ANATOMICAL-POSITIONING APPARATUS AND METHOD WITH AN EXPANDABLE DEVICE

• US 20130085413A1
• Filed: 06/13/2011
• Published: 04/04/2013
• Est. Priority Date: 06/13/2010
• Status: Abandoned Application

• Current Assignee: Omeq Medical Ltd.
• Original Assignee: Omeq Medical Ltd.
• Inventors: Tsamir, Oded, Margalit, Lior
• Application Number:
  US13/703,427
• Publication Number:
  US 20130085413A1
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/4896 Epidural space
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16

Abstract

An anatomical-positioning apparatus for acquiring mechanical data from a tissue to facilitate determining type of the tissue and transition between different tissues and cavities. The anatomical-positioning apparatus includes a cannula, having a tip an expandable device having a contracted form size and an expanded form size, wherein the expanded form size is substantially larger than the contracted form size. The anatomical-positioning apparatus further includes an introducer, having a longitudinal axis and a distal end, facilitating the introduction of the expandable device into the tissue, the expandable device being in a contracted state, an expanding-mechanism for expanding and contracting the expandable device, and a sensor for measuring physical parameters associated with the expandable device. An aspect of the present invention is to provide a method for acquiring mechanical data from a tissue by an expandable device, while the expandable device exerts pressure onto portions of the tissue.

Claims

1. An anatomical-positioning apparatus for acquiring mechanical data from a mammalian tissue to facilitate determining type of said tissue and transition between different tissues and cavities, comprising:

a) a cannula having a tip at the distal section of said cannula;

b) an expandable device having a contracted form size, when in a contracted state, and an expanded form size, when in an expanded state, wherein said expanded form size is substantially larger than said contracted form size;

c) an introducer, having a longitudinal axis and a distal end, facilitating the introduction of said expandable device into said mammalian tissue, said expandable device being in said contracted state;

d) an expanding-mechanism for expanding and contracting said expandable device; and

e) a sensor for measuring physical parameters associated with said expandable device, to thereby provide sensed data, while said expandable device exerts pressure onto portions of said mammalian tissue, to thereby facilitating determining the type of tissue that is in contact with said expandable device and to determine a transition between different tissues and cavities,

wherein said expandable device is securely attached to said tip of said cannula or on the external circumference of said cannula, proximal to said tip of said cannula; and

wherein when said expandable device expands from said contracted state to said expanded form size, said expandable device is disposed outside said introducer, and a blunt contact surface is formed at the external surface of said expanded expandable device.

2. The anatomical-positioning apparatus as in claim 1, wherein said expandable device protects said mammalian tissue or an anatomical structure ahead of said mammalian tissue, from being punctured by said introducer of said expandable device.

3. The anatomical-positioning apparatus as in claim 1, wherein said cannula protects said expandable device from being punctured by said introducer.

4. The anatomical-positioning apparatus as in claim 1, wherein said expandable device expands and contracts under fluid or gas pressure provided by said expanding-mechanism through said cannula.

5. The anatomical-positioning apparatus as in claim 1, wherein said sensor includes one or more sensing devices selected from the group of devices consisting of a pressure sensor, strain gauge, force sensor, tactile sensor, displacement sensor, volume sensor, flow sensor and a piezoelectric transducer.

6. The anatomical-positioning apparatus as in claim 5, wherein said sensing device includes an array of sensors disposed on said expandable device.

7. The anatomical-positioning apparatus as in claim 1, wherein said sensed data is indicated by one or more indication devices selected from the group of devices consisting of a display, a gage, a light indicator, an audio indicator and a tactile indicator.

8. The anatomical-positioning apparatus as in claim 1, wherein said introducer is an openable introducer, having an openable sharp tip;

wherein said openable sharp tip of said openable introducer has a closed state and an open state; and

wherein said expandable device is trapped inside said openable sharp tip, said openable sharp tip being in a closed state.

9. The anatomical-positioning apparatus as in claim 8, wherein said expandable device facilitates said openable sharp tip to remain in said closed state, when said expandable device is loaded by a preconfigured expanding force and said sharp tip is situated in a high density tissue;

wherein said expandable device facilitates the opening of said openable sharp tip, when said expandable device is loaded be a preconfigured expanding force and said openable sharp tip enters a low density tissue or cavity;

wherein said closed state facilitates advancement of said openable introducer through said mammalian tissue; and

wherein said open state prevents advancement of said openable introducer through said mammalian tissue.

