WO2008109408A2

WO2008109408A2 - Devices and methods for performing minimally invasive surgery

Info

Publication number: WO2008109408A2
Application number: PCT/US2008/055441
Authority: WO
Inventors: Stephen P. Moenning
Original assignee: Moenning Stephen P
Priority date: 2007-03-02
Filing date: 2008-02-29
Publication date: 2008-09-12
Also published as: WO2008109408A3

Abstract

Devices and methods for performing minimally invasive surgery. A first cannula (14) includes a distal end portion and a lumen capable of receiving an endoscope (20). The lumen includes a first seal element (22) configured to engage the endoscope during use in the minimally invasive surgery. A second seal element (30) is operatively coupled to the distal end portion and deployable into engagement with tissue (32) adjacent a nonvascular body cavity (24). The second seal element (30) further comprises a fluid delivery passage (30a) operable to deliver a fluid into the tissue (32) and/or into the nonvascular body cavity (24).

Description

DEVICES AND METHODS FOR PERFORMING MINIMALLY INVASIVE SURGERY

Cross Reference

[0001] This application claims the benefit of U.S. Provisional Patent

Application Serial No. 60/892,734, filed on March 2, 2007, the disclosure of which is hereby expressly incorporated by reference herein.

Technical Field

[0002] The present invention generally relates to devices and methods for performing minimally invasive surgery and, more particularly, those devices and methods that utilize one or more cannulas having one or more lumens for receiving various minimally invasive tools and instruments for performing surgical procedures in nonvascular body cavities.

Summary

[0003] In one aspect, a device is provided for performing minimally invasive surgery including a first cannula with a distal end portion and a lumen capable of receiving an endoscope. The lumen includes a first seal element configured to engage the endoscope during use in the minimally invasive surgery. A second seal element is operatively coupled to the distal end portion and deployable into engagement with tissue adjacent a nonvascular body cavity. The second seal element further includes a fluid delivery passage operable to deliver a fluid into the tissue and/or into the nonvascular body cavity.

[0004] Various additional aspects may be included in the device. For example, the second seal element may further comprise a fastener configured to penetrate into the tissue. The fastener may comprise a generally helically shaped coil element including a lumen for delivering the fluid. The generally helically shaped coil element may be formed of various materials, including shape memory alloys such as nickel-titanium. The second seal element may further comprise an expandable element movable between a delivery position suitable for delivery to a location adjacent the tissue and an expanded sealing position extended radially outward from the first cannula and engageable with the tissue. The second seal element may further comprise a generally flat element engageable with an inner or outer surface of the tissue. The device may further include a tissue cutting element configured for receipt within and movement through the first cannula and capable of cutting through the tissue to form an opening through the tissue into the nonvascular body cavity. The second seal element may further comprise a closure configured to close an opening in the tissue through which the endoscope passed during the minimally invasive surgery. At least the distal portion of the first cannula may be transparent to allow visualization of the tissue therethrough. The second seal element may be transparent to allow visualization of the tissue therethrough. [0005] In another aspect, a device for performing minimally invasive surgery includes a first cannula, a tissue penetration element, and a tissue cutting element. The first cannula includes a distal end portion and a lumen capable of receiving an endoscope. The lumen includes a first seal element configured to engage the endoscope during use in the minimally invasive surgery. The tissue penetration element is deployable from the distal end portion to penetrate into the tissue adjacent a nonvascular body cavity. The tissue cutting element is configured to be extended from the distal end portion of the first cannula and is capable of cutting through the tissue to form an opening through the tissue and into the nonvascular body cavity. [0006] Any of the other features discussed above may be incorporated together, or with still further features. For example, an inner seal element may be deployable relative to the distal end portion and configured to form a seal against the tissue from within the nonvascular body cavity. An outer seal element may be deployable relative to the distal end portion and configured to form a seal against the tissue outside of the nonvascular body cavity. At least one additional cannula may be provided for forming a telescoping assembly of cannulas. The cannula or cannulas may be flexible and adapted for Natural Orifice Transluminal Endoscopic Surgery.

