Devices, systems and methods for percutaneously accessing and securing internal organs or other target tissue within a patient

Abstract

A novel device and system for percutaneously accessing and securing target tissue / organs within a patient for interventional diagnosis or treatment followed by closure of the access site and methods for the same. The access device includes an elongated shaft having a lumen therethrough configured to engage a tissue via suction, and at least one anchor needle configured to deploy from the elongated shaft, and a securing member configured to deploy from the anchor to secure the device to tissue / organs. The system may include the novel device, an access needle and a closure device.

Description

[0001] DEVICES, SYSTEMS AND METHODS FOR PERCUTANEOUSLY ACCESSING AND SECURING INTERNAL ORGANS OR OTHER TARGET TISSUE WITHIN A PATIENT

[0002] BACKGROUND

[0003] The small intestine (small bowel), which connects the stomach to the large intestine, is the longest part of the digestive system, with an average adult length of about 7 meters (23 feet). It is also the most important absorptive organ in the human body, and its main functions include the systematic breakdown of food, absorption of nutrients, and extraction of water. Small intestine diseases are very common and can be detrimental to overall health and potentially fatal in addition to causing discomfort and digestive problems. For the diagnosis and therapy of small intestine disorders, minimally invasive surgery such as endoscopic surgery and laparoscopic surgery shows the advantages of less invasiveness, having fewer adverse events, and shorter hospital stays as compared with open surgery, but the length of small intestine is a substantial challenge for minimally invasive surgery.

[0004] In the 1970s, initial attempts using endoscopic techniques to examine the small intestine from the natural orifice were reported. Conventional push enteroscopy (PE) did not extend 80-90 cm beyond the upper or lower end of the small intestine. The introduction of capsule endoscopy (Pillcam) enabled visualization of the entire small intestine. However, biopsy and treatment cannot be performed using this method. Although double-balloon enteroscopy (DBE) system and single-balloon enteroscopy (SBE) system increased the depth of the small intestine access to 240 cm, they only reached approximately one-third of the entire small intestine length. It follows that despite numerous attempts and the emergence of novel endoscopic techniques such as capsule endoscopy (Pillcam), DBE and SBE, only a small portion of small intestine can be reached endoscopically or colonoscopically, which limits the application of minimally invasive surgeries in the diagnosis and treatment of small intestine diseases. Thus, small intestine has been considered inaccessible due to the limited depth of access using current techniques.

[0005] Another minimally invasive option is percutaneous endoluminal bowel surgery (PEBS), which has been shown to be successfully used for enteral nutrition in patients with the advantages of being less invasive, less costly, and faster recovery than the open surgery approach. PEBS is also currently used for procedures on the stomach and lower gastrointestinal tract, but it is difficult to perform complex procedures on the small intestine, such as placement of interventional tools. All PEBS still require endoscopic assistance, which is of little value for percutaneous endoscopic small bowel surgery (PESBS) due to the limited depth of access to small intestine with existing endoscopic techniques.

[0006] Advanced abdominal imaging methods, such as CT and 3D reconstruction, enable “direct path” access to abdominal organs for interventions by developing 20-30 cm long tools instead of 100 cm long tools passing through body orifices. Preliminary clinical data have shown that this novel image- guided PESBS is superior to conventional therapy in several aspects including the success rate in the treatment of small bowel obstruction (SBO). It is very likely that a new field of minimally invasive treatment of small intestine disorders will be presented before us. However, this new approach has not been fully explored due to the lack of suitable instruments. One of the main issues is the lack of an anchoring / stabilizing device that can safely and reliably fix specific small intestine loops for instrumentation or wound closure. For example, during advancement of a conventional catheter set commonly used in clinics for this procedure, T-fasteners are used as anchoring devices. The T- fasteners are made up of a short (e.g., no more than a centimeter long) piece of a wire or cannula with a suture (either resorbable or permanent) attached in its middle. Upon introduction, using a needle, the T-fastener is deployed inside the bowel, and the suture is pulled back, thereby pulling the T-fastener against the bowel wall, which in turn pulls the bowel wall to stabilize it against the abdominal wall. The benefit of the T-fastener is its small profile for placement. However, once the bowel is stabilized with the T-fastener, a second site of access is required, usually near the location of the T-fastener, to allow entry of devices / treatments needed to treat the diseased portion of the bowel. Furthermore, the T-fastener only provides limited support and stabilization of the bowel wall against the abdominal wall. Another main issue is the lack of a secure closing device for the access opening in the intestinal wall. Percutaneous access opening must currently be enlarged through the incision to allow surgical closure. Therefore, an innovative percutaneous access platform that provides access to internal organs, including the small intestine, is urgently needed to help overcome the major obstacles mentioned above, which is crucial for the progress of minimally invasive interventions for small intestine diseases.

