US20160331207A1 - Access visualization systems - Google Patents

Abstract

Methods and devices described herein facilitate improved access of locations within the body.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a non-provisional of U.S. Provisional Patent Application No. 62/160,997 filed on May 13,2015, the content of which is incorporated herein by reference in its entirety,
BACKGROUND OF THE INVENTION
• Methods and devices for access devices to allow improved access in preparation for performing surgical procedures or intervention in areas where collateral damage to sensitive tissue or organs can easily occur. For example, electrophysiologists or interventional cardiologists generally perform procedures under fluoroscopic guidance. However, issues arise when physician access the pericardial space because of their limited viewing capabilities under fluoroscopic guidance.
• Scope based surgical tools (e.g., elongated cannula/tubular devices that allow viewing of internal body tissues) provide surgeons with an ability to view a surgical site through a lens/fiber optic/camera of the scope and also provide an ability to access the surgical site through a working channel of the tool. In some cases, a scope permits the surgeon to access internal body tissue by passing the scope through a small diameter opening, port, or trocar placed in a surface of the body. For convenience, the present disclosure makes reference an endoscope as a scope-based device. However, the inventive devices and methods described herein specifically include the use of any number of scope based devices generally similar to an endoscope; for example, any type of rigid or flexible tube with or without a light delivery system and a visualization source that transmits an image to the viewer, and (optionally) a working channel or lumen that permits delivery of an additional device through the scope.
• In many surgical procedures, the surgeon must also dissect tissue to gain access to the intended target site. For example, U.S. Pat. No. 5,205,816 (the entirety of which is incorporated by reference) teaches a simple blunt dissector having a cannulated single lumen device with a mandrel inserted into the device for carrying a simple textured cloth that provides a textured surface. However, such basic devices are used in addition to the scopes that are used for such minimally invasive procedures. The additional blunt dissector requires an additional entry port or must be exchanged with other tools that are advanced through the entry site. In addition, a physician must manipulate a scope as well as the blunt dissection device.
• Increasingly, scopes are being adapted to assist in the dissection of tissue to eliminate the need for an additional dissection device. Clearly, doing so reduces the number of devices that a physician must manipulate in the surgical area as well as the number of devices that are advanced through the body opening/port/incision. Many conventional devices rely upon balloon-type structures for dissection of tissue via expansion of the balloon or close-ended obturator-type structures that dissect via dilation via insertion of the closed end.
• For example, U.S. Pat. No. 6,989,018 to Fogarty et at (the entirety of which is incorporated by reference herein) discloses a balloon dissection apparatus having an elongate balloon that performs the tissue dissection. However, because this dissection relies upon somewhat uncontrollable expansion of the balloon (as the internal balloon pressure increases), the physician typically has less control over the amount of tissue dissection as compared to using a non-expanding structure to physically dissect tissue.
• While obturator type devices avoid the problems with somewhat unpredictable dissection via balloon expansion, such devices are still not optimal. For example, U.S. Pat. Nos.: 6,592,604; 6,752,756; and 7,001,404 (the entirety of each patent incorporated by reference herein) describe tissue dissection devices having with closed ends (where such ends act as obturators). The closed ends are generally translucent to allow for visualization therethrough. Yet, dissection of tissue occurs via dilation of the tissue using the closed end. U.S. Pat. No. 7,300,448 (the entirety of which is incorporated by reference herein) discloses a combination balloon dissector having an obturator associated with the balloon dissector assembly.
• In any event the balloon dissection or dissection via obturator dilation as described above do not provide the physician with the ability to tease or loosen adjoining tissue for a more controlled dissection of tissue.
• Accordingly, there is a need for improved methods and devices that permit visualization to allow the physicians more comfort in performing various procedures while minimizing the risk of collateral damage to tissue or to the tissue being dissected/dilated.
SUMMARY OF THE INVENTION
• In one variation, the present method of solving this problem is using an integrated endoscope system, which provides electrophysiologists or interventional cardiologists visualization of the access procedure. The benefit of the integrated endoscope system is that it provides a safe and easy seamless passage for entering the pericardial space with visualization to minimize trauma to the heart. The integrated endoscope system may provide access to the pericardial space by percutaneous pericardial access.
