Internal compression tourniquet catheter system and method for wound track navigation and hemorrhage control

• US 20050143689A1
• Filed: 08/11/2004
• Published: 06/30/2005
• Est. Priority Date: 08/17/2003
• Status: Abandoned Application

• Current Assignee: CardioCommand, Inc.
• Original Assignee: CardioCommand, Inc.
• Inventors: Ramsey, Maynard III
• Application Number:
  US10/917,019
• Publication Number:
  US 20050143689A1
• Time in Patent Office: Days
• US Class Current: 604/103.130
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An internal compression tourniquet catheter system and method for controlling hemorrhage from wounds, particularly penetrating wounds. Its construction includes an inflatable member constructed of very thin, flexible, biocompatible, and nonelastic and puncture resistant material such that when deflated it lies flat and can be wrapped around the catheter shaft, which passes within and has a lumen to inflate it, to minimize overall diameter when deflated for insertion into the tissue track created by the wounding agent. The inflatable member is of large potential volume enabling full inflation with near zero internal pressure when unconstrained externally. When positioned within a wound track and inflated, the gas or liquid injected into the balloon lumen creates pressure because its expansion is constrained by the tissues of the wound, and that pressure is transmitted directly to the surrounding tissue of the wound track. The pressure exerted on the tissue can be precisely measured and controlled, automatically if appropriate, such that sufficient pressure is applied to tamponade bleeding, but not damage tissue. Since the balloon is of large potential volume, it can easily expand to fill and compress small, large, and irregular wound tracks and can successfully tamponade wounds that smaller, elastic balloon catheters would be unable to tamponade. The catheter system includes means to assist insertion into the wound track, including a rounded or bulbous exploring tip and an internal stylet with an external orientable handle. The distal end of the catheter-stylet assembly can be bent slightly to allow following a curved or irregular wound track, such wound track navigation further assisted by twisting the stylet handle to orient the bent catheter tip within the wound track.

Claims

1. A tamponade catheter which comprises a catheter shaft, a nonelastic inflatable means of greater than 60 ml of potential volume and which is attached to said catheter shaft by suitable attachment means, and where said inflatable means expands when inflated with a gas or liquid when placed within a tissue space to create pressure within the tissue for the purpose of controlling bleeding there from.

2. A tamponade catheter as in claim 1 in which said inflatable means is a balloon of large potential volume, being at least 65 ml of potential volume if unconstrained, constructed of nonelastic material and requiring essentially no pressure to be inflated to its full volume if unconstrained and hence permitting the accurate measurement of the pressure applied to the constraining tissue, after being inserted into the tissue space of the wound, by measuring the pressure within the balloon after its inflation to the desired pressure.

3. A tamponade catheter as in claim 1 in which said inflatable means is made of a very thin, biocompatible material, to form a single walled balloon of the desired size and shape.

4. A tamponade catheter as in claim 1 in which said inflatable means, the balloon, is made of a single layer of thin, puncture resistant biocompatible material, to form a balloon of the desired size and shape.

5. A tamponade catheter as in claim 1 in which said inflatable means, the balloon, is made of at least two layers of thin puncture resistant biocompatible material, the multi-layered balloon walls being present to enhance the puncture and cut resistance of the balloon to prevent loss of pressure when inflated once inside a tissue track, such tissue tracks caused by trauma often containing sharp objects which can puncture single layer tamponade balloons.

6. A tamponade catheter as in claim 1 in which said inflatable means is produced by heat welding thin flat sheets of flexible plastic material into the desired size and shape balloon, said heat being created by at least one of a source of thermal energy comprising direct caloric input as from a resistance heater or from the thermal energy created by radio frequency energy being directed through the balloon material at the edges of the desired size and shape of the balloon.

7. A tamponade catheter as in claim 1 which further comprises at least one inner lumen and a bendable and flexible stiffening stylet which is positioned in one of said lumens to aid insertion of the catheter into the wound track.

8. A tamponade catheter as in claim 1 which further comprises an exploring tip means on its distal tip to aid insertion into a tissue space.

9. A tamponade catheter as in claim 8 in which said exploring tip on its distal tip is removably affixed to and covers a smaller exploring tip by suitable means, said smaller exploring tip so designed to aid navigation of smaller tissue spaces than those suitable for navigation using the larger outer exploring tip.

