US20040122318A1 — Tissue penetrating catheters having integral imag…

Claim 1

Independent Claim 176 words

1 . A catheter device that is useable to penetrate from the lumen of a blood vessel within a patient's body in which the catheter device is positioned to a target location within the patient's body, said catheter device comprising: a catheter having a proximal end and a distal end, said catheter being advanceable into said first blood vessel; a tissue penetrator that is advanceable from the catheter, said tissue penetrator being operative to penetrate from the lumen of the blood vessel to target location an imaging transducer fixedly mounted to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the first blood vessel can be obtained; said imaging transducer and said marker being useable in cooperation with each other to enable the operator to rotationally orient the catheter until the penetrator path indicator is aimed at the second blood vessel, thereby indicating that when the tissue penetrator is subsequently advanced from the catheter it will extend into the lumen of the second blood vessel as desired.

Claim 2

Dependent Claim 176 words

1 . A catheter device that is useable to penetrate from the lumen of a blood vessel within a patient's body in which the catheter device is positioned to a target location within the patient's body, said catheter device comprising: a catheter having a proximal end and a distal end, said catheter being advanceable into said first blood vessel; a tissue penetrator that is advanceable from the catheter, said tissue penetrator being operative to penetrate from the lumen of the blood vessel to target location an imaging transducer fixedly mounted to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the first blood vessel can be obtained; said imaging transducer and said marker being useable in cooperation with each other to enable the operator to rotationally orient the catheter until the penetrator path indicator is aimed at the second blood vessel, thereby indicating that when the tissue penetrator is subsequently advanced from the catheter it will extend into the lumen of the second blood vessel as desired.

Claim 3

Dependent Claim 17 words

2 . The catheter device of claim 1 wherein the imaging transducer is an ultrasound imaging transducer.

Claim 4

Dependent Claim 28 words

3 . The catheter device of claim 2 wherein the ultrasound imaging transducer is a selected from the group consisting of: an annular phased array a rotatable transducer

Claim 5

Dependent Claim 24 words

4 . The catheter device of claim 3 wherein the phased array transducer is operative to image 360 degrees about the first blood vessel.

Claim 6

Dependent Claim 72 words

5 . The catheter device of claim 1 wherein the imageable marker includes a cage on the catheter, said cage comprises a plurality of longitudinal members disposed at circumferentially spaced apart locations about a hollow interior space, a first one of said longitudinal members being located at a circumferential position that is axially aligned with the path that will be followed by the tissue penetrator as it is advanced from the catheter.

Claim 7

Dependent Claim 60 words

6 . The catheter device of claim 1 wherein the tissue penetrator includes a needle member formed of resilient material that is biased to a preformed curved configuration, said needle member being initially disposed in a retracted position within the catheter and subsequently advanceable from the catheter to an extended position wherein the needle member assumes its preformed curved configuration.

Claim 8

Dependent Claim 219 words

7 . A catheter device that is useable to facilitate penetration from the lumen of a blood vessel within a patient's body in which the catheter device is positioned to a target location within the patient's body, said catheter device comprising: a flexible catheter having a proximal end and a distal end, said catheter being transluminally advanceable into said blood vessel; a tissue penetrator that is advanceable from the catheter to penetrate from the lumen of a blood vessel to a target location, provided that the catheter is rotationally oriented within the blood vessel such that the tissue penetrator is aimed at the target location; an imaging transducer that comprises a plurality of imaging elements fixedly mounted on the catheter to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained; and said imaging elements being mounted on the catheter at known circumferential locations relative to the path that will be followed by the tissue penetrator as the tissue penetrator exits the catheter, the image obtainable from the imaging signal from said imaging transducer being thereby useable by the operator to rotationally orient the catheter such that, when the tissue penetrator exits the catheter, the tissue penetrator will extend into the target location as desired.

Claim 9

Dependent Claim 219 words

7 . A catheter device that is useable to facilitate penetration from the lumen of a blood vessel within a patient's body in which the catheter device is positioned to a target location within the patient's body, said catheter device comprising: a flexible catheter having a proximal end and a distal end, said catheter being transluminally advanceable into said blood vessel; a tissue penetrator that is advanceable from the catheter to penetrate from the lumen of a blood vessel to a target location, provided that the catheter is rotationally oriented within the blood vessel such that the tissue penetrator is aimed at the target location; an imaging transducer that comprises a plurality of imaging elements fixedly mounted on the catheter to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained; and said imaging elements being mounted on the catheter at known circumferential locations relative to the path that will be followed by the tissue penetrator as the tissue penetrator exits the catheter, the image obtainable from the imaging signal from said imaging transducer being thereby useable by the operator to rotationally orient the catheter such that, when the tissue penetrator exits the catheter, the tissue penetrator will extend into the target location as desired.