[0007] BRIEF SUMMARY

[0008] Accordingly, a novel device and system for percutaneously accessing and securing target tissue / organs within a patient, including in the small intestine (and any part of the intestine), for interventional diagnosis and / or treatment and methods for the same are disclosed herein.

[0009] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the device comprises a base and a deployment portion. The base comprises an elongated engagement tube having a proximal end and a distal end, and a suture ring at or near the proximal end of the elongated tube. The engagement tube comprises concentric inner wall and outer wall positioned circumferentially along the length of the tube, the inner wall having a diameter less than the diameter of the outer wall, wherein the outer wall and the inner wall form at least one channel along the length of the tube between the outer wall and the inner wall terminating at an aperture at or near the distal end of the tube, and wherein the inner wall further defines a delivery lumen therethrough. The suture ring includes at least one vacuum port in communication with the proximal end of the engagement tube, the vacuum port being operatively connected to the at least one channel between the outer wall and the inner wall and capable of operative connection to the vacuum source to create suction in the at least one channel such that when the engagement tube is placed in contact with tissue or organ, such as the small intestine, the distal end of the engagement tube is capable of forming a vacuum seal between the engagement tube and the surface of the tissue when a vacuum source is operatively attached to the vacuum port.

[0010] The deployment portion of the percutaneous access device comprises an elongated body having a distal end and a proximal end, an elongated tube having a distal end and a proximal end, the tube extending axially through the center of the body and configured to extend beyond the distal end of the body, and at least one anchor needle slidably disposed in the body parallel with the elongated tube and configured to extend beyond the distal end of the elongated tube, the at least one anchor needle having a needle lumen defined therethrough terminating at a first needle aperture at or near a distal end of the anchor needle, and a securing member positioned within the needle lumen and configured to move between at least a first position and a second position, wherein when the at least one securing member is in the first position, the securing member is constrained within the needle lumen, and when the at least one securing member is in the second position, the securing member at least partially protrudes from the needle lumen. The present disclosure includes a percutaneous access device, wherein the securing member comprises a T-fastener configured such that the T-fastener is deployed from the first needle aperture when the T-fastener is in the second position.

[0011] The percutaneous access device is configured such that the base and deployment portion are operably connectable, wherein when the base and deployment portion are connected together, the elongated tube and at least one anchor needle of the deployment portion are slidably received within the base. The deployment portion is configured to deploy the at least one anchor needle from a first position, where the needle is within the engagement tube of the base and does not extend beyond the distal end of the engagement tube at least one channel of the base, and a second position where the distal end of the anchor needle protrudes beyond the distal end of the engagement tube.

[0012] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the at least one anchor needle of the deployment portion of the access device comprises two anchor needles.

[0013] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the at least one anchor needle of the deployment portion of the access device comprises three anchor needles. In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the at least one anchor needle of the deployment portion of the access device comprises four anchor needles.

[0014] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the at least one anchor needle of the deployment portion of the access device is beveled. The at least one anchor needle is positioned such that the beveled surface faces away from the elongated tube

[0015] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the engagement tube comprises concentric inner wall and outer wall positioned circumferentially along the length of the tube, the inner wall having a diameter less than the diameter of the outer wall, and a divider wall positioned circumferentially along the length of the tube, the divider wall having a diameter larger than the inner wall and less than the outer wall such that the divider wall is position between the inner and outer walls, wherein the outer wall and the divider wall form at least one channel along the length of the tube between the outer wall and the divider wall terminating at an aperture at or near the distal end of the tube, and wherein the divider wall and the inner wall form at least one channel along the length of the tube between the divider wall and the inner wall terminating at an aperture at or near the distal end of the tube, and wherein the inner wall further defines a delivery lumen therethrough.

