Apparatus and method for providing percutaneous access and medicament to a target surgical site

• US 20040199121A1
• Filed: 01/21/2004
• Published: 10/07/2004
• Est. Priority Date: 08/01/2001
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Wenchell, Thomas, Smith, Robert C.
• Granted Patent: US 7,449,011 B2
• Time in Patent Office: Days
• US Class Current: 604/167.06
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/349 Trocar with thread on outside

Abstract

Access system for forming and enlarging a percutaneous penetration are disclosed. The apparatus includes a radially expandable dilation assembly having a radially expandable sleeve body and a handle portion operatively coupled to the proximal end of the radially expandable sleeve body. The access system further includes an expansion assembly having an expansion member configured and adapted to radially expand the sleeve body upon insertion therein of the expandable member. The handle portion including a seal disposed across an aperture formed therein for creating a fluid-tight seal around a proximal end of the expansion member. The handle portion including a valve stem operatively and fluidly coupled thereto for delivering a fluid into the aperture of the handle portion. The expansion member including means for reducing the force required to slidably insert the expansion member into the sleeve body of the dilation assembly.

Claims

1. A surgical access system for forming and enlarging a percutaneous penetration, the surgical access system comprising:

a radially expandable dilation assembly having a radially expandable sleeve body defining a lumen having a first cross-sectional area and a handle portion coupled to a proximal end of the sleeve body, the handle portion defining an aperture formed therein, the handle portion including an introducer seal disposed across the aperture formed in the handle portion and defining an opening formed therein;

an expansion assembly including an expansion member having an axial lumen with a second cross sectional area, wherein the expansion member is configured and dimensioned to be selectively receivable within the aperture formed in the handle portion of the lumen of the sleeve body; and

a polymerical layer encasing the sleeve body.

2. The access and delivery system according to claim 1, wherein the radially expandable dilation assembly further includes a valve stem operatively coupled to the handle portion, the valve stem defining an injection lumen extending into the aperture formed in the handle portion.

3. The access and delivery system according to claim 2, wherein the sleeve body comprises a mesh of individual non-elastic filaments, wherein radial expansion of sleeve body causes axial shortening of sleeve body.

4. The access and delivery system according to claim 3, wherein the polymeric layer includes at least one radially oriented hole formed near a distal end thereof.

6. The access and delivery system according to claim 4, wherein the polymeric layer includes a plurality of radially oriented holes formed near a distal end thereof, wherein the plurality of holes are oriented in at least one of along a single side, along diametrically opposed sides, along multiple sides and randomly dispersed around the periphery thereof.

7. The access and delivery system according to claim 1, wherein the expansion member includes at least one radially projecting element provided on an outer surface thereof, wherein the at least one radially projecting element tents the sleeve body radially outward upon insertion of expansion member through the he handle portion and into the sleeve body of the dilation assembly.

8. The access and delivery system according to claim 7, wherein the at least one radially projecting element includes a plurality of longitudinal ribs extending the length of the expansion member.

9. The access and delivery system according to claim 8, wherein each of the plurality of longitudinal ribs has a cross-sectional profile selected from the group consisting of triangular, hexagonal, polygonal and hemi-spherical.

10. The access and delivery system according to claim 7, wherein the at least one radially projecting element includes a plurality of bumps projecting radially outward from an outer surface of the expansion member.

12. The access and delivery system according to claim 7, wherein the at least one radially projecting element is a helical thread.

14. The access and delivery system according to claim 7, wherein the at least one radially projecting element defines a channel extending along the length of the expansion member when the expansion member is inserted in the dilation assembly.

15. The access and delivery system according to claim 14, wherein the radially expandable dilation assembly further includes a valve stem operatively coupled to the handle portion, the valve stem defining an injection lumen extending into the aperture formed in the handle portion, wherein a fluid injected into the aperture of the handle portion, through the valve stem, will be forced distally through the channel.

31. The access and delivery system according to claim 1, wherein the at least one layer of fabric is spandex.

32. The access and delivery system according to claim 1, wherein the polymeric layer extends distally beyond the distal end of the sleeve body and defines a cuff seal configured and adapted to create a fluid-tight seal around the distal end of the expansion member when the expansion member extends through the dilation assembly.