10. The anatomical-positioning apparatus as in claim 1, wherein said introducer is selected from the group consisting of a veress needle, an epidural needle, a biopsy needle, a trocar, a cannula, a catheter, a Tuohy type needle and a surgical instrument.

11. The anatomical-positioning apparatus as in claim 1, wherein said expandable device is selected from a group of devices consisting of a balloon, a membrane, a diaphragm, a spring and a flexible device.

12. The anatomical-positioning apparatus as in claim 11, wherein said expandable device comprises one or more mechanical devices selected from a group of devices consisting of a spring and a balloon enclosed in a conical element, wherein said conical element protects said balloon from being punctured.

13. The anatomical-positioning apparatus as in claim 1, wherein said cannula and said expandable device is introduced on-demand and can be withdrawn during a procedure in order to enable utilization of other tools inside said mammalian tissue.

14. The anatomical-positioning apparatus as in claim 4, wherein said cannula includes a double lumen, wherein a first lumen facilitates a pathway for said fluid or gas into said expandable device, and wherein a second lumen facilitates a pathway for one or more devices selected from a group of devices consisting of a thin needle, a catheter, an optical fiber, an electrode and a surgical instrument.

15. The anatomical positioning apparatus as in claim 4, wherein said cannula includes a single lumen facilitating a pathway for said fluid or gas into said expandable device, and wherein said single lumen facilitating a pathway for an optical fiber or a miniature camera, to thereby facilitate visualization of said mammalian tissue through said expandable device, said expandable device being in contact with said mammalian tissue.

16. The anatomical-positioning apparatus as in claim 1 further comprises an advancement mechanism for incrementally advancing, in a controlled manner, one or more devices selected from the group consisting of said introducer, said cannula and said expandable device.

17. The anatomical-positioning apparatus as in claim 16, wherein said advancement mechanism is selected from the group of devices consisting of a motor based device, hydraulic device, gear based device and a screw based device.

18. The anatomical-positioning apparatus as in claim 16, wherein said introducer can be advanced incrementally together with said cannula and said expandable device.

19. The anatomical-positioning apparatus as in claim 16, wherein said introducer can be advanced incrementally with respect to said cannula and said expandable device.

20. The anatomical-positioning apparatus as in claim 1 further comprises a processor facilitated to record and analyze said sensed data, to thereby determine said type of tissue that is in contact with said expandable device and to determine said transition between tissues and cavities, wherein said sensed data is acquired while said expandable device is expanding, contracting or in a steady expansion level.

21. The anatomical-positioning apparatus as in claim 1, wherein said sensed data includes a measurement of the advancement of said cannula against said mammalian tissue, and wherein the displacement of said expandable device, along said longitudinal axis, is inferred from said sensed data.

22. The anatomical-positioning apparatus as in claim 1, wherein said sensed data includes a one-dimensional measurement of the displacement of said expandable device, during said expanding against said mammalian tissue or contracting away from said mammalian tissue.

23. The anatomical-positioning apparatus as in claim 1, wherein said sensed data includes one or more measurements selected from a group of measurements consisting of the pressure inside said expandable device, the volume of gas or fluid inside said expandable device, an external force applied on said expandable device by said mammalian tissue and the spatial pressure or spatial force applied on said expandable device by said mammalian tissue, while said expandable device exerts pressure onto portions of said mammalian tissue.

24. The anatomical-positioning apparatus as in claim 20, wherein said sensed data facilitates determining one or more measurements selected from a group of measurements consisting of the volume-pressure work performed by said expandable device, a volume-pressure profile of said expandable device, the work being done by said expandable device and the force-displacement profile of said expandable device, while said expandable device exerts pressure onto portions of said mammalian tissue.

