Granted Patent B2

US 12,648,850 · App. 17/817,791 · Granted Jun 9, 2026

Inventors: Aviad Galler (Tel Aviv, IL); Nadav Yellin (Even Yehuda, IL); Yoav Rozen (Binyamina, IL); Shuki Porath (Haifa, IL)

Assignee: Valcare Medical, Inc.

A61F2/2466A61F2/2445A61F2220/0016

Abstract

Claims (121)

1 . A system for bridging a gap between an article or a portion thereof and a target, and anchoring the article or its portion to the target, the system comprising:

a) an elongated delivery catheter having a distal end; and

b) a bridging and anchoring construction, operable to selectably translate in a distal and a proximal direction relative to the distal end of the elongated delivery catheter, the bridging and anchoring construction slidably coupled to the elongated delivery catheter, wherein the bridging and anchoring construction is operable to:

i. engage the target following the distal translation spanning the gap between the article or its portion and the target;

ii. eliminate the gap following the proximal translation of the bridging and anchoring construction thereby pulling the article or a portion thereof towards the target; and

iii. anchor the article or its portion to the target,

wherein the target is a structural heart valve.

2 . The system of claim 1 , wherein the delivery catheter is operable to transition between an insertion configuration and engagement configuration, wherein the distal end is contoured to abut at least a portion of the article or its portion's surface in its engagement configuration, the elongated delivery catheter further comprises:

a) a cylindrical sleeve, operable to slidably translate in a proximal direction; and

b) a cylindrical housing, defining a through bore, sized to accommodate the bridging and anchoring construction, the cylindrical housing having a distal end with an arcuate cross section sized to abut between about 1.0 radians, and about 4.5 radians of the at least portion of the article or its portion's surface.

3 . The system of claim 2 , wherein the cylindrical housing further comprises an expander, operable to transition between a strained position within the sleeve and an unstrained position outside the sleeve, wherein, in the unstrained position, a distal portion of the expander forms a complimentary arcuate cross section to the arcuate cross section of the distal end of the housing.

4 . The system of claim 2 , wherein the bridging and anchoring construction comprises:

a) a jacket;

b) at least one of: a coupling rod, sized to be accommodated coaxially within a pushtube, and a sheath nested within the jacket;

c) a piercing tip comprised of a plurality of lancing members configured to transition between a strained position within the jacket and an unstrained position outside the jacket;

d) a tubular foreshaft having a proximal end, the tubular foreshaft coupled proximally to the piercing tip, comprising:

i. a proximal region configured to transition between a strained position when coupled to at least one of: a coupling rod, and a sheath, and an unstrained position following proximally translating at least one of: the coupling rod inserted coaxially within the tubular foreshaft wherein and the sheath;

ii. a proximal end forming a portion of the proximal region, the proximal end operable to form an engagement section with a T-line interrupted wall; and e) the pushtube, having a distal end operable to form an engagement section with a T-line interrupted wall, complementary to the engagement section of the tubular foreshaft, releasably coupled coaxially to the proximal end of the tubular foreshaft.

5 . The system of claim 4 , wherein the coupling rod extends into the tubular foreshaft in a distal direction beyond the strained proximal region.

6 . The system of claim 2 , wherein the bridging and anchoring construction comprises:

a) a jacket,

b) at least one of: a coupling rod, sized to be accommodated coaxially within a tubular foreshaft, and a sheath, nested within the jacket;

c) a piercing tip comprised of a plurality of lancing members configured to transition between a strained position within the jacket and an unstrained position outside the jacket;

d) the tubular foreshaft having a proximal end, the tubular foreshaft coupled proximally to the piercing tip, comprising: i. a proximal region configured to transition between a strained position when coupled to a pushrod inserted coaxially within the tubular foreshaft and at least one of: a coupling rod, and a sheath, and an unstrained position following decoupling the pushrod and the at least one of: the coupling rod, and the sheath; and ii. a radial opening, defined in the tubular foreshaft's wall, the radial opening defined distal to the proximal region, having a proximal end and a distal end, the radial opening sized to accommodate a distal portion of the pushrod,

e) the pushrod, with the distal portion extending radially from the pushrod's distal end, wherein the distal portion forms a tab extending radially from the pushrod to a distance W is larger than the radius of an internal diameter of the tubular foreshaft and smaller than the internal diameter of the tubular foreshaft and wherein the proximal portion of the pushrod has an outer diameter that is not larger than the radius of the internal diameter of the cylindrical foreshaft.

7 . The system of claim 6 , wherein the coupling rod, extends in a distal direction beyond the strained proximal region, wherein the coupling rod has an outer diameter that is not larger than the radius of the internal diameter of the cylindrical foreshaft.