• The improved methods and devices described herein offer improved access to tissue regions within the body, especially those organs in the thoracic cavity. However, the devices and methods have applicability to any region in the body apart from the thoracic cavity.
• In a first variation, the present system includes an endoscope configured to provide remote visualization; a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue; a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and where the endoscope is advanceable through the guide tube passage such that a visualization end of the endoscope can be repositioned within the guide tube.
• The variation of the above system can further include a second endoscope extending through the dilator member and radially offset from the guide tube. In some examples, the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member.
• Variations of the system can include a configuration where the dilator member is slidable relative to the guide member.
• In order to aid in visualization using the scopes, any portion of the system can be transparent. Similarly, additional variations include portions of the system that are opaque.
• The guide member described herein can be removable from the dilator member or fixed to the dilator member.
• In another variation, the present disclosure includes a dilation system for use with an endoscope configured to provide remote visualization, the endoscope comprising a visualization end located at a distal portion, the dilation, system comprising: a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue; a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and where the endoscope is advanceable through the guide tube passage such that the visualization end of the endoscope can be repositioned within the guide tube.
• In an additional variation, the present disclosure includes methods for placement of an endoscope adjacent to a target site, in one example such a method comprises positioning an access device adjacent to an opening in tissue, the access device comprising a guide tube and a dilator member, where the guide tube is coupled, to at a distal end of the dilator member; inserting the guide tube of the access device within the opening in tissue; dilating the opening in tissue by advancing the dilator member of the access device through the opening in tissue; and imaging the target site using the endoscope while the endoscope is positioned through the dilator member.
• The method can further include visualizing using the endoscope while inserting the guide tube of the access de vice within the opening.
• In an additional variation, the method includes an opening in tissue which comprises an opening in a pericardial space.
• In certain variations, the method includes a guide tube is transparent and further comprising visualizing through a wall of the guide tube using the endoscope. Alternatively or in combination, where the dilator can be transparent and the method further comprises visualizing through a wall of the guide tube using the endoscope.
• In some variations of the method and devices, the endoscope is affixed to the dilator member and where imaging the target site using the endoscope while the endoscope is positioned through the dilator member comprises repositioning the dilator member to reposition the endoscope.
• Variations of the method further include advancing a second endoscope through the guide tube.
• The present methods can include the use of any conventional device to assist in accessing the body. For example, the methods can further include advancing a guidewire through the opening in tissue and where inserting the guide tube comprises advancing the guide tube over the guidewire.
• Variations of the access device and procedures described herein include combinations of features of the various embodiments or combination of the embodiments themselves wherever possible,
BRIEF DESCRIPTION Of DRAWINGS
• FIG. 1A illustrates a first variation of an endoscopic system or dilation system (when the endoscope is a stand-alone added component).
• FIGS. 1B and 1C illustrate additional variations of systems for navigation of an endoscopic device.
• FIGS. 2A to 2C illustrate another variation of a dilation system that can optionally be integrated with, an endoscope external to a guide tube of the system.
• FIG. 3 shows another variation of the system similar to that shown inFIG. 2A. In this variation, the system includes two scopes.
• FIGS. 4A-4E illustrates a variation of a process of positioning or placing an endoscope using the system described herein
DETAILED DESCRIPTION
• Methods and devices described herein provide for improved access of regions within the body using remote visualization, such as endoscopes. The improved methods and devices described herein offer improved access to tissue regions within the body, especially those organs in the thoracic cavity. For purposes of illustration, the following example discusses the methods and devices as used when a physician accesses a pericardial, space within a thoracic cavity of an individual, however, the devices and methods have applicability to any region in the body where the benefits of the methods and procedures can assist in the procedure.
