DIRECT PRESSURE-MEDIATED INTRA-BONE DELIVERY SYSTEM FOR CELLULAR THERAPEUTICS

• US 20160015893A1
• Filed: 02/28/2014
• Published: 01/21/2016
• Est. Priority Date: 03/01/2013
• Status: Active Application

• Current Assignee: United States Department Of Health And Human Services
• Original Assignee: United States Department Of Health And Human Services
• Inventors: Hoyt, Robert Franklin, Pantin, Jeremy Mark, Aras, Omer, Childs, Richard William, Choyke, Peter, Clevenger, Randall Ray, Hunt, Timothy John, Davidson-Moncada, Jan
• Application Number:
  US14/772,044
• Publication Number:
  US 20160015893A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/3494 with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors for the peridural space A61B17/3401
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/3458 threaded
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 2039/025 through bones or teeth, e.g. through the skull
• CPC Class Codes: A61M 2039/0267 comprising sensors or electrical contacts
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Disclosed are devices, apparatus, and methods for directly infusing one or more materials into a bone of a patient. More particularly, devices, apparatus and methods are provided for direct intra-bone infusion, wherein intra-bone pressure is continuously monitored and adjusted during infusion such that intra-bone pressure does not exceed levels of systemic blood pressure. Such devices, apparatus and methods are particularly suitable for use in performing bone marrow transplants.

Claims

1. An intra-bone infusion system for performing a bone marrow transplant comprising:

an infusion source;

an intra-bone device having a proximal end for insertion into bone marrow, a distal end in connection with the infusion source, and a pressure sensor at the distal end for measuring intra-bone pressure; and

a mechanism in communication with the pressure sensor and the infusion source, the mechanism configured and arranged to continuously monitor intra-bone pressure measurements by the pressure sensor, and to automatically adjust infusion of agents from the infusion source and into the intra-bone device so as to maintain intra-bone pressure at levels not exceeding systemic blood pressure.

2. The intra-bone infusion system of claim 1, wherein

the intra-bone pressure does not exceed 25-30 mmHg.

3. The intra-bone infusion system of claim 1, wherein the intra-bone device comprises an access cannula and an infusion cannula, wherein the access cannula has a hub, an elongate portion extending from the hub, and a lumen extending through a length of the elongate portion, and the infusion cannula has a handle and an elongate portion insertable within the lumen of the access cannula.

4. The intra-bone infusion system of claim 3, wherein a distal end of the elongate portion of the access cannula is threaded.

5. The intra-bone infusion system of claim 3, wherein a distal end of the infusion cannula has one or more openings through which agents may be infused, and wherein the elongate portion of the infusion cannula is hollow.

6. The intra-bone infusion system of claim 3, wherein when the infusion cannula is inserted within the lumen of the access cannula, a distal end of the infusion cannula extends beyond a distal end of the access cannula.

7. The intra-bone infusion system of claim 6, wherein the pressure sensor is disposed along the outer surface of the infusion cannula.

8. The intra-bone infusion system of claim 3, wherein the intra-bone device further comprises a penetrator, the penetrator having a handle and an elongate portion extending from the handle, wherein the penetrator is insertable within the lumen of the access cannula.

9. The intra-bone infusion system of claim 1, wherein the pressure sensor is a fiberoptic probe.

10. The intra-bone infusion system of claim 1, wherein the intra-bone device is imagable by a number of imaging modalities including MRI, CT, fluoroscopy guidance imaging, optical guidance imaging, ultrasound guidance imaging, and the like.

11. The intra-bone infusion system of claim 1, further comprising a robotic guidance system, a CT guidance system, an MRI guidance system, a CT imaging system, a fluoroscopy guidance imaging system, an optical guidance imaging system, or an ultrasound guidance imaging system.

12. A method for infusing one or more agents into a target bone comprising:

inserting an intra-bone device into a target bone;

infusing one or more agents into the target bone while continuously measuring intra-bone pressure; and

adjusting a rate of infusion of the one or more agents to maintain intra-bone pressure at levels not exceeding systemic blood pressure.

14. The method of claim 12, wherein the one or more agents are selected from bone marrow, hematopoetic stem cells, mesenchymal stem cells, therapeutic agents and gene therapy vectors.

15. The method of claim 12, wherein the agent is a hematopoetic stem cell.

16. The method of claim 12, wherein the target bone is the pelvic bone.

17. The method of claim 12, carried out under MRI imaging, CT imaging, fluoroscopy guidance imaging, optical guidance imaging, ultrasound guidance imaging, and the like.

18. The method of claim 12, wherein one or more of the steps of inserting the intra-bone device, infusing one or more agents, and adjusting a rate of infusion are carried out robotically.

13. (canceled)

19. A method for increasing engraftment in a human subject undergoing a bone marrow transplant comprising:

inserting an intra-bone device into a target bone, wherein the intra-bone device is provided with a pressure sensor for measuring intra-bone pressure;

infusing one or more agents through the intra-bone device while continuously measuring intra-bone pressure; and

adjusting a rate of infusion of the one or more agents to maintain intra-bone pressure at levels not exceeding systemic blood pressure.

20. The method of claim 19, wherein at least about 85% engraftment is provided.

21. The method of claim 20, wherein the infusion volume of the one or more agents is between 5-15 ml.

22. The method of claim 20, wherein the rate of infusion is less than 0.2 ml/s.

23. The method of claim 20, further comprising the step of temporary occlusion of the iliac vein.