Immobilizing objects in the body

• US 6,663,594 B2
• Filed: 03/31/2003
• Issued: 12/16/2003
• Est. Priority Date: 02/28/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Madenjian, Arthur, Little, Bill, Sahatjian, Ronald
• Primary Examiner(s): Ganey, Steven J.
• Application Number:
  US10/403,768
• Publication Number:
  US 20030195464A1
• Time in Patent Office: 260 Days
• Field of Search: 604/48, 604/93.01, 604/113, 604/164.08, 606/22, 606/27, 606/127, 606/128
• US Class Current: 604/113
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61B 2090/0815 Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61L 26/008 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

Abstract

Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material or other flowable material into the body of the patient so that the material contacts the object. The LCST material or other flowable material then forms a gel in the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

Claims

1. A method for stabilizing an object in a patient'"'"'s body comprising:

contacting a first material comprising a crosslinking polymer in a flowable form with a second material comprising a crosslinking agent to form a mixture;

injecting the mixture into the body to contact the object before transformation of the mixture into gel form; and

stabilizing the object by forming a gel that contacts the object in the patient'"'"'s body.

2. The method of claim 1 wherein the first material comprises one or more of an anionic crosslinkable polymer, a cationic crosslinkable polymer, or a non-ionically crosslinkable polymer.

3. The method of claim 1 wherein the first material comprises one or more of polyacrylic acids, polymethacrylic acid, alginic acid, pectinic acids, sodium alginate, potasium alginate, carboxy methyl cellulose, hyaluronic acid, heparin, carboxymethyl starch, carboxymethyl dextran, heparin sulfate, chondroitin sulfate, polyethylene amine, polysaccharides, chitosan, carboxymethyl chitosan, cationic starch or salts thereof.

4. The method of claim 1 wherein the second material comprises one or more of an anionic crosslinking ion, a cationic crosslinking ion, or a non-ionic crosslinking agent.

5. The method of claim 1 wherein the second material comprises one or more of phosphate, citrate, borate, succinate, maleate, adipate, oxalate, calcium, magnesium, barium, strontium, boron, beryllium, aluminium, iron, copper, cobalt, lead, or silver ions.

6. The method of claim 1 wherein the second material comprises one or more of di-vinylsulfone, polycarboxylic acids, polycarboxylic anhydrides, polyamines, epihalohydrins, diepoxides, dialdehydes, diols, carboxylic acid halides, ketenes, polyfunctional aziridines, polyfunctional carbodiimides, polyisocyanate, glutaraldehyde, or polyfunctional crosslinkers including functional groups capable of reacting with organic acid groups.

7. The method of claim 1 further comprising the step of retrieving the object from the gel.

8. The method of claim 1 further comprising the step of applying energy to the object causing it to break into at least two fragments, at least some of the fragments remaining at least partially in contact with the gel and stabilized by the gel.

9. The method of claim 8 wherein the energy is selected from the group consisting of mechanical, vibrational, light, chemical, and electromagnetic energy.

10. The method of claim 8 wherein the object is broken into at least two fragments by technique selected from the group consisting of extra-corporeal shock wave lithotripsy, intra-corporeal shock wave lithotripsy, or Holmium laser fragmentation.

11. The method of claim 8 further comprising the step of retrieving at least some of the fragments from the gel.

12. The method of claim 11 wherein the step of retrieving at least some of the fragments from the gel includes using a retrieval device to retrieve such fragments.

13. The method of claim 1 further comprising contacting the gel with a third material comprising a de-crosslinking agent.

14. The method of claim 13 wherein the third material comprises one or more of sodium phosphate, sodium citrate, inorganic sulfates, ethylene diamine tetraacetic acid and ethylene dime tetraacetate, citrates, organic phosphates (e.g., cellulose phosphate), inorganic phosphates (e.g., pentasodium tripolyphosphate, mono- and di-basic potassium phosphate, sodium pyrophosphate), phosphoric acid, trisodium carboxymethyloxy succinate, nitrilotriacetic acid, maleic acid, oxalate, polyacrylic acid, sodium, potassium, calcium, or magnesium ions.

15. A method of fragmenting an object in a patient'"'"'s body comprising:

contacting a first material in flowable form with a second material to form a mixture;

injecting the mixture into the body before transformation of the mixture into gel form;

stabilizing the object by forming a gel that contacts the object in the patient'"'"'s body; and

directing energy towards the object, the energy breaking the object into at least two fragments.

16. The method of claim 15 wherein the energy is produced by extra-corporeal shock wave lithotripsy.

17. The method of claim 15 wherein the first material comprises one or more of a crosslinkable polymer, a gelatin material or a lower critical solution temperature material.

18. The method of claim 17 wherein the first material comprises the lower critical solution temperature material, further comprising contacting the lower critical solution temperature material with a degradation modulating material.

19. The method of claim 18 wherein the degradation modulating material is selected from the group consisting of pluronic acid, polylactic acid, polyglycolic acid, and hyaluronic acid.

20. The method of claim 15 wherein the first material comprises a polyoxyethylene-polyoxypropylene block copolymer.

21. The method of claim 15 further comprising the step of retrieving the stabilized object from the gel.

22. The method of claim 15 further comprising the step of breaking the object into at least two fragments, at least some of the fragments remaining in contact with the gel.

23. The method of claim 22 further comprising the step of retrieving the at least some of the fragments from the gel.

24. A method for stabilizing an object in a patient'"'"'s body comprising:

contacting a first material comprising a crosslinkable polymer in a flowable form with a second material comprising a crosslinking agent to form a mixture;

injecting the mixture into the body to contact the object before transformation of the mixture into gel form;

stabilizing the object by forming a gel that contacts the object in the patient'"'"'s body; and

administering a third material comprising a de-crosslinking agent into the patient'"'"'s body to dissolve and facilitate removal of the gel.