Tissue tract sealing device

• US 20030009194A1
• Filed: 05/13/2002
• Published: 01/09/2003
• Est. Priority Date: 12/07/2000
• Status: Abandoned Application

• Current Assignee: Mark B. Saker
• Original Assignee: Mark B. Saker
• Inventors: Saker, Mark B., Kauphusman, James V.
• Application Number:
  US10/145,179
• Publication Number:
  US 20030009194A1
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19

Abstract

A device and system for delivery of a flowable biocompatible material to a tissue tract in a controlled manner generally includes reservoirs adapted to be in fluid connection with a cannula, a discharging mechanism adapted to discharge the contents of the reservoirs and a cannula retractor to withdraw the cannula. The cannula retractor is operably interconnected with the discharging mechanism so that a measured quantity of the reservoirs contents is smoothly discharged to substantially fill at least a portion of the tissue tract.

Claims

1. A tissue tract sealing device for use with a medical cannula to seal a tissue tract made in a living tissue by the medical cannula with a flowable biocompatible material, the tissue tract sealing device comprising:

at least two reservoirs, at least one of the reservoirs for containing the flowable biocompatible material;

means for discharging the flowable biocompatible material from the reservoirs in a controlled manner through the cannula; and

means operably connected to the means for discharging for withdrawing the cannula from the tissue tract in a controlled manner such that operation of the means for withdrawing causes the means for discharging to discharge the flowable biocompatible material into the tissue tract thereby substantially filling at least a longitudinal portion of the tissue tract with the flowable biocompatible material.

2. The tissue tract sealing device of claim 1, wherein the means for discharging comprises a piston and a cylinder.

3. The tissue tract sealing device of claim 2, wherein the piston is fixed in position relative to the cannula as the cannula is withdrawn.

4. The tissue tract sealing device of claim 2, wherein the piston is variable in position relative to the cannula as the cannula is withdrawn.

5. The tissue tract sealing device of claim 2, wherein a path of travel of the pistons is substantially parallel to a path of withdrawal of the cannula.

6. The tissue tract sealing device of claim 2, wherein a path of travel of the piston is substantially perpendicular to a path of withdrawal of the cannula.

7. The tissue tract sealing device of claim 1, wherein the reservoirs comprise flexible reservoirs and the means for discharging includes means for compressing the flexible reservoirs.

8. The tissue tract sealing device of claim 7, wherein the means for compressing comprises at least one roller for compressing at least a portion of the flexible reservoirs.

9. The tissue tract sealing device of claim 7, wherein the means for compressing comprises at least one pin over which the flexible reservoirs are drawn as the cannula is withdrawn thereby reducing an internal volume of the reservoir so as to discharge the flowable biocompatible material.

10. The tissue tract sealing device of claim 1, further comprising:

means for priming the cannula with a sufficient quantity of the flowable biocompatible material delivered into the cannula prior to withdrawal of the cannula so as to substantially fill the cannula such that the flowable biocompatible material is discharged from the cannula into the tissue tract as soon as withdrawal of the cannula begins.

11. The tissue tract sealing device of claim 10, wherein the priming means comprises a compressible bladder.

12. The tissue tract sealing device of claim 10, wherein the priming means comprises a piston and cylinder.

13. The tissue tract sealing device of claim 10, wherein the priming means is adapted to deliver an adjustable metered quantity of the flowable biocompatible material to the cannula such that the tissue tract sealing device is adaptable for use with different size cannulas.

14. The tissue tract sealing device of claim 13, wherein a cam mechanism controls the adjustable metered quantity.

15. The tissue tract sealing device of claim 1, wherein the flowable biocompatible material is selected from a group consisting of:

a haemostatic material, a procoagulant, fibrin, fibrinogen, thrombin, collagen, a cancer chemotherapeutic agent, cyanoacrylate, cross-linking polymer, hydrogel, photo-initiated adhesives, autologous blood, or any combination thereof.

17. The method as claimed in claim 16, further comprising priming the cannula by discharging a measured amount of the flowable biocompatible material into the cannula.

18. The method as claimed in claim 17, further comprising varying the measured amount in accordance with a size of the cannula such that the means for discharging is operable with different size cannulas.

20. The tissue tract sealing device of claim 19, further comprising:

a primer that primes the cannula with a sufficient quantity of the flowable biocompatible material from each reservoir delivered into the cannula prior to withdrawal of the cannula so as to substantially fill the cannula such that the flowable biocompatible material is discharged from the cannula into the tissue tract as soon as withdrawal of the cannula begins.

21. The tissue tract sealing device of claim 20, wherein the primer comprises a compressible bladder.

22. The tissue tract sealing device of claim 20, wherein the primer comprises a piston and cylinder.

23. The tissue tract sealing device of claim 20, wherein the primer is adapted to deliver an adjustable metered quantity of the flowable biocompatible material to the cannula such that the tissue tract sealing device is adaptable for use with different size cannulas.