[0016] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the engagement tube comprises concentric inner wall and outer wall positioned circumferentially along the length of the tube, the inner wall having a diameter less than the diameter of the outer wall, wherein the outer wall and the divider wall form at least one channel along the length of the tube between the outer wall and the divider wall terminating at an aperture at or near the distal end of the tube, and wherein the inner wall further defines a delivery lumen therethrough. In at least one embodiment of the engagement tube, the distal ends of the outer and inner walls are flush with one another. Alternatively, in at least one embodiment of the engagement tube, the distal end of the inner wall is recessed a certain distance from the distal end of the outer wall.

[0017] The percutaneous access device is configured such that the base and deployment portion are operably connectable, wherein when the base and deployment portion are connected together, the elongated tube and at least one anchor needle of the deployment portion are slidably received within the base. The deployment portion is configured to deploy the at least one anchor needle from a first position, where the needle is within the engagement tube of the base and does not extend beyond the distal end of the engagement tube at least one channel of the base, and a second position where the distal end of the anchor needle protrudes beyond the distal end of the engagement tube.

[0018] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the engagement tube further comprises at least one internal lumen support positioned within the at least one channel and attached to the outer wall and the inner wall, the at least one internal lumen support extending from the proximal end of the engagement tube along at least a substantial portion of the length of the tube defining an internal lumen within the at least one channel. In another embodiment, wherein the at least one internal lumen support comprises two internal lumen supports. In another embodiment, wherein the at least one internal lumen support comprises three internal lumen supports. In another embodiment, wherein the at least one internal lumen support comprises four or more internal lumen supports.

[0019] In at least one embodiment of a percutaneous access device for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the percutaneous access device is configured such that when the base and deployment portion are operably connected together, the elongated tube is slidably received within the delivery lumen of the base, and the at least one anchor needle of the deployment portion are slidably received within the lumen of the at least one internal lumen support in the at least one channel between the inner and outer walls of the engagement tube. The deployment portion is configured to deploy the at least one anchor needle from a first position, where the needle is within the engagement tube of the base and does not extend beyond the distal end of the engagement tube at least one channel of the base, and a second position where the distal end of the anchor needle protrudes beyond the distal end of the engagement tube.

[0020] In at least one embodiment of a system for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the system comprises a percutaneous access device, for example, as described herein, a trocar having an awl (which may be metal or plastic with a pointed or tapered tip) and a rigid, hollow cannula tube, and may be configured for advancement through the abdominal wall of a patient.

[0021] The present disclosure includes a method for using a percutaneous access device to access the small intestine (SI) the method comprising the steps of inserting a needle (e.g., a Veress open tip needle) through the abdominal wall, placing a guide wire through the needle and across the abdominal wall, injecting contrast and methylene blue, removing needle out over guide wire, advancing trocar over guidewire and across the abdominal wall, removing the awl of the trocar leaving the cannula in place, advancing the percutaneous access device over the guide wire and through cannula of trocar such that the distal end of the engagement tube of the access device contacts an external surface of the SI, applying suction to the access device thereby creating a vacuum seal between the distal end of the engagement tube and the external surface of the SI, actuating the deployment portion of the access device thereby causing the at least one anchor needle and securing member within the needle beyond the distal end of the engagement tube causing the at least one anchor needle to pierce the SI wall, retracting t-pusher and at least one anchor needle leaving securing member inside of SI wall, retracting securing member such that it engages internal surface of SI wall thereby securing SI to distal end of engagement tube, and detaching deployment portion from access device.

[0022] The access site of the SI wall is held securely and continuously to the engagement tube to provide a stabilized area with an opening through which instruments (such as introducer sheath, endoscope, dilation balloon, or closure device) can be inserted. After diagnosis or treatment, a closure device will be introduced through the access device, or alternatively, a closure device will be incorporated into the access device. The anchoring / fastening components of the device can be retrievable or non-retrievable. For example, the anchoring / fastening components may be configured as a deployable and retractable T-fasteners, barb sutures, harpoon sutures, or the like, which can be deployed from and withdrawn back into the access device and thus, released from the small intestine after the closure device has engaged the small intestine wall. Alternatively, the anchoring / fastening components may be left in the bowel after the closure device has engaged the small intestine wall.

