Active drainage system for use in defined natural or surgically created body cavities or lumina

• US 20070219488A1
• Filed: 12/15/2006
• Published: 09/20/2007
• Est. Priority Date: 12/16/2005
• Status: Abandoned Application

• Current Assignee: Xoft Incorporated (Elekta AB)
• Original Assignee: Xoft Incorporated (Elekta AB)
• Inventors: Francescatti, Darius
• Application Number:
  US11/639,495
• Publication Number:
  US 20070219488A1
• Time in Patent Office: Days
• US Class Current: 604/96.10
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

Cavity conforming balloons with active pressure gradients are provided to replace passive reliance on gravity flow of fluid from organs, body lumina, cavities and the like for more accurate and timely assessment and analysis of exudates. Diffuse drug delivery to cavities or lumina can be administered as an adjunct to the drainage process, as can application of brachytherapy.

Claims

1. A catheter or applicator for draining liquids from within a natural or surgically created body cavity or lumen, with quantitative flow measurement, comprising:

a shaft,

an expandable balloon at a distal end of the shaft,

an outer permeable layer on the outside of the balloon, expandable as the balloon is expanded,

the shaft having liquid withdrawal channel or lumen, the liquid withdrawal lumen being connected to the permeable layer and establishing a flow path for withdrawing liquid,

the shaft further having a lumen for introducing fluid under pressure to inflate the balloon, and

a liquid flow sensor for measuring volumetric flow rate, positioned in the flow path of the withdrawn liquid.

2. Apparatus according to claim 1, wherein the permeable layer comprises a compressible liquid-absorbing layer.

3. Apparatus according to claim 1, wherein the permeable layer comprises a series of channels formed on the outside of the balloon, the channels being capable of receiving liquid, and the liquid withdrawal lumen being connected to receive liquid moving along the channels toward the shaft.

4. Apparatus according to claim 1, wherein the shaft includes a lumen for delivery of therapeutic agents to tissue of the body cavity via the permeable layer.

5. Apparatus according to claim 1, in combination with a source of ionizing radiation, the shaft including a lumen for receiving the source of ionizing radiation into the interior of the balloon, for radiation therapy on tissues surrounding the body cavity.

6. Apparatus according to claim 5, further including a lumen for delivery of therapeutic agents to tissue of the body cavity via the permeable layer.

7. Apparatus according to claim 1, further including a sensor positioned in the path of the withdrawn liquid for qualitative analysis of the withdrawn liquid.

8. Apparatus according to claim 1, wherein the sensor for volumetric flow measurement is secured as a part of the shaft, and including a receiver console for indicating volumetric flow, the receiver console being connected wirelessly to the sensor for volumetric flow.

9. Apparatus according to claim 1, wherein the liquid withdrawn is urine, the catheter distal end being inserted into the bladder of the patient.

10. Apparatus according to claim 1, wherein the liquid withdrawn comprises seroma withdrawn from a surgical wound cavity.

11. Apparatus according to claim 1, including a suction-applying collection receptacle at a downstream end of the liquid withdrawal lumen, drawing liquids from the permeable layer with suction.

12. Apparatus according to claim 11, further including a vent lumen in the shaft and having an end open to a distal part of the permeable layer, to permit resting of the permeable layer when desired.

13. A method for draining liquids from within a natural or surgically created body cavity or lumen, with quantitative flow measurement, comprising:

inserting into the body cavity or lumen a catheter that includes a shaft with an expandable balloon at a distal end of the shaft, with an outer permeable layer on the outside of the balloon, the balloon being deflated on insertion,

with an inflation lumen in the shaft that communicates with the interior of the balloon, inflating the balloon by admitting pressurized fluid to substantially fill the body cavity or lumen with the balloon,

through a liquid withdrawal lumen in the shaft and extending to the permeable layer, applying suction and withdrawing liquid entering the permeable layer from tissue of the body cavity or lumen, and

measuring volumetric flow rate of liquid being withdrawn through the liquid withdrawal lumen.

14. The method of claim 13, further including wirelessly transmitting measured values of volumetric flow rate to a remote location where the values are recorded or displayed.

15. The method of claim 13, further including qualitatively analyzing the liquid as it is withdrawn by the applicator.

16. The method of claim 15, wherein qualitative analysis includes pH or spectrographic analysis.

17. The method of claim 16, further including wirelessly transmitting measured values of volumetric flow rate and qualitative analysis to a remote location where the values are recorded or displayed.

18. The method of claim 13, wherein the outer permeable layer comprises an absorbent, compressible material.

19. The method of claim 18, further including venting the permeable layer while suction is applied, using a venting lumen in the shaft that extends to a distal portion of the permeable layer, venting being accomplished by admitting a liquid.

20. The method of claim 19, wherein the venting liquid includes a therapeutic agent.

21. The method of claim 13, including delivering a liquid therapeutic agent to tissue of the body cavity via the permeable layer.

22. The method of claim 13, wherein the body cavity comprises a patient'"'"'s bladder, the quantitative measurement of flow rate being a urine flow measurement.

23. The method of claim 22, including qualitatively analyzing the urine, with any contaminants, as it is withdrawn through the liquid withdrawal channel.

24. The method of claim 13, wherein the body cavity is a surgically created cavity from resection of a tumor, the liquid withdrawn being primarily seroma.

25. The method of claim 13, wherein the permeable layer comprises a series of channels formed on the outside of the balloon, the channels being capable of receiving liquid, and the liquid withdrawal lumen being connected to receive liquid moving along the channels toward the shaft.

26. The method of claim 13, further including introducing a source of ionizing radiation through a lumen in the shaft and into the interior of the inflated balloon, and irradiating tissue of the body cavity or lumen surrounding the balloon.