External pressure-based gastric band adjustment system and method

• US 8,016,744 B2
• Filed: 03/07/2006
• Issued: 09/13/2011
• Est. Priority Date: 02/24/2005
• Status: Expired due to Fees

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Dlugos, Daniel F., Hassler, William L. Jr.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US11/369,389
• Publication Number:
  US 20060211912A1
• Time in Patent Office: 2,016 Days
• Field of Search: 600 29- 32, 600/37, 600/593, 128897-899, 604 27- 28, 604/909, 607/41, 606139-141, 606/157, 606201-203, 606/213, 606/228, 606/151
• US Class Current: 600/37
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2205/3327 Measuring
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

An external pressure sensing system may include an attachment for a syringe. The attachment may comprise a connector positioned between the barrel and the needle of the syringe. A pressure sensor may be in fluid communication with the connector, such that the pressure sensor may sense the pressure of fluid within the connector as the syringe is used to add fluid to or withdraw fluid from an injection port. Where an injection port is a component of an adjustable fluid-based gastric band system, pressure data obtained with the pressure sensor may be indicative of the pressure of fluid within the gastric band. The pressure sensor may communicate pressure data to a display device. A user may adjust the pressure of fluid within the gastric band using the syringe while viewing the display device for pressure-related readings.

Claims

1. A system, the system comprising:

(a) a connecting member operable to connect to a syringe barrel, wherein the connecting member is further operable to connect to a needle, wherein the connecting member comprises a conduit permitting communication of fluid from the syringe barrel to the needle when the connecting member is connected to the syringe barrel and the needle;

(b) a pressure sensor in fluid communication with the conduit, wherein the pressure sensor is configured to sense pressure of fluid within the connecting member, wherein the connecting member is configured to permit the pressure sensor to sense the pressure of the fluid while the fluid is communicated from the barrel to the needle; and

(c) an implantable device, wherein the implantable device is configured to be implanted within a patient, wherein the implantable device is configured to receive the needle, wherein the implantable device is further configured to receive fluid injected through the needle, wherein the pressure sensor is configured sense the pressure of fluid while the fluid is being communicated from the barrel through the connecting member through the needle and into the implantable device.

2. The system of claim 1, wherein

the pressure sensor is located within the connecting member.

3. The system of claim 1, further comprising a display device, wherein the display device is operable to display information relating to pressure sensed by the pressure sensor.

4. The system of claim 1, further comprising a communicator in communication with the pressure sensor, wherein the communicator is configured to communicate pressure data captured by the pressure sensor to a display device.

5. The system of claim 4, wherein the communicator comprises a cable.

6. The system of claim 4, wherein the communicator comprises one or more LEDs, wherein the one or more LEDs are operable to communicate pressure data via infrared light.

7. The system of claim 4, wherein the communicator comprises an RF coil, wherein the RF coil is operable to communicate pressure data via RF signals.

8. The system of claim 1, further comprising the syringe barrel and the needle, wherein the pressure sensor is substantially in line with the syringe barrel and the needle.

9. The system of claim 1, wherein the connecting member comprises a two-way luer activated valve.

10. The system of claim 1, further comprising:

(a) tubing, wherein the tubing is in fluid communication with the connecting member; and

(b) a pressure sensor housing, wherein the pressure sensor is located within the pressure sensor housing, wherein the pressure sensor housing is in fluid communication with the tubing.

11. The system of claim 1, wherein the connecting member lacks a stopcock.

19. The system of claim 1, wherein the implantable device comprises an injection port.

20. The system of claim 19, wherein the implantable device further comprises a gastric band in fluid communication with the injection port.

12. A kit, the kit comprising:

(a) a syringe, wherein the syringe comprises;

(i) a barrel,

(ii) a plunger, wherein at least a portion of the plunger is configured to fit within the barrel, and

(iii) a needle;

(b) a pressure sensing system, wherein the pressure sensing system comprises;

(i) a generally “

T”

-shaped member, wherein the generally “

T”

-shaped member is configured to fit between the barrel and the needle, wherein the generally “

T”

-shaped member provides a fluid path configured to permit communication of fluid from the barrel to the needle,

(ii) a pressure sensor, wherein the pressure sensor is configured to sense pressure of fluid within the pressure sensing system as fluid moves from the barrel to the needle or from the needle to the barrel when the generally “

T”

-shaped member is attachably positioned between the barrel and the needle, and

(iii) a communicator in communication with the pressure sensor, wherein the communicator is operable to communicate data obtained by the pressure sensor to a data processor; and

(c) an implantable device, wherein the implantable device is configured to be implanted within a patient, wherein the implantable device is configured to receive the needle of the syringe, wherein the implantable device is further configured to receive fluid injected through the needle of the syringe, wherein the pressure sensor is configured sense the pressure of fluid while the fluid is being communicated from the barrel through the generally “

T”

-shaped member through the needle and into the implantable device, wherein the communicator is operable to communicate the data obtained by the pressure sensor to the data processor as the fluid is being communicated from the barrel through the generally “

T”

-shaped member through the needle and into the implantable device.

13. The kit of claim 12, wherein the pressure sensor is located within the generally “

T”

-shaped member.

14. The kit of claim 12, wherein the pressure sensing system further comprises a tube in communication with the “

T”

-shaped member, wherein the tube is positioned between the “

T”

-shaped member and the pressure sensor.

15. A method for externally measuring the pressure of fluid in an implanted device, the method comprising:

(a) providing a syringe assembly, wherein the syringe assembly comprises;

(i) a syringe barrel, wherein the syringe barrel contains a fluid,

(ii) a plunger, wherein at least a portion of the plunger is located within the syringe barrel, and

(iii) a needle in fluid communication with the barrel;

(b) providing an external pressure sensor in fluid communication with the syringe assembly, wherein the external pressure sensor is located external to a patient;

(c) inserting the needle of the syringe assembly into the patient, wherein the needle is inserted into a fluid injection port located within the patient, wherein the fluid injection port contains a fluid;

(d) adjusting the pressure of fluid in the fluid injection port via the needle inserted in the fluid injection port, wherein the act of adjusting comprises pushing or pulling the plunger relative to the syringe barrel to add fluid to the port or withdraw fluid from the port, respectively; and

(e) obtaining pressure data with the external pressure sensor, wherein the pressure data relates to the pressure of the fluid communicated from the barrel to the needle, wherein the act of obtaining pressure data and the act of adjusting the pressure of fluid in the fluid injection port via the needle inserted in the fluid injection port are performed substantially simultaneously.

16. The method of claim 15, further comprising:

(a) processing the obtained pressure data; and

(b) displaying a processed result of the obtained pressure data to a user via a visual display.

17. The method of claim 16, wherein the act of displaying is performed after the act of adjusting.

18. The method of claim 15, wherein the pressure sensor is located within a connector positioned between the syringe barrel and the needle.