Transseptal needle assembly

• US 9,533,120 B1
• Filed: 12/03/2012
• Issued: 01/03/2017
• Est. Priority Date: 12/02/2011
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Boeshans, Gregory A., Romanowski, Jason M., Kimmel, Scott, Pietsch, Kevin, Nelson, Mark
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US13/692,759
• Time in Patent Office: 1,492 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like

Abstract

A transseptal needle assembly comprised of a cannula, a handle assembly and a stylet is described. The cannula of the needle assembly is of a uniform body construction such that the cannula main portion and needle portion are fluidly connected in one-piece. The handle assembly comprises a handle housing, a handle sleeve and a handle slug. The handle slug provides ballast which improves tactile feel of the needle assembly. In addition, the stylet comprises a stylet housing having a hinged designed that allows for easier control of the stylet.

Claims

1. A transseptal needle assembly, comprising:

a) an assembly handle, comprising;

i) a housing having a housing sidewall comprising an inner housing surface defining a housing lumen extending along a longitudinal axis from a proximal housing end wall at a proximal housing open end to a distal housing open end;

ii) a sleeve comprising a sleeve sidewall having an inner sleeve surface defining a sleeve lumen extending along the longitudinal axis from a proximal sleeve open end to a distal sleeve open end, wherein the sleeve is received in the housing lumen;

iii) a slug comprising a slug sidewall having an inner slug surface defining a slug lumen extending from a proximal slug open end to a distal slug open end, wherein the slug is received in the sleeve lumen with the proximal slug open end adjacent to the proximal sleeve open end; and

iv) an end cap comprising a cap sidewall having an inner cap surface defining a cap lumen extending for a cap length from a proximal cap open end to a distal cap end wall at a distal cap open end; and

b) an elongated cannula comprising a cannula sidewall having an inner cannula surface defining a cannula lumen extending from a distal cannula portion having a distal cannula open end to a proximal cannula portion having a proximal cannula open end,

c) wherein;

i) the proximal cannula portion is received in the slug lumen,

ii) the slug is received in the sleeve lumen, and

iii) the sleeve is received in the housing lumen, and

d) wherein the distal cannula portion having the distal cannula open end extends distally from the assembly handle, and

e) wherein with the proximal cannula portion received in the slug lumen of the slug received in the sleeve, in turn, received in the housing, the distal cap end wall contacts the proximal housing end wall to thereby fixedly house the proximal cannula end inside the assembly handle.

2. The transseptal needle assembly of claim 1 wherein the cannula sidewall tapers from a first, greater diameter at the proximal cannula portion to a second, lesser diameter at the distal cannula open end.

3. The transseptal needle assembly of claim 1 further comprising a stylet having a proximal stylet end connected to a stylet handle detachably connected to the assembly handle.

4. The transseptal needle assembly of claim 3 wherein the stylet handle comprises opposing lever arms connected in a hinged relationship to a stylet knob, and wherein the opposing lever arms are manipulatable to connect and disconnect the stylet to and from the assembly handle.

5. The transseptal needle assembly of claim 1 wherein the cannula distal portion is manipulatable into a curved shape having a radius of curvature ranging from about 2 inches to about 20 inches with respect to the longitudinal axis.

6. The transseptal needle assembly of claim 1 wherein a luer fitting of a stop cock is received in the proximal cap open end, the stop cock being in open communication with the cannula lumen.

7. The transseptal needle assembly of claim 1 wherein the slug is composed of a material selected from the group consisting of stainless steel, titanium, MP35N, platinum, palladium, niobium, and alloys thereof.

8. The transseptal needle assembly of claim 1 wherein the sleeve has a weight ranging from about 15 grams to about 25 grams.

9. The transseptal needle assembly of claim 2 wherein the second, lesser diameter portion of the cannula has a cross-sectional diameter ranging from about 0.05 cm to about 0.10 cm.

10. The transseptal needle assembly of claim 1 wherein the cannula forms a needle at the distal cannula open end.

11. The transseptal needle assembly of claim 1 wherein the housing and end cap are composed of a material selected from the group consisting of polyvinyl chloride (PVC), polyvinyl butyral (PVB), and an acrylic material.