[0007] Various methods are provided as well. For example, a method of performing minimally invasive surgery is provided, including delivering a first cannula with a distal end portion and a lumen to a location adjacent a nonvascular body cavity. A seal element is deployed relative to the distal end portion and into engagement with tissue adjacent the nonvascular body cavity, and fluid is delivered through the seal element and into the tissue and/or into the nonvascular body cavity. Various additional features and methods are disclosed herein generally involving the functional aspects described further below or methodology generally described below.

Detailed Description of Illustrative Embodiments [0008] The invention, including any of the illustrative aspects of the devices and methods disclosed herein, is applicable to various types of minimally invasive surgery. The invention includes features that are particularly, although not exclusively, advantageous to the latest procedures including Natural Orifice Transluminal Endoscopic Surgery (NOTES). For -A- θxamplθ, this includes transgastric, transcolonic, transvaginal, transvesicular and transrectal procedures.

[0009] Figs. 1 and 1 A illustrate the distal end of a device 10 including a cannula assembly 12. Assembly 12 includes a first cannula or outer cannula 14, a second cannula or intermediate cannula 16 and a third cannula or inner cannula 18. A larger number or fewer number of cannulas may be used instead. Fig. 1 A further illustrates an endoscopic instrument, sometimes referred to as a "scope," extending through the third cannula 18 and, more specifically, extending through a schematically illustrated valve element 22. The valve element 22 is a one-way valve designed to ensure at least a substantially airtight seal with the outer surface of the scope 20 as it moves through the valve element 22 along the interior lumen of the third cannula 18. This maintains the air pressure in the nonvascular body cavity 24 after insufflation thereof through the scope 20 in a known manner. Fig. 1 A further illustrates a generally helically formed tissue penetration element 30 (e.g., a needle) operatively coupled to the first cannula 14. In a general aspect, this needle 30 provides one illustrative form of a tissue penetration element 30 for penetrating into tissue 32 adjacent a nonvascular body cavity 24 for one or more various purposes. For example, the penetration element 30 may simply hold and stabilize the tissue 32 while various operations are performed on the tissue 32 or through the tissue 32, and/or the penetration element 30 may deliver any type of fluid to the tissue 32 or through the tissue 32 into the nonvascular body cavity 24. Such fluids may take any form, and may include gases or liquids for any purpose. For example, any medication may be dispensed into the tissue and/or into the nonvascular body cavity. In one exemplary but advantageous use of the device during Natural Orifice Transluminal Endoscopic Surgery (NOTES), the penetration element 30 may be used as a fastener for holding the tissue 32 against the distal end of the cannula assembly 12, such as the third cannula 18, as a cutting element 40 (Fig. 1 D) is used to cut the tissue 32 to create an opening for insertion of the scope 20 through the tissue 32 and into the nonvascular body cavity 24. If the penetration element 30 is also formed with a suitable passageway and one or more openings, such as the form of a needle having an open distal end 30a, medication may be introduced into the tissue 32 surrounding the port site area that will be cut by the cutting element 40. This medication may, for example, comprise epinephrine or the like for lessening bleeding at the port site. [0010] Figs. 1 B through 1 K illustrate the steps in one exemplary or illustrative method using the device 10 of Figs. 1 and 1 A. More specifically, Fig. 1 B illustrates that the assembly 12 has been inserted, for example, through a natural orifice of the patient, such that the distal end portion of the assembly 12 is positioned adjacent to tissue 32, such as the peritoneum. The tissue penetration element 30, illustrated as a generally helical needle formed of shape memory material, such as nickel-titanium, is deployed or extended from the distal end portion of the assembly 12. The deployment may include translation and rotation such that the helical penetration element 30 penetrates in a generally circular fashion through the tissue 32 and generally around the port site for the scope 20.