• Scope based surgical tools (e.g., elongated cannula/tubular devices that allow viewing of internal body tissues) provide surgeons with an ability to view a surgical site through a lens/fiber optic/camera of the scope and also provide an ability to access the surgical site through a working channel of the tool. In some cases, a scope permits the surgeon to access internal body tissue by passing the scope through a small diameter opening, port, or trocar placed in a surface of the body. For convenience, the present disclosure makes reference an endoscope as a scope-based device. However, the inventive devices and methods described herein specifically include the use of any number of scope based devices used for remotely viewing an area of tissue generally similar to an endoscope; for example, any type of rigid or flexible tube with or without a light delivery system and a visualization source that transmits an image to the viewer, and (optionally) a working channel or lumen that permits delivery of an additional device through the scope.
• FIG. 1A illustrates a first variation under tire present disclosure of anendoscopic system100 or dilation system100 (when the endoscope is a stand-alone added component). As illustrated thesystem100 includes adilator member102 having adistal dilation surface106 and adilator passage108 extending therethrough. Aguide tube104 extends distally from thedilator passage108 allowing for anendoscope150 to be advanced therethrough. Theend110 of the guide tube194 can be open or can be closed, in the illustrated variation, theend110 of theguide tube104 is configured to be atraumatic.
• The components of thesystem100 can include any conventional features useful for medical devices and/or procedures. For example, thesystem100 can be configured for coupling to avisual display50 for viewing the images transmitted/relayed from thevisualization end152 of theendoscope150. In addition, the system can include any number of auxiliary fixtures (such as a fluid source, vacuum source, controller for electrodes/pacing, etc.) In addition, theguide tube104 and/ordilator member102 can have steering capabilities or pre-set shapes to assist in navigating the respective component within tissue.
• FIGS. 1B and 1C illustrate additional variations ofsystems100 for navigation of anendoscopic device150. As shown, theguide tube104 can optionally extend through the length of thedilator102 and can optionally move relative to thedilator102 as indicated by arrows112. Furthermore, thedilation surface106 of the variation shown inFIG. 1B, can be stepped rather than conical (as shown inFIG. 1A). However, any atraumatic shape can be used for thedilation surface106.FIG. 1C also illustrates adilator102 having anadditional dilation feature114 such as a distensible ornon-distensible balloon114.
• In any of the variations of the systems described herein, one or more of the components can be configured to assist or improve visualization of a target site by the endoscope. For example, the dilator and/or the guide sheath can be fabricated from opaque or transparent materials. Alternatively, or in combination, the dilator and/or guide tube can include a transparent window that assist in visualization by the endoscope.
• FIGS. 2A to 2C illustrate another variation of a dilation system100 (that can optionally be integrated with an endoscope160). In this variation, adilator102 includes aguide tube100 ex tending therethrough with the distal end of theguide tube110 extending beyond thedilation surface106 of thedilator102. However, this variation also includes aninternal endoscope160 that is adjacent to theguide tube110. Such a configuration allows theinternal endoscope160 to provide an unobstructed view (via the display50) allowing the physician to visualize the tissue adjacent to thedilation surface106 as the dilator advances.
• FIGS. 2B and 2C illustrate the end of thedilator102 shown inFIG. 2A. As shown inFIG. 2B, thedilator102 can include a scalloped opening or one where there are two passages that are parallel Thepassages108 and114 can be joined (as shown inFIG. 2B) or separated (such as those found in a multi-lumen tube). Additional variations of the dilator opening can include various other shapes. However, in the illustrated variation, theopening114 provides space tor the internal scope (as shown inFIG. 2C). Similar to the variation shown inFIG. 1A, the dilator and/or guide tube may be composed of either opaque or transparent materials. Theinternal scope160 can be affixed to the dilator as shown inFIG. 2C. Alternatively, thescope160 can be moveable relative to thedilator102.
• FIG. 3 shows another variation of thesystem108 similar to the one shown inFIG. 2A. In this variation, thesystem100 includes twoscopes150,160. As noted above, as thedilator member102 includes an internal scope160 (either fixed or moveable within the dilator member102). Anadditional scope150 can be advanced through theguide member104 as discussed above with respect toFIG. 1A. The variation shown inFIG. 3 can include an additional monitor/display52. Alternatively, or in combination, the image generated by bothscopes150,160 can be projected on both monitors or a single monitor.