8 . The system of claim 2 , wherein the bridging and anchoring construction comprises:

a) a jacket;

b) a sheath;

c) a piercing tip comprised of a plurality of lancing members configured to transition between a strained position within the jacket and an unstrained position outside the jacket;

d) a pushtube, having a distal portion defining a helical wall channel, the helical wall channel having a predetermined pitch, configured to engage a proximal portion of a foreshaft; and e) the foreshaft having a distal end coupled to the piercing tip, and a proximal portion with a proximal end with a pair of diametrically opposed pegs extending radially from the proximal end of the foreshaft wherein:

i. the pair of diametrically opposed pegs extending laterally being sized and configured to be accommodated in the helical wall channel of the pushtube; and

ii. the proximal portion is configured to transition between a strained position while coupled to at least one of: the pushtube and the sheath, and an unstrained position when decoupled from the at least one of: the pushtube and the sheath.

9 . A method for bridging a gap between an article or a portion thereof and a target, and anchoring the article or its portion to the target, the method implementable in a system comprising an elongated delivery catheter having a distal end; and a bridging and anchoring construction, operable to selectably translate in a distal and a proximal direction relative to the distal end of the elongated delivery catheter, the bridging and anchoring construction slidably coupled to the elongated delivery catheter, wherein the bridging and anchoring construction is operable to engage the target following a distal translation spanning the gap between the article or its portion and the target; eliminating the gap following a proximal translation of the bridging an anchoring construction thereby pulling the article or a portion thereof towards the target; and anchoring the article or its portion to the target, the method comprising:

a) inserting the delivery catheter;

b) partially engaging the article or its portion to the delivery catheter;

c) translating the bridging and anchoring construction in a distal direction relative to the delivery catheter's distal end over the gap;

d) using the bridging and anchoring construction engaging the target;

e) translating the bridging and anchoring construction in a proximal direction relative to the delivery catheter's distal end thereby pulling the article or a portion thereof towards the target to the point where the target abuts the article or its portion; and

f) using the bridging and anchoring construction anchoring the article or its portion to the target,

wherein the target is a structural heart valve.

10 . The method of claim 9 , wherein the delivery catheter is operable to transition between an insertion configuration and engagement configuration, wherein the distal end is contoured to abut at least a portion of the article or its portion's surface in its engagement configuration, the elongated delivery catheter further comprises:

a) a cylindrical sleeve, operable to slidably translate in at least one of: a proximal direction, and a distal direction;

b) a cylindrical housing, defining a through bore, sized to accommodate the bridging and anchoring construction, the cylindrical housing having a distal end with an arcuate cross section sized to abut between about 1.0 radians, and about 4.5 radians of the at least portion of the article or its portion's surface; and

c) an expander, operable to transition between a strained position within the sleeve and an unstrained position outside the sleeve, wherein, in the unstrained position, a distal portion of the expander forms a complimentary arcuate cross section to the arcuate cross section of the distal end of the housing.

11 . The method of claim 10 , wherein the step of transitioning the delivery catheter from the insertion configuration to the engagement configuration comprises retracting the sleeve in a proximal direction, causing the expander to transition to the unstrained position.

12 . The method of claim 11 , further comprises: using a surface created by the distal end of the delivery catheter cylindrical housing and the unstrained expander, coupling the delivery catheter to the article or a portion thereof.

13 . The method of claim 12 , further comprising:

a) Decoupling the delivery catheter from the article or its portion;

b) translating the sleeve in a distal direction over the expander, transitioning the expander from the unstrained position to the strained position; and

c) retracting the delivery catheter.

14 . The method of claim 9 , wherein the gap between the article or its portion and the target, is between about 0.01 mm and about 40 mm.

15 . The method of claim 14 , wherein, using the bridging and anchoring construction of claim 4 , the step of translating the bridging and anchoring construction in a distal direction relative to the delivery catheter's distal end further comprises:

a) using the pushtube, translating the bridging and anchoring construction in the distal direction to the point where the distal end of the jacket abuts the target; and

b) translating the piercing tip in a distal direction, thereby piercing the target with the piercing tip.

16 . The method of claim 15 , wherein the step of engaging the target comprises: following piercing the target, further translating the piercing tip in a distal direction, causing the lancing members to transition to the unstrained position outside the jacket's distal end, reversing the lancing members' direction, thereby engaging the target.

17 . The method of claim 16 , wherein the step of translating the bridging and anchoring construction in a proximal direction comprises: using the pushtube, translating the bridging and anchoring construction in a proximal direction, to the point where the target abuts the article or its portion.