[0011] Fig. 1 C illustrates a further point in the process in which the penetration element 30 has been rotated one to two times through the tissue 32. At this time, medication such as epinephrine may be injected through the distal tip 30a of the needle 30 and into the tissue 32 for reasons as previously described. An actuating element 50, such as a pusher bar, may be pulled proximally thereby pulling on the helical fastener 30 that is holding the tissue

32. This moves the tissue 32 toward the distal end of the assembly 12, as illustrated by the arrows 52.

[0012] As shown in Fig. 1 D, the tissue 32 may be firmly held by the needle 30 in this position while a cutting element 40, such as an RF cutter, laser cutter, or any other type of cutting element, is used to cut or pierce an opening through the tissue 32 and into the nonvascular body cavity 24 on the opposite side of the tissue 32. The tissue penetrating element 30 may also serve as a filamentous sealing element for sealing the opening created by the cutting element 40, for example, for purposes of maintaining pneumatic pressure in the nonvascular body cavity 24 after insufflation. A trocar (not shown) may be used to assist penetration of a device such as a cannula having a working channel. [0013] Fig. 1 E illustrates the second and third cannulas 16, 18 inserted through the opening created by the cutting element 40. The tissue 32 at the port site is typically elastic so that a small opening may be stretched into a larger diameter. This elasticity, coupled with the optional sealing function provided by the tissue penetration element 30 (e.g., the helical fastener) can help to maintain a seal between the assembly 12 and the tissue 32 for purposes of maintaining pneumatic pressure in the nonvascular body cavity 24. [0014] Fig. 1 F illustrates further penetration of the third cannula 18 through the tissue 32 relative to the second cannula 16 and deployment or actuation of inner and outer annular sealing elements 60, 70 respectively against outer and inner surfaces 32a, 32b of the tissue 32. These seal elements 60, 70 may be constructed in any suitable shape and use any suitable actuation such as mechanical, pneumatic, choice of materials (e.g., shape memory), combinations of these or other methods. In the illustrated embodiment, the seal elements 60, 70 are generally flat members and include hollow interiors 62, 72. Hollow interior or passage 62 communicates with a passage 64 for the introduction of fluids. It will be appreciated that seal element 70 may be similarly designed. One or more holes 66 may be provided to communicate the fluids from the inner passage or passages 64 to the outside. This fluid again may be gaseous or liquid. Liquids, such as any suitable medication or other biologically active agent or substance may be delivered for any purpose. The seal elements 60, 70 are constructed as hinged members or elements that may be deployed from an unexpanded state shown in Fig. 1 E and suitable for delivery to the port site, to an expanded state, such as the radially expanded state shown in Fig. 1 F. Engagement of the seal elements 60, 70 against outer and inner surfaces 32a, 32b of the tissue helps maintain pneumatic pressure in the nonvascular body cavity 24. The endoscope 20 may then be used during the minimally invasive surgical procedure within the nonvascular body cavity 24.

