounding tissue and returns to the insertion or relaxed condition as the compression is removed to have a relatively smoothouter surface132. Thedevice300 can then be removed from the incision with minimal tissue damage.
In another embodiment, shown inFIGS. 4A and 4B, adevice400 is provided having a substantiallyrigid collar420 disposed adjacent to theflexible sleeve114. Thedevice400 can also include adistal ring430 coupled to the distal end of theflexible sleeve114. A bore can be formed through therigid collar420, theflexible sleeve114, and thedistal ring430 adapted for receiving abody410. Thebody410 can be any device or surgical tool known in the art, and in the illustrated embodiment, thebody410 is an obturator. In an exemplary embodiment, thebody410 can include aflange412 configured to be disposed adjacent to aproximal flange422 on therigid collar420 when thebody410 is disposed within the bore. Thebody410 can have an outer diameter OD that is larger than an inner diameter ID of thedistal ring430 so that thebody410 can be contained within the bore while being prevented from passing through thedistal ring430. When thebody410 is contained within the bore, theflexible sleeve114 is stretched so that theflexible sleeve114 has a relatively smoothouter surface132, as shown inFIG. 4A. When thebody410 is removed from the bore, theflexible sleeve114 returns to its natural state in which it is compressed between thedistal ring430 and therigid collar420, causingprotrusion130 to form in theouter surface132. In the illustrated embodiment, theprotrusions130 are in the form of threads.
In an exemplary embodiment, in use, thedevice400 can be inserted into an incision in a patient with thebody410 contained within the bore. Thebody410 causes theflexible sleeve114 to be stretched such that theouter surface132 of theflexible sleeve114 is relatively smooth in an insertion condition, allowing thedevice400 to be inserted with minimal tissue damage. After thedevice400 is placed as needed within the patient, thebody410 can be removed from the bore, thereby causing theflexible sleeve114 to be compressed between theproximal collar420 and thedistal ring430 in a compressed condition. As theflexible sleeve114 is compressed,protrusions130 form on theouter surface132 of theflexible sleeve114 to engage and form a seal with the surrounding tissue. Surgical instruments can be inserted and removed through the bore in the elongatesurgical access member102 to perform surgical procedures as needed. At a point in time when thedevice400 is no longer needed within the patient, thebody410 can be inserted into the bore, thereby moving thedistal ring430 distally and removing the compression from theflexible sleeve114 so that theprotrusions130 are removed from theouter surface132. Theflexible sleeve114 disengages from a seal with the surrounding tissue as the compression is removed, and thedevice400 can then be removed from the incision with minimal tissue damage.
The devices disclosed herein can also be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning and/or replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the devices described herein will be processed before surgery. First, a new or used device is obtained and if necessary cleaned. The device can then be sterilized. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in the sterile container. The sealed container keeps the device sterile until it is opened in the medical facility. It is preferred that the device is sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, or steam.
One skilled in the art will appreciate further features and advantages based on the above-described embodiments. Accordingly, the application is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.