Instrument, system, kit and method for catheterization procedures

• US 5,695,479 A
• Filed: 11/01/1993
• Issued: 12/09/1997
• Est. Priority Date: 11/01/1993
• Status: Expired due to Fees

• Current Assignee: Ravindar Jagpal
• Original Assignee: Ravindar Jagpal
• Inventors: Jagpal, Ravindar
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/146,495
• Time in Patent Office: 1,499 Days
• Field of Search: 604/164, 604/162, 604/171, 604/104, 604/264, 604/280, 604/272, 604/27, 604/53, 604/281-284
• US Class Current: 604/264
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

Abstract

A system and method of catheterization, includes a needle, a "Y" chamber, a syringe or other chamber, a dilator, a sheath, a protective sleeve and a shock sheath. This introduces a comprehensive, uniform and universal approach to catheterization. Discriminatory methods of treatment using the invention are described. Particular attention has been paid to current problems in catheterization and the prevention of transmission of communicable diseases from patient to practitioner and vice-versa (e.g., the risk of contracting the HIV virus is substantially reduced using this system and method.) The discriminatory treatment of diseases, in particular, cancer, is now rapid, safe and in some instances, novel| The invention makes possible substantial reductions in the cost of health-care while improving the efficiency of diagnosis and treatment. The invention allows the practitioner to perform simultaneous diagnosis and treatment of diseases using the same procedure, regardless of their location in or on the body. The number and duration of hospitalizations is minimized, and the quality of life and length of survival for the patient are improved.

Claims

1. An instrument for inserting or removing substances or devices into or from a target tissue or material comprising:

(a) a needle having an elongated shaft with at least one lumen, including a distal portion for insertion into said target tissue or material to a depth and a proximal portion which remains outside said target tissue or material into which said distal portion is inserted;

(b) a position-sensitive feature formed at a predetermined location not solely dependent on the depth of insertion of said needle on the distal portion of said needle; and

(c) distinctive mark associated with said proximal portion of said needle at a fixed position relative to said location of said position-sensitive feature, which indicia is observable outside of said tissue or material into which said distal portion of said needle is to be inserted and by which indicia said predetermined location of said position-sensitive feature formed at said distal portion of said needle is indicated.

2. The instrument of claim 1 wherein:

(a) said position-sensitive feature formed on said distal portion of said needle is a beveled needle end; and

(b) said distinctive mark is associated with said proximal portion of said needle in a fixed relationship to said angled direction of said bevel by which said direction of said bevel end may be observed from outside of said target tissue or material.

3. An instrument as in claim 1 further comprising:

(a) a first and a second lumen extending longitudinally inside of said elongated hollow needle shaft;

(b) wherein a relative position of said first lumen with respect to said second lumen is said position-sensitive feature of the distal portion of said needle; and

(c) said distinctive mark is associated with said proximal portion of said needle in a fixed position with respect to said relative position of said first and second lumens, and said distinctive mark may be observed from outside of the tissue or material into which the instrument is inserted so that said relative position of said first and second lumens is indicated.

4. The instrument of claim 1 wherein:

(a) said position-sensitive feature comprises a bent portion of said distal portion of said elongated needle; and

(b) said distinctive mark is associated with said proximal portion of said needle in a fixed position relative to a direction of said bent distal portion, which indicia is observable from outside of said tissue or material into which said needle is inserted so that said bent direction is indicated.

5. A "Y" chamber and needle assembly for insertion or withdrawal of substances, devices, tissue, or material, comprising a:

(a) a needle having first and second longitudinal lumens and a connection hub, said longitudinal needle lumens in communication with said substances, devices, tissue or material; and

(b) a "Y" chamber detachably connected to said needle thereto, said "Y" chamber including a first lumen of said needle having an opening in communication with said first lumen of said needle, and said "Y" chamber further including at least one side arm connected to said first lumen of said "Y" chamber, each said at least one side arm having a second lumen of said "Y" chamber with a separate entry opening and said second lumen of said "Y" chamber in communication with said second lumen of said needle detachably connected to said connection hub for communication with said needle.