[0015] Fig. 1 G illustrates retraction of the inner or distal seal element 70 after the minimally invasive surgical procedure is complete. Fig. 1 H illustrates retraction of the outer or proximal seal element 60. [0016] Fig. 1 1 illustrates that the tissue penetration element 30 may optionally be used as a tissue closure. For example, the generally helical configuration of the tissue penetration element 30 may be designed such that, upon rotation into the tissue 32 and around the port site as shown in Fig. 1 1, the tissue 32 may be urged together against the outer surface of the third cannula 18. Other forms of closures may be used instead. Optionally, a tissue adhesive may be dispensed through fluid passages associated with the device 10. [0017] Fig. U illustrates the tissue penetration element 30, in the optional form of a helical closure, deployed completely, and Fig. 1 K illustrates withdrawal of the cannula assembly 12. It will be understood that one or more elements of the cannula assembly 12 may be left closely adjacent the proximal end of the helical tissue penetration element 30, although these elements have been removed for clarity in Fig. 1 K. As schematically illustrated, a suitable cutting device 80 may be used to cut any excess proximal portion of the closure element 30, or any guide element 82 associated therewith. In other embodiments, the closure element may take any other form that may be suitably deployed around the port site opening to close the same. As shown in Fig. 1 K, the helical coil nature of the tissue penetration element 30 includes a converging shape that can help close the tissue opening, as shown. [0018] Figs. 2A-2D illustrate another exemplary or illustrative embodiment of the invention. Like reference numerals are used to denote like elements with the first embodiment. This embodiment again comprises a device 100 formed as an assembly 102 of three cannulas including a first or outer cannula 104, a second or intermediate cannula 106 and a third or inner cannula 108. The third cannula 108 includes again a valve element 1 10 including first and second valve members 1 12, 1 14 that may be formed as conventional one-way valves in any suitable manner for the reasons previously discussed. By reviewing Figs. 2A-2D, it will be recognized that the general procedure is similar with this embodiment as described with respect to the first illustrative embodiment. Thus, the initial steps, including insertion of the tissue penetration element, holding of the tissue, cutting of the port site opening and other steps common to the first embodiment, are not shown for the sake of brevity. [0019] The device 100 of this embodiment includes annular seal elements 120, 122 on the outside of the second and third cannulas 106, 108 that are different in operation from the analogous seal elements 60, 70 shown in the first embodiment. Although not shown, elements 60, 70 may also have fluid delivery capability. As shown in Fig. 2A, the third or inner cannula 108 is pushed inwardly into the nonvascular body cavity 24. As further shown in Fig. 2B, the first or outer cannula 104 is pulled or moved in a proximal direction relative to the second or intermediate cannula 106 thereby exposing the proximal seal element 120 on the outer surface of the second cannula 106. This seal element 120 is designed to automatically bias itself in a radially outward direction as indicated by the arrow 124 in Fig. 2B. This function may be accomplished in any suitable manner, such as through the choice of materials used for the seal element, including, for example, shape memory materials. As further shown in Fig. 2C as the assembly 102 is moved proximally to expose more of the proximal seal element 120 from the tissue 32, the proximal seal element 120 will expand fully radially outward so that it may engage against the outside surface 32a of the tissue 32. Movement of the inner or third cannula 108 in a distal direction relative to the second cannula 106 will then expose the distal seal element 122 which likewise will automatically expand in a radial direction as shown in Fig. 2C and indicated by the arrows 130. The inner or third cannula 108 may then be pulled proximally to firmly engage the distal seal element 122 against the inner surface 32b of the tissue 32 whereupon the endoscope 20 and any other instrument may be used to perform any desired surgical procedure within the nonvascular body cavity 24. As shown in Fig. 2D, the second cannula 106 may be pulled or moved proximally relative to the first or outer cannula 104 to collapse the proximal seal θlθmθnt 120 as shown and the inner or third cannula 108 may likewise be moved proximally to collapse the distal seal element 122 as shown during removal of the third cannula 108 through the port site opening. Any other manner of collapsing seal elements 120, 122 may be used instead. The remainder of the steps may be performed as generally described above with respect to the first embodiment.

[0020] Figs. 3A and 3B illustrate one of many alternative tissue penetration elements 200 comprised of a generally helical filamentous element also having a generally planar shape as appreciated from the slight perspective view of Fig. 3B.

[0021] Figs. 4 and 5 illustrate two additional exemplary or illustrative embodiments of tissue penetration elements 202, 204.

[0022] In each embodiment, one or more portions of the devices 10, 100 may be made transparent to assist with visualization. In addition, especially for

NOTES procedures, the assemblies 12, 102 are made to be flexible.