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33. A surgical access system for forming and enlarging a percutaneous penetration, the surgical access system comprising:

a radially expandable dilation assembly having a radially expandable sleeve body defining a lumen having a first cross-sectional area and a handle portion coupled to a proximal end of the sleeve body, the handle portion defining an aperture formed therein, and at least one engaging member integrally formed with the handle portion and projecting radially inward;

an expansion assembly including an expansion member having an axial lumen with a second cross-sectional area, wherein the expansion member is configured and dimensioned to be selectively receivable within the aperture formed in the handle portion and the lumen of the sleeve body, and at least one engaging element formed in an outer surface thereof for co-operable engagement with a respective engaging member of the dilation assembly, wherein the at least one engaging member of the dilation assembly cooperates with the corresponding engaging element of the expansion member to axially advance the expansion member through the dilation assembly upon a rotation of the expansion member; and

a polymeric layer encasing the sleeve body.

34. The access and delivery system according to claim 33, wherein the engaging members of the dilation assembly include at least one boss projecting radially inward from the handle portion.

35. The access and delivery system according to claim 34, wherein the engaging elements of the expansion assembly include at least one helical groove formed in an outer surface of the expansion member.

36. The access and delivery system according to claim 35, wherein at least one of the bosses includes a lumen extending from an exterior of the handle portion of the dilation assembly through to the aperture formed in the handle portion.

37. The access and delivery system according to claim 36, wherein the distal end of the lumen formed in the boss is oriented in a direction which is substantially co-linear with a pitch of a respective helical groove.

38. The access and delivery system according to claim 37, wherein the radially expandable dilation assembly further includes a valve stem operatively coupled to the handle portion and being in fluid communication with the lumen formed in the boss.

39. The access and delivery system according to claim 38, wherein the handle portion of the radially expandable dilation assembly includes a seal extending across the aperture and disposed at a location proximal to the valve stem, wherein the seal forms to a fluid-tight seal around the expansion member upon insertion of the expansion member into the handle portion of the dilation assembly.

40. A method of forming and enlarging a percutaneous penetration, the method comprising the steps of:

providing a radially expandable dilation assembly having a needle assembly removably inserted in a axial lumen thereof, the radially expandable dilation assembly having a radially expandable sleeve body defining a lumen and an introducer seal disposed across the lumen and defining an opening formed therein;

penetrating the radially expandable dilation assembly and needle assembly through tissue to a target surgical site;

withdrawing the needle assembly from the radially expandable dilation assembly; and

inserting an expansion assembly through the opening formed in the introducer seal and into the axial lumen of the radially expandable dilation assembly.

41. The method according to claim 40, wherein the radially expandable dilation assembly includes a handle assembly operatively coupled to a proximal end of the sleeve body, the handle assembly defines an aperture formed therein, and wherein the sleeve body is made up of a radially expandable tubular braid.

42. The method according to claim 41, wherein the sleeve body includes a polymeric layer encasing the tubular braid.

43. The method according to claim 42, wherein the dilation assembly includes a valve stem operatively coupled to the handle portion, the valve stem defining an injection lumen extending into the aperture formed in the handle portion.

44. The method according to claim 43, wherein the polymeric layer includes at least one radially oriented delivery hole formed therein.

45. The method according to claim 44, wherein the seal forms a fluid-tight seal around the expansion member upon insertion of the expansion member into the radially expandable dilation assembly.

46. The method according to claim 45, further including the step of injecting a fluid into the aperture of the handle portion after the expansion member is inserted into the dilation assembly, wherein the seal prevents the fluid from escaping from the proximal end of the dilation assembly and forces the fluid to flow distally through the dilation assembly.

47. The method according to claim 46, wherein the expansion member includes at least one radially projecting element provided on the outer surface thereof, wherein the at least one radially projecting element tents the sleeve body radially outward upon insertion of expansion member through the handle portion and into the sleeve body of the dilation assembly, wherein the radially projecting element defines at least one channel extending along the length of the expansion member when the expansion member is inserted in the dilation assembly, whereby the fluid flows along the at least one channel when the fluid is injected into the aperture of the handle portion.

48. The method according to claim 46, wherein the dilation assembly includes at least one engaging member integrally formed with the handle portion and projecting radially inward, and wherein the expansion member includes at least one corresponding engaging element formed in an outer surface thereof for co-operable engagement with a respective engaging member of the dilation assembly, wherein the at least one engaging member of the dilation assembly cooperates with the corresponding engaging element of the expansion member to axially advance the expansion member through the dilation assembly upon rotation of the expansion member.

49. The method according to claim 48, wherein the engaging elements of the expansion assembly include at least one helical groove formed in an outer surface of the expansion member.

50. The method according to claim 49, further including the steps of:

coupling the engaging member of the handle portion with the helical groove of the expansion member; and

rotating the expansion member relative to the dilation assembly in order to axially advance the expansion member through the dilation member.

51. The method according to claim 50, wherein the fluid is injected through at least one of the engaging members into the corresponding helical groove such that the fluid flows out the distal end of the sleeve body via the helical groove.