• FIGS. 4A-4E illustrates a variation of a process of positioning or placing an endoscope using the system described herein. As show inFIG. 4A, a variation of the procedure usesminimal incisions10 and12 to access the chest cavity. Alternatively, or in combination, anincision14 can be made that requires traversing a diaphragm of the individual1 in order to access the thoracic cavity. In some variations, the procedure can be performed percutaneously. Again, alternate variations of the method can occur in an open surgical procedure or with any number of surgical incisions. The integrated system can be inserted into the patient through any number of conventionally known access methods.
• FIG. 4B illustrates aheart4 surrounded by apericardium4 in order to demonstrate an example of a process for placement of a scope using the system described herein. Any number of commercial devices can be used in conjunction with the systems described herein. For example, a commercially available dilator (e.g., for renal applications) can optionally be inserted be to provide access to thepericardium4. As shown, a physician can percutaneously insert aneedle20 into thepericardial sac4 via an initial pericardial incision orentry point6. Next, under fluoroscopic guidance (optional), aguidewire22 can be delivered through theneedle20 into the pericardial space. In another variation, a physician can use an expandable cannula to Insert die integrated system disclosed herein. The physician can use this expandable cannula with an initial insertion profile to minimize the size the pericardial opening to enter the pericardium. Once inserted, the physician expands the expandable cannula to al low for insertion of any of the disclosed integrated endoscope systems.
• FIG. 4C illustrates the state where the physician removes theneedle20 leaving theguidewire22 in place. Next, the physician introduces asystem100 adjacent to the site and advances aguide tube104 over theguidewire22 through thepericardial incision6 and into the pericardial space. As illustrated, afirst scope150 can optionally be inserted through theguide tube104 to assist the physician by allowing for visualization of the in the pericardial space that is otherwise obscured by thepericardium4. In some variations of the device theguidewire22 must be removed to advance thescope150. In alternate variations, theguide tube104 is configured to accommodate both a scope and guidewire. Additionally or alternatively, variations of the system including aninternal scope160 allow the physician visual access to the region adjacent to the distal end of thedilator member102 and guidetube104.
• FIGS. 4D and 4E illustrate examples of a dual scope system and a single scope system, respectively. As noted above for those variations, as shown inFIG. 4D, a physician can use aninternal scope160 that is positioned adjacent to adilation surface106 of thedilator member102 for visualization. The physician also has the option of using asecond scope150 that passes through theguide tube104,FIG. 4E illustrates an example of the system where thescope150 is positioned through theguide tube104. As noted in either ofFIGS. 4D and 4E, the physician can advance thedilator member102 to further dilate theopening6.
• Once the opening is dilated and the physician inspects the area of interest, the physician can then advance an additional cannula or a hollow sheath the dilator member of the system. Alternatively, a commercial dilator can be advanced over thedilator member102 to permit removal of thedilator member102 and system to prepare the site for further surgical devices.
• For example, integrated vacuum coagulation probes provided by AtriCure, Ohio, are examples of devices that can be inserted through the openings provided by the systems described above. Such devices are capable of heating the soft tissue until achieving irreversible injury making the soft tissue non-viable and unable to propagate electrical impulses, mutate, or reproduce. These integrated vacuum coagulation probe embodiments maybe in conjunction with the access devices described herein to treat atrial fibrillation, ventricular tachycardia or other arrhythmia substrate, or eliminating cancer in lung, or other soft thoracic tissue by destroying target cells.
• Examples of such probes are disclosed in commonly assigned U.S. publications and patents: US20060009762A1 entitled VACUUM COAGULATION PROBE FOR ATRIAL FIBRILLATION TREATMENT; US20060200124A1 entitled VACUUM COAGULATION PROBES; US20060206113A1 entitled METHODS FOR COAGULATION OF TISSUE; US20060235381A1 entitled VACUUM COAGULATION PROBES; US2006-0293646A1 entitled VACUUM COAGULATION & DISSECTION PROBES; US20070043351A1 entitled VACUUM COAGULATION PROBES; US20080114354A1 entitled VACUUM COAGULATION PROBES; US20080114355A1 entitled VACUUM: COAGULATION PROBES; and U.S. Pat. Nos. 6,893,442 entitled VACUUM COAGULATION PROBE FOR ATRIAL FIBRILLATION TREATMENT; U.S. Pat. No. 7,063,698 entitled VACUUM COAGULATION PROBES; the entirety of each of which, is hereby incorporated by reference.
• Although the present methods and devices have been described in terms of the embodiments above, numerous modifications and/or additions to the above-described preferred embodiments would be readily apparent to one skilled in the art. It is intended that the scope of the present inventions extend to all such modifications and/or additions and that the scope of the present inventions is limited solely by the claims of the invention.