24. The tissue tract sealing device of claim 23, wherein a cam mechanism controls the adjustable metered quantity.

25. The tissue tract sealing device of claim 19, wherein the piston is fixed in position relative to the cannula as the cannula is withdrawn.

26. The tissue tract sealing device of claim 19, wherein the piston is variable in position relative to the cannula as the cannula is withdrawn.

27. The tissue tract sealing device of claim 19, wherein a path of travel of the piston is substantially parallel to a path of withdrawal of the cannula.

28. The tissue tract sealing device of claim 19, wherein a path of travel of the piston is substantially perpendicular to a path of withdrawal of the cannula.

29. The tissue tract sealing device of claim 19, wherein the flowable biocompatible material is selected from a group consisting of:

a haemostatic material, a procoagulant, fibrin, fibrinogen, thrombin, collagen, a cancer chemotherapeutic agent, cyanoacrylate, cross-linking polymer, hydrogel, photo-initiated adhesives, autologous blood, or any combination thereof.

16. A method of sealing a tissue tract left behind by the medical insertion and removal of a tube-like member, the method comprising:

filling at least one of at least two reservoirs with flowable biocompatible materials;

interconnecting the reservoirs with a cannula and with means for discharging the flowable biocompatible material from the reservoir in a controlled manner through the cannula;

withdrawing the cannula while at the same time the means for discharging discharges the flowable biocompatible material so as to substantially fill at least a portion of the tissue tract.

19. A tissue tract sealing device for use with a medical cannula to seal a tissue tract made in a living tissue by the medical cannula with a flowable biocompatible material, the tissue tract sealing device comprising:

at least two independent reservoirs for containing the flowable biocompatible materials;

at least one piston that discharges the flowable biocompatible material from each of a corresponding one of the two reservoirs in a controlled manner through the cannula; and

a withdrawal actuator operably connected to the piston that withdraws the cannula from the tissue tract in a controlled manner such that operation of the withdrawal actuator causes the at least one piston to discharge the flowable biocompatible material into the tissue tract thereby substantially filling at least a longitudinal portion of the tissue tract with the flowable biocompatible material.

30. A tissue tract sealing device for use with a medical cannula to seal a tissue tract made in a living tissue by the medical cannula with a flowable biocompatible material, the tissue tract sealing device comprising:

at least two flexible reservoirs that contains the flowable biocompatible material;

a compression mechanism operably connected to the flexible reservoirs that discharges the flowable biocompatible material from the reservoirs in a controlled manner through the cannula; and

a cannula retractor operably connected to the compression mechanism that withdraws the cannula from the tissue tract in a controlled manner such that operation of the cannula retractor causes the compression mechanism to compress the flexible reservoirs so as to discharge the flowable biocompatible material into the tissue tract thereby substantially filling at least a longitudinal portion of the tissue tract with the flowable biocompatible material.

31. The tissue tract sealing device of claim 30, wherein the compression mechanism is fixed in position relative to the cannula as the cannula is withdrawn.

32. The tissue tract sealing device of claim 30, wherein the compression mechanism is variable in position relative to the cannula as the cannula is withdrawn.

33. The tissue tract sealing device of claim 30, wherein a path of travel of the compression mechanism is substantially parallel to a path of withdrawal of the cannula.

34. The tissue tract sealing device of claim 30, wherein a path of travel of the compression mechanism is substantially perpendicular to a path of withdrawal of the cannula.

35. The tissue tract sealing device of claim 30, further comprising:

a control member that controls operation of the compression mechanism to compress the flexible reservoirs prior to operation of the cannula retractor so as to prime the cannula with a sufficient quantity of the flowable biocompatible material delivered into the cannula prior to withdrawal of the cannula so as to substantially fill the cannula such that the flowable biocompatible material is discharged from the cannula into the tissue tract as soon as withdrawal of the cannula begins.

36. The tissue tract sealing device of claim 35, wherein the control member is adapted to deliver an adjustable metered quantity of the flowable biocompatible material to the cannula such that the tissue tract sealing device is adaptable for use with different size cannulas.

37. The tissue tract sealing device of claim 36, wherein the control member is a cam mechanism that controls the adjustable metered quantity.

38. The tissue tract sealing device of claim 30, wherein the flowable biocompatible material is selected from a group consisting of:

a haemostatic material, a procoagulant, fibrin, fibrinogen, thrombin, collagen, a cancer chemotherapeutic agent, cyanoacrylate, cross-linking polymer, hydrogel, photo-initiated adhesives, autologous blood, or any combination thereof.

40. The kit of claim 39, wherein at least one reservoir is pre-filled with the flowable biocompatible material.

41. The kit of claim 39, wherein the reservoirs and the discharge mechanism are operably arranged as a first device and the tube-like mechanism is a separate second device.