Claim 10

Dependent Claim 19 words

8 . A catheter device as defined in claim 7 wherein the imaging transducer is an ultrasound imaging transducer.

Claim 11

Dependent Claim 20 words

9 . A catheter device as defined in claim 8 wherein the ultrasound imaging transducer is a phased array transducer.

Claim 12

Dependent Claim 26 words

10 . A catheter device as defined in claim 9 wherein in the phased array transducer is operative to image 360° about the first blood vessel.

Claim 13

Dependent Claim 40 words

11 . A catheter device as defined in claim 7 wherein the catheter device includes an imageable marker on the catheter to form, on the image obtainable from the imaging signal, an indication of the circumferential location of said path.

Claim 14

Dependent Claim 78 words

12 . A catheter device as defined in claim 11 wherein the imageable marker includes an imaging structure formed or mounted on the catheter, said imaging structure comprising a plurality of longitudinal members disposed at circumferentially spaced apart locations about a hollow interior space, a first one of said longitudinal members being located at a circumferential position that is aligned with the path that will be followed by the tissue penetrator as it is advanced from the catheter.

Claim 15

Dependent Claim 183 words

13 . A catheter comprising: a catheter body having a proximal end, a distal end and a peripheral wall; said catheter of body being receivable within a blood vessel of a human patient; said catheter body having a penetrator lumen that terminates distally at an exit location on the peripheral wall of the catheter; a penetrator operatively engaged to exit from the penetrator lumen, out of the exit location, and away from the catheter body on a predetermined penetrator path; and a phased array transducer fixedly mounted to the catheter body, said phased array transducer comprising a plurality of transducer elements positioned at circumferentially spaced apart locations, and in known circumferential location relative to said exit port to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained to enable the operator to rotationally orient the catheter until the target location is aligned with the location of the exit port such that when the tissue penetrator exits from the catheter it will extend into the target location as desired.

Claim 16

Dependent Claim 183 words

13 . A catheter comprising: a catheter body having a proximal end, a distal end and a peripheral wall; said catheter of body being receivable within a blood vessel of a human patient; said catheter body having a penetrator lumen that terminates distally at an exit location on the peripheral wall of the catheter; a penetrator operatively engaged to exit from the penetrator lumen, out of the exit location, and away from the catheter body on a predetermined penetrator path; and a phased array transducer fixedly mounted to the catheter body, said phased array transducer comprising a plurality of transducer elements positioned at circumferentially spaced apart locations, and in known circumferential location relative to said exit port to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained to enable the operator to rotationally orient the catheter until the target location is aligned with the location of the exit port such that when the tissue penetrator exits from the catheter it will extend into the target location as desired.

Claim 17

Dependent Claim 81 words

14 . A catheter as defined as in claim 13 including an imageable marker which includes a plurality of circumferentially spaced imageable members which can be sensed by the phased array transducer, said the imageable members being carried by the catheter body in a known circumferential orientation relative to the exit location so that they can be used to locate the target location and in identifying the angular orientation of the exit location. identifying the angular orientation of the exit location.

Claim 18

Dependent Claim 61 words

15 . A catheter as defined in claim 13 wherein the phased array transducer comprises a plurality of imaging elements arranged on the catheter body with at least one of said elements being at a known circumferential location relative to said exit location whereby said at least said one element is useable to identify the angular orientation of the exit location.

Claim 19

Dependent Claim 25 words

16 . A catheter as defined in claim 13 wherein the catheter body is sized to be receivable in an artery of a human patient.

Claim 20

Dependent Claim 171 words

17 . A catheter comprising: an elongated catheter body having a proximal end, a distal end, a guidewire lumen opening at the distal end of the catheter body and a peripheral wall, at least a distal region of said catheter body being flexible; said catheter body being receivable within a first blood vessel of a human patient; said catheter body having a penetrator lumen terminating distally at an exit location on the peripheral wall and a penetrator disposed within said lumen and advanceable out of said exit location; said catheter body including a major section which includes the proximal end and said exit location and a distal tip section extending from the major section to the distal end of the catheter body; said distal portion of the distal tip section being of smaller cross sectional area than the adjacent region of the major section; and an active imaging apparatus carried by the catheter body and including imaging elements the distal tip section and a lead extending proximally from said imaging elements.