[0023] When advancing the access device, the method may further include using a camera, or scope to guide the access device.

[0024] BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The disclosed embodiments and other features, advantages, and disclosures contained herein, and the matter of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein:

[0026] FIG. 1 shows a perspective view of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0027] FIG. 2 shows a side view of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0028] FIG. 3 shows a side view of a percutaneous access device, according to an exemplary embodiment of the present disclosure; FIG. 4 shows a side view of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0029] FIG. 5 shows a side view of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0030] FIG. 6 shows a top view of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0031] FIG. 7 shows a bottom view of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0032] FIG. 8 shows a perspective view of a percutaneous access device with anchor needles deployed, according to an exemplary embodiment of the present disclosure;

[0033] FIG. 9. shows a side view of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0034] FIG. 10. shows a side view of a deployment portion of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0035] FIG. 11. shows a perspective view of a deployment portion of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0036] FIG. 12. shows a side perspective view of a component of a base of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0037] FIG. 13. shows a perspective view of a component of a base of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0038] FIG. 14. shows a side view of a percutaneous access device with certain components removed, according to an exemplary embodiment of the present disclosure;

[0039] FIG. 15. shows a perspective view of a percutaneous access device with certain components removed, according to an exemplary embodiment of the present disclosure;

[0040] FIGS. 16-17 show a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0041] FIG. 18 shows a distal end of an engagement tube of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0042] FIG. 19 shows a distal end of an engagement tube of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0043] FIG. 20 shows a distal end of an engagement tube of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0044] FIG. 21 shows a distal end of an engagement tube of a percutaneous access device, according to an exemplary embodiment of the present disclosure; FIG. 22 shows a distal end of an engagement tube of a percutaneous access device, according to an exemplary embodiment of the present disclosure;

[0045] FIG. 23 shows a distal end view of a portion of a percutaneous access device with anchor needles retracted, according to an exemplary embodiment of the present disclosure;

[0046] FIG. 24 shows a distal end view of a portion of a percutaneous access device with anchor needles forward and securing members constrained within the needles, according to an exemplary embodiment of the present disclosure;

[0047] FIG. 25 shows a distal end view of a portion of a percutaneous access device with anchor needles forward and securing members partially deployed, according to an exemplary embodiment of the present disclosure;

[0048] FIG. 26 shows a distal end view of a portion of a percutaneous access device with anchor needles forward and securing members deployed, according to an exemplary embodiment of the present disclosure;

[0049] FIG. 27 shows a distal end view of a portion of a percutaneous access device with securing members deployed and anchor needles retracted, according to an exemplary embodiment of the present disclosure;

[0050] FIG. 28 shows a distal end view of a portion of a percutaneous access device with anchor needles retracted and securing members deployed from needles but retracted towards the distal end of the percutaneous access device, according to an exemplary embodiment of the present disclosure; and

[0051] FIG. 29 shows a perspective view of a percutaneous access device, according to an exemplary embodiment of the present disclosure.

[0052] An overview of the features, functions and / or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described. Some of these non-discussed features, as well as discussed features are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and / or configuration.

[0053] DESCRIPTION

[0054] For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended.

[0055] In the present disclosure, the term “distal” is used to refer to the part of the device farthest from an operator or closest to a patient. The term “proximal” is used to describe the part of the device closest to an operator or farthest from a patient. For example, the part of the device that is inserted into the patient first will be the distal part.

[0056] In one embodiment of the invention, a percutaneous access device 100 comprises a base 110 and a deployment portion 120. As shown in FIGS. 12-13, the base 110 comprises an elongated engagement tube 130 having a proximal end 140 and a distal end 150. The engagement tube 130 comprises an outer wall 160 and an inner wall 170 positioned concentrically within the outer wall 160, the inner wall 170 having a diameter less than the diameter of the outer wall 160, wherein the outer wall 160 and the inner wall 170 form at least one channel 180 along the length of the tube 130 between the outer wall 160 and the inner wall 170 terminating at an aperture at or near the distal end 150 of the tube 130, and wherein the inner wall 170 further defines a delivery lumen 190 therethrough.