12. The transseptal needle assembly of claim 1 wherein an intermediate cannula portion between the proximal and distal cannula open ends contacts the inner housing surface at the distal housing open end.

13. The transseptal needle assembly of claim 1 wherein, with the sleeve received in the housing lumen, the proximal slug open end extends proximally out past the proximal sleeve open end.

14. The transseptal needle assembly of claim 1 wherein, with the sleeve received in the housing lumen, the proximal sleeve open end extends proximally out past the proximal housing open end.

15. The transseptal needle assembly of claim 1 wherein the cannula is composed of a material selected from the group consisting of stainless steel, titanium, MP35N, platinum, palladium, niobium, and alloys thereof.

16. The transseptal needle assembly of claim 1 wherein a series of ridges protrude circumferentially from an exterior surface of the housing sidewall.

17. The transseptal needle assembly of claim 1 wherein the housing sidewall comprises at least one depression area.

18. A transseptal needle assembly, comprising:

a) an assembly handle, comprising;

i) a housing having a housing sidewall comprising an inner housing surface defining a housing lumen extending along a longitudinal axis from a proximal housing end wall at a proximal housing open end to a distal housing open end;

ii) a sleeve comprising a sleeve sidewall having an inner sleeve surface defining a sleeve lumen extending along the longitudinal axis from a proximal sleeve open end to a distal sleeve open end, wherein the sleeve is received in the housing lumen;

iii) a slug comprising a slug sidewall having an inner slug surface defining a slug lumen extending from a proximal slug open end to a distal slug open end, wherein the slug is received in the sleeve lumen with the proximal slug open end adjacent to the proximal sleeve open end; and

iv) an end cap comprising a cap sidewall having an inner cap surface defining a cap lumen extending for a cap length from a proximal cap open end to a distal cap end wall at a distal cap open end;

b) an elongated cannula comprising a cannula sidewall having an inner cannula surface defining a cannula lumen extending from a distal cannula portion having a distal cannula open end to a proximal cannula portion having a proximal cannula open end,

c) wherein;

i) the proximal cannula portion is received in the slug lumen,

ii) the slug is received in the sleeve lumen, and

iii) the sleeve is received in the housing lumen, and

d) wherein the distal cannula portion having the distal cannula open end extends distally from the assembly handle, and

e) wherein with the proximal cannula portion received in the slug lumen of the slug received in the sleeve, in turn, received in the housing, the distal cap end wall contacts the proximal housing end wall to thereby fixedly house the proximal cannula end inside the assembly handle;

f) a stop cock comprising a luer fitting received in the proximal cap open end, wherein the stop cock including the luer fitting is in open communication with the cannula proximal open end received in the slug, and wherein a proximal stop cock end has a first outer diameter extending distally to a second outer diameter less than the first outer diameter; and

g) a stylet extending from a proximal stylet end at a stylet handle to a distal stylet end, wherein the stylet handle resides proximal the stop cock with the stylet being movably received in the cannula, and wherein the stylet handle has opposing lever arms connected in a hinged relationship by respective support members to a centrally located stylet knob,

h) wherein with the stylet handle removably connected to the stop cock, the opposing lever arms are manipulatable into an open position spaced further apart than the first outer diameter of the proximal stop cock end so that the stylet handle is axially manipulatable;

i) in a proximal direction away from the stop cock to move the distal stylet end proximally inside the cannula; and

ii) in a distal direction toward the stop cock to thereby cause the distal stylet end to move distally inside the cannula with the opposing lever arms being further manipulatable into a closed position to removably contact the stop cock where the first outer diameter meets the second, lesser outer diameter to thereby fix the stylet with respect to the cannula lumen.

19. The transseptal needle assembly of claim 18 wherein each lever arm of the stylet handle comprises a distal lip portion extending inwardly toward the longitudinal axis so that with the stylet handle in the closed position, the distal lip portions of the lever arms removably contact the proximal stop cock end.

20. The transseptal needle assembly of claim 18 wherein the cannula sidewall tapers from a third, greater diameter to a fourth, lesser diameter at the distal cannula open end.

21. The transseptal needle assembly of claim 18 wherein the slug is composed of a material selected from the group consisting of stainless steel, titanium, MP35N, platinum, palladium, niobium, and alloys thereof.