[0023] While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features discussed herein may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of illustrative aspects and embodiments the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims. What is claimed is:

Claims

1. A device for performing minimally invasive surgery, comprising: a first cannula including a distal end portion and a lumen capable of receiving an endoscope, said lumen including a first seal element configured to engage the endoscope during use in the minimally invasive surgery; and a second seal element operatively coupled to the distal end portion and deployable into engagement with tissue adjacent a nonvascular body cavity, said second seal element further comprising a fluid delivery passage operable to deliver a fluid into the tissue and/or into the nonvascular body cavity.

2. The device of claim 1 , wherein said second seal element further comprises a fastener configured to penetrate into the tissue.

3. The device of claim 2, wherein the fastener comprises a generally helically shaped coil element including a lumen for delivering the fluid.

4. The device of claim 3, wherein said generally helically shaped coil element further comprises a shape memory alloy material.

5. The device of claim 4, wherein said shape memory alloy material further comprises nickel-titanium.

6. The device of claim 1 , wherein said second seal element further comprises an expandable element movable between a delivery position suitable for delivery to a location adjacent the tissue, and an expanded sealing position extended radially outward from said first cannula and engageable with the tissue.

7. The device of claim 6, wherein said second seal element further comprises a generally flat element engageable with an inner or outer surface of the tissue.

8. The device of claim 1 , further comprising a tissue cutting element configured for receipt within and movement through said first cannula and capable of cutting through the tissue to form an opening through the tissue into the nonvascular body cavity.

9. The device of claim 1 , wherein said second seal element further comprises a closure configured to close an opening in the tissue through which the endoscope passed during the minimally invasive surgery.

10. The device of claim 1 , wherein at least the distal end portion of said first cannula is transparent to allow visualization of the tissue therethrough.

1 1 . The device of claim 1 , wherein the second seal element is transparent to allow visualization of the tissue therethrough.

12. A device for performing minimally invasive surgery, comprising: a first cannula including a distal end portion and a lumen capable of receiving an endoscope, said lumen including a first seal element configured to engage the endoscope during use in the minimally invasive surgery; a tissue penetration element deployable from the distal end portion to penetrate into the tissue adjacent a nonvascular body cavity; and a tissue cutting element configured to be extended from the distal end portion of said first cannula and capable of cutting through the tissue to form an opening through the tissue and into the nonvascular body cavity.

13. The device of claim 12, wherein said tissue penetration element further comprises a closure element configured to close an opening in the tissue through which the endoscope passed during the minimally invasive surgery.

14. The device of claim 12, wherein said tissue penetration element further comprises a fluid delivery passage operable to deliver a fluid into the tissue and/or into the nonvascular body cavity.

15. The device of claim 12, further comprising: an inner seal element deployable relative to said distal end portion and configured to form a seal against the tissue from within the nonvascular body cavity; and an outer seal element deployable relative to said distal end portion and configured to form a seal against the tissue outside of the nonvascular body cavity.

16. The device of claim 12, wherein said tissue penetration element comprises a generally helically shaped coil element.

17. The device of claim 16, wherein said generally helically shaped coil element further comprises a shape memory alloy material.

18. The device of claim 17, wherein said shape memory alloy material further comprises nickel-titanium.

19. The device of claim 12, wherein at least the distal end portion of said first cannula is transparent to allow visualization of the tissue therethrough.

20. The device of claim 1 , wherein the second seal element is transparent to allow visualization of the tissue therethrough.

21 . The device as set forth in any previous claim, further comprising a least one additional cannula for forming a telescoping assembly of cannulas.

22. The device as set forth in any previous claim, wherein said cannula(s) are flexible and adapted for Natural Orifice Transluminal Endoscopic Surgery.

23. A method of performing minimally invasive surgery, comprising: delivering a first cannula, including a distal end portion and a lumen, to a location adjacent a nonvascular body cavity; deploying a seal element relative to the distal end portion and into engagement with tissue adjacent the nonvascular body cavity; and delivering fluid through the seal element and into the tissue and/or into the nonvascular body cavity.

24. The method of claim 23, wherein deploying the seal element further comprises penetrating into the tissue with the seal element.