6. The "Y" chamber and needle assembly of claim 5 wherein said "Y" chamber includes a plurality of lumens, and said needle includes a corresponding plurality of lumens, said needle attachable to said "Y" chamber so that said corresponding lumens in said "Y" chamber and in said needle are aligned.

7. The "Y" chamber and needle assembly as in claim 5 further comprising at least one self-sealing device interposed in at least one of said lumens of said "Y" chamber and needle assembly for restricting movement of substances therethrough.

8. The "Y" chamber of claim 7 wherein said self-sealing device comprises a one-way valve restricting movement of substances in at least one longitudinal direction.

9. A "Y" chamber as in claim 7 wherein said self-sealing device comprises a self-sealing grommet formed of a resilient material such that a device may be inserted therethrough and such that said grommet automatically closes upon removal of said device.

10. An instrument for facilitating catheterization comprising:

(a) a needle having a substantially uniform diameter for puncturing a tissue or material to be catheterized;

(b) a dilator having an exterior diameter increasing from a distal portion to a proximal portion and circumferentially disposed around said needle for expanding said punctured tissue or material so that catheterization is facilitated;

(c) a distal portion and a proximal portion of said needle and at least one lumen extending through said needle between said distal and proximal portions; and

(d) at least one "Y" chamber attached to said proximal portion of said needle in fluid communication with one of said at least one lumen and for insertion or removal of substances or devices therethrough.

13. An instrument for facilitating catheterization as in claim 10 or 11 further comprising:

(a) a catheter or catheterization device operatively associated with said needle and said dilator having a diameter sized and adapted for insertion into said target tissue or material expanded by said dilator when said dilator is removed from target tissue; and

(b) a protective sleeve at least partially encompassing said catheter or catheterization device.

15. A device as in claim 10 or 11 further comprising an at least reversibly aspiratable chamber connected to said needle to allow detection of tissue or material or insertion of substances.

11. A instrument for facilitating catheterization comprising:

(a) a needle having a smoothly tapered surface with a distal portion smaller than a proximal portion; and

(b) a dilator having an exterior diameter increasing from a distal portion to a proximal portion circumferentially disposed around said needle for expanding said punctured tissue or material so that catheterization is facilitated.

12. An instrument for facilitating catheterization as in claim 11 further comprising:

(a) a distal portion and a proximal portion of said needle and at least one lumen extending through said needle between said distal and proximal portions; and

(b) at least one "Y" chamber attached to said proximal portion of said needle in fluid communication with one of said at least one lumen and for insertion or removal of substances or devices therethrough.

14. An instrument for facilitating catheterization as in claim 11 further comprising:

(a) a catheter or catheterization device sized for insertion into tissue or material expanded by said dilator; and

(b) a protective sleeve at least partially encompassing said catheter or catheterization device exterior to said tissue or material.

22. A kit for use in a catheterization procedure as in claim 12 or 21 further comprising:

(a) a catheter or catheterization device having a diameter sized and adapted for insertion into said punctured and expanded tissue or material which is the target of catheterization when said dilator is removed from said punctured and expanded tissue or material; and

(b) a protective sleeve at least partially encompassing said catheter or catheterization device without containing said tissue or material which is the target of catheterization.

40. A device as in claim 11 or 15 wherein:

(a) said needle further comprises a position-sensitive feature on a distal portion thereof not solely dependent on the depth of insertion of said needle; and

(b) distinctive mark associated with a proximal portion of said needle in a fixed spatial relationship with respect to said position-sensitive feature such that said distinctive mark can be observed when the needle is inserted into said target tissue or material so that the position of said position-sensitive feature is indicated.

43. An instrument for facilitating catheterization as in claims 11 or 16 wherein a self-sealing device is interposed with an elongated lumen in said needle for restricting movement of substances in at least one longitudinal direction through said lumen of said needle.

16. An instrument for catheterization comprising:

(a) a needle for puncturing a target tissue or material to be catheterized;

(b) a "Y" chamber attached to said needle for insertion or removal of substances or devices to or from said target tissue or material to be catheterized and through said needle and said "Y" chamber;

(c) a catheter or catheterization device operatively associated with said instrument for catheterization adapted to be at least partially insertable into said target tissue or material after it is punctured by said needle; and

(d) a protective sleeve, at least partially encompassing said catheter or catheterization device without contacting said target tissue.