42. The kit of claim 42, wherein both the first device and the second device are housed in a common sterile packaging.

43. The kit of claim 39, further comprising:

a separate container of the flowable biocompatible materials; and

means for loading the flowable biocompatible material from the separate container into the reservoirs prior to operation of the discharge mechanism.

44. The kit of claim 43, wherein the separate container and the means for loading are housed in a sterile packaging separate from the sterile packaging for the reservoir.

46. The tissue tract sealing device of claim 45, wherein the cannula retractor comprises a pair of opposed finger grip assemblies slidable within a pair of opposed longitudinal channels defined in the elongated housing.

47. The tissue tract sealing device of claim 46, wherein at least one of the finger grip assemblies further includes a priming member that operates to prime the cannula with a predetermined amount of the biocompatible flowable material without longitudinal movement of the finger grip assembly.

48. The tissue tract sealing device of claim 47, further comprising an adjustment mechanism operably connected to the priming member to selectively adjust the predetermined amount of the biocompatible flowable material used to prime the cannula when the priming member is operated.

49. The tissue tract sealing device of claim 47, wherein the priming member comprises a compression member.

50. The tissue tract sealing device of claim 45, further comprising a second coupling at a proximal end of the elongated housing that provides fluid connection to the reservoirs for loading the reservoir with the flowable biocompatible material.

39. A kit for sealing a tissue tract comprising:

a tube-like mechanism adapted for insertion into and withdrawal from living tissue;

at least two reservoirs adapted to hold a quantity of a flowable biocompatible material;

a discharge mechanism operably connectable between the tube-like mechanism and the reservoirs to discharge the flowable biocompatible material in a controlled manner into a tissue tract created by insertion of the tube-like mechanism in response to withdrawal of the tube-like mechanism so as to substantially fill at least a longitudinal portion of the tissue tract.

45. A tissue tract sealing device for use with a medical cannula to seal a tissue tract made in a living tissue by the medical cannula with a flowable biocompatible material, the tissue tract sealing device comprising:

an elongated housing having a coupling on a distal end adapted to fluidly couple the device to the medical cannula;

at least two reservoirs within the housing at least one of the two reservoirs containing at least a portion of the flowable biocompatible material;

at least one piston arrangement within the housing in fluid connection with the reservoirs that discharge the flowable biocompatible material from the reservoirs to the coupling; and

a cannula retractor operably engaged in at least one longitudinal channel defined along at least a portion of the elongated housing, the cannula retractor operably connected to the coupling and the piston arrangement such that sliding of the cannula retractor along the channel causes the cannula to withdraw from the tissue tract and causes the piston arrangement to discharge the flowable biocompatible material into the tissue tract.

51. A tissue tract sealing device for use with a medical cannula to seal a tissue tract made in a living tissue by the medical cannula with a flowable biocompatible material, the tissue tract sealing device comprising:

at least two reservoirs within the housing the at least two reservoirs each containing at least a portion of the flowable biocompatible materials;

an elongated housing having a coupling on a distal end adapted to fluidly couple the device to the medical cannula such that the at least two reservoirs both discharge into the medical cannula;

at least one piston arrangement within the housing in fluid connection with the reservoirs that discharge the flowable biocompatible material from the reservoirs to the coupling; and

a cannula retractor operably engaged in at least one longitudinal channel defined along at least a portion of the elongated housing, the cannula retractor operably connected to the coupling and the piston arrangement such that sliding of the cannula retractor along the channel causes the cannula to withdraw from the tissue tract and causes the piston arrangement to discharge the flowable biocompatible material into the tissue tract.

52. The tissue tract sealing device of claim 51, wherein the cannula retractor comprises a pair of opposed finger grip assemblies slidable within a pair of opposed longitudinal channels defined in the elongated housing.

53. The tissue tract sealing device of claim 51, wherein at least one of the finger grip assemblies further includes a priming member that operates to prime the cannula with a predetermined amount of the biocompatible flowable material without longitudinal movement of the finger grip assembly.

54. The tissue tract sealing device of claim 52, further comprising an adjustment mechanism operably connected to the priming member to selectively adjust the predetermined amount of the biocompatible flowable material used to prime the cannula when the priming member is operated.

55. The tissue tract sealing device of claim 52, wherein the priming member comprises a compression member.

56. The tissue tract sealing device of claim 51, further comprising a second coupling at a proximal end of the elongated housing that provides fluid connection to the reservoir for loading the reservoir with the flowable biocompatible material.

57. The tissue tract sealing device of claim 51, in which the at least two reservoirs are dischargeable simultaneously.

58. The tissue tract sealing device of claim 51, in which the at least two reservoirs are dischargeable sequentially.

59. The tissue tract sealing device of claim 51, further comprising a mixing device adapted to mix the flowable biocompatible materials.