10. A tamponade catheter as in claim 9 in which said removable affixment means is an inner thread on cavity of the outer exploring tip and a mating thread on the outside of the smaller exploring tip which is covered by the outer exploring tip when the two are screwed together using said mating threads.

11. A tamponade catheter as in claim 9 in which said removable outer exploring tip is frangible and hence separable from the smaller inner exploring tip by rapid inward pressure on the stylet and catheter by the user when said outer exploring tip is blocked by solid tissue from further movement into the tissue space.

12. A tamponade catheter as in claim 9 in which said smaller exploring tip is shaped with a round pointed tip such that it is capable of piercing muscle tissue with firm inward pressure on the stylet without injury to major arteries in its path.

13. A tamponade catheter as in claim 9 in which said smaller exploring tip shaped with a round pointed tip, where said rounded pointed tip has approximately like the ogive of a standard .22 caliber round nose bullet.

14. A tamponade catheter as in claim 1 in which said inflatable means is a balloon constructed of at least one layer of a thin, plastic coated, tightly woven fabric material.

15. A tamponade catheter as in claim 7 in which said stylet is also bendable, and has an external handle at its proximal end, such that when said stylet is bent, said stylet bend provides a similar bend in the catheter as an aid to wound track navigation.

16. A tamponade catheter as in claim 15 in which said stylet is longer than the catheter by at least {fraction (1/2)} inch, said stylet also having a bulbous and rounded exploring tip on its distal end, and where said stylet, with its attached exploring tip, is extensible through the distal end of said catheter into the tissue space by external manipulation of the stylet handle, where said stylet handle has at least one of a tactile or a visual means of determining its rotational position.

17. A tamponade catheter as in claim 16 in which said stylet handle has at least one of a tactile means or a visual means of determining its rotational position and hence the rotation position of the tip of the catheter within the tissue space.

18. A tamponade catheter as in claim 15 in which said stylet is the same length of the catheter, and where said catheter has a bulbous or rounded exploring tip on its distal end and said stylet a handle on its proximal end, and where said stylet when bent near its distal tip will cause said catheter to assume a similar bend and hence result in a catheter tip orbiting motion if said stylet handle is rotated by the user, said rotation being accomplished either manually or automatically using an automatic rotator means attached to said stylet'"'"'s external handle.

19. A tamponade catheter as in claim 18 in which said stylet handle has at least one of a tactile means or a visual means of determining its rotational position and hence the rotation position of the tip of the catheter within the tissue space.

20. A tamponade catheter as in claim 1 in which said inflatable means, the balloon, is protected during catheter insertion by a snuggly fitting sheath of thin material which is removable once the catheter is within the tissue space to permit subsequent inflation of the balloon within said tissue space.

21. A tamponade catheter as in claim 20 in which said sheath is partially removable to permit the inflation of only the distal end of the balloon for the purpose of dilation of the tissue space as an aid to deeper catheter insertion within the tissue space.

22. A tamponade catheter as in claim 20 in which the distal end of said sheath is separably connected to the exploring tip of the catheter, said separable connection preventing tissue from becoming entrapped between the sheath and the exploring tip of the catheter during the insertion process.

23. A tamponade catheter as in claim 22 in which there is an additional outer cylindrically shaped sheath which covers said balloon protective sheath, hence called the inner sheath, and where said outer sheath mates with said catheter exploring tip to provide a smooth junction between said exploring tip and said outer sheath, said outer sheath providing additional stiffness and maneuverability for said catheter as an aid to facilitate tissue track navigation during the insertion process.

24. A tamponade catheter as in claim 23 in which said outer sheath maintains the inner catheter and stylet assembly, which have a preformed distal bend, in a straight configuration while said distal portion of the catheter assembly is within said outer sheath such that when said distal portion of the inner catheter assembly is extended beyond the distal end of said outer sheath, said inner assembly assumes the configuration of the preformed curve as an aid to tissue space navigation.

25. A tamponade catheter as in claim 23 in which said cylindrical outer sheath, once it is no longer needed as a part of the insertion process, is removable by withdrawal over the inner sheath, the catheter shaft, and the stylet handle.

26. A tamponade catheter as in claim 25 in which removal of said cylindrical outer sheath is aided by a stylet extension means attached to the stylet handle by suitable means, the stylet extension helping to prevent inadvertent withdrawal of the entire catheter assembly during the removal of said outer sheath.

27. A tamponade catheter as in claim 1 where at least one of said catheter or said inflatable member is coated with a clot promoting substance to enhance the hemostatic action of the tamponade catheter system.