17. The catheterization instrument of claim 16 further comprising a guide-wire for insertion through said "Y" chamber and said needle into said target tissue or material for facilitating insertion of said catheter or catheterization device into said target tissue or material.

18. The instrument as in claim 16 further comprising a reversibly aspiratable chamber in fluid communication with said needle to allow detection of tissue or material or insertion of substances.

19. A kit for use in a catheterization procedure comprising:

(a) a needle with a substantially uniform diameter for puncturing a tissue or material which is the target of catheterization;

(b) a dilator having an exterior diameter increasingly sized and adapted for engagement over said needle circumferentially disposed around said needle for expanding said punctured tissue or material which is the target of catheterization; and

(c) at least one "Y" chamber constructed to be attachable to a proximal portion of said needle for insertion or removal of substances or devices therethrough.

20. A kit for use in a catheterization procedure comprising:

(a) a needle with a tapered shaft having a distal end smaller than a proximal end for puncturing a tissue or material which is the target of catheterization; and

(b) a dilator having an exterior diameter increasingly sized for engagement over said needle circumferentially disposed around said needle for expanding said punctured tissue or material which is the target of catheterization.

21. A kit for use in a catheterization procedure as in claim 20 further comprising at least one "Y" chamber attachable to a proximal portion of said needle for insertion or removal of substances or devices therethrough.

23. A kit for use in a catheterization procedure as in claim 20 further comprising:

(a) a catheter or catheterization device sized and adapted for insertion into said punctured tissue or material expanded by said dilator when said dilator is removed from said punctured and expanded tissue or material; and

(b) a protective sleeve at least partially encompassing said catheter or catheterization device along a portion thereof which is exterior to said tissue or material which is the target of catheterization.

24. A kit for use in a catheterization procedure as in claim 20 further comprising a guide-wire insertable through said needle into said tissue or material and by which insertion of a device used for catheterization into said tissue or material is facilitated.

25. A kit as in claim 20 further comprising a reversibly aspiratable chamber in fluid communication with said needle to allow detection of tissue or material or insertion of substances.

41. A kit as in claim 20 or 26 wherein:

(a) said needle further includes a position-sensitive feature at a distal portion thereof not solely dependent on the depth of insertion of said needle; and

(b) further comprising a distinctive mark associated with a proximal portion of said needle in a fixed relative position with respect to said position-sensitive feature so that observation of said distinctive mark outside of said target tissue or material indicates the position of said position-sensitive feature.

44. A kit for use in a catheterization procedure as in claims 20 or 26 wherein:

(a) said needle further comprises at least one lumen extending longitudinally therethrough; and

(b) further comprising a self-sealing device interposable within said elongated lumen for restricting movement of substances in at least one longitudinal direction through said lumen of said needle.

26. A kit for catheterization of a target tissue or material comprising:

(a) a needle for insertion into a tissue or material which is the target of catheterization;

(b) a "Y" chamber attached to said needle for insertion or removal of substances or devices from said tissue or material which is the target of the catheterization through said needle and said "Y" chamber;

(c) a catheter or catheterization device at least partially insertable into said target tissue or material into which said needle has been inserted; and

(d) a protective sleeve at least partially encompassing said catheter or catheterization device.

27. A kit for catheterization as in claim 26 further comprising a guide-wire for insertion through said "Y" chamber and said needle into said target tissue or material for facilitating insertion of said catheter or catheterization device into said target tissue or material.

28. A kit as in claim 26 further comprising a reversibly aspiratable chamber in fluid communication with said needle to allow detection of tissue or material or insertion of substances.

29. A kit for catheterization of a target tissue or material comprising:

(a) a hollow tubing for use in inserting or withdrawing substances or devices from the target tissue or material to be catheterized;

(b) a "Y" chamber attachable to said hollow tubing through which substances or devices may be inserted or tissue or material withdrawn through said hollow tubing which is in communication with said target tissue or material;

(c) a catheter or catheterization device operatively associated with said hollow tubing for communicating with said target tissue; and

(d) a protective sleeve for at least partially encompassing said catheter or catheterization device at a point thereon which is exterior to said tissue or material which is the target of catheterization.