[0057] The base 110 also comprises a suture ring 200 at or near the proximal end 140 of the engagement tube 130. The suture ring 200 includes at least one vacuum port 210 in communication with the proximal end 140 of the engagement tube 130, the vacuum port 210 being operatively connected to the at least one channel 180 between the outer wall 160 and the inner wall 170 and capable of operative connection to a vacuum source (not shown) to create suction in the at least one channel 180 such that when the engagement tube 130 is placed in contact with a tissue or organ, such as the small intestine, the distal end 150 of the engagement tube 130 is capable of forming a vacuum seal between the engagement tube 130 and the surface of the tissue when a vacuum source is operatively attached to the vacuum port.

[0058] As shown in FIGS. 10-11, the deployment portion 120 of the percutaneous access device 100 comprises an elongated body 220 having a distal end 230 and a 240 proximal end, an elongated tube 250 having a distal end 260 and a proximal end 270, the tube 250 extending axially through the center of the body 220 and configured to extend beyond the distal end 230 of the body 220, and at least one anchor needle 280 slidably disposed in the body 220 parallel with the elongated tube 250 and configured to extend beyond the distal end 260 of the elongated tube 250, the at least one anchor needle 280 having a needle lumen 290 defined therethrough terminating at a first needle aperture 300 at or near a distal end 310 of the anchor needle 280. In the present embodiment, there are four anchor needles 280 shown, but it is understood that a device 100 can include 1, 2, 3, 4, or more anchor needles 280.

[0059] The percutaneous access device 100 is configured such that the base 110 and deployment portion 120 are operably connectable, wherein when the base 110 and deployment portion 120 are connected together, the elongated tube 250 and at least one anchor needle 280 of the deployment portion 120 are slidably received within the base 110. The deployment portion 120 is configured to deploy the at least one anchor needle 280 from a first position, where the needle 280 is within the engagement tube 130 of the base 110 and does not extend beyond the distal end 150 of the engagement tube 130 in at least one channel 180 of the base 110, and a second position where the distal end 290 of the anchor needle 280 protrudes beyond the distal end 150 of the engagement tube 130.

[0060] As shown in FIGS. 23-28, the percutaneous access device 100 includes securing members 342 in the form of a T-fasteners configured to be advanced through the needle lumen 290 of each anchor needle 280. T-fasteners 342 may be a short (e.g., no more than a centimeter long) piece of a wire or cannula with a suture 344 (either resorbable or permanent), attached in its middle, or other similar configuration known to one of ordinary skill in the art. The T-fasteners are operable and deployable in the same fashion as disclosed in PCT / US24 / 38745, the entire disclosure of which is incorporated herein by reference. As shown in FIGS 14-15, the deployment portion 120 includes a button, or trigger 350, which is operably connected to anchor needles 280 and T-fasteners 342. For example, the trigger 350 can be actuated to drive a pusher 360 to a first position whereby the pusher 360 advances anchor needles 280 out from the distal end 260 of the elongated tube 250. The trigger 350 can then be actuated to drive the pusher 360 to a second position whereby the pusher 360 pushes the T-fasteners 342 forward along the longitudinal axis of the needle 280 to deploy the T-fastener 342 from the distal tip 310 of needle 280 (as seen in FIGS. 27 and 28). The T-fasteners 342 can be delivered in the elongate configuration through the lumen 290 of anchor needle 280 and moved to the deployed configuration by pulling the suture 344 proximally to rotate the T-fasteners 342 such that the T- fasteners 342 are non-parallel with respect to the pusher 360, the distal tip 310 of the anchor needle 280, and / or the suture 344. The trigger 350 can then be released thereby retracting the pusher 360, which then pulls the anchor needles 280 back within the tube 250. The suture or sutures 344 can be pulled back thereby pulling the T-fasteners 342 back towards the distal end 260 of the tube 250 (FIG. 29) thereby causing the T-fastener to lodge against tissue at the distal end 260 of the tube 250 of the percutaneous access device 100 securing the tissue thereto. The securing members (or T-fasteners) 342 can also be deployed in any manner known in the art.

[0061] In at least one embodiment of a system for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the system comprises a percutaneous access device, for example, as described herein, a trocar having an awl (which may be metal or plastic with a pointed or tapered tip) and a rigid, hollow cannula tube, and may be configured for advancement through the abdominal wall of a patient.