Claims (40)

What s claimed is:

1. An endoscopic system comprising:

an endoscope configured to provide remote visualization;

a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue;

a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and

where the endoscope is advanceable through the guide tube passage such that a visualization end of the endoscope can be repositioned within the guide tube.

2. The endoscopic system ofclaim 1, further comprising a second endoscope extending through the dilator member and radially offset from the guide tube,

3. The endoscopic system ofclaim 2, where the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member.

4. The endoscopic system ofclaim 1, where the dilator member is slidable relative to the guide member.

5. The endoscopic system ofclaim 1, where the guide member is transparent

6. The endoscopic system ofclaim 1, where the dilator member is transparent.

7. The endoscopic system ofclaim 1, where the guide member is flexible.

8. The endoscopic system ofclaim 1, where the dilator member is flexible.

9. The endoscopic system ofclaim 1, where the guide member is removable from the dilator member.

10. The endoscopic system ofclaim 1, where the endoscope is advanceable through the dilator passage.

11. The endoscopic system ofclaim 1, where the distal end of the guide tube is tapered.

12. The endoscopic system ofclaim 1, further comprising a second dilator member slidable over the dilator member.

13. The endoscopic system ofclaim 1, where endoscope further comprises a flexible a body having the visualization end located at a distal portion of the flexible body.

14. A dilation system for use with an endoscope configured to provide remote visualization, the endoscope comprising a visualization end located at a distal portion, the dilation system comprising:

a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue;

a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and

where the endoscope is advanceable through the guide tube passage such that the visualization end of the endoscope can be repositioned within the guide tube.

15. The endoscopic system ofclaim 14, further comprising a second endoscope extending through the dilator member and radially offset from the guide tube.

16. The endoscopic system ofclaim 15, where the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member.

17. The endoscopic system ofclaim 14, where the dilator member is slidable relative to the guide member.

18. The endoscopic system ofclaim 14, where the guide member is transparent.

19. The endoscopic system ofclaim 14, where the dilator member is transparent.

20. The endoscopic system ofclaim 14, where the guide member is flexible.

21. The endoscopic system ofclaim 14, where the dilator member is flexible.

22. The endoscopic system ofclaim 14, where the guide member is removable from the dilator member.

23. The endoscopic system ofclaim 14, where the endoscope is advanceable through the dilator passage.

24. The endoscopic system ofclaim 14, where the distal, end of the guide tube is tapered.

25. The endoscopic system ofclaim 14, further comprising a second dilator member slidable over the dilator member.

26. A method for placement of an endoscope adjacent to a target site, the method comprising;

positioning an access device adjacent to an opening in tissue, the access device comprising a guide tube and a dilator member, where the guide tube is coupled to at a distal end of the dilator member;

inserting the guide tube of the access device within the opening in tissue;

dilating the opening in tissue by advancing the dilator member of the access device through the opening in tissue; and

imaging the target site using the endoscope while the endoscope is positioned through the dilator member.

27. The method ofclaim 26, further comprising visualizing using the endoscope while inserting the guide tube of the access device within the opening.

28. The method ofclaim 26, where the opening in tissue comprises an opening in a pericardial space.

29. The method ofclaim 26, where the guide tube is transparent and further comprising visualizing through a wall of the guide tube using the endoscope.

30. The method ofclaim 26, where the dilator is transparent and further comprising visualizing through a wall of the guide tube using the endoscope.

31. The method ofclaim 26, further comprising advancing, the endoscope through the dilator member.

32. The method ofclaim 31, further comprising advancing the endoscope through the guide tube.

33. The method ofclaim 26, where the endoscope is affixed to the dilator member and where imaging the target site using the endoscope while the endoscope is positioned through the dilator member comprises repositioning the dilator member to reposition the endoscope.

34. The method ofclaim 33, further comprising advancing a second endoscope through the guide tube

35. The method ofclaim 26, further comprising advancing a guidewire through the opening in tissue and where inserting the guide tube comprises advancing the guide tube over the guidewire.

36. The method ofclaim 26, where the dilator member is moveable over guide tube.

37. The method ofclaim 36, further comprising removing the dilator from the guide tube and advancing a second dilator over the guide tube.

38. The method ofclaim 36, further comprising advancing a hollow member over the dilator and removing the dilator from the opening in tissue.

39. The method ofclaim 38, further comprising advancing one or more medical devices through the hollow member.

40. The method ofclaim 26, wherein the dilator comprises an expandable member.

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