Claim 21

Dependent Claim 171 words

17 . A catheter comprising: an elongated catheter body having a proximal end, a distal end, a guidewire lumen opening at the distal end of the catheter body and a peripheral wall, at least a distal region of said catheter body being flexible; said catheter body being receivable within a first blood vessel of a human patient; said catheter body having a penetrator lumen terminating distally at an exit location on the peripheral wall and a penetrator disposed within said lumen and advanceable out of said exit location; said catheter body including a major section which includes the proximal end and said exit location and a distal tip section extending from the major section to the distal end of the catheter body; said distal portion of the distal tip section being of smaller cross sectional area than the adjacent region of the major section; and an active imaging apparatus carried by the catheter body and including imaging elements the distal tip section and a lead extending proximally from said imaging elements.

Claim 22

Dependent Claim 49 words

18 . A catheter as defined in claim 17 wherein the major section terminates distally in a distal opening and a proximal portion of the distal tip section is received in said distal opening and a distal portion of the distal tip section extends distally of said distal opening.

Claim 23

Dependent Claim 22 words

19 . A catheter as defined in claim 18 including an imageable marker on said distal portion of the distal tip section.

Claim 24

Dependent Claim 293 words

20 . A percutaneous, transluminal method for creating a flow channel between a first blood vessel that has a wall and a lumen and a second blood vessel that has a wall and a lumen, said method comprising the steps of: A. providing a catheter device that comprises: i. a catheter having a proximal end and a distal end, said catheter being advanceable into the lumen of the first blood vessel; ii. a tissue penetrator that is advanceable from the catheter, said tissue penetrator being operative to penetrate from the lumen of a first blood vessel, through the walls of the first and second blood vessels and into the lumen of a second blood vessel when the catheter is positioned and rotationally oriented within the first blood vessel such that the tissue penetrator is aimed at the second blood vessel; iii. an imaging transducer fixedly mounted on the catheter to provide an imaging signal from which an image of the second blood vessel and other anatomical structures located adjacent the first blood vessel can be obtained; and, iv. an imageable marker on the catheter to provide, on the image obtainable from the imaging signal from the imaging transducer, a penetrator path indication indicative of the path that will be followed by the tissue penetrator when the tissue penetrator is advanced from the catheter; B. percutaneously inserting and transluminally advancing the catheter into the first blood vessel; C. actuating the imaging transducer and moving the catheter within the first blood vessel until the penetrator path indication is aimed at the lumen of the second blood vessel; and, D. advancing the tissue penetrator from the catheter, through the walls of the first and second blood vessels and into the lumen of the second blood vessel.

Claim 25

Dependent Claim 293 words

20 . A percutaneous, transluminal method for creating a flow channel between a first blood vessel that has a wall and a lumen and a second blood vessel that has a wall and a lumen, said method comprising the steps of: A. providing a catheter device that comprises: i. a catheter having a proximal end and a distal end, said catheter being advanceable into the lumen of the first blood vessel; ii. a tissue penetrator that is advanceable from the catheter, said tissue penetrator being operative to penetrate from the lumen of a first blood vessel, through the walls of the first and second blood vessels and into the lumen of a second blood vessel when the catheter is positioned and rotationally oriented within the first blood vessel such that the tissue penetrator is aimed at the second blood vessel; iii. an imaging transducer fixedly mounted on the catheter to provide an imaging signal from which an image of the second blood vessel and other anatomical structures located adjacent the first blood vessel can be obtained; and, iv. an imageable marker on the catheter to provide, on the image obtainable from the imaging signal from the imaging transducer, a penetrator path indication indicative of the path that will be followed by the tissue penetrator when the tissue penetrator is advanced from the catheter; B. percutaneously inserting and transluminally advancing the catheter into the first blood vessel; C. actuating the imaging transducer and moving the catheter within the first blood vessel until the penetrator path indication is aimed at the lumen of the second blood vessel; and, D. advancing the tissue penetrator from the catheter, through the walls of the first and second blood vessels and into the lumen of the second blood vessel.

Claim 26

Dependent Claim 53 words

21 . The method of claim 20 wherein the tissue penetrator is an elongate member that has a lumen extending longitudinally therethrough and wherein said method further comprises the step of: E. advancing a first crossing guidewire through the lumen of the tissue penetrator and into the lumen of the second blood vessel.

Claim 27

Dependent Claim 47 words

22 . The method of claim 21 wherein the method further comprises: F. retracting the tissue penetrator into the catheter leaving the first crossing guidewire in place such that it extends from the lumen of the first blood vessel into the lumen of the second blood vessel.