[0062] The access site of the SI wall is held securely and continuously to the engagement tube to provide a stabilized area with an opening through which instruments (such as introducer sheath, endoscope, dilation balloon, or closure device) can be inserted. After diagnosis or treatment, a closure device will be introduced through the access device, or alternatively, a closure device will be incorporated into the access device. The anchoring / fastening components of the device can be retrievable or non-retrievable. For example, the anchoring / fastening components may be configured as a deployable and retractable T-fasteners, barb sutures, harpoon sutures, or the like, which can be deployed from and withdrawn back into the access device and thus, released from the small intestine after the closure device has engaged the small intestine wall. Alternatively, the anchoring / fastening components may be left in the bowel after the closure device has engaged the small intestine wall.

[0063] When advancing the access device, the method may further include using a camera, or scope to guide the access device.

[0064] The following description of use of a percutaneous access device 100 of the kind disclosed herein will be in the context of providing access to the small intestine, but it is understood that the percutaneous access device 100 can be used to provide access to any internal organ. In use, a needle is inserted (e g., a Veress open tip needle) through the abdominal wall. A guidewire is placed through the needle and across the abdominal wall. Contrast and methylene blue may be injected. The needle is removed leaving the guidewire. A trocar having an awl and a rigid, hollow cannula tube is advanced over the guidewire and across the abdominal wall. The awl is then removed leaving the cannula in place. A percutaneous access device 100 is then advanced over the guidewire and through the cannula of the trocar such that the distal end 150 of the engagement tube 130 of the access device 100 contacts an external surface of the SI. Using a vacuum source operably connected to the device 100, suction is applied thereby creating a vacuum seal between the distal end 150 of the engagement tube 130 and the external surface of the SI. The deployment portion 120 of the access device 100 is actuated thereby causing the at least one anchor needle 280 and securing member 342 within the needle 280 beyond the distal end 150 of the engagement tube 130 causing the at least one anchor needle 280 to pierce the SI wall. The at least one anchor needle 280 is retracted leaving securing member 342 inside of SI wall. The securing member 342 is then retracted such that it engages internal surface of SI wall thereby securing SI to distal end 150 of engagement tube 130. The deployment portion 120 may then be detached from the access device 100.

[0065] While various embodiments of devices and systems for percutaneously accessing and securing target tissue / organs within a patient and methods for the same have been described in considerable detail herein, the embodiments are merely offered as non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof.

[0066] Further, in describing representative embodiments, the present disclosure may have presented a method and / or a process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth therein, the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and / or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and remain within the scope of the present disclosure.

Claims

CLAIMS1. A percutaneous access device, comprising: an elongated shaft having a lumen defined therethrough terminating at an aperture at or near a distal end of the elongated shaft, the elongated shaft configured to engage a tissue via suction; and at least one anchor needle disposed in the lumen of the elongated body and configured to at least partially protrude from the aperture of the elongated body, the at least one anchor needle having a needle lumen defined therethrough terminating at a first needle aperture at or near a distal end of the anchor needle, and a securing member positioned within the needle lumen and configured to move between at least a first position and a second position, wherein when the at least one securing member is in the first position, the securing member is constrained within the needle lumen, and when the at least one securing member is in the second position, the securing member at least partially protrudes from the needle lumen.

2. The percutaneous access device of claim 1, wherein the securing device comprises a T- fastener, the securing device configured such that the T-fastener is deployed from the first needle aperture when the at least one securing member is in the second position.

3. The percutaneous access device of claim 1, wherein the securing device is configured to be manually triggered using a manual mechanism.

4. The percutaneous access device of claim 1, forming part of a kit, the kit further comprising a closure device.

5. A system comprising the percutaneous access device of claim 1, and further comprising: an access needle having a stabilizing wire; and a closure device.

6. A method for using a percutaneous access device to access an internal organ the method comprising the steps of: inserting an elongated shaft into a patient at or near the internal organ, wherein the elongated shaft needle comprises a distal end, a proximal end, and securing means at the distal end; attached the distal end of the elongated shaft to the internal organ via suction; and deploying the securing means to attach the percutaneous access device to the internal organ.

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