30. A kit for use in catheterization as in claim 29 further comprising a guide-wire insertable through said "Y" chamber and insertable through said hollow tubing and into said target tissue or material to facilitate catheterization.

31. A kit as in claim 29 further comprising a reversibly aspiratable chamber attachable in fluid communication with said hollow tubing to allow detection of tissue or material or insertion of substances.

42. A kit as in claim 29 wherein:

(a) said hollow tubing further comprises a position-sensitive feature at a distal portion thereof not solely dependent on the depth of insertion of said hollow tubing; and

(b) further comprising a distinctive mark associated with a proximal portion of said hollow tubing in a fixed relative position with respect to said position-sensitive feature so that observation of said distinctive mark outside of said target tissue or material indicates the position of said position-sensitive feature.

46. A kit for catheterization as in claim 29 further comprising a self-sealing device interposed within said hollow tubing for restricting movement of substances in at least one longitudinal direction therethrough.

32. A method for catheterization of a tissue or material which is the target of catheterization comprising the steps of:

(a) circumferentially disposing a dilator around a needle;

(b) inserting said needle into said target tissue or material;

(c) sliding said dilator along said needle into said tissue or material to be catheterized for expanding said tissue or material so that catheterization is facilitated; and

(d) using a "Y" chamber for insertion of substances or devices or removal of tissue or material through said needle.

33. A method as in claim 32 further comprising the steps of:

(a) inserting a catheter or catheterization device into the target tissue or material to be catheterized; and

(b) at least partially encompassing said catheter or catheterization device with a protective sleeve exterior to said tissue or material.

34. A method as in claim 32 further comprising the step of inserting a guide-wire through said needle and dilator and into said tissue or material which is the target of catheterization thereby facilitating insertion of said catheter or catheterization device.

35. A method as in claim 32 further comprising a step of reversibly aspirating fluid in communication with said needle into a reversibly aspiratable chamber to allow detection of tissue or material or for insertion of substances.

36. A method for catheterization of a target tissue or material comprising the steps of:

(a) puncturing said target tissue or material for catheterization with a hollow needle;

(b) inserting a catheter or catheterization device through a "Y" chamber which is attached to said hollow needle and thence into said punctured tissue or material which is the target of catheterization; and

(c) partially encompassing said catheter or catheterization device with a protective sleeve exterior to said tissue or material which is the target of catheterization.

37. A method as in claim 36 further comprising the steps of:

(a) circumferentially disposing a dilator around said hollow needle; and

(b) sliding said circumferentially disposed dilator along said hollow needle and thereby expanding said punctured target tissue or material.

38. A method as in claim 36 further comprising a reversibly aspiratable chamber in fluid communication with said needle to allow detection of tissue or material or insertion of substances.

39. A method of catheterization comprising the steps of:

(a) inserting a guide-wire through a "Y" chamber and then into said target tissue or material;

(b) inserting a catheter or other catheterization device along said guide-wire into said target tissue or material; and

(c) at least partially encompassing said catheter or catheterization device with a protective sleeve.

45. A device for catheterization of a target tissue or material comprising a dilator including at least one side-port for infusion or withdrawal of substances or devices into or from said target tissue or material through said dilator and said side-port, further comprising a self-sealing device interposed within an elongated lumen formed in said dilator, said self-sealing device for restricting movement of substances in at least one longitudinal direction therethrough.

47. An instrument for facilitating catheterization comprising:

(a) a needle having a substantially uniform diameter for puncturing a tissue or material to be catheterized;

(b) a dilator having an exterior diameter increasing from a distal portion to a proximal portion and circumferentially disposed around said needle for expanding said punctured tissue or material so that catheterization is facilitated;

(c) a catheter or catheterization device operatively associated with said instrument and sized and adapted for insertion into tissue or material expanded by said dilator after said dilator is removed; and

(d) a protective sleeve at least partially encompassing said catheter or catheterization device exterior to said tissue or material.

