Method and assembly for introducing multiple catheters into a biological vessel

• US 4,771,782 A
• Filed: 11/14/1986
• Issued: 09/20/1988
• Est. Priority Date: 11/14/1986
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Millar Instruments
• Inventors: Millar, Huntly D.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US06/931,273
• Time in Patent Office: 676 Days
• Field of Search: 128/637, 128/642, 128/672, 128/673, 128/675, 128/748
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place

Abstract

A method and assembly for inserting a plurality of sensors into a biological fluid vessel for diagnosing the condition of the vessel or fluid. A pressure sensor is described which is particularly adapted for use with a steerable guidewire for selective positioning in the vessel. In one use, the method is used in coronary diagnosis, to determine the pressure gradient across a coronary valve or stenosis in the coronary arterial tree. In this method, a guiding catheter is percutaneously inserted with its distal end proximate the ostium. A guidewire is inserted through the guiding catheter and subselectively positioned in a region of interest in the coronary arterial tree. Multiple pressure sensors are then threaded down the guidewire and positioned in the region of interest. Advantageously, such pressure sensors are approximately 3 French in diameter, allowing multiple sensors to be threaded through the guiding catheter and positioned in the small arteries of the coronary arterial tree. Such pressure sensors can be used in conjunction with other sensors (e.g. temperature, pH, or Doppler sensors) and are useful in a variety of applications (e.g. venous, urinary tract, esophageal).

Claims

1. A pressure sensor adapted for engaging a steerable guidewire, comprising:

an elongated body;

transducer means mounted to the body

for cooperatively defining with the body an interior cavity, the cavity being isolated from the exterior biological fluid proximate the transducer means with the sensor inserted in a biological vessel, and

for measuring, with the sensor inserted in the fluid of a biological vessel, the pressure differential between the biological fluid proximate to the transducer and the fluid pressure within the cavity;

a tubular catheter coupled to the body and having a lumen;

lead means coupled to the transducer means and having a portion disposed within the lumen; and

an elongated coupling structure depending from the body, extending less than or equal to the length of the body and longitudinally aligned therewith, the structure having a longitudinally oriented passage for slidably receiving the guidewire.

2. A pressure sensor in accordance with claim 1, the passage comprising an elongated bore.

3. A pressure sensor in accordance with claim 1, the passage comprising a groove defined between a pair of flexible, resilient fingers which are curled towards each other at its distal tips.

4. A pressure sensor in accordance with claim 1, the maximum diameter of the body and coupling structure being less than about 2 mm.

5. A pressure sensor in accordance with claim 4, the diameter of the catheter being less than about 2 mm.

6. An assembly for meauring in vivo the fluid characteristics in a region of biological fluid-carrying vessel, comprising:

an elongated, flexible, steerable guidewire adapted for insertion in the vessel and having a distal end positionable in the region;

a first pressure sensor device adapted for engaging the guidewire and positionable in the region, the pressure sensor including

an elongated body having a cavity isolated from the biological fluid with the sensor inserted in the vessel;

structure means connected to the body defining a passage longitudinally oriented with the body for slidably receiving the guidewire,

an elongated catheter coupled to the body in longitudinal alignment therewith and defining a lumen in communication with the cavity,

transducer means mounted to the body for measuring, with the sensor inserted in the vessel, the pressure differential between the biological fluid proximate the transducer means and the pressure within the cavity;

a second device adapted for engaging the guidewire and positionable in the region, the device including

an elongated body,

structure means connected to the body defining a passage longitudinally oriented with the body for slidably receiving the guidewire,

an elongated catheter coupled to the body in longitudinal alignment therewith,

the first and second devices being adapted for reception on the guidewire in the region of the vessel with the respective catheters spaced about the guidewire.

7. The assembly according to claim 6, each passage comprising an elongated bore in the body.

8. The assembly according to claim 6, each passage comprising a guidewire-receiving groove defined by a pair of spaced-apart fingers.

9. The assembly according to claim 6, the guidewire having a constricted fitting region outside the vessel with the distal end positioned in the region.

10. The assembly according to claim 6, the second device including a sensor coupled to the body, the passage-defining structure of the first and seocnd device being complementally positioned relative to the respective body for positioning the transducer means and sensor in the same general transverse cross-section of the vessel.

11. A method of positioning multiple devices in a region of biological fluid-carrying vessel, comprising the steps of:

inserting an elongated, flexible guidewire into the vessel with the distal end of the guidewire extending into the region;

connecting to the guidewire a first device having a body, an elongated catheter connected to the body, and a coupling structure depending from the body which is adapted for engaging the guidewire;

inserting the first device into the vessel region with the coupling structure slidably engaging the guidewire and the catheter generally longitudinally aligned and juxtaposed relative to the guidewire;

connecting to the guidewire a second device having a body, an elongated catheter connected to the body, and a coupling structure depending from the body which is adapted for engaging the guidewire;

inserting the second device into the vessel region with the coupling structure slidably engaging the guidewire and the catheter generally longitudinally aligned and juxtaposed relative to the guidewire, positioning the first and second devices along the guidewire with their respective bodies in the region and with the first and second catheters spaced about the guidewire.

12. The method according to claim 11, the first and second devices having cooperative coupling structure, said positioning step including positioning the first and second bodies in generally the same transverse cross-section of the vessel.

13. The method according to claim 11, said positioning step including spacing the first and second devices radially around the guidewire and longitudinally along the guidewire in the region.

14. The method according to claim 11, including the steps of:

withdrawing the second device from the vessel while maintaining the position of the guidewire and first device within the vessel;

disconnecting the second device from the guidewire while maintaining the position of the guidewire and first device within the vessel; and

connected a third device to the guidewire and inserting the third device into the vessel while maintaining the position of the guidewire and first device within the vessel.

15. The method according to claim 14, the coupling structure of the second device comprising a pair of spaced-apart fingers defining an elongated, guidewire-receiving grove, the disconnecting step including the substep of shifting the guidewire from the groove in a direction transverse to the longitudinal axis of the grove.

16. The method according to claim 11, including the steps of:

providing a guidewire having a constricted fitting region located outside the vessel with the distal end of the guidewire extending into the region;

providing a second device with a coupling structure comprising a pair of spaced-apart fingers defining a guidewire-receiving groove,

connecting the guidewire to the second device by shifting the fitting region between the fingers into the groove.

17. The method according to claim 16, the fingers comprising a generally inflexible material, including the step of inserting the second device into the vessel along the guidewire past the fitting region to effect slidable, locking engagement of the fingers about the guidewire.