Claim 28

Dependent Claim 123 words

23 . The method of claim 22 wherein the catheter device provided in Step A has a main guidewire lumen that extends longitudinally through at least a portion of the catheter and wherein the method further comprises the steps of: I. moving the first crossing guidewire from the lumen of the tissue penetrator, and reintroducing a crossing guidewire into the main guidewire lumen of the catheter; and, H. readvancing the catheter over the first crossing guidewire to a position wherein the catheter extends through the lumen of the first blood vessel, through the openings created in the walls of the first and second blood vessels by advancement of the tissue penetrator in Step D, and into the lumen of the second blood vessel.

Claim 29

Dependent Claim 76 words

24 . The method of claim 23 wherein the method further comprises the steps of: I. actuating the imaging transducer and moving the catheter within the second blood vessel as required to cause the penetrator path indication to be aligned with the lumen of the first blood vessel; and J. advancing the tissue penetrator from the catheter, through the walls of the first and second blood vessels and into the lumen of the first blood vessel.

Claim 30

Dependent Claim 34 words

25 . The method of claim 24 further comprising the step of: K. advancing a second crossing guidewire through the lumen of the tissue penetrator and into the lumen of the first blood vessel.

Claim 31

Dependent Claim 57 words

26 . The method of claim 25 wherein the method further comprises: L. retracting the tissue penetrator into the catheter leaving the second crossing guidewire in place such that it extends from the lumen of the first blood vessel into the lumen of the second blood vessel and back into the lumen of the first blood vessel.

Claim 32

Dependent Claim 108 words

27 . The method of claim 26 wherein the method further comprises the steps of: M. providing a connector delivery catheter accompanying a radially expandable connector; N. advancing the connector delivery catheter over the second crossing guidewire and implanting the radially expandable connector such that the connector extends from the lumen of the first blood vessel, through the openings created in the walls of the first and second blood vessels in Step D, through the lumen of the second blood vessel, through the openings created in the walls of the first and second blood vessels in Step J and back into the lumen of the first blood vessel.

Claim 33

Dependent Claim 67 words

28 . The method of claim 24 wherein the method is carried out to bypass an obstruction in the first blood vessel and wherein the openings created in the walls of the first and second blood vessels in Step D are proximal to the obstruction and the openings created in the walls of the first and second blood vessels in Step J are distal to the obstruction.

Claim 34

Dependent Claim 61 words

29 . A catheter device according to claim 13 wherein the phased array imaging transducer comprises an annular array of transducer elements, at least one of said transducer elements being a penetrator path indicator element that is in known spacial relationship to the path that will be followed by the tissue penetrator as the tissue penetrator is advanced from the catheter.

Claim 35

Dependent Claim 26 words

30 . The catheter device of claim 29 further in combination with an image display screen for displaying an image received from the phased array transducer.

Claim 36

Dependent Claim 46 words

31 . The catheter device of claim 29 wherein indicia are provided on the image display screen to distinguish between the portion of the image being received from the penetrator path indicator transducer element and those portions of the image received from the other transducer elements.

Claim 37

Dependent Claim 58 words

32 . The catheter device of claim 31 wherein said indicia are selected from the group of indicia consisting of: a series of hash marks that indicate the circumferential location of the iamge received from said penetrator path indicating element; and, a line that indicates the circumferential location of the image received from said penetrator path indicating element.

Claim 38

Dependent Claim 41 words

33 . The catheter device of claim 31 wherein the portion of the image received from the penetrator path indicating transducer element is electronically modified to be visually discernible from the remainder of the image received from the other transducer elements.

Claim 39

Dependent Claim 213 words

34 . A catheter device that is useable to direct an operative device, substance or flow of energy from the lumen of a luminal vessel within a patient's body to a target location within the patient's body, said catheter device comprising: a catheter having a proximal end, a distal end and a peripheral wall, said catheter being advanceable into the lumen of said vessel; an exit location from which an operative device, substance or flow of energy may be directed fron the catheter; an imaging transducer fixedly mounted in a known circumferential location relative to either i) said exit location or ii) a known path that will be followed by the operative device, substance or flow of energy as it is directed from the catheter, said tranducer providing an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained to enable the operator to rotationally orient the catheter until the target location is aligned with either i) said exit location or ii) the known path that will be followed by the operative device, substance or flow of energy as it is directed from the catheter, such that the operative device, substance or flow of energy will pass into the target location.

Claim 40

Dependent Claim 213 words

34 . A catheter device that is useable to direct an operative device, substance or flow of energy from the lumen of a luminal vessel within a patient's body to a target location within the patient's body, said catheter device comprising: a catheter having a proximal end, a distal end and a peripheral wall, said catheter being advanceable into the lumen of said vessel; an exit location from which an operative device, substance or flow of energy may be directed fron the catheter; an imaging transducer fixedly mounted in a known circumferential location relative to either i) said exit location or ii) a known path that will be followed by the operative device, substance or flow of energy as it is directed from the catheter, said tranducer providing an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained to enable the operator to rotationally orient the catheter until the target location is aligned with either i) said exit location or ii) the known path that will be followed by the operative device, substance or flow of energy as it is directed from the catheter, such that the operative device, substance or flow of energy will pass into the target location.