25. The method of claim 24, wherein the seal element further comprises a filamentous element with a lumen, and delivering fluid further comprises delivering the fluid through the lumen of the filamentous element into the tissue.

26. The method of claim 23, wherein the seal element further comprises a generally helically shaped coil element including a lumen for delivering the fluid and deploying the seal element further comprises rotating the generally helically shaped coil element into the tissue.

27. The method of claim 26, wherein the generally helically shaped coil element further comprises a shape memory alloy material.

28. The method of claim 27, wherein the shape memory alloy material further comprises nickel-titanium.

29. The method of claim 23, wherein deploying the seal element further comprises: expanding the seal element from a delivery position used while delivering the first cannula to the location adjacent the nonvascular body cavity to a sealing position extended radially outward from the first cannula and engageable with the tissue.

30. The method of claim 29, wherein the seal element further comprises a generally flat element and deploying the seal element further comprises engaging the seal element with an inner or outer surface of the tissue.

31 . The method of claim 23, further comprising: cutting the tissue with a tissue cutting element deployed relative to the distal end portion to form an opening through the tissue into the nonvascular body cavity.

32. The method of claim 31 , further comprising: delivering an endoscope through the opening.

33. The method of claim 31 , further comprising: using the seal element as a closure to close the opening in the tissue after completion of the minimally invasive surgery.

34. The method of claim 23, further comprising: visualizing the tissue through one or more transparent portions in the distal end portion of the first cannula.

35. The method of claim 23, further comprising: visualizing the tissue through one or more transparent portions in the seal element.

36. A method of performing minimally invasive surgery, comprising: delivering a first cannula, including a distal end portion and a lumen, to a location adjacent a nonvascular body cavity; deploying a tissue penetration element operatively coupled to the distal end portion so as to penetrate into the tissue adjacent the nonvascular body cavity; and delivering fluid through the tissue penetration element and into the tissue and/or into the nonvascular body cavity.

37. The method of claim 36, wherein the tissue penetration element further comprises a fastener and the method further comprises holding the tissue with the fastener.

38. The method of claim 36, wherein the tissue penetration element further comprises a filamentous element with a lumen, and delivering fluid further comprises delivering the fluid through the lumen of the filamentous element into the tissue.

39. The method of claim 36, wherein the tissue penetration element further comprises a generally helically shaped coil element including a lumen for delivering the fluid and deploying the tissue penetration element further comprises rotating the generally helically shaped coil element into the tissue.

40. The method of claim 39, wherein the generally helically shaped coil element further comprises a shape memory alloy material.

41 . The method of claim 40, wherein the shape memory alloy material further comprises nickel-titanium.

42. The method of claim 36, further comprising: expanding a seal element from a delivery position used while delivering the first cannula to the location adjacent the nonvascular body cavity to a sealing position extended radially outward from the first cannula and engageable with the tissue.

43. The method of claim 42, wherein the seal element further comprises a generally flat element and deploying the seal element further comprises engaging the seal element with an inner or outer surface of the tissue.

44. The method of claim 36, further comprising: cutting the tissue with a tissue cutting element deployed relative to the distal end portion to form an opening through the tissue into the nonvascular body cavity.

45. The method of claim 44, further comprising: delivering an endoscope through the opening.

46. The method of claim 36, further comprising: using the tissue penetration element as a closure to close the opening in the tissue after completion of the minimally invasive surgery.

47. The method of claim 36, further comprising: visualizing the tissue through one or more transparent portions in the distal end portion of the first cannula.

48. The method as set forth in any previous claim, further comprising: using at least one additional cannula and forming a telescoping assembly of cannulas.

49. The method as set forth in any previous claim, wherein delivering the cannula(s) further comprises: delivering the cannula(s) during a Natural Orifice Transluminal Endoscopic Surgical procedure.

50. The device of claim 12, wherein the tissue penetration element further comprises a fastener for holding the tissue stable while the cutting element is used to form the opening.