48. An instrument for facilitating catheterization comprising:

(a) a needle having a substantially uniform diameter for puncturing a tissue or material to be catheterized;

(b) a dilator having an exterior diameter increasing from a distal portion to a proximal portion and circumferentially disposed around said needle for expanding said punctured tissue or material so that catheterization is facilitated; and

(c) an at least reversibly aspiratable chamber connected to said needle to allow detection of tissue or material or insertion of substances.

49. A kit for use in a catheterization procedure comprising:

(a) a needle with a substantially uniform diameter for puncturing a tissue or material which is the target of catheterization;

(b) a dilator having an exterior diameter increasingly sized and adapted for engagement over said needle and circumferentially disposed around said needle for expanding said punctured tissue or material which is the target of catheterization;

(c) a catheter or catheterization device sized and adapted for insertion into said punctured tissue or material expanded by said dilator when said dilator is removed from said tissue; and

(d) a protective sleeve at least partially encompassing said catheter or catheterization device along a portion thereof which is exterior to said tissue or material which is the target of catheterization.

50. A kit for use in a catheterization procedure comprising:

(a) a needle with a substantially uniform diameter for puncturing a tissue or material which is the target of catheterization;

(b) a dilator having an exterior diameter increasingly sized and adapted for engagement over said needle circumferentially disposed around said needle for expanding said punctured tissue or material which is the target of catheterization; and

(c) a guide wire insertable through said needle into said tissue or material and by which insertion of a device used for catheterization into said tissue or material is facilitated.

51. A kit for use in a catheterization procedure comprising:

(a) a needle with a substantially uniform diameter for puncturing a tissue or material which is the target of catheterization;

(b) a dilator having an exterior diameter increasingly sized and adapted for engagement over said needle and circumferentially disposed around said needle for expanding said punctured tissue or material which is the target of catheterization; and

(c) a reversibly aspiratable chamber in fluid communication with said needle to allow detection of tissue or material or insertion of substances.

52. An instrument for facilitating catheterization comprising:

(a) a needle having a substantially uniform diameter for puncturing a tissue or material to be catheterized;

(b) a dilator having an exterior diameter increasing from a distal portion to a proximal portion and circumferentially disposed around said needle for expanding said punctured tissue or material so that catheterization is facilitated;

(c) said needle further comprising a position-sensitive feature on a distal portion thereof not solely dependent on the depth of insertion of said needle; and

(d) a distinctive mark associated with a proximal portion of said needle in a fixed spatial relationship with respect to position-sensitive feature such that said distinctive mark can be observed when the needle is inserted into said target tissue or material so that the position of the position-sensitive feature is indicated by said distinctive mark.

53. A kit for use in a catheterization procedure comprising:

(a) a needle with a substantially uniform diameter for puncturing a tissue or material which is the target of catheterization;

(b) a dilator having an exterior diameter increasingly sized for engagement over said needle and circumferentially disposed around said needle for expanding said punctured tissue or material which is the target of catheterization;

(c) said needle further including a position-sensitive feature at a distal portion thereof not solely dependent on the depth of insertion of said needle; and

(d) a distinctive mark associated with a proximal portion of said needle in a fixed relative position with respect to said position-sensitive feature so that observation of said distinctive mark outside of said target tissue or material indicates the position of said position-sensitive feature.

54. An instrument for facilitating catheterization comprising:

(a) a needle having a substantially uniform diameter for puncturing a tissue or material to be catheterized;

(b) a dilator having an exterior diameter increasing from a distal portion to a proximal portion and circumferentially disposed around said needle for expanding said punctured tissue or material so that catheterization is facilitated; and

(c) a self-sealing device interposed within an elongated lumen in said needle for restricting movement of substances in at least one longitudinal direction through said lumen of said needle.

55. A kit for use in a catheterization procedure comprising:

(a) a needle with a substantially uniform diameter for puncturing a tissue or material which is the target of catheterization;

(b) a dilator having an exterior diameter increasingly sized and adapted for engagement over said needle and circumferentially disposed around said needle for expanding said punctured tissue or material which is the target of catheterization;

(c) said needle further comprising at least one elongated lumen extending longitudinally therethrough; and

(d) a self-sealing device interposed within said elongated lumen for restricting movement of substances in at least one longitudinal direction through said lumen of said needle.