Method and device for tissue removal and for delivery of a therapeutic agent or bulking agent

• US 7,806,871 B2
• Filed: 05/09/2005
• Issued: 10/05/2010
• Est. Priority Date: 05/09/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Li, Jamie (Jianmin), Bucay-Couto, Weenna
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US11/124,827
• Publication Number:
  US 20060253069A1
• Time in Patent Office: 1,975 Days
• Field of Search: 604/22, 604/27, 604/35, 604/500, 604/506, 604/514, 604/517, 604/93.01, 604/164.01, 604/164.06, 604/264, 604/269, 604/270, 604/271, 604/272, 606/167, 606/168, 606/170, 606/180, 600564-567
• US Class Current: 604/164.06
• CPC Class Codes: A61B 10/0241 for prostate
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

According to an aspect of the present invention, a medical device is provided, which comprises the following: (a) a hollow elongate body (e.g., a elongate cylinder, such as a needle) having distal and proximal ends; and (b) a rotatable member comprising a tissue morselizer and an elongate shaft (e.g., an auger-like tissue-drilling bit). The device (i) advances material (e.g., morselated tissue) toward the proximal end of the hollow elongate body when the shaft is rotated in a first direction, and (ii) advances material (e.g., a therapeutic agent and/or a bulking agent) toward the distal end of the hollow elongate body when the shaft is rotated in a second direction that is opposite the first direction. The invention also provides a method of treatment for morselizing and removing tissue from within the patient and creating a void within the patient and introducing a therapeutic agent and/or a bulking agent into the void.

Claims

1. A medical device comprising:

(a) a hollow elongate body having an open distal end, a proximal end, and a side port adjacent the distal end; and

(b) a rotatable member having an elongate shaft with a raised helical blade having a cutting edge extending along at least a portion of the elongate shaft, the raised helical blade extending laterally outward from the elongate shaft, and with a tissue morselizer that includes a drill bit with a tissue-morselizing tip, said elongate shaft disposed in part within said hollow elongate body and extendable at least in part through the open distal end, wherein rotation of the rotatable member in a first direction causes the tip to morselize tissue or material and progressive movement of the helical blade severs tissue or material that is engaged with the side port.

2. The medical device of claim 1, wherein said distal end of said hollow elongate body is adapted for penetration of tissue.

3. The medical device of claim 1, wherein said hollow elongate body comprises a hollow needle.

4. The medical device of claim 3, wherein said hollow needle is a 10 to 22 gauge hollow needle.

5. The medical device of claim 3, wherein said hollow needle is a 12 to 18 gauge hollow needle.

6. The medical device of claim 1, wherein said tissue morselizer is adapted to grind tissue.

7. The medical device of claim 1, wherein said tissue morselizer is adapted to slice tissue.

8. The medical device of claim 1, wherein said rotatable member is axially moveable with respect to said hollow elongate body.

9. The medical device of claim 1, wherein said tissue morselizer is adapted to morselize tissue at the distal end of said hollow elongate body.

10. The medical device of claim 1, wherein said medical device is adapted for insertion into a body lumen and wherein said distal end of said hollow elongate member is adapted to pierce the wall of the body lumen and access a tissue region proximate the body lumen.

11. The medical device of claim 1, further comprising at least one of a vacuum source and irrigation source, in communication with the proximal end of said hollow elongate body.

12. The medical device of claim 1, further comprising a tissue collection container in communication with the proximal end of said hollow elongate body.

13. The medical device of claim 1, wherein the material comprises a therapeutic agent or bulking agent, wherein said therapeutic agent is selected from anticoagulants, analgesics, antispasmodic agents, hemostatic agents, necrosis agents and antineoplastic agents.

14. The medical device of claim 1, wherein the material comprises a therapeutic agent or bulking agent, wherein said therapeutic agent or said bulking agent is in a liquid or semi-liquid form.

15. The medical device of claim 1, wherein the material comprises a therapeutic agent or bulking agent, wherein said therapeutic agent or said bulking agent is in a solid or semi-solid form.

16. The medical device of claim 1, wherein the material comprises a therapeutic agent or bulking agent, wherein said therapeutic agent or said bulking agent is in particulate, granulated or pelletized dosage form.

17. A method of treatment comprising:

inserting the medical device of claim 1 into tissue of a patient;

morselizing and removing tissue from within said patient while rotating said shaft in a first direction, thereby creating a void within the patient; and

introducing at least one of a therapeutic agent or a bulking agent into the void.

18. The method of claim 17, wherein the therapeutic agent, the bulking agent, or both are introduced while rotating said shaft in a second direction that is opposite said first direction.

19. The method of claim 17, wherein said tissue removal is enhanced by applying a vacuum.

20. The method of claim 17, wherein the tissue is selected from prostate, brain, and soft cancer tissue.

21. The method of claim 17, wherein said therapeutic agent is selected from anticoagulants, analgesics, antispasmodic agents, hemostatic agents, necrosis agents and antineoplastic agents.

22. The medical device of claim 1, wherein said elongate shaft further comprises a central lumen for passage of fluids.

23. The medical device of claim 1, wherein the material comprises a therapeutic agent or bulking agent.

24. The medical device of claim 1, wherein the device further comprises a fluid pump in communication with the proximal end of the hollow elongate body.

25. The medical device of claim 24, wherein the device further comprises a container for containing a therapeutic agent or a bulking agent in liquid or semi-liquid form, said container in communication with said fluid pump.

26. The medical device of claim 25, wherein said container comprises an ampoule.

27. The medical device of claim 1, wherein the material comprises a therapeutic agent or bulking agent, wherein said therapeutic agent comprises analgesics further comprising opioid analgesics comprising codeine, fentanyl, meperidine, methadone, morphine, pentazocine, and tramadol, non-opioid analgesics comprising etodolac, fenoprofen, ketoprofen, ketorolac, mefenamic acid, paracetamol, and piroxicam, non-steroidal anti-inflammatory drugs comprising aspirin, diclofenac, ibuprofen, indomethacin, and naproxen.

28. The medical device of claim 1 wherein the elongate shaft is an untapered elongate shaft.

29. A medical device comprising:

(a) a hollow elongate body having an open distal end and a proximal end;

(b) a rotatable member having a tissue morselizer at its distal end that includes a drill bit with a tissue-morselizing tip and an elongate shaft provided with a raised helix extending laterally outward from the elongate shaft, said elongate shaft being disposed in part within said hollow elongate and extendable at least in part through the open distal end, wherein the raised helix engages with tissue or a material occupying voids between the raised helix of the elongate shaft to (i) advance the tissue or the material toward the proximal end of said hollow elongate body when said shaft is rotated in a first direction, and (ii) advance the tissue or the material toward the distal end of said hollow elongate body when said shaft is rotated in a second direction that is opposite said first direction; and

(c) a side port located in the hollow elongate body adjacent the distal end and configured to receive tissue or material therein so that the tissue or material can be severed by progressive movement of the raised helix within the hollow elongate body.

30. The medical device of claim 29 wherein the elongate shaft is an untapered elongate shaft.