25. A method for acquiring mechanical data from a mammalian tissue by an expandable device, while said expandable device exerts pressure onto portions of said mammalian tissue, the method comprising the steps of:

a) providing an anatomical-positioning apparatus including;

i. a cannula having a tip at the distal section of said cannula;

ii. an expandable device having a contracted form size, when in a contracted state, and an expanded form size, when in an expanded state, wherein said expanded form size is substantially larger than said contracted form size, and wherein said expandable device is securely attached to said tip of said cannula or on the external circumference of said cannula, proximal to said tip of said cannula;

iii. an introducer, having a distal end, facilitating the introduction of said expandable device into said mammalian tissue, said expandable device being in said contracted state;

iv. an expanding-mechanism for expanding and contracting said expandable device; and

v. a measuring-mechanism for measuring physical parameters associated with said expandable device, while said expandable device exerts pressure onto portions of said mammalian tissue;

b) inserting said introducer inside said mammalian tissue, wherein said distal end of said introducer enters first;

c) advancing said expandable device through said introducer, using said cannula;

d) expanding said expandable device outside said distal end of said introducer; and

e) measuring said physical parameters associated with said expandable device, while said expandable device exerts pressure onto portions of said mammalian tissue, thereby creating sensed data.

26. The method as in claim 25 further including the step of analyzing said sensed data, using a processor, thereby determining the type of said mammalian tissue being in contact with said expandable device, and determining a transition between different mammalian tissues and cavities.

27. The method as in claim 25, wherein said sensed data includes one or more measurements selected from a group of measurements consisting of the displacement of said expandable device and cannula, the pressure inside said expandable device, the volume of gas or fluid inside said expandable device, the external force applied on said expandable device by said mammalian tissue and the spatial pressure or spatial force applied on said expandable device by said mammalian tissue, while said expandable device exerts pressure onto portions of said mammalian tissue.

28. The method as in claim 26, wherein said sensed data facilitates determining one or more measurements selected from a group of measurements consisting of the volume-pressure work performed by said expandable device, the volume-pressure profile of said expandable device, the work being done by said expandable device and the force-displacement profile of said expandable device, while said expandable device exerts pressure onto portions of said mammalian tissue.

29. The method as in claim 25, wherein said measuring of said sensed data is performed during states selected from a group of states consisting of an expansion of said expandable device, a contraction of said expandable device and a displacement of said cannula and said expandable device, while said expandable device is expanded.

30. A method for a controlled insertion of an introducer into and through an elastic mammalian tissue, the method comprising the steps of:

a) providing a device including;

i. a cannula having a tip at the distal section of said cannula;

ii. an expandable device having a contracted form size, when in a contracted state, and an expanded form size, when in an expanded state, wherein when in expanded state, said expandable device has a front end;

wherein said expanded form size is substantially larger than said contracted form size; and

wherein said expandable device is securely attached to said tip of said cannula or on the external circumference of said cannula, proximal to said tip of said cannula;

iii. an introducer, having a sharp tip at the distal end, facilitating the introduction of said expandable device into said mammalian tissue, said expandable device being in said contracted state;

iv. an expanding-mechanism for expanding and contracting said expandable device; and

v. an advancement mechanism for incrementally advancing, in a controlled manner, devices selected from the group consisting of said introducer, said cannula and said expandable device;

b) expanding said expandable device by said expanding-mechanism, outside said tip of said introducer, whereby said expandable device exerts pressure onto portions of said mammalian tissue, wherein said mammalian tissue is initially in an undistorted position;

c) advancing said introducer incrementally to a preconfigured position situated beyond said undistorted position of said mammalian tissue, said mammalian tissue being pushed by said expandable device, wherein said tip of said introducer is posterior to the instantaneous position of said front end of said expandable device, with respect to said elastic tissue;

d) holding said introducer in secured position; and

e) contracting said expandable device at a preconfigured rate, thereby facilitating said mammalian tissue, being elastic, to spring back powerfully towards said undistorted position of said mammalian tissue, thereby penetrating said mammalian tissue by said tip of said introducer, being disposed beyond said undistorted position of said mammalian tissue.

31. The method as in claim 30, wherein said incremental advancing of said introducer is performed while also incrementally advancing said expandable device, wherein said expandable device is expanded.