28. A tamponade catheter as in claim 1 where said catheter has at least one lumen suitable for the introduction of a clot promoting substance such that said clot promoting substance will be deposited at the tip of said catheter to effect hemostasis deep within the wound.

29. A tamponade catheter as in claim 1 where said catheter has at least one lumen suitable for the introduction of a clot promoting substance such that said clot promoting substance will be deposited at the tip of said catheter to effect hemostasis deep within the wound and said lumen has additionally multiple openings along a segment of its length that will permit the dispersal of said clot promoting substance along a length of said catheter and hence dispersed along a length of said wound.

30. A tamponade catheter as in claim 1 where said inflatable member of said catheter has at least one hole in it to allow leakage of the inflating substance, which contains the clot promoting means, out of said balloon and into the wound track for assisting hemostasis.

31. A tamponade catheter as in claim 1 where said inflatable member of said catheter has a multiplicity of holes in it to allow leakage of the inflating substance which contains clot promoting means out of said balloon and into the wound track for assisting hemostasis.

32. A tamponade catheter as in claim 30 where said holes in said inflatable member of said catheter will not open to release the inflating medium, which contains clot promoting means, unless the pressure in said balloon is greater than a specified amount.

33. A tamponade catheter as in claim 31 where said hole in said inflatable member of said catheter will not open to release the inflating medium which contains clot promoting means unless the pressure in said balloon is greater than a specified amount.

35. In a tamponade catheter system as in claim 15, an automatic rotator means which is capable of clockwise or counter clockwise rotation of said stylet.

36. As in claim 35, an automatic rotator means where said rotator means is electrically powered and capable of clockwise or counter clockwise rotation of a bent catheter stylet to effect a rapid rotation of the tip of said catheter stylet which hence causes the tip of said catheter to orbit within the wound.

37. In a tamponade catheter system as in claim 1, where said nonelastic inflatable means is constructed of a very thin plastic film by at least one of heat sealing and radio frequency welding.

38. In a tamponade catheter system as in claim 1, where said nonelastic inflatable means is constructed of a very thin plastic film by at least one of heat sealing and radio frequency welding and said catheter has an inflation lumen for the balloon and a drainage lumen for draining body fluids from tissue space in which the catheter is placed.

39. In a tamponade catheter system as in claim 1, where said nonelastic inflatable means is constructed of a very thin plastic film and constructed and attached to said catheter shaft by at least one of heat sealing and radio frequency welding, where said balloon size and shape is suitable for packing a body cavity to apply pressure for the purposes of stopping or preventing bleeding.

40. In a tamponade catheter system as in claim 1, a means for the automatic inflation of said inflatable means to a desired pressure level, and for the subsequent automatic maintenance of said desired pressure level and such that substantial deviation from the desired level will result in at least one of an visual and an audible alarm to alert the user of the error condition.

Method claims

41. A method of stanching hemorrhage consisting of inserting a catheter with an attached non-elastic expansile element into a tissue space produced by ballistic injury, expanding said expansile element within said tissue space to effect hemostasis.

42. A method of stanching hemorrhage as in claim 41 were said expansile element is a nonelastic balloon which is inflated to a known pressure in order to apply that same known pressure to adjacent tissue.

43. A method of stanching hemorrhage as in claim 42 where said balloon pressure is between 30 and 300 mmHg.

44. A method of stanching hemorrhage as in claim 42 where said balloon pressure is greater than the measured systolic blood pressure of the subject.

45. A method of stanching hemorrhage as in claim 42 where said balloon pressure is greater than the measured diastolic blood pressure of the subject.

46. A method of stanching hemorrhage as in claim 42 where said balloon pressure is created and maintained by connection to a vessel of liquid held at sufficient height above the balloon to create the desired hydrostatic pressure.

47. A method of stanching hemorrhage as in claim 42 where said balloon pressure is created and measured by a manually operated squeeze bulb with integral pressure gauge.

48. A method of stanching hemorrhage as in claim 42 where said balloon pressure is created and maintained at the desired pressure by an automatic pressure maintaining means.

49. A method of stanching hemorrhage as in claim 42 where said balloon pressure is created and maintained at the desired pressure, said desired pressure being determined as a fraction of at least one of the systolic, diastolic and mean arterial blood pressures as determined using the oscillometric method of blood pressure determination where said oscillometric method is implemented by using the inflated balloon as a tissue compressive element after it has been inserted into the tissue space.