22. The transseptal needle assembly of claim 18 wherein the housing and end cap are composed of a material selected from the group consisting of polyvinyl chloride (PVC), polyvinyl butyral (PVB), and an acrylic material.

23. The transseptal needle assembly of claim 18 wherein the cannula is composed of a material selected from the group consisting of stainless steel, titanium, MP35N, platinum, palladium, niobium, and alloys thereof.

24. The transseptal needle assembly of claim 18 wherein the proximal slug open end extends proximally out past the proximal sleeve open end inside the housing.

25. The transseptal needle assembly of claim 18 wherein the proximal sleeve open end extends proximally out past the proximal housing open end inside the housing.

26. A transseptal needle assembly, comprising:

a) an assembly handle, comprising;

i) a housing having a housing sidewall comprising an inner housing surface defining a housing lumen extending along a longitudinal axis from a proximal housing end wall at a proximal housing open end to a distal housing open end, wherein the housing lumen has a proximal housing lumen portion of a first, greater diameter extending distally from the proximal housing open end partway along the housing length to a distal housing lumen portion of a second, lesser diameter extending distally the remainder of the housing length to the distal housing open end;

ii) a sleeve comprising a sleeve sidewall having an inner sleeve surface defining a sleeve lumen extending along the longitudinal axis from a proximal sleeve open end to a distal sleeve open end, wherein the sleeve is received in the housing lumen with the distal sleeve open end contacting the housing where the proximal housing lumen portion of the first, greater diameter meets the distal housing lumen portion of the second, lesser diameter, and wherein the proximal sleeve open end is disposed adjacent to the proximal housing open end;

iii) a slug comprising a slug sidewall having an inner slug surface defining a slug lumen extending from a proximal slug open end to a distal slug open end, wherein the slug is received in the sleeve lumen with the proximal slug open end adjacent to the proximal sleeve open end; and

iv) an end cap comprising a cap sidewall having an inner cap surface defining a cap lumen extending for a cap length from a proximal cap open end to a distal cap open end, wherein the cap lumen has a proximal cap lumen portion of a third diameter extending distally from the proximal cap open end partway along the cap length to an intermediate cap lumen portion of a fourth diameter extending distally to a distal cap lumen portion of a fifth diameter extending distally the remainder of the cap length to the distal cap open end, and wherein the third diameter is less than the fourth diameter of the intermediate cap lumen portion which, in turn, is less than the fifth diameter of the distal cap lumen portion;

b) an elongated cannula comprising a cannula sidewall having an inner cannula surface defining a cannula lumen extending from a distal cannula portion having a distal cannula open end to a proximal cannula portion having a proximal cannula open end,

c) wherein;

i) the proximal cannula portion is received in the slug lumen,

ii) the slug is received in the sleeve lumen, and

iii) the sleeve is received in the housing lumen,

d) wherein the distal cannula portion having the distal cannula open end extends distally from the assembly handle,

e) wherein with the proximal cannula portion received in the slug lumen of the slug received in the sleeve, in turn, received in the housing, the distal cap end wall contacts the proximal housing end wall to thereby fixedly house the proximal cannula end inside the assembly handle, and wherein the end cap has a surface where the intermediate cap lumen portion of the fourth diameter meets the distal cap lumen portion of the fifth diameter that contacts the sleeve adjacent to the proximal sleeve open end;

f) a stop cock comprising a luer fitting received in the proximal cap open end, wherein the stop cock including the luer fitting is in open communication with the cannula proximal open end received in the slug, and wherein a proximal stop cock end has a first outer diameter extending distally to a second outer diameter less than the first outer diameter; and

g) a stylet extending from a distal stylet end to a proximal stylet end connected to a stylet handle, wherein the stylet handle resides proximal the end cap with the stylet being movably received in the cannula, and wherein the stylet handle is axially manipulatable to move the distal stylet end inside the cannula.

27. The transseptal needle assembly of claim 26 wherein the proximal open slug end extends proximally out past the proximal open sleeve end inside the housing.

28. The transseptal needle assembly of claim 26 wherein the proximal open sleeve end extends proximally out past the proximal open housing end inside the housing.