32. The method as in claim 30, wherein said incremental advancing of said introducer is performed, while said expandable device is expanded and in steady position, wherein said introducer is incrementally displaced beyond said undistorted position of said mammalian tissue, and wherein said introducer tip is kept at a shorter distance from said mammalian tissue, with respect to steady position of said front end of said expandable device.

33. A method for a controlled insertion of a cannula, using an inner needle, into and through an elastic mammalian tissue, the method comprising the steps of:

a) providing a device including;

i. a cannula having a double lumen and a tip at the distal section of said cannula;

ii. an expandable device having a contracted form size, when in a contracted state, and an expanded form size, when in an expanded state, wherein when in expanded state, said expandable device has a front end;

wherein said expanded form size is substantially larger than said contracted form size; and

wherein said expandable device is securely attached on the external circumference of said cannula, proximal to said tip of said cannula;

iii. an introducer, facilitating the introduction of said expandable device into said mammalian tissue, said expandable device being in said contracted state;

iv. an expanding-mechanism for expanding and contracting said expandable device;

v. an inner needle being introduced through said cannula; and

vi. an advancement mechanism for incrementally advancing, in a controlled manner, devices selected from the group consisting of said introducer, said cannula, said inner needle and said expandable device;

b) Advancing said cannula together with said inner needle outside distal tip of said introducer, wherein said tip of said inner needle is secured inside said cannula near the distal end of said cannula;

c) expanding said expandable device by said expanding-mechanism, whereby said expandable device exerts pressure onto portions of said mammalian tissue, wherein said mammalian tissue is initially in an undistorted position;

d) advancing said cannula together with said inner needle incrementally to a preconfigured position wherein said distal end of said cannula together with said tip of said inner needle are situated beyond said undistorted position of said mammalian tissue, said mammalian tissue being pushed by said expandable device;

e) locking said inner needle and said cannula in a secured position;

f) contracting said expandable device at a preconfigured rate, while unlocking said cannula, thereby facilitating said mammalian tissue, being elastic, to spring back powerfully towards the undistorted position of said mammalian tissue, while pushing backwards said cannula, thereby penetrating said mammalian tissue by said tip of said inner needle, being disposed beyond said undistorted position of said mammalian tissue; and

g) incrementally advancing said cannula over said inner needle to a position wherein said distal end of said cannula shields said tip of said inner needle.

34. The method as in claim 33 further comprises the step of expanding said expandable device by said expanding-mechanism, thereby anchoring said cannula in position, upon transition of said expandable device from said elastic tissue into a different tissue or cavity.

35. A method for a controlled insertion of an openable introducer into and through a mammalian tissue, the method comprising the steps of:

a) providing a device including;

i. a cannula having a double lumen;

ii. an openable introducer, including an openable sharp tip having a closed state and an opened state, wherein said closed state facilitates advancement of said openable introducer through said mammalian tissue; and

wherein said open state prevents advancement of said openable introducer through said mammalian tissue;

iii. an expandable device having a contracted form size, when in a contracted state, and an expanded form size, when in an expanded state,

wherein when in expanded state, said expandable device has a front end;

wherein said expanded form size is substantially larger than said contracted form size;

wherein said expandable device is securely attached on the external circumference of said cannula, proximal to said tip of said cannula;

wherein said openable introducer facilitates the introduction of said expandable device into said mammalian tissue, said expandable device being in said contracted state; and

wherein said expandable device facilitates opening of said tip of said openable introducer when said expandable device is in said expanded state wherein said tip enters a cavity or a low dense tissue;

iv. an expanding-mechanism for expanding and contracting said expandable device;

b) advancing said cannula together with said openable introducer into and inside said mammalian tissue, said openable sharp tip being in said closed state;

c) maintaining a constant preconfigured pressure inside said expandable device; and

d) advancing said cannula together with said openable introducer until said tip of said openable introducer enters into a low density tissue or cavity;

thereby facilitating rapid expanding of said expandable device by said expanding mechanism, said constant preconfigured pressure inside said expandable device being larger than the external pressure applied on said tip of said openable introducer by said low density tissue or cavity.

36. The method as in claim 35, wherein said device further includes an advancement mechanism for incrementally advancing, in a controlled manner, devices selected from the group consisting of said openable introducer, said cannula and said expandable device.