50. A method of stanching hemorrhage as in claim 42 where said catheter is inserted through the skin entry wound.

51. A method of stanching hemorrhage as in claim 42 where said catheter is inserted through the skin exit wound.

52. A method of stanching hemorrhage as in claim 42 where more than one of said catheters are inserted through at least one of the skin entry and exit wounds.

53. A method of stanching hemorrhage as in claim 42 where said catheter is inserted through the skin wound in the known direction of the track created by the wounding agent, said wound track direction being first obtained by insertion of at least one finger through the skin hole and into the wound track to determine the path of said wound track.

54. A method of stanching hemorrhage as in claim 53 where said skin wound is enlarged by creating a larger skin entry hole by creating at least one radially directed small cut at the skin wounds periphery, thus enlarging said skin wound to better admit the exploring finger and the exploring tip of said catheter.

55. A method of stanching hemorrhage as in claim 42 where said catheter is inserted into the tissue space using an introducer means to facilitate catheter placement deep within the tissue space.

56. A method of stanching hemorrhage as in claim 55 where said introducer means comprises a stylet which can be bent at its tip to cause a bend in the tip of said catheter, said bend being used to find and follow a curved wound track.

57. A method of stanching hemorrhage as in claim 46 where said bent stylet can be rotated manually using the stylet handle, in either clockwise or counter clockwise direction, to cause the bent stylet and catheter tip to orbit within the wound track as an aid to finding and following the wound track to its terminus.

58. A method of stanching hemorrhage as in claim 46 where said stylet can be rotated automatically in either clockwise or counter clockwise direction using an automatic rotation means.

59. A method of stanching hemorrhage as in claim 42 where said catheter is introduced using an outer sheath to manipulate the exploring tip and direct it into the wound track.

60. A method of stanching hemorrhage as in claim 59 where said catheter is additionally extended from the distal end of said outer sheath which thus results in the previously straight catheter assembly becoming curved such that the bent tip can be orbited within the wound track using said stylet handle to impart said tip orbiting, said tip orbiting being useful in finding and following the wound track.

61. A method of stanching hemorrhage as in claim 60 where said rotation of said stylet to cause said distal tip orbiting is produced using an automatic rotation means.

62. A method of stanching hemorrhage as in claim 50 where said catheter is introduced by partial balloon sheath retraction which exposes a portion of the distal balloon, such uncovered portion of the distal balloon then becomes a wound track dilating balloon, said dilating balloon is then inflated to cause wound track dilatation to permit the extension of the extensible stylet with its rounded bulbous tip, such that once said bulbous tip is extended further into the wound track, the catheter can then be further inserted into the wound track by inward force on the exterior portion of the catheter shaft resulting in the catheter assembly following the previously extended stylet into the wound, said process being repeated as many times as necessary to insert the catheter to the terminus of the wound track.

63. A method of stanching hemorrhage as in claim 62 where said dilating balloon is deflated prior to further insertion of the catheter over the previously advanced stylet, and inflated again prior to advancement of the stylet further into the dilated wound track.

64. A method of stanching hemorrhage as in claim 42 further comprising the insertion process of enlarging the skin wound if needed with at least one small cut, inserting at least one finger to tactilely determine the direction of the wound path, inserting the catheter into the wound directed in the previously determined wound track direction, directing the tip of the catheter, using the sheath and stylet as stiffening means, into the wound as far as it will go, and if not at the terminus, finding the remaining wound track by using at least one of the pilot balloon wound track dilation method and the catheter extension with tip orbiting method, to find and follow the wound track to its terminus, where upon all sheaths are removed and the balloon is inflated to the desired pressure and sealed using sealing means to prevent inadvertent balloon deflation.

65. A method as in claim 42 of introducing a tamponade catheter for the purpose of stanching hemorrhage further comprising the intentional creation of a new tissue path if it is impossible to fully navigate the true wound track to its terminus, said new tissue path being created such that it generally follows the direction of the true wound track.

66. A method of stanching hemorrhage as in claim 65 in which the outer exploring tip is frangibly removed, while the catheter assembly is within the wound track, by firm inward pressure of the stylet or catheter against the tissue, thus exposing the smaller inner exploring tip, said smaller tip having an ogive such that it can penetrate muscle and other soft tissues, when pushed forward with moderate force, but without piercing large arteries, said arteries being deflected by the rounded ogive of the smaller exploring tip.