Claim 41

Dependent Claim 41 words

35 . A catheter device that is useable to direct an operative device, substance or flow of energy from the lumen of a luminal vessel within a patient's body to a target location within the patient's body, said catheter device comprising:

Claim 42

Dependent Claim 41 words

35 . A catheter device that is useable to direct an operative device, substance or flow of energy from the lumen of a luminal vessel within a patient's body to a target location within the patient's body, said catheter device comprising:

Claim 43

Dependent Claim 17 words

36 . The catheter device of claim 35 wherein the imaging transducer is an ultrasound imaging transducer.

Claim 44

Dependent Claim 21 words

37 . The catheter device of claim 36 wherein the ultrasound imaging transducer is an annular phased array of transducer elements.

Claim 45

Dependent Claim 23 words

38 . The catheter device of claim 37 wherein the phased array transducer is operative to image 360 degrees about the blood vessel.

Claim 46

Dependent Claim 18 words

39 . The catheter device of claim 35 wherein a tissue penetrator is advanceable from said exit location.

Claim 47

Dependent Claim 15 words

40 . The catheter device of claim 39 wherein said tissue penetrator is a needle.

Claim 48

Dependent Claim 19 words

41 . The catheter device of claim 40 wherein said tissue penetrator needle has a lumen extending longitudinally therethrough.

Claim 49

Dependent Claim 15 words

42 . The catheter device of claim 40 wherein said tissue penetrator is an electrode.

Claim 50

Dependent Claim 17 words

43 . The catheter device of claim 40 wherein said tissue penetrator is a flow of energy.

Claim 51

Dependent Claim 66 words

44 . The catheter device of claim 35 wherein said known circumferential location relative to either i) said exit location or ii) a known path that will be followed by the operative device, substance or flow of energy as it is directed from the catheter is displayed on an image display by enhancing the imaging signal received from the imaging transducer correlating to that circumferential location.

Claim 52

Dependent Claim 68 words

45 . The catheter device of claim 35 wherein said known circumferential location relative to either i) said exit location or ii) a known path that will be followed by the operative device, substance or flow of energy as it is directed from the catheter is displayed by at least one line that is enhancing the imaging signal received from the imaging transducer correlating to that circumferential location.

Claim 53

Dependent Claim 174 words

46 . A catheter device that is useable to penetrate from the lumen of a patient's blood vessel in which the catheter device is positioned to a target location within the patient's body, said catheter device comprising: a catheter that has a proximal end and a distal end, said catheter being advanceable into said first blood vessel; a tissue penetrator that is advanceable from the catheter, said tissue penetrator being operative to penetrate from the lumen of the blood vessel to target location provided that the catheter is rotationally oriented within the first blood vessel such that the tissue penetrator is aimed at the target location; a catheter braid being incorporated in at least a portion of said catheter body, said catheter braid having a braid angle and a pick count, the braid angle of said catheter braid being such that the pick count is less than 100 picks per inch to thereby minimize the longitudinal elongation of the catheter that may occur as the catheter is warmed from room temperature to body temperature.

Claim 54

Dependent Claim 174 words

46 . A catheter device that is useable to penetrate from the lumen of a patient's blood vessel in which the catheter device is positioned to a target location within the patient's body, said catheter device comprising: a catheter that has a proximal end and a distal end, said catheter being advanceable into said first blood vessel; a tissue penetrator that is advanceable from the catheter, said tissue penetrator being operative to penetrate from the lumen of the blood vessel to target location provided that the catheter is rotationally oriented within the first blood vessel such that the tissue penetrator is aimed at the target location; a catheter braid being incorporated in at least a portion of said catheter body, said catheter braid having a braid angle and a pick count, the braid angle of said catheter braid being such that the pick count is less than 100 picks per inch to thereby minimize the longitudinal elongation of the catheter that may occur as the catheter is warmed from room temperature to body temperature.

Claim 55

Dependent Claim 23 words

47 . The catheter device of claim 45 wherein the braid angle is such that the pick count is 20-30 picks per inch.

Tissue penetrating catheters having integral imaging transducers and their methods of use

Abstract

Inventors

Bibliographic Details

Claims Analysis

References Cited (Backward Citations)

USPTO Annuity & Maintenance Windows

Assigned Categories & Tags

Assign Category Tag