18 . The method of claim 17 , wherein the step of anchoring the article or its portion to the target comprises at least one of:

a) retracting at least one of: the coupling rod, and the sheath in a proximal direction beyond the distal end of the pushtube,

b) decoupling the pushtube from the tubular foreshaft, and

c) retracting at least one of: the coupling rod, and the shaft beyond the proximal end of the tubular foreshaft, causing the strained proximal region to transition to the unstrained position, hooking the article or its portion, thereby anchoring the article or its portion to the target.

19 . The method of claim 14 , wherein, using the bridging and anchoring construction of claim 6 , the step of translating the bridging and anchoring construction in a distal direction relative to the delivery catheter's distal end further comprises:

a) using the pushrod, translating the bridging and anchoring construction in a distal direction by pushing the tab extending radially from the pushrod against the distal end of the radial opening, defined in the tubular foreshaft's wall to the point where the distal end of the jacket abuts the target; and;

b) translating the piercing tip in a distal direction, exposing the piercing tip and penetrating the target with the piercing tip.

20 . The method of claim 19 , wherein the step of engaging the target comprises: further translating the piercing tip in a distal direction, causing the lancing members, once beyond the distal end of the jacket to transition to the unstrained position outside the jacket, reversing the lancing members' direction, thereby engaging the target.

21 . The method of claim 20 , wherein the step of translating the bridging and anchoring construction in a proximal direction comprises: using the pushrod, translating the bridging and anchoring construction in a proximal direction by pulling the tab extending radially from the pushrod against the proximal end of the radial opening, defined in the tubular foreshaft's wall, to the point where the target abuts the article or its portion.

22 . The method of claim 21 , wherein the step of anchoring the article or its portion to the target comprises:

a) retracting at least one of: the coupling rod in a proximal direction beyond the proximal end of the tubular foreshaft, and the sheath in a proximal direction beyond the proximal end of the tubular foreshaft;

b) removing the tab extending radially from the pushrod's distal end from the radial opening defined in the tubular foreshaft; and

c) retracting the pushrod in a proximal direction beyond the distal end of the tubular foreshaft, causing the strained proximal region of the tubular foreshaft to transition to the unstrained position, hooking the article or its portion, thereby anchoring the article or its portion to the target.

23 . The method of claim 22 , wherein the step of engaging the target comprises: further retracting the piercing tip in a distal direction and penetrating the target, causing the lancing members to transition to the unstrained position once beyond the distal end of the jacket, thereby reversing the lancing members' direction and engaging the target.

24 . The method of claim 23 , wherein the step of translating the bridging and anchoring construction in a proximal direction comprises: using the pushtube, translating the bridging and anchoring construction in a proximal direction, to the point where the target abuts the article or its portion.

25 . The method of claim 24 , wherein the step of anchoring the article or its portion to the target comprises:

a) retracting the sheath in a proximal direction beyond the distal end of the pushtube; and b) rotating the pushtube in a direction configured to cause the pushtube to translate proximally, causing the strained proximal region of the foreshaft to transition to the unstrained position, hooking the article or its portion, thereby anchoring the article or its portion to the target.

26 . The method of claim 14 , wherein, using the bridging and anchoring construction of claim 8 , the step of translating the bridging and anchoring construction in a distal direction relative to the delivery catheter's distal end further comprises:

a) using the pushtube, translating the bridging and anchoring construction in a distal direction to the point where the distal end of the jacket abuts the target;

b) translating the jacket in a proximal direction, exposing the piercing tip; and

c) piercing the target with the piercing tip.

27 . The method of claim 9 , wherein the structural heart valve comprises an annulus, and

wherein the anchoring comprises anchoring the article or its portion to the annulus of the structural heart valve.

28 . The method of claim 9 , wherein the structural heart valve is a mitral valve, a tricuspid valve, or a pulmonary valve.

29 . The method of claim 28 , wherein the article is an annuloplasty ring or a portion thereof.

30 . The method of claim 29 wherein anchoring the annuloplasty ring or its portion is configured to anchor the annuloplasty ring or its portion to a trigon.

31 . A use of a gap bridging and anchoring system in the process of bridging a gap between an article or a portion thereof and a target, and in the process of anchoring the article or its portion to the target, the system comprising:

c) an elongated delivery catheter having a distal end; and

d) a bridging and anchoring construction, operable to selectably translate in a distal and a proximal direction relative to the distal end of the elongated delivery catheter, the bridging and anchoring construction slidably coupled to the elongated delivery catheter, wherein the bridging and anchoring construction is operable to:

i. engage the target following a distal translation spanning the gap between the article or its portion and the target;

ii. eliminate the gap following a proximal translation of the bridging and anchoring construction thereby pulling the article or a portion thereof towards the target; and

iii. anchor the article or its portion to the target,

wherein the target is a structural heart valve.

32 . The use of claim 31 , wherein the delivery catheter is operable to transition between an insertion configuration and engagement configuration, wherein the distal end is contoured to abut at least a portion of the article or its portion's surface in its engagement configuration, the elongated delivery catheter further comprises:

a) a cylindrical sleeve, operable to slidably translate in a proximal direction;

b) a cylindrical housing, defining a through bore, sized to accommodate the bridging and anchoring construction, the cylindrical housing having a distal end with an arcuate cross section sized to abut between about 1.0 radians, and about 4.5 radians of the at least portion of the article or its portion's surface; and

c) an expander, operable to transition between a strained position within the sleeve and an unstrained position outside the sleeve, wherein, in the unstrained position, a distal portion of the expander forms a complimentary arcuate cross section to the arcuate cross section of the distal end of the housing.

33 . The use of claim 31 , wherein the bridging and anchoring construction comprises:

a) a jacket;

b) at least one of: a coupling rod, sized to be accommodated coaxially within a pushtube, and a sheath nested within the jacket;

c) a piercing tip comprised of a plurality of lancing members configured to transition between a strained position within the jacket and an unstrained position outside the jacket;

d) a tubular foreshaft having a proximal end, the tubular foreshaft coupled proximally to the piercing tip, comprising: i. a proximal region configured to transition between a strained position when coupled to at least one of: a coupling rod, and a sheath, and an unstrained position following proximally translating at least one of: the coupling rod inserted coaxially within the tubular foreshaft wherein and the sheath; ii. a proximal end forming a portion of the proximal region, the proximal end operable to form an engagement section with a T-line interrupted wall; and

e) the pushtube, having a distal end operable to form an engagement section with a T-line interrupted wall, complementary to the engagement section of the tubular foreshaft, releasably coupled coaxially to the proximal end of the tubular foreshaft.

34 . The use of claim 31 , wherein the bridging and anchoring construction comprises:

a) a jacket,

b) at least one of: a coupling rod, sized to be accommodated coaxially within a tubular foreshaft, and a sheath, nested within the jacket;

c) a piercing tip comprised of a plurality of lancing members configured to transition between a strained position within the jacket and an unstrained position outside the jacket;

d) the tubular foreshaft having a proximal end, the tubular foreshaft coupled proximally to the piercing tip, comprising:

i. a proximal region configured to transition between a strained position when coupled to a pushrod inserted coaxially within the tubular foreshaft and at least one of: a coupling rod, and a sheath, and an unstrained position following decoupling the pushrod and the at least one of: the coupling rod, and the sheath; and

ii. a radial opening, defined in the tubular foreshaft's wall, the radial opening defined distal to the proximal region, having a proximal end and a distal end, the radial opening sized to accommodate a distal portion of the pushrod,

e) a pushrod, with the distal portion extending radially from the pushrod's distal end, wherein the distal portion forms a tab extending radially from the pushrod to a distance W is larger than the radius of an internal diameter of the tubular foreshaft and smaller than the internal diameter of the tubular foreshaft and wherein the proximal portion of the pushrod has an outer diameter that is not larger than the radius of the internal diameter of the cylindrical foreshaft.

35 . The use of claim 31 , wherein the bridging and anchoring construction comprises:

a) a jacket;

b) a sheath;

c) a piercing tip comprised of a plurality of lancing members configured to transition between a strained position within the jacket and an unstrained position outside the jacket;

d) a pushtube, having a distal portion defining a helical wall channel, the helical wall channel having a predetermined pitch, configured to engage a proximal portion of a foreshaft; and

e) the foreshaft having a distal end coupled to the piercing tip, and a proximal portion with a proximal end with a pair of diametrically opposed pegs extending radially from the proximal end of the foreshaft wherein:

i. the pair of diametrically opposed pegs extending laterally being sized and configured to be accommodated in the helical wall channel of the pushtube; and

ii. the proximal portion is configured to transition between a strained position while coupled to at least one of: the pushtube and the sheath, and an unstrained position when decoupled from the at least one of: the pushtube and the sheath.

36 . The use of claim 31 , wherein the structural heart valve comprises an annulus, and

wherein the anchoring comprises anchoring the article or its portion to the annulus of the structural heart valve.

37 . The use of claim 31 , wherein the structural heart valve is a mitral valve, a tricuspid valve, or a pulmonary valve.

38 . The use of claim 37 , wherein the article is an annuloplasty ring or a portion thereof.

39 . The use of claim 38 wherein anchoring the annuloplasty ring or its portion is configured to anchor the annuloplasty ring or its portion to a trigon.

Assignments (2)

Continuity (2)

References Cited (400)